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Drugmakers large and small score FDA nods in busy week of approvalsA group of drugmakers large and small scored FDA nods in a busy week for the agency. Aside from a blockbuster nod for Shire, Kala Pharmaceuticals secured a Thursday approval for Inveltys to treat ocul2018/8/27
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Pfizer, Astellas speed up 2 Xtandi studies in market duel with Johnson & JohnsonLocked in a prostate cancer market battle with rival Johnson & Johnson, Pfizer and its partner Astellas have acceleratedtrial timelines for Xtandi in two studies in patients withhormone-sensitiv2018/8/24
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AstraZeneca cans HQ contractor and delays glitzy £500M project—againAstraZeneca staffers eager to move into pricey,brand-new headquarters and R&D facility in Cambridge, U.K., will have to keep waiting. After numerous delays and cost overruns, the company confi2018/8/23
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GlaxoSmithKline’s Indian consumer sale heats up with Reckitt, Kellogg joining the fray: reportMore big-name suitors are jumping into the mix for GlaxoSmithKline’s Indian consumer health unit. After earlier reports that Danone, Nestle and others were on the verge of a bidding war, Kellogg and2018/8/22
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NICE stands firm on 'no' vote for Roche's Perjeta in postsurgery breast cancerBack in June, England’s cost watchdog refused to recommend Roche’s Perjeta for postsurgery breast cancer patients. And it’s sticking by that decision. In a new guidance document, the National Insti2018/8/21
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Trump urges Justice Department to target opioid makers with a ‘major lawsuit’Months ago, the Department of Justicebacked the hundreds of lawsuits that accuse drugmakers and distributors of their alleged contribution to the nation’s opioid epidemic. Now, President Donald Trum2018/8/20
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Analyst chastises Mylan—not known for its transparency—for under-the-radar dealmakingMylan unveiled plenty of news in its second-quarter earnings release last week, including that its revenues were down year over year and that it was lowering guidance. But there was also some key info2018/8/17
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As biosimilars loom, Roche's Genentech plans to lay off 223 staffers in CaliforniaAs Roche braces for the biosimilar assault on blockbuster cancer drugs, its Genentech unit is parting ways with 223 staffers in California. In a WARN notice posted on the state’s website, Genentechd2018/8/16
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AIDS health group brings Gilead patent skirmish to Supreme CourtThe AIDS Healthcare Foundation (AHF) has been battling Gilead over its patents on tenofovir alafenamide fumarate (TAF) since January of 2016. When its federal lawsuit alleging the company manipulate2018/8/15
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After FDA about-face, Amicus' Galafold nabs Fabry disease nod to challenge SanofiOnce thought unlikely to reach the U.S. until 2020 because of an FDA roadblock, Amicus Therapeutics’ Fabry disease drug Galafold won a green light Friday. Now, to duel with Sanofi's standard therapy2018/8/14