Drug Development
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
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.
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.
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Amid shortages of its Mounjaro and Zepbound blockbuster drugs, Eli Lilly on Friday said it is investing an additional $5.3 billion in its production site in Lebanon, Indiana, to boost output of their active ingredient.
Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
Full data from the FLOW study show that Novo Nordisk’s top-selling GLP-1 receptor agonist semaglutide can significantly reduce the risk of death by 20% in diabetes patients with chronic kidney disease.
After selling off its oral TYK2 blocker to Takeda for $4 billion, Nimbus Therapeutics has posted strong early-stage data for its other clinical candidate, NDI-101150, in solid tumors.
Phase I/II data for Regeneron Pharmaceuticals’ costimulatory bispecific antibody were disappointing, with only one complete response when used as a combination treatment with Libtayo for solid tumors.
Johnson & Johnson’s radiopharma candidate JNJ-6420 returned mixed results in an early-stage study, demonstrating strong biochemical and radiographic response but also resulting in four patient deaths.
Tango Therapeutics reported Thursday that solid tumor patients who stayed in the Phase I study for more than eight weeks developed Grade 3 and 4 liver function abnormalities.
Riding the growing wave of interest in molecular glue degraders, Takeda has partnered with Chinese biotech Degron Therapeutics to develop novel therapies for oncology, neuroscience and inflammation.
In advance of Friday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, the FDA has raised concerns about hypoglycemia linked to Novo Nordisk’s insulin icodec, according to a briefing document.
BioSpace’s Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.