Phase III
After last week’s avalanche of clinical trial news associated with the American Society of Hematology Annual Meeting, there are far fewer announcements, but some companies are getting their news out ahead of the holidays.
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
Novartis announced it has licensed BeiGene’s ociperlimab, a late-stage TIGIT inhibitor, to bolster its immunotherapy pipeline.
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.
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.
Biopharmaceutical companies across the world are fighting an increasingly important battle against COVID-19: the struggle to treat the disease.
The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
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