Phase II
Four companies, Pipeline Therapeutics, Prothena, Neuroplast, and Taysha Gene Therapies, announced launches of clinical trials in the CNS space.
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
The 2022 American Academy of Dermatology Annual Meeting saw several milestones for treatment explorations for inflammatory diseases. Here is some of the major news:
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Seattle-based Icosavax’s stock plunged 50% after the company reported topline interim data from its ongoing Phase I/II COVID-19 vaccine trial.
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
Although it was relatively quiet in COVID-19-related clinical trials, there was plenty of other clinical trial news. Here’s a look.
The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.
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