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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You are what you eat, and your defense system notices that.
Altimmune announced Monday that the U.S. Food and Drug Administration (FDA) has approved a Phase II clinical trial for investigational new obesity drug pemvidutide.
The decision came after the Phase IIb study results demonstrating a statistically significant decrease in non-HDL-C and statistically significant reductions in triglycerides and ANGPTL3.
WRNMC researchers have found a way to create a vaccine that can recognize multiple spike proteins at once by using ferritin. Here’s more about pan coronavirus vaccine.
News that a subvariant of the Omicron variant has appeared in the U.S. and parts of Europe doesn’t seem like good news. The latest data suggest it’s 1.5 times more transmissible than the original Omicron variant, but not necessarily deadlier.
Scientists believe that, perhaps, Alzheimer’s disease is a cause of not just beta-amyloid accumulation but, digging more deeply, immune system dysfunction.
Shares of Madrigal Pharmaceuticals went up in premarket trading after the company announced positive topline data from its Phase III assessment of resmetirom in non-alcoholic fatty liver disease.
The FDA’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.
Eli Lilly and Company announced that it was discontinuing the Phase III development program for Olumiant (baricitinib) in lupus.
The resubmission follows a Type B pre-BLA resubmission meeting with the US Food and Drug Administration (FDA).