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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Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
The researchers believe Keytruda and possibly other anti-PD-1 checkpoint inhibitors might help the immune system track the last signs of HIV while also preventing HIV’s ability to hide.
In the last two years, the sheer volume of scientific research focused on COVID-19 has been astounding—thousands of clinical studies, dozens of vaccines and new compounds, and hundreds of approved drugs tested for efficacy against COVID-19.
Some might go as far as to consider the pharmaceutical industry as mankind’s best hope for survival. But now, as the world enters the third year of the pandemic, has that perception changed?
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.
Vaccinex announced positive interim response data in a Phase Ib study assessing pepinemab in combination with Merck’s vaunted checkpoint inhibitor, Keytruda.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.