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EU drugs agency recommends suspension of Medtronic implant

Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is made. The European Medicines Agency (EMA) began a review of Inductos following an inspection by Dutch and Spanish authorities of a site that makes an […]

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Amgen wins EU green light for first virus-based cancer drug

A first-in-class drug from Amgen based on a tumor-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of months.   The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness. The European […]

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PTC says DMD drug data supports U.S. approval despite trial failure

PTC Therapeutics Inc’s experimental muscle disorder drug failed to meet the main goal in a keenly watched late-stage study, but the company said data from all trials on the drug supported a U.S. marketing application. The company’s stock fell about 16 percent in extended trading on Thursday, before reversing course to notch marginally gains. PTC […]

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Welsh stem cell firm wins fast-track filing path in Europe

A biotech company founded by a Nobel prize winner has won the go-ahead from European regulators to begin the application process for conditional marketing authorization of a stem cell-based regenerative heart treatment. Conditional approval, if granted, would allow Cardiff-based Cell Therapy to start selling its Heartcel product for regenerating damaged areas of heart while continuing […]

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