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Generate:Biomedicines’ Nicole Clouse is one of the key legal minds trying to understand who owns what AI creates. The answers are critical to the future of biotech.
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While a substantial portion of pipeline assets are externally sourced, many Big Pharmas are tapping into incubators and venture funds to uncover cutting-edge scientific trends, determine their future focus points and even carve out a niche in an emerging geographical hotspot.
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel.
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.
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For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes.
The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according to analysts at BMO Capital Markets.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
Papzimeos is the first immunotherapy approved for recurrent respiratory papillomatosis, a rare lung disorder involving the development of benign tumors in the airways.
The move comes after Robert F. Kennedy Jr. received pressure from the Children’s Health Defense, an anti-vaccine non-profit that he co-founded, which last month sued him over his failure to run the “statutorily required Task Force on childhood vaccine,” according to the lawsuit.
The Department of Health and Human Services’ mRNA pullback only applies to their use in upper respiratory disease, according to Secretary Robert F. Kennedy Jr.
As Trump has pressured drugmakers to lower the cost of medicines in the U.S., the pharma industry has coalesced behind a message of rebalancing what nations pay to better reflect the innovation and value of drugmaking.
The Boston-based AI/ML startup focuses on endocrine and cardiometabolic diseases and will use that expertise to generate new small molecule obesity medications for Lilly.
WARN notices provide a heads up that staff will soon be unemployed, but the act that mandates them has some nuances. An attorney explains how the law works, common misconceptions about it and how it helps those about to lose their jobs.