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Archive for March, 2020

Vir Biotechnology Announces Intent to Collaborate with Biogen on Manufacturing of Antibodies to Potentially Treat COVID-19 – GlobeNewswire

Thursday, March 12th, 2020

SAN FRANCISCO, March 12, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc.(Nasdaq: VIR) today announced that it has signed a letter of intent with Biogen Inc. (Nasdaq: BIIB) for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Because of the urgency of the situation, the companies have begun work while a Clinical Development and Manufacturing Agreement is being negotiated. Subject to the completion of a definitive agreement, Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Virs proprietary antibodies.

These exceptional circumstances presented by the threat of COVID-19 require that we work with great urgency in the interest of the public good, said George Scangos, Ph.D., CEO, Vir. Biogen is one of the global leaders in cell line and process development for advanced biologics; tapping into their capabilities will provide us with a U.S. base for supply and manufacture of antibody therapies.

Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2, which were isolated from individuals who had survived a SARS (Severe Acute Respiratory Syndrome) infection. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

About Virs Antibody Platform

Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in theDemocratic Republic of Congo), hepatitis B virus, influenza A, malaria, and others.

AboutVir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus, and tuberculosis. For more information, please visit http://www.vir.bio.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend, potential and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the companys efforts to neutralize the SARS-CoV-2 virus and identify additional potential therapies for SARS-CoV-2, its ability to address the emerging public health epidemic, and its ability to enter into an agreement with Biogen, and its ability to secure a U.S. base for supply and manufacture of antibody therapies. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, difficulty in reaching a definitive agreement with Biogen, challenges of collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with theU.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:Vir Biotechnology, Inc.Investors Neera Ravindran, MDHead of Investor Relations & Strategic Communications nravindran@vir.bio+1-415-506-5256

Media Lindy Devereux Scient PR lindy@scientpr.com +1-646-515-5730

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Vir Biotechnology Announces Intent to Collaborate with Biogen on Manufacturing of Antibodies to Potentially Treat COVID-19 - GlobeNewswire

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Nutrition influences the course of MS – European Biotechnology

Thursday, March 12th, 2020

New data prove that propionic acid modulates the intestine-mediated immune regulation in people with multiple sclerosis (MS).

In Cell the team headed by Aiden Haghikia from University Bochum demonstrated that the administration of propionic acid (PA) in addition to MS standard therapy reduced the relapse rate and the risk of disability increase in the long term. Furthermore, MRI studies indicate that propionic acid may reduce brain shrinkage of patients with Multiple sclerosis (MS), which is regarded as a measure for neuronal cell death.

Haghikia et al. demonstrated that

PA is reduced in MS patients, particularly early after disease manifestation; PA reduction is associated with an altered gut microbiome composition; after 14days of PA supplementation, Treg cell/TH17 imbalance was restored; longitudinal PA supplementation might have clinical implications.

The reseach team together with co-working groups at MDC Berlin and University of Halle-Wittenberg demonstrated that the microbiome composition is altered in MS patients. In addition, for the first time they were able to show a deficiency of propionic acid in the stool and serum of MS patients, which was most pronounced in the earliest phase of the disease. Propionic acid is an EFSA-approved antibacterial food supplement.

"Intestinal bacteria can directly and indirectly influence anatomically distant structures such as the brain," explained study head Haghikia, who together with Flexopharm Brain GMBH & Co. KG holds a patent on the invention. The company markets a related food supplement. "The intestinal microbiome thus corresponds to an independent endocrine organ that is in contact with the environment."

In the current study, the scientists transfered results previously obtained in cell culture and disease models co-developed witha group from Bar-Ilan University in Israel to MS patients: short-chain fatty acids such as propionic acid or its salt propionate led to the increased formation and increased function of T regulatory cells (Tregs) of the immune system. "These cells stop excessive inflammatory reactions and reduce auto-immune cells in the context of autoimmune diseases such as MS," said co-author Ralf Gold, Director of Neurology at St. Josef Hospital. The increase in Treg function is due to improved energy utilization through an altered function of the mitochondria.

However, the short-chain fatty acids represent only a fraction of the metabolic products of intestinal bacteria. "Further research into this largely unknown organ and the knowledge gained from it will make it possible to develop further innovative dietary measures to complement the known therapeutics in the future," commented Haghikia.

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The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap…

Thursday, March 12th, 2020

Here's a roundup of top developments in the biotech space over the last 24 hours:

(Biotech stocks that hit 52-week highsMarch 9.)

(Biotech stocks that hit 52-week lows March 9.)

See also:Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Mesoblast limited (NASDAQ: MESO) said it plans to evaluate its allogenic mesenchymal stem cell product candidate remestemcel-L in patients with acute respiratory distress syndrome caused by COVID-19 in the U.S., Australia, China and Europe.

The company said it is in active discussions with various government and regulatory authorities, medical institutions and pharma companies.

In premarket trading Tuesday, the shares were surging 28.35% to $7.90.

Emergent Biosolutions Inc (NYSE: EBS) said it has entered into an agreement with Novavax, Inc. (NASDAQ: NVAX), under which the former will use its molecule-to-market contract development and manufacturing service to support bringing intothe latter's vaccine candidate to protect against COVID-19 into the clinic.

Emergent will produce the COVID-19 experimental vaccine candidate developed using Novavax's proprietary recombinant protein nanoparticle technology platform. Emergent said it has initiated work and anticipatescommencement of a Phase 1 study within the next four months.

Separately, Novavax said the Coalition for Epidemic Preparedness awarded it an initial funding of $4 million to support its COVID-19 vaccine program.

In premarket trading Tuesday, Emergent shares were adding 0.95% to $53.02 and Novavax shares were surging up 24.35% to $12.46.

GENMAB A/S/S ADR (NASDAQ: GMAB) announced the appointment of Anthony Mancini as EVP and COOeffective March 23. Mancini's rolecalls for himto oversee the company's commercial, corporate development, business development and information technology functions.

Ophthalmic medtech and pharma company Glaukos is set to join the S&P SmallCap 600 Index, effective prior to the open of trading March 13, replacing AK Steel Holding Corporation (NYSE: AKS), which has agreed to be acquired by Cleveland-Cliffs Inc (NYSE: CLF).

Glaukos shares were trading 7.5% higher at $38.49 in the premarket session.

MediciNova, Inc. (NASDAQ: MNOV) said it plans to initiate the development of MN-166 for severe pneumonia and acute respiratory distress syndrome following positive results in a recent preclinical study in an animal model. The animal study showed treatment with the investigational candidate reversed histological changes, including inflammation, hemorrhage, alveolar congestion and alveolar edema.

Medical Resources Acquisition said on Feb. 25 it offered Rockwell Medical Inc (NASDAQ: RMTI) $15 million in equity investment for three board seatscurrently held by John Cooper, Mark Ravich and Lisa Colleran.

The investment firm said Rockwell's board hasfailed to provide appropriate governance, resulting in reckless spending, acash deficiency and a lack of operational controls that have impacted stock performance.

Rockwell acknowledged receiving an email from Medical Resources Acquisition in a press release.

"The Board of Directors is in the process of reviewing the materials submitted by MRAG. Stockholders do not need to take any action at this time," the company said.

The stock was trading 9.37% higher at $3.50 in Tuesday's premarket session.

Acceleron Pharma Inc (NASDAQ: XLRN) saidtreatment with ACE-083 in patients with Charcot-Marie-Tooth disease did not demonstrate functional improvement in aPhase 2 trial.

The companysaid it is discontinuing the development of ACE-083.

Organogenesis Holdings Inc's (NASDAQ: ORGO) fourth-quarter revenues climbed 17% to $74.6 million. The net loss per share narrowed from 12 cents to 4 cents. For 2020, the company guided to revenues of $273 million to $277 million. The results as well as the guidance were above consensus.

The stock jumped 14.56% to $3.54 in after-hours trading.

Aduro BioTech Inc (NASDAQ: ADRO) said its fourth-quarter revenues increased from $2.8 million in 2018 to $3.6 million in 2019. The loss per share narrowed from 33 cents to 24 cents, while analysts expected a narrower loss of 21 cents per share.

The stock slipped 4.89% to $2.92 in after-hours trading.

Assertio Therapeutics Inc (NASDAQ: ASRT) reported fourth-quarter revenues of $59.23 million and a loss of $2.65 per share. In the year-ago quarter, the company reported revenues of $42.6million and a loss of 38 cents per share. On a non-GAAP basis, the company reported a loss of 14 cents per share for the recent quarter compared to expectations for a profit of 14 cents per share.

The stock fell 11.21% to 95 cents in after-hours trading.

The FDA is set to rule on Bristol-Myers Squibb Co's (NYSE: BMY) sBLA for Opdivo + Yervoy as treatment option for patients with advanced hepatocellular carcinoma who werepreviously treated with Bayer AG (OTC: BAYRY) and Onyx Pharma's Nexavar.

Related Link: The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap...

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The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues – Benzinga

Thursday, March 12th, 2020

Biotech stocks rebounded in the week ended March 6, recovering from the previous week's steep sell-off.

The week was light on news flow, barring some smid-cap earnings andCOVID-19 treatment and vaccine news.

The following arekey catalysts in the unfolding week that a biotech investor should stay tuned to.

Barclays Global Healthcare Conference: March 10-12 in Miami, Florida.American Academy of Allergy Asthma and Immunology, or AAAAI, Annual Meeting: March 13-16 in Philadelphia, Pennsylvania.

The FDA is set to rule on Bristol-Myers Squibb Co's (NYSE: BMY) sBLA for Opdivo + Yervoy as a treatment option for patients with advanced hepatocellular carcinoma who were previously treated with Bayer AG (OTC: BAYRY) and Onyx Pharma's Nexavar. The PDUFA date has been set for Tuesday.

Blueprint Medicines Corp (NASDAQ: BPMC) is scheduled to present at the AAAAI annual meeting with Phase 2 data for Avapritinib, which is being evaluated for treating indolent and smoldering systemic mastocytosis.

See also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Monday

Tuesday

Wednesday

Friday

Imara, a biopharma company that is developing therapies for rare hemoglobinopathies, has filed to offer 4.45 million shares in an IPO, to be priced between $16 and $18. The company seeks to list its shares on the Nasdaq under the ticker symbol "IMRA."

Revolution Medicines Inc (NASDAQ: RVMD)

Related Link: How The COVID-19 Outbreak Is Benefiting Biotech Investors

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues - Benzinga

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UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2019 Financial Results – GlobeNewswire

Thursday, March 12th, 2020

SOUTH SAN FRANCISCO, Calif., March 11, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today reported financial results for the fourth quarter and full year ended December 31, 2019. Unity issued a press release providing pipeline and business updates on February 25, 2020.

Fourth Quarter and Full Year 2019 Financial Results

Cash, cash equivalents and investments totaled $125.0 million as of December 31, 2019 compared with $171.1 million as of December 31, 2018.

Operating loss for the twelve months ended December 31, 2019 was $89.7 million compared to $79.5 million for the twelve months ended December 31, 2018. Cash used in operations during the year ended 2019 was $72.4 million compared to $56.6 million for the year ended 2018. Total operating loss for the three months ended December 31, 2019 was $23.1 million compared to $22.8 million for the fourth quarter of 2018. Cash used in operations during the fourth quarter of 2019 was $15.7 million compared to $12.8 million for the fourth quarter of 2018.

Research and development expenses were $71.0 million for the year ended December 31, 2019 compared to $58.9 million for the year ended December 31, 2018. The increase of $12.1 million was primarily due to a net increase of $2.3 million for personnel-related expenses, which was partially offset by a decrease of $1.1 million related to non-cash stock compensation expense,$6.7 million for outside research and development activities and $3.1 million in lab and facilities-related costs. Research and development expenses were $18.2 million for the three months ended December 31, 2019 compared to $16.3 million for the three months ended December 31, 2018. The increaseof $1.9 million was primarily due to $0.5 million for personnel-related expenses and $1.1 million for outside research and development activities.

General and administrative expenses were $20.0 million for the year ended December 31, 2019 compared to $16.0 million for the year ended December 31, 2018. The increase of $4.0 million was primarily due to an increase of $3.4 million for personnel-related expenses, of which $2.5 millionwas related to non-cash stock compensation expense,and $0.6 million in insurance-related expenses, partially offset by $0.5 million decrease in professional fees. General and administrative expenses were $4.9 million for the three months ended December 31, 2019 compared to $4.3 million for the three months ended December 31, 2018.The $0.6 million increase was primarily due to personnel-related costs, primarily attributable to non-cash stock-based compensation expense.

About UNITYUNITY is developing therapeutics to extend healthspan with an initial focus on cellular senescence. UNITY believes that the accumulation of senescent cells is a fundamental mechanism of aging and a driver of many common age-related diseases. Cellular senescence is a natural biological state in which a cell permanently halts division. As senescent cells accumulate with age, they begin secreting inflammatory factors, proteases, fibrotic factors, and growth factors, that disturb the tissue micro-environment. This collection of secreted proteins is referred to as the Senescence Associated Secretory Phenotype, or SASP. UNITY is developing senolytic medicines to eliminate senescent cells and thereby stop the production of the SASP, which UNITY believes addresses a root cause of age-related diseases. By stopping the production of the SASP at it source, UNITY believes senolytic medicines could slow, halt, or reverse diseases such as osteoarthritis and age-related eye diseases.More information is available atwww.unitybiotechnology.comor follow us onTwitter.

Forward-Looking StatementsThis press release contains forward-looking statements including statements related to the potential for UNITY to develop therapeutics to extend healthspan. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITYs most recently filed Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the Securities and Exchange Commission on November 6, 2019, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.

Investors Endurance AdvisorsPeter Rahmerprahmer@enduranceadvisors.com

Media Canale CommunicationsJason Sparkjason@canalecomm.com

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UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2019 Financial Results - GlobeNewswire

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Kymera Therapeutics Announces $102 Million Series C Financing to Advance its Protein Degrader Pipeline and Platform – BioSpace

Thursday, March 12th, 2020

CAMBRIDGE, Mass., March 12, 2020 /PRNewswire/ -- Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to invent breakthrough protein degrader medicines for patients, today announced the closing of a $102 million Series C financing. The round was led by Biotechnology Value Fund (BVF) and Redmile Group with participation from Wellington Management Company, Bain Capital Life Sciences, funds managed by Janus Henderson Investors and BlackRock, Rock Springs Capital and a large US-based, healthcare-focused fund. Existing investors also participated in the round.

Kymera also received a strategic investment from The Leukemia & Lymphoma Society's Therapy Acceleration Program (LLS TAP) directed toward advancing the company's work to treat blood-based cancers.

"We are very excited to be joined by a top-tier group of investors as we continue on our path to become a fully integrated biotech company," said Nello Mainolfi, PhD, co-founder, President and CEO of Kymera Therapeutics. "We are well capitalized to advance up to three programs to the clinic by next year, while we continue to enhance our best-in-class platform to unlock new biology and invent new medicines."

Kymera's Pegasus targeted protein degradation platform harnesses the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on un-drugged nodes in validated pathways currently inaccessible with conventional therapeutics.

Kymera's lead program targets IRAK4, a protein known to play a significant role in inflammation mediated by toll-like and IL-1 receptors. Kymera is planning to advance its IRAK4 degrader program in a variety of autoinflammatory and autoimmune diseases, as well as in precision-medicine targeted oncology indications. The company is also developing novel protein degrader therapies to target STAT3, an un-drugged oncogenic transcription factor as well as a driver of inflammation and fibrosis, in a range of cancers and chronic diseases.

"Targeted protein degradation is one of the most promising new therapeutic modalities, with the potential to transform medicine as we know it. Kymera is leading the way with an incredible team, a sophisticated drug discovery platform and important new protein degrader therapies designed to address the most elusive drug targets" said Bruce Booth, DPhil, co-founder, Chairman of the Board of Kymera Therapeutics and partner at Atlas Venture.

About Kymera Therapeutics

Kymera Therapeutics is a biotechnology company pioneering a transformative new approach to treating previously untreatable diseases. The company is advancing the field of targeted protein degradation, accessing the body's innate protein recycling machinery to degrade dysregulated, disease-causing proteins. Powered by Pegasus, a game-changing integrated degradation platform, Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients. For more information visit, http://www.kymeratx.com.

About Pegasus

Pegasus is Kymera Therapeutics' proprietary protein degradation platform, created by its team of experienced drug hunters to improve the effectiveness of targeted protein degradation and generate a pipeline of novel therapeutics for previously undruggable diseases. The platform consists of informatics driven target identification, novel E3 ligases, proprietary ternary complex predictive modeling capabilities, and degradation tools.

About The Leukemia & Lymphoma Society and Therapy Acceleration Program (TAP)

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the potential to change the standard of care. LLS TAP funds late stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance these more quickly along the drug development and approval pathway. To learn more, visit http://www.LLS.org.

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SOURCE Kymera Therapeutics Inc.

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Kymera Therapeutics Announces $102 Million Series C Financing to Advance its Protein Degrader Pipeline and Platform - BioSpace

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‘Cotton ball’ sensation is a sign of neuropathy – Coastal Courier

Thursday, March 12th, 2020

DEAR DR. ROACH: Im a 63-year-old male diagnosed with chronic myelogenous leukemia, Type 2 diabetes and coronary heart disease. I am 5 feet, 11 inches and weigh 240 pounds. I have two stents and take Sprycel for the CML. My levels are good, and the coronary disease is under control.

For a few years Ive had what feels like cotton balls under the skin in the area of the balls of my feet. Now it feels like its migrating to the arch. While not too uncomfortable, it is almost impossible to walk barefooted. Some type of foot covering is needed to keep from noticing the feeling. My doctor says its the diabetes, and to lose weight or see a podiatrist. Other than losing the weight, do you have any opinion about this? N.M.

ANSWER: Cotton-ball sensation is one way that many people describe the beginning of neuropathy, a general term for a variety of different conditions that affect the nerves of the body.

In a person with cancer (like CML, chronic myelogenous leukemia, a cancer of the bone marrow) and a new symptom, it is always wise to consider whether it could be due to the cancer, the treatment for the cancer or from something else. In your case, usually CML is not associated with neuropathy. However, the medicine you are taking, dasatinib (Sprycel), has been associated with a severe kind of reversible neuropathy. I read the case reports of this condition carefully, and I doubt that is what is going on with you, as the symptoms you have are different from those reported.

People with longstanding diabetes frequently develop a particular disease of the nerves, diabetic neuropathy. This almost always begins with sensation changes in the feet. I agree with your doctor that diabetes is the most likely cause.

Seeing a podiatrist is absolutely a good idea. He or she can test you for this condition (usually a careful physical exam will make the diagnosis), in addition to looking carefully for any early signs or risk factors for injury or infection. You also should learn how to do a daily inspection of your feet and recognize the signs, so you can get to medical attention promptly should any damage to your feet occur. The podiatrist will make sure you have appropriate footwear.

Many people with diabetes benefit from weight loss, but the important thing is to be sure your diabetes is under good control. This is achieved through good diet, regular exercise and medication, if needed, in addition to weight loss in people who are overweight.

DEAR DR. ROACH: Due to cancer, my prostate was removed about seven years ago. My PSA reading has increased since 2012 from 0.09 to 0.304. Should I be concerned? I am 78 years old and in relatively good health. B.D.

ANSWER: PSA readings can go up and down, but a threefold increase could mean that the cancer is coming back, and you should see the specialist taking care of your prostate cancer to discuss getting additional testing.

Not having disease for seven years after treatment is a good sign, but the PSA test is pretty specific for cancer recurrence if two separate readings are above 0.2. You may need additional therapy, but only further investigation will show how concerned you need to be.

Dr. Roach regrets that he is unable to answer individual questions, but will incorporate them in the column whenever possible. Readers may email questions to ToYourGoodHealth@med.cornell.edu.

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'Cotton ball' sensation is a sign of neuropathy - Coastal Courier

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Neuropathy Pain Treatment Market by Companies, Regions, Type and Application 2026| Pfizer, Depomed, Eli Lilly – Weekly Wall

Thursday, March 12th, 2020

Los Angeles, United State The report titled Global Neuropathy Pain Treatment Market Research Report 2020 is one of the most comprehensive and important additions to QY Researchs archive of market research studies. It offers detailed research and analysis of key aspects of the global Neuropathy Pain Treatment market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Neuropathy Pain Treatment market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Neuropathy Pain Treatment market is carefully analyzed and researched about by the market analysts.

Global Neuropathy Pain Treatment Market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

Top Key Players of the Global Neuropathy Pain Treatment Market: Pfizer, Depomed, Eli Lilly, Endo, Grnenthal Group, Arbor Pharmaceuticals,

Download Full PDF Sample Copy of Report: (Including Full TOC, List of Tables & Figures, Chart): https://www.qyresearch.com/sample-form/form/1436343/global-neuropathy-pain-treatment-market

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Global Neuropathy Pain Treatment Market Segmentation By Product:

Calcium Channel Alpha 2-delta LigandsSerotonin-norepinephrine Reuptake InhibitorsOthers

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Retail PharmaciesHospitalsOthers

In terms of region, this research report covers almost all the major regions across the globe such as North America, Europe, South America, the Middle East, and Africa and the Asia Pacific. Europe and North America regions are anticipated to show an upward growth in the years to come. While Neuropathy Pain Treatment Market in Asia Pacific regions is likely to show remarkable growth during the forecasted period. Cutting edge technology and innovations are the most important traits of the North America region and thats the reason most of the time the US dominates the global markets. Neuropathy Pain Treatment Market in South, America region is also expected to grow in near future.

Key questions answered in the report

* What will be the market size in terms of value and volume in the next five years?

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Get Customized Report in your Inbox within 24 hours @https://www.qyresearch.com/customize-request/form/1436343/global-neuropathy-pain-treatment-market

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* Data triangulation and market breakdown

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We provide detailed product mapping and analysis of various market scenarios. Our analysts are experts in providing in-depth analysis and breakdown of the business of key market leaders. We keep a close eye on recent developments and follow latest company news related to different players operating in the global Neuropathy Pain Treatment market. This helps us to deeply analyze companies as well as the competitive landscape. Our vendor landscape analysis offers a complete study that will help you to stay on top of the competition.

About Us:

We established as a research firm in 2007 and have since grown into a trusted brand amongst many industries. Over the years, we have consistently worked toward delivering high-quality customized solutions for wide range of clients ranging from ICT to healthcare industries. With over 50,000 satisfied clients, spread over 80 countries, we have sincerely strived to deliver the best analytics through exhaustive research methodologies.

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Neuropathy Pain Treatment Market by Companies, Regions, Type and Application 2026| Pfizer, Depomed, Eli Lilly - Weekly Wall

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Breast Cancer Survivors Suffer Greater Loss of Well-Being than Noncancer Patients Later in Life – DocWire News

Thursday, March 12th, 2020

For breast cancer patients, the adverse effects of the cancer and its treatments do not cease when the disease leaves the body, and well-being remains affected. A new study found that older breast cancer survivors live with a higher level of actionable symptoms and greater loss of wellbeing over time compared to patients without cancer.

According to the authors, they undertook the study because there is little research regarding the long-term symptom burden carried by this population, as well as how this burden affects overall well-being and if lifestyle interventions influence it.

The study focused on breast cancer survivors aged 60 years with newly diagnosed, nonmetastatic breast cancer, who were compared to noncancer controls. Recruitment took place between August 2010 and June 2016. The following parameters were used to measure symptom burden: pain (yes or no), fatigue (on the Functional Assessment of Cancer Therapy [FACT]Fatigue scale), cognitive problems (on the FACTCognitive scale), sleep problems (yes or no), depression (on the Center for Epidemiologic Studies Depression scale), anxiety (on the StateTrait Anxiety Inventory), and cardiac problems and neuropathy (yes or no). A 100-point FACT-General scale was used to determine well-being. Lifestyle was assessed by factors including smoking, alcohol use, body mass index, physical activity, and leisure activities. Correlations were analyzed between treatment group (chemotherapy with or without hormone therapy, hormone therapy only, and controls) and symptom burden, lifestyle, and covariates; further analyses assessed how fluctuations in symptom burden and lifestyle affected function.

Symptoms were high at baseline across the whole cohort. The most significant differences between the cancer survivors and controls were observed in cognitive problems, sleep problems, anxiety, and neuropathy. In adjusted analyses, survivors who had undergone chemotherapy had the highest burden score, followed by those who had received hormone therapy, compared to controls (P<0.001). Factors that influenced the burden score were physical, emotional, and mental well-being; survivors with lower burden scores, compared to those with higher burden scores, had 12.4-point higher physical well-being scores. Lifestyle did not affect symptom burden or well-being, although physical activity played a large role in both (P<0.005).

The study was published in the March 15 issue of Cancer.

Cancer and its treatments are associated with a higher level of actionable symptoms and greater loss of wellbeing over time in older breast cancer survivors than in comparable noncancer populations, suggesting the need for surveillance and opportunities for intervention, summarized the study authors.

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CarolinaEast oncology massage therapist followed calling [sponsored content] – New Bern Sun Journal

Thursday, March 12th, 2020

Patients undergoing chemotherapy or radiation therapy at the SECU Comprehensive Cancer Center at CarolinaEast Medical Center can receive three complimentary oncology massage treatments.

Arnie Smalldridge, a former administrative assistant at CarolinaEast, said she was inspired to pursue oncology massage therapy training after seeing how massaging her mother-in-laws feet helped to relieve cancer pain.

She also served as secretary to a patient and family advisory where she heard cancer patients talk about what helped to relieve them from pain.

While we were building the foundation of the cancer center, there were two patients who said massage was the only thing that helped them to handle their pain, Smalldridge said. I knew then that I wanted to go back to school. I was just blessed that CarolinaEast opened up this position for me.

Smalldridge graduated from a massage therapy program at Lenoir Community College in 2017, received an online certificate of completion for oncology massage and in May completed 32 hours of hands-on oncology massage therapy training in Raleigh.

It definitely was a calling, she said. Ive always believed strongly in the power behind the human touch. Sometimes I have patients in here and they live alone. They dont really have a caregiver. Just having someone to touch them and soothe them in that manner, thats all they need. Its psycho-social, if you will.

About five patients a day receive 45-minute treatments in her massage room at the cancer center. The low lighting, relaxing music and aroma therapy helps them to relax, she said.

I sit down with them first and talk with them about their condition to better know what I need to do for them, Smalldridge said. When you do oncology massage therapy, you have to be very mindful of your pressure with an oncology patient. If there is a tumor site, you have to avoid that.

She said oncology massage therapy is different from typical massage therapy in that the therapist must know where the cancer is in the patients body, the types of treatment they are undergoing and any side effects theyre experiencing.

You have to know if the cancer has spread, especially if it has metastasized into the bone marrow, Smalldridge said. The bones can be so fragile that you really want to watch your pressure in that area. You want to avoid any tumor sites. But you do want to focus on the tissue in those areas where the pain is and just do a very light treatment on them to try to release those tissues.

She said oncology massage therapy helps patients to relax and manage their pain better without the use of many pain medications.

It helps their sleep, improves immune function, Smalldridge said. They get peripheral neuropathy relief from massage and they get relief from nausea. They have so many side effects from their medications as far as joint pain, inflammation. Massage helps with that as well.

Therapy also helps with patients undergoing radiation treatments, she said.

The radiation treatment targets the tumor site, but it also irradiates tissues around that site, Smalldridge said. Breast cancer patients can end up with frozen shoulders. Humans guard themselves from pain. You see this in breast cancer patients. They throw their shoulders forward, which messes up their entire gait.

Some patients fear the pain they feel means the cancer has spread or metastasized, she said.

What I do is I help them to understand that these are side effects, that its not a metastasized site, Smalldridge said.

She usually sees patients who are in treatment for cancer, but doctors have referred some patients to her who are three to five years out of treatment.

What I have seen there is that even in their survivor state, three to five years later, theyre still showing effects of the chemo treatment or the radiation treatment, Smalldridge said. They have to get used to the new normal.

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These new stem cells have the ability to generate new bone – Tech Explorist

Thursday, March 12th, 2020

Bone remodeling and regeneration are dependent on resident stem/progenitor cells with the capability to replenish mature osteoblasts and repair the skeleton.

Until now, it has been thought that stem cells for bone lie within the bone marrow and the outer surface of the bone. Many studies have described the existence of a network of vascular channels that helped distribute blood cells out of the bone marrow. However, none of the studies had proved the existence of cells within these channels.

A new study by the scientists from the UConn School of Dental Medicine has discovered the population of stem cells that reside along the vascular channels within the cortical bone and have the ability to generate new bone. These stem cells stretch across the bone and connect the inner and outer parts of the bone.

Lead investigator Dr. Ivo Kalajzic, professor of reconstructive sciences, said, This is a discovery of perivascular cells residing within the bone itself that can generate new bone-forming cells. These cells likely regulate bone formation or participate in bone mass maintenance and repair.

This is the first study that reports the existence of these progenitor cells within the cortical bone that can generate new bone-forming cellsosteoblaststhat can be used to help remodel a bone.

To reach this conclusion, the scientists observed the stem cells within an ex vivo bone transplantation model. These cells migrated out of the transplant and started to reconstruct the bone marrow cavity and form new bone.

However, further study is required to determine the cells potential to regulate bone formation and resorption.

The study is presented in the journal Stem Cells.

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Bone Therapeutics announces 2019 full year results – OrthoSpineNews

Thursday, March 12th, 2020

Gosselies, Belgium, 11 March 2020, 7am CET BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces its business update and full year financial results for the year ending 31 December 2019, prepared in accordance with IFRS as adopted by the European Union.

During the past year, Bone Therapeutics has laid a strong foundation for advancing our key assets, the allogeneic cell therapy platform ALLOB and the enriched protein solution JTA-004, into the next phase of clinical development and beyond, saidMiguel Forte, MD, PhD, CEO of Bone Therapeutics.We have obtained additional clinical evidence supporting the safety and efficacy for ALLOB in patients undergoing spinal fusion procedures. We have also successfully implemented the optimised allogeneic cell therapy manufacturing process and additionally submitted the clinical trial applications for the crucial Phase III JTA-004 and Phase IIb ALLOB studies. With the preparation of both clinical trials complete, we are fully focussed on timely execution of our clinical programmes and delivering our business and partnering strategy in 2020. This will enable us to move toward our goal of creating innovation solutions that will make a true difference in the lives of patients suffering from debilitating orthopaedic conditions.

Clinical and operational highlights during 2019

Corporate highlights 2019

Financial highlights 2019

Outlook for the remainder of 2020

Bone Therapeutics anticipates starting patient recruitment for the Phase III study with JTA-004, for the treatment of pain in patients with knee osteoarthritis in Q1 2020, subject to the approval of the CTA by the regulatory authorities.

The company has started the CTA submission process in Europe for a Phase IIb clinical trial with its allogeneic bone cell therapy product, ALLOB, in patients with tibial fractures at risk for delayed healing, using its optimized production process. The company expects to enroll the first patient in Q2 2020.

In the second half of 2020, the company expects to report results from the 2-year follow-up period of thePhaseIIa study with ALLOB in patients undergoing a spinal fusion procedure.

Good cost and cash management will remain a key priority. The net cash burn for the full year 2020 is expected to be in the range of 15-17 million assuming normal operation as the effect of the ongoing COVID-19 epidemy cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into Q3 2020.

In this context, strengthening the cash position is a key priority. The company is currently evaluating and working on different financing options and plans to raise new funds from the capital markets and/or through alternative funding strategies.

Conference call

Miguel Forte, MD, PhD, CEO, and Jean-Luc Vandebroek, CFO, will host a conference call today at 5pm CET / 11am EST / 8am PST. To participate in the conference call, please select your dial-in number from the list below quoting the conference ID 7547944#:

Belgium: +32 (0)800 48 740 / +32 (0)2 400 98 74France: +33 (0)805 103 028 / +33 (0)1 76 70 07 94United Kingdom: +44 (0)800 376 7922 / +44 (0)844 571 8892United States: +1 (866) 966 1396 / +1 (631) 510 7495

Shortly prior to the call, the presentation will be made available on the Investors section of the Companys website. A replay will be available by dialling the following number +44 (0)333 300 9785 / +33 (0)1 70 95 03 48 and by using the conference ID: 7547944#

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering Phase III development for the treatment of pain in knee osteoarthritis. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) to start the pivotal Phase III program has been submitted to the regulatory authorities in Europe and Hong Kong SAR. The trial is expected to start in Q1 2020.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the promising Phase IIa efficacy and safety results for ALLOB, the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Global Precision Medicine Market was Estimated to Grow at a Rate of 20.9% During the Forecast Period due to Increasing Focus of Healthcare Sector on…

Thursday, March 12th, 2020

The primary participants engaged in precision medicine market include Novartis, Qiagen, Biocrates Life Sciences, Pfizer, Eagle Genomics, Tepnel Pharma Services

PUNE, India, March 11, 2020 /PRNewswire/ -- Precision medicine is a healthcare model that enables the dynamic methodology of healthcare, with medical choices, diagnosis, policies, or items being custom-made to the specific patient. Methodologies involved in precision medicine majorly include molecular diagnostics, imaging, and analytics. The global precision medicine market is growing at a spectacular rate owing to growing online interactive forums, growing attempts to classify genes and advances in cancer biology which have become the key factors driving the growth of this sector. The basic concept of precision medicine is to understand the genetic makeup and variation at a population level, and further at an individual level, in order to tailor a medication that targets a specific gene type. Sequencing or characterizing genes is therefore the most important method of gathering information on genes and their possible mutations. Precision medicine includes the administration of panomic examination to examine the after effects of individual patient's disease and then to utilize targeted treatments to identify the individual patient's disease timeframe and to provide better diagnostic solutions.

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Technological advances in big data analysis and the introduction of new technologies will have a positive impact on the growth of the precision medicine market. It is anticipated that the attention of healthcare and diagnostic companies on providing several new oncology and respiratory technologies among others will help the overall growth of the industry. In addition, precision medicine software is specifically designed to develop precise medicines which are used in the treatment of chronic and genetic diseases to ensure faster recovery of patients. Massive demand for such software will increase the growth of the precision medicine market in healthcare companies for better patient engagement. Furthermore, rising applications in artificial intelligence is further advancing the precision medicine initiative. Machine learning algorithms are applied for changing genomic sequence and to analyze and draw conclusions from the massive volumes of patients' information.

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The detailed research study provides qualitative and quantitative analysis of precision medicine market. The market has been analyzed from demand as well as supply side. The demand side analysis covers market revenue across regions and further across all the major countries. The supply side analysis covers the major market players and their regional and global presence and strategies. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa and Latin America.

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Precision Medicines Market:

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Global Precision Medicine Market was Estimated to Grow at a Rate of 20.9% During the Forecast Period due to Increasing Focus of Healthcare Sector on...

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BridgeBio Pharma’s QED Therapeutics Announces Dosing of First Patients in Phase 3 and Phase 2 Clinical Trials of Infigratinib in Tumors with FGFR…

Thursday, March 12th, 2020

PROOF 302 Trial Enrolling Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations

Ohio State University-Led Trial to Study Infigratinib for Treatment of Patients with Advanced or Metastatic Solid Tumors with FGFR Genetic Alterations

SAN FRANCISCO, March 12, 2020 (GLOBE NEWSWIRE) --BridgeBio LLC, Inc. (Nasdaq: BBIO) affiliate company QED Therapeutics announced today that patients have been dosed in separate Phase 3 and Phase 2 clinical trials of infigratinib in cancer indications.

The Phase 3 PROOF 302 trial sponsored by QED is studying infigratinib for the adjuvant (post-surgery) treatment of invasive urothelial carcinoma. A second, investigator-initiated trial, led by Sameek Roychowdhury, M.D., Ph.D., of The Ohio State University (OSU) Comprehensive Cancer Center, is studying infigratinib for the treatment of advanced and metastatic solid tumors with confirmed FGFR gene fusions/translocations or other FGFR alterations.

In the PROOF 302 trial, investigators are enrolling subjects with invasive urothelial cancer harboring susceptible FGFR3 genetic alterations who are at high risk of recurrence following surgical resection. Subjects will be randomized (1:1) to receive once daily oral infigratinib or placebo. The primary outcome is disease-free survival, and secondary outcomes include metastasis-free survival, overall survival, and safety and tolerability measures.

Many patients with invasive urothelial carcinoma will have their cancer recur within two years after surgery, said PROOF 302 trial lead Sumanta Pal, M.D., professor of medical oncology and therapeutics research at City of Hope Comprehensive Cancer Center. Correspondingly, I believe there are many patients who could benefit from an oral, post-surgery treatment option that targets FGFR3 alterations, the genetic driver of many urothelial carcinomas.

The Phase 2 study at OSU and selected sites within the Oncology Research Information Exchange Network (ORIEN)will evaluate the efficacy of infigratinib in patients who have advanced or metastatic solid tumors that are positive for FGFR1-3 gene fusions/translocations or other FGFR alterations. The open-label study will assess overall response rate as the primary outcome. Secondary outcomes include progression-free survival, best overall response, disease control rate, overall survival and measures of safety and tolerability.

Increasingly, oncologists are learning to classify their patients cancers based on genetic mutations, going beyond the origin of the tumor, noted Dr. Roychowdhury. Given the activity we have seen with infigratinib in FGFR2-fusion-driven bile duct cancers and FGFR3-altered urothelial carcinoma, our hope is that infigratinib will demonstrate similar activity in additional cancers that appear to be driven by alterations in FGFR. There appear to be multiple FGFR alterations that can drive cancer growthand we hope to see these patients benefit too.

For additional information on the PROOF 302 trial, including eligibility, patients should ask their physician, visit clinicaltrials.gov, or email PROOF302@QEDtx.com.

For additional information on the Phase 2 trial in metastatic solid tumors with FGFR gene alterations, including eligibility, patients should ask their physician, visit clinicaltrials.gov, or email OSUCCCClinicaltrials@osumc.edu.

About QED Therapeutics QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Our lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that we believe to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED intends to submit a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for second and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in preclinical studies for the treatment of achondroplasia. We plan to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with other FGFR-driven tumor types and rare disorders.

For more information on QED Therapeutics, please visit the companys website at qedtx.com.

About BridgeBio Pharma, Inc.

BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBios pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit bridgebio.com.

BridgeBio Pharma Forward-Looking Statements

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as anticipates, believes, estimates, expects, intends, may, plans, projects, seeks, should, will, and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding QED Therapeutics regulatory approval process, clinical trial designs, clinical development plans, clinical trial results, timing and completion of clinical trials, clinical and therapeutic potential of infigratinib, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, QED Therapeutics ability to initiate and continue its ongoing and planned clinical trials of infigratinib, the availability of data from these trials, its ability to advance infigratinib in clinical development according to its plans, and the timing of these events, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma, Inc.s most recent Annual Report on Form 10-K and our other SEC filings. Moreover, QED Therapeutics operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

QED Contact:Carolyn HawleyCanale Communicationscarolyn@canalecomm.com858-354-3581

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Vertex’s Trikafta: treating the genetic basis of cystic fibrosis – Pharmaceutical Technology

Thursday, March 12th, 2020

As the coronavirus reaches more than 100 countries and the WHO declares nCoV as a global pandemic, Pharmaceutical Technology lists the top ten most affected countries by the Covid-19 coronavirus outbreak in China, by the number of cases.

China, including Hong Kong and Macau, is the worst affected country by the novel coronavirus (nCoV) outbreak, officially named Covid-19 by the World Health Organization (WHO).

China witnessed more than 3,000 deaths and approximately 74% of the global coronavirus cases as of 09 March, which quickly came down to approximately 67% by 11 March as the number of cases in rest of the world surged.

Hubei is the most-affected province within China and Wuhan, the capital city of Hubei, is the city affected worst by the coronavirus. Hubei has witnessed more than 67,000 coronavirus-positive cases as of 11 March.

The number of cases in China, however, has been on the decline starting March due to the rapid control measures and response by the Chinese government.

Coronavirus is getting severe in Italy, making it the most-affected in Europe as well as outside Asia. Travel to Italy and Italians travelling to other countries during the outbreak has been traced to have caused Covid-19 spread.

Northern Italy, where the majority of the Italian Covid-19 cases are recorded, is kept on a high alert with affected cities locked-down. The Italian governments early measures such as closing educational institutions temporarily might have limited the spread, although the aged population remains a concern.

Coronavirus deaths in Italy raised sharply from 366 on 08 March to 631 on 10 March and further to 827 on 11 March. Total cases reached 12,462.

Iran, another country from where coronavirus spread to rest of the world, currently has more than 9,000 confirmed cases and has recorded 354 deaths. Iran has been suspected to have delayed acknowledging the spread of corona virus in their country and under-reporting the cases.

A number of countries have traced their coronavirus-infected having contracted the disease during travel to Iran. Many government officials and politicians including MPs in Iran have contracted coronavirus, some of who died.

Amid fears of further coronavirus spread, Iran announced the temporary release of approximately 70,000 prisoners, according to Mizan news agency.

South Korea is hit the most by coronavirus infection outside China due to its proximity to the latter. Coronavirus cases in South Korea started surging in February and are currently close to reaching 7,900.

Deaths due to coronavirus in South Korea reached 66. The country is being assisted by China, whose experience in containing the outbreak has resulted in controlling the local spread of the epidemic.

France is the second most-affected European nation by the 2019 coronavirus. Covid-19 nCoV cases in France have reached 2,284, while death toll got close to 50.

The French government has banned public gatherings involving more than 1,000 people. The popular Louvre Museum in Paris was temporarily closed as a precautionary measure. The Paris city has reported Covid-19 coronavirus-positive cases, apart from other regions including Amiens, Bordeaux, and Eastern Haute-Savoie.

A worker at Disneyland Paris was reported by Reuters as having contracted the coronavirus. France currently has only a few clusters with coronavirus. The ongoing outbreak remains a concern to the French tourism industry as coronavirus fears are resulting in a drop in visitors.

Since the first coronavirus case confirmed on 01 February, the Spanish Covid-19 nCoV-infected cases got closer to 1,000 in early hours of 09 March and rose sharply to 2,277 by 11 March.

Spain is the second most-affected European country with coronavirus. Spanish coronavirus death toll has increased to 55 making the government and citizens nervous.

Tourism, a crucial sector for Spain, is expected to face an adverse impact due to the global coronavirus fears. The Spanish government has advised companies to ask employees to work from home to avoid spread.

Germany, which borders France and Switzerland, also has hundreds of coronavirus-positive cases, which stand at 1,966 currently.

Similar to its neighbour France, Germany too banned public events involving huge crowds in order to prevent spread. Trade fair, The Hannover Messe, has been postponed due to the coronavirus outbreak situation.

Germany has reported three coronavirus deaths as of 11 March.

Coronavirus situation in the US is grim with the cases and deaths increasing fast. The US Covid-19 cases nearly doubled in two days, to cross 1,300 on 11 March, while the death toll passed 30.

Community spread and delayed testing is currently a major concern to Americans as enough test kits are not available across states.

The first coronavirus case in the US was confirmed on 21 January, but the cases surged from the second half of February.

Japan was among the countries that reported first coronavirus cases early following the Wuhan outbreak. In addition to the cases reported on cruise ship Diamond Princess docked in Japanese waters, the country reported 639 Covid-19 cases as of 11 March.

The Japanese governments response to containing the spread among those onboard the Diamond Princess cruise ship met with criticism.

Japan has witnessed 17 deaths due to coronavirus and is likely to feel an impact on travel and trade.

Switzerland, a popular tourist destination, is the fifth most affected European country by the novel coronavirus outbreak. The positive Covid-19 coronavirus cases in Switzerland, whose borders are close to Milan, Italy, crossed 650 on 11 March.

Some of the major cities in Switzerland, such as Geneva and Zurich, have reported confirmed coronavirus cases.

Three deaths have been reported in Switzerland due to coronavirus. The Swiss hotel and tourism industries will be affected if the coronavirus situation continues to stay for long.

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Viewpoint: Promise of genomics and precision medicine a ‘wave of hype without substance’ – Genetic Literacy Project

Thursday, March 12th, 2020

An undeclared civil war is breaking out in biomedicine.On one side is precision medicine, with its emphasis on tailoring treatments to ever-narrower groups of patients. On the other side is population health, which emphasizes predominantly preventive interventions that have broad applications across populations.

Which vision will provide the most durable and efficient path to improved health for all?

Disregarding the breakthrough announcements that appear on a regular basis, the question of whether precision medicine will lead to better health for all remains an open one.

We believe that genomics and precision medicine have ridden a wave of hype without substance for far too long. Unless they are able to go well beyond their thin record of empirical success and demonstrate their effectiveness in meeting the actual health needs of populations, they will be marginal players with regard to any lasting impact on the health of the public.

Fortunately, it appears that the tide is beginning to turn toward population health, especially as a more balanced perspective of the value ofpolygenic risk scores one of the most widely advocated innovations of the precision medicine movement is beginning to emerge.

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Modern genetic tools are helping to control the most critical pig diseases – The Pig Site

Thursday, March 12th, 2020

Modern genetic technology has provided new tools to allow the use of genomic selection for disease resilience. Speaking to Farmscape, Dr John Harding, a Professor with the Western College of Veterinary Medicine, notes scientists have been looking at disease resilience or resistance for the last 20 to 30 years.

"One of the most historic examples that I can remember in my career is the identification of the halothane gene and how we've used it since the early 1990s to eliminate porcine stress syndrome from the pig industry," says Dr Harding.

"There are other examples of single mutations, including the FUT1 gene. It codes for E. coli and has been used to help control post weaning diarrhoea back 15 to 20 years ago.

"We see more recent examples which are really related more to resilience. That is the PRRS WUR SNP which codes for the GBP5 protein which has been used by some of the breeding companies to create animals that are more resilient to PRRS.

"There's a similar gene called synaptogyrin which has been used for PCV2 resilience now.

"We're not seeing that one in the industry quite yet but I'm sure it will come quickly and then we've got the whole aspect of gene editing with the Prather group editing out the CD163 gene, making pigs that are completely resistant to PRRS infection. That's very exciting.

"Whether that comes to market is another big question that the regulators and industry will have to struggle with over the next couple of years.

"More recently, what we're involved with is more general disease resilience and we have set up a project in Quebec to look at resilience to many diseases and that's through a natural challenge model system."

Dr Harding says scientists will continue their work so stay tuned.

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Ultra-Fast Genome Sequencing Could Save the Lives of Newborns – WIRED

Thursday, March 12th, 2020

Maverick Coltrin seemed like any other newborn when he first came home from the hospital, wearing his beanie cap with bear ears and blue-and-gray onesie and following the typical around-the-clock cycle of sleeping and breastfeeding. But within a couple of days, his parents noticed something was off. At 6 days old, Maverick completely stopped feeding. His arms and legs would stiffen and then release, the spasms punctuated by his cries.

His parents rushed him to Rady Childrens Hospital in San Diego, where EEG monitors recorded that he was having as many as 30 seizures an hour. Doctors scrambled to find the cause. Anti-seizure medicines didnt work, so he was sedated to stop the damage to his brain. His organs started to fail, and his skin turned a dusky blue. His mother, Kara Coltrin, walked into his empty nursery at home and cried.

So when doctors from Radys Institute for Genomic Medicine asked for permission to sequence Mavericks genome as part of a clinical trial of ultra-rapid sequencing for newborns who are critically ill from an unknown cause, Mavericks parents didnt hesitate. The doctors cautioned that they couldnt guarantee that they would pinpoint a genetic disorder or, if they did, that it could be treated. They gave the standard caveat about genetic testingthat identifying a genetic disorder could affect Mavericks eligibility for life insurance someday. But even if the sequencing didnt help him, his participation would contribute to a study that could benefit other babies. Obviously, the pros outweighed the cons manyfold, his mother says. We just wanted his pain to stop.

Within 36 hours, the Coltrins had an answer: Maverick has pyridoxine-dependent epilepsy, caused by a rare mutation of the ALDH7A1 gene, which codes for the enzyme antiquitin. By giving him high doses of vitamin B6 and controlling a couple of amino acids in his diet, doctors stopped the seizures. Maverick, now 2 years old, runs around like a normal, rambunctious toddler. He has hit all his developmental milestones, although they have been somewhat delayed. He hasnt had a seizure since his treatment began. Every once in a while, I think back on him being dusky blue and super skinny and hooked up to all these tubes, says Kara Coltrin. I look at him and its hard to believe that happened to him. People who see him on a normal basis would never know he was ever sick.

The technology that saved Mavericks life stretched the limits of bioinformatics, returning results far sooner than is typical for genetic testing. Rapid sequencing typically takes about seven days for a preliminary diagnosis, while Rady completes ultra-rapid sequencing in three days or less. (In 2018, Rady set a Guinness World Record by sequencing a babys genome in 20 hours and 10 minutes.)

But now ultra-rapid sequencing is moving from an investigational tool to a standard of care. Blue Shield of California is the first insurer to cover rapid and ultra-rapid sequencing of babies and children who have life-threatening and unexplained medical conditions. Since the new policy began in July 2019, 28 babies or children in California have received the testing through Blue Shield, which is just beginning to promote the new coverage.

Blue Shield expects that 250 to 500 newborns will be eligible for the whole genome sequencing each year, which represents about 10 percent of their insured babies treated in neonatal intensive care units in California. Company executive vice president Terry Gilliland said he will encourage other Blue Cross and Blue Shield plans around the country to adopt a similar policy. When you think about all the pain and suffering families go through with sick babies, this is going to be an enormous benefit, he says.

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Ultra-Fast Genome Sequencing Could Save the Lives of Newborns - WIRED

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EDGC goes all out for global supply of COVID-19 test kit – Korea Biomedical Review

Thursday, March 12th, 2020

EONE-DIAGNOMICS Genome Center (EDGC) said Thursday that its global network would go into full operation to respond to requests for supply contracts and export of its new coronavirus diagnosis test kit.

EDGC is a genetic precision medicine company manufacturing molecular diagnostics kits through its subsidiary, Solgent. The company is negotiating with many countries for the export of several million test kits of COVID-19.

The global demands for diagnostic kit exploded after the World Health Organization declared the current situation as a pandemic, the sixth and highest of an alert level on Wednesday. COVID-19 is WHOs third pandemic, following the Hong Kong flu in 1968, and the swine flu in 2009.

Solgent acquired approval for the urgent of its test kit from the Korea Centers for Disease Control and Prevention on Feb. 27 and won the nod of Conformite Europeen (CE) certification for two of its products the following day. The company is operating an emergent manufacturing system to deal with surging demand

EDGC is negotiating with various countries, including the United States, Australia, Japan, China, Hong Kong, Philippines, Singapore, Vietnam, Malaysia, Bangladesh, the United Arab Emirates, Kuwait, Turkey, Kazakhstan, Germany, the United Kingdom, and Estonia.

Among the four local companies that won urgent use approval from KCDC, Solgent is the only one that makes COVID-19 diagnosis kit with self-developed raw material.

The company said it is producing the test kits by grafting its technology and know-how to its quality management, proven by ISO 9001 and ISO 13485 international certifications as well as Korea Good Manufacturing Practice.

shim531@docdocdoc.co.kr

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EDGC goes all out for global supply of COVID-19 test kit - Korea Biomedical Review

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Veterinary Medical and Biomedical Sciences Professor David Steffen honored with top industry award – Fence Post

Thursday, March 12th, 2020

Growing up on a farm near the small community in of Fordyce in Northeast Nebraska, David Steffen dreamed of one day becoming a country vet.

His family raised cows, sows and broilers, and he got to know the country veterinarians who tended to the livestock of his family and his neighbors. Their days seemed interesting and varied, Steffen said. Veterinarians helped both animals and the people who cared for them. All of these things appealed to Steffen.

He attended college at the University of Nebraska-Lincoln, where he studied animal science. After graduation, he went on to Iowa State University, where he got his DVM.

For a few years, he did become a country vet. But his wife, whose expertise was in computers, had a difficult time finding a job, and Steffen began looking for a position someplace where she could put her degree to work, too. He and his wife moved to Manhattan, Kan., where he began work on a doctoral degree at Kansas State University. This put him on track for an academic career, with a stop at North Dakota State University before he returned to Nebraska.

Today, he provides leadership in diagnostic pathology and as the quality control section head of the veterinary diagnostic center. And recently, he received the highest honor in the field of veterinary diagnostics the 2019 Dr. Edward P. Pope Memorial Award, presented by the American Association of Veterinary Laboratory Diagnosticians.

The award was a huge honor and came as somewhat of a surprise to Steffen, whose favorite part of the job remains helping people.

On a recent morning in his office in the Veterinary Diagnostic Center, he looked at slides from feeder lambs that were succumbing to a mystery affliction, as well as from a Scottish terrier with a terrible looking liver. Steffen finds it rewarding to figure out a diagnosis for a livestock producer whose livelihood is affected by disease, or for a pet owner who wants to know why their pet is sick.

It is a blessing to work using scientific knowledge to help others, Steffen said in a story about the award in the Journal of Veterinary Diagnostic Investigation. Every day I am provided the opportunity to develop meaningful, productive relationships with clients and scientists as we partner to improve the economic vitality of animal agriculture, the emotional health of pet owners, and the general health of animal populations and all people.

No two days are quite alike, and Steffen enjoys that, too.

You get to see all kinds of weird, interesting stuff, he said. You get to be a detective.

One particularly interesting mystery he encountered was a fatal type of dwarfism that showed up in several different breeds of calves. Steffen was able to pinpoint a genetic cause for the disease, which ultimately allowed for development of a test for breeders. Over his career, Steffen was able to identify seven different genetic disorders all of which led to the development of tests that livestock producers can use to determine whether their animals are afflicted.

With genomics now, we can go from recognizing a disease to having a test for it within a year, he said.

Throughout his career, he has dedicated time and expertise to advance animal health and veterinary pathology at state and national levels, serving on the Nebraska Poultry Health Committee, the Nebraska State Lab Response Network, and the Johnes Disease Committee. He has been a member of the American association of Veterinary Laboratory Diagnostics since 1996, over the years serving as both vice president and president. He also served as an associate editor for the Journal of Veterinary Diagnostic Investigation. He has author or co-authored more than 60 peer-reviewed publications on topics including diagnostics, comparative medical sciences and many other issues and received numerous other awards. He also served as an undergraduate adviser for more than a decade, and has kept in contact with many of his old students.

Dave has made many significant contributions to animal health, livestock management and veterinary pathology, said Ron Yoder, associate vice chancellor for the Institute of Agriculture and Natural Resources at the University of Nebraska-Lincoln. We highly value his work here at the university, as do livestock producers across Nebraska and the country.

Steffen didnt imagine that his plan to be a country vet would have led him down the path it did. But the things that drew him into vet medicine in the first place the variety, the opportunity to meet people and to help them have remained central throughout his career. Hes more likely, though, to do so from his office than on a farm like the one where he grew up.

My happy place is here at my microscope, he said.

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Veterinary Medical and Biomedical Sciences Professor David Steffen honored with top industry award - Fence Post

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