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The Latest Breaking News from FDA

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.

Tribune News Service

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

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…

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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…

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…

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…

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

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

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:&

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

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.

Medicare weighs premium cut after limiting Alzheimer's drug

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

The Independent UK

See Why Does HC Wainwright Maintain Neutral On Akebia Stock

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.

FDA Places Partial Hold On Vadadustat Pediatric Studies, Akebia Cuts Over 40% Staff

FDA Places Partial Hold On Vadadustat Pediatric Studies, Akebia Cuts Over 40% Staff

Battered after a surprising FDA rejection for its lead pipeline program last week, Akebia Therapeutics Inc (NASDAQ:AKBA) has layoffs that are now on the way. In a filing with the SEC, Akebia said the FDA issued a partial clinical hold on the drug's pediatric studies. As a result, Akebia will suspend all vadadustat studies…

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Minerva Neurosciences Inc (NASDAQ: NERV) received the

Werewolf Therapeutics Shares Jump On Cancer Product Pact With Jazz Pharma

Werewolf Therapeutics Shares Jump On Cancer Product Pact With Jazz Pharma

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) has acquired exclusive global development and commercialization rights to Werewolf Therapeutics Inc's (NASDAQ:HOWL) WTX-613. WTX-613 is a differentiated, conditionally-activated interferon-alpha (IFNα) INDUKINE molecule. "We believe WTX-613 has the potential to minimize the toxicity associated with systemic IFNα therapy, preferentially delivering IFNα to tumors, and thereby expanding its clinical utility in treating…

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The Daily Biotech Pulse: Pfizer Goes Shopping, AstraZeneca Inks Bispecific Antibody Deal, Aptinyx Faces Clinical Study Setback, Erytech Jumps On Data And More

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

Biophytis Shares Fall As It Stops Enrollment In Sarconeos COVID-19 Trial, Data Expected In Q3 2022

Biophytis SA (NASDAQ:BPTS) said that it is currently assessing FDA comments and recommendations and preparing to submit Phase 2-3 trial designs for sarconeos (BIO101) trial in sarcopenia. Enrollment is expected to start in 2H of 2022 in the SARA Phase 2 trial. In October 2021, sarconeos at the highest dose of 350 mg…

The Guardian - US

Mail-order abortion pills become next US reproductive rights battleground

The FDA has dropped a requirement for the abortion drug mifepristone to be picked up in person – but some Republicans states are clamping down

Morning Brief: Top Stories Dominating Financial Media on Thursday, April 7

Reuters Here’s Why HP Shares Are Trading Higher Premarket

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Adverum Moves Forward With IND Amendment For ADVM-022 Phase 2 Trial In Wet AMD

Adverum Biotechnologies Inc (NASDAQ: ADVM) received feedback via a

FDA Official Says Frequent COVID-19 Booster Shows Not Sustainable: WSJ

According to a U.S. health regulator, asking people to get COVID-19 boosters frequently wasn't sustainable because of vaccine fatigue, and authorities needed to develop a long-term strategy for protection against the evolving virus.

The high-stakes push to get COVID vaccines to young children

The Omicron variant and and anti-vaccine backlash are complicating the effort.

These 3 Psychedelic Stocks Will Benefit When The FDA Green-Lights MDMA (Molly, Ecstasy)

What Happened: According to the Multidisciplinary Association of Psychedelic Studies (MAPS), a non-profit organization, the FDA is close to greenlighting MDMA as a treatment for PTSD. MAPS reported positive results from a phase-3 trial testing the efficacy of MDMA-assisted therapy.

Why Did FDA Pull Authorization For GSK-Vir's COVID-19 Therapy? Read Here

The U.S. health regulator said GlaxoSmithKline Plc (NYSE:GSK) and Vir Biotechnology Inc's (NASDAQ:VIR) antibody therapy was no longer authorized as a COVID-19 treatment. The decision was made as the CDC now estimates that the proportion of Covid-19 cases caused by BA.2 is above 50% nationwide. "Sotrovimab is no longer authorized to treat COVID-19 in any…

40 Stocks Moving In Wednesday's Mid-Day Session

Gainers Advent Technologies Holdings, Inc. (NASDAQ: ADN) shares jumped 77.7% to $3.5950. Advent Technologies and Hyundai Motor Company entered into technology assessment, sales and development agreement.

The Independent UK

US experts discuss COVID boosters for the fall and beyond

Vaccine experts are meeting to discuss the U.S. strategy for future COVID-19 booster campaigns

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