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The Lead

EMA Provides Update on Stolen Vials of Herceptin

April 18, 2014 8:26 am | News | Comments

Italian law enforcement authorities are currently investing the theft. However, the situation goes beyond EU and national current practices for handling quality or product defects; these are extraordinary circumstances driven by criminal activities that require special measures and strong collaboration from authorities across the EU.

EMA Reports Vials of Falsified Herceptin Identified

April 16, 2014 8:41 am | News | Comments

The European Medicines Agency (EMA) has been informed that vials of the cancer medicine...

EMA PRAC Recommends Restricting Use of Domperidone

March 7, 2014 8:31 am | News | Comments

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed...

European Medicines Agency Recommends that Protelos/Osseor Remain Available But with Further Restrictions

February 21, 2014 8:23 am | News | Comments

The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended...

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FDA and European Medicines Agency Strengthen Collaboration in Pharmacovigilance Area

February 19, 2014 1:45 pm | News | Comments

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

Teva and Active Biotech to Continue Development of NERVENTRA® for MS

January 24, 2014 8:52 am | News | Comments

Teva Pharmaceutical and Active Biotech announced today that both companies remain committed to the NERVENTRA ® clinical development program for multiple sclerosis (MS) following the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

EMA Begins Review of Emergency Contraceptives

January 24, 2014 8:17 am | News | Comments

The European Medicines Agency has started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy.    

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EMA Recommends Approval of a New Medicine for Multidrug-Resistant Tuberculosis

December 20, 2013 8:25 am | News | Comments

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorization for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

FDA and European Medicines Agency Launch Generic Drug Application Inspections Initiative

December 18, 2013 1:36 pm | News | Comments

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals.   

Cubist Shares Up On Antibiotic Trial Results

December 16, 2013 4:01 pm | by The Associated Press | News | Comments

The company said the drug ceftolozane/tazobactam, in combination with antibiotic metronidazole, met the U.S. Food and Drug Administration and the European Medicines Agency thresholds for showing that it is equally effective as existing antibiotic meropenem.

EMA Starts Further Review of Iclusig

December 6, 2013 8:44 am | News | Comments

The European Medicines Agency has started an in-depth review of the benefits and risks of the leukemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.   

EU Regulator: No More Problems with Roche Drugs

November 19, 2013 9:04 am | News | Comments

The European Medicines Agency says it has finished an investigation of the way pharmaceutical giant Roche reported side effects for 19 drugs in the U.S. and has found no new safety concerns.          

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AstraZeneca’s Fluenz Tetra Receives Positive Opinion in EU from CHMP

September 20, 2013 8:08 am | News | Comments

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.

European Medicines Agency Reveals New Structure

September 16, 2013 11:03 am | News | Comments

The European Medicines Agency (EMA) has announced details of its new organizational structure. The changes fundamentally reorganize the Agency’s operations to support better its public and animal health mission, and its role as part of the European medicines regulatory system.

European Regulators: No Pancreas Risk with Diabetes Meds

July 26, 2013 1:56 pm | by The Associated Press | News | Comments

The European Medicines Agency said Friday it uncovered no new evidence of pancreas-related safety issues after reviewing a group of recently approved diabetes drugs. The agency's Committee for Medicinal Products for Human Use reviewed the safety of so-called GLP-1 diabetes therapies after a study...

FDA and EMA Approve Critical Path Institute's Clinical Trial Simulation Tool for Alzheimer’s Disease

July 11, 2013 8:14 am | News | Comments

In a big step forward for Alzheimer’s disease (AD) therapy development, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have independently reached favorable decisions on the value of Critical Path Institute’s new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease.

European Regulators Expand Pfizer Vaccine Approval

July 10, 2013 8:42 am | by The Associated Press | News | Comments

European regulators have become the first to approve Pfizer Inc.'s Prevenar 13 vaccine for patients at all stages of life by including adults between the ages of 18 and 49. The New York drugmaker said Wednesday that the vaccine, known as Prevnar 13 in the United States, had already been approved...

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Eli Lilly and and Boehringer Ingelheim Announce Regulatory Submission for New Insulin Glargine Biosimilar Product

July 8, 2013 8:52 am | News | Comments

Eli Lilly and Company and Boehringer Ingelheim today announced that the companies' marketing authorization application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA).

Halozyme Gets Positive Recommendation on Herceptin

July 1, 2013 8:35 am | News | Comments

Halozyme Therapeutics said that its development partner Roche has received a positive recommendation from a European drug regulator for the administration of a breast cancer drug by subcutaneous injection. Halozyme's stock jumped 24 percent.

Bayer and Onyx Pharmaceuticals Submit Nexavar Applications to FDA and EMA

July 1, 2013 8:21 am | News | Comments

Bayer HealthCare and Onyx Pharmaceuticals today announced the submission of a supplemental New Drug Application (sNDA) to the FDA and an application for marketing authorization to the EMA for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

Hospira Gets Positive Europe Opinion on Inflectra

June 28, 2013 2:35 pm | by The Associated Press | News | Comments

Drug and medical device maker Hospira has received a positive opinion from a European drug regulator for a drug that can be used to help treat rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. Its shares climbed to the highest point in more than a year. ...

Apricus impotence drug approved in 10 countries

June 10, 2013 12:45 pm | by The Associated Press | News | Comments

Apricus Biosciences Inc. said Monday that its impotence drug Vitaros has been approved in 10 European countries. The company said Vitaros is now approved in the Netherlands, Germany, France, Italy, and the U.K., among other countries, for the treatment of erectile dysfunction. Apricus sought...

Aegerion Gets EU Vote on Cholesterol Disorder Drug

May 31, 2013 10:10 am | by The Associated Press | News | Comments

Aegerion Pharmaceuticals Inc. said Friday that a European Union advisory panel recommended its drug Lojuxta be approved as a treatment for a rare inherited disease that causes extremely high levels of bad cholesterol. Regulators are expected to make a decision on the drug during the third...

BioMarin Says US, EU Now Reviewing Vimizim

May 31, 2013 8:55 am | News | Comments

BioMarin Pharmaceutical Inc. said Thursday that regulators in the U.S. and Europe are reviewing its drug Vimizim and are expected to make decisions on the drug in early 2014. BioMarin said European Union regulators could approve Vimizim in the first quarter of 2014.

EMA Recommends Restricting Trobalt to Last-Line Therapy in Partial Epilepsy

May 31, 2013 8:29 am | News | Comments

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of the anti-epileptic medicine Trobalt (retigabine) only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.

EMA Recommends Approval of Pomalidomide for the Treatment of Multiple Myeloma

May 31, 2013 8:20 am | News | Comments

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Pomalidomide Celgene (pomalidomide) to treat patients with multiple myeloma. Multiple myeloma is a rare and incurable cancer of the bone marrow that primarily affects older adults. In Europe, approximately 27,800 new cases are diagnosed each year.

French Drugmaker on Trial, Suspected in Deaths

May 21, 2013 2:51 pm | News | Comments

The 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 | Comments

Pfizer 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 | Comments

The 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).

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