BioSpace News Archive

Depression

J&J Axes Late-Stage Depression Trial After Underwhelming Efficacy

Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression.

March 7, 2025

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2 min read

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Tristan Manalac

Contemporary art collage showing a hand giving a thumbs down surrounded by red arrows pointing down, concept of negative feedback and bad review

Regulatory

Biogen, Eisai’s Leqembi Suffers Overseas Setbacks as UK Denies Coverage, Australia Denies Approval

Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.

March 7, 2025

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2 min read

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Tristan Manalac

Marty Makary speaks on a panel at the New America Foundation

Government

Makary Shows Soft Support for FDA Vaccines Committee at Confirmation Hearing

Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”

March 7, 2025

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2 min read

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Tristan Manalac

Composite photo collage of hand hold magnifier glass research examine secret object question mark secret isolated on painted background.

Editorial

This Might Be a Moot Point but the FDA’s Priority Review Vouchers Need Transparency

While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too.

March 7, 2025

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3 min read

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Annalee Armstrong

Editorial

FDA Weathers Bait-and-Switch Storm as Staff and Sites Come and Go

Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.

March 7, 2025

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3 min read

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Jef Akst

Novo Nordisk headquarters in Silicon Valley

Obesity

Novo’s Studies of GLP-1s for Addiction Limited to Ongoing Phase II

Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional clinical trials of its GLP-1 drugs in addiction beyond a Phase II trial testing semaglutide and two other drugs with alcohol use as a secondary endpoint.

March 7, 2025

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2 min read

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Dan Samorodnitsky

Pictured: AstraZeneca's manufacturing facility in

Stomach cancer

AstraZeneca Builds Stomach Cancer Case for Imfinzi With Strong Phase III Data

Imfinzi is one of AstraZeneca’s key growth drivers for 2025, with potential approvals in stomach and bladder cancers. The PD-L1 blocker brought in over $4.7 billion in sales last year.

March 7, 2025

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2 min read

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Tristan Manalac

Press Releases

CENTENE TO PRESENT AT BARCLAYS 27TH ANNUAL GLOBAL HEALTHCARE CONFERENCE

March 7, 2025

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1 min read

Press Releases

RetinalGenix Technologies to Participate at the 37th Annual Roth Conference