Acting CBER chief installed as FDA's CMO exits
 

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For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty

To innovators in the cell and gene therapy field, Peter Marks’ exit from the FDA means losing a seasoned regulator and key ally.
 

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'Patently illegal': NIH and HHS face new lawsuit over $1.1B in revoked research grants

The American Public Health Association and several researchers are suing the NIH and the HHS—plus respective leaders Jay Bhattacharya, M.D., Ph.D., and Robert F. Kennedy Jr.—in an effort to reverse and prevent further cancellations of federal research grants.

With biosimilar competition looming, Roche takes a hit with failure of high-dose Ocrevus

With its multiple sclerosis powerhouse Ocrevus expected to lose patent protection by the end of the decade and face competition from cheaper biosimilars, Roche is looking for ways to extend its exclusivity for the top-selling drug in the indication. But the Swiss company can check one potential solution off its list as a phase 3 trial of its high-dose version of Ocrevus in patients with relapsing multiple sclerosis (RMS) has failed to move the needle.

FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure

Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research.

FDA’s Chief Medical Officer Hilary Marston is out amid mass layoffs

The FDA’s Chief Medical Officer Hilary Marston, M.D., is leaving her position at the agency amid huge cuts to staff across the FDA.

Elon Musk expected to step down from DOGE leadership role: Politico

In the upcoming weeks, Tesla CEO Elon Musk is expected to step down from his position helming the federal Department of Government Efficiency (DOGE), according to Politico.

#FierceMadness: Syfovre’s Henry Winkler faces Airsupra’s dinosaur in the 2025 Drug Ad Tournament final—VOTE NOW

As the college basketball March Madness tournament gets underway, so too does Fierce Pharma Marketing’s annual #FierceMadness competition.

Amid uncertainty in the US, Boehringer Ingelheim projects 'slight' revenue increase for '25

Boehringer Ingelheim picked a challenging day to reveal its 2024 financial results and guidance for this year. With President Donald Trump announcing his plan on tariffs on Wednesday and uncertainty surrounding if and how they will affect the export of pharmaceutical products to the U.S., the German company is treading lightly with its projection of a “slight year-on-year increase” in revenue.

Princeton and Harvard join other Ivy League schools facing funding cuts, putting research at risk

The Trump administration is halting research funding to Princeton University and reviewing more than $9 billion in federal grants and contracts to Harvard University, the latest escalation of the government’s cuts to scientific research institutions.

British biotech CellCentric expands to Boston with plans to grow into late-stage clinical development

British biotech CellCentric is settling into a new office in Boston, part of the company’s expansion into the U.S. as multiple myeloma asset inobrodib progresses to late-stage clinical development.

CMR Surgical nets $200M to support Versius robot’s US launch

Following the FDA clearance of its Versius robot last fall, CMR Surgical has raised more than $200 million in new funding to bolster its U.S. commercial launch.

Medtronic inks stroke AI partnership with European developer Methinks

The medtech giant plans to integrate Methinks AI’s apps with its portfolio of ischemic stroke treatment hardware, including blood clot aspiration systems and stent-based retrievers.
 
Fierce podcasts

Don’t miss an episode

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.
Whitepaper

The Oncology Market: 2025 Outlook

Read about four trends that will shape the innovations, therapies, & market landscape in oncology during 2025 & beyond.
Whitepaper

Redefining vaccine trial recruitment

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.
Whitepaper

Solutions for CAR-Engineered Cell Characterization

Develop your CAR molecule faster
 

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