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Lilly’s Olumiant, spurned by FDA, gets nod from NICEEli Lilly has won a nod from NICE for its anticipated blockbuster and Humira competitor, Olumiant, a modicum of good news for a drug the FDA rejected in April. England’s cost watchdog, in final guida2017/7/25
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Bayer stops production of Gynera contraceptive in BrazilBrazilian authorities, which earlier ordered drugmaker Bayer to pull its Essure birth control device from the market, have now asked for the recall of more than a dozen lots of a Bayer birth control p2017/7/25
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As Congress battles over healthcare, Johnson & Johnson CEO says real reform will take time—and cooperationWhile Republican senators work feverishly on a healthcare bill, one prominent pharma CEO says overhauling the system won't take a few weeks of work. Think years, even decades—and he'd like Democrats t2017/7/24
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Need proof that CV outcomes are make-or-break? See Merck's reaction to anacetrapib trial winFew thought Merck & Co.’s cholesterol-fighting candidate anacetrapib would hit its phase 3 trial goals. After all, three other drugs in the CETP inhibitor class failed dismally. But anacetrapib pu2017/7/24
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FDA warning slams drugmaker that made teething tablets containing belladonnaAn FDA warning letter has slammed the New Jersey CMO that produced belladonna-treated teething products sold by CVS thatthe agency last year warnedmight cause hallucinations and seizures in infants.2017/7/21
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Senators lay into Sanofi for Zika vaccine deal, call for public hearingSanofi’s commitment to limit price hikes hasn’t won over sixU.S. senatorswho are railing on the drugmaker for a Zika dustup that’s gained considerable attention since vaccine licensing plans were anno2017/7/21
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US FDA accepts Pfizer’s sNDA for Xeljanz to treat ulcerative colitisThe US Food and Drug Administration (FDA) has accepted for filing Pfizer’s supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate), an investigational oral solution to treat adult p2017/7/20
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Glenmark secures UK MHRA approval for anti-malarial medicationGlenmark Pharmaceuticals Europe (Glenmark)has securedfinal approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Maloff Protect, its range ofatovaquone / proguanil film-c2017/7/20
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Synlogic completes first phase in ongoing R&D collaboration with AbbVieUS-based pharmaceutical firm Synlogic has met the first discovery milestone in its ongoing research and development (R&D) collaboration with AbbVie. In the completed first discovery phase, Synlog2017/7/19
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Roivant forms new subsidiary to develop urology therapiesHealthcare firm Roivant Sciences has formed a new subsidiary known as ‘Urovant Sciences’ to develop new therapies for addressing urologic conditions. Urovant has licensed global rights, except in cer2017/7/19