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.
Criminal and civil charges related to insider trading were filed Sept. 10 against Dishant Gupta based on his stock purchases of Epizyme Inc. in the months leading up to its acquisition by Ipsen SA.
The Stock Exchange of Hong Kong is “all ears” to foster local biotech IPOs, speakers said at the Bio Hong Kong 2024 conference Sept. 11, and more than 60 companies have jumped on board since the introduction of the Chapter 18A listing regime in 2018.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the ChinaBio Partnering Forum in Shanghai Sept. 10-11.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abacus, Alimera, Alopexx, Ani, Bharat, Biogen, C4, Carisma, Genesis, Gilead, Kallyope, KM Biologics, Mirum, Moderna, Novo Nordisk, Osivax, Sanofi, Santhera Pharmaceuticals, Treos, Vir.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aisa, Arrowhead, ARS, Stealth.
Another day, another insider trading deal involving biopharma stock. One of the latest U.S. SEC cases involves a retired dentist, Stephen Forlano Sr., who traded on a tip passed on through his son from a close friend who was an analyst at an investment firm handling a strategic financing collaboration with Harmony Biosciences Holdings Inc.