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With cancer kickoff, Amgen bets on BeiGene's fast-growing Chinese sales forceCompared with multinational rivals such as Novartis, Roche and AstraZeneca, Amgen didn’t have a strong oncology presence in China. That situation has ended with theofficial launchof a strategic partn2020/1/3
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Migraine, cholesterol upstarts top the list of FDA decisions to watch this quarterIt's a new year, which means it's a new opportunity for drugmakers hoping to pass FDA muster for new therapies––some of which could be sniffing after blockbuster sales. In the first quarter, the FDA2020/1/2
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NICE stiff-arms Akcea's rare disease med Waylivra on unacceptably high priceThe FDA quashed Akcea Therapeutics'hopes for Waylivra in the U.S. in 2018, at least temporarily, but the rare disease med did win a European nod last year. Now, though, it's running into reimbursemen2020/1/2
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Homegrown rivals to Pfizer, Merck cash cow vaccines win nods in ChinaPfizer’s Prevnar 13 and Merck & Co.’s HPV franchise Gardasil are the world’s best-selling vaccines, and China sales have been driving growth for both of them. Now, thanks to new approvals, they'r2019/12/30
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Regeneron to lay off field staffers as it restructures Sanofi partnershipWith its long-standing partnership with Sanofi in its final days, Regeneron is in a belt-tightening phase as it prepares for its new reality. Now, the first blow has landed with some of the New York-2019/12/30
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Sanofi beat out 3 suitors and one last-minute bid in its pricey $2.5B Synthorx buyoutWhen Sanofi picked up biotech Synthorx for a cool $2.5 billion this month, it paid a rich premium to enter an increasingly competitive immunotherapy field.But in the face of stiff competition, someti2019/12/27
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AstraZeneca, Merck's Lynparza lands FDA nod in tough-to-treat pancreatic cancerEarlier this month, FDA experts voted—barely—that the agency should approve AstraZeneca and Merck’s Lynparza in pancreatic cancer. But that small majority was enough to convince regulators to follow2019/12/27
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Allergan scores year-end FDA nod for CGRP migraine med Ubrelvy, plans early 2020 launchThe CGRP migraine prevention field already has three meds from Amgen, Eli Lilly andTeva vying for market share, and now Allergan has scored the first approval for an oral CGRP to treat migraines as t2019/12/26
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Intra-Cellular nabs nod for schizophrenia drug Caplyta after FDA twists and turnsIntra-Cellular Therapies had quite a journey toward an FDA decision on its antipsychotic contender. It involved mixed clinical data, a canceled advisory committee meeting and a three-month review ext2019/12/26
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No holiday gift for GSK: FDA sends long-acting HIV injectable back to workHIV patients looking for relief fromthe burden of daily pills will have to wait a little longer. Saturday, GlaxoSmithKline’s ViiV Healthcare said that the FDA hadrejectedits long-acting HIV injection2019/12/25