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WuXi STA Passes the First U.S. FDA Drug Product Pre-Approval Inspection at its Shanghai Waigaoqiao siteSHANGHAI, CHINA, January 4, 2022 – WuXi STA – a subsidiary of WuXi AppTec, announced that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (2022/1/4
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2022 forecast: Biopharma M&A lags in 2021. Will drugmakers still look for bolt-on deals or large transactions?In contrast to the bustling dealmaking by medtech and life sciences service businesses, merger and acquisition activity by drugmakers went largely quiet in 2021. But after all the slim-downs, biophar2021/12/30
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Particulate problem prompts hold on 10 Gilead studies of HIV hopeful lenacapavirA second major HIV prospect has been put on hold, this time from Gilead Sciences. But unlike the recent halt on Merck's drug islatravir, which was related to a drop in trial patients' immune cell cou2021/12/30
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Pfizer's megablockbuster-to-be COVID pill Paxlovid scores FDA nodIn the years-long battle against COVID-19, has a new age dawned with the emergence of antiviral pills to fight infection? On Wednesday, the FDAsanctionedPfizer’s Paxlovid for emergency use. The drug2021/12/28
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Novartis aims to avoid pitfalls of earlier PCSK9 launches with its new blockbuster hopeful LeqvioAfter a surprising FDA rejection and a change in manufacturing facility, Novartis has won FDA backing for its blockbuster hopeful Leqvio. With an additional year of preparation and a unique marketing2021/12/28
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Novo Nordisk's weight loss drug Wegovy to run short amid contract manufacturer hiccupDemand for Novo Nordisk’s obesity medicine Wegovy is high, but a manufacturing hitch with one of the Danish company’s partners has put near-term supply in jeopardy. Novo Nordisk on Friday2021/12/24
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With Sanofi's mighty Dupixent chasing behind, Takeda's Eohilia suffers FDA rejection after mysterious delayAnother piece of bad news has hit Takeda’s Wave 1 pipeline, dealing a blow to the Japanese pharma’s plan to deliver a boost to near-term sales. After missing a decision deadline in April, the FDA has2021/12/24
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2022 forecast: Biopharma M&A lags in 2021. Will drugmakers still look for bolt-on deals or large transactions?In contrast to the bustling dealmaking by medtech and life sciences service businesses, merger and acquisition activity by drugmakers went largely quiet in 2021. But after all the slim-downs, biophar2021/12/22
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Particulate problem prompts hold on 10 Gilead studies of HIV hopeful lenacapavirA second major HIV prospect has been put on hold, this time from Gilead Sciences. But unlike the recent halt on Merck's drug islatravir, which was related to a drop in trial patients' immune cell cou2021/12/22
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2022 forecast: With omicron extending the pandemic, how will biopharma respond to COVID?Think back to this time last year. Remember the uncertainty the COVID-19 pandemic posed? Well, thanks to omicron, here we are again, asking many of the same questions and with renewed anxiety about t2021/12/20