Just revealed in briefing documents which were released in advance of a scheduled Thursday meeting of the FDA’s Advisory Committee for Reproductive Health Drugs, which will be considering whether to recommend denosumab for approval, are significant concerns that denosumab, the investigational biologic drug for osteoporosis, may increase risk of serious infections through its activity against [...]
November 21 is our country’s first annual Men’s Health Night. We’re asking every home to light a blue bulb that night, as a way to think about ourselves and the men we love, our sons, boyfriends, Dad’s, Uncles, Granddads, brothers, friends, partners, and husbands. One blue light bulb, one night a year, showing we care [...]
— A New Trial Marks Expanded Phase 3 Development of MDV3100 into Earlier-Stage Disease — Medivation, Inc. and Astellas Pharma Inc. today announced the launch of a second Phase 3 clinical trial of their investigational drug MDV3100. This trial marks the expansion of the Phase 3 development of their novel, triple-acting oral androgen receptor antagonist [...]
Researchers at the Department of Urology, University of Michigan, Ann Arbor, Michigan evaluated the complications associated with the male bone-anchored sling (BAS) to determine the appropriate preoperative counseling for men considering surgery. The BAS is a surgical option for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. The researchers reviewed 119 [...]
It was announced by the pharmaceutical manufacture, Amgen, that they are recalling certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) The recall is prompted because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The lamellae result from the interaction of the formulation with glass vials over the shelf life of [...]