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Sanofi, Regeneron one step closer to owing PCSK9 royalties as judge upholds Amgen patent rulingAmgen has been in a tight race with Sanofi and Regeneron to win market acceptance for a new class of drugs that fight ultra-high cholesterol by inhibiting an enzyme called PCSK9—a fight that includes2017/2/8
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Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be EliminatedTrump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated 唐纳德?特朗普总统周二告诉制药公司的CEO们,他的管理团队会以前所未有的方式裁撤制药行业的法规,这也预示着美国FDA(食品药品管理局)将要发生的事情。 In a sign of what’s to come for the US Food2017/2/7
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Should the U.S. try M&A to save on hep C? Gilead would be a good buy, experts sayHere’s a radical solution for hepatitis C treatment in the U.S.: The government could play private-equity investor and buy the leading drugmaker in the field, Gilead Sciences. Price: $156 billion. Pay2017/2/7
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McKesson paying record $150M to settle with feds over opioid salesSome years back, McKesson got fined $13.25 million for not reporting suspicious sales of controlled drugs from its distribution centers. The feds now say the drug distributor didn’t learn its lesson a2017/2/6
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Bad news for biosim makers: FDA sets 'high bar' in interchangeability guidanceThe FDA rolled out much-awaited biosimilar interchangeability draft guidelines Tuesday, tipping its hand to developers looking to challenge sales of the world’s top biologics. The gist? Winning the de2017/2/6
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Drugmakers 'hijacked' the FDA's orphan system to score premium pricing on mass-market meds: reportThere’s no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. But they’ve also helped mass-market drugmakers rack up millions in2017/2/4
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Trump's latest pharma-fighting plan? Use Twitter to force prices down, manufacturing to U.S.Pharma is fast becoming President-elect Donald Trump’s favorite whipping boy. Last month, Trump vowed tobring downdrug prices. Last week, heslammedthe industry for “getting away with murder.” And Satu2017/2/4
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Surprise Keytruda-chemo FDA filing puts Merck ahead in I-O combo raceMerck & Co.’s immunotherapy drug Keytruda is yet another step closer to eclipsing its competitors in lung cancer. In an out-of-the-blue announcement late Tuesday, the U.S.-based drugmaker said the2017/2/3
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Sanofi's Brandicourt announces at JPM that plant issues leading to CRL for RA drug have been fixedSanofi CEO Olivier Brandicourt believes the French drugmaker has fixed the issues at a fill/finish plant in France that led it and partner Regeneron to get a complete response letter for experimental2017/2/3
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EU regulators come down on repackager they say faked dataEuropean regulators have come down on a Danish pharma repackager that they say tried to hide violations from inspectors. According to areporton the European Medicines website, the Danish Medicines Ag2017/1/25