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RSS FeedPosted by Michael Wonder on 30 Nov 2018
Revised guideline to assess risk of human medicines for the environment
30 November 2018 - EMA has published a PDF revision of its guideline on the environmental risk assessment ...
Posted by Michael Wonder on 30 Nov 2018
Vertex announces European Commission approval for Kalydeco (ivacaftor) to treat patients with cystic fibrosis aged 12 to <24 months with certain mutations in the CFTR gene
29 November 2018 - Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 29 Nov 2018
The evolution of adaptiveness: balancing speed and evidence
29 November 2018 - 'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years. ...
Posted by Michael Wonder on 29 Nov 2018
Five additional countries to benefit from EU-US mutual recognition agreement for inspections
29 November 2018 - In November 2018, the US FDA confirmed the capability of five additional EU Member States to carry ...
Posted by Michael Wonder on 29 Nov 2018
European Commission approves Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and Pifeltro (doravirine), an NNRTI, both for the treatment of HIV-1 in appropriate patients
28 November 2018 - Approvals based on findings from the Pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials evaluating the efficacy and ...
Posted by Michael Wonder on 29 Nov 2018
Novartis announces EU approval of Gilenya for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe
29 November 2018 - Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon ...
Posted by Michael Wonder on 28 Nov 2018
Melinta Therapeutics granted European Commission marketing authorisation for Vabomere (meropenem with vaborbactam)
27 November 2018 - Melinta Therapeutics today announced that the European Commission has approved Vabomere (meropenem and vaborbactam) for use in ...
Posted by Michael Wonder on 28 Nov 2018
Bayer receives EU approval for its haemophilia A treatment Jivi
27 November 2018 - The safety and efficacy profile of Jivi has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 28 Nov 2018
European Commission approves Alunbrig (brigatinib) for ALK positive, non-small cell lung cancer in patients previously treated with crizotinib, advancing treatment paradigm in Europe
28 November 2018 - Alunbrig demonstrated unprecedented median progression-free survival of 16.7 months and overall survival of 34.1 months in the ...
Posted by Michael Wonder on 27 Nov 2018
Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo (pegfilgrastim)
27 November 2018 - Biosimilar Ziextenzo (pegfilgrastim), a long-acting version of supportive oncology medicine filgrastim, is now approved for use in ...
Posted by Michael Wonder on 27 Nov 2018
Kyowa Kirin announces Poteligeo receives marketing authorisation in Europe for the treatment of mycosis fungoides and Sézary syndrome
26 November 2018 - Poteligeo will be the first biologic agent targeting CCR4 to be available for patients in Europe. ...
Posted by Michael Wonder on 25 Nov 2018
European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy
23 November 2018 - Pelmeg was developed by Cinfa Biotech, now part of the Mundipharma network of independent associated companies. ...
Posted by Michael Wonder on 23 Nov 2018
Novartis's pricing might be tested with costly eye therapy
23 November 2018 - Novartis’s price-setting muscle is about to be tested after it won European Union approval for a blindness-fighting ...
Posted by Michael Wonder on 23 Nov 2018
Novartis announces landmark EU approval for one-time gene therapy Luxturna to restore vision in people with rare inherited retinal disease
23 November 2018 - Luxturna (voretigene neparvovec) is the first gene therapy to treat an inherited retinal disease, indicated for children ...
Posted by Michael Wonder on 23 Nov 2018
Oasmia Pharmaceutical receives approval from European Commission for Apealea (paclitaxel micellar) in the European Union
22 November 2018 - Apealea is approved in the European Union for treatment of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer ...