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The Latest Breaking News from FDA

The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Booster Data In Kids, Regeneron's COVID-19 Therapy Decision Pushed, Protagonist's Rusfertide Breakthrough Tag Update And More

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

Benzinga

FDA Extends Review Period For Regeneron's COVID-19 Antibody Therapy

The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the…

Benzinga

The FDA approved a new drug to treat Alzheimer's, but Medicare won't always pay for it – a doctor explains what researchers know about Biogen's Aduhelm

Medicare finalized its decision to restrict its coverage of Aduhelm, Biogen’s new Alzheimer’s disease drug, on April 8, 2022.

The Conversation

From analysis to the latest developments in health,
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FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer

Protagonist Therapeutics Inc (NASDAQ: PTGX)

Benzinga

Amneal Scores Second US Biosimilars Approval With Alymsys In Oncology

The

Benzinga

Outlook poses tough questions for next steps on COVID-19 vaccines

Preparations for another potential round of COVID-19 vaccines are prompting more questions than answers as federal health officials contend with the threat of future variants amid waning public interest in additional shots.

Tribune News Service

New type of cigarette that ‘helps you smoke less’ debuts in Chicago stores this week, amid some controversy

Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.

Chicago Tribune

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The FDA's Rejection of a Major Vaping Brand Shows It Is Arbitrarily Applying a Nebulous Legal Standard

The agency's obsession with adolescent vaping is driving decisions that undermine public health.

Reason

Read Why Pliant Therapeutics Shares Are Soaring Today

Pliant Therapeutics Inc (NASDAQ: PLRX) says that with just two FDA-approved Idiopathic Pulmonary Fibrosis drugs, it believes that is a high unmet need.

Benzinga

Phathom Pharma's Vonoprazan Commercial Preparation Update At Needham Healthcare Conference

At the Needham Healthcare Conference, Phathom Pharmaceuticals Inc (NASDAQ:PHAT) says that licensor Takeda Pharmaceutical Co Ltd (NYSE: TAK) reported Takecab (vonoprazan) Q4 FY21 sales of $221 million and $900 million in FY21. Phathom estimates that around 30% is from erosive esophagitis (EE), approximately 60% is from gastroesophageal reflux disease (GERD)/other, and less than 10% is…

Benzinga

FDA Sends Warning Letters To Online Pharmacies Selling ADHD Drug, Adderall, Illegally

The FDA and the U.S. Drug Enforcement Administration have jointly issued warning letters to two websites for illegally selling Adderall, an attention deficit hyperactivity disorder (ADHD) treatment. Kubapharm.com and Premiumlightssupplier.com were both accused of selling amphetamine drugs marketed as the ADHD drug Adderall without a prescription, according to an FDA statement. The…

Benzinga

Oncternal Discontinues Enrollment In ONCT-216 Study For Soft Tissue Cancer

Oncternal Therapeutics Inc (NASDAQ:ONCT) will deprioritize further development of ONCT-216 to reallocate resources to zilovertamab, and its Phase 3 trial is expected to start in Q3 of 2022. The Company has discontinued enrollment in the Phase 1/2 study evaluating ONCT-216 in relapsed or refractory Ewing sarcoma, a type of tumor that forms in…

Benzinga

Coeptis Therapeutics Intends To Acquire Statera's TLR5 Agonist Platform

Coeptis Therapeutics Inc (OTC:COEP) has entered into a strategic agreement with Statera Biopharma Inc (NASDAQ:STAB) that gives Coeptis the right to acquire Statera'stoll-like receptor 5 (TLR5) agonist platform, including entolimod. Coeptis will agree to pay Statera Biopharma $6 million and revenue-based milestone payments to be defined in the definitive agreement. TLR5 is an innate immunity…

Benzinga

ProQR Therapeutics Pulls Plug On Inherited Retinal Disease Programs, Cuts 30% Workforce

ProQR Therapeutics N.V. (NASDAQ:PRQR) has decided to prioritize the development of genetic eye disease candidates and the Axiomer RNA base-editing technology platform. The Company will suspend the development of QR-1123 for autosomal dominant retinitis pigmentosa, QR-504a for Fuchs endothelial corneal dystrophy, and all other Inherited Retinal diseases (IRD)-related research activities. ProQR will implement…

Benzinga

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Benzinga

Cannabis And Pancreatic Cancer: Botanical Drug Kills 100% Of Cancer Cells, Research On The Cell Model Reveals

Cannabotech (CNTC.TA), which is involved in the development of a botanical drug based on an extract of the Cyathus striatus fungus and a cannabinoid extract from the cannabis plant, reports that in experiments conducted on a cell model, the fungus extract eliminated 100% of pancreatic cancer cells relatively selectively and…

Benzinga

DEA Sued By Rhode Island Lab Over 'Foot Dragging' On Marijuana Pharmaceutical Licensing, Here's What We Know So Far

Two Rhode Island cannabinoid research laboratories are suing the DEA for standing in the way of what they consider to be the crucial development of pharmaceutical-grade cannabis products for use in clinical trials for the treatment of Multiple Sclerosis and Huntington's Disease.

Benzinga

Halozyme Buys Antares In $960M Deal To Create One Drug Delivery, Specialty Product Entity

Halozyme Therapeutics Inc (NASDAQ:HALO) will acquire Antares Pharma Inc (NASDAQ:ATRS) for $5.60 per share, valuing Antares at approximately $960 million. The transaction is expected to be accretive to Halozyme's 2022 revenue and adjusted earnings and accelerate top-and bottom-line growth through 2027, with multiple growth drivers beyond 2027. Antares' suite of FDA-approved and partner products utilizing…

Roll Call

Outlook poses tough questions for next steps on COVID-19 vaccines - Roll Call

Health care officials face tough questions as they set policy to deal with the next phase of the pandemic and try to get the messaging right.

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news in one place.

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Benzinga

BTAI: IGALMI™ Approved by the FDA…

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

Liverpool Echo

Warning to pet owners as common dog bowl cleaning mistake can make them ill

Up to 18% of pet owners never wash their dog's bowls

The Guardian - US

‘People really need to know’: can we trust beauty products to be safe?

In a shocking new docuseries, the highly unregulated and highly dangerous world of cosmetics is thrust into the spotlight

Daily Record

Common dog bowl cleaning mistake putting owners and pets at serious health risk

The Food and Drug Association (FDA) carried out the research to find out more about dog owners' feeding habits and consider the impact of hygiene recommendations on food dish contamination.

Benzinga

FDA Places Clinical Hold On Ocugen's Late-Stage COVID-19 Vaccine Trial

The

Benzinga

What's Going On With Myovant Sciences Stock Today?

Myovant Sciences Ltd (NYSE: MYOV) shares are trading significantly lower Tuesday after the company and Pfizer Inc (NYSE: PFE) announced an update on the Supplemental New Drug Application for MYFEMBREE for the manag

Benzinga

FDA Approves BioCardia's Phase 1 Trial With Cell Therapy In COVID-19, Shares Jump

The FDA has signed off BioCardia Inc's (NASDAQ:BCDA) Investigational New Drug (IND) application for BCDA-04 to initiate Phase 1/2 trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. BCDA-04 is a proprietary allogeneic mesenchymal cell (MSC) that is Neurokinin-1 receptor-positive (NK1R+). The trial is expected to start in…

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