Eli Lilly and Co.’s oral selective estrogen receptor degrader (SERD) imlunestrant has been approved by the U.S. FDA for treating late-stage breast cancer patients. Branded Inluriyo, the second-line treatment is for treating adults with estrogen receptor-positive, human epidermal growth factor receptor-2-negative estrogen receptor 1-mutant advanced or metastatic breast cancer.
Crinetics Pharmaceuticals Inc.’s green light under priority review from the U.S. FDA for Palsonify (paltusotine) in first-line acromegaly sets up a not-uncommon David vs. Goliath-type scenario in the indication caused by excessive growth hormone made by the pituitary gland.
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.
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