BioSpace News Archive

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Deep Dive: Biopharma In Turmoil As Peter Marks Forced Out of FDA

Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.

May 9, 2025

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2 min read

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Annalee Armstrong

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Regulatory

FDA Delays Continue as Regulator Misses Review Date for GSK’s Nucala

The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.

May 9, 2025

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2 min read

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Tristan Manalac

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Artificial intelligence

Amid Layoffs, Delays, FDA Turns to AI for Speedy Reviews

The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the rollout immediately.

May 9, 2025

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2 min read

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Tristan Manalac

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Layoffs

Sanofi Cuts Off Antibody Partner, Forcing 80% Headcount Reduction at IGM

After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review of potential strategic alternatives and options for the business.

May 9, 2025

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2 min read

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Tristan Manalac

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Editorial

Rest Up, Biopharma. Trump’s Drug Pricing Policy Is Coming on Monday

With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.

May 9, 2025

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4 min read

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Annalee Armstrong

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Layoffs

Rallybio Downsizes by 40% After Dropping Lead Asset

The company discontinued development last month of its most mature asset, RLYB212, following disappointing mid-stage pharmacokinetic findings in a rare bleeding disorder.

May 9, 2025

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2 min read

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Tristan Manalac

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Editorial

Doubts About Job Market Turning Around Soon Easy To Understand

In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later. It’s easy to see why people are skeptical, especially when you consider recent hiring activity and layoffs.

May 9, 2025

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3 min read

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Angela Gabriel