European Medicines Agency (EMA)
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London
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United Kingdom
Tel: 44-0-20-7523-7600
Website: http://www.ema.europa.eu/ema/
Email: info@ema.europa.eu
527 articles with European Medicines Agency (EMA)
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European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima®
12/3/2018
European Medicines Agency started to officially review ‘Remsima SC’; expecting European approval in the second half of next year
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The UK’s exit from the European Union, Brexit, will impact numerous industries in the UK and Europe, but the biopharma industry has its own unique challenges.
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Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
11/16/2018
Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years
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Modis Therapeutics Announces PRIME Designation Granted by the European Medicines Agency to MT1621 for the Treatment of TK2 Deficiency
11/13/2018
Modis Therapeutics announced today that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d).
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Viagra and Cialis: PDE-5 Inhibitors May Have Broader Applications in Cancer, Neurology and Cardio...
11/13/2018
Viagra (sildenafil), Pfizer’s blockbuster drug for erectile dysfunction, is a classic example of how a drug developed for one thing can turn out to be successful for another. -
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
11/5/2018
Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML
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An FDA advisory committee overwhelmingly votes in support of Sage's post-partum depression drug, clearing the way for regulatory approval.
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Days after Novartis axed one-fifth of its research programs, the Swiss pharma giant said it intends to seek regulatory approval for 60 new treatments between 2019 and 2021.
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Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
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Biopharma companies set to release financial reports next week have reported positive news in recent months.
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Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
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As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
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This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
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Part of the Trump Administration and the U.S. Food and Drug Administration (FDA)’s strategy to push down drug prices is to develop ways to increase competition. As such, the agency launched a Drug Competition Action Plan that has several components.
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The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.
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Genentech, a Roche company, released data from a long-term clinical trial of Ocrevus in multiple sclerosis. Meanwhile, Novartis isn’t standing still on MS. Earlier this week the company announced that both the FDA and EMA had accepted its NDA and MAA, respectively, for siponimod.
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Celgene Corporation presented data at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Berlin, Germany with results from two Phase III trials.
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Gene Therapy Company MeiraGTx Buys Vector Neurosciences for Its Phase II Parkinson's Product
10/9/2018
MeiraGTx, headquartered in London, UK, acquired Vector Neurosciences in an all-stock deal. As part of the deal, MeiraGTx picks up Vector’s Phase II gene therapy program for Parkinson’s disease. -
Swiss pharma giant Novartis could be on its way to securing regulatory approval for its secondary progressive multiple sclerosis (SPMS) treatment siponimod.
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Orchard Therapeutics, with locations in Boston and London, UK, received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for OTL-300, a lentiviral gene therapy for transfusion-dependent beta-thalassemia (TDBT).