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515 articles with European Medicines Agency (EMA)
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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).
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Two antimalarial strategies have been published from Imperial College London in the past month: new compounds that prevent the malaria parasite from infecting mosquitoes and gene-edited mosquitoes that cannot reproduce, leading to population destruction.
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Trelegy Ellipta Receives Positive CHMP Opinion Supporting Expanded COPD Indication in Europe
9/21/2018
GlaxoSmithKline plc and Innoviva, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion today supporting the use of Trelegy Ellipta
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Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib
9/21/2018
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
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Ipsen Receives Positive CHMP Opinion for Cabometyx® (Cabozantinib) for the Second-line Treatment of Patients with Hepatocellular Carcinoma (HCC)
9/21/2018
Ipsen announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx® (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults
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Exelixis’ Partner Ipsen Announces Positive CHMP Opinion for CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
9/21/2018
In the phase 3 pivotal CELESTIAL trial, CABOMETYX demonstrated a statistically significant and clinically meaningful overall survival benefit
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Cinfa Biotech receives positive CHMP opinion for Pelmeg® (pegfilgrastim), a proposed biosimilar to Neulasta®
9/21/2018
Cinfa Biotech today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Pelmeg® (B12019)
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CHMP Recommends Approval of Buvidal® (CAM2038) for the Treatment of Opioid Dependence
9/21/2018
On approval, Buvidal® would be the first long-acting medicine for treatment of opioid dependence in the EU
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AbbVie Receives Positive CHMP Opinion for a Novel, Chemotherapy-free Combination of VENCLYXTO® (venetoclax tablets) with Rituximab as a Treatment with a Fixed Duration for Patients with Chronic Lymphocytic Leukemia
9/21/2018
If approved by the European Commission (EC), VENCLYXTO® plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
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CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe
9/21/2018
Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038
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Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection
9/20/2018
Merck today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™
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European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma
9/18/2018
Bristol-Myers Squibb Company today announced that the European Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies
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More than a year after Maryland-based Sigma-Tau Pharmaceuticals changed its name to Leadiant Biosciences, the newly-dubbed company is now being associated with a much darker name – that of jailed biotech entrepreneur Martin Shkreli.