Clinical research
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
Pfizer has paused screening and dosing of a Phase Ib study of its experimental gene therapy treatment for Duchenne muscular dystrophy following the unexpected death of a patient.
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.
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.
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