25/05/2012 European Medicines Agency confirms positive benefit-risk balance of MabTheraBatches produced at the Vacaville manufacturing site do not pose risk to public healthFollowing a quality review of the genetically engineered monoclonal antibody MabThera, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the batches of the active substance of MabThera, rituximab, produced at the Vacaville manufacturing site in the United States do not present a risk to public health.MabThera is indicated in non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis.The review of MabThera was initiated after the unexpected detection of Leptospira licerasiae at an early stage (pre-harvest) of the manufacturing process of rituximab in bioreactorsat Vacaville. The contaminant was not detected ... Continue reading →

25/05/2012 European Medicines Agency updates patient and prescriber information for PradaxaData confirm positive benefit-risk balance of anticoagulant medicine, but modifications to product information for clearer guidance neededThe European Medicines Agency has recommended updating the product information for the blood thinner Pradaxa, to give clearer guidance to doctors and patients on how to reduce and manage the risk of bleeding associated with the anticoagulant medicine. Bleeding is a well-known complication of all anticoagulant medicines and Pradaxa has therefore been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) since its initial authorisation.Pradaxa is an anticoagulant (a medicine that prevents the blood from clotting). It is prescribed to adults who have had hip or knee replacement surgery to prevent venous thromboembolic ... Continue reading →

Yvetta Fedorova The definition of an optimist:Someone, like me, who plans to get more done than time permits.Having failed to achieve the impossible, someone, like me, who is sure everything will somehow get done anyway.A more classical definition from the Mayo Clinic: “Optimism is the belief that good things will happen to you and that negative events are temporary setbacks to be overcome.”In one study, adults shown to be pessimists based on psychological tests had higher death rates over a 30-year period than those who were shown optimistic. No doubt, the optimists were healthier because they were more inclined to take good care of themselves.Jane Brody on health and aging. Unlike Voltaire’s Candide, I’ve yet to be stripped of my optimism, though there are clearly ... Continue reading →

Don’t Let Polio, Nearly Dead and Gone, Come Back to Life By the Editors 2012-05-24T23:00:00Z Nothing demonstrates human interconnectedness like the spread of infectious disease. Polio is now endemic to just three countries: Afghanistan, Nigeria and Pakistan. In recent years, visitors have carried it back to 39 previously polio-free states. Thus people everywhere have a stake in eradicating polio, as we have stamped out smallpox. Immunizing the last unvaccinated children on the planet is an expensive and complex undertaking, and worth it in the long run. The world not only would be forever spared an incurable, crippling and often fatal disease. It would also save a lot of money. If polio transmission could be stopped by 2015, the net benefit from reduced treatment costs and ... Continue reading →

Glaxo Diabetes Drug Data Revealed Amid Hostile Takeover By Makiko Kitamura - 2012-05-24T23:01:00Z GlaxoSmithKline Plc (GSK) will reveal detailed results today on an experimental treatment for diabetes that’s part of the reason for a $2.6 billion hostile takeover bid for Human Genome Sciences Inc. (HGSI), its partner on the drug. Glaxo will present data from two of eight late-stage studies, dubbed Harmony 6 and Harmony 7, of the once-weekly drug albiglutide ahead of the American Diabetes Association’s annual meeting next month. Abstracts of those studies will be posted on the ADA website today. Albiglutide, along with the lupus treatment Benlysta and darapladib for heart disease, form a trio of drugs Glaxo has developed with Human Genome. If approved, the product would compete with existing medicines ... Continue reading →

May 25 (Bloomberg) -- Bloomberg's Shannon Pettypiece reports on a catheter made by Medtronic Inc. that is used in an experimental 20-minute procedure to treat hypertension by cauterizing nerves near the kidneys that control blood pressure. (Source: Bloomberg) For three decades Gael Lander fought for her life against the same high blood pressure that contributed to her father’s fatal heart attack and caused a series of debilitating strokes in her mother. Now Lander’s hard-to-treat hypertension is under control, the result of an experimental 20-minute procedure that cauterized nerves near her kidneys that control blood pressure. The nerves were seared using a catheter made by Medtronic Inc. (MDT), the leader among dozens of companies developing similar products that may help re-energize the medical devices industry with ... Continue reading →