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J&J's Xarelto pads artery disease case by reducing amputation, death rates vs. aspirinJohnson & Johnson is hoping Xarelto can win approval in peripheral and coronary artery disease patients after dropping positive data in August. Now, it has more results to back up its case—and hel2017/11/15
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Ultragenyx snares FDA nod for ultraorphan med Mepsevii, and a valuable voucher, tooRare disease biotech Ultragenyx has won its firstFDA approvalwith Mepsevii, an enzyme replacement therapy expected to carry a high price to treat a tiny group of patients. And with that approval, Ul2017/11/15
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With only 2 warnings in 2017, pharma's ad police hits historic lowAs the end of the year nears, the pharma industry can usually look back at FDA enforcement letters for insight into the agency'sthinking and guidance on marketing communications. But this year, there’2017/11/14
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Merck, GlaxoSmithKline face hepatitis A vaccine shortage amid U.S. outbreaksIt was only August when Merck and GlaxoSmithKline had to deal with a global shortage of their hepatitis B vaccines, and now unexpected demand in the U.S. has sent both companies scrambling to cope wit2017/11/14
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FDA eyes even more pricing competition with another round of generics movesCongress hasn't made any progress on drug pricing legislation, but that hasn't stopped the government from acting. Now, FDA Commissioner Scott Gottlieb has unveiled yet another move to step up compe2017/11/13
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Takeda, Lundbeck plan U.S. test for depression app in latest beyond-the-pill forayCan keeping track of medication doses and mood swings help improve depression treatment? Takeda is tackling another beyond-the-pill tech project aimed at finding out. The pharma hasteamedwith Lundb2017/11/13
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FiercePharmaAsia—Teva’s China JV? Lupin plants’ roadblock, EOC’s $32M series BWelcome to this week's FiercePharmaAsia report, which includes stories about Teva's rumored Chinajoint venture, Lupin's regulatory hit that could hurt its U.S. sales, EOC Pharma's $32 million series B2017/11/10
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Hikma FDA dispute lines Novartis' Sandoz up for Advair coupThose waiting for Hikma and Vectura’s copy of GlaxoSmithKline blockbuster Advair may be waiting awhile. After receiving a May rejection of the knockoff from the FDA, Hikma now says the partners are2017/11/10
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Novartis breast cancer med Kisqali, struggling against Ibrance, finds niche in younger womenNovartis breast cancer med Kisqali has struggled to gain traction in a field dominated by Pfizer blockbuster Ibrance. So it’s branching out. Wednesday, the Swiss drugmakersaidthe med had nailed its2017/11/9
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AstraZeneca executives try to shift I-O focus with China, Brilinta winsYou know executives are over the immuno-oncology questions when one of them offers to hand out a bottle of champagne to the first person to ask a question about cardiovascular, metabolic or respirator2017/11/9