Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Arialys, Biogen, Biostar, Eisai, Nrx, Vertex.
Biopharma happenings, including deals and partnerships, and other news in brief: Cidara, Evaxion, Gossamer, Lunia Bioworks, Merck, Qurient, Respira, Synaffix, Tiziana, Verona.
Biopharmas raising money in public or private financings, including: Arecor, Drugs Made In America, Immuneering, Kalvista, Ligand, MBX, Pepgen, Sanofi.
The U.S. FDA released a trio of draft guidances to help sponsors in developing and monitoring cell and gene therapies, as well as other regenerative medicine therapies.
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.
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