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The Latest Breaking News from FDA

The Daily Biotech Pulse: Aeglea Stock Jumps On Inherited Metabolic Disease Data, Partial Hold Lifted On Gilead's 2 Blood Trials, Early Data From Novartis' KRAS Inhibitor And More

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

Benzinga

Here's Why Ocugen Shares Are Falling

Ocugen Inc (NASDAQ: OCGN) shares are trading lower by 5.86% to $2.73 during Tuesday's pre-market session after the company announced that it was informed by the FDA that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN, OCU-002, on clinical hold.

Benzinga

Common dog bowl cleaning mistake that could make you ill as well as your pet

The Food and Drug Administration (FDA) has been investigation dog owners' feeding habits and studying its impact on dog food dish contamination - saying they 'poses significant health risk'

Daily Mirror

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FDA Lifts Partial Clinical Hold On Gilead's MDS, AML Magrolimab Studies

The FDA has

Benzinga

Aeglea Bio Stock Gains On Additional Pegzilarginase Data For Rare Metabolic Disease

Aeglea BioTherapeutics Inc (NASDAQ:AGLE) shared additional data from the PEACE Phase 3 study evaluating Pegzilarginase in Arginase 1 Deficiency. Arginase-1 deficiency is a rare inherited disorder characterized by a complete or partial lack of the enzyme arginase in the liver and red blood cells. Arginase plays a role in the breakdown and removal…

Benzinga

Baby formula shortages hit stores across US with some rationing supplies

Product recalls after illnesses and deaths linked to powdered infant formula products combine with supply chain problems

The Guardian - US

Melatonin won't cure your sleep problems — and it might even be harmful

From widely varying melatonin supplement content to limited, temporary efficacy, practicing good sleep hygiene is better for insomnia than melatonin supplements

Inverse

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Eton Pharmaceuticals Names James Gruber Finance Chief

Eton Pharmaceuticals Inc (NASDAQ:ETON) has appointed James Gruber as Chief Financial Officer effective immediately. He succeeds Wilson Troutman, who is retiring. Mr. Troutman will remain with the company through May to ensure a smooth transition. Mr. Gruber, most recently, was the U.S. Controller at Horizon Therapeutics (NASDAQ:HZNP) for seven years, where he oversaw…

Benzinga

After Leukemia Trial, FDA Puts Partial Hold On Curis' Lymphoma Study

The FDA has placed a partial clinical hold on Curis Inc's (NASDAQ:CRIS) TakeAim Lymphoma study. The TakeAim Lymphoma study is a Phase 1/2 open-label dose-escalating clinical trial investigating emavusertib in patients with B-cell malignancies. This week's notification extends the partial hold across both lymphoma and leukemia studies. As previously announced, the Company had…

Benzinga

Can ‘liquid biopsy’ cancer blood tests live up to promise of saving lives?

Research is under way even as one company touts its blood test to people with no signs of cancer as a way to detect tumors that have no recommended screening method.

Chicago Sun-Times

Veru's Stock Nearly Triples As COVID-19 Drugs Cuts Reduces Deaths By 55% In Hospitalized Patients

Veru Inc (NASDAQ: VERU) has

Benzinga

Can cancer blood tests live up to promise of saving lives?

A new type of blood test that checks for signs of cancer in healthy people has hit the market

The Independent UK

You're probably handling your pet's food wrong, new study finds

A new study shows how most pet owners don't know or follow FDA food handling guidelines, which could negatively affect human and canine health.

Inverse

Doctors trying to prescribe abortion pills across state lines stymied by legislation

Soon after Dr. Mai Fleming finished her medical residency in the San Francisco Bay Area, she got to work on her Texas medical license. The family medicine doctor had no intention of moving there but invested nine months to master Texas medical law, submit to background checks, get fingerprinted and…

Tribune News Service

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Tribune News Service

Medicare’s strict Alzheimer’s policy raises ante for drugmakers

The U.S. Medicare program’s decision to tightly limit coverage for the first drug meant to slow the course of Alzheimer’s disease has raised the stakes for companies trying to make the next one.

Tribune News Service

Commentary: Medicare is cleaning up the FDA’s mess on Biogen’s Alzheimer’s drug

Medicare has decided once and for all not to pay for Biogen’s new Alzheimer’s drug Aduhelm unless patients are enrolled in a clinical study.

Benzinga

Needham Sees Clear View Into STAAR Surgical's Durable Double-Digit Revenue Expansion

Needham is initiating coverage on STAAR Surgical Company (NASDAQ:STAA) with a Buy rating and an $87 price target. The analysts note that FDA approval of STAA's EVO Implantable Collamer Lens (ICLs) should serve as a meaningful tailwind for revenue. The Company generates most of its revenue from outside US markets. But after the FDA approval…

Benzinga

Is The UK Becoming A Global Center For Psychedelic Medicine?

This article by Freddie Earlam was originally published on Microdose and appears here with permission. If the industry-defining research already conducted at UK centers such as Imperial College, King’s college or even Exeter University’s recent Ketamine Research isn’t enough to convince you, then two more crucial factors surely will. Firstly, a new ‘accelerated pathway’ has…

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Benzinga

Zynex Tightens Q1 Sales, EBITDA Guidance; CM-1600 Blood & Fluid Monitor Awaits FDA Approval

Zynex Inc (NASDAQ:ZYXI) expects Q1 FY22 sales of $30.5 million - $31.5 million, approximately 26% higher than Q1 2021, in line with the consensus of $31.04 million. Earlier, the Company had forecasted sales of $29 million - $32 million. The Company expects adjusted EBITDA between $3 million - $4 million versus the prior…

Benzinga

Amphastar's Generic Ganirelix Acetate Injection Scores FDA Approval

The FDA has approved Amphastar Pharmaceuticals Inc's (NASDAQ:AMPH) Abbreviated New Drug Application for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. The FDA determined Amphastar's ganirelix is bioequivalent and therapeutically equivalent to Organon & Co's (NYSE:OGN) Ganirelix…

Benzinga

Morning Brief: Top Stories Dominating Financial Media on Friday, April 8

Reuters

Benzinga

Biogen's Alzheimer's Drug Aduhelm Medicare Coverage Restricted To Just Clinical Trials, CMS Finalizes

Centers for Medicare and Medicaid Services (CMS) finalized its decision to restrict coverage for Biogen Inc's (NASDAQ:&

Axios

Medicare's limits on Aduhelm coverage sparks questions about future drugs

The Biden administration announced Medicare will cover Aduhelm, but will require patients to be enrolled in a clinical trial in order to access the drug.

The Independent UK

Medicare weighs premium cut after limiting Alzheimer's drug

Medicare says it’s considering a cut in enrollee premiums, after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs

Benzinga

See Why Does HC Wainwright Maintain Neutral On Akebia Stock

Akebia Therapeutics Inc (NASDAQ: AKBA) announced three poster presentations at the National Kidney Foundation (NKF) Spring Clinical Meetings 2022.

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