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EC approves Mundipharma’s Pelmeg to treat febrile neutropenia
pharmaceutical-technology
November 27, 2018
The Mundipharma network of independent associated companies has received European Commission (EC) approval for the use of Pelmeg (pegfilgrastim) for treatment of febrile neutropenia in adult cancer patients.
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New oral treatment for metastatic melanoma receives EU authorisation
cphi-online
November 15, 2018
Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).
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EC approves Vertex’s Symkevi for cystic fibrosis
pharmaceutical-technology
November 05, 2018
The European Commission has approved London-based Vertex’s Symkevi (ivacaftor+tezacaftor) in combination with ivacaftor for patients with specific mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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Eisai gets marketing approval from EC for LENVIMA
biospectrumasia
August 24, 2018
As First-Line Treatment in Adults with Advanced or Unresectable Hepatocellular Carcinoma
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A new era for migraine patients
cphi-online
August 07, 2018
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.
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EC approves Pfizer's Herceptin biosimilar
pharmatimes
August 02, 2018
Pfizer's Herceptin (trastuzumab) biosimlar Trazimera has been approved by the European Comission.
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EC proposes adjustment to pharma intellectual property rules
pharmaceutical-technology
June 01, 2018
The European Commission (EC) has proposed a targeted amendment to intellectual property rules covering pharmaceuticals to improve the existing system and eliminate competitive disadvantage for manufacturers in the European Union (EU).
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EC grants marketing authorisation of Dupixent for atopic dermatitis
europeanpharmaceuticalreview
September 29, 2017
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the EC has granted marketing authorisation for Dupixent for use in adults with moderate-to-severe atopic dermatitis…
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EC approves Janssen’s Symtuza
pharmatimes
September 27, 2017
Janssen-Cilag International has received European approval for its once-daily pill Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to treat patients with human immunodeficiency virus type 1 (HIV-1).
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EC approves for Merck's Keytruda for bladder cancer indication
pharmatimes
September 07, 2017
The European Commission has approved Merck & Co's Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.