BioSpace News Archive

FDA signage at its headquarters in Maryland

Regulatory

After Drug Rejection, Vanda Blasts ‘Unacceptable’ FDA Conduct in Letter to Commissioner

Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”

January 9, 2025

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2 min read

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Tristan Manalac

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Deals

Biopharma Finishes 2024 Strong With ‘Robust’ VC, Upfront Payments: JP Morgan

J.P. Morgan releases its quarterly look-ahead days before the entire biopharma industry descends on San Francisco for the annual J.P. Morgan Healthcare Conference.

January 9, 2025

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3 min read

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Annalee Armstrong

Illustration of employer’s hand holding employee who was laid off to drop him out of office

Layoffs

From Bad to Worse: 3 Ways Biopharmas Make Layoffs More Painful for Employees

Being laid off is bad enough. When companies mishandle the layoff process, it can make the situation even worse. Four biopharma professionals share how some employers are getting it wrong.

January 9, 2025

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5 min read

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Angela Gabriel

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Startups

Verdiva Jumps Into Hot Obesity Market With $410M Debut, Eyes Next-Gen Therapies

The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability.

January 9, 2025

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2 min read

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Tristan Manalac

Lilly Institute for Genetic Medicine building in Boston, Ma, USA, on November 11, 2023. Eli Lilly and Company is an American pharmaceutical company.

Government

Lilly Wins Medicare Coverage for Zepbound in Sleep Apnea

According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.

January 9, 2025

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2 min read

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Tristan Manalac

A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.

Autoimmune disease

MaaT Clears Phase III in GVHD, Eyes European Submission By Midyear

MaaT013 in 2022 was put under clinical hold by the FDA, which cited safety and efficacy concerns with the sample-pooling method used to produce the investigational therapy. The hold was lifted in April 2023.

January 9, 2025

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2 min read

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Tristan Manalac