The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”
Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Artios, Astrazeneca, Bioartic, Biogen, Cure Rare Disease, Daiichi Sankyo.
Biopharma happenings, including deals and partnerships, and other news in brief: Cyclerion, Denali Capital Acquisition, Eli Lilly, Healx, Ironwood, Kancera, Kayothera, Kinea Bio, Medic Life, Novakand, Palvella, Remedium, Semnur, Seres, Solid Biosciences, Theralase, Tisento, Vuja de Sciences.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
The winding regulatory road for the BLA to Capricor Therapeutics Inc.’s cell therapy for Duchenne muscular dystrophy has more clarity. Out of a recent type A meeting between Capricor and the U.S. FDA, prompted by a complete response letter in July regarding lead asset CAP-1002 (deramiocel), the two are in agreement about a path to potential approval.
RSS
