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European Commission (EC)

The European Commission (EC) has granted a marketing authorisation for the oral receptor tyrosine kinase (RTK) inhibitor, LENVIMA (lenvatinib mesylate), as first-line treatment for adults with advanced or unresectable hepatocellular carcinoma (HCC). Read more

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Akcea Therapeutics and Ionis Pharmaceuticals have announced that Tegsedi (inotersen) has received European marketing authorisation approval for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hATTR Read more

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The European Federation of Pharmaceutical Industries and Associations (EFPIA) has revealed its deep concern over the European Commission’s proposal to open the supplementary protection certificates (SPC) legislation to introduce a manufacturing waive Read more

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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive opinion to Akcea Therapeutics’ volanesorsen for the treatment of familial chylomicronaemia syndrome (FCS) under the Early Access to Medicines Scheme (EAMS). Read more

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The European Commission (EC) has approved Roche’s routine prophylactic treatment in people with haemophilia A with factor VIII inhibitors, Hemlibra (emicizumab). Read more

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The European Commission (EC) has revealed its decision to grant conditional marketing authorisation to Kyowa Kirin for Crysvita (burosumab) to treat X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children & adolescents Read more

Biopharmaceutical company, Tesaro, has revealed that the European Commission has approved its monotherapy for the maintenance treatment of women with recurrent ovarian cancer. Read more

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GlaxoSmithKline (GSK) has announced that its once-daily single inhaler triple therapy, Trelegy Ellipta, for the treatment of chronic obstructive pulmonary disease (COPD) has been granted marketing authorisation by the European Commission. Read more

Technology

The European Biopharmaceutical Enterprises (EBE) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have issued a statement calling on the EC to improve transparency on hospital exemptions for advanced therapies. Read more

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The European Commission (EC) has granted orphan designation to Apogenix’s lead product candidate, asunercept (APG101), for the treatment of myelodysplastic syndromes (MDS). Read more

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The European Commission (EC) has granted marketing authorisation to Sanofi and Regeneron Pharmaceuticals for dupilumab (Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. Read more

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Janssen has announced that the European Commission (EC) has approved its darunavir-based single-tablet regimen (STR), Symtuza▼, for the treatment of HIV-1 in adults and adolescents in Europe. Read more

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Biotech company, VAXIMM, has received orphan designation from the European Commission (EC) and the US Food and Drug Administration (FDA) for its lead product candidate, VXM01, for the treatment of glioma. Read more

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The European Commission (EC) has approved Samsung Bioepis’ Imraldi — a biosimilar referencing adalimumab (Humira) — for the treatment of 10 inflammatory conditions. Read more

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Dermatology specialist, LEO Pharma, has announced that the European Commission (EC) has granted marketing authorisation for its new biologic, Kyntheum (brodalumab), for the treatment of moderate-to-severe plaque psoriasis in adults within the EU. Read more

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The European Commission (EC) has sent Teva Pharmaceuticals a statement of objections concerning its agreement with Cephalon, which has been preliminarily concluded as in breach of antitrust rules. Read more

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The European Commission (EC) has awarded Antares Vision, provider of serialisation-based track and trace solutions for the pharma industry, a grant for the development of new technology for the inspection of lyophilised injectables. Read more

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Merck has confirmed receipt of a Statement of Objections from the European Commission (EC) related to a packaging technology in development by Sigma-Aldrich, at the time it was acquired in 2015. Read more

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Sanofi and Regeneron Pharmaceuticals have announced that the European Commission (EC) has granted marketing authorisation of Kevzara in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adults Read more

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The European Commission (EC) has granted marketing authorisation for Servier’s Lonsurf for the treatment of patients with advanced metastatic colorectal cancer (mCRC) Read more

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