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The Latest Breaking News from FDA

States weigh shielding doctors' COVID misinformation, unproven remedies

The controversy began in September, more than a year into the pandemic, when the Tennessee Board of Medical Examiners issued a warning to doctors in the state: Spreading misinformation about COVID-19 vaccines could land them in big trouble with the board, including the possible revocation of their medical licenses.

Tribune News Service

Novartis' Breast Cancer PI3K Drug, Scores FDA Approval For Ultra-Rare Indication

The FDA has granted accelerated approval to Novartis AG's (NYSE: NVS) Vijoice (alpelisib) for patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Benzinga

FDA Approves BioXcel's Igalmi - First Orally Dissolving Sublingual Film For Schizophrenia-Associated Agitation

The

Benzinga

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Repurposing generic drugs can reduce time and cost to develop new treatments – but low profitability remains a barrier

Discovering new ways to use existing drugs can come about intentionally or by chance.

The Conversation

The Daily Biotech Pulse: BioXcel's Igalmi Gets FDA Nod, Citius Spikes On Positive Phase 3 Data, Iovance Receives Positive Regulatory Feedback For Skin Cancer Therapy

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

Benzinga

Iovance Outlines Frontline Melanoma Strategy For Lifileucel / Pembrolizumab Combo Therapy

The

Benzinga

Experts eye a new game plan for COVID vaccines

An FDA panel mulls long-term strategy for COVID shots

Axios

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Future of COVID boosters comes down to crucial meeting of FDA Advisers

An all-star panel of COVID-19 experts will convene this week to hash out how and when vaccines should be updated to address future variants as the virus continues to rapidly mutate.

Tribune News Service

US pulls GSK's COVID drug as omicron sibling dominates cases

U.S. regulators say GlaxoSmithKline’s COVID-19 antibody drug should no longer be used because it is likely ineffective against the latest version of the virus that accounts for most cases

The Independent UK

Under Oregon's Proposed Rules, Legal Psilocybin Will Be All-Natural, Organic, and GMO-Free

The state's regulators plan to start accepting applications from manufacturers and "service centers" on January 2.

Reason

MindMed Appoints Francois Lilienthal As New CCO

With over twenty years of experience in the biopharmaceutical industry, Francois Lilienthal, MD, has joined Mind Medicine Inc. (NASDAQ:MNMD) as chief commercial officer (CCO). He had been serving as a consultant for the company for the last six months. Lilienthal has a long trajectory with pharmaceutical companies—in 1997, he was…

Benzinga

Nasdaq-Listed Field Trip Gets First Patent Approved For Improved Psychedelic Drug

Field Trip Health Ltd. (NASDAQ:FTRP), a biotech and care delivery company in the psychedelics space, has been granted its first patent by the U.S. Patent and Trademark Office. The patent covers claims around FT-104, the company’s flagship proprietary psychedelic molecule, for composition of matter, use and manufacturing of the compound…

Benzinga

Allergan Shares Topline Data For Twice Daily Vuity (Pilocarpine) In Blurry Vision Study

Allergan, an AbbVie Inc (NYSE: ABBV) company, announced topline data from Phase 3 VIRGO trial evaluating Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia, age-related blurry near vision.

Benzinga

Bluebird Bio Joins Layoff Band Wagon As Gene Therapy Biotech Cuts Staff To Reduce Costs

Bluebird Bio Inc (NASDAQ:BLUE) is laying off about 30% of its workforce before the FDA decides the fate of two of its gene therapies. The gene therapy-focused company is showing the exit to nearly one-third of its staff to extend its cash runway into the first half of 2023 and save $160 million…

Benzinga

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Benzinga

The Daily Biotech Pulse: Thervance Gains On Positive Late-Stage Readout, Bristol-Myers Squibb Snags 3 Approvals In Europe, Decision Day For BioXcel

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

Roll Call

Michigan Rep. Fred Upton announces plan to retire - Roll Call

A former chairman of the Energy and Commerce Committee, Upton faced a primary against a fellow Republican because of redistricting.

Benzinga

From Pharma To Psychedelics, Robert Barrow, CEO Of MindMed: Meet Our Speakers

With over ten years of experience in the pharmaceutical industry, Robert Barrow, CEO of Mind Medicine Inc. (NASDAQ:MNMD) is someone who certainly knows the ins and outs of the business. Barrow joined MindMed in January 2021 as Chief Development Officer (CDO) but was later appointed as CEO and member of…

Benzinga

It's Official: House Approves Bill To Further Expand Medical Marijuana Research

The House of Representatives passed the Medical Marijuana Research Act, which will substantially expand scientific research on marijuana, including allowing scientists to study products from dispensaries.

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Benzinga

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

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

GBS: Institutional Review Board Approval for Glucose

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

Benzinga

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

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

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

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…

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