FDA Issues Warning Letters To Two Chinese Producers Of Adulterated Heparin: Could Prosecution Lie Ahead?
BEIJING - In a move that could ultimately lead to civil or criminal prosecution, U.S. FDA has issued warning letters to two Chinese producers of raw heparin that was discovered to be contaminated with a look-alike chemical
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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
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The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.
Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.