The U.S. Commerce Department isn't expected to complete its Section 232 investigation to build a national security case for imposing tariffs on biopharmaceuticals until the end of the month, but that didn’t stop President Donald Trump from once again teasing a “very, very high” tariff for medicines and their ingredients.
Rhythm Pharmaceuticals Inc. will be sitting down with regulators in the U.S. and Europe to discuss phase III plans in the wake of positive phase II data from the study testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
In the second largest M&A deal of the year, Merck & Co. Inc. has strengthened its cardiopulmonary portfolio with the $10 billion acquisition of London-based Verona Pharma plc. The deal brings Merck Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease.
With the June 9 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allurion, Astrazeneca, Denali, Kalvista, Lexeo, Mustang, Nurix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alembic, Biotx.ai, Brii, Chugai, Gero, Heartbeat, Joincare, Laboratoires Théa, Lenz, Utility.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Apogee, Beyondspring, Blue Lake, Cogent, Cyanvac, Immix, Jasper, Yiviva.
New hires and promotions in the biopharma industry, including: Allarity, Baxter, Biocryst, Genelux, Immunoprecise Antibodies, Immuthera, Nervgen, Nuevocor, Sellas.