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 RestrictionsFebruary 21, 2014 8:23 am | News | Comments
The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended...
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new...
Teva Pharmaceutical and Active Biotech announced today that both companies remain committed to...
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.
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.
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.
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.
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.
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 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.
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.
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 DiseaseJuly 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 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 ProductJuly 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 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 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.
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 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 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 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.
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.
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.
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.
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 DiabetesMarch 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).
The 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.
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.
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