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CHMP
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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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European Commission Approve Roche's MabThera 1400mg Solution for SC Injection
Feb 7, 2014The EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve Roche's MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms ...
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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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European Commission Would Amend The Erbitux® (Cetuximab) Product Information
Dec 23, 2013Merck Serono, the biopharmaceutical division of Merck, today announced that the European Commission has approved the Type II variation to amend the Erbitux® (cetuximab) product information, updating the indication for Erbitux to the ...
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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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Bayer Healthcare Has Received Marketing Authorization From The European Commission
Nov 19, 2013Bayer HealthCare has received marketing authorization from the European Commission (EC) for its Xofigo injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral ...
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GSK Has Received Positive Opinion From The EMA's
Oct 30, 2013British drug maker GlaxoSmithKline (GSK) has received positive opinion from the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) for additional indication for Synflorix, a pediatric pneumococcal ...
Tags: drug, Pneumonia Indication
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Novo Nordisk Has Received Biologics Licence Application Approval From FDA
Oct 18, 2013Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
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EMA Committee for CHMP Has Recommended Marketing Approval for Abilify Maintena
Sep 27, 2013Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for ...
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EU's Committee for Medicinal Products for Human Use Has Issued a Positive Opinion
Sep 25, 2013Swiss drugmaker F. Hoffmann-La Roche has announced that the EU’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending authorization of Kadcyla as a single agent for the treatment of adult ...
Tags: Breast Cancer Drug
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AstraZeneca Has Received Positive Opinion From The Committee for Medicinal Products
Sep 24, 2013British drugmaker AstraZeneca has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its new four-in-one flu vaccine Fluenz Tetra. Fluenz Tetra, a nasally ...
Tags: Astrazeneca, Medicine