A key House subcommittee chairman has called for the resignation of U.S. FDA Commissioner Andrew von Eschenbach in the wake of reports that FDA failed to inspect a Chinese API manufacturer that may be linked to adverse reactions in patients taking injectable heparin, a blood thinner marketed by Baxter Healthcare (PharmAsia News, Feb. 14, 2008)
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.
Coming one day after Boehringer’s underwhelming data, PureTech’s tweaked molecule, deupirfenidone, shows promise in slowing idiopathic pulmonary fibrosis.
The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.
