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Stem Cell Therapeutics obtains FDA orphan drug status for leukaemia drugCanadian biopharmaceutical development firm Stem Cell Therapeutics (SCT) has received an orphan drug designation from the US Food and Drug Administration (FDA) for the use of tigecycline to treat acut2013/11/5
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FDA helps generic drugmakers get copies of Glaxo's Advair to marketGlaxoSmithKline's asthma drug Advair is hard to copy. The British pharma ($GSK) has said it time and again, and recently, generics giant Teva backed up that claim, saying producing a generic would be2013/11/4
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Roche's Rituxan successor first up in market scramble for first-line treatment of CLLA number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia (CLL), and Roche's ($RHHBY) Genentech and B2013/11/4
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DSM and Opthea Sign Agreement to Manufacture Opthea’s Lead Product for Eye DiseaseDSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has signed an agreement with Opthea Pty Ltd of Melbourne, Australia. The contract covers process developmen2013/11/1
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Vertex's Incivek unseats Celebrex as fastest drug launch everA new report starkly illustrates how quickly things can change in the pharma industry, showing how a drug darling becomes a market dud. An evaluation of data by EP Vantage says that Vertex's ($VRTX)2013/11/1
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Pfizer aims ambitious PCSK9 program at payers,skeptical regulatorsTantalized by various megablockbuster projections for the PCSK9field of cholesterol drugs, Pfizer ($PFE) has mapped out one of the most ambitious late-stage programs in the industry for RN-316. This2013/10/31
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Sanofi profits plummet as sales in China,Brazil sufferSanofi's third-quarter results show emerging markets can be a double-edged sword. Though the company's growth in these fast-growing countries often outclasses that of its peers, this time--for the s2013/10/31
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Sunk by generics, Pfizer clings to emerging markets, cancer medsPfizer's third-quarter results perfectly capture the forces shaping Big Pharma these days. Patent losses linger, with hundreds of millions lost togeneric competitionold and new. But Pfizer had growth2013/10/30
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JAMA: Fast-tracked drugs tested less, with follow-up studies laggingWhen theFDAputs drugs on the fast track for approval, they do make it to market sooner. But they're tested for a shorter period of time than are drugs reviewed under the agency's standard process, acc2013/10/30
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With Opsumit approved, analysts say Actelion primed for takeoverThe EU on Friday recommended approval of Actelion's ($ATLN) Opsumit, following FDA approval the week before, and by today the takeover talk was in full swing. With regulators giving thumbs-up to a dru2013/10/29