EMEA Authority
FREE Daily Email Newsletter
French Drugmaker on Trial, Suspected in Deaths
May 21, 2013 2:51 pm | News | CommentsThe makers of a diabetes and weight loss drug suspected in the deaths of hundreds of people went on trial Tuesday, facing charges they misled the public about the product's safety. But after years of delays in one of France's biggest recent health scandals, the proceedings could still be pushed back further.
European Regulators Reject Pfizer Arthritis Drug
April 25, 2013 5:00 pm | by The Associated Press | News | CommentsPfizer Inc. said Thursday that the European Union's committee of medical experts has rejected the company's drug Xeljanz for patients with rheumatoid arthritis. The European Medicines Agency committee recommended against approving the drug because its benefits did not sufficiently outweigh its...
European Medicines Agency to Investigate Findings on Pancreatic Risks with GLP-1-Based Therapies For Type-2 Diabetes
March 27, 2013 8:13 am | News | CommentsThe European Medicines Agency is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and precancerous cellular changes called pancreatic-duct metaplasia in patients with type-2 diabetes treated with so-called GLP-1-based therapies (glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors).
European Medicines Agency Recommends Restricting Use of Cilostazol-Containing Medicines
March 22, 2013 8:16 am | News | CommentsThe European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits.
Novartis Europharm Withdraws Marketing-Authorization Application for Ruvise
January 25, 2013 3:07 am | News | CommentsThe 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.
Arena Slumps on Continued Concerns for Belviq
January 23, 2013 3:06 am | News | CommentsShares of Arena Pharmaceuticals Inc. slumped Tuesday after the company said European Union regulators still have questions about its weight-loss drug Belviq.
Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MS
January 17, 2013 3:25 am | News | CommentsBiogen Idec and Elan Corporation have submitted applications to the FDA and European Medicines Agency (EMA) requesting updates to the TYSABRI ® (natalizumab) labels.
Lilly's Amyvid Receives European Approval
January 16, 2013 2:57 am | News | CommentsEuropean regulators approved the use of an imaging agent from Eli Lilly, which can help doctors diagnose Alzheimer's disease.
EYLEA Injection Approved for the Treatment of Wet Age-Related Macular Degeneration in Europe
November 27, 2012 3:53 am | News | CommentsRegeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).
Roche Investigated For Not Reporting Side Effects
October 23, 2012 3:55 am | by Associated Press | News | CommentsThe European Medicines Agency has started an infringement procedure against pharmaceutical giant Roche for allegedly failing to properly report side effects in patients in the U.S.
European Regulator: Gene Therapy Treatment OK
July 23, 2012 4:17 am | by MARIA CHENG,Associated Press | News | CommentsLONDON (AP) — The European Medicines Agency is recommending the first-ever approval of a gene therapy treatment in the EU, in a significant move for a type of treatment that has so far failed to deliver on its promise to cure diseases.
EU Committee Recommends Approval for Amag Drug
April 23, 2012 4:19 am | News | CommentsLEXINGTON, Mass. (AP) — Amag Pharmaceuticals Inc. said Friday a European Union regulatory committee is recommending approval for its iron deficiency drug Feraheme.
Janssen Creates new Division to Launch TMC435 and Help Conquer Hepatitis C in EMEA
April 19, 2012 4:23 am | News | CommentsToday sees the launch of Janssen Therapeutics EMEA, a division of Janssen Pharmaceutica NV, dedicated to bringing the investigational protease inhibitor TMC435 to hepatitis C patients in the EMEA region.
Shire Announces European Approval of Manufacturing Facility for VPRIV
February 22, 2012 3:00 am | News | CommentsShire announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has approved the production of VPRIV (velaglucerase alfa) in its new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, MA.
Genzyme Announces European Approval of Framingham Manufacturing Plant
January 18, 2012 3:04 am | News | CommentsGenzyme has announced that the EMA has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme(R).
FDA and EMA Pressures - Are Agencies on the Defense?
December 1, 2011 3:18 am | by Ken Appel, Life Science Manager of Regulated Markets, Vaisala | Blogs | CommentsWith imports of pharmaceuticals to the U.S. on the rise and criticism of the U.S. Food and Drug Administration (FDA) that it has not inspected foreign plants with any regularity. The FDA is clearly on the defensive.
Roactemra Approved In Europe for Children With Rare and Severe Form of Arthritis
August 3, 2011 4:13 am | News | CommentsRoche has announced today that the European Commission has approved the use of RoACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroid.
Merck Serono Receives European Approval for Three Pre-filled, Ready-To-Use Pen Injectors for Fertility Treatment
July 5, 2011 4:32 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, has announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment.
Pfizer Asks EU to Approve Kidney Cancer Drug
June 1, 2011 4:21 am | News | CommentsNEW YORK (AP) — Pfizer Inc. said today it asked European Union regulators to approve its drug candidate axitinib as a treatment for kidney cancer.
CSL Behring Receives European Commission Marketing Authorization for Hizentra
April 21, 2011 7:23 am | News | CommentsCSL Behring announced today that the European Commission has granted marketing authorization for Hizentra(R) (Human Normal Immunoglobulin), 20 percent solution for subcutaneous injection, for treating patients diagnosed with primary immunodeficiency (PI) as well as secondary immunodeficiencies.
Teva Receives Positive Opinion for NOMAC E2 from the European Committee for Medicinal Products
March 18, 2011 4:38 am | News | CommentsTeva Pharmaceutical Industries Ltd. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for NOMAC-E2, an investigational contraceptive pill combining 1.5 mg of 17-beta-estradiol with 2.5 mg of nomegestrol acetate in a 24/4 monophasic regimen.
European Medicines Agency Witholds FAMPYRA Approval
January 21, 2011 3:28 am | News | CommentsBiogen Idec announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA(R) (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union.
Bayer AG Seeks EU Approval for New Blood Thinner
January 5, 2011 3:32 am | News | CommentsBERLIN (AP) — Germany's Bayer AG says it has submitted an application seeking authorization to sell its new anti-clotting drug Rivaroxaban within the European Union
Biogen Idec and Elan Submit Applications to Update TYSABRI Labeling
December 22, 2010 4:09 am | News | CommentsBiogen Idec and Elan Corporation, plc have submitted a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.
Pfizer and Protalix BioTherapeutics Submit taliglucerase alfa for European Marketing Authorization
November 29, 2010 5:11 am | News | CommentsPfizer Inc. and Protalix BioTherapeutics, Inc. today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease.
