Clinical research
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.
After their latest trial delivered disappointing results, Pfizer and BioNTech are ready to test if a third dose of their COVID-19 vaccine would trigger an immune response in very young children.
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.
Full results from the Phase III trial of Novavax’s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
The agreement between the two companies includes a lead, potential first-in-class preclinical candidate, and research collaboration to jointly develop the additional novel candidates.
Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.
Nodexus and Aramis Biosciences will use their funds to expand their company’s pipeline and build their commercialization capabilities.
Researchers have published a study describing how chemotherapy and a drug used to treat cardiac failure is able to regress tumor growth of patients with triple negative breast cancer.
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