Judge blocks FDA lab-developed test rule

Today’s Big News

Apr 1, 2025
 

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Biopharmas laid off staffers at least 63 times in Q1: Fierce Biotech analysis

At least 63 biopharma layoff rounds were conducted in the first quarter of this year, with cell and gene biotechs accounting for nearly a third of those rounds. The cuts were accompanied by eight biotech closures as the sector faces deep uncertainty tied to recent geopolitical changes.
 

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FDA's new commissioner Marty Makary signed off on Peter Marks ouster: Politico

Peter Marks, M.D., Ph.D., a target for RFK Jr. and allies, last week turned in his resignation as director of the FDA's Center for Biologics Evaluation and Research. Before that, FDA commissioner Marty Makary signed off on his ouster, according to Politico.

Federal judge blocks FDA’s regulation of lab-developed tests

The ruling was issued for a pair of lawsuits brought against the FDA by the American Clinical Laboratory Association and the Association for Molecular Pathology.

After dismissal of 3rd bankruptcy settlement, Johnson & Johnson says it will take on talc cases in court

With the decision of a Texas federal judge to dismiss Johnson & Johnson's third effort to resolve some 90,000 talcum powder lawsuits through a planned $9 billion Chapter 11 settlement, the company said it will abandon its efforts to rectify the cases through bankruptcy proceedings and is ready to take them on in court.

After Eric Green's exit, new leader of NIH's genome research institute put on administrative leave: Stat

Vence Bonham Jr., the highest ranking official at the National Human Genome Research Institute, has been put on administrative leave.

Pharma majors put lobbyists to work to stagger tariff rollout: Reuters

As President Donald Trump threatens to impose sweeping geographic tariffs this week and rekindles discussions around industry-specific duties on drugmakers, pharmaceutical makers are lobbying the administration to buy themselves some extra time, Reuters reported Tuesday.

Carisma winds down operations, lays off 95% of remaining staff

After a year of stripping back its head count and pipeline, Carisma Therapeutics is winding down operations and laying off any staff “not deemed necessary to pursue strategic alternatives.”

Cerevance fails phase 2 trial in early, untreated Parkinson’s

Cerevance’s attempt to unlock the first-line Parkinson's disease market has hit a snag, with solengepras performing no better than placebo in phase 2 when given to people with early, untreated symptoms.

DC court backs HHS in rejecting Vertex's proposed fertility support program for Casgevy patients

A District Court backed the U.S. government in its ruling that Vertex's fertility support program, which proposed offering up to $70,000 in fertility services for eligible Casgevy patients, would violate anti-kickback statutes.

State AGs file lawsuit against HHS' $11B clawback of COVID-19, public health grants

The Department of Health and Human Services rescinded $11.4 billion in funds to states, cities and organizations receiving grants for COVID-19 efforts and other public health programs. Meanwhile, the HHS told employees to identify contracts that lead to censorship or misinformation on topics not limited to COVID-19.

Lilly continues full-court press against breast cancer with women’s March Madness event sponsorships

As the women’s NCAA March Madness tournament draws to a close, Eli Lilly is aiming for a slam dunk of its own.

SynCardia artificial heart maker Picard Medical plans to go public

Picard Medical, which owns and operates the implant manufacturer SynCardia, aims to list on the New York Stock Exchange under the ticker PMI.
 
Fierce podcasts

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What diversity means in medtech

This week on "The Top Line," we hear from Nada Hanafi, co-founder of MedTech Color, about the importance of diversity in healthcare settings.
 

Resources

Research

Best Practice Customer-Facing Organization Study Report

We interviewed 15 biopharma leaders on the critical success factors for building a Best Practice customer-facing organization. This report shares what we learned.
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Discover how to revolutionize your vaccine trials with Avacare's latest white paper. Gain exclusive access to innovative, data-driven recruitment strategies that ensure diverse, efficient, and high-quality vaccine trials.
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Solutions for CAR-Engineered Cell Characterization

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