The week in pharma: action, reaction and insight – week to April 7, 2023

9 April 2023

By Barbara Obstoj-Cardwell. Editor

Regulatory news last week featured the combination of Padcev and Keytruda, developed by US biotech Seagen and Japan’s Astellas Pharma, gaining accelerated approval from the US Food and Drug Administration (FDA) for the treatment of urothelial cancer. Also, Germany’s InflaRx gained emergency use authorization (EUA) for its COVID-19 treatment Gohibic (vilobelimab). On the research front, US biotech OncoSec Medical had a major setback last week, when it reported that its TAVO-EP, in combination with Merck & Co’s mega-blockbuster immune-oncology drug Keytruda, missed the endpoint of a Phase II study in melanoma. With better news, UK pharma major AstraZeneca announced positive results from the DUO-O Phase III trial of Lynparza in combination with Imfinzi for the treatment of ovarian cancer.

FDA grants accelerated approval to Padcev + Keytruda in first-line UC

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