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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The planned testing for DNL919 was held back pending additional documentation required to initiate the studies and information on the preclinical toxicology assessment.
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
Exo Therapeutics’ approach is not only different, it has revolutionary potential.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.
Curevo, a clinical-stage biotechnology company, is developing safe and highly-effective vaccines to fight infectious diseases such as shingles.
The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.
New research published this week gives a greater understanding of why the CDC warned of an increased risk of stillbirth for women infected by SARS-CoV-2 during pregnancy in November.