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European Medicines Agency
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Can-Fite Submits Phase III Protocol Design And Registration Plan To EMA For CF101 To Treat Rheumatoid Arthritis
Mar 21, 2016Can-Fite BioPharma has submitted to the European Medicines Agency (EMA) a protocol design for its Phase III trial and Registration Plan for the Company's lead compound CF101 in the treatment of rheumatoid arthritis following a ...
Tags: Phase III trail, CF101, Can-Fite
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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Furiex Announced Top-Line Results Indicating The Two Pivotal Phase III Clinical Trials
Feb 14, 2014Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable ...
Tags: Furiex
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GlaxoSmithKline Says It Received a Positive Opinion in Europe for Albiglutide
Feb 10, 2014LONDON, Jan. 26 (UPI) -- GlaxoSmithKline says it received a positive opinion in Europe for albiglutide, under the brand name Eperzan, for treatment of type 2 diabetes. GSK officials said the Committee for Medicinal Products for Human Use ...
Tags: Albiglutide, Glaxosmithkline, FDA
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Teva and Active Biotech Have Announced That Both Companies Remain
Feb 10, 2014Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for ...
Tags: Medicine, clinical studies, Nerventra
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CHMP Has Issued a Positive Opinion for The Use of Novartis' Xolair as an Add-on Therapy
Feb 10, 2014The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous ...
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CHMP Adopted a Positive Opinion on FINOX Biotech's MAA for BEMFOLA
Feb 7, 2014The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on FINOX Biotech's marketing authorisation application (MAA) for BEMFOLA (follitropin alfa solution for injection in ...
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All Persons Taking Strontium Supplements Are Warned
Jan 19, 2014All persons taking strontium supplements are warned that significant risks have been identified. Strontium drugs are not approved for treatment of osteoporosis in the United States. Now, the Risk Assessment Committee of the European ...
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FDA and EMA Have Announced The Launch of a Joint Initiative to Share Information
Dec 20, 2013The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
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FDA Has Approved Sovaldi 400mg Tablets
Dec 10, 2013Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
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EMA Has Fully Validated and Granted Accelerated Assessment
Nov 28, 2013The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
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Insulin Pump Therapy for Diabetics Get Easier Due to Novo Nordisk and Roche Diabetes
Nov 26, 2013Denmark-based Novo Nordisk has announced that the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of the NovoRapid PumpCart in Europe. NovoRapid PumpCart is a 1.6ml ...
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EMA Has Issued Positive Opinion
Nov 26, 2013European Medicines Agency's (EMA) the Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion for AstraZeneca and Bristol-Myers Squibb's of Xigduo for adults aged 18 and older with type 2 diabetes mellitus. The ...
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GSK Have Received Marketing Authorization From The European Commission for Relvar Ellipta
Nov 20, 2013GlaxoSmithKline (GSK) and Theravance have received marketing authorization from the European Commission (EC) for their jointly-developed asthma and chronic obstructive pulmonary disease (COPD) drug 'Relvar Ellipta'. Relvar, which is a ...
Tags: GSK, Relvar Ellipta
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Merck Secured Priority Review Status From The Us FDA for an Investigational Solution
Nov 20, 2013Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...