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In Wake Of Heparin Deaths, FDA Set To Launch Pilot Project Aimed At Preventing Imports Of Adulterated Drugs
BEIJING - One year after adulterated heparin sourced from China began triggering scores of adverse reactions and deaths in U.S. patients, U.S. FDA is preparing to launch a voluntary pilot program aimed at helping prevent contaminated drugs from entering the country
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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.
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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 list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
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Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.
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Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.