EMEA-coordinated PROTECT project has been accepted for funding
- Details
- Category: EMA
The PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance.
EMEA, EC and Health Canada agree implementation plan for confidentiality arrangement
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- Category: EMA
The European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan.
EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab)
- Details
- Category: EMA
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine.
European Medicines Agency welcomes continuation of D:A:D study
- Details
- Category: EMA
The European Medicines Agency (EMEA) has welcomed the commitment of the sponsors to continue the D:A:D study at least until 2012. This ensures that the study, which was started on the initiative of the EMEA in 1999, will remain one of the most powerful pharmacovigilance tools to monitor the long-term safety of antiretroviral medicines.
FDA Approves Drug for Patients with Advanced Prostate Cancer
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- Category: FDA
The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer.
FDA's Monthly Video Series Wins Award
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- Category: FDA
"FDA Patient Safety News," the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.
EMEA recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)
- Details
- Category: EMA
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed.
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- FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
- EMEA recommends suspension of the marketing authorisation of Acomplia
- European Medicines Agency recommends update of product information of Tysabri
- FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
- FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts