Friday the 13th could be a make-or-break day in the U.S. for Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid). That’s the day the company will make its case before the FDA’s Gastrointestinal Drugs Advisory Committee for turning an 8-year-old accelerated approval into traditional approval.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
By combining an activator of the pro-apoptotic protein Bax with an inhibitor of the anti-apoptotic protein BCL-XL, researchers at Albert Einstein College of Medicine have been able to overcome resistance to apoptosis in both a wide range of cell lines and animal studies. The team reported its findings in the March 7, 2022, issue of Nature Communications.
Genfit SA’s global development and commercialization deal with Ipsen Pharma SA for phase III-stage elafibranor in primary biliary cholangitis (PBC) – plus a separate arrangement for rights to an asset earlier in development from Genoscience Pharma SA – represent “the logical next steps in the implementation of a strategy that we outlined to you about 18 months ago,” Genfit CEO Pascal Prigent said during a conference call with investors.
