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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Researchers at the Wuhan Institute of Virology (WIV), which is potentially linked to the origins of COVID-19, reported the discovery of a novel DNA virus in animals in the journal Virologica Sinica.
Day One Biopharmaceuticals aims to provide a business solution to a moral problem: the inequity in pediatric oncology drug development.
Clover’s SCB-2019 showed a robust immune response to the Omicron BA.5 sub-variant, while BrainsWay, TikoMed and more provide updates on their businesses and pipelines.
Amgen announced Tuesday that initial Phase III data of Lumakras in KRAS G12C-mutated NSCLC met the primary endpoint of progression-free survival.
Aria Pharmaceuticals secured six provisional patents to cover the lead drug candidates for its lupus, idiopathic pulmonary fibrosis and chronic kidney disease research programs.
Jounce Therapeutics announced that a Phase II trial assessing a combination treatment for non-small cell lung cancer failed to meet its primary endpoint.
Umoja CEO Andy Scharenberg spoke with BioSpace about the company’s unique tri-platform approach to immunotherapy which aims to attack and destroy hematologic and solid organ-based tumors.
Alnylam Pharmaceuticals reported positive Phase II results for cemdisiran, an RNA interference (RNAi) drug developed to treat IgA nephropathy.
AstraZeneca reported a pre-specified pooled analysis from its Phase III trial of the diabetes drug Farxiga in patients with heart failure.
Phase III data shows the potential of Bayer’s Kerendia to reduce the risk of all-cause and cardiovascular mortality in type 2 diabetes patients with chronic kidney disease.