April 15, 2013
- Roche and Ascletis announced today that they have entered into a collaboration to develop and commercialize Roche’s investigational drug danoprevir in China for the treatment of Hepatitis-C Virus (HCV).
TOKYO, April 15, 2013 - Astellas Pharma Inc. (“Astellas”; Tokyo: 4503) today announced that Songlin Xue, M.D., Ph.D. has been named head of Global Pharmacovigilance (GPV). Dr. Xue will be located at Astellas’ Headquarters for the Americas in Northbrook, Illinois, USA and will report to Sef Kurstjens, M.D., Ph.D., newly named Chief Medical Officer at Astellas.
- Recent comprehensive reviews revealed: Medical researchers are worried about hidden mitochondrial toxicity of their drug candidates causing attrition in late-stage. Searching in PubMed database on 'drug-induced mitochondrial toxicity' leads to more than 7,000 hits. Quite often drug-induced mitochondrial toxicity can't be detected by conventional cancer cell-based in vitro toxicity assays. Most highly proliferable cells used for in vitro cytotoxicity assays rely on glycolysis for energy...
- Merck Serono, a division of Merck, Darmstadt, Germany, today announced the launch of the EspeRare Foundation, a nonprofit organization set up by three Merck Serono employees, in the framework of the Merck Serono Entrepreneur Partnership Program (EPP). Merck Serono will donate an initial €2.8 million funding to the EspeRare Foundation. In addition, Merck...
April 14, 2013
- One of the most widely used medications to treat arrhythmias may increase the risk of developing cancer, especially in men and people exposed to high amounts of the drug. That is the conclusion of a new retrospective study published early online in CANCER, a peer-reviewed journal of the American Cancer Society. The study's results indicate that a potential link between amiodarone and cancer warrants further investigation.
April 12, 2013
- The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Equilis West Nile from Intervet International B.V. a vaccine for the active immunisation of horses against West Nile virus to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
- The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions in the use of Protelos/Osseor (strontium ranelate) based on the outcome of a routine benefit-risk assessment of the medicine, known as a periodic safety update report or PSUR. Pending confirmation from the Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a PSUR assessment leads directly to a recommendation to restrict the use of a medicine.
- Clinical pharmacologists at Heidelberg University Hospital have achieved major progress for improving the reliability of drugs. In a pharmacological study, they showed for the first time that interactions between drugs can be detected with minute doses in the range of nanograms. However, at these low doses, the drugs are neither effective nor do they have side effects. This means that studies on interactions occurring in drug combinations can be conducted practically without posing risks or...
April 11, 2013
- The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety...
- Group sales rose 6% to 11.6 billion Swiss francs as demand for Roche's cancer medicines and clinical laboratory products grew strongly in the first three months of the year. Higher sales of Tamiflu due to a severe flu season in North America also supported Roche's performance in the first quarter.