In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result.
Nearly a month ahead of the PDUFA date, red blood cell maturation drug luspatercept cleared the FDA for treating anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions. Branded Reblozyl, the drug, developed in a collaboration between Celgene Corp. and Acceleron Pharma Inc., is expected to be available in one week following approval.Read More
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. will get $100 million in up-front payments in a commercialization deal for two of its biosimilar candidates with U.S. company Biogen Inc. Under the deal, Samsung Bioepis will also be eligible for up to $270 million in milestone and option payments, as well as a share of sales revenue. Read More
Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.
PERTH, Australia – Melbourne-based Cartherics Pty Ltd. plans on taking its pluripotent stem cell technology into the clinic next year. It is employing advanced gene editing techniques for the next generation of CAR T therapy. Read More
Researchers at Harvard Medical School and The Banner Alzheimer's Institute have identified a potential protective variant that appears to have delayed the onset of clinical symptoms by several decades in one individual with a presenilin mutation. Presenilin mutations cause an autosomal dominant, early onset form of AD that usually leads to clinically noticeable cognitive impairments in one's 40s. Read More
