Clinical research
It was a particularly busy week for clinical trial announcements. Let’s take a look.
The FDA requested additional data analyses from the pediatric studies that Merck stated it has submitted. The final decision is expected on July 1, 2022.
Although the data suggests the vaccines are extremely effective and generally safe, analysis is still coming in about adverse events as well as effectiveness in specific patient populations.
Cerevance reported positive clinical trial results for CVN424, an experimental treatment for Parkinson’s disease.
Vertex Pharmaceuticals has announced meaningful results from two Phase II studies of its therapeutic VX-548. It is a non opioid pain medication that promises results.
Taysha Gene Therapies announced that it will focus its efforts on clinical programs targeting Rett Syndrome and giant axonal neuropathy (GAN), resulting in a 35% reduction in its workforce.
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
It’s a promising day for advanced ovarian cancer research as two biopharma companies achieved positive results. Here’s what you need to know about research.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
The FDA has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
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