Research, Industry, Medical and Scientific News

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Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.

Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder

Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: Business Wire, April 12, 2021

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First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI.  Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. Read more.

Source: Business Wire, March 10, 2021

Isolated and Alone: Nonprofits See Explosion of Need for Adult Incontinence Products

Before the pandemic and when she had the extra money, Lucy Jackson would sometimes go out to buy the adult incontinence products she needed to get through the day and night. But now, worried about catching the coronavirus, she rarely leaves her Newark, New Jersey, boarding house. To get supplies, she relies more on friends, family and the Modestly Cover Diaper Bank of Essex County, New Jersey. “During this pandemic, it’s been very, very difficult,” Jackson, 72, said. Read more.

Source: NBC Universal, March 8, 2021

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Principle Business Enterprises Celebrates 60 Years

Principle Business Enterprises, Inc. (PBE) celebrates 60 years of manufacturing safety and absorbent products for the healthcare industry by announcing the evolution of its Tranquility brand of incontinence products and ongoing commitment to being an employer of choice. Since welcoming the company’s third generation of family leadership with the appointment of Andrew Stocking as president and CEO, PBE has continued to focus on product innovation and its mission to uplift, enlighten, and enrich the lives of its customers and associates. Read more.

Source: Nonwovens Industry, March 3, 2021

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Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020

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Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.  Read more. 

Source: Urology Times, November 20, 2020

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Essity Launches Pilot of Digital Incontinence Solution

Hygiene and health company Essity, which makes TENA incontinence and skincare products, has launched a pilot program of its TENA SmartCare Change Indicator, a system that uses digital sensors and a smartphone app to reduce manual checks of incontinence patients. Cleared by the U.S. Food and Drug Administration (FDA) earlier this year, SmartCare Change Indicator notifies caregivers via smartphone when they should consider changing a patient’s TENA absorbent products. Read more.

Source: HME Business, October 29, 2020