Clinical research
Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.
When ImmunoGen announced top-line results from the Phase III SORAYA trial in November 2021, the primary endpoint - confirmed objective response rate - was met at 32.4%.
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.”
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
AstraZeneca will showcase its early oncology portfolio at the American Association for Cancer Research set to begin on April 8.
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.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
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.
PRESS RELEASES