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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 ($ATLN) Opsumit, following FDA approval the week before, and by today the takeover talk was in full swing. With regulators giving thumbs-up to a dru2013/10/29
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FDA Approves Extended-Release, Single-Entity Hydrocodone ProductFDA has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternativ2013/10/29
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Japan's frustrated Eisai loses fight with DEARegulators sometimes are an irritation to drugmakers, andJapan'sEisaihas been really, really irritated as of late. The drugmaker, which this week lashed out at the U.K.'s cost watchdog as too restrict2013/10/28
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J&J gets FDA panel backing for simeprevir in hot race for hep C drugJohnson & Johnson ($JNJ) is out of the gate in the horse race that is shaping up aroundinterferon-free cocktails for treatinghepatitis C. An FDA panel voted 19-0 to recommend its simeprevir, an NS2013/10/28
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Capsugel Expands Global Manufacturing for Finished Dosage FormsMORRISTOWN, N.J. and BORNEM, Belgium, September 19, 2013 –Capsugel’s Dosage Form Solutions (DFS) business unit unveiled extensive upgrades and expansions to three of its manufacturing facilities in th2013/10/25