So much for stability at the U.S. FDA. Three weeks after accepting the position as director of the FDA’s CDER, Richard Pazdur has informed the agency of his intention to retire at the end of the year.
The next stop on the comeback tour for the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher program is the Senate, after the House unanimously passed the Mikaela Naylon Give Kids a Chance Act, H.R. 1262, Dec. 1.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Celltrion, Cullinan, Eisai, Iaso, Innovent, Ionis, Johnson, Kedrion, Mannkind, Medivir, Merck, Sound, Vanda.
Bao Pharmaceuticals Co. Ltd., a developer of subcutaneous biologic drugs, priced its IPO at HK$26.38 on Dec. 2, aiming to raise about HK$1 billion (US$128 million). Bao expects net proceeds of HK$921.5 million after expenses, which will fund its “two-anti” strategy – developing both antibody and antibiotic drugs worldwide, mainly in China, the U.S. and Europe.
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
The U.K. government has secured a deal guaranteeing there will be no tariffs on the £6.6 billion (US$8.7 billion) of pharmaceutical products exported annually to the U.S., as part of a package of measures under which the U.K. will pay more for patented drugs.
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