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FDA nod helps BMS' Opdivo even the head-and-neck cancer score with Merck's KeytrudaThursday was quite the day for Bristol-Myers Squibb’s Opdivo. After becoming the first med to succeed in a Phase III gastric cancer trial, the drug nabbed anFDA approvalin head-and-neck cancer--and ev2016/11/15
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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