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Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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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.
Judge Zahid Quraishi on Thursday appeared unconvinced by the pharmaceutical companies’ arguments that the Inflation Reduction Act’s Drug Price Negotiation Program violated the U.S. Constitution.
BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma.
Gilead Sciences is partnering with Dutch biotech Merus to find novel dual tumor-associated antigens that target tri-specific antibodies.
The antibody-drug conjugate beat the standard of care in second-line multiple myeloma, the company reported on Thursday, as it seeks to get the cancer drug back on the U.S. market.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
Novo Nordisk’s early-stage amylin and GLP-1 co-agonist elicited a 13.1% reduction in body weight, with an overall favorable safety profile, the Danish drugmaker reported Thursday at an investor event.