STAT+: Celcuity’s breast cancer drug approved, its first
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FDA's new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout
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Good morning. Wash your lettuce extra thoroughly! There’s never been a better reason to get a salad spinner.
The need-to-know this morning
Johnson & Johnson reported second-quarter earnings.
Another Phase 3 study win for sac-TMT, the targeted chemotherapy drug from China-based Kelun Biotech and partner Merck. In the OptiTROP-Lung05 study conducted in China, sac-TMT plus Keytruda significantly delayed tumor progression compared to chemotherapy plus Keytruda in patients with first-line, PDL1-negative, non-squamous lung cancer. A preliminary survival benefit favoring the sac-TMT arm was also reported. This is the second China-run Phase 3 study of sac-TMT to show superiority over standard treatments in patients with lung cancer.
Veradermics said its oral, extended-release formulation of minoxidil induced hair growth in women with mild-to-moderate pattern hair loss, achieving the goal of a single-arm midstage study. The company is enrolling female participants in a Phase 2/3 study with results expected next year.
FDA’s new CBER chief is seeking a return to normalcy
After the FDA’s former biologics chief, Vinay Prasad, pushed out several subordinates, overruled career scientists, and earned the ire of the rare disease community, his acting replacement is now tasked with calming the waters.
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