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In wake of Opana ER's demise, FDA plans to intensify pharma's opioid-education jobOpioid makers may have a new task that’s partly old, partly new: educating prescribers on the proper use and serious risks of their medications. That’s an extension of the agency’s current requirement2017/8/1
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Years after accelerated approval debacle, FDA panel backs Pfizer's MylotargSeven years after the FDA pushed Pfizer's Mylotarg off the market for flunking a confirmatory trial, it's in line for a return. An agency panel backed a new approval for the acute myeloid leukemia (AM2017/8/1
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Pharma hits back at NHS England's cost-cutting overhaulAmid a tough budget situation in England, the pharma industry is challenging a new clampdown for meds projected to cost the country’s health system more than £20 million per year. The Associati2017/7/31
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Biogen, AbbVie hit with Zinbryta safety action in EU as MS market heats upBiogen and AbbVie’s new multiple sclerosis drug Zinbryta faces fresh prescribing restrictions in Europe after regulators there reviewed liver injuries and one death in patients taking the drug. The E2017/7/31
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Fosun stock tumbles over rumors of chairman disappearance—againFosun Chairman Guo Guangchang is not missing, the Chinese conglomerate said, as it tried to refute online rumors that sent subsidiary Fosun Pharma’s shares down more than 8% in Shanghai Thursday morni2017/7/28
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Endo caves to FDA pressure, will pull Opana ER from the marketUnder pressure from the FDA, Endo has decided to pull from the market its opioid painkiller Opana ER, a drug that generated nearly $160 million in sales last year. The Dublin-based drugmakersaidthat2017/7/28
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Forget Sanofi's Zika shot. A new measure would limit pricing on all DOD-funded medicationThe controversy over Sanofi's eventual pricing for an in-development Zika vaccine might just spawn pricing constraints for all treatments developed with the help of Defense Department funding. Under2017/7/27
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Trial deaths frustrate Merck's bid to pair Keytruda with Celgene's myeloma starsAfter reviewing deaths in two Keytruda trials, the FDA put both Merck studies on clinical hold and stopped Keytruda dosing in a third, thwarting Merck's hopes for combining Keytruda with Celgene's big2017/7/27
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Amgen, Teva hikes show pharma can't blame rebates for all price increases: analystPharma companies and pharmacy benefit managers have engaged in a back-and-forth for months over who’s to blame for high drug prices. Drugmakers say they're raising prices largely to keep ahead of PBMs2017/7/26
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With its €5.3B buyout scuppered, Stada brings in new CEO, CFOAfter failing to win the shareholder support needed to complete a €5.32 billion buyout, Stada is changing key executives. The company announced the resignations of CEO Matthias Wiedenfels and CFO Helm2017/7/26