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Valeant, Ackman will split the bills for years-long Allergan shareholder suitValeant and Bill Ackman’s Pershing Square Capital Management have been battling Allergan shareholders for years over the duo’s failed hostile-takeover attempt of the company. And with the legal war st2017/3/3
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Sanofi, Regeneron avoid Praluent disaster as appeals court stays injunction in PCSK9 patent caseRegeneron and Sanofi won’t have to pull Praluent off the market after all—at least not yet. A U.S. appeals court on Wednesdaydecidedto let the PCSK9 cholesterol drug remain on pharmacy shelves while i2017/3/3
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Opdivo price cut may be just the beginning as Japan looks to expedite drug pricing reviewsAs it turned out, Japan’s price cut to cancer med Opdivo was not a one-off move on a pricey drug. The unconventional timing looks to be the prelude to a permanent change to the country’s drug review t2017/3/2
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China’s healthcare reforms will shake up the country’s pharmaceutical marketThe Chinese pharma market remains one of the fastest growing, with forecasts that it will reach $167 billion by 2020. But with the Chinese government continuing to change the rules as it tries to keep2017/3/2
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FDA slaps Indian API maker in warning letterIn a warning letter, the FDA showedits dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness. Theletterwas issued to Resonance Laborator2017/3/1
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China facility of Ausmetics hit with FDA warning letterThe FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with“significant violations” of cGMP regulations saying that it did not do enough to test its active in2017/3/1
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Another Japanese drugmaker cited in FDA warning letterFor the third time in recent months, the FDA has slammed a Japanese drugcompany in a warning letter, this timefor not doing enough to prevent contamination during aseptic filling. The most recent FD2017/2/28
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Italian sterile drugmaker Facta Farmaceutici slammed in FDA warning letterThe FDA has caught an Italian drugmaker apparently manipulating testing dataas it reported only passing tests even though original reports indicated out-of-specification results for things like partic2017/2/28
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FDA and EMA both hammer Brazilian sterile antibiotics maker over contamination concernsA Brazilian antibiotics maker that was hammered in an FDA warning letter issued last month also caught the attention of the European Medicines Agency, which has banned its products because of concerns2017/2/27
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FDA warning savages Porton for contamination that led to shortage of Jazz Pharma leukemia drugThe FDA has savaged U.K.-based Porton Biopharma (PBL) in a warningletterfor repeated contamination of batches of Erwinaze, a blood cancer drug for children that it manufactures for Jazz Pharmaceutical2017/2/27