European Notebook: Piloting Adaptive Pathways; Hepatitis C Pricing; IPO Window
The first six medicines are selected to pilot Europe’s speedier patient access scheme; France’s proposed health care reforms attract opposition, including a doctors' strike; European biotech companies expect a continuing funding stream from IPOs over the next 12 months.
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Foundation Medicine gets a $400 million cash infusion to continue its cancer diagnostic R&D while Roche acquires a majority interest in the company and will use its products to guide and optimize its clinical trials for cancer immunotherapies.
Newron expects partner Zambon to start marketing safinamide in the first half of 2015 in Europe, and to resubmit it soon for U.S. approval. Other positive CHMP opinions this month include Orexigen’s obesity therapy Mysimba and Durata’s antibiotic Xydalba.
The spread of Ebola to Europe is prompting regulators and industry to explore in more detail adaptive licensing pathways to speed access to potentially life-saving drugs.