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The Latest Breaking News from FDA

Read Why Did WHO Suspend UN Supply of Bharat Biotech's Covaxin COVID-19 Vaccine

According to Reuters, the World Health Organization suspended the supply of Covaxin through UN agencies for the COVID-19 vaccine. WHO said it would allow the manufacturer to improve its facilities and address issues found in a WHO post-emergency use listing (EUL) inspection of Bharat Biotech's manufacturing. The details of what…

Benzinga · Apr 4, 2022

See Why Did FDA Extend Review Period For Alnylam's Vutrisiran In Amyloidosis

The FDA has extended the review timeline for Alnylam Pharmaceuticals Inc's (NASDAQ:ALNY) marketing application for vutrisiran for transthyretin-mediated (ATTR) amyloidosis. The updated Prescription Drug User Fee Act (PDUFA) goal date is July 14. The FDA needs additional time to review newly added information related to the new secondary packaging and labeling facility for investigational RNAi…

Benzinga · Apr 4, 2022

GBS: Institutional Review Board Approval for Glucose

By John Vandermosten, CFA NASDAQ:GBS READ THE FULL GBS RESEARCH REPORT

Benzinga · Apr 4, 2022

From analysis to the latest developments in health,
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BCLI: Awaiting Clarity on Regulatory Environment Before Deciding on Next Steps for NurOwn®…

By David Bautz, PhD NASDAQ:BCLI READ THE FULL BCLI RESEARCH REPORT

Benzinga · Apr 4, 2022

FDA Grants Priority Review To Roche's Actemra For Hospitalized COVID-19 Adults

The FDA has granted priority review to Roche Holdings AG's (OTC:RHHBY) Actemra/RoActemra (tocilizumab) for COVID-19 in hospitalized adults. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for treating COVID-19 in hospitalized patients," Roche said. The Compay also added that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra…

Benzinga · Apr 4, 2022

Are Psychedelics Stocks In Trouble Or Is The Market Reaching Maturity?

Long gone is the heyday of investor enthusiasm and easy access to capital that marked the launch of the psychedelics industry into the public markets. In recent months, psychedelics stocks entered into a period of turmoil characterized by declining valuations and a generalized capital dry spell.

Benzinga · Apr 4, 2022

Lexicon Touts New Favorable Data On Sotaglifozin Cardio Data

At the American College of Cardiology, Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) highlighted a new data analysis from the SCORED Phase 3 trial of sotagliflozin in Type 2 diabetes and kidney disease patients. Sotagliflozin significantly reduced major adverse cardiovascular events (MACE) of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke compared to placebo. Also See: Lexicon Announces…

Benzinga · Apr 4, 2022

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Pills are the next big abortion battleground

As the U.S. Supreme Court considers a potential end to Roe v. Wade, "abortion pills" are seen as the next major battleground.

Axios · Apr 4, 2022

Against Scientific Gatekeeping

Science should be a profession, not a priesthood.

Reason · Apr 3, 2022

Why Big Pharma loves Tim Scott

During the second half of 2021, Scott was the top recipient of drug campaign cash in Congress

Salon · Apr 3, 2022

Can evusheld treat Covid-19? An infectious disease expert answers 7 key questions

Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

Inverse · Apr 2, 2022

Welcome to the Nicotine Prohibition Era

Regulators have long targeted tobacco products, but there's new energy behind outright bans on vapes and cigarettes.

Reason · Apr 2, 2022

Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

Benzinga · Apr 1, 2022

The House Just Approved Marijuana Legalization Again, but GOP Support Remains Nearly Nonexistent

Just three Republicans voted for the MORE Act, two fewer than in 2020.

Reason · Apr 1, 2022

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Benzinga · Apr 1, 2022

Mydecine Reports Financial Results For 2021

Late Thursday, Mydecine Innovations Group (OTC:MYCOF) reported financial results for the fiscal year ended December 31, 2021. 2021 Financial Results Net loss attributable to common stockholders was $28.9 million, which consisted of a $5.3 million loss from discontinued operations, for 2021, or a basic and diluted loss per share…

Benzinga · Apr 1, 2022

T2 Biosystems Secures Additional BARDA Funding To Develop Blood Test Panels To Detect Sepsis-Causing Pathogens

The Biomedical Advanced Research and Development Authority (BARDA) is providing an additional $4.4 million in funding for the multiple-year cost-share contract between BARDA and T2 Biosystems Inc (NASDAQ:TTOO) If all contract options are exercised, the total potential BARDA funding is $69.0 million. The additional funding will be used to advance the U.S. clinical trials for…

Benzinga · Apr 1, 2022

FDA Pushes Merck's Pneumococcal Vaccine Decision Date Into July For Expanded Use In Kids

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental marketing application for Merck & Co Inc's (NYSE: MRK) pneumococcal 15-valent conjugate vaccine

Benzinga · Apr 1, 2022

The Daily Biotech Pulse: SELLA In-licenses Oncology Asset, Merck's Pneumococcal Vaccine Review Extended, Arc Biopharma COVID Drug Flunks Mid-Stage Study

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

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The Conversation · Apr 1, 2022

Tomorrow's COVID safety guidelines will be different from today's – but that doesn't mean yesterday's were wrong

No one gave a second thought to the safety of dining out before the pandemic. Fast-forward to today, and it’s normal to wonder whether there is a city, state or federal policy around whether you need a mask or proof of vaccination to eat in a restaurant. The public policies…

Inverse · Apr 1, 2022

Beyond longevity: The DIY quest to cheat death and stop aging

Biohackers engage in DIY biology, experimenting on themselves to enhance their brain and body. And many of them see longevity as the ultimate prize.

Tribune News Service · Apr 1, 2022

Commentary: FDA shouldn’t approve ALS drug without more data

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

Benzinga · Mar 31, 2022

FDA Approves Edwards Lifesciences' Resilia Valve For Mitral Replacement Surgery

The FDA has approved Edwards Lifesciences Corp's (NYSE: EW) Mitris Resilia valve, a tissue valve replacement specifically designed for the heart's mitral position.

Benzinga · Mar 31, 2022

Sorrento To Start Late-Stage Trial Of Abivertinib In Critically-Ill COVID-19 Patients

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) Phase 3 trial of abivertinib in severe COVID-19 patients. The clinical trial will be conducted in 2 phases, and the initial run-in will define the recommended Phase 3 Dose. In October last year, Sorrento released preliminary results of two phase 2 studies that seemed to show…

Benzinga · Mar 31, 2022

InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients

InflaRx N.V. (NASDAQ:IFRX) announced topline data from Phase 3 part of Phase 2/3 PANAMO study of vilobelimab in critically ill COVID-19 patients. Vilobelimab in mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9% (vilobelimab 31.7% versus placebo 41.6%), which was not statistically significant (p=0.094). At the recommendation of…

Benzinga · Mar 31, 2022

Supply Chain Challenges To Hit Masimo's Q1 FY22 Sales

Masimo Corp (NASDAQ:MASI) expects Q1 FY22 product revenue of $285 million - $315 million, lower than expected. Shortages of critical components and other supply chain issues, including freight carrier delays, have led to lower-than-expected sales in the first quarter. Related: Joe Kiani, Chairman, and CEO, said, "In prior quarters, we were able…

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