In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.
AstraZeneca today announced that the European Commission has granted Marketing Authorization for...
Shares of Orexigen Therapeutics jumped Monday after the company said a European Union review of...
Access to potentially life-extending cancer drugs varies significantly in different regions of...
European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.
Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.
The European Commission has published approval of Octapharma’s Nuwiq ® (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). Nuwiq ® is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin.
European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary EmbolismJuly 29, 2014 8:38 am | News | Comments
Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.
EYLEA Injection Recommended for Approval for the Treatment of Visual Impairment due to Diabetic Macular Edema in the EUJune 27, 2014 8:33 am | News | Comments
Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME).
Vertex Pharmaceutical today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of KALYDECO™ (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European UnionJune 27, 2014 8:20 am | News | Comments
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes.
European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Ranbaxy Laboratories’ manufacturing site in Toansa, India that had led to the suspension of the GMP certificate for the site in the European Union (EU).
The European Commission granted marketing authorization for Jardiance (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced.
Medivir AB has announced that simeprevir has been granted marketing authorization by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic hepatitis C in combination with other medicinal products.
Biogen Idec said Monday it will launch its new multiple sclerosis drug Tecfidera in Europe in the coming weeks following approval by the European Commission. The European Union regulatory agency cleared the once-a-day pill for patients with relapsing multiple sclerosis, the most common form of the immune disease in which the body attacks the brain and spinal cord.
AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU).
The European Commission has fined pharmaceuticals giants Johnson & Johnson and Novartis a combined $22 million for colluding to delay the entrance of a cheap generic form of a pain killer to the Dutch market.
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorization to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age
Onyx Pharmaceuticals and Bayer have announced that European Union regulators approved their pill Stivarga as a treatment for colorectal cancer. The companies said Stivarga was approved for the treatment of metastasized colorectal cancer in adults. In the U.S. Stivarga is approved as a treatment for...
The company said that the European Commission cleared the drug for use in the European Union to treat visual impairment from macular edema following central retinal vein occlusion, a condition for which the drug already has received approval in the United States.
Verastem, Inc. announced that VS-6063 has received orphan medicinal product designation from the European Commission for use in mesothelioma. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
A panel of advisers to the European Union's health agency has again rejected Vivus Inc.'s weight-loss drug for sale in Europe. Vivus, based in Mountain View, Calif., said Thursday after markets closed that the Committee for Medicinal Products for Human Use confirmed its October decision to decline an application to sell the drug under the name Qsiva.
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission (EC) has granted marketing authorization in the European Union for ZALTRAP 25mg/ml concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen
The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralized marketing authorization for the medicine Ruvise.
European regulators approved the use of an imaging agent from Eli Lilly, which can help doctors diagnose Alzheimer's disease.
Genzyme, a Sanofi company, today announced it has received European Commission approval of a product label expansion for the use of Thyrogen®.
European Commission Approves Viread® for HIV-1 Infection in Children and Adolescents and for Chronic Hepatitis B in AdolescentsNovember 28, 2012 3:05 am | News | Comments
Gilead Sciences, Inc. has announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread® (tenofovir disoproxil fumarate).
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