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EMA recommends suspending medicines over flawed studies

May 22, 2015 9:31 am | News | Comments

The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.

EMA: Compare Drug Combinations With Individual Components

May 20, 2015 10:51 am | by FDA | News | Comments

Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm...

CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European...

EMA Recommends Suspending GVK Biosciences Medicines over Flawed Studies

January 23, 2015 8:06 am | News | Comments

A number of medicines for which authorization in the European Union (EU) was primarily based on...

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EMA: No Consistent Evidence of an Increased Risk of Heart Problems with Testosterone Medicines

November 21, 2014 8:13 am | News | Comments

The CMDh, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism).

EMA Advises on Development Plan for GSK Ebola Vaccine

October 29, 2014 11:15 am | News | Comments

The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the current Ebola outbreak that EMA has given ‘rapid scientific advice’ using an accelerated procedure.

EMA to Start Assessment of Ebola Vaccines and Treatments as Soon as Data are Made Available

October 23, 2014 1:35 pm | News | Comments

The EMA has established a form of rolling review that allows experts to continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process. The initial review and subsequent updates will be shared with healthcare decision-makers in the most affected and other countries.


AbbVie Receives EMA and FDA Orphan Drug Designation for Investigational Compound ABT-414

August 4, 2014 8:10 am | News | Comments

AbbVie today announced the EMA and the FDA have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme.

GSK Asks European Regulator to OK Malaria Shot

July 24, 2014 8:18 am | News | Comments

The experimental shot is the most advanced candidate vaccine for malaria but results from previous trials have been disappointing. Research published in 2012 showed the shot only reduced malaria cases by about 30 percent in babies aged six to 12 weeks, the target age for immunization.

EU Regulator: Morning-After Pill OK for All Women

July 24, 2014 8:11 am | News | Comments

The European Medicines Agency says a commonly used morning-after pill is suitable for use by heavier women after reviewing the evidence, sparked by a French pharmaceutical company's declaration last year that the drugs didn't work in women weighing more than 176 pounds.

Bayer HealthCare Extends Access to Clinical Trial Data

May 14, 2014 10:38 am | News | Comments

By joining the portal, Bayer HealthCare is supporting efforts of the European Medicines Agency (EMA) to increase the transparency of data from clinical studies. As a member company of the pharmaceutical trade associations EFPIA and PhRMA, Bayer is following their declared principles on responsible clinical trial data sharing.

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 Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.

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 a review of domperidone-containing medicines and has recommended changes to their use throughout the European Union (EU).      

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 further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis.      

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.    

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.          

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...

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).

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