Look back at pharma news in week to March 22

24 March 2019

By Barbara Obstoj-Cardwell. Editor

Among regulatory news last week, Spectrum Pharmaceuticals suffered a setback when, following a US Food and Drug Administration request for further information, it withdrew its Biological License Application (BLA) for its neutropenia drug Rolontis. There was good news for Sage Therapeutics with FDA approval for its Zulresso, making it the first new drug to be cleared for the treatment of post-partum depression. Disappointing clinical trials featured strongly in last week’s news, most notably Biogen and Eisai’s decision to drop the development of their late-stage Alzheimer’s disease candidate aducanumab. Also, Germany’s Merck KGaA and Pfizer have ditched a Phase III trial of ovarian cancer drug Bavencio.

Spectrum suffers BLA setback but, based on deadline, it was for the better

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