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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AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency.
Marinus Pharmaceuticals reported that its Phase III RAISE trial of IV ganaxolone for status epilepticus will be delayed, thanks to the pandemic.
Public health officials begin to think we’ve turned the corner on the pandemic as new global cases drop 21% last week, the third consecutive week numbers and deaths have declined.
The DSMB endorsed the use of mRNA-1345 for the Phase III ConquerRSV study following positive preliminary Phase II data that demonstrates the vaccine’s safety profile.
Shares of Kodiak Sciences plunged nearly 70% in premarket trading after its Phase II/III study of KSI-301 failed to demonstrate non-inferior visual acuity gains compared to Regeneron’s Eylea.
Veru’s enobosarm shows good proof of concept data even when 90% of patients have failed first-line therapies.
More biotech companies turn to private investors as the market churns volatile for life sciences. Here’s who’s scooping up the cash this week.
Weeks after announcing that its lead monoclonal antibody was demonstrating efficacy against the Omicron variant, Adagio Therapeutics CEO Tillman Gerngross steps down.
Halberd has demonstrated it can control each of the top 10 antigens associated with various neurodegenerative diseases, including Alzheimer’s, Parkinson’s, epilepsy, TBI and PTSD.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.