Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Acadia, Amgen, Apellis, Bio-Thera, GSK, Immunitybio, Kymera, Merck, Novo Nordisk, Sobi, Stada.
Biopharma happenings, including deals and partnerships, and other news in brief: Cosette, Everest Medicines, Genmab, Geron, Hasten, Hyloris, Mayne, Merus.
Clinical updates, including data readouts and publications: AB Science, Anixa, Arcus, Ausperbio, Avenzo, Beyondspring, Cullgen, Innovent, Innoviva, Relay, Tenaya.
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024.
A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.
The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
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