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Vedanta is parting ways with 23 employees, or approximately 20% of its headcount, after Phase II data for microbiome therapy VE202 failed to demonstrate significant response rates in patients with ulcerative colitis.
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Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines.
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A2 Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to A2B530 for the treatment of germline heterozygous HLA-A*02(+) patients with colorectal cancer that expresses carcinoembryonic antigen (CEA) and has lost HLA-A*02 expression.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month.
The deal marks an end for CAR T company Cargo Therapeutics, which has been slashing its workforce and cutting programs since the January decision to halt its lead candidate for a certain type of aggressive large B cell lymphoma.
President Donald Trump’s One Big Beautiful Bill, signed into law last week, reintroduces broader exemptions for orphan drugs from the IRA’s drug price negotiation program—a move welcomed by the biopharma industry. The new tax law also cuts Medicaid funding, posing a minimal risk to pharma’s bottomlines and potentially jeopardizing hospitals’ 340B status. It does not, however, include new rules for pharmacy benefit managers that had been in an earlier draft.
After issues with a batch of Jasper Therapeutics’ investigational antibody led to “lower” therapeutic effects in several patients, analysts at BMO Capital Markets said they “believe investors won’t feel comfortable coming back to the story.”
Societies, including the American Academy of Pediatrics, allege that Kennedy’s directive to remove COVID-19 from vaccination guidelines for healthy pregnant women and healthy children puts these vulnerable groups at risk of serious illness.
A readout from the company’s SUMMIT trial put its small molecule bezuclastinib on a collision course with rival Blueprint’s Ayvakit, which Leerink analysts said does not sufficiently treat all patients.
The partnership will give Chugai access to Gero’s artificial intelligence technology to discover novel targets in aging-related diseases. Chugai will then develop antibody-based drugs based on the findings.
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies.
Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due to resource constraints and reports surfaced that Commissioner Marty Makary tried to have the application rejected.
Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of its former self under Health Secretary Robert F. Kennedy Jr.