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EYLEA Injection Recommended for Approval for the Treatment of Visual Impairment due to Diabetic Macular Edema in the EU

June 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 Receives European CHMP Positive Opinion for KALYDECO in Eight Non-G551D Gating Mutations

June 27, 2014 8:24 am | News | Comments

Vertex Pharmaceutical today announced that the European Committee for Medicinal Products for...

CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European Union

June 27, 2014 8:20 am | News | Comments

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion...

Ranbaxy, Toansa Assessment Concluded - No Risk to Public Health

June 5, 2014 9:14 am | News | Comments

European regulatory authorities have finalized their assessment of reported non-compliance with...

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European Commission Approves Jardiance Tablets for Use in Adults in Europe

May 23, 2014 8:02 am | News | Comments

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.

Simeprevir Approved in the European Union

May 16, 2014 8:29 am | News | Comments

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 Wins European Approval for New MS Drug

February 3, 2014 1:32 pm | News | Comments

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.


XIGDUO™ Approved in the European Union for Type 2 Diabetes

January 22, 2014 8:06 am | News | Comments

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).

EU Fines Pharmaceutical Giants $22M

December 10, 2013 9:56 am | News | Comments

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.      

European Commission Approves Fluenz Tetra for the Prevention of Seasonal Influenza in Children

December 6, 2013 8:26 am | News | Comments

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

EU Approves Onyx and Bayer's Cancer Pill Stivarga

August 30, 2013 10:06 am | by The Associated Press | News | Comments

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...

Regeneron Receives EU OK for New Use of Eylea

August 29, 2013 8:46 am | News | Comments

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 Receives Orphan Medicinal Product Designation for VS-6063 in Mesothelioma

June 13, 2013 9:32 am | News | Comments

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.

EU Committee Rejects Vivus Weight-Loss Drug

February 22, 2013 7:49 am | News | Comments

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.

ZALTRAP Approved in the EU for Patients with Previously Treated Metastatic Colorectal Cancer

February 5, 2013 8:10 am | News | Comments

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

Novartis Europharm Withdraws Marketing-Authorization Application for Ruvise

January 25, 2013 3:07 am | News | Comments

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.

Lilly's Amyvid Receives European Approval

January 16, 2013 2:57 am | News | Comments

European 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 | Comments

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 Adolescents

November 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).

Novartis Cancer Drug Receives EU OK for New Use

November 5, 2012 5:33 am | by The Associated Press | News | Comments

A 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 | Comments

Amylin 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 | Comments

AstraZeneca'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 | Comments

Roche 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 | Comments

Genzyme 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 | Comments

Basilea 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 | Comments

With 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 | Comments

Novartis 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 | Comments

Bristol-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 | Comments

The European Commission said Thursday that pharmaceutical companies must develop more-effective medications against multi-drug resistant bacteria.

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