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In a Phase 1 study, 82% of patients on VIR-5500 achieved at least a 50% reduction in PSA levels—a result analysts praised as competitive in the prostate cancer space.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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FDA
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 investment, which will expand Eli Lilly’s existing campus in Puerto Rico, is slated to create 100 new jobs, on top of around 1,000 construction-related roles.
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
The clinical hold comes days after Intellia voluntarily paused enrollment and dosing in the same two studies.
Pfizer called Novo’s offer “reckless and unprecedented,” in a statement issued Thursday morning.
Nearly one-third of biotech and pharma professionals are thinking about leaving the U.S. to find biopharma jobs, according to a BioSpace LinkedIn poll. Career coaches discuss why people are considering relocating and what they should do before heading for the exit.
Looking for a biopharma job in New York? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.
Late-breaking Phase III data show ianalumab, Novartis’ dual-targeted antibody, reduced disease activity and patient burden in Sjögren’s disease, the pharma reported at the American College of Rheumatology Convergence congress on Wednesday.
Genentech is letting go of 118 employees in South San Francisco. The news comes about two months after the biotech ended a partnership with Adaptive Biotechnologies.
Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.