When potentially dangerous high liver enzymes showed up in two asymptomatic participants during Third Harmonic Bio Inc.’s ongoing phase Ib study of the KIT inhibitor THB-001, the company decided to discontinue the clinical trial. Read More
Minervax Aps has closed a €72 million (US$76.6 million) financing round, enabling it to accelerate phase II development of its group B streptococcus (GBS) vaccine for the prevention of stillbirth and serious infections in newborns and complete the program next year. Read More
3D Medicines Inc. has raised HK$408 million (US$52.5 million) in a listing on the Hong Kong Stock Exchange. Its shares opened at HK$29 apiece, jumped by more than 20% by the middle of the day, and closed at HK$31.45 on the first trading day of Dec. 15. Read More
Chatter about an impending acquisition of Horizon Therapeutics plc sent its shares soaring 61% throughout November, making it the best performing stock of the month among the 30 companies that are part of BioWorld’s Drug Developers Index (BDDI). Read More
Innovent Biologics Inc. has in-licensed LG Chem Ltd.’s tigulixostat (LC-350189), a late-stage non-purine xanthine oxidase inhibitor (XOI) for managing chronic hyperuricemia in patients with gout, in a deal worth up to $95 million. Read More
Responding to concerns about corporate insider trading, especially among life sciences companies, the U.S. SEC unanimously adopted final rules Dec. 14 establishing a 90-day cooling-off period before trades can be made under 10b5-1 plans that provide a safe harbor to insider trading. Read More
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance. Read More
New hires and promotions in the biopharma industry, including: Appia, Bolt, Circle, Codagenix, Comanche, Cybrexa, Duality, Generate, Hookipa, Lyell, Parthenon, Pepper. Read More
New and updated clinical data presented by biopharma firms at the American Society of Hematology annual meeting and exposition, including: Amgen, Beigene, Novartis, Pharming. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anheart, Astrazeneca, Biomea, Biosyngen, CASI, Kintara, Merck & Co., Pharmather, Pliant, Regeneron, Sanofi, Soligenix, Thea, Xbrane. Read More
