NEW YORK, Feb. 14, 2012 /PRNewswire/ -- MolecularHealth, Inc., a leader in clinico-molecular informatics™, today announced the establishment of a five-year research collaboration agreement with the U.S. Food and Drug Administration (FDA) to evaluate and refine MolecularHealth's Molecular Analysis of Side Effects (MASE), a software system intended to support mechanism-based drug safety assessment and prediction. The FDA's Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate non-proprietary molecular and clinical endpoints of regulatory interest into MASE, along with non-proprietary information on patient populations, drug promiscuity, molecular modes of action and mechanisms of disease. "We are pleased to collaborate with the FDA to obtain their input into the evaluation of the analytical power of MASE for assessing drug safety in the U.S.," said Jeffrey D. Marrazzo, chief business officer of MolecularHealth. "MASE has the potential to benefit pharmaceutical developers, regulators and clinicians alike, helping them to develop and monitor drugs in a safer, more efficient manner." MASE uses information about drug modes of action and the molecular implications of interacting treatments, co-morbidities and genetic profiles to enable a more precise assessment of drug safety. MASE enables the exploration and analysis of adverse event information from both statistical and … Continue reading →

The Rottenstein Law Group, which represents clients with claims stemming from the severe side effects of the drug Fosamax, is cautiously optimistic about the possibility that a new process will improve bone growth. New York, NY (PRWEB) February 14, 2012 According to a press release from the University of California, “[a] research team led by UC Davis Health System scientists has developed a novel technique to enhance bone growth by using a molecule which, when injected into the bloodstream, directs the body's stem cells to travel to the surface of bones.” The results of the study were published in Nature Medicine. Wei Yao, the principal investigator and lead author of the study, remarked that while there are many step cells, even in the elderly, those stem cells “'do not readily migrate to bone.'” Discovering a molecule that attaches to stem cells and guides them to desired targets “'is a real breakthrough.'” “Osteoporosis is a major public health problem for 44 million Americans,” the release notes. “One in two women will suffer a fracture due to osteoporosis in their lifetime. Although effective medications are available to help prevent fracture risk, including alendronate, their use is limited by potential harmful effects of … Continue reading →

Posted by Michael MonheitFebruary 14, 2012 5:58 AM Patients who are taking the anticoagulant drug Pradaxa need to be particularly alert to a dangerous—and potentially life-threatening—side effect: excessive bleeding. The FDA announced in December that it is evaluating a number of reports of serious bleeding events in patients taking Pradaxa. While bleeding is a well-recognized complication for all anticoagulant drugs, the FDA is specifically trying to determine whether those risks are greater for patients taking Pradaxa. Pradaxa (dabigatran etexilate mesylate) was approved for use in October 2010 and since that time hundreds of thousands of patients have been prescribed the drug. Pradaxa acts as a blood thinning agent to reduce the risk of stroke in patients who suffer non-valvular arterial fibrillation. But these anticoagulant medications carry the risk of excessive bleeding, including internal bleeding, ulcers, and cerebral hemorrhages. These events of excessive bleeding are the current concern with Pradaxa. In just one year of being on the market, the maker of the drug disclosed that there were 260 deaths caused by internal bleeding; which doesn’t include other bleeding events that did not result in death. The FDA received 307 adverse event reports in just the first three months that the … Continue reading →