• Regulatory NewsRegulatory News

    European Regulatory Roundup: AstraZeneca Pulls Cancer Drug After Disagreement With EMA (29 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ‘Differences of Opinion’ with EMA Prompt AstraZeneca to Pull Cancer Drug Filing AstraZeneca has withdrawn its EMA marketing authorization application for cediranib in a subset of ovarian cancer patients. The company took the action after running into “differences of opinion” with EMA about the side effects of the drug and the way the study was run, The Telegraph repor...
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    Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

    Congress and President Barack Obama have one week to reauthorize the rare pediatric priority review voucher (PRV) program or else it will end on 30 September 2016, after seven pediatric PRVs have been awarded, one of which sold for $350 million last year. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments, affecting fewer than 200,000 patients under the age of 18. The vouchers can be used to speed FDA’s review ...
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    FDA Issues Form 483 for Alexion’s Rhode Island Site

    Rare disease drugmaker Alexion disclosed late Monday in an SEC filing that the US Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of the company’s Smithfield, Rhode Island manufacturing facility and issued a Form 483 with three observations. “These observations are inspectional, and do not represent a final FDA determination of compliance. The observations pertain to: completion and closure of certain ...