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Latest From Aidan Fry
Greater clarity in reviewers’ comments and limiting the effect of originators’ label changes on pending applications would help improve the rate of generic applications approved by the FDA on the first review cycle, a US government report proposes.
With permission to export bulk drugs from China to the US expected soon, Siegfried is also making strides on offering services for filling biological drugs.
By licensing Covis’ Alvesco ciclesonide inhaler in central and eastern Europe, as well as preparing to launch thee Qysmia weight-loss brand for which it just obtained approval in Korea, Alvogen is expanding its portfolio of branded drugs.
With a constitutional challenge still pending in Germany, and lingering uncertainties over Brexit, Germany’s federal government appears to have little idea when a planned European unified patent court could come into effect.
Amgen’s Mvasi and Kanjinti alternatives to Roche’s Avastin bevacizumab and Herceptin trastuzumab brands will from 1 October be preferred by plans administered by the largest US health insurer, UnitedHealthcare.
Sandoz and Sun’s Taro can be added to a pending trial over Canadian patents protecting Bayer’s Xarelto cardiovascular drug. Teva and Apotex had sought to be alone in their dispute over the rivaroxaban brand.