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The Latest Breaking News from FDA

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 · Apr 11, 2022

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 · Apr 11, 2022

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

Veru Inc (NASDAQ: VERU) has

Benzinga · Apr 11, 2022

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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 · Apr 11, 2022

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 · Apr 10, 2022

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 · Apr 10, 2022

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 · Apr 10, 2022

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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 · Apr 10, 2022

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 · Apr 8, 2022

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…

Benzinga · Apr 8, 2022

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 · Apr 8, 2022

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 · Apr 8, 2022

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

Reuters

Benzinga · Apr 8, 2022

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:&

Benzinga · Apr 8, 2022

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Axios · Apr 8, 2022

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 · Apr 7, 2022

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 · Apr 7, 2022

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.

Benzinga · Apr 7, 2022

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…

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Benzinga · Apr 7, 2022

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Minerva Neurosciences Inc (NASDAQ: NERV) received the

Benzinga · Apr 7, 2022

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…

Benzinga · Apr 7, 2022

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:

Benzinga · Apr 7, 2022

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 · Apr 7, 2022

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

Benzinga · Apr 7, 2022

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

Reuters Here’s Why HP Shares Are Trading Higher Premarket

Benzinga · Apr 7, 2022

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

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

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