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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.
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.
Genzyme Receives European Label Expansion for Thyrogen
December 7, 2012 2:55 am | News | CommentsGenzyme, 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 Adolescents
November 28, 2012 3:05 am | News | CommentsGilead Sciences, Inc. has announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread® (tenofovir disoproxil fumarate).
Novartis Cancer Drug Receives EU OK for New Use
November 5, 2012 5:33 am | by The Associated Press | News | CommentsA cancer treatment from Novartis received approval to be sold in Europe as a treatment for some patients with non-cancerous kidney tumors from a rare genetic disorder.
BYETTA Approved for Use with Basal Insulin in Europe
March 23, 2012 4:16 am | News | CommentsAmylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the European Commission has granted marketing authorization to BYETTA (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.
EC Approves AstraZeneca's Caprelsa for Thyroid Cancer
February 21, 2012 4:10 am | by Matthew Dennis | News | CommentsAstraZeneca's Caprelsa (vandetanib) received approval from the European Commission for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease, the company reported Tuesday.
Roche's Zelboraf Garners EU Clearance
February 21, 2012 4:01 am | by Matthew Dennis | News | CommentsRoche announced Monday that the European Commission approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adults with BRAF V600 mutation-positive unresectable or metastatic melanoma.
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).
Basilea Seeks Marketing Authorization For Pneumonia Treatment
January 5, 2012 3:09 am | News | CommentsBasilea Pharmaceutica Ltd. today announced that it will apply in the second half of 2012 for approval of its antibiotic ceftobiprole in Europe.
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.
Novartis Gets European OK for Blood Pressure Pill(2)
November 28, 2011 3:26 am | News | CommentsNovartis AG said Monday the European Commission has approved Rasitrio, a blood pressure treatment that combines three drugs into one pill.
ONGLYZA Approved for Use in Europe as Combination Therapy With Insulin in Adults With Type 2 Diabetes
November 28, 2011 3:23 am | News | CommentsBristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved ONGLYZA(R)(saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes.
EU Regulators Call on Drugmakers
November 18, 2011 5:37 am | by Lianne Dane | News | CommentsThe European Commission said Thursday that pharmaceutical companies must develop more-effective medications against multi-drug resistant bacteria.
Pfizer Receives EU Approval to Extend Use of Prevenar 13 to Adults 50 Years and Older for the Prevention of Invasive Pneumococcal Disease
October 27, 2011 4:19 am | News | CommentsPfizer Inc. announced today that the European Commission has approved the Company's pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed), for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
Ironwood EU Partner Files for Linaclotide Approval(2)
September 30, 2011 4:45 am | News | CommentsDrug developer Ironwood Pharmaceuticals Inc. said Thursday that its partner Almirall SA has asked European Union regulators to approve its experimental drug linaclotide as a treatment for irritable bowel syndrome.
EU Regulator Issues Positive Opinion on Eli Lilly’s Alimta
September 27, 2011 6:33 am | by Lianne Dane | News | CommentsEli Lilly announced Monday that EU regulators issued a positive opinion for the use of Alimta (pemetrexed) as continuation maintenance therapy for patients with advanced nonsquamous non-small-cell lung cancer (NSCLC).
EU Body Backs Expanded Approval of Bayer's Xarelto
September 26, 2011 5:44 am | by Matthew Dennis | News | CommentsBayer announced Friday that European regulators recommended expanding approval of Xarelto (rivaroxaban) to include use for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF).
WuXi AppTec Bioanalytical Services Unit Receives GLP Certificate from OECD and EU
August 24, 2011 5:27 am | News | CommentsWuXi AppTec announced today that its Bioanalytical Services (BAS) unit had received a certificate of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD) and the European Union (EU).
