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CFDA issues three Appendixes for Good Manufacturing Practice for Medical DevicesIn order to strengthen the supervision and management of medical devices, improve enterprises' quality management level and ensure the safety and effectiveness of medical devices, China Food and Drug2015/7/22
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Amgen's Neupogen won't face Novartis biosim till September: courtNovartis' ($NVS)Sandozmay have the firstFDA-approved biosimilar inZarxio, but it doesn't have permission to launch--and it won't be getting that until September, the country's top patent court ruled T2015/7/22
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Bristol-Myers' next-gen HIV med gets FDA 'breakthrough' designationBristol-Myers Squibb ($BMY) nabbed a "breakthrough" tag from the FDA for its next-genHIVtherapy aimed at patients who become resistant to the drugs now in use. The U.S.-based company now gains an insi2015/7/22
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CFDA releases 2014 Annual Report for National Adverse Drug Reaction MonitoringChina Food and Drug Administration (CFDA) recently released the 2014 Annual Report for National Adverse Drug Reaction Monitoring. In 2014, the national adverse drug reaction monitoring network receive2015/7/21
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New long-acting Baxalta med bests Advate in hemophilia ANewly independentBaxaltarelies heavily on hemophilia sales, particularly its top-selling Advate. As competition heats up in that market, the company has something new to brag about: Its Advate follow-2015/7/21
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Bayer homes in on €10B plastics IPO with plans for summer roadshowBayeris gearing up to spin off its plastics unit and become a life-sciences-focused company, and as part of that prep, it's going on an investor roadshow to seek feedback on its plans. Baye2015/7/21
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CFDA issues Rules for Classification of Medical DevicesChina Food and Drug Administration (CFDA) recently issued the Rules for Classification of Medical Devices, which will be implemented as of January 1, 20162015/7/20
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Amgen's Blincyto puts leukemia patients in remission, building its case for a new FDA nodAmgen's ($AMGN) working to expand the label of cancer-fighterBlincyto, and on that front, it's got some solid new data to help it make its case. In a Phase II study, a "clinically meaningful" number2015/7/20
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Eisai turns North Carolina facility over to Biogen as it continues its cost-cuttingEisaihas been whittling down its U.S. workforce as part of broader cost-cutting moves in the face of a tough patent cliff go. Now the Japanese drugmaker will trim another 135 people from its payroll w2015/7/20
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Specialty pharmacies don't always live up to their billing: NYTAs payers steer patients toward their own pharmacies and drugmakers opt to distribute their meds solely through specialty channels, service problems are interfering with patient refills and threatenin2015/7/17