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European Commission

The European Commission has granted marketing authorisation to Cablivi (caplacizumb) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). more

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Marketing authorisation for Darzalex (daratumumab), from the Janssen Pharmaceutical Companies of Johnson & Johnson, to be used as a frontline treatment for newly diagnosed patients with multiple myeloma has been granted by the European Commission. more

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Earlier this year, the European Commission proposed the introduction of a manufacturing exemption for SPCs. Here, Alexander Kritharidis, Taylor Wessing, London, who is specialising in patents law, goes into more detail… more

Opinion

The European Commission (EC) has approved Novartis’ Aimovig (erenumab) for the prevention of migraine in adults experiencing four or more migraines per month. more

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A label change for MSD’s (known as Merck in the US and Canada) ulcerative colitis (UC) treatment — SIMPONI (golimumab) — has received approval from the European Commission. more

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The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the European Commission has granted marketing authorisation for Juluca (dolutegravir/rilpivirine) — a two-drug regimen, once-daily, single pill for the treatment of HIV-1. more

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The first allogenic stem cell therapy — Alofisel (darvadstrocel) from TiGenix and Takeda Pharmaceutical Company — has received marketing authorisation approval from the EC for the treatment of complex perianal fistulas in Crohn’s disease more

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The university’s School of Veterinary Medicine has been awarded the money by the European Commission, with which it will undertake interdisciplinary research to tackle the growing threat of food borne zoonoses and the rise of AMR. more

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As Brexit moves to the next phase, thanks to ‘sufficient progress’ being made in phase one of the negotiations as announced by the European Commission president Jean-Claude Juncker and prime minister Theresa May, some industry bodies welcome the news more

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Veltassa, a sodium-free potassium binder treatment for hyperkalaemia, has been approved for marketing by the European Commission (EC) with the first launches planned for the end of this year or early next year. more

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In a press statement from the European Commission, it has been announced that the proposed acquisition of Huber Silica by Evonik has been approved, subject to divestment of some of both companies’ activities relating to precipitated silica. more

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The BIOCAPAN Project has been funded for four years by the European Commission. It was started to develop an innovative GMP-grade cell-therapy product to treat diabetes without insulin injections, says Florence Rivera more

Opinion

IMS Health has published a new report which provides an assessment of the effects of biosimilar competition on price and volume across Europe more

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The Access to Safe Medicines Europe Forum (ASM Europe) 2016 will take place on 19-20 January 2016 at the Sheraton Skyline, Heathrow, London more

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Novartis drug Odomzo gains approval for locally advanced basal cell carcinoma, providing non-invasive therapy for patients more

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To observe the 50th anniversary of the adoption of the first EU pharmaceutical law, the European Commission is organising a one-day conference that will take place in Brussels on 28 September. more

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