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Gene Therapy for Ovarian Cancer Market top key players, size, Analysis, growth, research, Types, Regions and Forecast from 2019-2023 – Daily Science

March 30th, 2020 5:49 am

Growth Prospects of the Global Gene Therapy for Ovarian Cancer Market

The comprehensive study on the Gene Therapy for Ovarian Cancer market provides crucial insights to the stakeholders who are vying to solidify their presence in the current and future market landscape. The various factors that are likely to shape the course of the Gene Therapy for Ovarian Cancer market over the next decade are thoroughly analyzed in the report. The study represents the market share in terms of US$ XX Mn/Bn and volume (XX units).

The report splits the global Gene Therapy for Ovarian Cancer market based on product type wherein a complete analysis of the various products including, product 1, product 2, product 3, and product 4 is provided. The market share of each product, the adoption rate, pricing analysis and more is included in the report along with accurate tables, graphs, and figures. The market is further segmented on the basis of end use and tracks the scope of each end use over the stipulated time frame. The various end uses covered in the report include end use 1, end use 2, end use 3, and end use 4.

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The report addresses the following queries pertaining to the Gene Therapy for Ovarian Cancer market:

Application analysis

The presented study dissects the global Gene Therapy for Ovarian Cancer market on the basis of application and provides accurate data related to the size, share, and revenue growth of each application over the forecast period.

The quantitative and qualitative analysis of the market scenario in different regions and key success factors impacting the growth of the market in each region is provided in the market study. The different regions covered in the report include:

The key players covered in this studyTakara BioVBL TherapeuticsCELSIONTargovax

Market segment by Type, the product can be split intoIntravenousIntratumoralIntraperitoneal

Market segment by Application, split intoOvarian Cancer (unspecified)Recurrent Ovarian Epithelial CancerPlatinum-Resistant Ovarian Cancer

Market segment by Regions/Countries, this report coversUnited StatesEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

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Essential findings of the market study:

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Tips and tricks for regulators regarding advanced therapies – Pharmaceutical Technology

March 30th, 2020 5:49 am

Despite revolutionising healthcare, advanced therapies pose significant challenges to regulators and their approval pathways. Credit: Shutterstock.

Advanced therapies, including cell and gene therapies, have revolutionised healthcare. Created by altering a patient, or donors, cells using novel gene editing tools, these highly personalised therapies provide the possibility of long-term, life-improving treatment that could even be curative.

This approach to treating conditions, often those that were previously viewed as untreatable, has been gaining significant momentum; there are now three approved gene therapies on the market and more and more studies are being conducted in the area.

In the UK alone, there was a 45% increase in the number of advanced therapy trials from 85 in 2018 to 127 in 2019, according to Innovate UKs Cell and Gene Therapy Catapults clinical trials database. Non-profit Alliance for Regenerative Medicines 2019 clinical trials report highlighted although there was stagnation in the numbers of studies in Europe, there has been a global increase of 32% between 2014 and 2018.

However, the uniqueness of these therapies creates significant challenges for the pharma industry, particularly for regulators and their existing approval and reimbursement methods. The Alliance for Regenerative Medicine European public policy senior director Annie Hubert explains: Because advanced therapies are very different from traditional pharmaceuticals, both in the way they are manufactured and in the potential therapeutic effect for patients, traditional regulatory pathways are often ill-suited to the regulation of advanced therapies.

Often these therapies are developed for rare disorders with small patient populations meaning there is less safety and long-term efficacy data available upon approval than regulators are used to with randomised control trials. It is also often not seen as ethical to recruit placebo arms for the types of severe conditions these diseases treat.

As a result of their durable and sometimes curative effects, these therapies have a high upfront cost Novartiss gene therapy for spinal muscular atrophy Zolgensma is priced at $2.1m per patient, making it the most expensive drug in the world.

The Alliance for Regenerative Medicines 2019 Getting Ready: Recommendations for Timely access to advanced therapy medicinal products in Europe report also notes this cost is also linked to the incredibly complex, manufacturing process required for advanced therapies. Hubert notes the different manufacturing process also poses a challenge for regulators when applying traditional quality control and other standards to the production of advanced therapies.

How can regulators support continued R&D and allow for the commercialisation and reimbursement of these ground-breaking therapies?

Despite regulators creating new pathways for quicker assessment and approval of these challenging, but innovative medicines, there still remain significant barriers to development, approval and reimbursement of these therapies.

Since randomised, placebo-controlled trials with clinically validated endpoints are not usually appropriate for advanced therapies, there is a need for regulators to be adaptive to the different types of trials, data and endpoints to support the approval of advanced therapies.

In terms of innovative trial design, Hubert notes regulators can help to facilitate this by enhancing the acceptability of validated surrogate endpoints to estimate long-term outcomes, as well as improving the infrastructure for gathering real-world evidence [RWE] to supplement traditional clinical trial data.

RWE can help to mitigate some of the uncertainty around the long-term, durable therapeutic benefits of these advanced therapies. However, it can also be used to collect so-called natural history data of trial participator to be used as the comparator for trials, meaning there is no need for a placebo trial arm.

A primary recommendation of Alliance for Regenerative Medicines 2019 report is to consider to new payment structures that take into account the longer-term value these therapies have on patients and their families, as well as the overall cost-savings to the healthcare systems.

Increased predictability in reimbursement determinations post-approval would also likely promote growth in clinical development, adds Hubert.

The non-profit recommends a range of different models, including conditional reimbursement, paying based on outcomes and annuity-based payments.

All of these models would be supported by more and easier RWE collection, but Hubert picks out conditional approval schemes as benefitting the most; RWE can help to offset the perceived risk of providing and reimbursing products with limited follow-up data available, while still ensuring patients can access safe and effective therapies as efficiently as possible.

Conditional reimbursement schemes involve temporary reimbursement, which is contingent on the collection and review of further evidence; an example of an existing model is NHS Englands Cancer Drugs Fund, and Boris Johnsons Conservative Government has expressed a desire to expand this into an Innovative Drugs Fund to include disease areas beyond oncology.

Outcome-based reimbursement models are similar, but they are specifically linked to certain pre-determined benefits of the drug the UKs Cell and Gene Therapy say these can be clinical, economic or patient-reported experience measures, and the best way to support them is through the development of interconnected data registries. The Pistoia Alliances 2030 retrospective report also discussed the need to move away from a pay-per-pill approach towards payments based on outcomes when dealing with personalised medicines.

Finally, annuitypayments can help to spread the cost of therapy out over several years Hubert explains. This allows healthcare providers to plan their resource allocation for the therapy, as well as facilitates affordable access. The Alliances recommendations-focused report finds that these have been discussed, but not yet implemented.

The central vision of both the Cell and Gene Therapy Catapult and the Alliance for Regenerative Medicine is to better connect all the groups involved in advanced medicine, ranging from patients, drug developers to regulators.

Dialogue between industry, researchers, regulators, and other stakeholders is essential to ensure that safe and effective next-generation therapies are able to reach patients in a timely manner.

This becomes even more important as new, even more complex therapies are being developed; early dialogue would allow regulators to prepare their processes in advance, rather than trying to catch up after the fact.

In addition, the Alliances Getting Ready report also notes the need for regulators to communicate with one another to create international standards. This makes it easier for developers looking to launch a product in multiple countries, as well as reducing duplicative or contradictive regulatory requirements, which can be particularly burdensome for smalldevelopers with limited resources which dominate this field, Hubert concludes.

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Drive-by birthday party for 3-year-old with rare disease – FOX 31 Denver

March 30th, 2020 5:49 am

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DENVER (KDVR) -- Even with a stay-at-home order in place, there was no way Amber Freed was cancelling her 3-year-old twins birthday party.

The Denver mother set up an entire partys worth of decorations in the front yard, complete with a giant blow-up dinosaur, and dozens of balloons.

What I did was pull out every seasons decorations all at once.We had Thanksgiving, dinosaurs, Halloween, and everything for a birthday, Freed said, laughing.

She asked friends and neighbors to drive by in their car and wish her twinsMaxwell and Rileyahappy birthday, by honking three times.

I am going to remember this day and smile so big, said Amber Freed.

The drive-by style party brought a few hours of joy to the Freed family, during an otherwise time of darkness.

I definitely was up late last night, trying to piecemeal this party together, knowing that this might be Maxwells last healthy birthdayand also knowing that all the progress we made may be falling apart right now, said Freed, with tears in her eyes.

Maxwell suffers from a rare, genetic disorderso rare, in fact, it doesnt have a real name.For now, its referred to as SLC6A1 and is similar to Parkinsons disease.

In the next year, were expecting a debilitating form of epilepsy to begin, that is not treatable with drugs.His 4th birthdayhe may lose a lot of the skills he has fought so hard to gain, Freed said.

A drug, and possible cure, is already being tested on mice.

Gene therapy was set to start later this year, but the timeline has slowed down significantly in the face of the COVID-19 pandemic.

Only a few scientists can be in laboratory at a time, and a lot of students and PhDs were working on our projectsand universities have shut down, Freed explained.Because universities have shut down, there are just no resources, she added.

Its a devastating setback for her son.

Days and minutes count for us.We need to have him treated soon, or else he will have no quality of life.

Theyll still need an additional $3.5 million, minimum, to conduct a full clinical trailat a time where many Americans are now experiencing financial strain.

Im so deeply sad that we came this far, and everything was working out perfectly.I was fighting so hard to save my baby boy, and all of that is in complete limbo right now, Freed said.

Which is why Saturday was much more than just a party, in her eyes.

I cannot believe how many people showed up to support Maxwell and Riley.It made the day so special for us.And it just meant the entire world for my family.

Learn more on Milestones for Maxwell or donate to help the family fund research and a clinical trial.

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Abeona Therapeutics Stakeholder Letter in Response to the COVID-19 Pandemic – Associated Press

March 30th, 2020 5:49 am

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

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NEW YORK and CLEVELAND, March 27, 2020 (GLOBE NEWSWIRE) -- The COVID-19 pandemic has created extraordinary challenges across all aspects of healthcare. Many institutions and their brave staff of providers are now focused on caring for patients stricken by the virus. We at Abeona are thankful for their sacrifices and efforts, and stand behind these healthcare institutions whose resources are focused on the greater good. We are dedicated to being a good global citizen in doing our part by following guidance from local health officials in New York, Cleveland, and Madrid, and where remote employees reside.

Above all, we will take every reasonable measure to ensure the safety of our patients and employees, while sustaining our business operations during this uncertain time. Abeona is fully focused on getting through the pandemic by working closely with our clinical trial sites to ensure that patient safety remains paramount.

Clinical DevelopmentWe remain committed to advancing our clinical programs, but recognize delays are inevitable in these uncertain times, especially as healthcare resources are justly redirected to those who need them most. We are continually assessing the dynamic situation and implementing plans to minimize disruption. We are also constantly reviewing these plans and associated processes and policies to ensure our patients and employees are safe, and continuity in our scaled back operations remains.

While the full impact on our clinical programs cannot be quantified at this point, what we do know is that all current clinical trial sites remain active. We can say with certainty that some sites have paused screening and delays are expected as the situation evolves globally. What we wont know for the foreseeable future is the long-term impact. However, we remain dedicated to communicating frequently and openly with our stakeholders as more information becomes available, including updates on material changes to prior guidance as we continue to follow applicable government, regulatory and institutional guidelines.

Business OperationsLooking inward, the safety of our employees is a top priority. We have instituted additional protective measures since news of COVID-19 broke, and we frequently assess and improve our safety practices and policies. Operations at our Cleveland manufacturing facility have been significantly scaled back to ensure that employees and those around them have the best chance to remain safe, and to accommodate reduced clinical development activities. Only employees deemed essential by senior management to maintaining the manufacturing operation are entering the facility and under strict safety protocols to mitigate their risk. More traditional means of risk mitigation including a global work from home policy and suspended business travel are also in place.

As we try to rationalize the unprecedented developments sweeping the globe, please be assured that Abeona is doing all it can to protect our patients, employees, and the communities around us. This includes company operations that underpin our aspirations to bring new medicines to patients in need.

Abeona is about great Science and great People, and its important we continue to do everything we can to preserve both.

We will get through this but only if we work together.

About Abeona TherapeuticsAbeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Companys clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively. The Companys portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Abeona has received numerous regulatory designations from the FDA and EMA for its pipeline candidates, including Regenerative Medicine Advanced Therapy designation for two candidates (EB-101 and ABO-102). http://www.abeonatherapeutics.com

Investor Contact:Dan FerryLifeSci Advisors, LLC+1 (617) 535-7746 daniel@lifesciadvisors.com

Media Contact:Scott SantiamoDirector, Corporate CommunicationsAbeona Therapeutics+1 (718) 344-5843 ssantiamo@abeonatherapeutics.com

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Nomura Sticks to Its Buy Rating for Voyager Therapeutics (VYGR) – Smarter Analyst

March 30th, 2020 5:49 am

Nomura analyst Christopher Marai maintained a Buy rating on Voyager Therapeutics (VYGR) on March 27 and set a price target of $16.00. The companys shares closed last Friday at $9.05, close to its 52-week low of $6.27.

According to TipRanks.com, Marai is a 2-star analyst with an average return of -0.6% and a 43.7% success rate. Marai covers the Healthcare sector, focusing on stocks such as Global Blood Therapeutics, Alexion Pharmaceuticals, and BioMarin Pharmaceutical.

Currently, the analyst consensus on Voyager Therapeutics is a Moderate Buy with an average price target of $19.67, implying a 129.5% upside from current levels. In a report issued on March 19, Benchmark Co. also initiated coverage with a Buy rating on the stock.

See todays analyst top recommended stocks >>

Based on Voyager Therapeutics latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $32.67 million and GAAP net loss of $12.57 million. In comparison, last year the company earned revenue of $2.01 million and had a GAAP net loss of $22.53 million.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Voyager Therapeutics, Inc. operates as a clinical-stage gene therapy company, which develops treatments for patients suffering from central nervous system. Its pipeline of gene theraphy programs include VY-AADC, VY-SOD101, VY-HTT01, VY-FXN01, Tau Program, and VY-NAV01. The company was founded by Guangping Gao, Mark A. Kay, Krystof Bankiewicz and Phillip Zamore in June 2013 and is headquartered in Cambridge, MA.

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bluebird bio Provides Assessment of Impact of COVID-19, Update on Business Operations and Clinical Program Development – Business Wire

March 30th, 2020 5:49 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) today provided an update in response to the global COVID-19 pandemic. The company has taken steps to ensure the safety of its patients and employees, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.

The COVID-19 pandemic has created new challenges for bluebird, the broader biotech community, and society as a whole. During this unprecedented time, we remain focused on caring for the patients who rely on us, said Nick Leschly, chief bluebird. In addition, we are prioritizing the safety and well-being of our employees, making a positive impact as a member of our local community, and continuing to execute on our business strategy. While we all face tremendous challenges and uncertainty at this time, I am confident in bluebirds ability to face these headwinds with ingenuity, empathy, and a relentless commitment to the people we serve.

bluebird bio continues to evaluate the impact of COVID-19 on the healthcare system and work with healthcare providers supporting its clinical studies to mitigate risk to patients while taking into account regulatory, institutional, and government guidance and policies. The company remains committed to maintaining its development plans but acknowledges the potential impact on clinical studies given the rapidly evolving global environment. Generally, the company expects the COVID-19 pandemic to shift the timing of enrollment and completion of clinical studies by at least three months and expects timing shifts to vary by clinical trial and by program.

Regulatory Activities

Commercial Launch of ZYNTEGLO

Operating PlanIn light of the impacts of the COVID-19 pandemic on the business and the anticipated changes to commercial, regulatory and development timelines, the company is currently re-evaluating its operating plan. The company will be adjusting priorities and overall expenses. An update will be provided by the companys Q1 2020 earnings release.

Ongoing Programs and Clinical StudiesBelow is the current status of bluebird bio sponsored clinical trials:

Our People and Businessbluebird bio is evaluating all business-critical actions to determine how best to mitigate risk while being as minimally disruptive as possible. Safety of bluebird bio employees remains a top priority for the company. As of March 10, the company transitioned to a global work from home policy. Business-critical laboratory, manufacturing and related support activities continue and have been subject to heightened precautions to ensure safety of employees and the continuation of highest priority activities. The company continues to assess company policies, business continuity plans and employee support.

Conference Call DetailsInvestors may listen to the call on March 26, 2020 at 8:30 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2666529.

To access the live webcast of bluebird bios presentation, please visit the Events & Presentations page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

ZYNTEGLO, LentiGlobin, Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.

The full common name for ZYNTEGLO: A genetically modified autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiviral vector encoding the A-T87Q-globin gene.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for development and commercialization for ZYNTEGLO and the companys product candidates, including plans for our ongoing clinical trials, expectations regarding timing for the first patient treated with ZYNTEGLO in the commercial context, our plans and timing expectations for regulatory submissions for ide-cel, LentiGlobin for -thalassemia, LentiGlobin for SCD, and Lenti-D for CALD, our plans for data disclosures in 2020, and our plans and expectations in light of and in response to the COVID-19 pandemic and its impacts on global healthcare systems and our business. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic may disrupt our business and/or the global healthcare system more severely than we have anticipated, which may have the effect of further delaying our ability to enroll and complete our ongoing clinical trials (which may include potential delays of the ide-cel clinical trials beyond April 13, 2020), further delaying our ability to treat the first patient in the commercial context and obtaining market access and reimbursement for our approved product, and further delaying our timelines for regulatory submissions for our product candidates; the risk that we will encounter further challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; the risk that our collaborations, including the collaborations with Bristol-Myers Squibb, will not continue or will not be successful; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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ReCode Therapeutics Raises $80 Million in Oversubscribed Series A Financing – BioSpace

March 30th, 2020 5:49 am

- New company formed from combination of TranscripTx and ReCode Therapeutics

- Advancing mRNA-mediated protein replacement and tRNA NanoCorrector therapies for primary ciliary dyskinesia and cystic fibrosis

- Developing proprietary non-viral lipid nanoparticle delivery platform for organ-specific delivery of RNA therapies and gene editing components

MENLO PARK, Calif. & DALLAS--(BUSINESS WIRE)-- ReCode Therapeutics (ReCode) (the Company), a private biopharmaceutical company pioneering precision medicines for pulmonary diseases, today announced the close of an oversubscribed $80 million Series A financing round. OrbiMed Advisors LLC and Colt Ventures co-led the round, with participation from MPM Capital, Vida Ventures LLC, Hunt Technology Ventures, L.P. and Osage University Partners. ReCode will use the proceeds to continue the preclinical development of its lead programs in primary ciliary dyskinesia (PCD) and cystic fibrosis (CF). The Company expects to file an Investigational New Drug Application (IND) for both programs in 2021. In addition, the Company will advance its proprietary non-viral lipid nanoparticle (LNP) delivery platform for organ-specific delivery of RNA therapies and gene editing components.

Our preclinical studies demonstrate that our targeted RNA therapies have great potential for the treatment of life-threatening pulmonary diseases, commented David Lockhart, Ph.D., CEO and president, ReCode Therapeutics. We are pleased to close this financing round with world-class investors who believe in the bold vision of our new company. With these additional resources, were focused on advancing our preclinical programs into the clinic over the next two years.

Lockhart continued, Im especially grateful to ReCodes founders, professors Daniel Siegwart, Ph.D., and Philip Thomas, Ph.D., at the University of Texas Southwestern Medical Center, and Professor Emeritus Arthur Johnson from Texas A&M University whose foundational research played an instrumental role in cultivating both the LNP delivery platform and the CF therapeutic program. Finally, we are grateful to the Cystic Fibrosis Foundation, whose financial support has allowed us to play a pivotal role in understanding the pathogenesis of CF and led to the development of a novel therapeutic approach for correcting nonsense mutations for this severe disease.

Along with the financing, ReCode has appointed a new board of directors. The directors comprise representatives from the Company including Dr. David Lockhart and key investors including Dr. Peter Thompson, partner at OrbiMed, Ed Hurwitz, J.D., managing director at MPM Capital, Helen S. Kim, managing director at Vida Ventures, R.A. Session II, chief business officer of the gene therapy subsidiaries at BridgeBio, and ReCode founder and new vice president of R&D, Dr. Michael Torres.

We believe that ReCode has an exceptional opportunity to advance its targeted RNA therapies and LNP delivery platform to address the critical needs of patients living with devastating genetic respiratory diseases, said Dr. Peter Thompson, partner, OrbiMed. The board looks forward to supporting ReCodes evolution as it moves these compelling therapies into the clinic.

Chardan acted as sole placement agent on the Series A financing, and as M&A advisor to ReCode Therapeutics.

About ReCode Therapeutics

ReCode Therapeutics is a biopharmaceutical company developing precision medicines for genetic respiratory diseases with significant unmet medical need. ReCodes diverse pipeline includes lead programs for primary ciliary dyskinesia and nonsense mutations in cystic fibrosis. The Companys proprietary non-viral lipid nanoparticle platform enables the delivery of a variety of payloads, and precise organ targeting of nucleic acid and protein payloads via both systemic and local delivery. ReCode is leveraging its nanoparticle and nucleic acid technologies across multiple modalities, including mRNA-mediated protein replacement therapies, first-in-class tRNA NanoCorrectors for diseases caused by nonsense mutations, and gene editing. For more information, visit http://www.recoderx.com

About OrbiMed Advisors LLC

OrbiMed is a leading healthcare investment firm, with over $14 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies. To learn more, visit http://www.orbimed.com.

About Colt Ventures

Colt Ventures is a family office that was established in 2003 to invest the capital of Darren Blanton. Colt invests in a variety of private and public companies, and has deep domain expertise in biotechnology and energy. Dr. Sundeep Agrawal leads the firms investment activities with a focus on biotechnology/therapeutics. Colt is headquartered in Dallas with a presence in New York City. To learn more, visit http://www.coltventures.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200326005123/en/

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Pros and Cons of Stem Cell Research – ThoughtCo

March 30th, 2020 5:47 am

Debates over the ethics of embryonic stem cell research have divided scientists, politicians, and religious groups for years.

However, promising developments in other areas of stem cell research have led to solutions that help bypass these ethical barriers and win more support from those against embryonic stem cell research; the newer methods don't require the destruction of blastocysts.

Many parties continue to have strong opinions that trigger ongoing debates about stem cell research, and the following pros and cons provide a snapshot of some the points on each side of the issue.

The excitement about stem cell research is primarily due to the medical benefits in areas ofregenerative medicineand therapeutic cloning. Stem cells provide huge potential for finding treatments and cures to a vast array of medical issues:

Different diseasesincluding cancers, Alzheimer's, Parkinson's, and morecan be treated with stem cells by replacing damaged or diseased tissue. This can include neurons that might affect neurological diseases and even entire organs that need to be replaced.

There is endless potential for scientists to learn about human growth and cell development from studying stem cells. For example, by studying how stem cells develop into specific types of cells, scientists potentially could learn how to treat or prevent relevant ailments.

One of the areas of potential is embryonic treatment. This stage of pregnancy is when many birth defects or other potential issues begin. Studying embryonic stem cells possibly could lead to a better understanding of how embryos develop and maybe even lead to treatments that can identify and address potential problems.

Because the cells can replicate at a high rate, a limited number of initial cells eventually can grow into a much greater number to be studied or used in treatment.

Medical benefits such as regenerating organ tissue and therapeutic cell cloning

May hold the answer to curing various diseases, including Alzheimer's, certain cancers and Parkinson's

Research potential for human cell growth and development to treat a variety of ailments

Possibility of use for embryonic treatment

Requires only a small number of cells because of the fast replication rate

The difficulty of obtaining stem cells and the long period of growth required before use

Unproven treatments often come with high rejection rates

Cost can be prohibitive for many patients

Ethical controversy over use of stem cells from lab-fertilized human eggs

Additional ethical issues regarding the creation of human tissues in a lab, such as cloning

Stem cell research presents problems like any form of research, but most opposition to stem cell research is philosophical and theological, focusing on questions of whether we should be taking science this far:

It's not easy to obtain stem cells. Once harvested from an embryo, stem cells require several months of growth before they can be used. Obtaining adult stem cells, such as from bone marrow, can be painful.

As promising as the field is, stem cell treatments still are unproven, and they often have high rejection rates.

The cost also can be prohibitive for many patients, with a single treatment costing well into the thousands of dollars, as of 2018.

The use of embryonic stem cellsforresearchinvolves the destruction of blastocysts formed from laboratory-fertilized human eggs. For those who believe that life begins at conception, the blastocyst is a human life, and to destroy it is unacceptable and immoral.

A similar theological problem is an idea of creating living tissue in a laboratory and whether that represents humans taking on the role of God. This argument also applies to the potential for human cloning. For those who believe God created people, the prospect of people creating people is troublesome.

In 1998, the first published research paper on the topic reported that stem cells could be taken from human embryos. Subsequent research led to the ability to maintain undifferentiated stem cell lines (pluripotent cells) and techniques for differentiating them into cells specific to various tissues and organs.

The debates over the ethics of stem cell research began almost immediately in 1999, despite reports that stem cells cannot grow into complete organisms.

In 20002001, governments worldwide were beginning to draft proposals and guidelines to control stem cell research and the handling of embryonic tissues and reach universal policies. In 2001, the Canadian Institutes of Health Research (CIHR) drafted a list of recommendations for stem cell research. In the U.S., the Clinton administration drafted guidelines for stem cell research in 2000. Australia, Germany, the United Kingdom, and other countries followed suit and formulated their own policies.

Debates over the ethics of studying embryonic stem cells continued for nearly a decade until the use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)became more prevalent and alleviated those concerns.

In the U.S. since 2011, federal funds can be used to study embryonic stem cells, but such funding cannot be used to destroy an embryo.

Use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)from blood, cord blood, skin, and other tissues have been demonstrated as effective in treating different diseases in animal models. Umbilical cord-derived stem cells obtained from the cord blood also have been isolated and used for various experimental treatments. Another option is uniparental stem cells. Although these cell lines are shorter-lived than embryonic cell lines, uniparental stem cells hold vast potential if enough research money can be directed that way: pro-life advocates do not technically consider them individual living beings.

Two recent developments from stem cell research involve the heart and the blood it pumps. In 2016, researchers in Scotland began working on the possibility of generating red blood cells from stem cells in order to create a large supply of blood for transfusions. A few years earlier, researchers in England began working on polymers derived from bacteria that can be used to repair damaged heart tissue.

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Pros and Cons of Stem Cell Research - ThoughtCo

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Triple-Negative Breast Cancer: Overview, Treatment, and More

March 30th, 2020 5:47 am

Triple-negative breast cancer is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein.

These results mean the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. So, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. Still, other medicines are used to successfully treat triple-negative breast cancer.

About 10-20% of breast cancers are triple-negative breast cancers. For doctors and researchers, there is intense interest in finding new medications that can treat this kind of breast cancer. Studies are trying to find out whether certain medications can interfere with the processes that cause triple-negative breast cancer to grow.

Cell receptors are special proteins found inside and on the surface of cells. These receptor proteins are the eyes and ears of the cells, receiving messages from substances in the bloodstream and then telling the cells what to do.

Hormone receptors inside and on the surface of healthy breast cells receive messages from the hormones estrogen and progesterone. The hormones attach to the receptors and provide instructions that help the cells continue to grow and function well. Most, but not all, breast cancer cells also have these hormone receptors. Roughly two of three breast cancers test positive for one or both of these hormone receptors. (For a more complete explanation, see the Hormone Receptor Status page.)

A smaller percentage of breast cancers about 20% make too much of the HER2 protein. In normal, healthy breast cells, the HER2 stimulates cell growth. When breast cancer cells have too much of the HER2 protein, however, the cells grow and divide too quickly. (For a more complete explanation, see the HER2 Status page.)

Hormonal therapies and HER2-targeted therapies disrupt the effects of estrogen, progesterone, and the HER2 protein on breast cancer, which can help slow or even stop the growth of breast cancer cells.

About 10-20% of breast cancers test negative for both hormone receptors and excess HER2 in the lab, which means they are triple-negative. Since hormones arent fueling the cancers growth, the cancer is unlikely to respond to hormonal therapy medicines, including tamoxifen and aromatase inhibitors. Triple-negative breast cancer also is unlikely to respond to medicines that target the HER2 protein, such as Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki), Herceptin (chemical name: trastuzumab), Kadcyla (chemical name: T-DMA or ado-trastuzumab emtansine), Nerlynx (chemical name: neratinib), Perjeta (chemical name: pertuzumab), or Tykerb (chemical name: lapatinib).

Three common features of triple-negative breast cancer

Who gets triple-negative breast cancer?

Anyone can be diagnosed with triple-negative breast cancer. Still, researchers have found that it is more common in:

If you are diagnosed with triple-negative breast cancer

It can be upsetting and scary to find out that youve been diagnosed with a type of breast cancer that is often more aggressive than other types and isnt a good candidate for treatments that target the hormone receptors or HER2 protein.

Still, its important to remember that the lack of hormone receptors and excess HER2 protein are just two factors that you and your doctor will take into consideration when deciding on a treatment plan. The stage and grade of the cancer are also crucial to your prognosis.

Its also important to remember there are therapies available that can treat triple-negative breast cancer.

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Triple-negative breast cancer is typically treated with a combination of surgery, radiation therapy, and chemotherapy.

Neoadjuvant chemotherapy

Research has shown that when triple-negative breast cancer is treated with chemotherapy before surgery what doctors call neoadjuvant chemotherapy and there is a pathologic complete response, disease-free survival and overall survival are better.

One way for doctors to judge the effectiveness of neoadjuvant treatment is to look at the tissue removed during surgery to see if any active cancer cells are present. If no active cancer cells are present, doctors call it a pathologic complete response or pCR.

Disease-free survival is how long a person lives without the cancer recurring. Overall survival is how long a person lives whether or not the cancer recurs.

PARP inhibitors

PARP inhibitors, such as Lynparza (chemical name: olaparib) and Talzenna (chemical name: talazoparib), have been approved to treat advanced-stage HER2-negative breast cancer in people with a BRCA1 or BRCA2 mutation.

The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. Research has shown that medicines that interfere or inhibit the PARP enzyme make it even harder for cancer cells with a BRCA1 or BRCA2 mutation to fix DNA damage. This makes it harder for the cancer cells to survive. In other words, a PARP inhibitor makes some cancer cells less likely to survive their DNA damage.

Immunotherapy

The immunotherapy medicine Tecentriq (chemical name: atezolizumab) in combination with the chemotherapy medicine Abraxane (chemical name: albumin-bound paclitaxel or nab-paclitaxel) is approved as a first treatment for unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.

Immunotherapy medicines work by helping your immune system work harder or smarter to attack cancer cells. Tecentriq is an immune checkpoint inhibitor medicine, which means it targets a specific protein that helps cancer cells hide from the immune system, in this case, the PD-L1 protein. By inhibiting PD-L1, Tecentriq essentially allows immune system cells to see the cancer cells and kill them.

You can visit Treatment and Side Effects for more information about surgery, radiation therapy, chemotherapy, targeted therapies such as PARP inhibitors, and immunotherapy.

Clinical trials using these and other therapies could play a key role in improving the treatment of triple-negative breast cancer. Talk to your doctor if you think you might be interested in taking part in a clinical trial.

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Your Guide to the Breast Cancer Pathology Report is an on-the-go reference booklet you can fill out with your doctor or nurse to keep track of the results of your pathology report. Order a free booklet by mail or download the PDF of the booklet to print it at home.

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Triple-Negative Breast Cancer: Overview, Treatment, and More

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Kalytera Therapeutics: improving bone marrow transplants with CBD – Health Europa

March 30th, 2020 5:47 am

The development of bone marrow transplantation procedures is widely considered one of the greatest victories in the war against cancer. The vast majority of bone marrow transplant recipients are patients with various forms of blood cancers, such as leukaemia, lymphoma or multiple myeloma. A real game changer, bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to over 85%.

Unfortunately, however, patients receiving bone marrow transplants are at high risk of developing Graft versus Host Disease (GvHD), a life-threatening complication that occurs when the transplanted cells from the donor the graft identify the transplant recipient the host as foreign.

This triggers an immune reaction that can wreak havoc in the transplanted patients body as it is attacked by the donated cells. This can occur from just days (in the case of acute GvHD) up to months or years (for chronic GvHD) after the haematopoietic cell transplantation (HCT) procedure has taken place.

The mortality rate of acute GvHD is very high in the case of grade 4 GvHD, it is over 90%. The overwhelmingly positive preliminary response of patients to CBD in preventing and treating GvHD shown in early trials, could be the key to significantly decreasing the incidence of this terrible condition.

Before we go on, there is a distinction to be made between a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue, as may be the case in liver or heart transplants, and GvHD, which occurs when the while blood cells in the donors reject the recipient.

There are two types of bone marrow transplant: autologous (from the patients own stem cells) and allogeneic (stem cells from a donor). It is in the latter where GvHD may occur.

GvHD from allogeneic bone marrow transplants can manifest itself in many forms and degrees; ranging from mild, moderate or severe, to potentially fatal for the patient. Acute GvHD can cause rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhoea, jaundice; and may attack the lungs, liver and eyes. It is often associated with chronic illness, infections, disability, reduced quality of life, and is a major cause of morbidity and mortality following HCT.

Researchers estimate that despite aggressive preventive measures with immunosuppressive treatments, 30% to 50% of transplanted patients whose donors were fully matching siblings and 50% to 70% of patients whose donors were unrelated to them develop some level of GvHD.

Though it may sound surprising, currently there are no FDA approved therapies for either the prevention or treatment of acute GvHD.

Enter Kalytera Therapeutics, a clinical-stage pharmaceutical company aiming to develop cannabidiol (CBD) for the treatment of serious diseases. The companys drug development expertise and intellectual property portfolio put it at the forefront in the development of CBD-based medicines for a range of important unmet medical needs. Currently, its resources are being focused mainly on mitigating the effects of GvHD following bone marrow transplantation.

Kalytera Therapeutics lead programme, in which we are evaluating CBD for the prevention and treatment of GvHD, is in late-stage clinical testing. Kalytera Therapeutics have an ongoing open label Phase 2 clinical study to evaluate the pharmacokinetic profile, safety and efficacy of CBD for the prevention of acute GvHD with encouraging preliminary results; we are currently approaching the end of cohort 2. A series of Phase 1 studies requested by the FDA, such as the effect of food intake on the absorption of oral CBD, have also been completed.

At this stage, Kalytera Therapeutics are ready to plan a meeting with the FDA to discuss the possibility of starting a pivotal study later this year. Following the approval of Epidiolex for Dravet Syndrome by GW Pharma, the FDA has encouraged that Kalytera apply for a 505(b)2 regulatory pathway, which provides manufacturers of some types of drugs to apply for FDA approval without performing all the work required in a new drug application.

Kalytera Therapeutics have also received a Fast Track Designation to aid in the development and expedite review of drugs intended for serious or life-threatening disease and addressing an unmet medical need, for the companys CBD products for prevention and treatment of acute GvHD. This could accelerate the approval process for these products.

The obvious first step in attempting to prevent GvHD is to find donor cells that match the genetics of the immune system of the transplant recipient as closely as possible. But even in the ideal case of the donors being a sibling, the patient still must rely on drugs specially developed to cause immunosuppression of the donor cells, through either T-cell depletion or drugs. Treatments usually used for this include methotrexate, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil and antithymocyte globulin (ATG), as determined by each medical team and institution.

When it comes to treating GvHD, the grafts immune cell activation needs to be suppressed with medication, so that donor-host immune tolerance can be established once again. Most patients are given corticosteroids, which directly suppress the donors immune cell attack on the hosts tissues. This also raises the risk of infection and the relapse of cancer.

As of now, there are guidelines but there is no standard treatment for either prevention or treatment of acute GvHD. Only 30% to 50% of patients with moderate to severe GvHD respond to corticosteroids, leaving many at risk of fatal outcomes. Everyone in the healthcare system should be aware that more research is necessary to discover better treatment options to reduce the rates of mortality and morbidity in transplantation patients.

The programme Kalytera is now implementing is based on previous Phase 2a clinical trials, which showed outstanding preliminary results in the prevention of the disease by giving patients CBD orally. In the first study, 48 patients received CBD for seven days prior to the bone marrow transplant procedure and for 30 days thereafter, as opposed to a group of 101 historical controls who had been given the usual GvHD prophylaxis and treated in the same BMT unit by the same medical team.

Remarkably, results showed none of the 48 patients had developed acute GvHD in the 30 days of treatment with CBD. Those who developed GvHD did so within a median time of 60 days, whereas the control group of 101 historical controls began to develop acute GvHD in a median time of 20 days only (ranging from nine to 137).

In the CBD treated group, the rates of grade 2 to grade 4 acute GvHD by day 100 were 12.1%, compared with 46% in the control. The rate of severe grade 3 to grade 4 was 5%, compared to 10% in the control. Equally important is the finding that CBD was also safe and well tolerated, with no severe adverse events attributed to its consumption. This is consistent with safety data previously reported on CBD administered to humans, even with three to four times higher doses and even when taken over extended periods of time.

In light of these encouraging initial results, it was decided to test the efficacy of a prolonged treatment covering 100 days: the time window in which acute GvHD usually occurs. In a second study, 12 patients were administered CBD at the same dose starting from seven days before the bone marrow transplant procedure until 100 days post-transplantation. No safety issues were observed here either and only one noncompliant patient, representing 8% of the CBD treatment group, developed acute GvHD; compared to a 46% incidence at the same institution in the historical group of 101 patients described above. This is despite the fact that the majority of the patients (10 out of 12) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors, which would normally increase their chance of developing GvHD.

In a third Phase 2a study, which was performed for treatment of already sick patients, 10 patients with acute GvHD, who were refractory to standard treatment with high dose steroids (only 60% of patients respond to first line therapy with high dose steroids), were administered daily doses of CBD for up to three months. Strikingly, nine of the 10 patients enrolled in the study responded to treatment, seven of them achieving complete remission of GvHD and two more achieving a near-complete response.

These results are impressive when we take into account that the 12-month mortality rate among patients with grade 3 and grade 4 GvHD who do not respond to steroids exceeds 60% and 80%, respectively. Indeed, these preliminary results compare favourably with the results of the historical control group of 29 patients with steroid-refractory grades 3 and 4 GvHD, among which 26 patients died from GvHD and its complications.

With a median follow-up period of 13 months, six patients were still alive. Two patients died from leukaemia relapses, and two patients died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment. This underlines the urgency of developing a product that can prevent and treat GvHD.

On the list of the 10 most expensive medical procedures, allogeneic BMT ranked fourth; while autologous BMT, at less than half the outrageous cost, still made it to the eighth place. Depending on the country and institution, costs range from tens of thousands to hundreds of thousands of dollars per procedure. The need and incentive to increase the rate of success are indisputable.

The life-saving ability of Kalyteras CBD products for the prevention and treatment of acute GvHD, currently classified as an orphan disease, means the company has good chances of obtaining premium pricing for a course of treatment. Over 20,000 patients suffer from acute GvHD following bone marrow transplantation in the six major markets of the US, Germany, the UK, France, Spain and Japan every year.

According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential market for a successful drug for prevention and treatment of GvHD in the seven major jurisdictions of the US, Germany, France, Italy, Spain, the UK and Japan is estimated to be over $408m in 2018; and could grow to approximately $1.3bn by 2027.

Once Kalyteras CBD products are approved by the FDA, the company believes that treating physicians would not be expected to prescribe anything other than its approved formulation of CBD (as opposed to a non-approved CBD that might be available online or from other commercial sources), especially since patients are often in isolation in the intensive care unit. It is safe to assume that neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD in the jurisdictions where Kalytera intends to market its CBD product.

Conducting proper, large scale clinical trials with CBD is of utmost importance. Although in some areas CBD seems to be generally safe in the broader healthy population, it can be harmful to some groups, such as young adults, women of childbearing age, pregnant women, children, people with known heart conditions or low blood pressure, and the elderly.

Despite all the hype about the multiple health benefits of cannabis-based products trumpeted by many (though not clearly stated due to possible risks of liabilities for unsubstantiated claims), so far only one CBD-based drug has received FDA approval for the treatment of two rare and serious types of epilepsy.

Contrary to popular belief and anecdotal evidence, CBD is not a biologically inert compound. Rather, CBD has a complex pharmacokinetic and pharmacodynamic profile similar to any other medication with the potential to interact with other medications and medical conditions. CBD is metabolised in the liver by enzymes responsible for metabolising a large percentage of other drugs. When taken concomitantly, CBD may reduce or neutralise the intended action of those other medications. Kalytera has completed drug to drug interaction testing in vitro and is now planning to start testing in healthy subjects.

CBD oil can have negative side effects too, such as drowsiness, drop in blood pressure when taken in large doses, being potentially harmful for people with low blood pressure. Other problems are dizziness or light-headedness, appetite changes, diarrhoea, hormonal changes, hypokinesia and resting tremor when used for epilepsy. In psychotic disorders it has side effects too, but they are milder than on other drugs used until today. It can benefit some Parkinsons patients, but not all of them.

Kalytera has a solid, experienced leadership team and very strong intellectual property portfolio. We have three issued US and European patents covering the use of CBD in the prevention and treatment of GvHD, as well as four orphan drug designations for the treatment and prevention of GvHD in the US and Europe.

Our promising preliminary results indicate we will be able to help BMT patients and their donated bone marrow get along better. This will greatly improve patients quality of life, productivity and life expectancy by keeping them GvHD free.

Dr Sari SagivStero Biotechs+972 36176173david@sela.co.il

Please note: Kalytera Therapeutics Inc. have recently acquired Stero Biotechs.

This article will appear in the second issue ofMedical Cannabis Network which will be available to read in April 2020.

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Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with…

March 30th, 2020 5:47 am

VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the three-day results post-leronlimab treatment of the first four patients under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA). A total of seven patients have been enrolled thus far under EIND in the same leading medical center in the New York City area.

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, said, IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm. Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved.

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, These preliminary results give hope that leronlimab may help hospitalized patients with COVID-19 recover from the pulmonary inflammation that drives mortality and the need for ventilators. A leading medical center in the heart of the New York City epidemic was instrumental in giving the preliminary data.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said: We are extremely pleased for the coronavirus patients under the care of the treating medical team and that the FDA is so responsive to advance our Phase 2 clinical trial. I am very hopeful that leronlimab can help to reduce the rate of mortality among COVID-19 patients with severe symptoms of ARDS and to assist our government to fight this battle.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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Multiple Sclerosis and Russian Treatments

March 30th, 2020 5:46 am

Do you have any desire to travel to Russia?

You might if you have multiple sclerosis.

People with multiple sclerosis (MS) in the United States and Canada are traveling to Russia for an experimental treatment thats a potential cure for the disease.

However, there are still a number of risks involved.

Hematopoietic Stem Cell Transplantation (HSCT) is a therapy for MS that has, in many cases, been shown to halt progression of the disease with a single treatment.

However, in North America, the procedure is still considered experimental and isnt widely available. Its also costly.

For individuals facing a potential lifetime of MS, the allure of a cure abroad is tantalizing.

According to Bruce Bebo, executive vice president of research at the National Multiple Sclerosis Society, HSCT treatment is promising. But he cautions there still arent enough rigorous clinical studies on it to weigh the real risks and benefits.

MS is a demyelinating autoimmune disease in which the bodys immune system begins to attack the myelin, the protective insulation of the nervous system.

These attacks cause scarring (sclerosis) that leads to a host of neurological symptoms from tremors and loss of vision, to difficulty with speech.

Its typically diagnosed in individuals between the ages of 20 and 40.

HSCT is a complex procedure that requires a bone marrow transplant similar to that used by oncologists for certain blood cancers.

The treatment is an attempt to reboot the immune system and stop it from attacking the brain and spinal cord.

One way to think about it is that you are reeducating and creating a new immune system, Bebo told Healthline. It appears that in many cases when you do this, that new immune system learns that the central nervous system isnt dangerous anymore and it doesnt attack it anymore.

In the first step of HSCT treatment, chemotherapy is used to stimulate the production of bone marrow stem cells and promote their release into the bloodstream. This blood is then drawn and stored.

The patient is then given a strong dose of more chemotherapy, most often in a hospital setting, for up to 11 days.

During that time, immune cells are either dramatically weakened or killed entirely.

Finally, the patients stored stem cells are infused back into the body, learning to leave the nervous system intact.

The process can be strenuous.

Patients must take antibiotics to fight off infections while their immune systems are suppressed.

They must also stay in the hospital for weeks at a time while their immune system rebuilds.

A recent study said that the average hospital stay after the stem cell infusion lasted between 10 and 160 days.

That may be a small price to pay to stop a chronic illness, especially for individuals diagnosed young.

Theres also the matter of the real price as in dollars.

I think [the reason] people are leaving the country has to do with cost, said Bebo. Im aware of many people who although they have to fight tooth and nail to get it, can get their insurance company to cover most or all the costs of this procedure in the U.S. Its expensive.

The cost is in the six-figure range. Healthline previously reported that it could be done in the United States for about $125,000.

Its a lot cheaper to go to Mexico or Russia to get HSCT therapy, where they will perform the therapy for a fraction of the cost, said Bebo.

There are also caveats to the treatment, dependent on the MS diagnosis.

Broadly speaking, there are two major types of MS: relapsing and progressive.

Relapsing, the more common form, is identified by intermittent attacks or exacerbations in which symptoms will worsen for a period and then dissipate.

As the disease progresses, the exacerbations get worse and the overall disability of the person increases.

Bebo describes progressive MS as a slow, steady progression of disability. Its less common but significantly more difficult to treat.

What little evidence we have at this point suggests that people with progressive MS dont respond to HSCT, said Bebo.

Typical drug regimens for relapsing MS, called disease modifying therapies (DMTs), also tend to be less effective for progressive MS.

This gap, as Bebo puts it, in treatment between progressive and relapsing MS may be driving medical tourism abroad.

Against doctors recommendations, patients may still elect to travel abroad to seek out HSCT for progressive MS.

New drugs, such as Ocrevus (ocrelizumab), have been approved more recently by the FDA for the treatment of progressive MS.

HSCT treatment isnt without risks.

Its not a trivial procedure and has been known for its serious mortality risk.

A study from 2017 concluded that while the procedure showed significant benefit against MS progression, the overall transplant-related mortality rate was about 2 percent.

As the procedure has improved, so have mortality rates. An older 2002 study of 85 MS patients treated with HSCT documented seven deaths in the group a mortality rate of about 8 percent.

I think there are still many neurologists who remember the older studies, the high risk of mortality, said Bebo, and until there is a rigorous, well-controlled study that documents the effectiveness and mortality risk, then I think some neurologists are going to be hesitant to recommend the therapy.

But Bebo and his colleagues at the MS society are also enthusiastic about the growing interest and research being done on HSCT.

I do see the neurology community being more accepting of this approach than they have in the past.

However, he emphasizes that HSCT isnt an MS panacea.

Depending on the diagnosis, the procedure must find its way into established therapy methods.

While HSCT is available in the United States today, it could still be years before its easily accessible and affordable.

We really look forward to the day when we have results from a really well-controlled, rigorous clinical trial to really tell us once and for all whats the full benefit of this, what are the full risks, and who is the person most likely to benefit from it, said Bebo.

Until then, people living with MS may choose to seek out treatment abroad, where the chance at a permanent cure may already be available.

In the race against a chronic illness, the U.S. medical system may just be moving too slowly for the young and the desperate.

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Stem-Cell Craze Spreads in Russia | WIRED

March 30th, 2020 5:46 am

MOSCOW While scientists worldwide are only studying stem cells, dozens of Russian clinics and beauty salons claim they are already using both adult and embryonic stem cells to treat everything from wrinkles to Parkinson's disease to impotence.

Scientists warn that while stem cells are still being researched in laboratories, treatment by clinics claiming to use stem cells may cost patients their health and fortunes. Moreover, they say, even though it's illegal, enforcement is lax and no one knows if the injections patients are getting contain stem cells.

When Svetlana Galiyeva found a clinic offering to treat her multiple sclerosis with embryonic stem cells, she grabbed the opportunity. Twenty-thousand dollars later she is still in a wheelchair and desperate. And there is no proof her injections had anything to do with stem cells.

Stem cells are the building blocks of the human body immature cells that can grow into bone, muscle and other tissues. They are plentiful in the embryo and fetus and are believed to be more versatile than stem cells from adult bone marrow and fat. But embryonic stem cells are controversial because they involve destruction of human embryos.

In leading clinics around the world, most stem-cell research is limited to the lab dish and animals. In Russia, however, it's a different story.

Galiyeva, a 40-year-old gynecologist in the Ural Mountains city of Perm, developed multiple sclerosis nine years ago. She gradually lost control over her muscles and was enduring nearly constant muscle spasms, leaving doctors pessimistic about her ability to recuperate.

"I understood what was awaiting me. It was either death or ...," Galiyeva said by telephone from Perm.

Driven to despair, Galiyeva traveled to a Moscow clinic for a series of injections that her doctors said were embryonic stem cells, costing her about $20,000 a huge sum in a country where the average monthly salary equals about $300.

Initially, her body nearly rejected the treatment with a 104 degree fever. Her limbs then regained some sensation, but that didn't last.

"Continuing that treatment was useless," she said bitterly.

Things didn't end there. She says her condition has improved after a new series of injections, said to contain adult stem cells, at Beauty Plaza, a private clinic in Moscow that advertises stem-cell treatments for a variety of diseases. She still cannot walk, but can stand unaided for brief periods, she said.

Meanwhile, hundreds of patients are rushing to Russian clinics and beauty salons that claim to offer embryonic stem-cell therapy for a range of diseases as well as cosmetic therapy.

Dr. Roman Knyazev's Cellulite, a clinic in central Moscow, advertises injections of stem cells from aborted fetuses into thighs, buttocks and stomachs to help women get rid of cellulite and look younger.

Yelena, a 37-year-old Moscow entrepreneur, says they worked for her. "After giving birth my belly was hanging like a rag and I had lots of stretch marks. Now it's all gone," she said after shelling out $2,850 for injections at Knyazev's clinic. She declined to give her last name.

But experts say the procedure carries potentially dangerous side effects.

"No one has been given any licenses for injecting (stem cells) these are only experiments. This is all being done at their own risk. This is all illegal," said Vladimir Smirnov, director of the Institute of Experimental Cardiology, who runs an adult stem-cell bank.

He said he knew of several state research institutes attempting occasional experimental treatment using adult stem cells from bone marrow and fat. Many other clinics, however, run with little regulation as to what they advertise and inject, Smirnov said.

Scientists say cultivating and isolating stem cells requires skill and expensive equipment that the clinics do not necessarily have. Therefore, what is claimed to be stem cells may be anything from a fetal tissue extract to skin cells. Some clinics reportedly use animal stem cells.

"If I was a patient, I wouldn't want that to be done on me.... The risks are potentially very high," said Joshua Hare, director of the cardiovascular section at the Johns Hopkins Institute for Cell Engineering in Baltimore.

Andrei Yuriyev, deputy head of the Federal Health Care Inspection Service, said the law permits only extraction and storage of stem cells not their use in treatment. Yuriyev said his service is investigating nearly 20 cosmetic clinics that claim to practice stem-cell therapy.

But with such vaguely defined regulations, dozens of clinics continue operating.

Dr. Alexander Teplyashin, head of Beauty Plaza, says he has used adult stem cells from patients' or donors' fat and bone marrow to treat diabetes, vision disorders and other diseases. He acknowledges that what he's doing is technically not permitted.

"We are taking advantage of the loopholes in the law ... what is not forbidden is allowed," he told The Associated Press at his clinic in downtown Moscow.

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Global Myocardial Fibrosis Market Insights, Forecasts to 2026 : Merck, Evotec AG, Miragen Therapeutics, TRACON Pharmaceuticals – Global Industry News…

March 30th, 2020 5:46 am

Global Myocardial Fibrosis Market 2020 provides in-depth analysis of the current and upcoming market and synopsis of product type, specification, product innovation, and production analysis considering major key factors, like Cost, Revenue, Gross, and Gross Margin and provides the entirely analysis of Myocardial Fibrosis Market using manufacturing process, price analysis and SWOT analysis (Strength, Weakness, Opportunities, and Threat) is examined in this study report.

This market understand repository presents readers with an encyclopedic evaluation of the global Myocardial Fibrosis market. Each aspect of the global Myocardial Fibrosis market is assessed in thorough detail in the report to provide a 360-degree review of the markets workings for interested parties. The past, present, and future growth trajectory of the Myocardial Fibrosis Market are assessed in the report, with detailed analysis of the historical trajectory of the market providing a solid database for reliable predictions regarding the Myocardial Fibrosis Market future.

Get FREE Sample PDF of This Research Report: https://www.syndicatemarketresearch.com/market-analysis/myocardial-fibrosis-market.html#sample

Company Coverage (Company Profile, Sales Revenue, Price, Gross Margin, Main Products, etc.): Merck, Evotec AG, Miragen Therapeutics, TRACON Pharmaceuticals, Daewoong Pharmaceutical, Galectin Therapeutics GTx, Invivosciences, Lead Discovery Center, MandalMed

Segmentation By Product Type and analysis of the Myocardial Fibrosis Market:Small Molecule Therapeutic Modality, Protein Therapeutic Modality, Peptide Therapeutic Modality, Endoglin Antibody Therapeutic Modality, Stem Cell Therapeutic Modality, Rna Therapeutic Modality, Other

Segmentation By Application and analysis of the Myocardial Fibrosis Market:Hospital, Clinics, Research Laboratories

Overview of the Report: The report begins with a market overview and moves on to cover the growth prospects of the markets. Global Myocardial Fibrosis industry 2020 is a comprehensive, professional report delivering market research data that is relevant for new market entrants or established players. Key methodologies of the organizations working in the business sectors and their effect included for the report. Moreover, the main player's revenue share, business overview, and analysis in the Myocardial Fibrosis market are available in the report.

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Geographical Segmentation And Analysis Of The Myocardial Fibrosis Market

Regionally, the market is divided into North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. In which North America ruled the global Myocardial Fibrosis market in 2019.

North America (USA, Canada, & Mexico)South America (Brazil, Argentina)Asia-Pacific (China, Japan, Korea, India, Indonesia, & Australia)Europe (Turkey, Germany, Russia, UK, Italy, France)The Middle East and Africa (GCC Countries & Egypt)and the rest countries of each region

Key Questions Answered In The Report Include:

What will the growth rate and market size be in 2026?What are the key factors driving the global Myocardial Fibrosis market?What are the key market trends impacting the growth of the global Myocardial Fibrosis market?What are the challenges to market growth?Who are the key vendors in the global Myocardial Fibrosis market?What are the market opportunities and threats faced by the vendors in the global Myocardial Fibrosis market?Growing factors affecting the market shares of the EMEA, Americas, and APAC.What are the key outcomes of the five forces analysis of the global Myocardial Fibrosis market?

What the Report has in Store for you?

Industry Size & Forecast: The industry analysts have offered historical, current, and estimated projections of the industry size from the value and volume point of view

Future Opportunities: In this section of the report, Myocardial Fibrosis participants are provided with the information on the future prospects that the Myocardial Fibrosis industry is likely to offer

Industry Trends & Developments: Here, authors of the report have talked about the major trends and developments taking place in the Myocardial Fibrosis marketplace and their estimated impact on the overall growth

Study on Industry Segmentation: Detailed breakdown of the key Myocardial Fibrosis industry segments including product type, application, and vertical has been done in this portion of the report

Regional Analysis: Myocardial Fibrosis vendors are offered crucial information about the high growth regions and their respective countries, thus helping them to invest in profitable regions

Competitive Landscape: This unit of the report throws light on the competitive scenario of the Myocardial Fibrosis industry by focusing on the key strategies taken up by the vendors to consolidate their presence in the Myocardial Fibrosis business.

The study report includes the following chapters:

Chapter 1, describe market overview, market opportunities, market driving force, market risks, and Myocardial Fibrosis product scopeChapter 2, profile the top manufacturers of Myocardial Fibrosis, with sales, revenue, price, and global market share of Myocardial Fibrosis in 2019 and 2020Chapter 3, the Myocardial Fibrosis competitive situation, sales, revenue and global market share of leading manufacturers are analyzed decisively by landscape contrastChapter 4, the Myocardial Fibrosis breakdown data are shown at the regional level, to show the sales, revenue, and growth by regions, from 2020 to 2025Chapters 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue, and market share for key countries in the world, from 2020 to 2026Chapters 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2020 to 2026Chapter 12, Myocardial Fibrosis market forecast, by regions, type, and application, with sales and revenue, from 2020 to 2026Chapter 13, 14 and 15, to describe Myocardial Fibrosis sales channel, distributors, customers, research findings and conclusion, appendix and data source

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Global Cell Culture Market 2020 Valuable Growth Prospects and Upcoming Trends till 2025 – The Fuel Fox

March 30th, 2020 5:46 am

The latest report entitled Global Cell Culture Market Growth 2019-2024 provides a detailed evaluation of the business vertical which contains a detailed evaluation of the business vertical. An exceptionally workable estimation of the present industry scenario has been delivered in the report, highlighting regional market scope, product-market various applications, market size according to a specific product, sales and revenue by region, manufacturing cost analysis, industrial chain, market effect factors analysis, market size forecast for 2020 to 2025 time-period, and more. The report discusses industry top manufacturers along with their companys profiles, financial analysis, overview, market revenue, by geographical regions.

Top companies in the global Cell Culture market: Thermo Fisher , PromoCell , Merck Millipore , GE Healthcare , BD , Corning , HiMedia , Takara , CellGenix , Lonza , ,

On the basis of region, the market is categorized into the following regions: Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries)

DOWNLOAD FREE SAMPLE REPORT: https://marketandresearch.biz/sample-request/99495

The research study demonstrates a complete view of the global Cell Culture market by diversifying it in terms of product type, application, and region. Moreover, the report revises the market share held by the key players and forecast their development in the upcoming years. It offers a better understanding of the market competitors, key trends, product innovations, market size value/volume (regional/country level, industry segments), and market share of top players/products. A comprehensive analysis of the market dynamics that is all-inclusive of market drivers, restraints, and opportunities is part of the report.

Market segment by type covers: Classical Media & Salts , Serum-free Media , Stem Cell Media , Others , ,

Market segment by applications can be divided into: Biopharmaceutical Manufacturing , Tissue Culture & Engineering , Gene Therapy , Other , ,

Further analysts have analyzed the production and consumption of the market. Here the analysis of the production, revenue, gross margin of its main manufacturers and the unit price with respect to production has been presented. With respect to consumption, the report analyzes the consumption volume, consumption value, sale price, import and export in different regions from 2014 to 2020. The study also gives a prediction of its production and consumption in the coming 2020-2025. Additionally, down, upcoming advancements and changes in the global Cell Culture are further expected to fuel the growth of the global market during the forecast period of 2020-2025.

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Here Are Some Key Takeaways From The Global Cell Culture Report:

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Cell Sorting Market 2020 to Witness Exponential Growth. Top Growing Companies are Breathalyzers, Akers Biosciences Inc., Alcohol Countermeasure…

March 30th, 2020 5:46 am

In this Cell Sorting market report, breakdown and estimations of important industry trends, market drivers, market restraints, market size, market share and sales volume have been explained very well. This global market report gives CAGR value fluctuation during the forecast period of 2020-2027 for the Healthcare industry that helps in estimating investment and costing. To take decisions of growing or lessening the production of goods depending on the general market conditions and demand, plentiful information accompanied with deep Cell Sorting market insights plays a supportive role. Most recent and established tools and techniques are utilized exceptionally to make the report outstanding.

Cell sorting market is expected to experience market growth at a rate of 7.87% in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 502.27 million by 2027. Due to the wide-scale acceptance of cell sorting techniques as a method of increasing the understanding of tissues and cell samples, market players have developed specialized reagents designed for each individual application of cell sorting methods.

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The major players covered in the Cell Sorting Market report are Abcam plc, Sepmag, BD, Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Sony Biotechnology Inc., Miltenyi Biotec, Thermo Fisher Scientific Inc., Sysmex Partec GmbH, On-chip Biotechnologies. Co., Ltd., Cytonome/ST, LLC, Union Biometrica, Inc., Luminex Corporation, pluriSelect Life Science UG (haftungsbeschrnkt) & Co. KG, STEMCELL Technologies Inc., TERUMO BCT, INC., Cellular Highways, Abgenex, among other players domestic and global. Market Share data is available for Global, North America, Europe, Asia-Pacific, Middle East & Africa and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Market Analysis and Insights:Global Cell Sorting Market

In February of 2019, Institute of Life Sciences announced that they had developed a modernized magnetic cell separation kit designed for its application in various research-based and medical applications. This kit termed as QuikSort has been developed to improve the cost-effectiveness of the cell sorting instruments and kits currently commercialized in the market where Abgenex will be responsible for its commercialization. The kit has been based on the patented technology and will be responsible for the separation of only specific cells

Cell sorting is defined as that technology field which enables isolation of cells from the tissue sample based on their type. This technology invokes differentiation of cells based on the different size, shape, surface protein expression amongst various others. This technology results in the growth of these cells in a clump that does not consist of any adhesion.

There has been a renewed level of focus from the healthcare industry on furthering their understanding of human tissues and cells, this focus has essentially given rise to an increased level of consumption for different varieties of research based products, solutions and technologies consisting of cell sorting techniques of research. Along with the growing volume of research activities, the significant growth witnessed by the pharmaceutical and biotechnology organizations resulting in enhanced consumption rate for research based products and solutions are all factors expected to drive the growth of cell sorting market in the forecast period of 2020 to 2027.

This market report provides details of market share, new developments, product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Briefour team will help you create a revenue impact solution to achieve your desired goal.

Global Cell Sorting Market Scope and Market Size

Cell sorting market is segmented on the basis of technology, product & service, application and end user. Each individual segments growth is analysed and these insights are subsequently considered before providing you with the market overview which can help you in understanding and identification of your core applications in the broad market.

Based on technology, cell sorting market consists of gradient centrifugation, cell markers-based and sorting on microchips. Cell markers-based segment is further segmented as fluorescence-based droplet cell sorting, magnetic-activated cell sorting (MACS) and micro-electromechanical systems (MEMS)-Microfluidics. Fluorescence-based droplet cell sorting is further sub segmented into jet-in-air cell sorting and cuvette-based cell sorting.

Cell sorting market has been segmented based on product & service into cell sorters, cell sorting reagents & consumables and cell sorting services. Cell sorters have been sub-segmented on the basis of price range into high-range cell sorters (above USD 300,000), mid-range cell sorters (USD 200,000-USD 300,000) and low-range cell sorters (below USD 200,000).

On the basis of applications, cell sorting market has been segmented as research applications and clinical applications. Research applications segment consists of immunology & cancer research, stem cell research, drug discovery and others.

Cell sorting market has also been categorized into research institutes, medical schools & academic institutions, pharmaceutical & biotechnology companies and hospitals & clinical testing laboratories on the basis of end user.

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Cell Sorting Market Country Level Analysis

Global cell sorting market is analysed and market size information is provided by country, technology, product & service, applications and end user as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific in the Asia-Pacific, Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa as a part of Middle East & Africa, Brazil, Argentina and Rest of South America as part of South America.

North America will be responsible for having the largest market share in the cell sorting market, whereas Asia-Pacific will hold the highest growth rate. This position of North America is due to the availability of advanced healthcare infrastructure, focus of the market players in the region to advance the levels of cancer research and improvements in therapeutics development processes. Whereas, Asia-Pacific is experiencing high prevalence of chronic diseases such as HIV, cancer and other applicable disorders resulting in lucrative opportunities for market growth in the forthcoming period.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, disease epidemiology and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands impact of sales channels are considered while provided forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Cell sorting market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for cell sorting market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the cell sorting market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Cell Sorting Market Share Analysis

Cell sorting market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies focus related to cell sorting market.

TTP plc in April 2019 announced that they had invested approximately USD 2.2 million to improve the pace of commercialization for their Highway 1, companys bench-top cell sorting instrument. The instrument is developed to meet the various requirements such as improvements in cell sorting operations of different applications such as cell therapies, liquid biopsy diagnostics and high-throughput drug discovery amongst various others. The instrument has been based on the companys Vortex-Actuated Cell Sorting technology and will be commercialized by Cellular Highways which has been established as a spin-off of TTP plc

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Cell Sorting Market 2020 to Witness Exponential Growth. Top Growing Companies are Breathalyzers, Akers Biosciences Inc., Alcohol Countermeasure...

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From Coronovirus to the Green New Deal – The Bullet – Socialist Project

March 30th, 2020 5:46 am

Environment March 30, 2020 Richard Sandbrook

When we have dealt with the coronavirus crisis, we need to address the climate emergency. We have learned a lot from handling the pandemic that will help in tackling climate change.

Having learned these lessons, one hopes that recovery from the pandemic-recession would be the ideal time to leap to a green economy. Carbon emissions have fallen, as has consumption, and fracking and oil-sands production are no longer economically viable. [Canadian Crude has dropped from $52 a year ago to $8.50 today.] The battle against the coronavirus has demonstrated the importance of public goods such as health services and unemployment benefits and the centrality of collective action in an emergency. To reverse the economic slump, create good jobs and decarbonize the economy, we could massively invest in green energy and green infrastructure.

We could do so. It makes good sense to do so. Many people might now be willing to support such measures. But the problem is that global heating is primarily a political problem. Even with existing technologies, let alone those that will be available within five years, we could attain a carbon-neutral economy in a decade or two. The 2017 book Drawdown: The Most Comprehensive Plan Ever Proposed to Reverse Global Warming presents a hundred ranked solutions to global warming, drawing on the work of about 200 scientists. Climate activists and scientists have reason and evidence-based projections on their side, but power structures and the culture of possessive individualism buttress the existing carbon-intensive system.

The problem is not that we dont know what to do, but that we dont do it. What we should do is implement a Green New Deal that combines socioeconomic transformation with ecological protection. This is rapidly becoming the defining position of the broad left, as ably presented by Naomi Klein in a recent book On Fire: The (Burning) Case for a Green New Deal. But achieving such a goal is fraught with political dangers and obstacles. We need to reckon with these now in order to avoid the shoals. The passage is inevitably perilous.

It is widely believed, at least by those under 40, that only a mass movement creating a lot of disruption can prevail on governments to take climate change seriously. Few readers of The Bullet would disagree. And this is an era of mass protests, many successful. In 2019, these protests occurred on every continent and across 114 countries, in the global south and north. But forming a mass movement, though a difficult challenge by itself, is just the beginning. In a turbulent and polarized era, spontaneity must give way to strategic planning.

Recently, the climate movement has gained considerable momentum. The ramping up of campaigns to divest from carbon stocks, the climate strikes organized by school students throughout the world, the worldwide protests of Extinction Rebellion and other groups. The flurry of dire reports on climatic trends all these events have brought climate issues to the forefront in rich countries. In the US, there is evidence of a cultural shift that has fossil fuel companies running scared. And media outlets are also reporting more and more urgently on climate issues, in some cases (for example UKs The Guardian) adopting the phrases climate crisis or climate emergency in reportage. We are making progress, and the struggle to banish the coronavirus shows what can be done in an emergency. But much more needs to be done.

Reversing global warming at this late stage requires deep changes in production, distribution and consumption. You dont need to be a socialist to accept this statement; it is common sense. If we had seriously responded two or three decades ago, when the science of climate change was already established, more minor actions might have sufficed. A robust and progressive carbon tax, if instituted then, might have been enough. But remediation at this point demands more radical measures.

Consider the magnitude of the challenge. The safe concentration of CO2 in the atmosphere is 350 ppm. In February, readings recorded 413 and 414 ppm. According to NASA, this concentration is higher than its been in 3 million years. Although there is a lag between high concentrations and climate heating, that heating will come even if we achieve a carbon neutral economy. The challenge is not just net-zero emissions but drawing carbon out of the atmosphere. And to hold warming to under 2C (the maximum tolerable change), according to the well-known estimate of the Intergovernmental Panel on Climate Change (IPCC), requires cutting carbon emissions in half in a decade and attaining net-zero by 2050. And that in a time when emissions were rising (until the coronavirus-induced recession).

This urgency has given rise to the advocacy of a Green New Deal (GND), Green Marshall Plans, and Just Transitions. The Leap Manifesto, the forerunner of these programs in Canada, contained most of the elements. They included a transition to 100% renewable energy by 2050, the building of a more just society in the process, the enactment of higher, and new forms of, taxes, and a grassroots movement to back the needed changes and to deepen democracy.

Although Green New Deals (the most popular formulation) vary in their ambition from one iteration to another, the logic is the same. Ecological transformation cannot be achieved without deep economic and social changes, both as an end (to cut emissions) and as a means (to win popular support). The transition to a net-zero carbon economy must be just and systemic to be effective.

Famously or infamously, the GND sponsored by Alexandria Ocasio-Cortez and Ed Markey in the form of a resolution in the US House of Representatives in 2019, follows this logic. Denounced as a socialist plot, the plan is closer to a Rooseveltian New Deal for the 21st century. It calls for a 10-year national mobilization to achieve 100% renewable energy, giant investments in infrastructure and a carbon-free economy, and jobs for all who want to work. Accompanying the transition are measures that are mainstream in Western welfare states: universal healthcare, free higher education, affordable housing, enhanced labour rights, a job guarantee, and remedies for racism. Enforcement of anti-trust laws would, if successful, weaken the economic and political power of oligopolies. We can argue about the degree of systemic change that is needed. Any effective plan, however, must garner support through a vision of a better life, not just fear.

Conservatives, especially right-wing populists, have become climate-deniers, partly on the grounds that combatting climate change is a socialist Trojan horse. They are certainly right that the GND is a progressive project, but whether it is necessarily a socialist project is debatable. It depends partly on ones definition of socialism. For the sake of unity in a diverse movement, that debate is one we should avoid.

Regardless of ones position, we can agree the stakes are high. Powerful interests will lose out, and they will resist.

The deep economic and tax changes required to drastically cut emissions will saddle major corporations and wealthy individuals with major losses in assets, income and power. As reported in the Globe & Mail on 12 Feb 2020, Canadas banking regulator says the financial sector should assume the transition to a low-carbon economy will be sharply negative. A few brief illustrations suggest why.

These threats to the profitability and even survival of major corporations add up to a major challenge to plutocracy.

Plutocracy is a term now widely used, in this neoliberal era, to describe the fusing of economic with political power in Western liberal democracies. The result is that economic and other policies are skewed to the advantage of the top one per cent. This idea is so widely accepted that even economists, mainly the maverick variety such as Paul Krugman, employ the concept.

Its applicability, however, should not be restricted to degraded liberal democracies such as the US and the UK, but extended to authoritarian cases such as Russia and China. In the latter cases, political power has encroached on economic power, a reversal of the process in the West. But the outcome is similar: a power structure highly resistant to the major changes proposed by Green New Deals. True, some investors are attracted to the investment opportunities offered by the green economy. However, the threat to key industries may cast climate activists not as benign tree-huggers, but as security threats.

Even a cursory Google search uncovers disconcerting evidence that security services view climate activists as threats to national security. In the United Kingdom, an anti-extremism briefing issued by the government to all schools and other institutions in late 2019 included environmental groups and anti-racism organizations along with neo-Nazi and Islamist groups in the list of suspects. Greenpeace, Extinction Rebellion, Sea Shepherd, Stop the Badger Cull, PETA and a vegan organization all respectably non-violent in tactics appeared. Readers were advised to be aware of the symbols employed by extremist groups and report any concerns to counter-terrorism police.

In Canada, documents released under Freedom of Information Act revealed that, during the era of Conservative government under Stephen Harper, the two main counter-terrorism agencies regarded environmental and indigenous activists as extremists. Security and police services regularly monitored these activists. Security agencies regarded protests and opposition to Canadas resource-based economy, especially oil and gas, as national-security threats (Guardian, Feb 14, 2013). The National Observer, an award-winning digital newspaper specializing in human-rights issues, reported in 2016 and 2017 that surveillance of environmental activists (which includes indigenous activists) was undertaken by the RCMP (the national police force), Canadian Security and Intelligence Service, provincial police forces and, in some large cities, municipal police forces. Jeffrey Monaghan, a Carleton University criminologist studying espionage, identifies a petro-security apparatus linking security agencies to energy corporations in Canada. This collaboration flows from the alleged threat to critical infrastructure posed by environmental activists. So the warning signs are there.

Its a safe bet that climate activists, albeit engaged in legitimate non-violent action, are under surveillance in plutocracies both western and eastern. And thats in a time of relative calm. Perhaps thats just par for the course in what has been dubbed surveillance capitalism. What is troubling is that the means of surveillance facial recognition and tracking of individuals via their cell phones is now far advanced. Should it come to a crackdown, security agencies will already know who is involved in climate activism and where they live. Civil disobedience will be seen as extremism.

What makes this outcome probable is that the climate crisis is not a stand-alone crisis; it is part of a multi-dimensional crisis of neoliberalism. This unbridled variety of capitalism has fostered problems it is unable to solve. That of course is one reason why the Green New Deals normally advocate social and economic, in addition to ecological, transformation. The Green New Deal is an alternative to neoliberalism, though not necessarily to capitalism. It is a reasonable and just response. That matters little, however, in a context increasingly characterized by dislocation, insecurity and polarization. The multidimensional crisis threatens disorder and therefore property rights. The deeper the disorder and polarization, the more likely a right-wing reaction becomes.

We might describe the simultaneous crises in various ways. They afflict the countries of the global south even more than the north, but here Im narrowing my attention to the latter. In the West in particular, three trends are asserting themselves:

These trends in tandem produce a treacherous environment.

Consider the robotics revolution. The significance of this technological shift is best understood in the context of recent history.

Neither digitalization nor the more recent sharing economy lived up to its early promise of ushering in shared prosperity or more flexible working arrangements. Instead, the neoliberal age has seen inequality and insecurity rise to new levels. This story is well known. The gig economy with its precarious and poorly paid jobs has expanded to encompass one-third of all jobs in the US, according to some estimates. Millennials in particular have had trouble finding good jobs, as well as being saddled with high debts from post-secondary education. Moreover, the economic collapse of 2008 dealt a heavy blow to many in the middle and working classes. Their recovery took years, and it is now threatened by the recession induced by the coronavirus pandemic in 2020.

The fourth industrial revolution of robotics is wreaking further insecurity. The higher productivity wrought by artificial intelligence could lead to a greener, more egalitarian future where available work is shared and working hours shrink. But that will not happen automatically, especially in societies already characterized by inequality, precarious employment and weak democracy.

The employment impact during the next 30 years is likely to be major. Artificial intelligence, as it well understood, displaces workers not just in routine activities in the industrial and service sectors, but in professional occupations as well. A 2017 report by the McKinsey Global Institute estimates that just over half of the waged tasks in 2017 could be done by robots and computers by 2050. In the next decade, 14 per cent of the global workforce will lose their jobs according to the institutes mid-way estimate. The job loss in industrial countries such as the US, Japan and China are much higher than the world average. These estimates, of course, simply tell us what could happen, given technological developments, not what will happen. Political trade-offs and union power, where it exists, may intercede to save jobs. Nonetheless, a lot of people in good jobs as well as bad are going to be out of work.

Economists are confident that the economy will develop new jobs to replace those that are lost: in the longer run. There will be a lag. And will those who lose their jobs be qualified for the tech-savvy, knowledge-based jobs that do emerge? Perhaps if the governments were willing to invest heavily in retraining people for the new economy. However, we cant expect that expensive path to be taken in plutocracies responsive to the demands for the wealthy for lower taxes. We are more likely to see, in many Western countries, further marginalization and inequality.

You dont need to be a rocket scientist, or even a political scientist, to foresee the political dynamics of the unfolding crisis of neoliberalism. Social stress is rising. A growing sense of marginalization and precarity is likely to produce higher anger and resentment, especially at times of recession.

Simultaneously unless we respond swiftly global heating will precipitate extreme weather events that wreak widespread damage. More extensive heat waves, floods, droughts, fresh-water shortages, inundations of coastal cities and islands, falls in agricultural and fishing yields and declines in human health are rendering certain regions uninhabitable while inducing panic.

The consequent population movements add another element of instability. The global south, suffering a more extreme climatic shift than in the north, will witness a growing stream of climate migrants to join the existing refugees displaced by war and disorder. Estimates of the numbers of climate migrants vary, but the most frequent estimate is 150-200 million by 2050. This total includes temporary as well as permanent migrants, and those who are internally displaced as well as cross-border migrants. At the minimum, several millions will join political refugees in heading for sanctuary in Europe, North America and Australia in recurrent waves.

These migrants are the victims of a climatic shift for which they bear virtually no responsibility. The rich countries, having generated most of the carbon in the atmosphere, have an ethical duty to be generous in their reception of these migrants. And yet. The movement of just a million migrants to Europe in 2015-2016 amplified support for right-wing populist parties throughout the continent. The new waves are likely to be far more numerous.

The political danger is clear. With threats to property posed by mass movements and the radical policies of the Green New Deal, concentrated economic power may ally with reactionary political forces. Conservatives feeling under threat from social movements and generalized anxiety will be tempted to turn to reactionary political forces as a means of re-establishing order and safeguarding power and property (as in the 1930s). Hitherto climate-deniers on the right may see in the unfolding of climate change an unparalleled opportunity: to appeal to the ethno-nation, casting migrants and immigrants and their elite enablers as the enemy.

The situation is the more dangerous owing to the decline of democratic institutions. Trust in government has declined during the past two decades world-wide according to numerous surveys. The Edelman Trust Barometer 2020, which surveyed population in 28 countries in late 2019, concluded that a global trust crisis is deepening. More than half the population of developed liberal democracies felt that democracy is losing its effectiveness and 56 per cent believed that capitalism does more harm than good. The far right thrives on declining trust, fear and lies.

Fortress America or Fortress Europe is the opposite of the Green New Deal. It means restricting liberal freedoms, closing borders, blaming aliens, repressing dissent and regulating national economies while safeguarding existing property rights and ethnic and class hierarchies. It involves abandoning the global south to its fate and reversing globalization. Fascism has no viable answer to the climate crisis or the socioeconomic crisis except repression.

Our future could indeed be dark, but our task is to ensure that what could happen, doesnt happen. Within limits, we can make history.

Reversing climate change is a hard sell in societies where right-wing populists have gained a following among the less-educated and more rural elements of the population. Climate change is as much a threat to these elements as to cosmopolitan elites, but the former do not see it that way. Climate change has become entangled in political polarization. Conservative populists have cast climate change as a hoax allowing governing elites to impose new taxes, expand state intervention and welcome new waves of migrants. The populist message resonates with those who feel left behind. Inequality, the exodus of good jobs, and a loss of status in multicultural societies generate resentment, anger and mistrust. Populists have shaped this anger; the left has not.

How then can the climate movement break through the class division? How can they dispel the mistrust to expand their support beyond affluent urbanites and the more highly educated? The only feasible strategy is one that attacks inequality and precarity together with global warming. Hence the importance of the Green New Deal. It envisions a more desirable and feasible future than that offered by nationalist populists.

The GND provides a vision of universal well-being to counter the hateful message of ethno-nationalism. We all the people are vulnerable to climate change, and thus must work in unison. We have a common enemy threatening our future: an economic system that is out of control. We can win the struggle by making a just transition to a net-zero carbon economy through measures that also create an egalitarian, secure and democratic society. That story-line may not work, but its the best available.

But can we forge a broad coalition of progressive forces animated by this vision? Unity and coherence are key. Civil society encompasses a variety of social movements, each with its own agenda, whether social, economic, or ecological. Furthermore, the movements operate at different levels. Some are local, some regional or national, and others transnational. Consequently, there is a cacophony of voices: how do we make them into a choir, singing the same hymn? Presumably, a political party tries to organize and channel the demands. Which party, however?

That raises the issue of the political hue of the GND. Naomi Klein contends, and I agree, that the climate movement is inherently a movement of the left. It seeks social and economic change to achieve its climate objectives. But what left? The fact is that the left has never been good at creating unity (unlike the right); some factions seem more engaged in attacking back-sliders in their own camp than engaging with the real enemy. Achieving an accord is a major challenge.

Can this change, as the threat from the far right escalates? The coalition, to be successful, would surely need to unite most climate activists with left liberals, human-rights defenders, trade unions, social democrats, socialists, indigenous activists, and identity-based groups seeking justice. Perhaps the most fruitful coalition-building strategy is to articulate a powerful vision but offer a program that remains vague in details about the future sustainable society.

But we can all agree that, in means as well as ends, the Green New Deal is a democratic project. Democracy, unfortunately, does not now favour the project of halting global heating. When given the opportunity, electorates throughout the world have voted against, or even rebelled against (as with the gilets jaunes in France), carbon taxes and other inconvenient climate measures. Political polarization and widespread alienation are having this effect. Democracy is thus a gamble, but a necessary one. Only if the Green New Deal is popular will it succeed. Yet if the polarization deepens, the struggle will ultimately be waged between a democratic and egalitarian new deal and an increasingly authoritarian, ultra-nationalist populism.

Finally, we need to counter ethno-nationalism with progressive internationalism. The fight for a Green New Deal cannot be exclusively fought at the national level. Climate change is a global issue and requires global cooperation. I cannot broach the many issues surrounding a progressive international order here. But one contentious issue open borders as part of a just transition does require comment.

Presumptive admission of climate migrants to apparent havens in North America, Europe and Australia is ethically admirable. The emissions that have caused the crisis in the global south have emanated largely from the global north (in addition to China and India more recently). But presumptive admission would likely be politically disastrous. It would provide the Far Right with an issue it could exploit.

If open borders is a policy that is right in principle but disastrous in practice, one is obliged to discuss other options. Winning power or influence is crucial for our success. Certainly, we must support a generous immigration policy. But that will not be enough to fulfill our moral obligation. Major transfers from the rich countries to the global south for mitigating climate change are critical. The Paris Agreement obliges rich countries to make financial and other transfers, but governments have shirked their obligations. A Green New Deal must include provisions for a generous immigration policy (though not presumptive admission for all), together with major transfers of green technologies and financial resources to the beleaguered populations of the global south. Even those pragmatic measures, however, may not be enough to stem the popular appeal of Fortress Europe and Fortress America.

The climate movement, with its allies, is called upon to make history at a critical juncture. The threat posed by climate change is more complex and, in the longer term, more deadly than that posed by the corona virus. But the pandemic has shown what can be done in an emergency. Can we harness the lessons weve learned? Whether we succeed cannot be foretold, and a livable and just world hangs in the balance.

Richard Sandbrook is Professor Emeritus of Political Science, University of Toronto.

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The human DNA is littered with fossils of viruses past that attacked us. And lost – Telegraph India

March 30th, 2020 5:44 am

English naturalist Charles Robert Darwins seminal book On the Origin of Species by Means of Natural Selection went to press in 1859. That was 40 years before the concept of viruses was introduced to the world of science by Russian botanist Dmitri Ivanovsk. It took another century for viral researchers to decipher the genetic make-up of these infectious agents, to find out how they replicate and spread disease.

Darwin shunned and ridiculed after the publication of his book would probably be amazed to know that viruses such as the Covid-19 are considered living evidence of his theory of evolution.

If Charles Darwin reappeared today, he might be surprised to learn that humans are descended from viruses as well as from apes, British microbiologist Robin Weiss wrote in the journal Retrovirology. He was referring to fragments of retroviruses close cousins of the coronavirus found in the human genome.

These fragments are the fossils of a number of killer viruses, including several novel reassortments of influenza or coronaviruses that ravaged humans on a large scale in the past. These so-called endogeneous retroviruses (ERVs) are actually trophies of ancient molecular battles between viruses and their human hosts one which the humans eventually won. Some 8 per cent of human DNA represents fossil retroviral genomes, pointed out Weiss in his seminal research paper in 2010.

When competing groups of scientists in different parts of the world fully mapped the human genome in 2003, they found something they had never anticipated: bits that have no known function. Many scientists termed these seemingly inert shards junk DNA that littered our bodies. In the following decade, however, geneticists realised that some of those bits were actually endogenous retroviruses, fossils of defeated viruses that managed to invade our bodies but were disabled by our immune system. In Darwinian terms, in the struggle for existence our immune system got better of them and there was survival of the fittest through natural selection. Instead of getting buried as mineralised relics, these viruses reside within our DNA as bits of genetic code carrying records of millions of years but forever disabled, with no power to make us sick.

The discovery of the human genome as a living document of ancient and now extinct viruses prompted the emergence of a new field called palaeovirology. Two of its proponents, Michael Emerman and Harmit S. Malik, at the Fred Hutchinson Cancer Research Center in Seattle, US, define palaeovirology as the study of extinct viruses (called palaeoviruses) and the effects these agents have had on the evolution of their hosts. In other words, indirect evidence of these viral fossils can help reconstruct the past and offer clues on how to fight emerging viral epidemics or pandemics.

Malik grew up in Bombay and studied chemical engineering at the Indian Institute of Technology there. He studies evolving proteins and the genetics of evolutionary conflict embedded in the molecules, which has helped him uncover previously unrecognised sources of conflict.

As a pioneer palaeovirologist, Malik is fascinated by the constant battle being waged between humans and viruses for hundreds of thousands of years. In the course of his study, he found telltale imprints in our genome that narrate the story of how viruses infected our cells, how sometimes we have fought back by changing our protein and how sometimes viruses evaded them to get an upper hand. This evolutionary cat-and-mouse game has shaped our defence against viruses.

Palaeovirologists have also studied how similar viruses have attacked our close relatives, the primates chimpanzees and gorillas and compared how we have fared in these battles. For instance, the virus that leads to to the killer disease Aids in humans does not have much of an effect on chimps. What makes chimps relatively immune to this scary virus? Malik and Emerman found the clue to this mystery in an endogenous retrovirus called Pterv found in chimps (and other apes) but not in humans. They surmised that the retrovirus may have infected both humans and chimps about 4 million years ago. We learnt to stave off the virus while the chimps were hit by an epidemic. A gene called Trim 5 alpha is believed to have helped humans make a protein to purge the virus.

Malik and his colleagues reconstructed a part of the Pterv through computer modelling and found that while Trim 5 alpha helped us prevent the entry of the virus, it made us vulnerable to the HIV virus that causes Aids. However, the monkey version of the gene helps protect the apes from HIV and Aids. They concluded that if we can develop a therapy based on the Trim 5 alpha protein, it could defeat HIV. Research on drugs based on such evolutionary principles, however, is few and far between

Scientists have been studying several resurrected palaeoviruses like Pterv through evolution-guided reconstruction procedures. In 2005, researchers at the US Centers for Disease Control and Prevention (CDC), reconstructed the influenza virus that caused the 1918-19 flu pandemic, which killed as many as 50 million people worldwide. According to CDC, the research provides new information about the properties that contributed to its exceptional virulence. The natural emergence of another pandemic virus is considered highly likely by many experts, and therefore insights into pathogenic mechanisms can and are contributing to the development of prophylactic and therapeutic interventions needed to prepare for future pandemic viruses, says a CDC release.

The rapid evolution of viruses and emergence of the new coronavirus Covid-19 has once again shown that viruses evolve by the same means as humans. Many of these viruses hop from animals to humans and evolve, swapping genetic material in and out of respective genomes. Thats why we can have immunity to a virus weve had in the past, but get seriously affected by one our body has never seen before.

Somewhere, Darwin must be feeling vindicated that his theory is so starkly exposed in a viral machinery.

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The distorted idea of ‘cool’ brain research is stifling psychotherapy – The Next Web

March 30th, 2020 5:44 am

There is always a well-known solution to every human problem neat, plausible, and wrong.From Prejudices (1920) by H L Mencken

There has never been a problem facing mankind more complex than understanding our own human nature. And no shortage of neat, plausible, and wrong answers purporting to plumb its depths.

Having treated many thousands of psychiatric patients in my career, and having worked on the American Psychiatric Associations efforts to classify psychiatric symptoms (published as the Diagnostic and Statistical Manual of Mental Disorders, or DSM-IV and DSM-5), I can affirm confidently that there are no neat answers in psychiatry. The best we can do is embrace an ecumenical four-dimensional model that includes all possible contributors to human functioning: the biological, the psychological, the social, and the spiritual. Reducing people to just one element their brain functioning, or their psychological tendencies, or their social context, or their struggle for meaning results in a flat, distorted image that leaves out more than it can capture.

The National Institute of Mental Health (NIMH) was established in 1949 by the federal government in the United States with the practical goal of providing an objective, thorough, nationwide analysis and reevaluation of the human and economic problems of mental health. Until 30 years ago, the NIMH appreciated the need for this well-rounded approach and maintained a balanced research budget that covered an extraordinarily wide range of topics and techniques.

But in 1990, the NIMH suddenly and radically switched course, embarking on what it tellingly named the Decade of the Brain. Ever since, the NIMH has increasingly narrowed its focus almost exclusively to brain biology leaving out everything else that makes us human, both in sickness and in health. Having largely lost interest in the plight of real people, the NIMH could now more accurately be renamed the National Institute of Brain Research.

Read: [How tech is helping brain-injured patients with decision-making]

This misplaced reductionism arose from the availability of spectacular research tools (eg, the Human Genome Project, functional magnetic resonance imaging, molecular biology, and machine learning) combined with the naive belief that brain biology could eventually explain all aspects of mental functioning. The results have been a grand intellectual adventure, but a colossal clinical flop. We have acquired a fantastic window into gene and brain functioning, but little to help clinical practice.

The more we learn about genetics and the brain, the more impossibly complicated both reveal themselves to be. We have picked no low-hanging fruit after three decades and $50 billion because there simply is no low-hanging fruit to pick. The human brain has around 86 billion neurons, each communicating with thousands of others via hundreds of chemical modulators, leading to trillions of potential connections. No wonder it reveals its secrets only very gradually and in a piecemeal fashion.

Genetics offers the same baffling complexity. For instance, variation in more than 100 genes contributes to vulnerability to schizophrenia, with each gene contributing just the tiniest bit, and interacting in the most impossibly complicated ways with other genes, and also with the physical and social environment. Even more discouraging, the same genes are often implicated in vulnerability to multiple mental disorders defeating any effort to establish specificity. The almost endless permutations will defeat any easy genetic answers, no matter how many decades and billions we invest.

The NIMH has boxed itself into a badly unbalanced research portfolio. Playing with cool brain and gene research toys trumps the much harder and less intellectually rewarding task of helping real people.

Contrast this current NIMH failure with a great success story from NIMHs distant past. One of the high points of my career was sitting on the NIMH granting committee that funded psychotherapy studies in the 1980s. We helped to support the US psychologist Marsha Linehans research that led her to develop dialectical behavior therapy; the US psychiatrist Aaron T Becks development of cognitive therapy; along with numerous other investigators and themes. Subsequent studies have established that psychotherapy is as effective as medications for mild-to-moderate depression, anxiety, and other psychiatric problems, and avoids the burden of medication side-effects and complications. Many millions of people around the world have already been helped by NIMH psychotherapy research.

In a rational world, the NIMH would continue to fund a robust psychotherapy research budget and promote its use as a public-health initiative to reduce the current massive overprescription of psychiatric medication in the US. Brief psychotherapy would be the first-line treatment of most psychiatric problems that require intervention. Drug treatments would be reserved for severe psychiatric problems and for those people who havent responded sufficiently to watchful waiting or psychotherapy.

Unfortunately, we dont live in a rational world. Drug companies spend hundreds of millions of dollars every year influencing politicians, marketing misleadingly to doctors, and pushing pharmaceutical treatments on the public. They successfully sold the fake marketing jingle that all emotional symptoms are due to a chemical imbalance in the brain and therefore all require a pill solution. The result: 20% of US citizens use psychotropic drugs, most of which are no more than expensive placebos, all of which can produce harmful side-effects.

Drug companies are commercial Goliath with enormous political and economic power. Psychotherapy is a tiny David with no marketing budget; no salespeople mobbing doctors offices; no TV ads; no internet pop-ups; no influence with politicians or insurance companies. No surprise then that the NIMHs neglect of psychotherapy research has been accompanied by its neglect in clinical practice. And the NIMHs embrace of biological reductionism provides an unintended and unwarranted legitimization of the drug-company promotion that there is a pill for every problem.

A balanced NIMH budget would go a long way toward correcting the two biggest mental-health catastrophes of today. Studies comparing psychotherapy versus medication for a wide variety of mild to moderate mental disorders would help to level the playing field for the two, and eventually reduce our massive overdependence on drug treatments for nonexistent chemical imbalances. Health service research is desperately needed to determine best practices to help people with severe mental illness avoid incarceration and homelessness, and also escape from them.

The NIMH is entitled to keep an eye on the future, but not at the expense of the desperate needs of the present. Brain research should remain an important part of a balanced NIMH agenda, not its sole preoccupation. After 30 years of running down a bio-reductionistic blind alley, it is long past time for the NIMH to consider a biopsychosocial reset, and to rebalance its badly uneven research portfolio.

This article was originally published at Aeonby Allen Frances and has been republished under Creative Commons.

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CMSS: 800000 physicians across 40 specialties continue to support travel and gathering restrictions – YubaNet

March 30th, 2020 5:44 am

March 27, 2020

Dear President Trump, Vice President Pence, and Ambassador Birx:

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Thank you for actively engaging the health care communityparticularly the nations physicians and the organizations that represent themin addressing the COVID-19 pandemic in the United States.

As more than 800,000 physicians across more than 40 specialties in medicine, we continue to support travel and gathering restrictions to slow the transmission of coronavirus disease 2019 (COVID-19). Physicians, other health professionals, and staff are putting themselves in harms way without adequate personal protective equipment or necessary tools (such as ventilators) as well as with no proven treatment or vaccine for the virus.

Significant COVID-19 transmission continues across the United States, and we need your leadership in supporting science-based recommendations on social distancing that can slow the virus. Our societies have closely adhered to these measures by moving our staff to fulltime telework and canceling in-person meetings (including annual meetings). These actions have helped to keep physicians and other health professionals in health care facilities, including hospitals, and reduce the risk of spreading COVID-19.

Statewide efforts alone will not sufficiently control this public health crisis. A strong nationwide plan that supports and enforces social distancingand recognizes that our health and our economy are inextricably linkedshould remain in place until public health and medical experts indicate it can be lifted.

Federal, state, and local governments should only set a date for lifting nationwide social distancing restrictions consistent with assessments by public health and medical experts. Lifting restrictions sooner will gravely jeopardize the health of all Americans and extend the devastation of the COVID-19 pandemic.

Again, thank you for actively engaging the nations physicians and the organizations that represent them. We appreciate your considering these comments and welcome an opportunity for further dialogue.

Sincerely,

Council of Medical Specialty Societies

American Academy of Allergy, Asthma & ImmunologyAmerican Academy of DermatologyAmerican Academy of Family PhysiciansAmerican Academy of Hospice and Palliative MedicineAmerican Academy of NeurologyAmerican Academy of OphthalmologyAmerican Academy of Orthopaedic SurgeonsAmerican Academy of PediatricsAmerican Academy of Physical Medicine and RehabilitationAmerican Association of Clinical EndocrinologistsAmerican College of CardiologyAmerican College of Emergency PhysiciansAmerican College of Medical Genetics and GenomicsAmerican College of Obstetricians and GynecologistsAmerican College of Occupational and Environmental MedicineAmerican College of PhysiciansAmerican College of Preventive MedicineAmerican College of RadiologyAmerican College of RheumatologyAmerican College of SurgeonsAmerican Epilepsy SocietyAmerican Gastroenterological AssociationAmerican Geriatrics SocietyAmerican Medical Informatics AssociationAmerican Psychiatric AssociationAmerican Society of AnesthesiologistsAmerican Society for Clinical PathologyAmerican Society of Colon and Rectal SurgeonsAmerican Society of HematologyAmerican Society of NephrologyAmerican Society for Radiation OncologyAmerican Society for Reproductive MedicineAmerican Thoracic SocietyAmerican Urological AssociationAssociation for Clinical OncologyInfectious Diseases Society of AmericaNorth American Spine SocietySociety of Critical Care MedicineSociety of Gynecologic OncologySociety of Hospital MedicineSociety of Interventional RadiologySociety of Nuclear Medicine and Molecular ImagingSociety of Thoracic SurgeonsSociety for Vascular Surgery

Founded in 1965 as the Tri-College Council, CMSS was created to provide an independent forum for the discussion by medical specialists of issues of national interest and mutual concern.Founding members were the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American College of Surgeons.In 1967, as other specialty societies joined, CMSS adopted its current name.Today,43 societies with more than 790,000 U.S. physician membersare members of CMSS. CMSS is a 501(c)(3) not-for-profit association incorporated in the state of Illinois. http://www.cmss.org

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