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The Latest Breaking News from FDA

Covaxin trials in U.S. put on hold

WHO had announced suspension of the vaccine supplies through UN procurement agencies

The Hindu

Magenta Therapeutics Trims R&D, Cuts Workforce

Magenta Therapeutics Inc (NASDAQ:MGTA) is cutting 14% of staff and axing a planned dosing optimization trial for a stem cell mobilization med, focused on extending its cash runway into Q2 2024. The cost-saving measures focus on shaving administrative expenses and new research investments, including the Company's planned dosing and administration optimization trial…

Benzinga

Adagio Pauses FDA Emergency Use Request For Its COVID-19 Therapy

Adagio Therapeutics Inc (NASDAQ:ADGI) provided an update on the anticipated timing for its Emergency Use Authorization (EUA) request for adintrevimab (ADG20) for the prevention and treatment of COVID-19. Adintrevimab has demonstrated broadly neutralizing activity in vitro against variants of concern, including Alpha, Beta, Delta, Delta Plus, Gamma, and Omicron BA.1. But, the candidate has markedly…

Benzinga

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E-cigs using synthetic nicotine come under FDA oversight

The Food and Drug Administration says it will begin cracking down on e-cigarettes that have used synthetic nicotine to skirt oversight

The Independent UK

Why Lexaria Shares Are Rising Today

Lexaria Bioscience Corp (NASDAQ:LEXX) said that all data analyses from its simulated pulmonary hypertension clinical study HYPER-H21-3 are complete, assessing a single 300mg dose of DehydraTECH-processed cannabidiol (DehydraTECH-CBD). The study findings indicated a tendency (p=0.1) during 15 minutes of simulated low levels of oxygen (hypoxia) for reduced pulmonary artery systolic pressure (PASP)…

Benzinga

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

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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

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

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

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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…

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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

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.

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

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