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Vertex Announces European Commission Approval for KALYDECO (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosi…

November 5th, 2020 9:55 am

Vertex Announces European Commission Approval for KALYDECO (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosis as Early as Four Months of Age

- Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe -

LONDON 4 November 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the EuropeanCommission has granted approval of thelabel extension for KALYDECO (ivacaftor) granules to include the treatment of infants with cystic fibrosis (CF) ages 4 months and older and weighing at least 5 kg who have the R117H mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

Our very first CFTR modulator, KALYDECO, was first approved eight years ago, for certain CF patients ages 6 years and older. With todays approval, babies as young as 4 months are eligible and we believe early treatment is important in managing CF, said Reshma Kewalramani, M.D., Chief Executive Officer and President, Vertex. Todays approval is a testament to our commitment to keep going until all people with CF have a treatment option.

The label update is based on data from a cohort in the 24-week Phase 3 open-label safety study (ARRIVAL) consisting of six children with CF ages four months to less than six months who have eligible gating mutations.

KALYDECO (ivacaftor) will be now available to additional eligible patients in Germany and will be available shortly in countries that have entered into innovative long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland. In all other countries, Vertex will work closely with relevant authorities in Europe to secure access for eligible patients.

KALYDECO (ivacaftor) is already approved in Europe for people with CF ages 6 months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N or S549R.

About Cystic Fibrosis

Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

About KALYDECO (ivacaftor)

Ivacaftor is the first medicine to treat the underlying cause of CF in people with specific mutations in theCFTRgene. Known as a CFTR potentiator, ivacaftor is an oral medicine designed to keep CFTR proteins at the cell surface open longer to improve the transport of salt and water across the cell membrane, which helps hydrate and clear mucus from the airways.

For complete product information, please see the Summary of Product Characteristics that can be found on http://www.ema.europa.eu.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 inCambridge, Mass.,Vertex's global headquarters is now located inBoston'sInnovation Districtand its international headquarters is inLondon. Additionally, the company has research and development sites and commercial offices in North America,Europe,AustraliaandLatin America.Vertexis consistently recognized as one of the industry's top places to work, including11 consecutive years onScience magazine'sTop Employers listand a best place to work for LGBTQ equality by the Human Rights Campaign. For company updates and to learn more about Vertex's history of innovation, visitwww.vrtx.comor follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Dr. Reshma Kewalramani in this press release, and statements regarding the eligible patient population in Europe, our expectations regarding the timing of access to KALYDECO for eligible patients four months of age and older across countries in Europe, and our plans to secure access to KALYDECO for additional eligible patients four months of age and older in Europe. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, risks related to commercializing KALYDECO in Europe, and other risks listed under Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Vertex Pharmaceuticals IncorporatedInvestors:InvestorInfo@vrtx.com

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617-961-7163

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WIRED Health:Tech 2020: Latest advances and the fight against COVID-19 – Medical News Today

November 5th, 2020 9:54 am

WIRED Health:Tech is one of the most prominent annual conferences exploring technological advances in medicine. This year, the main topics included artificial intelligence, remote surgical systems, and the ongoing fight against COVID-19.

This years WIRED Health:Tech conference took place online last month, in an effort to adapt to the challenges posed by the current pandemic.

A range of specialists held presentations about the latest advances in medical technology, including remote surgical systems, e-health, CRISPR technology, and the issue on everyones mind this year: how research can combat the COVID-19 pandemic.

In this Special Feature, we offer an overview of the panels and main takeaways from the presentations.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

Throughout many of the WIRED Health:Tech presentations, the recurring theme was how technology is helping or hindering the fight against SARS-CoV-2, the coronavirus that has given rise to the current pandemic.

Prof. Heidi Larson from the London School of Hygiene & Tropical Medicine in the United Kingdom spoke of the global response to vaccines, an issue of paramount importance in the context of the pandemic.

Prof. Larson noted that according to her and her colleagues research which appears in The Lancet peoples feelings about vaccines have become far more volatile.

Its a lot more like political opinion polling. They used to be much more stable 1020 years ago. You knew who agreed and who was less confident around vaccines, but thats changing very frequently, she observed.

However, she did offer some positive news:

The overall picture is that [] there is a general trend where people are becoming a little more confident [about vaccines] than they were 5 years ago.

According to Prof. Larson, this may be because public health specialists and communicators are more proactive in dismantling pervasive myths about vaccination over the past few years.

Nevertheless, she cautioned, we do see that Europe remains the lowest in confidence, the most skeptical, with countries like Lithuania [where] only 19% strongly believe that vaccines are safe. The highest [rate] is [in] Finland, at 66% and thats just strongly believe.'

Poland had the most significant drop in confidence in vaccines, she noted.

She also emphasized these fluctuations in confidence in vaccines across the globe occurred before the pandemic. In the current situation, Prof. Larson said, sentiments surrounding vaccinations have become even more volatile.

Because of the hyper-uncertainty and the whole environment of trust and distrust around the COVID vaccine, there are groups that have gotten together to resist even the COVID vaccine, she warned.

The danger of anti-vaccination mentalities can only be mitigated by giving science more of a human face, Prof Larson argued:

We need to bring together the scientific, technological advances that are so valuable, and not lose the human face, but bring that back together [with the scientific perspective]. This isnt just a misinformation problem. This is a relationship problem. This is a cultural revolution, saying we need to change, we need to get back to a more human face in the scientific and medical field.'

Prof. Devi Sridhar a public health advisor and the chair of the Global Public Health department at the University of Edinburgh in the U.K. spoke of the next steps in the fight against the pandemic.

Speaking of the U.K. situation, Prof. Sridhar said that there are certain key actions that the country needs to take to put a stop to the spread of the virus more efficiently:

I think the crucial thing is getting the testing sorted. You need to have a test turnaround time [of] less than 24 hours and have testing widely available. And also [] a strategy: What is the point of a lockdown, what [is] the point of the restrictions?

Other countries have used the lockdown Im thinking of New Zealand, Taiwan, Vietnam, Thailand, Australia [] but theyre using the lockdown to try and eliminate the virus, to get rid of it, and then put in place checks for reimportation, she added.

Prof. Agnes Binagwaho vice chancellor at the University of Global Health Equity in Rwanda went on to speak of the innovations that Rwandan authorities implemented to curb the spread of the new coronavirus in the country.

Prof. Binagwaho said that the first step was to identify both the obstacles and facilitators when it came to stopping the spread of SARS-CoV-2.

According to the expert, having a clear idea of these factors allowed the authorities to establish the best strategy for containing the spread of the virus.

Most importantly, however, according to Prof. Binagwaho, Rwandan authorities made sure to keep its citizens up-to-date with all the daily news regarding the local spread of the virus both good and bad.

[W]hen you need the population to do something to protect itself [] that is not usual, trust counts more than money, she commented.

Some of the technological innovations that the country implemented during the pandemic were robots that take peoples temperatures in airports and hospitals, to limit human contact, and drones that carry supplies to areas that lack appropriate resources.

Prof. Christofer Toumazou from Imperial College London in the U.K. spoke of how technological advances could help during the current pandemic.

Prof. Toumazou, an electronic engineer, created DnaNudge, a fast and accessible DNA testing technology. Its original purpose was helping people understand what health conditions their genetic makeup might predispose them to, so they could make healthier choices.

At WIRED, the researcher and his colleagues said that they adapted this technology to detect COVID-19, creating tests with a turnaround time of only 90 minutes.

In the U.K., the government ordered 5.8 million such tests for state hospitals.

Effectively, it took a pandemic for us to get a technology thats [] prepared for personalized medicine into the hospital system. So the only way that we could bulldoze this was through COVID, Prof. Toumazou noted.

The researcher emphasized just how important this step may be for health, particularly for people with mental health conditions, who would not have to anxiously wait for 48 hours in isolation for their test results.

In a panel discussion, Dr. Indra Joshi director of Artificial Intelligence at NHSx, the U.K. governmental unit responsible for developing national health policies also went on to stress that advanced technology may help not just to better understand the pathology of COVID-19, but also to identify the people who are most at risk.

This, she added, could allow healthcare professionals to provide help faster to those who are likely to be the most affected by infection with the new coronavirus.

In Dr. Joshis view, advances in technology could therefore offer a holistic view of a persons health status and risks, beyond diagnosing COVID-19.

Another panel discussion focused on recent developments in finding a vaccine against the new coronavirus.

The two participants were Tal Zaks, Chief Medical Officer of Moderna Therapeutics, and Prof. Uur ahin, co-founder and CEO of BioNTech.

Both Moderna and BioNTech are testing mRNA candidate vaccines, which use genetic information rather than a viral base to train the immune system against the new coronavirus.

Speaking of the advantages of an mRNA vaccine versus other forms of vaccines, Zaks said that it is better in a number of fundamental ways.

The first is that because we start with genetic information, there is a component of speed that allows you to get into the clinic and then, once youre in the clinic, scale-up manufacturing. Its not by chance that the two leading efforts both leverage mRNA technologies, he pointed out.

I think the second one [] is the biological preciseness so, when you make a recombinant protein, or you otherwise characterize a biologic, the process makes a lot of difference and a lot of things can go wrong. When youre transmitting the [genetic] information, theres no way for the cell to make the wrong bit. So the biological fidelity, if you will, has a higher likelihood to then translate into the kind of immune response you want.

Tal Zaks

I think the last element here is its a very flexible platform, and this takes us a little bit beyond COVID, but the infrastructure required is relatively small and quick, which means, in the manufacturing space, you have tremendous agility that usual technologies dont, Zaks added.

At the time of the WIRED conference, clinical trials for the Moderna and BioNTech candidate vaccines were at similar stages. Since the two approaches have similar premises, the question arises: does this create a sense of competition between the two companies?

According to Zaks, in the context of a pandemic, this is not a valid question. I only have two competitors here: the virus and the clock, he asserted.

He added that should both the Moderna and the BioNTech candidate vaccines demonstrate safety and efficacy, this would be an ideal situation.

The world needs more than one company to succeed here, he said, noting that, if the virus is truly here to stay, as previous research suggests, more than one vaccine may become necessary in the long run.

Prof. ahin agreed:

The way [in which] the whole industry developed vaccines against COVID-19 [] is the best performance of collaboration. Its important to see how people team up for collaboration. Moderna teamed up with the NIH [the National Institutes of Health], we teamed up with Pfizer, AstraZeneca teamed up with Oxford University. So there are several models of collaboration, and we have the strongest transparency in the development of a vaccine.

People see the data almost in real-time coming in, and people understand how [a] phase 1 trial works, how a phase 3 trial works, and Moderna and we even shared our phase 3 protocols so that everyone can see in a transparent fashion how the studies perform and how they are evaluated, Prof. ahin added.

The two researchers also emphasized that this sense of transparency regarding the development of new pharmaceutical products is essential in the long run. They also expressed hope that it may persist after the pandemic subsides.

When asked whether the candidate vaccine development was rushed, so that pharmaceuticals can distribute them sooner rather than later, Prof. ahin explained that the pandemic has caused researchers to find a better, more efficient method of proceeding with clinical trials not a less reliable one.

One important aspect is that instead of skipping [steps] or cutting corners, we decided to do things in parallel. Usually, [in] vaccine development [] you do a phase 1 study, and maybe 6 or 12 months later a phase 2 study, and then decide whether you would do a phase 3 study, he explained.

This is based on minimizing the cost risk, but also based on the traditional way [in which a vaccine] is developed. It is not the best way it is just the traditional way, he also emphasized.

While many of the talks at WIRED Health:Tech revolved around the fight against COVID-19, some also focused on other technological advances in improving patient care.

Dr. Eric Topol founder and director of the Scripps Research TranslationalInstitute talked about using technology to make medicine more humanistic.

The main objective of AI for healthcare and medicine has been to improve accuracy, so that doctors can improve how they diagnose disease and care for their patients, he observed.

This is what is known as precision medicine. But Dr. Topol believes that using AI in medical practice could bring about more far-reaching benefits.

This could include freeing healthcare practitioners from tasks, such as filing information about their patients into digital systems, so that they can pay more attention to their patients.

Medicine has eroded terribly its a rushed job, Dr. Topol asserted in his talk. We see patients in a single-digit number of minutes, and thats not enough.

You need the gift of time, which AI can give back so that people dont feel so rushed and doctors and nurses and clinicians dont feel so rushed either. [] We want to have clinicians and doctors spending more time with patients and less time [at the computer] keyboard.

Dr. Pearse Keane a National Institute for Health Research clinician-scientist at the Institute of Ophthalmology at University College London spoke of how doctors could soon use AI algorithms to diagnose and treat early-stage retinal diseases a set of eye problems that can lead to vision loss.

Dr. Keane made a similar point to Dr. Topols argument, stressing that so many people are affected by eye diseases in the U.K. that specialists are often overwhelmed by the sheer amount of patients waiting for diagnosis and treatment.

Some people are essentially going blind because they cannot be seen and treated early enough, Dr. Keane said. But new technologies and in particular, AI, have at least some role in addressing this problem, he added.

Dr. Keane and colleagues from Moorfields Eye Hospital collaborated with scientists specializing in using the AI technology DeepMind, in demonstrating how to train the system to diagnose retinal diseases correctly and fast-track referrals for specialist treatment.

The researchers published the results of their study in Nature Medicine in 2018. Now, Moorfields Eye Hospital are building a new care and research center, with plans to integrate more advanced technology into this setting.

But Dr. Keane argues that clinical AI help by linking various health data, therefore offering a bigger picture of a persons overall health status and health risks.

Dr. Mark Slack chief medical officer and co-founder of CMR Surgical spoke of the potential of Versius, a surgical robotic system that can help specialists carry out minimally invasive keyhole surgery.

Is keyhole surgery better than open surgery? There are huge advantages for keyhole surgery, Dr. Slack asserted in his presentation.

If you have a large wound [following open surgery], about 50% of those patients will go back to the hospital. If you have a small, minimal-access wound, almost none will go back. If you have a large wound, about a fifth of patients will be required to go back into [the operating] theater if they get a wound infection [] [but] roughly 50% of complications are reduced by having keyhole surgery rather than open [surgery].

Dr. Mark Slack

Finally, Prof. Jennifer Doudna a biochemist at UC Berkeley and founder of the Innovative Genomics Institute, who co-invented CRISPR technology spoke of the revolutionary potential of gene editing. This new technology has taken the medical research world by storm.

Prof. Doudna described gene-editing technology as molecular surgery its a way to alter the DNA in cells and organisms in ways that allow precise correction of disease-causing [genetic] mutations and also allow scientists to do all sorts of other kinds of manipulations of genetic material on living cells and organisms, she explained.

One way in which gene-editing tools might be helpful, she said, might be by helping treat severe blood disorders such as sickle cell disease. Other applications might be in the treatment of eye diseases or even muscular dystrophy.

The scientist explained that, besides CRISPR technologys potential in treating disease, it could also come in handy when detecting viruses, including the new coronavirus.

She even suggested that in the coming months, there may be a CRISPR-based point-of-care diagnostic tool that could help doctors identify infections much faster.

She concluded her talk by noting that:

The potential of this technology continues to advance. I think the keys will be delivery and control of the editing and, of course, ensuring safety, effectiveness, and access. The possibilities are extraordinary its really an exciting time to be working in this field.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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Companion Diagnostics Market should experience the strongest growth of 2027 with the main key players Agilent Technologies, Foundation Medicine,…

November 5th, 2020 9:54 am

The Global Companion Diagnostics Market Report, published by Emergen Research, offers a complete assessment of the major segments of the global Companion Diagnostics market, estimating the market growth rate over the forecast timeline (2020-2027). The latest research report can be viewed as a valuable source of data and information about this particular business sphere. Our team of market experts has performed a thorough future market growth analysis and assessed the demand & supply graphs and the markets historical and future revenue generation. The report is equipped with a vivid description of the current trends of the global Companion Diagnostics market. It holds an unbiased perspective of the leading market players, intense competition, the major regions/countries, end-use industries, and a broad continuum of products available in this market. Therefore, the market intelligence report offers a 360 view of the global Companion Diagnostics industry and provides significant information pertinent to the various growth-inducing and growth-restraining factors in detail.

The latest study unravels the unfavorable impacts of the COVID-19 pandemic on the global Companion Diagnostics business sector. According to our expert team, the corona virus outbreak has had an overwhelming impact on the global economic landscape, and consequently, on this business vertical. The pandemic is expected to contribute to the potential downturn of the Companion Diagnostics industry substantially. Reportedly, this sector has been financially beleaguered since the COVID-19 lockdown restrictions were put into effect. Hence, the report highlights the financial obstacles that have slowed numerous businesses progress in this sector and disrupted the global supply chains.

Request a sample copy of the Companion Diagnostics market report @ https://www.emergenresearch.com/request-sample-form/31

Competitive Overview:

The global Companion Diagnostics market report closely studies the functioning mechanisms of the key companies participating in the global market. These companies are said to be following a slew of business expansion strategies to reinforce their financial positions in this market. As per the report, these companies account for a major portion of the overall Companion Diagnostics market share. Therefore, this section of the report emphasizes the principal strategic initiatives led by these companies, including mergers & acquisitions, joint ventures, new business deals, new product launches, collaborations, technological upgradation, and several others.

Key Market Players:

Agilent Technologies, Foundation Medicine, Myriad Genetic Laboratories, Thermo Fisher Scientific, Johnson & Johnson, Arup Laboratories, Abbott, MolecularMD, BioMrieux, and Illumina

For the purpose of this report, Emergen Research has segmented into the global Companion Diagnostics Market based on the technology, disease indication, application, and region:

Geographical Terrain of the Companion Diagnostics Market:

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Global Companion Diagnostics Market Report Table of Contents:

1.1 Research Scope

1.2 Key Companion Diagnostics market segments

1.3 Target players

1.4 Market analysis by type

1.5 Market analysis by application

1.6 Key learning objectives

1.7 Report timeline

2.1 Global Companion Diagnostics market size

2.2 Latest trends of the Companion Diagnostics market by region

2.3 Key corporate trends

3.1 Global Companion Diagnostics Market size by manufacturers

3.2 Global Companion Diagnostics Market key players

3.3 Products/solutions/services of major players

3.4 New entrants in the Companion Diagnostics market

3.5 Mergers, acquisitions, joint ventures, and expansion plans

4.1 Global Companion Diagnostics Sales by Product

4.2 Global Companion Diagnostics by Product Revenue

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Key highlights of the report:

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About Emergen Research

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Our expertise umbrellas the technological environment of all major industries, and our services help you map your actions to ensure optimal yield. Our analysts utilize their market proficiency to offer actionable insights that help our clients implement profitable strategies and optimize their return on investment. Our services are wide-ranging, right from technological environment analysis to technological profiling that highlights the existing opportunities in the market you can capitalize on to stay ahead of your competitors.

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Fred Hutch researchers uncover new genetic details of White House COVID-19 outbreak – GeekWire

November 5th, 2020 9:54 am

Judge Amy Coney Barrett delivers remarks after President Donald Trump announces her nomination to the U.S. Supreme Court, Sept. 26, 2020, in the Rose Garden of the White House. The event is believed to be responsible for the spread of COVID-19 among some attendees. (Official White House Photo by Andrea Hanks, Public Domain)

Since it was revealed in early October, details about President Trumps COVID-19 infection have been in short supply, including the likely source of his exposure and when he was tested.

New research from the Fred Hutchinson Cancer Research Center in Seattle gives a glimpse into the spread of the disease among Americas first family and White House staff and guests.

Two journalists who directly interacted with White House officials at the end of September but were not in each others company contracted variations of the virus that were highly genetically similar. The genetic code from the SARS-CoV-2, the virus that causes COVID, that infected the journalists contained five unique mutations and were distinct from the genomes of more than 160,000 publicly available virus sequences.

The scientists said this particular lineage of the virus was first documented in the U.S. in April or May, but its exact spread from there was unclear.

Shortly after Trump was infected, Anthony S. Fauci the nations top infectious-disease expert said that the White House had been the site of a so-called super spreader event when it hosted a Rose Garden reception for Judge Amy Coney Barrett, now a member of the U.S. Supreme Court. Photos show that many in attendance did not wear masks. At least 50 COVID-19 cases have been connected to an outbreak associated with the White House, according to the researchers.

Trump Administration officials at the time of the outbreak made little effort to do contact tracing to potentially help contain the spread a decision that drew criticism from some health experts.

When it comes to the source of the White House infections, its sort of an unknowable question, where it entered the environment, said White House deputy press secretary Brian Morgenstern, in a press conference on Oct. 7.

The Fred Hutch-led research calls that assertion into question. While its too late to use the information to limit spread from the initial event, genomic sequencing could provide additional insights into the path of transmission if more samples were tested. It could also help build a more complete picture of the outbreaks spread by analyzing infections that occur weeks or months following the White House event.

Weve seen repeatedly with COVID-19 that the absence of scientific statements provides shelter for speculation and even conspiracy theories to grow. My strategy since January has been to try to address these issues as directly and transparently as I can, said Trevor Bedford, the studys lead.

That includes debunking unfounded theories about COVID spreading in California in the fall of 2019, or being created in a lab.

I still believe that science plays a role in dampening speculation and getting society to a firmer, shared factual footing, Bedford said.

The new investigation was shared Sunday as a pre-print of non peer-reviewed research, posted on medRxiv. The site, pronounced med-archive is a free platform that in recent months has featured up-to-the-minute research during the COVID pandemic.

The studys researchers include scientists from the University of Washington, Seattles Brotman Baty Institute for Precision Medicine, and Howard Hughes Medical Institute in Seattle.

Bedford and his team have done similar lineage analysis for public health departments in Washington, Florida, California, Utah, Minnesota and Michigan, as well as the U.S. Centers for Disease Control and Prevention, the European Centre for Disease Prevention and Control and Public Health England.

A story in the New York Times on Sunday shared the source of the two samples as being Times reporters. One had traveled with the president and other staff on Air Force One on Sept. 26, coming in close proximity with Trump, who was not wearing a mask. On the same day, a second journalist covered the Rose Garden event as well as a news conference the next day, with exposure to unmasked officials who later tested positive.

Both journalists, who wore masks, opted to share their identities, according to the Times.

The researchers ended the study pre-print with a slightly exasperated call to action on the U.S. COVID response.

Science has made a great many discoveries and innovations since [the 1918 influenza pandemic], with genome sequencing being a fairly recent addition to the toolkit to combat infectious disease, they wrote. We, as a society, have the tools to control COVID-19, they just have to be employed.

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Fred Hutch researchers uncover new genetic details of White House COVID-19 outbreak - GeekWire

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bluebird bio to Present Data from Gene and Cell Therapy Programs During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition -…

November 5th, 2020 9:54 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 5, 2020--

bluebird bio, Inc. (Nasdaq: BLUE) announced today that data from its gene and cell therapy programs for sickle cell disease (SCD), transfusion-dependent beta-thalassemia (TDT) and multiple myeloma (MM) will be presented, including seven oral presentations, at the 62 nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020.

Updated results from patients in Group C of the companys Phase 1/2 HGB-206 study of LentiGlobin for SCD gene therapy (bb1111) will be presented.

bluebird bio will also present updated long-term efficacy and safety results from the LTF-303 follow-up study; outcomes across genotypes; and outcomes in pediatric patients from Phase 3 studies HGB-207 and HGB-212 of betibeglogene autotemcel (beti-cel; formerly LentiGlobin for -thalassemia) in TDT.

Data from across the companys multiple myeloma program will be presented. Presentations will include updated safety and efficacy results from the Phase 1 CRB-401 clinical study of idecabtagene vicleucel (ide-cel, bb2121) and preliminary data from the ongoing Phase 1 CRB-402 clinical study of bb21217, as well as subgroup analyses of the pivotal Phase 2 KarMMa study of ide-cel. Ide-cel and bb21217 are investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immune therapies being studied, in partnership with Bristol-Myers Squibb, for the treatment of adult patients with MM.

Sickle Cell Disease Data at ASH

Improvements in Health-Related Quality of Life for Patients Treated with LentiGlobin for Sickle Cell Disease (bb1111) Gene Therapy

Presenting Author: Julie Kanter, MD, University of Alabama at Birmingham, Birmingham, AL

Date/Time: Oral #365, Sunday, December 6, 2020, 9:45 am PST

Resolution of Serious Vaso-occlusive Pain Crises and Reduction in Patient-Reported Pain Intensity: Results from the Ongoing Phase 1/2 HGB-206 Group C Study of LentiGlobin for Sickle Cell Disease (bb1111) Gene Therapy

Presenting Author: Alexis A. Thompson, MD, Hematology Section Head, Ann & Robert H. Lurie Childrens Hospital, Chicago, IL

Date/Time: Oral #677, Monday, December 7, 2020, 1:30 pm PST

The GRNDaD Registry: Contemporary Natural History data and an analysis of real-world patterns of use and limitations of Disease Modifying Therapy in adults with SCD

Presenting Author: Alexandra Boye-Doe, MD, University of North Carolina School of Medicine, Chapel Hill, NC

Date/Time: Poster #1730, Sunday, December 6, 2020, 7:00 am 3:30 pm PST

Transfusion-Dependent -Thalassemia Data at ASH

Long-Term Efficacy and Safety of Betibeglogene Autotemcel Gene Therapy for the Treatment of Transfusion-Dependent -Thalassemia: Results in Patients with up to 6 Years of Follow-up

Presenting Author: Janet L. Kwiatkowski, MD, MSCE, Director, Thalassemia Center at Children's Hospital of Philadelphia, Philadelphia, PA

Date/Time: Oral #153, Saturday, December 5, 2020, 12:00 pm PST

Favorable Outcomes in Pediatric Patients in the Phase 3 HGB-207 (Northstar-2) and HGB-212 (Northstar-3) Studies of betibeglogene autotemcel Gene Therapy for the Treatment of Transfusion-dependent -thalassemia

Presenting Author: Alexis A. Thompson, MD, MPH, Hematology Section Head, Ann & Robert H. Lurie Childrens Hospital of Chicago, Chicago, IL

Date/Time: Oral #154, Saturday, December 5, 2020, 12:15 pm PST

Improvement in Erythropoiesis Following Treatment with Betibeglogene Autotemcel Gene Therapy in Patients with Transfusion-Dependent -Thalassemia in the Phase 3 HGB-207 Study

Presenting Author: John B. Porter, MA, MD, FRCP, FRCPath, Head of Red Cell Unit, University College London Hospital, London, UK

Date/Time: Poster #776, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Response of patients with transfusion-dependent -thalassemia (TDT) to betibeglogene autotemcel (beti-cel; LentiGlobin for -thalassemia) gene therapy based on HBB genotype and disease genetic modifiers

Presenting Author: Mark C. Walters MD, Medical Director, Jordan Family Center for BMT & Cellular Therapies Research, UCSF Benioff Childrens Hospital Oakland, Oakland, CA

Date/Time: Poster #1699, Sunday, December 6, 2020, 7:00 am 3:30 pm PST

Multiple Myeloma Data at ASH

Updated results from the Phase I CRB-402 study of anti-BCMA CAR-T cell therapy bb21217 in patients with relapsed and refractory myeloma: correlation of expansion and duration of response with T cell phenotypes

Presenting Author: Melissa Alsina, MD, Department of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

Date/Time: Oral #130, Saturday, December 5, 2020, 9:45 am PST

Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in patients with relapsed and refractory multiple myeloma: updated results from phase 1 CRB-401 study

Presenting Author: Yi Lin, MD, PhD, Division of Hematology, Mayo Clinic, Rochester, MN

Date/Time: Oral #131, Saturday, December 5, 2020, 10:00 am PST

Secondary Quality-of-Life Domains in Patients With Relapsed and Refractory Multiple Myeloma Treated With the BCMA-Directed CAR T Cell Therapy Idecabtagene Vicleucel (ide-cel; bb2121): Results from the KarMMa Clinical Trial

Author: Nina Shah, MD, University of California San Francisco, San Francisco, CA

Date/Time: Oral #437, Sunday, December 6, 2020, 12:15 pm PST

Efficacy and Safety of Idecabtagene Vicleucel (ide-cel, bb2121) in Elderly Patients with Relapsed/Refractory Multiple Myeloma: KarMMa Subgroup Analysis

Presenting Author: Jess Berdeja, MD, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN

Date/Time: Poster #1367, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Characterization of Cytokine Release Syndrome in the KarMMa Study of Idecabtagene Vicleucel (ide-cel, bb2121) For Relapsed and Refractory Multiple Myeloma

Presenting Author: Ankit Kansagra, MD, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX

Date/Time: Poster #1378, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Molecular and Phenotypic Profiling of Drug Product and Post-infusion Samples from CRB-402, an Ongoing: Phase I Clinical Study of bb21217 a BCMA-directed CAR T Cell Therapy

Presenting Author: Olivia Finney, PhD, Associate Director, Immunotherapy, bluebird bio

Date/Time: Poster #1401, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Effects of Prior Alkylating Therapies on Preinfusion Patient Characteristics and Starting Material for CAR T Cell Product Manufacturing in Late-Line Multiple Myeloma

Presenting Author: Julie Rytlewski, PhD, Bristol Myers Squibb, Princeton, NJ

Date/Time: Poster #1405, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

KarMMa-4: Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Targeted CAR T Cell Therapy, in High-Risk Newly Diagnosed Multiple Myeloma

Presenting Author: Saad Z. Usmani, MD, Director, Clinical Research in Hematologic Malignancies, Levine Cancer Institute/Atrium Health, Charlotte, NC

Date/Time: Poster #1418, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Healthcare Resource Utilization and Cost of Cytokine Release Syndrome and Neurologic Events in Patients with Relapsed and Refractory Multiple Myeloma Receiving the BCMA-directed CAR T Cell Therapy Idecabtagene Vicleucel (ide-cel, bb2121) in the KarMMa Trial

Presenting Author: Parmeswaran Hari, MD, Medical College of Wisconsin, Milwaukee, WI

Date/Time: Poster #1598, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

A Matching-Adjusted Indirect Comparison of Efficacy Outcomes for Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-directed CAR T Cell Therapy Versus Conventional Care in Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Presenting Author: Nina Shah, MD, University of California San Francisco, San Francisco, CA

Date/Time: Poster #1653, Saturday, December 5, 2020, 7:00 am 3:30 pm PST

Idecabtagene Vicleucel (ide-cel, bb2121) Responses Are Characterized by Early and Temporally Consistent Activation and Expansion of CAR T Cells With a T Effector Phenotype

Presenting Author: Nathan Martin, PhD, Bristol Myers Squibb, Princeton, NJ

Date/Time: Poster #2315, Sunday, December 6, 2020, 7:00 am 3:30 pm PST

KarMMa-3: A Phase 3 Study of Idecabtagene Vicleucel (ide-cel,bb2121), a BCMA-Targeted CAR T Cell Therapy Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma

Presenting Author: Michel Delforge, MD, PhD, University Hospital Leuven, Leuven, Belgium

Date/Time: Poster #2323, Sunday, December 6, 2020, 7:00 am 3:30 pm PST

Idecabtagene Vicleucel (ide-cel, bb2121) in Relapsed and Refractory Multiple Myeloma: Analyses of High-Risk Subgroups in the KarMMa Study

Presenting Author: Noopur S. Raje, MD, Massachusetts General Hospital, Boston, MA

Date/Time: Poster #3234, Monday, December 7, 2020, 7:00 am 3:00 pm PST

Health State Utility Valuation in Patients with Triple-Class Exposed Relapsed and Refractory Multiple Myeloma Treated with the BCMAdirected CAR T Cell Therapy, Idecabtagene Vicleucel (idecel, bb2121): Results from the KarMMa Trial

Presenting Author: Michel Delforge, MD, PhD, University Hospital Leuven, Leuven, Belgium

Date/Time: Poster #3465, Monday, December 7, 2020, 7:00 am 3:00pm PST

Abstracts outlining bluebird bios accepted data at ASH are available on the ASH conference website.

About LentiGlobin for SCD (bb1111)

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive events (VOEs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complicationssuch as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.

LentiGlobin for SCD (bb1111) is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

LentiGlobin for SCD was designed to add functional copies of a modified form of the -globin gene ( A-T87Q -globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once patients have the A-T87Q -globin gene, their red blood cells can produce anti-sickling hemoglobin (Hb A-T87Q ) that decreases the proportion of HbS, with the goal of reducing sickled red blood cells, hemolysis and other complications.

As of March 3, 2020, a total of 37 patients have been treated with LentiGlobin for SCD to-date in the HGB-205 (n=3) and HGB-206 (n=34) clinical studies. The HGB-206 total includes: Group A (n=7), B (n=2) and C (n=25).

LentiGlobin for SCD received orphan medicinal product designation from the European Commission for the treatment of SCD, and Priority Medicines (PRIME) eligibility by the European Medicines Agency (EMA) in September 2020.

The U.S. Food and Drug Administration (FDA) granted orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for SCD. LentiGlobin for SCD continues to be evaluated in the ongoing Phase 1/2 HGB-206 and Phase 3 HGB-210 studies.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

LentiGlobin for SCD is investigational and has not been approved in any geography.

About betibeglogene autotemcel

Transfusion dependent beta-thalassemia (TDT) is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT require chronic blood transfusions to maintain adequate Hb levels. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Betibeglogene autotemcel (beti-cel) adds functional copies of a modified form of the -globin gene ( A-T87Q -globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q -globin gene, they have the potential to produce HbA -T87Q, which is gene therapy-derived adult hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

The European Commission granted conditional marketing authorization (CMA) for beti-cel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0 / 0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available.

As of March 3, 2020, a total of 60 pediatric, adolescent and adult patients, including 11 patients with at least 5 years of follow-up, across genotypes of TDT have been treated with beti-cel in the Phase 1/2 Northstar (HGB-204) and HGB-205 studies, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies. In studies of beti-cel, patients were assessed for transfusion independence, defined as no longer needing red blood cell transfusions for at least 12 months while maintaining a weighted average Hb of at least 9 g/dL.

Non-serious adverse events (AEs) observed during clinical studies that were attributed to beti-cel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, tachycardia and non-cardiac chest pain. One serious adverse event (SAE) of thrombocytopenia was considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for beti-cel. The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. FDA granted beti-cel orphan drug designation and Breakthrough Therapy designation for the treatment of TDT. Beti-cel is not approved in the United States. Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of beti-cel.

About idecabtagene vicleucel (ide-cel, bb2121)

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio. Ide-cel was granted accelerated assessment by the European Medicines Agency (EMA) on March 26, 2020, and the Marketing Authorization Application (MAA) was validated by the EMA on May 20, 2020. The FDA accepted the ide-cel Biologics License Application (BLA) for priority review on September 22, 2020.

KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adults with RRMM in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other secondary endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 10 6 CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

CRB-401 (NCT02658929) is an open-label Phase 1 study evaluating the preliminary safety and efficacy of ide-cel in patients with relapsed and refractory multiple myeloma (RRMM). The primary endpoint of the study is safety. CRB-401 was designed as a two-part (dose escalation and dose expansion) study to determine the maximum tolerated dose and further evaluate the safety, tolerability and clinical activity at the recommended Phase 2 dose; these findings established the recommended dose of the Phase 2 KarMMa trial. All patients have been treated in the study and follow-up is ongoing.

In addition to the pivotal KarMMa and CRB-401 trials, bluebird bio and Bristol Myers Squibbs broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) exploring ide-cel combinations and activity in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

Ide-cel is not approved for any indication in any geography.

About bb21217

bb21217 is an investigational BCMA-targeted CAR T cell therapy that uses the ide-cel CAR molecule and is cultured with the PI3 kinase inhibitor (bb007) to enrich for T cells displaying a memory-like phenotype with the intention to increase the in vivo persistence of CAR T cells. bb21217 is being studied for patients with multiple myeloma in partnership with Bristol Myers Squibb.

bluebird bios clinical development program for bb21217 includes the ongoing Phase 1 CRB-402 study. CRB-402 is the first-in-human study of bb21217 in patients with relapsed and refractory multiple myeloma (RRMM), designed to assess safety, pharmacokinetics, efficacy and duration of effect. CRB-402 is a two-part (dose escalation and dose expansion), open-label, multi-site Phase 1 study of bb21217 in adults with RRMM. For more information visit: clinicaltrials.gov using identifier NCT03274219.

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bluebird bio to Present Data from Gene and Cell Therapy Programs During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition -...

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Lynparza approved in the EU for the treatment of BRCA- mutated metastatic castration-resistant prostate cancer | Small Molecules | News Channels -…

November 5th, 2020 9:54 am

DetailsCategory: Small MoleculesPublished on Thursday, 05 November 2020 11:37Hits: 150

Only PARP inhibitor to improve overall survival vs. new hormonal agent treatments in BRCA-mutated metastatic castration-resistant prostate cancer

LONDON, UK I November 5, 2020 I AstraZeneca and MSDs Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.

Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million patients diagnosed worldwide in 2018.1 Approximately 12% of men with mCRPC have a BRCA mutation.2

The approval by the European Commission was based on a subgroup analysis of the PROfound Phase III trial which showed Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations.

Lynparza is the first and only PARP inhibitor approved in the EU in biomarker-selected advanced prostate cancer. It follows therecommendation for approvalby the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.

Johann de Bono, one of the principal investigators of the PROfound Phase III trial, Head of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, said: This approval in the EU is a landmark moment that begins a new era of precision medicine in prostate cancer. Lynparza now provides a targeted treatment option at a molecular level to patients with advanced prostate cancer who have historically poor prognosis and few treatment options.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: Lynparza more than tripled radiographic progression-free survival and is the only PARP inhibitor to show an overall survival benefit versus certain new hormonal agents for men with BRCA-mutated metastatic castration-resistant prostate cancer. This approval means BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: The PROfound Phase III trial showed Lynparza provided a clinical benefit for men living with BRCA1/2-mutated metastatic castration-resistant prostate cancer, offering an important option to improve overall survival for these patients in the EU. MSD, along with our collaborator AstraZeneca, looks forward to making this targeted treatment available for patients across the EU as quickly as possible.

The subgroup analysis from the PROfound Phase III trial showed Lynparzareduced the risk of disease progression or death by 78% (based on a hazard ratio [HR] of 0.22, 95% confidence interval [CI], 0.15-0.32; nominal p<0.0001) and improved rPFS to a median of 9.8 months versus 3.0 with enzalutamide or abiraterone in men with mCRPC with BRCA1/2 mutations. Lynparza reduced the risk of death by 37% (based on a HR of 0.63, 95% CI 0.42-0.95) with median OS of 20.1 months versus 14.4 with enzalutamide or abiraterone.

The primary results and overall survival results from the PROfound Phase III trial were published in The New England Journal of Medicine earlier this year.

The full EU approved indication for Lynparza is for the treatment of adult patients with mCRPC and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

Lynparzawas approved in the US for men with HRR gene-mutated mCRPC inMay 2020based on the PROfound Phase III trial. Regulatory reviews are ongoing in other countries around the world.

AstraZeneca and MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial testingLynparzaas a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.

Metastatic castration-resistant prostate cancer

Prostate cancer is associated with a significant mortality rate.1 Prostate cancer is often driven by male sex hormones called androgens, including testosterone. 3 In patients with mCRPC, prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.3 Approximately 10-20% of men with advanced prostate cancer will develop CRPC within five years, and at least 84% of these men will have metastases at the time of CRPC diagnosis. 4 Of men with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years. 4 Despite advances in treatment for men with mCRPC, five-year survival is low and extending survival remains a key treatment goal.4

BRCA mutations

BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors includingLynparza.5-8

PROfound

PROfound is a prospective, multicentre, randomised, open-label, Phase III trial testing the efficacy and safety ofLynparzaversus enzalutamide or abiraterone in patients with mCRPC who have progressed on prior treatment with NHA treatments (abiraterone or enzalutamide) and have a qualifying tumour mutation in BRCA1/2, ATM or one of 12 other genes involved in the HRR pathway.

The trial was designed to analyse patients with HRR gene mutations in two cohorts: the primary endpoint was rPFS in those with mutations in BRCA1/2 or ATM genes and then, ifLynparzashowed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRR gene mutations (BRCA1/2, ATM, CDK12 and 11 other HRR gene mutations). AstraZeneca and MSD announcedin August 2019that the trial met its primary endpoint of rPFS.

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCAm, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated mCRPC (BRCAm and other HRR gene mutations). Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZenecas industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the worlds first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. Bray et al. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), pp.394-424.

2. Abida et al. (2020). Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration. Journal of Clinical Oncology, 38.

3. de Bono et al. (2020) Olaparib for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 382, pp.2091-102.

4. Cancer.Net. (2014). Treatment of metastatic castration-resistant prostate cancer. Available at: https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer. [Accessed September 2020]

5. Kirby, M. (2011). Characterising the castration-resistant prostate cancer population: a systematic review. International Journal of Clinical Practice, 65(11), pp.1180-1192.

6. Wu J, et al. (2010) The role of BRCA1 in DNA damage response. Protein Cell. 2010;1(2):117-123.

7. Roy R, et al. (2012). BRCA1 and BRCA2: different roles in a common pathway of genome protection. Nat Rev Cancer. 2011;12(1):68-78. Published 2011 Dec 23. doi:10.1038/nrc3181.

8. Gorodetska I, et al. (2019). BRCA Genes: The Role in Genome Stability, Cancer Stemness and Therapy Resistance. J Cancer. 2019;10(9):2109-2127.

SOURCE: AstraZeneca

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Lynparza approved in the EU for the treatment of BRCA- mutated metastatic castration-resistant prostate cancer | Small Molecules | News Channels -...

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Latest Study explores the Stem Cell Banking Market Witness Highest Growth in nea – GroundAlerts.com

November 5th, 2020 9:53 am

The ' Stem Cell Banking market' research report now available with Market Study Report, LLC, is a compilation of pivotal insights pertaining to market size, competitive spectrum, geographical outlook, contender share, and consumption trends of this industry. The report also highlights the key drivers and challenges influencing the revenue graph of this vertical along with strategies adopted by distinguished players to enhance their footprints in the Stem Cell Banking market.

The latest research report on the Stem Cell Banking market assesses the major factors influencing industry growth with respect to the competitive dynamics and geographical reach. It also ensembles the challenges prevalent in this industry vertical and identifies opportunities that will further aid business expansion. Further, the report revisits all areas of the business to cover the impact of COVID-19 pandemic so as to assist stakeholders in devising new strategies and reinforcing their position in the market.

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Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 – PRnews Leader

November 5th, 2020 9:53 am

The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism

Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

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Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic productsMore than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cellsIt is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regionsWithin these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domainPresently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

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Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visithttps://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html

or email [emailprotected]

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Contact:

Gaurav Chaudhary+1 (415) 800 3415+44 (122) 391 1091[emailprotected]

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Canine Stem Cell Therapy Market Size, Share Analysis by Manufacturers, Regions, Type and Application to 2026 – PRnews Leader

November 5th, 2020 9:53 am

AllTheResearch, now has a research study on the Canine Stem Cell Therapy market which delivers a precise summary of the industry estimates, SWOT analysis, industry size, profit estimation and regional outlook of the business. The report offers a concise estimation of future growth prospects and obstacles awaiting market players of this industry, while further examining their existing competitive settings and business strategies.

The global Canine Stem Cell Therapy market was valued at US$ 118.5 Mn in 2018 year and is expected to reach US$ 240.7 Mn in 2026, growing at a CAGR of 9.3% during the forecast period.

Key Questions Answered in the Report:

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The research report on Canine Stem Cell Therapy market, covering the COVID-19 impact, provides a comparative analysis of the historical data with the current market scenario to unveil the growth projections for the industry over the analysis period. As per the study, the Canine Stem Cell Therapy market is expected to garner substantial returns and showcase a healthy growth rate throughout the forecast duration.

The Major Players Covered in Canine Stem Cell Therapy Market Study are:

Check all key players mentioned in this report. Lets connect with the analyst @ https://www.alltheresearch.com/speak-to-analyst/206

Major Segments Covered in Canine Stem Cell Therapy Market Reports are based on types and Applications as Follows:

Based on Types Canine Stem Cell Therapy Market Segmentation:

Based on Applications Canine Stem Cell Therapy Market Segmentation:

COVID-19 Impact on Canine Stem Cell Therapy Market:

The outbreak of COVID-19 has brought along a global recession, which has impacted several industries. Along with this impact COVID Pandemic has also generated few new business opportunities for Canine Stem Cell Therapy Market. Overall competitive landscape and market dynamics of Canine Stem Cell Therapy has been disrupted due to this pandemic. All these disruptions and impacts has been analysed quantifiably in this report, which is backed by market trends, events and revenue shift analysis. COVID impact analysis also covers strategic adjustments for Tier 1, 2 and 3 players of Canine Stem Cell Therapy Market.

Get Brief Information on Pre COVID-19 Analysis and Post COVID-19 Opportunities in Canine Stem Cell Therapy Market @https://www.alltheresearch.com/impactC19-request/206

How Report will help you to make decisions for business:

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Touch on the Medical Team: As Massage is Implemented in Integrative Care, Specialized Competencies Become More Important – Massage Magazine

November 5th, 2020 9:52 am

In recent decades, as the evidence base for massage and the acceptance of massage have grown, professional opportunities available to massage therapists have also broadened.

Now with integrative health care becoming more prevalent, massage is often part of these integrative care teams, with massage therapists working alongside medical, allied health care and other complementary practitioners. Hospital environments and integrative care settings are both areas that benefit from massage training that addresses specific competencies related to them.

These varying work environments mean that massage therapists are working with a wide range of patients, some with complex and serious health conditions and very specific health needs. These may necessitate adaptations to treatment or may involve contraindications.

They may require working around equipment, a deep understanding of specific diseases or knowledge of specific medical treatments. These varied environments also find massage therapists working with health care practitioners from a range of disciplines, which makes an understanding of each others work, abilities, specialties and scope of practice important.

Current massage therapy education varies from one school to another. The competencies provided by standard massage therapy training in the U.S. are more than sufficient for working in more general environments. However, the therapist presented with some of these specialized clinical opportunities may benefit from additional training that provides enhanced competencies to meet their very specific needs.

Some schools offer hospital-based massage therapy programs; however, among them there may be a lack of consistency regarding curriculum and competencies. While there have been ever-increasing trends toward integrative care and interdisciplinary research, training that addresses specific competencies for complementary health care practitioners working in integrative environments is not as common.

Within the medical community there have been efforts to define outcome-based competencies for health care1. Doing the same for massage in hospital or integrative care environments seems prudent.

The Academic Collaborative for Integrative Health (ACIH) established the Hospital-Based Massage Therapy (HBMT) Task Force in 2012. Their goal was to assess current HBMT training and implementation and to develop a set of specific HBMT competencies. The ACIH Competencies for Optimal Practice in Integrated Environments were used as a basis for broad categories of competencies and feedback from representatives of hospitals that included HBMT programs was incorporated.

The HBMT Task Force identified that there was a wide range of practice standards and delivery of massage therapy in hospital settings. While some HBMT programs required specific education of their therapists, many did not and many felt that therapists required further specific training once hired to meet the needs of the particular programs2.

The competencies that representatives of HBMT programs felt were often lacking included some related to clinical practice and others that related to the environment, such as oncology training, proper documentation of assessments and treatment plans, appropriate therapeutic relationships, an understanding of medical terminology and medical devices, infection control, and competencies related to the hospital environment and interdisciplinary collaboration2.

The finalized competencies developed by the HBMT Task Force included some relevant competencies from the ACIH along with new ones that address issues that are specifically relevant to HBMT practice. These include competencies related to:

There are a number of benefits to having a set list of competencies specifically related to working in the hospital environment. They can be of benefit to massage therapists, to hospital-based massage therapy programs, and to other stakeholders.

Distinct competencies related to HBMT can be of benefit to massage therapists by first helping them to ascertain if this type of work will be a good fit for them. Not only will they be able to determine if they have the skills required, but also if they would enjoy working in this environment. Knowing what competencies are involved will also allow therapists to seek out appropriate training to prepare them to succeed in these roles.

HBMT competencies can help with the development of education. Massage schools and continuing education providers will be able to develop training to address these specific competencies.

Regulatory bodies and professional associations could use the competencies as the basis for specialty certification. We have seen this in other areas, for example in performing arts medicine and in oncology massage.

Hospitals could use these competencies to inform the interview process and to evaluate potential massage therapists for their programs. Additionally, hospitals could benefit from these competencies as they could provide standards for those wishing to establish HBMT programs.

Research is another area that could benefit from these competencies. The rigor of research studies carried out within these programs may be enhanced by ensuring that the delivery of massage interventions are carried out by therapists with specific competencies related to the hospital environment.

And finally, the public would benefit from HBMT competencies. First, patient needs could be better met if massage therapists have training that provides them with the relevant competencies. And secondly, we may find that there is increased interest in and appreciation of massage because of these definitive skills and competencies.

There is some overlap between competencies for integrative care settings and those of HBMT, as a number of HBMT programs could be considered to be integrative. However, as integrative care becomes more commonplace, there are opportunities for this type of collaborative and integrative workplace, both outside of the hospital setting and within it in outpatient clinics in which one may not encounter patients with serious or life-threatening illness.

Massage therapists are often working alongside other health care practitioners in collaborative and integrative teams.Regardless of the type of integrative care setting, inter-professional education and integrative health care education are important for anyone working in these environments.

More than 50% of all medical schools in North America now have programs in integrative medicine3. There are a number of programs that have developed in recent years that address inter-professional education, such as the BRIDG (Building Research across Interdisciplinary Gaps) program4. They allow complementary and integrative clinicians to learn alongside biomedical clinicians and researchers. They provide each group with knowledge and understanding of the other so that they might work together more effectively.

The Academic Consortium for Complementary and Alternative Health Care (ACCAHC), an organization whose aim is to advance collaborative and integrative care, has developed Competencies for Optimal Practice in Integrated Environments5. These competencies emphasize inter-professional education, practice and communication, as well as knowledge of roles and responsibilities6.

There are several specific competencies that may enable massage therapists to work effectively and successfully within integrative settings. One of these is knowledge of other modalities and indications for their use. Coupled with this is a basic understanding of other clinicians scope of practice.

Education regarding effective communication across disciplines is also important. Additionally, training around strategies to foster inter- and intra-disciplinary collaboration is beneficial.

The skillful use of electronic patient records (EPR) is another helpful competency. This allows for easy communication with other clinicians regarding patients and patient notes and can enable collaboration.

The benefits of specific competencies for working in integrative settings are many. There are benefits for the massage therapist, for other practitioners, for the clinic or program itself and for the patient.

Knowledge of others disciplines and scopes of practice can promote a team atmosphere. This ability to work as a team is linked to practitioner satisfaction and well-being, as well as decreased stress7. An understanding of other disciplines, scopes of practice and specializations facilitates appropriate referrals, thus benefitting patients, and fosters respect among practitioners.

A collaborative, cohesive clinical team has also been shown to promote innovation and effectiveness8. Patient needs are more effectively addressed when practitioners have an understanding of how different therapies can be combined to complement and build on each other, providing outcomes that are greater than the sum of their individual parts9.

Programs such as BRIDG, which cultivate knowledge of research best practices among clinicians and knowledge of clinical research amongst researchers, can lead to greater practitioner involvement in research studies4. This will enable massage research that is practice-driven, and which can be used to inform practice.

As massage and other complementary health care practices take on a bigger role in our health care system, specialized training and very specific competencies may be necessary to allow therapists to thrive in a range of environments.

Regardless of the professional path we choose to take, giving ourselves the tools we need to have a successful and satisfying career is the first step of that path. We cannot build the career we wish without a solid foundation upon which to build it.

Leisa Bellmore, MSc, ST, wrote this article on behalf of the Massage Therapy Foundation. She has been practicing shiatsu therapy since 2001 and is part of the integrative team at Toronto Western Hospitals Artists Health Centre. She has presented and published around the world. She is a past president of Natural Health Practitioners of Canada and sits on the Massage Therapy Foundation Writing Committee. Bellmore has an MSc in Complementary Medicine Research. Her research interests include neurological conditions, chronic pain and self-management.

1. Grant, K. E., Balletto, J., LMT, B. S., Gowan-Moody, D., Rmt, H., Healey, D., LMP, P. (n.d.). Steps Toward Massage Therapy Guidelines: A First Report to the Profession.

2. Brennan, M. K., Healey, D., Tague, C., & Rosenthal, B. (2019). Hospital based massage therapy specific competencies. Journal of Bodywork and Movement Therapies, 23(2), 291294. doi.org/10.1016/j.jbmt.2019.01.009

3. Eisenberg, D.M., Kaptchuk, T.J., Post, D.E., Hrbek, A.L., OConnor, B.B., Osypiuk, K., Levy, D.B. (2016). Establishing an integrative medicine program within an academic health center: Essential considerations. Academic Medicine, 91(9), 12231230.

4. Bradley, R., Booth-Laforce, C., Hanes, D., Scott, C., Sherman, K.J., Lin, Y.S., & Zwickey, H. (2019). Design of a multidisciplinary training program in complementary and integrative health clinical research: Building research across interdisciplinary gaps. Journal of Alternative and Complementary Medicine, 25(5), 509516.

5. Goldblatt, E., Wiles, M., Schwartz, J., Weeks, J. (2013, September). Competencies for optimal practice in integrated environments: Examining attributes of a consensus interprofessional practice document from the licensed integrative health disciplines. Explore: The Journal of Science and Healing.

6. Goldblatt, E., Weeks, J., & Rosenthal, B. (2010). Competencies for Optimal Practice in Integrated Environments. Academic Consortium for Complementary & Alternative Health Care. (June). Retrieved from

7. Haward, R., Amir, Z., Borrill, C., Dawson, J., Scully, J., West, M., Sainsbury, R. (2003). Breast cancer teams: the impact of constitution, new cancer workload, and methods of operation on their effectiveness. British Journal of Cancer, 89(1), 1522.

8. Proudfoot, J., Jayasinghe, U.W., Holton, C., Grimm, J., Bubner, T., Amoroso, C., Harris, M.F. (2007). Team climate for innovation: What difference does it make in general practice? International Journal for Quality in Health Care. 19(3), 164169.

9. Boon, H.S., Mior, S.A., Barnsley, J., Ashbury, F.D., & Haig, R. (2009). The Difference Between Integration and Collaboration in Patient Care: Results From Key Informant Interviews Working in Multiprofessional Health Care Teams. Journal of Manipulative and Physiological Therapeutics. 32(9), 715722.

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Asia Pacific cannabis market is expected to reach US$ 22,870.6 million by 2027 from US$ 2,318.6 million in 2019 – GlobeNewswire

November 5th, 2020 9:52 am

New York, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Asia Pacific Cannabis Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Product Type ; Application ; Compound, and Country" - https://www.reportlinker.com/p05978820/?utm_source=GNW However, restriction on the use of cannabis in the region is likely to hinder the market growth during the forecast period.

In recent years, the liberation for the use of cannabis in the medical industry has created various growth opportunities in Southeast Asian countries.Growing legal jurisdictions have enabled the progress of research activities in countries, such as South Korea, Australia, and New Zealand.

Also, various international companies have shown interest in effective market strategies.The companies have strategically enhanced their operational activities by partnering with local players.

For instance, a Canadian market player, Canopy Growth, has expanded its production in South Korea and Thailand.Similarly, MYM Nutraceuticals has expanded its business through its subsidiary MYM Australia.

Such expansions by the companies are expected to drive the cannabis market in the region.

Thailand is among the largest producers of cannabis.In late 2018, it became a cannabis production hub for legalized medical cannabis.

In addition, in December 2018, the military of Thailand voted to legalize medical cannabis use and in February 2019, Thailand legalized medical use of cannabis.Similarly, in January 2019, the Philippine House of Representatives approved the legalization of cannabis in the Philippines.

It has also created a Medical Cannabis Compassionate Center to initiate the creation of a legal cannabis industry.In March 2019, South Korea legalized medical use of cannabis.

Moreover, in March 2019, Japan approved the cannabis compound Epidiolex for clinical trials. Thus, such approvals for cannabis-based products are likely to drive market for cannabis in the Asia Pacific region.On the other hand, the COVID-19 outbreak is growing in an unexpected way.For instance, according to an article published in May 2020, saying, "The study mentions how they have identified a minimum of 13 cannabis plants that are high in CBD that can affect the ACE2 pathways that the coronavirus uses to get inside ones body".

Therefore, it is expected to increase the use of medical cannabis to treat symptoms of COVID-19.

Based on product type, the Asia Pacific cannabis market is segmented into flower, concentrates, and others.In 2019, the flower segment held the largest market share of the cannabis market.

However, the concentrates segment is expected to witness the highest CAGR in the next few years.In terms of application, the Asia Pacific cannabis market is segmented into medical and recreational.In 2019, the medical segment held larger share of the market.

However, the recreational segment is anticipated to witness fastest growth during the forecast period.

Based on compound, the Asia Pacific cannabis market is segmented into tetrahydrocannabinol (THC)-dominant, cannabidiol (CBD)-dominant, and balanced THC and CBD.In 2019, the tetrahydrocannabinol (THC)-dominant segment held the largest share of the market.

However, the cannabidiol (CBD)-dominant segment is anticipated to witness fastest growth during the forecast period.

Council of Scientific Researchs Indian Institute of Integrative Medicine, Centre for Narcotics Training, and International Cannabis and Ministry of Food and Drug Safety are among the major primary and secondary sources for the Asia Pacific cannabis market.Read the full report: https://www.reportlinker.com/p05978820/?utm_source=GNW

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Recipients of the Sunstar|RDH Award of Distinction 2020 | Registered Dental Hygienist – RDH

November 5th, 2020 9:52 am

Introduction

The Sunstar/RDH Award of Distinction is presented to licensed dental hygienists who go above and beyond typical hygiene practice. They serve as role models and mentors to us all and use their education and talents to make this world a better place. Traditionally, award recipients are honored at RDH Under One Roof, a three-day action-packed event offering quality hygiene education and a chance to mingle with fellow hygienists. Due to the COVID-19 pandemic, this years event was held virtually on October 911.

Although the 2020 recipients of the Sunstar/RDH Award of Distinction were unable to receive their awards in person this year, we still take immense pride in introducing the four recipients of the award to you here. Jennifer Geiselhofer, Jaci Klepadlo, Lisandra Maisonet, and Karen Thomas are the four newest dental hygienists to join this prestigious group of key influencers. Congratulations to the 2020 Sunstar/RDH Award of Distinction recipients! You make us all proud to be dental hygienists!

(Denver, Colorado)

Like most hygienists, Jennifer Geiselhofer began her career in private practice. During her 23 years in a general dentistry practice, she found that her real passion was for dental Missions of Mercy. This passion for the underserved led her to create a portable preventive dental business called Dental at Your Door.

Jennifer Geiselhofer, RDHDental at Your Door is a for-profit business that brings much-needed oral health care to Denvers homeless and underserved population. Jennifer brings preventive dental care to those in homeless shelters, correctional facilities, substance abuse facilities, group homes, womens shelters, runaway youth shelters, human trafficking recovery facilities, and more.

The mission of Dental at Your Door is to provide access to high-quality preventative dental health care. This includes serving patients of all ages with significant health issues, mobility challenges, and financial limitations.

But still, Jennifer worried about those whom she couldnt treatthe people who had to be turned away because they did not have private insurance or did not qualify for state assistance and couldnt afford to self-pay. So she created a 501(c)(3) nonprofit called Deserving Dental, which is funded through grants and donations.

Jennifer has three dental assistants and four hygienists working with her to provide preventive oral health services to those who would not be able to afford it otherwise. They provide prophies, scaling and root planing, digital x-rays, oral cancer screenings, exams, sealants, silver diamine fluoride, and referrals to dental and medical officesall while providing their patients with hope and teaching them the value of a clean mouth and how it can affect their overall health.

One of Jennifers dental assistants nominated her for the Sunstar/RDH Award of Distinction. She stated, After having a dental visit with Jennifer, a lot of patients are so happy with their care that they leave emotional, grateful, and even like to give hugs.

Many of their male patients have shaved their beards after a cleaning because they dont want to hide their teeth anymore!

Referrals to dentists and physicians are important for patients who have completed visits with Jennifer and her team. Jennifer has partnered with several Medicaid-approved providers such as general dentists, oral surgeons, head-and-neck physicians, and ENTs for continuing-care referrals.

One nominator stated, Dental at Your Door was a huge accomplishment considering how many hoops she had to jump through, tears shed, and countless hours spent getting everything in order that she needed to start her dream! Because Jennifer followed that dream of serving the underserved, she has become a recipient of the 2020 Sunstar/RDH Award of Distinction.

Congratulations, Jennifer Geiselhofer!

(Mays Landing, New Jersey)

Invest in yourself and give back to others is Jaci Klepadlos advice to other hygienists. Giving back to others is second nature to Jaci. In addition to working as a clinical hygienist for 13 years, she has served as past president of the New Jersey Dental Hygienists Association (NJDHA) and is currently cochair of Veterans Smile Day Foundation. According to one of Jacis nominators, Finding out Jaci was cochair on the team was no surprise at all. Her hard work and determination are a force to reckon with. She could get through any hurdles thrown her way.

Jaci Klepadlo, BSDH, RDHAs president of the NJDHA, Jaci introduced a bill for dental hygienists to have direct access to providing oral health care, because she strongly believes that public health dental hygienists are willing and fully qualified to reach the underserved where they live.

Jaci became involved with Veterans Smile Day Foundation with her employer, a former navy dentist. After serving in Afghanistan, her employer returned to New Jersey and learned that veterans receive dental benefits only if they have retired from the military or were injured in the line of duty. This information left the vast majority of those who served without dental care, and those who do receive it have to travel great distances to get to a VA clinic that has a dental component on-site.

Jaci and her employer made it their mission to give back to veterans, and they founded the Veterans Smile Day Foundation. As cochair, Jaci has spent the past six years working with our nations veterans and dental providers across the nation to deliver free dental care to the men and women who have served selflessly for our country but who do not receive dental benefits. Each year you will find her offering her expertise to the local veterans for free to help make a difference in their oral care and overall health. She strongly believes in helping our veterans live a better life.

The Veterans Smile Day Foundation is a nonprofit 501(c)(3) whose mission is to recruit dental professionals and corporate sponsorships to help fill in that void by Serving Those Whove Served. Since its inception in 2012, it has grown to include private dental offices, dental schools, hospitals, and dental societies throughout the United States.

Jaci invites you to volunteer with the Veterans Smile Day Foundation. Find out how you can use your dental hygiene skills to serve those whove served by contacting Jaci at jaciklepadlo@gmail.com. Because Jaci followed her passion for serving our veterans, she has become a recipient of the 2020 Sunstar/RDH Award of Distinction.

Congratulations, Jaci Klepadlo!

(Pennsylvania)

Mentoring, educating, creating systems within the dental office, igniting passion in dental hygienists, meeting challengesthese are all aspects of Lisandra Lisandra Maisonet, BS, RDH, PHDHP, EFDAMaisonets present day-to-day life. But she began her career as a clinical hygienist in a pediatric dentistry practice. In that capacity, Lisandra implemented a strong preventive protocol that led to an incredible decrease in dental disease in the practice. She was able to inspire every team member to actively participate in the efforts to improve the oral health of thousands of patients.

While working in both the preventive and restorative aspects of dentistry and assisting in IV sedation cases in the pediatric practice, Lisandra questioned why they were treating a disease that was totally preventable. Answering this question became the driving force that brought her to her current role as director of operations and hygiene and leader to 50 dental hygienists in 22 practices, where she has created strong systems that focus on disease prevention and education on oral-systemic health.

Lisandra has made a positive impact on her community in many ways. She is an educator for the Healthy Teeth Healthy Children program, where she goes to pediatricians offices and educates medical professionals on the importance of oral health and fluoride application. She is a volunteer for Mission of Mercy, providing dental care to the underserved in her state, and she has presented numerous courses for the Cavity Free Kids program in Pennsylvania to educate the community on the importance of oral health.

During her active membership with the Pennsylvania Dental Hygienists Association (PDHA), Lisandra served as president for three years. In that time, she worked hard to push initiatives forward to enhance the profession of dental hygiene. She mentors and inspires hygienists to become involved and serve in their association.

With financial help from the PDHA, Lisandra was given the opportunity to create a video that highlights the dental hygienist. While working diligently on this video, she was diagnosed with an autoimmune disorder and hospitalized. Nevertheless, Lisandra continued with editing of the video with the desire to leave it as a legacy at the end of her PDHA presidency. The goal of the video was to share with patients and legislators the fact that dental hygienists are educated preventive specialists who are willing and capable of providing care to the most vulnerable populations. While daunting at times, her passion for this project was what kept her going through difficult times. Lisandras hope is that, through this video, hygienists will finally gain the respect they deserve.

Because Lisandra followed her inner drive to make a difference on so many levels, she has become a recipient of the 2020 Sunstar/RDH Award of Distinction.

Congratulations, Lisandra Maisonet!

(Raleigh, North Carolina)

Karen Thomas began her career as a clinical dental hygienist in Florida. She later became a research dental hygienist at the University of North Carolina at Chapel Hill and was the examiner for patients with temporomandibular disorder (TMD), fibromyalgia, chronic fatigue, episodic headaches, and pelvic pain. It broke her heart to see patients in so much pain. As an examiner, she gathered data but did not have the opportunity to make a personal connection with the Karen Thomas, MSc, BS, RDH, CNS, LN, ND, FDN-P, CHHC, Biological RDHpatients. She thought, Thereve got to be better ways to help these people.

Then, life took a turn in Karens career and her health. Her future mother-in-law became seriously ill days before her wedding. Over a short period of time, the house she was selling caught fire the day before closing, her father passed away, her new home needed significant renovations, and her new husband ended up in the hospital. Karen was told he would not make it. Unfortunately, her mother-in-law did pass on, but Karens husband came home from the hospital and is fine today.

The stress became too much to bear and, as Karen puts it, her body simply shut down. She took a medical leave from her job and spent the next two years in bed, doing little more than sleeping.

After two years of doctors appointments, 15 different diagnoses, multiple medications, and still no improvement, Karen took matters into her own hands. She had been diagnosed with Hashimotos thyroiditis as a teenager. Karen found research stating that 2%5% of people with Hashimotos also have celiac disease, but no doctor had tested her for that. Karen ordered tests on her own and presented the results to her doctor, who finally diagnosed her with celiac disease. She gave up gluten, among several other dietary changes, and got her life back. As one of her nominators for the award said, Thankfully, the dental hygiene curriculum and the way we as RDHs are taught to decipher information are ultimately what helped her heal herself through food.

Karen had regained her life but still wanted to help others. She went back to college to learn more about integrative medicine and combined that education with her dental hygiene training to help others link oral health with systemic health. She attained a master of science in human nutrition and functional medicine and became a licensed nutritionist, a certified nutrition specialist, a certified integrative nutrition health coach, and a certified functional diagnostic nutrition practitioner. Karen is also the award-winning author of Overwhelmed and Undernourished: Use Food as Medicine and Turn Your Life Around. She currently works as a functional medicine nutritionist and teaches continuing education in dentistry.

It is easy to see why Roy T. Bennett's quote is one of Karens favorites: Your hardest times often lead to the greatest moments of your life. Keep going. Tough situations build strong people in the end.

Congratulations, Karen Thomas!

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Meet This Year’s Be Well Philly Health Hero Finalists – Philadelphia magazine

November 5th, 2020 9:52 am

News

You can vote now for the winner of the 2020 Health Hero challenge.

You can start voting right now for the winner of the 2020 Be Well Philly Health Hero Challenge.

Were thrilled to announce that we now have our three finalists for the 2020 Be Well Philly Health Hero Challenge presented by Independence Blue Cross. Here at Be Well Philly, we constantly strive to highlight people who are helping others in the greater Philadelphia area live healthier and better lives. The Health Hero Challenge is our way of honoring the incredible and often unseen work that people do every day, even in the most challenging of circumstances.

We set out at the beginning of this challenge looking for medical providers, nonprofit leaders, entrepreneurs, teachers, anyone really whos making a difference in our community from a health and wellness perspective. And, you all delivered. You shared powerful personal stories of the heroes making a difference in our community, which led to to the nomination of these three finalists. Now, its time to choose the winner.

Name: Asasiya Muhammad (@thepeoplesmidwife), womens health advocate and midwife at Inner Circle Midwifery (@innercirclephilly), a private home birth practice based in Germantown.

Nonprofit of choice: Maternity Care Coalition. Since 1980, Maternity Care Coalition has assisted more than 135,000 families throughout Southeastern Pennsylvania, focusing particularly on neighborhoods with high rates of poverty, infant mortality, health disparities, and changing immigration patterns. A familys needs change as they go through pregnancy and their childs first years, and MCC offers a range of services and programs for every step along the way.

What motivates you to try to make Philadelphia a healthier place, and what policy would you institute if you could? I cherish Philadelphia as the place where I have had my most life-shaping experiences, some high such as graduating college, becoming a mother, and raising a family and others low. Ive had experiences that have left me feeling isolated, lost, and voiceless. As a Black mother, I have faced the feelings of fear and uncertainty many Black women in Philadelphia face, because of the haunting statistic that we are two times more likely to die during pregnancy, or within a year of giving birth due to pregnancy-related complications. As a midwife, I understand that the majority of these complications are preventable, and therefore have made it my mission to build a community-based a practice that is committed to diminishing this disparity in Philadelphia. My practice is unique in that it has a wraparound care component that bundles nutritional counseling and fitness classes into standard midwifery care.

I would institute a policy that expanded the use of and access to community-based providers and particularly related to those specializing in natural health and food access. This would look like expanding insurance access to providers like midwives, doulas, nutritional counselors, and fitness experts so that these services are both normalized and accessible to a larger part of the population. This would further look like creating sustainable food cooperatives in neighborhoods that are distant from larger markets and who now rely on stores that mostly carry processed foods.

Name: Vicky Borgia, a local doctor who utilizes Direct Primary Care (DPC), an alternative payment model for healthcare services. She specializes in reproductive health, LGBTQIA health and integrative medicine.

Nonprofit of choice: Womens Medical Fund. Racial justice and reproductive justice issues are intertwined. In 1976, Congress banned federal Medicaid coverage for abortion through the Hyde amendment. Then, in 1985, Pennsylvania prohibited state Medicaid coverage for abortion. Since then, Womens Medical Fund has provided funding to thousands of individuals struggling to get by and enrolled in Medicaid. Womens Medical Fund has expanded their mission to include advocacy and community organizing.

What motivates you to try and make Philadelphia a healthier place, and what policies would you institute if you could? I believe that healthcare is a human right. I serve communities that have historically been medically disenfranchised because I can use my skills and education to make changes in a system rife with health inequities. I center access, inclusion and equity in my direct primary care practice, which enables me to take the time I need with my patients and give the care they deserve.

Since it is well-established that racism and other forms of systemic oppression are major factors in increased morbidity, mortality, and generational trauma for all, my policy recommendations focus on dismantling systems of oppression in Philadelphia. This includes reprioritizing city investments from policing and instituting PILOTS where big health and educational nonprofits would volunteer a portion of their revenue to the general fund. These resources could be then be used to fund education and invest in communities by improving access to services, opportunities, food, and healthcare.

Name: Christy Silva, cofounder of Aidans Heart Foundation, a nonprofit committed to providing awareness, education, and support to the communities of the southeast Pennsylvania region and its surrounding area to create heart-safe communities for youth regarding the prevention of, or response to, tragic instances of Sudden Cardiac Arrest.

What motivates you to try to make Philadelphia a healthier place and what policy would you institute if you could ?

My motivation for wanting to make Greater Philadelphia a healthier place actually comes from a tragedy in my family. In September of 2010, my seven-year-old son Aidan, who had no prior health conditions, died without warning from sudden cardiac arrest, or SCA. I had never even heard of SCA prior to his death. As I struggled with my grief and tried to understand why my seemingly healthy child collapsed one sunny Saturday, I plunged into research. I learned that, nationally, approximately one out of every 300 youth has an undetected heart condition that could cause SCA. The American Heart Association quotes that more than 7,000 children under age 18 are struck by SCA each year. This equates to one young person, nearly every hour, every day, every year. Its a little known fact that Sudden Cardiac Arrest (SCA) is the leading cause of death in student athletes on school grounds. As a result of what I learned, I became determined to still be Aidans mom and try to prevent SCA from taking more young lives in our local communities. Im motivated by these facts to do everything possible to decrease the number of preventable deaths in young people in Philadelphia and its surrounding suburbs. I co-founded Aidans Heart Foundation shortly after Aidans death. To date, we have placed 89 AEDs in youth based sports facilities, trained 6,100 youth on how to perform CPR and how to use an AED, and we have partnered with pediatric cardiologists to provide 2,100 free heart screenings to kids and teens in efforts to detect heart conditions through a simple, non-invasive ECG exam.

If I could institute a policy to make Greater Philadelphia a healthier region, it would center around protecting hearts. Annual electrocardiogram exams at every well-child visit, particularly for young athletes; CPR and AED training for all teachers, coaches, instructors, etc. who work with physically active youth; and AED devices available in all schools, child care centers, dance, martial arts, gymnastics and other studios where kids are active, in addition to AEDs being prominently placed on every athletic playing field. These arent impossible tasks, but they do take the awareness of the public, particularly parents, to urge our community leaders and policymakers to implement these measures. We owe it to our kids to keep them safe at play.

Vote now to select your 2020 winner. Remember: the winner will be named the 2020 Health Hero and will receive a $15,000 donation to her charity of choice, and the two runners-up will each receive $2,500 donations to the charities of their choice.

Vote HERE now. (Remember, you can vote once a day until November 16th!) Stay in touch with @bewellphilly and @phillymagevents.

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Meet This Year's Be Well Philly Health Hero Finalists - Philadelphia magazine

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17 Breathing Videos That Will Help You Relax and Unwind – Self

November 5th, 2020 9:52 am

In an already high-stress year, this week just might take the top spot. Theres no easy way to calm down fast, but taking time to do some guided breathingwith the help of handy breathing videosmight help you feel a little better.

For many of us, the months leading up to Election Day have been a source of long-term, slow-burning stress, Christiane Brems, Ph.D., a registered yoga teacher, clinical professor, and director of YogaX at Stanford Psychiatry, tells SELF. This type of stresssustained and low gradecan wreak havoc on our nervous system, she says.

When your body is stressed, it releases the stress hormones adrenaline and cortisol, kicking off your fight-flight-freeze response, Manuela Kogon, M.D., clinical associate professor at the Stanford Center for Integrative Medicine, tells SELF. But purposeful breathing can trigger your parasympathetic system, or the part of your autonomic nervous system that opposes the fight-flight-freeze response. As a result, it may help you feel rested and relaxed.

Breathing is so powerful because unlike so many things in life, it's something we have control over, Rachel Allyn, Ph.D., a psychologist and yoga teacher based in Minneapolis, tells SELF. By improving the way you breathe, you can shift your nervous system from the stress-response mode to a state of regulation and relaxation.

And the good news is you dont need to do an extensive breathing routine to get the benefitsand you dont need to do them for a prolonged amount of time, either.

In fact, you can feel calming benefits in as little as 30 seconds of purposeful breathing exercises, Catherine Cook-Cottone, Ph.D. a licensed psychologist and registered yoga instructor based in Buffalo, New York, tells SELF. It doesnt need to be complicated, she says. Orienting back to your own breathjust noticing itis a powerful first step.

For a little more structure, check out these 17 expert-approved breathing videos to help you get started.

Length: 9 minutes

What to expect: This guided meditation cultivates focus and stability through concentration and mindfulness with breathing.

I like this simple technique of paying attention to the gap between your exhale and inhale. It is so calming and the time floats by, leaving you feeling clear and aware when complete. Diane Malaspina, Ph.D, psychologist, yoga teacher, and therapeutic specialist in Virginia Beach, Virginia

Try the breathing routine.

Length: 3 minutes

What to expect: Gabby Bernstein, New York Times best-selling author and kundalini yoga and meditation teacher, shares a calming five-count breathing technique.

This three-minute video is great for a technique called box breath, where we silently count to five on the inhale, hold the inhale to a count of five, exhale for five, and hold our breath for a count of five (before the next inhale to a count of five). Beyond the immediate sense of calm it brings, the box breath is easy to do anywhere and enhances feelings of relaxation and peace. Diane Malaspina

Try the breathing routine.

Length: 4 minutes

What to expect: Thich Nhat Hanh guides you through the first exercises of mindful breathing, from following the in breath and out breath all the way through to generating the energy of mindfulness by being with your body.

I love this video because Thich Nhat Nahn, one of the most profound teachers, makes the breathing exercises simple and approachable. With these practices, we find the magic in the simple act of breathing. Laurasia Mattingly, meditation and mindfulness teacher and founder of the Sit Society in Los Angeles

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Maui Grown Therapies to Organize a Webinar on Cannabis Hosted by Dr. Andrew Weil on November 5 – London Daily Post

November 5th, 2020 9:52 am

Maui Grown Therapies has announced to organize a webinar titled, Cannabis and the Anti-Inflammatory Lifestyle that is going to be held on November 5. There are no charges imposed on participation in this webinar. The event will take place from 11:00 (HST) to 2:00 (PST) and it will be presented by Dr. Andrew Weil.

Andrew Weil is the MD, founder, and director of the Andrew Weil Center for Integrative Medicine at the University of Arizona. In addition to this, he is the chief science officer for Maui Grown Therapies. He has always endorsed the importance of living an anti-inflammatory lifestyle to get rid of many health problems.

In the webinar, Cannabis and the Anti-Inflammatory Lifestyle, participants will learn important information about reducing inflammation. Moreover, they will know about the ways to boost the natural defense mechanisms of the body.

Additionally, the light will be thrown on the subject of the importance of various compounds present in the cannabis plants namely, CBD, THC, and terpenes. The webinar will conclude with a live Q&A after the online presentation on the subject of living an inflammatory lifestyle.

Dr. Andrew Weil has been endorsing the anti-inflammatory lifestyle for a long time. He conducted the first human trials in the nation using various cannabis products. Dr. Weil has gained global recognition for his worthy contribution to integrative medicine.

He completed his undergraduate degree in botany from Harvard and gained his M.D from Harvard Medical School. Dr. Weil always endorses the consumption of cannabis seeds to gain healthy fats and essential fatty acids.

He is associated with Maui Grown Therapies, Hawaiis first state-licensed medical cannabis dispensary, to spread awareness about living an anti-inflammatory lifestyle by consuming various cannabis products. Know more about the webinar and register for the webinar by clicking the links mentioned below.

Register for the Webinarhttps://manao.mauigrown.com/maui-grown-manao

Youtube Linkhttps://www.youtube.com/watch?v=yz8ryqanQDM

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YOUR GUIDE TO CANNABIS & THE ANTI-INFLAMMATORY LIFESTYLE

Your Guide to Cannabis and an Anti-Inflammatory Lifestyle by THE MEDIA BUTLER

Address

Maui Grown Therapies44 Paa St, Kahului, HI 96732(808) 866-7576

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Maui Grown Therapies to Organize a Webinar on Cannabis Hosted by Dr. Andrew Weil on November 5 - London Daily Post

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Synthace and Ipsen Partner to Accelerate Novel Therapeutic Development Through Automation – BioSpace

November 5th, 2020 9:52 am

Nov. 5, 2020 09:00 UTC

BOSTON & LONDON--(BUSINESS WIRE)-- Synthace Ltd and Ipsen, a global biopharmaceutical company focused on innovation and specialty care, have partnered to accelerate development of novel biotherapeutics targeting multiple therapeutic areas, including oncology, endocrinology, pain management, regenerative medicine and rare diseases. Ipsen has automated design and construction of therapeutic candidates using Synthaces integrative software platform, Antha. The process aims to speed up biotherapeutic candidate entry into the screening pipeline and shorten development time for treatment of diseases via targeted secretion inhibition.

Ipsen has developed novel biotherapeutic molecules, called Targeted Secretion Inhibitors (TSIs). TSIs are a fusion of select parts of the botulinum neurotoxin with another protein domain to redirect its mode of action, resulting in a unique targeted therapeutic. The design and construction of TSIs is both labour intensive and manually complex, typically taking 30 days to develop between 24-48 constructs which then go on to therapeutic screening.

The Ipsen R&D team required a solution to increase throughput and efficiency of its TSI generation and screening pipeline, while utilizing its Type IIs construct assembly method. They looked to fellow innovators Synthace, whose flexible and integrative software Antha has built-in workflows for automating processes such as Type II construct assembly, bacterial transformation, plating, data generation and analysis.

Synthaces Antha platform allowed the Ipsen team to plan, simulate, and test their assemblies in silico before executing the protocol. The partnership of Antha and Ipsen produced approximately 90 constructs five times faster than previous methods, substantially increasing the number of molecules entering the screening cascade. Antha was also able to increase efficiency by re-using core DNA building blocks for multiple construct assemblies, resulting in a 10-fold reduction in costs associated with DNA synthesis.

Dr. Karen Bunting, Director of Protein Science at Ipsen said, The development of novel biotherapeutics like TSI is key to treating debilitating illnesses across multiple therapeutic areas. The first step in this is generating and screening high quality molecules as therapeutic candidates. Using Antha, our team increased throughput at this crucial step, allowing us to design, construct, and screen novel TSI candidates rapidly and helping to advance our therapeutic solutions.

Drug discovery is a costly and laborious process where thousands of candidates are generated, screened and validated, but only a select few are chosen to move forward in the pipeline. Pharma companies are turning to automation and software to aid in the design, construction and screening of these compounds, reducing costs and increasing efficiency without compromising on quality.

To achieve this, biopharmaceutical companies like Ipsen are partnering with specialists in integrating the digital and physical aspects of R&D, providing an easy-to-use interface between scientists, design software, automated devices, and data handling downstream. This flexible, integrated approach to the discovery process has clear advantages in boosting efficiency at the earliest stages of drug development, with the ultimate goal of making more effective treatment options available to patients sooner.

Dr. Tim Fell, CEO of Synthace concluded, We are thrilled to see our Antha platform applied to develop new biotherapeutics. Antha has accelerated Ipsens TSI construction and screening programme while reducing costs and the time scientists spent in the lab. Automating processes like these allows scientists to focus on experimental design and data analysis rather than liquid handling, enabling them to create more beneficial therapeutics for patients,.

To learn more about automating drug discovery and development protocols, visit: https://www.synthace.com/customers/case-studies/detail/construct-assembly-for-the-development-of-new-therapeutics-with-ipsen/

Follow Synthace Synthace Blog Join the Twitter Conversation Join us on LinkedIn

About Synthace Based in London, UK and Boston, US, Synthace is accelerating biological discovery & optimization through computer-aided biology. Our cloud software platform, Antha, empowers biologists by enabling them to flexibly program their lab automation without the need to code. The graphical user interface has been designed by biologists for biologists, intuitively enabling them to automate their whole experiment from planning to execution, data collection and analysis. Antha is the cornerstone of the lab of the future, seamlessly connecting the digital realm of data with the physical of lab automation and wet-lab biology, automatically collecting and structuring data to accelerate biological understanding.

Synthace is unlocking the potential of biology for humankind and our environment. Synthace works with biopharmaceutical companies, and in 2016 was recognized by the World Economic Forum as a Technology Pioneer that is helping shape the Fourth Industrial Revolution, and in 2018 as a cool vendor by Gartner.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201105005418/en/

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Specialdocs Informs and Inspires at Concierge Medicine Industry’s Signature Event Nov. 12th – 14th – Benzinga

November 5th, 2020 9:52 am

CHICAGO, Nov. 3, 2020 /PRNewswire/ --At the 2020 Concierge Medicine Forum (CMF), Terry Bauer, CEO of Specialdocs Consultants, a pioneer in concierge medicine transitions and management, along with a group of the company's outstanding physician-clients, will share an inside look at the practice model that continues to fuel one of the healthcare industry's rare success stories in a year of unprecedented challenge. A completely virtual experience for the first time, the highly anticipated annual industry event spans three days of presentations, workshops and live chat sessions with concierge industry leaders; all focused on the relevant theme of collaboration in medicine.

"At this pivotal point in healthcare, we are privileged to share our collective experience and stories of transformation."

"This year has exposed the vulnerabilities of traditional fee-for-service practices in ways we could never have foreseen," says Bauer. "And 2020 has also underscored the resilience and rewards of the Specialdocs model of personalized medicine and inspired rising numbers of physicians to consider this beneficial alternative for themselves and their patients. At this pivotal point in American healthcare, we are privileged to share with Concierge Medicine Forum attendees our collective experience and first-person stories of transformation from our network of dedicated doctors."

Michael Tetreault, CMF organizer and editor of Concierge Medicine Today, says: "The virtual format enables us to host a more diverse gathering of healthcare professionals than ever before, and offer 24/7 on-demand access to insights from the industry's most creative minds. We're thrilled to feature groups like Specialdocs, pioneers and continual innovators in the concierge medicine space."

Specialdocs will be featured at events including: (all ET)

Thursday, Nov. 12th Pre-conference workshop

Friday, Nov. 13th

After 2 pm

Saturday, Nov. 14th

Since 2002, concierge medicine transition and management experts Specialdocs Consultants have helped physicians nationwide transform their practices with a uniquely customized and sustainable concierge model.

Contact: Mindy Kolof, mkolof@specialdocs.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/specialdocs-informs-and-inspires-at-concierge-medicine-industrys-signature-event-nov-12th--14th-301166040.html

SOURCE Specialdocs Consultants

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Maui Grown Therapies’ Webinar, Cannabis and the Anti-inflammatory Lifestyle to be Held on Nov. 5 – California Herald

November 5th, 2020 9:52 am

Maui Grown Therapies webinar titled, Cannabis and the Anti-Inflammatory Lifestyle is scheduled to take place on November 5. It will be presented by Andrew Weil who is MD, founder, and director of the Andrew Weil Center for Integrative Medicine at the University of Arizona and chief science offer for Maui Grown Therapies.

Maui Grown Therapy is Hawaiis first state-licensed medical cannabis dispensary. The timing of the webinar is set at 11:00 (HST) to 2:00 (PST) on Thursday, Nov. 5, 2020. The webinar will highlight the importance of living an anti-inflammatory lifestyle to improve overall health and wellness. It will end with a live Q&A post the online presentation.

Dr. Andrew Weil has always supported the anti-inflammatory lifestyle to live a healthy life. He is globally renowned for his pioneering work in integrative medicine. He earned his undergraduate degree in botany from Harvard and he completed his M.D. from Harvard Medical School. It was in 1969 when Dr. Weil conducted the nations first human trials with the use of cannabis.

The participants of the webinar, Cannabis and the Anti-Inflammatory Lifestyle will learn ways to reduce inflammation and boost the natural defense mechanisms of the body. In addition to this, the value of compounds in cannabis plants such as CBD, THC, and terpenes will also be discussed.

Dr. Weil also recommends consuming cannabis seeds (edible hemp seeds) as a rich source of healthy fats and essential fatty acids. They are an excellent protein source that contains vitamin E, phosphorus, potassium, sodium, magnesium, sulfur, calcium, iron and zinc.

Register for the Webinar https://manao.mauigrown.com/maui-grown-manao

Youtube Link https://www.youtube.com/watch?v=yz8ryqanQDM

Read More Here

YOUR GUIDE TO CANNABIS & THE ANTI-INFLAMMATORY LIFESTYLE

Your Guide to Cannabis and an Anti-Inflammatory Lifestyle by THE MEDIA BUTLER

Address

Maui Grown Therapies44 Paa St, Kahului, HI 96732(808) 866-7576

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Maui Grown Therapies' Webinar, Cannabis and the Anti-inflammatory Lifestyle to be Held on Nov. 5 - California Herald

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Daylight Saving Time: What happens to your body when we fall back – Yahoo Canada Shine On

November 5th, 2020 9:52 am

Daylight saving time ends on Nov. 1 at 2 a.m. While many simply see this as gaining an hour of sleep on Sunday, there are various lasting effects that this time change will bring, both mentally and physically. Yahoo Life is joined by two experts who share what to expect and ways to combat the negative effects.

Integrative medicine physician and wellness expert Dr. Taz Bhatia explains that when we set the clocks back, were also adjusting our internal clock and throwing off our circadian rhythm.

Our circadian rhythms, or the flow of when we sleep and when were awake, dictates so many different processes in the body, says Bhatia.

When our circadian rhythms are thrown off, our sleep cycles become inconsistent, our weight is less regulated due to a change in insulin, and the risk of heart disease, stroke and heart attack increases.

Judy Ho, a licensed clinical and forensic neuropsychologist, highlights how experiencing one less hour of light each day can heavily impact ones mood, causing us to experience more depression and sadness.

So what can we do to cope with these changes? During the day, its crucial to take advantage of any kind of sunlight, whether its indirectly through a window or through a sun lamp as light therapy has been proven to work wonders on mood and sleep.

With less sunlight during the day, we also receive less vitamin D, also known as the sunshine vitamin. We can, however, make up for the lack of vitamin D in other ways. It's important now more than ever to exercise regularly, as it helps with the endorphin release and boosts our mood, says Bhatia.

Ho recommends establishing a calming nighttime routine that involves putting away all devices, especially blue light devices. To combat sleep deprivation, people should go to bed earlier, but not too early.

You dont want to go to bed too early just to make sure that youre in bed by a certain hour because then you might be awake for longer than you need to be, Ho explains. Then the bed becomes associated with anxiety and stress.

Since 2020 has been anxiety-inducing for many, Bhatia points out that our threshold for anxiety and depression is lower right now.

When we have additional disruptions like disruptions to our sleep cycle, disruptions to the amount of light we're getting in when we're awake, its just one more factor in an already really tough year for so many people, she says.

Ho reiterates how beneficial it is to maintain social connections on a daily basis with friends and loved ones.

Even a brief interaction like that can bring you a lot of positivity and feeling of community when you need it most, she says.

Video produced by Jenny Miller

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Who are this year’s Best of the Press? – Press of Atlantic City

November 5th, 2020 9:52 am

On Oct. 14 2020, in Ocean City, Car Caress was named Best Auto or Boat Detailer for this years Best of The Press contest.

When you buy a new car, it has that crisp, clean smell of wax, leather and upholstery. But over time, that fresh scent can be overtaken by cigarettes, fast food, spilled coffee and pet odors.

If the thought of cleaning your car seems overwhelming, take it to Car Caress Custom Auto Detailing, which earned Best of the Press in the Automotive/Transportation category.

Owner Brian Coggins is honored by the accolade and owes his success to his employees.

Customer services is No. 1, and that makes all the difference. I have a good group of people working for me, he says. I cant do everything myself. They do a great job.

With three locations Ocean City, Marmora and Somers Point Car Caress restores vehicles with services that shine, buff, polish and freshen your car or boat, inside and out.

Services include detailing; ceramic coating, a longer-lasting way to protect the paint than wax alone; ozone treatment, which disinfects and destroys bacteria in your car and the ventilation system; and automatic car washing.

Car detailing along with these other services requires a desire for perfection.

You have to be picky to do this kind of work, says Coggins. Youre not there just to make it look OK. You want to get the car or boat looking perfect. So you have to get into all the cracks and crevices.

It also takes skill, particularly buffing the car or boat.

Buffing isnt using a rag to shine something, Coggins explains. Theres a high-speed rotary buffer that runs at 1,500 rpms to 2,000 rpms. Using this machinery requires real craftsmanship, says Coggins, because if you dont know what youre doing, you can scratch the car and do damage.

For these reasons, Coggins is grateful most of his 15 employees stayed with him, even while his business was closed during quarantine.

Although COVID-19 sidelined Car Caress, it has created a silver lining for the family-owned business, namely sanitizing vehicles. Coggins explains the difference between cleaning and sanitizing.

With sanitizing, youre killing the germs and bacteria that are on the surfaces of whatever youre cleaning. When youre cleaning with a regular soap, youre not necessarily killing all the germs, he says.

Thats where ozone cleaning comes in, a service thats becoming increasingly more popular now that COVID-19 is a way of life. Ozone is a gas that removes odors, as well as disinfects and destroys viruses and bacteria. Unlike a liquid disinfectant, ozone gets into the places you cant clean, including the ventilation and AC systems, carpet fibers and upholstery.

Customers are requesting this service more, as well as used car dealerships, and those in the private transportation business, such as Uber drivers.

Although coping with COVID-19 was difficult during quarantine, Coggins biggest challenge still is operating a seasonal business.

Summers are super busy here, he Coggins. We hire summer workers, and it takes a while for them to learn. Just when they start getting good at this, they go home and leave.

Thats why Coggins is grateful to his employees, who take the sting out of summer workers departures.

The guys I have are really good, and most came back after quarantine, which was nice. I owe this (Best of The Press) to them, he says.

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