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UPDATED: Gilead snags FDA approval for improved hep B drug VemlidyGilead Sciences, whose hepatitis C dynasty has been slipping, haswon approvalfor its next-gen hepatitis B treatment. The Foster City, CA-based drugmaker said Thursday that the FDA had approvedVemlidy2016/11/14
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DOJ's price-fixing investigation could lead to sizable liabilities, analyst saysWhile industry closely tracks developments on the Department of Justice price-fixing investigation into a host of generics companies, one influential analyst has run the numbers on potential liabiliti2016/11/14
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UPDATED: FDA's new citizen petition rules remove speed bumps for generic, biosim approvalsBranded drugmakers may have one less tool to delay generic competitors--and, crucially, biosimilar versions of some of the industry's top-selling products--with Tuesday’s decision by the FDA to amend2016/11/11
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Senators seek FTC probe of Mylan's EpiPen practicesMonths into a bruising EpiPen pricing scandal, congressional scrutiny on Mylan continues to heat up. Top members of the Senate Judiciary Committee havecalled onthe Federal Trade Commission to examine2016/11/11
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Already facing $200M in damages, J&J seeks to move talc cases out of St. LouisLooking to rebound from three talc case defeats in St. Louis totaling nearly $200 million in damages, Johnson & Johnson is petitioning for a change of venue. The New Jersey drugmaker will argue2016/11/10
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DOJ pricing probe threatens $1B-plus fines, but few generics makers will face charges: AnalystsNews that the Justice Department is preparing criminal charges in its long-standing investigation into generic drug pricing hit those companies hard Thursday afternoon, wiping out $8.5 billion in mark2016/11/10
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Eisai wins NICE backing for older Halaven but still isn't happy about LenvimaAfter weighing new data and a discount, England’s drug-cost watchdogsbackedEisai’s Halavento treat advanced breast cancer, making it the first drugto win a green lightin breast cancer in nearly a deca2016/11/9
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NICE says Merck KGaA's Erbitux falls short in mouth cancer, despite new discount, dataCiting “significant uncertainties” about Merck KGaA's Erbitux for head and neck cancer, England’s cost-effectiveness watchdogs have shot down the treatment in a newassessment. Currently available thro2016/11/9
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Teva asks FDA to raise the bar on new Copaxone copiesTeva may be at a court’s mercy when it comes to IP protection for its long-lasting multiple sclerosis therapy, Copaxone. But that doesn’t mean the company is just sitting around. The Israeli drugmake2016/11/8
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With addiction rates rising, NY counties join march to sue opioid manufacturersWith addiction rates continuing to climb, officials in New York's Broome County say they're looking to do what states such as Illinois and New Hampshire have done: sue opioid manufacturers for mislead2016/11/8