Urination

Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

Retrieved on: 
Montag, Mai 13, 2024
New Drug Application, Patient, SMPA, Food, Vibegron, Shanda, Urine, FDA, Safety, PDUFA, OAB, Ageing, Week, Urinary incontinence, Overactive bladder, Urination, BPH, Nocturia, Pharmaceutical industry

MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).

Key Points: 
  • MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH).
  • If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH.
  • The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).
  • "We are pleased the FDA has recognized the strength of the Phase 3 data for vibegron in the URO-901-3005 study within our application.

Sumitomo Pharma Presents Urology and Oncology Data at AUA 2024 Annual Meeting

Retrieved on: 
Dienstag, Mai 7, 2024
American Urological Association, SMPA, Week, The Journal of Urology, Urination, Vibegron, Overactive bladder, Safety, BPH, AUA, OAB, Pharmaceutical industry

MARLBOROUGH, Mass., May 7, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc., (SMPA) today announced the presentation of data from URO-901-3005, a Phase 3 randomized, double-blind, parallel-group, fixed-dose study evaluating the efficacy, safety, and tolerability of vibegron (GEMTESA®) versus placebo over 24 weeks in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH) at the American Urological Association (AUA) Annual Meeting. Following the podium presentation at AUA, these results were published in Journal of Urology.

Key Points: 
  • Following the podium presentation at AUA, these results were published in Journal of Urology .
  • "There is currently no approved treatment for persistent OAB symptoms in men who are receiving treatment for BPH.
  • We are happy to share these results with the scientific community at AUA."
  • "We are proud to have our urology and oncology teams together and among the leaders at AUA sharing positive data that underpins our steadfast commitment to those living with unmet urological conditions."

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Freitag, Mai 3, 2024
FDA, Mayo Clinic, Safety, Food, American Urological Association, Urinary bladder, Carcinoma, Immunotherapy, Hematuria, Abstract, BCG, CIS, Patient, Face, NMIBC, AUA, Urination, Rush University Medical Center, Death, Clinical trial, Annual general meeting, Quality of life, Pharmaceutical industry

IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024. These data were featured today at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX. In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.

Key Points: 
  • 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.
  • “The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients.
  • “Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction.
  • A webcast replay will be available in the investor relations section on the company's website following the completion of the call.

TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non-muscle-invasive bladder cancer

Retrieved on: 
Freitag, Mai 3, 2024
FDA, Congress, Cancer, Urinary tract infection, Urinary diversion, Safety, Carcinoma, Survival, Johnson & Johnson, Immunotherapy, CRS, Abstract, Cohort, BCG, Disease, Bladder cancer, Dysuria, Patient, Metastasis, Medicine, NMIBC, AUA, Biopsy, BTD, Urination, Interim, Food and Drug Administration, SAN, Pharmaceutical industry

SAN ANTONIO, May 3, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from Cohort 2 of the Phase 2b SunRISe-1 study evaluating the efficacy and safety of investigational TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, who are ineligible for, or decline, radical cystectomy. These data were featured today in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place May 3-6, 2024, in San Antonio, Texas.

Key Points: 
  • "These results address an area of high unmet need for bladder sparing therapies in this patient population."
  • Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy.
  • The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI], 70.6-91.4).
  • Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Dienstag, März 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

Urethral Dilator Market to reach $390.1 million by 2031, at a CAGR of 6.1%, says Coherent Market Insights

Retrieved on: 
Montag, April 8, 2024
Hospital, Urination, Friction, Growth, Prevalence, Risk, Trauma, Research, Dilator, Cook Group, Urethral stricture, Urethra, MED, Medical imaging

Another trend is the rising demand for reusable urethral dilators, driven by cost-effectiveness and environmental sustainability considerations among healthcare providers.

Key Points: 
  • Another trend is the rising demand for reusable urethral dilators, driven by cost-effectiveness and environmental sustainability considerations among healthcare providers.
  • The market for urethral dilators is witnessing significant growth due to the rising prevalence of urethral strictures.
  • This has led to an increased demand for urethral dilators, which are used to widen the urethra and alleviate the symptoms of urethral strictures.
  • The growing adoption of minimally invasive procedures, such as urethral dilatation, is also contributing to the market opportunity for urethral dilators.

Urethral Dilator Market to reach $390.1 million by 2031, at a CAGR of 6.1%, says Coherent Market Insights

Retrieved on: 
Montag, April 8, 2024
Hospital, Urination, Friction, Growth, Prevalence, Risk, Trauma, Research, Dilator, Cook Group, Urethral stricture, Urethra, MED, Medical imaging

Another trend is the rising demand for reusable urethral dilators, driven by cost-effectiveness and environmental sustainability considerations among healthcare providers.

Key Points: 
  • Another trend is the rising demand for reusable urethral dilators, driven by cost-effectiveness and environmental sustainability considerations among healthcare providers.
  • The market for urethral dilators is witnessing significant growth due to the rising prevalence of urethral strictures.
  • This has led to an increased demand for urethral dilators, which are used to widen the urethra and alleviate the symptoms of urethral strictures.
  • The growing adoption of minimally invasive procedures, such as urethral dilatation, is also contributing to the market opportunity for urethral dilators.

Olympus Announces iTind™ Treatment Milestone with Availability Through Major GPOs

Retrieved on: 
Donnerstag, März 28, 2024
Urination, Risk, Prostate, Nursing, BPH, Hospital, Improper integral, GPO

CENTER VALLEY, Pa., March 28, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today a milestone for its iTind™ device with its availability and greater patient access through the largest healthcare group purchasing organization (GPO) contracts in the United States.

Key Points: 
  • The iTind procedure is a minimally invasive procedure for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate.
  • The Healthcare Supply Chain Association estimates nearly all hospitals and a majority of non-acute care centers in America belong to at least one GPO.1
    "The availability of the iTind device through major GPO contracts marks an important milestone for Olympus," said Jay Sullivan, Group Vice President, Enterprise Solutions, Medical Systems Group, Olympus.
  • BPH is a common health problem for men over 50 as the risk increases with age.
  • Symptoms of BPH include frequent urination with a sense of urgency and a weak urinary stream and excessive urination at night.2

Filtering The Facts: The Urology Care Foundation Spreads Awareness for National Kidney Month

Retrieved on: 
Freitag, März 1, 2024
Urination, Diabetes, Fever, Woman, Anemia, Penis, Workplace, Kidney, Blood, Smoking, Mineral, Hormone, Pain, Weight loss, Infection, Rib, Nausea, Vomiting, Human, Kidney cancer, University, Somatic symptom disorder, AUA, Tobacco, Disease, Urine, Risk factor, Low back pain, Risk, American Urological Association, Salt, Water, Phosphorus

BALTIMORE, March 01, 2024 (GLOBE NEWSWIRE) -- March is National Kidney Month, and the Urology Care Foundation, the official foundation of the American Urological Association (AUA), wants to help share all the tools and information you need to take charge of your kidney health.

Key Points: 
  • BALTIMORE, March 01, 2024 (GLOBE NEWSWIRE) -- March is National Kidney Month, and the Urology Care Foundation, the official foundation of the American Urological Association (AUA), wants to help share all the tools and information you need to take charge of your kidney health.
  • The kidneys also make hormones that help to keep blood pressure stable, make red blood cells and help keep bones strong.
  • Kidney health deserves equal awareness,” said Dr. Timothy Averch, chair of the Urology Care Foundation’s Kidney and Adrenal Health Committee.
  • For National Kidney Month, the Urology Care Foundation is focusing on information about kidney cancer and kidney stones:
    It is estimated that there will be over 81,000 new kidney cancer cases and over 14,000 cancer deaths in the United States in 2024.

Nordic Naturals Issues Voluntary Recall of Baby's Vitamin D3 Liquid Due to Elevated Levels of Vitamin D3

Retrieved on: 
Samstag, Februar 17, 2024
FDA, Urination, Natural, Health, D3, SKU, Vitamin D, Somatic symptom disorder, Thirst, Vomiting, Cholecalciferol, PST, Dietary supplement

WATSONVILLE, Calif., Feb. 17, 2024 (GLOBE NEWSWIRE) -- Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid, 0.76 fl.

Key Points: 
  • WATSONVILLE, Calif., Feb. 17, 2024 (GLOBE NEWSWIRE) -- Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid, 0.76 fl.
  • This recall is being conducted due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose.
  • Prolonged use of the recalled Baby’s Vitamin D3 Liquid could potentially lead to elevated vitamin D levels, resulting in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.
  • Nordic Naturals can also be contacted directly at [email protected] or 888-294-7440, Monday – Friday, 8:00 a.m. - 5:00 p.m. PST.