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FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
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From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace’s NextGen Class of 2026 told us about the issues keeping them up at night.
Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.
Candid Therapeutics follows closely behind Neurona Therapeutics, which UCB acquired in mid-April in a potential $1.15 billion deal.
In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential mega-blockbusters raises the risk of “significant value destruction from a single program failure.”
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.
CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.
Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.