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In this episode of Denatured, you’ll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo.
Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.
Alto Neuroscience’s depression treatment failed to beat placebo just nine months after the biotech went public. The stunning failure called to mind Acelyrin, which faced a similar fate last year.
Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease.
For biopharma executives who are between roles, navigating the transitionary time can be challenging. However, they can remain visible and valuable so they’re ready to seize their next big opportunity.
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.