European Medicines Agency implements internal reorganisation
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- Category: EMA
The European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009.
FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
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- Category: FDA
The U.S. Department of Health and Human Services (HHS) marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.
The bacterial challenge - time to react
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- Category: EMA
There is a need for more development of antibiotics that are effective against multidrug-resistant bacteria. That is the conclusion of a new report prepared jointly by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) with contributions from the international network Action on Antibiotic Resistance (ReAct).
FDA: Cancer Warnings Required for TNF Blockers
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- Category: FDA
The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn's disease, and other inflammatory diseases.
European Medicines Agency review of pandemic vaccines underway
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- Category: EMA
The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available.
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
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- Category: FDA
The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.
European public health agencies evaluate antibiotic resistance of Staphylococcus aureus
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- Category: EMA
The European Food Safety Authority (EFSA), the European Centre for Disease Control and Prevention (ECDC) and the European Medicines Agency (EMEA) have published today a joint Scientific Report on meticillin resistant Staphylococcus aureus (MRSA) in livestock, pets and foods.
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- European Medicines Agency welcomes continuation of D:A:D study
- FDA Approves Drug for Patients with Advanced Prostate Cancer
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