News
FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
As the field grows rapidly, companies are luring people from other nuclear industries and tapping the expanding educational talent pipeline, but are constrained by a steep learning curve and the value of real-world experience.
The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
Novo Nordisk has sued Hims for allegedly violating patents protecting semaglutide, seeking potentially “hundreds of millions” in damages, John Kuckelman, the pharma’s general counsel, said. The wellness platform pulled its version of the drug just days after launching it.
The gene therapy uses an AAV vector to restore healthy levels of the alpha-galactosidase enzyme, which is rendered dysfunctional in patients with Fabry disease, leading to the toxic build-up of lipids in cells.
The FDA in July last year declined to approve UX111 for Sanfilippo syndrome, a rare neurodegenerative disorder, citing manufacturing issues. Ultragenyx Pharmaceutical resubmitted its application ten days ago, expecting a six month review time.
The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business risk and opportunity. Understanding key 2025 trends will be critical to developing regulatory strategies and maximizing opportunities for success.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
Sales of Johnson & Johnson’s esketamine-based nasal spray jumped in the fourth quarter last year, priming the pump for a suite of other pharmas, including AbbVie, champing at the bit with their own psychedelics.
With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth.