Tag Archives: EU

August, 2017

25 August
Samsung, Biogen Biosimilar Version of AbbVie’s Humira Approved in the European Union

ZUG, Switzerland–(BUSINESS WIRE)–The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.1 IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, …
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27 June
Merck Gets CHMP Positive Opinion for Keytruda as Advanced NSCLC Treatment

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of …
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8 May
Novartis’ Zykadia Receives EU Approval for Treatment of Lung Cancer

Novartis’ lung cancer drug gained European approval for treatment of patients with non-small cell lung cancer (NSCLC). The company said that the European Commission (EC) has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC previously treated with crizotinib. The European Union’s (EU) approval of …
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