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Could Sandoz have stalled Mylan's generic Advair? Maybe so, analyst says, citing FDA postNovartis has done its best to stall rivals setting up for the Advair generics party, at least until its Sandoz unit is ready to join. And one analyst says there's a chance it worked. Monday—just one2017/4/1
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Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparibCall it an early spring surprise for Tesaro. The company’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—wonan FDA nod Monday, months before its scheduled decision date. And not onl2017/3/31
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Serelaxin's demise ups the stakes on Novartis' latest Entresto-boosting movesNovartis needs Entresto to step up now more than ever. A follow-up heart failure drug, serelaxin, bombed a phase 3 trial last week, and though the Swiss drugmaker did not say it’s giving up on the med2017/3/31
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Appeals court ruling resurrects 5,000 lawsuits tied to Merck & Co. Fosamax dangersThree years after a federal judge dismissed about 5,000lawsuits by patients claiming Merck & Co.’s osteoporosis drug Fosamax was responsible for their femur fractures, a higher court says Merck wi2017/3/30
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Purdue and Shionogi's new constipation approval goes up against AZ, Valeant rivalsAstraZeneca’s Movantik and Valeant’s Relistor have been battling it out in the opioid-induced constipation arena since winning their FDA approvals back in September2014. Now there’s a third competitor2017/3/30
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Pfizer, Merck KGaA score watershed FDA nod on cancer immunotherapy BavencioPfizer and Merck KGaA are officially fourth to market with their checkpoint inhibitor avelumab—but first with approval to target a rare, aggressive form of skin cancer, Merkel cell carcinoma. Now bra2017/3/29
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It's not just lower U.S. drug prices Trump wants. He wants the lowest, periodPresident Donald Trump is back with more drug-pricing promises. This time, he says he's aiming to push prices lower than anywhere else in the world. Speaking at a meeting with members of the Congress2017/3/29
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FDA's orphan drug program under GAO scrutiny after senators allege abuseJust weeks after senators raised questions about the FDA's orphan drug program—and after Marathon Pharmaceuticals caught fire for an $89,000 list price on an old-turned-new orphan med—the GAO has agre2017/3/28
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FDA signs off on Parkinson's add-on drug XadagoAn add-on Parkinson’s med already available in various countries in Europe will soon make its way to the U.S. as the FDA on Tuesday approved Newron Pharmaceuticals’ Xadago. Xadago earned the FDA thum2017/3/28
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China proposes new FDA rules to speed up foreign drug approvalsChina's FDApublished(Chinese) a slate of suggested amendments to its foreign drug registration rules Friday, whichcould dramatically revamp the country’s pharmaceutical market landscape by eliminating2017/3/27