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Merck's next-gen pneumococcal shot scores FDA nod, setting up high-stakes clash with rival PfizerLet the games begin. Yes, it's asignal for the start of the Olympics. But it's also a call to arms for the next-gen pneumococcal vaccine race. A month after Pfizer gained an approval for its pneumoco2021/7/20
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AbbVie, Lilly atopic dermatitis hopefuls hit with more delays as FDA's JAK inhibitor holdups carry onWith the FDA’s JAK hesitations wearing on, atopic dermatitis hopefuls fromAbbVie and Eli Lilly will have to keep waiting for a chance to see the market. The companiesseparately said on Friday2021/7/20
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FDA chief asks for independent investigation into approval of Biogen's Alzheimer's drug AduhelmThe FDA’s reportedly cozy relationship with Biogen ahead of its controversial approval of the drugmaker’s Alzheimer’s disease therapy, Aduhelm, has been at the center of calls for an investigation. N2021/7/13
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Pfizer to meet with FDA to discuss COVID-19 boosters, but will the U.S. get on board?Amid little consensus on the best strategy to defend against the Delta variant of the coronavirus, Pfizer is making its pitch to the United States government in hopes of speeding abooster shot to Ame2021/7/13
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Ex-Genentech staffers plead guilty to trade secrets theft as DOJ targets biotech partners for $101M Sanofi dealA lawsuit that charges ex-staffers at Roche’s Genentech withtrade secrets theft nears closure as key insiders plead guilty. But federal prosecutors are now targeting their co-conspiratorswho allegedl2021/7/9
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Is China's drug regulator suddenly raising the bar on cancer med R&D? Not exactly, say expertsChina’s drug regulators released a draft guideline on cancer therapy development last week. Stock prices of several leading oncology drugmakers and CROs took a beating as investors feared the new rul2021/7/9
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GlaxoSmithKline touts 'widespread' investor support, backs CEO Walmsley in heated fight with ElliottA proxy fight is gaining steam at GlaxoSmithKline. Buoyed by “widespread and strong” investor support, the company is hitting back at Elliott Management, which just yesterday attacked the leadership2021/7/6
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U.K. Supreme Court rejects NHS claim of €220M financial loss in Servier patent lawsuitIn the culmination of a 10-year case, the U.K. Supreme Court hasruledin favor of Servier Laboratories in its defense against England’s National Health Service over a patent on cardio drug Coversyl.2021/7/6
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Bayer's gene therapy CDMO Viralgen cuts ribbon on first phase of $142M viral vector expansionViralgen, the gene therapy CDMO coinedby Bayer’s Asklepios BioPharmaceutical, is wading into commercial waters. The Spanish contractor on Wednesdaysaiditcut the ribbon on the first $83 million piece2021/7/1
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Eyeing $600M in peak sales, Scynexis preps ambitious launch for antifungal BrexafemmeEyeing the outskirts of blockbuster land with its newly minted antifungal, Jersey City's Scynexis is hitting the gas with a drug launch into a massive and largely deserted field. The new drug, Brexaf2021/7/1