Clinical research
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
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 two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs’ potential to improve the quality of life of patients diagnosed with DME and nAMD.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
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