Archive for October, 2009

Skylight Healthcare Systems Launches of iCarePassport(TM)

Skylight Healthcare SystemsSkylight Healthcare Systems launched iCarePassport, a breakthrough patient care and outcomes system for ongoing patient engagement that delivers hospitals the ability to provide personalized communication throughout the continuum of care. iCarePassport includes industry standard outcomes modules that patients can easily complete online which provide healthcare organizations information critical to monitoring and measuring evidence-based quality outcomes. iCarePassport provides surgeon-prescribed, diagnosis-specific, and personalized content that has flexible data gathering applications for patients and clinicians.

Approval of Denosumab may be delayed

AmgenDenosumab, a potential game-changer for Amgen Inc, is expected to be the most notable launch in the biotech industry in years. However, many on Wall Street expect the FDA’s approval decision to be delayed by about three months from the expected date of October 19 because the agency has a history of missing deadlines and may want more time to analyze the safety record of a new drug like denosumab.

FDA to decide on Xiaflex shortly

AuxiliumAuxilium Pharma is awaiting a decision from the FDA on its key pipeline candidate, Xiaflex, for the treatment of Dupuytren’s Contracture. The drug has received favorable recommendation from the FDA’s Arthritis Advisory Committee. Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that about 240,000 people suffer from Dupuytren’s in the US and the EU. This represents significant commercial opportunity for Auxilium.

Study: Bone loss drug may also help in cartilage repair

Rochester medical centerA recent study, conducted by researchers at University of Rochester Medical Center and presented at the annual meeting of the American Society for Bone and Mineral Research in Denver, indicated that a drug already approved to heal bone loss from osteoporosis may also help to prevent and reverse the damage to cartilage that leads to osteoarthritis. Currently, there are no drugs to treat cartilage loss in osteoarthritis, a condition that’s expected to affect some 50 million Americans by 2020. Parathyroid hormone, sold as the prescription drug teriparatide (Forteo), is already approved by the FDA to maintain and heal bone, and earlier studies have suggested that it also affects cartilage cells.

Positive results for Wyeth Pharma bazedoxifene in reducing vertebral fractures

WyethWyeth Pharmaceuticals reported promising results for bazedoxifene from a placebo-controlled Phase 3 study. The drug, a selective estrogen receptor modulator (SERM), is under clinical investigation for the prevention and treatment of postmenopausal osteoporosis. The trial of bazedoxifene 20 mg indicated a significant reduction in new vertebral fractures in postmenopausal women with osteoporosis.