Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
FEATURED STORIES
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.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.
The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.
Otonomy shares plunged 50.1% at news that its drug to treat Meniere’s disease failed to hit the primary endpoint in its Phase III trial.
Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause.
It was a busy week for clinical trial announcements. Here’s a look.
There’s plenty of COVID-19-related news today. Here’s a look.
The vaccine will be manufactured and distributed around the world by Novavax and Serum Institute of India (SII).
Shares in the company shot up 212.6% following the news it had isolated the potentially variant-neutralizing antibodies.
An open letter from a group of academics is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).