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Supreme Court urged to weigh in on six-month biosimilar delaysNovartis’ Sandoz unit has been marketing Zarxio, its biosimilar version of Amgen’s blockbuster drug Neupogen, for more than a year, but the drug is still tangled in a patent fight that boils down to o2016/12/8
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Here's an FDA overhaul: Trump considers Thiel VC partner as commissioner, Bloomberg reportsIf President-elect Donald Trump is to “reform” the FDA as he's promised, he might start with an outsider pick to lead the agency. According to Bloomberg’s sources, the incoming administration is consi2016/12/7
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U.K. watchdog smacks Pfizer with record fine, citing a 2,600% price hikeThe U.K. government slapped Pfizer with a recordfine for an epilepsy drug licensing deal that triggereda 2,600% price increase. The Competition and Markets AuthoritysaysPfizer dodged price controls b2016/12/7
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Lilly's Jardiance snags FDA approval for reducing CV risk in Type 2 diabetesEli Lilly got a big boost for its diabetes drug franchise on Friday when the FDA approved its SGLT2 diabetes drug Jardiance to reduce the risk of cardiovascular death in adult patients with Type 2 dia2016/12/6
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UPDATED: New cancer drug benefit study sure to add to debate over drug pricesDrugmakers are already facing growing backlash to the perceived high prices of drugs, but a new study about the real benefits of cancer drugs is sure to add fuel to the fire. It says that follow-up st2016/12/6
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Merck's Keytruda wins NICE backing in lung cancer with new data, discountReversing a previous denial, the U.K.'s cost watchdogs have endorsed Merck’s Keytruda for some patients with advanced lung cancer after weighing new data and a new discount. The move will affect about2016/12/5
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Merck's Keytruda snags second FDA 'priority' tag this week, this time in Hodgkin'sMerck’s Keytruda has nabbed its second FDA priority review tag of the week—and it’s one that’ll help it gain ground on archrival Opdivo from Bristol-Myers Squibb. Thursday, the New Jersey drugmakeran2016/12/5
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Analysts say Sanofi plant failings could pose issues for 2 expected blockbustersSanofi and Regeneron are facing a possible delay on one potentially big drug, sarilumab, after receiving a complete response letter tied to manufacturing problems at a plant in France. But Leerink ana2016/12/2
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Pharma has 'hijacked' 21st Century Cures bill, Elizabeth Warren saysThe 21stCentury Cures Act seeks to ease the path to FDA approval for drug and device companies, but ifSen. Elizabeth Warren, D-Mass.,gets her way, the long-awaited bill could stall once again. On Nov.2016/12/2
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Merck's Keytruda nabs FDA's 'priority' tag in microsatellite instability-high cancerMerck’s Keytruda isn’t letting rival Opdivo from Bristol-Myers Squibb soak up all the November regulatory attention. The immuno-oncology med has taken the spotlight back with apriority review tagfrom2016/12/1