MUMBAI - U.S. FDA issued a warning letter to Caraco Pharmaceuticals, a subsidiary of India's Sun Pharmaceuticals, after the drug regulator found quality control lapses at its Detroit facilities, Curaco announced Nov. 3. U.S. FDA said the QC lapses conflicted with the company's standard operating procedures
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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
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.
LTZ Therapeutics and Beijing Sungen Biomedical are among the Chinese biotechs raising new funding, of around $40m each, based on their clinical assets with novel mechanisms of action. While fundings have risen, they remain moderate however.
