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Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.
Source: PRNewswire, June 29, 2017
An interview with Dr Michael Kennelly, urologist and Medical Director for the Charlotte Continence Center at Carolinas Medical Center, conducted by April Cashin-Garbutt, MA (Cantab) What are the main symptoms of overactive bladder syndrome (OAB)? Symptoms of OAB include leakage, the strong sudden need to “go right away,” and going to the bathroom too often. Read more.
Source: News-Medical.Net, June 28, 2017
Sweden’s Svenska Cellulosa Aktiebolaget or SCA dates back to 1929 as a holding company for ten forestry businesses. Over the proceeding decades, SCA began acquiring various hygiene businesses although they remain the largest private land owner of forest land in Europe holding roughly 2.6 million hectares (6.4 million acres). Separating these two businesses made sense and hopefully will allow the true value of each to be realized. In 2016, Essity (OTC:ESSYY) accounted for 86% ($11.5 billion) of SCA’s total revenue so while SCA was originally founded as a forest products company, in reality, it was a health and hygiene business and had been for many years. It earned around $480 million and generated $790 million in owner earnings last year. Read more.
Source: Seeking Alpha, June 19, 2017
GTx, Inc. (Nasdaq: GTXI) today announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society’s website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI. Read more.
Source: BusinessWire, June 12, 2017
Significantly lower levels of oestrogen in peri-menopausal and post-menopausal women could increase their risk of stress urinary incontinence, according to Austrian researchers. They noted that sex steroid levels changed markedly during menopause, and oestrogen deficiency after menopause caused changes within the urogenital tract. Their study included 47 women with stress urinary incontinence who were matched with 47 controls. The findings suggested that low levels of circulating sex steroids might have a negative impact on the function of the lower urinary tract and on mechanisms involved with continence. Read more.
Nursing Times, June 8, 2017
Urinary incontinence in women is common, with almost 50% of adult women experiencing leakage at least occasionally. Genetic or heritable factors are known to contribute to half of all cases, but until now studies had failed to identify the genetic variants associated with the condition. Speaking at the annual conference of the European Society of Human Genetics today (Monday), Dr Rufus Cartwright, MD, a visiting researcher in the Department of Epidemiology and Biostatistics, Imperial College, London, UK, will say that his team’s investigations hold out the promise that drugs already used for the treatment of other conditions can help affected women combat this distressing problem. Read more.
Source: Medical Xpress, May 29, 2017