Regulatory
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%.
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 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.
Pfizer has announced it received Breakthrough Therapy Designation from the FDA for its vaccine candidate intended to prevent infections caused by the respiratory syncytial virus (RSV).
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
Pfizer is lining up a potential New Drug Application for an ulcerative colitis treatment for patients who are not seeing an improvement in their condition from currently available options.
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
An FDA Investigational New Drug application has been approved for NeuroSense Therapeutics Ltd.’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS).
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