Vandria SA published phase I data on a potential new mechanism of action in treating Alzheimer’s disease, demonstrating its orally available and brain-penetrant mitochondria-boosting compound, VNA-318, engages its intended target. Read More

Wall Street was sorting through two batches of news from Jasper Therapeutics Inc., which made public positive data from the phase Ib study called Etesian with KIT-targeting briquilimab in adults with allergic asthma, while making known the outcome of a probe into the phase Ib/II Beacon study with the same drug in chronic spontaneous urticaria. Read More

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. Read More

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. Read More

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. Read More

“I love the idea of ‘micropublications’ (preparing one now),” the neurobiologist Oded Rechavi commented on social media in July. The term clearly suggests a short article, and although the publishing model has been around for more than a decade, not everyone is familiar with this type of scientific communication. What are they? What’s their impact? Rechavi, a professor at the School of Biochemistry, Neurobiology and Biophysics at Tel Aviv University, was pointing to an emerging discussion among scientists, the search for alternative formats for their work. Read More

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. Read More

U.S. Health and Human Services Secretary Robert Kennedy continued his last-minute musical chairs ahead of the Dec. 4-5 meeting of the Advisory Committee for Immunization Practices (ACIP) when he named Kirk Milhoan as the new chair of the panel that advises the CDC on vaccine schedules. Read More

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. Read More

New hires and promotions in the biopharma industry, including: Altimmune, Boehringer Ingelheim, Circle, Faron, Genfit, Incyte, Kriya, Medicus, NRG, Opterion, Tyra, Vera, Vistagen, Whitehawk, Zelluna. Read More

Biopharmas raising money in public or private financings, including: Algernon, Edison, Juniper, Karolinska, Pasithea. Read More

Clinical updates, including data readouts and publications: Abbvie, Alligator, Belite, Cardiol, Inmune, Kelun, Mendus, Nuvation. Read More

Biopharma happenings, including deals and partnerships, and other news in brief: Apimeds, Ascletis, Freya, Novo Nordisk, Omeros, Regeneron, Tessera. Read More

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. Read More