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Docs to FDA: Biosimilars should have different names than branded drugsEver since theFDAdrafted a set of rules forbiosimilarsin 2012, a debate has been raging over whether those drugs should carry the same generic names as the products they emulate. Now, some doctors are2014/8/19
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Biogen ready to steal market share with newly minted MS drug PlegridyBiogen Idec ($BIIB) has added another bow to itsmultiple sclerosisquiver. With the FDA's approval of Plegridy, a long-acting form of its popular Avonex, Biogen can fight for an even bigger share of th2014/8/19
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Roche's Avastin nabs quick FDA nod for cervical cancer useAfter promising last month to fast track its review of Roche's ($RHHBY) Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency app2014/8/18
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Pfizer, Merck, pick up hefty vax sales bump with CDC nod in seniorsPfizer's ($PFE)Prevnar 13, the world's best-selling vaccine, scored a big win Wednesday, nabbing a CDC committee nod for universal use in adults over the age of 65. And once payer coverage kicks in, t2014/8/18
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Sanofi introduces authorised generic version of EloxatinSanofi US has introduced an authorised generic version of Eloxatin (oxaliplatin injection), a platinum-based drug used in combination with infusional 5-fluorouracil / leucovorin. Launched through San2014/8/15
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US FDA grants orphan drug designation to Mirati’s mocetinostat for DLBCLUS-based pharmaceutical company Mirati Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its mocetinostat for diffuse large B-cell lymphoma (DLBCL).2014/8/15
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New era about to dawn: Novartis, and now Celltrion, present biosimilars to the FDABiosimilarshold huge promise, with estimates for this decade running from $35 billion to $200 billion and growing exponentially from there. And of course the U.S., being the world's largest pharma mar2014/8/14
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Indian regulators punch up standards as FDA action takes a toll on the industryTheFDAhas come down hard on some top Indian generic drugmakers in the last couple of years after realizing that they were cutting serious corners to get drugs to market. And while the infractions have2014/8/14
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BMS, Pfizer marketing efforts have Eliquis showing signs of lifeEliquis, the third entrant in the next-gen anticoagulant market, got off to a sluggish start. But now, marketers Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) are pulling out all the stops when it com2014/8/13
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New use for Bayer's Eylea in EU gives it more market power against Novartis' LucentisLast week, Regeneron ($REGN) announced that sales of its macular degeneration treatmentEyleajumped 26% to $415 million in the second quarter, blowing past analysts' estimates of $410 million. Now, its2014/8/12