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Blockbuster in the balance: Celgene's Reblozyl faces FDA committee for myelodysplastic syndromesIn its final days as an independent company, Celgene scored a win last month with the FDA's approval of rare blood disease med Reblozyl––a potential blockbuster in some analysts' eyes. Now, the FDA w2019/12/2
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Roche's flu med Xofluza drives drug resistance and may be a bad choice for kids, study saysA few days after an 11-year-old boy in Japan was diagnosed with the H3N2 strain of the flu and prescribed Xofluza from Roche’s Genentech, he stopped responding to the drug. Then his sister came down2019/11/29
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Acadia's Nuplazid rebounds in schizophrenia with study winAcadia's Nuplazid suffered a big loss in July after a late-stage trial as an add-on treatment for schizophrenia fell flat. But that study wasn't Nuplazid's last go at the indication, and now a phase2019/11/29
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ICER gets on board with AbbVie's Rinvoq for RA but frets over 'fair pricing' of next-gen drugsWhen the Institute for Clinical and Economic Review (ICER) first released its draft report on the cost effectiveness of next-generation JAK inhibitors to treat rheumatoid arthritis, it blasted all th2019/11/28
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Teva, others talk settlements with feds in yearslong generics price fixing probe: reportFederal prosecutors have been probing alleged generics price fixing for years, and, over the summer, lawmakers urged them to get moving with the investigation. Now, Teva and otherdrugmakersare in tal2019/11/28
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Global Blood Therapeutics scores blockbuster FDA nod for Oxbryta, forecasts 'paradigm shift' in sickle cell diseaseAnother day, another early FDA nod. Global Blood Therapeutics has its first drug approval, and it’s one that’ll bring a “paradigm shift” in how patients with sickle cell disease are treated, execs sa2019/11/27
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Takeda's dengue vaccine efficacy slips between 12- and 18-month analysesTakeda just this month released 12-month efficacy data from a massive dengue vaccine study showing the shot was 80% effective against all dengue strains. But a newer data set shows the efficacy fell2019/11/27
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Novartis flexes CV marketing muscles against PCSK9 rivals with MedCo dealWatch out, Amgen, Sanofi and Regeneron. Thanks to Novartis'$9.7 billionMedicines Company buyout pact, PCSK9 competition is about to get a lot more intense. But while theSwiss drugmaker will enter the2019/11/26
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SK Biopharmaceuticals, fresh off an FDA nod, preps for $850M IPO in January: reportRight on the heels of an FDA approval for seizure medXcopri, South Korea’s SK Biopharmaceuticals is reportedly planning aninitial public offering to raise about $850 million. The company plans to lis2019/11/26
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Roche scores FDA priority review for risdiplam, threatening Biogen and Novartis SMA medsBiogen and Novartis arebattling in the lucrative spinal muscular atrophy (SMA) field, but a third entrant could shake up the market in 2020. Roche and PTC Therapeutics’risdiplamjustpicked upan FDA pr2019/11/25