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The rescheduling of the Advisory Committee on Immunization Practices comes amid fresh leadership upheaval at the CDC as NIH director Jay Bhattacharya replaces Jim O’Neill as acting head of the agency.
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Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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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.
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
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.