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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
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The approval, which Bristol Myers Squibb reported on Thursday, positions the company to compete with Astellas and Pfizer’s Padcev.
According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.
The company announced Thursday it terminated its BTK inhibitor evobrutinib for multiple sclerosis, which did not meet the primary endpoints in two late-stage trials.
MindMed’s stock price jumped over 50% Thursday as its LSD-based candidate for generalized anxiety disorder got a breakthrough therapy designation from the FDA.
President Biden called for expanding the Inflation Reduction Act to lower prescription drug prices. What would Trump do if he wins the 2024 election?
BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.
The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.
Friday’s topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.
AstraZeneca and Sanofi’s respiratory syncytial virus immunizing antibody Beyfortus reached effectiveness of 90% against infection-related hospitalization in infants, according to the Centers for Disease Control and Prevention.