Ureter

Olympus Announces FDA Clearance of RenaFlex™, Its First Single-use Flexible Ureteroscope

Retrieved on: 
Tuesday, April 2, 2024
System, U.S. FDA, Burns, Urology, Small Business Saturday, Lithotripsy, Endoscopy, Risk, Patient, Perforation, Infection, Health professional, Bleeding, Ureteroscopy, Kidney, Ureter, Urethra, Physician, Medical imaging

CENTER VALLEY, Pa., April 2, 2024 /PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today U.S. FDA 510(k) clearance of its first single-use ureteroscope system, RenaFlex™, with full market availability to be announced at a later date.

Key Points: 
  • The RenaFlex single-use flexible ureteroscope system is used to access and visualize the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones.
  • The RenaFlex ureteroscope can be used with endotherapeutic accessories to perform diagnostic and therapeutic procedures within the urinary tract.
  • The RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible Single-use Endoscopes.
  • Visit the urology product page for more information about the complete line of Olympus urology solutions.

ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial

Retrieved on: 
Wednesday, February 21, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Large intestine, Bangladesh Technical Education Board, Cancer, HNPCC, Medicine, B cell, TTY, DCP, FDA, Safety, Hereditary nonpolyposis colorectal cancer, National Cancer Institute, Vaccine, Risk, Biliary tract, Stomach, Antigen, Ureter, Patient, Pancreas, NK, Clinical trial, Protein, Diagnosis, Translational research, Colorectal cancer, Adenoviridae, Immune system, Brain, Pharmaceutical industry

The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.

Key Points: 
  • The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.
  • Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.
  • The vaccine combination is studying whether activation of dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer occurs.
  • Safety and efficacy of these investigational agents have not been established by any Health Authority, including the FDA.

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Pembrolizumab, Brentuximab vedotin, PDUFA, Inc., Pharmaceutical industry

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022.

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Astellas Pharma, FDA, Pembrolizumab, Brentuximab vedotin, PDUFA, Pharmaceutical industry

TOKYO and BOTHELL, Wash., Nov. 30, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • We are committed to delivering on our goal of helping patients with advanced urothelial cancer live longer."
  • "Through our clinical development program, data have consistently shown the impact of combining enfortumab vedotin with pembrolizumab for advanced bladder cancer.

The Inner Circle Acknowledges, Joe Littlejohn, Jr as a Top Pinnacle Professional for his contributions to the field of Medical Technology and Urology

Retrieved on: 
Friday, June 16, 2023
Male, Telehealth, Society, Howard University Hospital, Paruresis, Neurogenic bladder dysfunction, Gland, University, National Medical Association, Test management, University of Connecticut Health Center, EMR, Health technology, Data collection, American Urological Association, Penn State Health Children's Hospital, Medicine, DEI, Privacy, Christianity, Assistant, Inner circle, American Board of Commissioners for Foreign Missions, Patient, Love, Specialization, Ureter, NewYork-Presbyterian Hospital, General surgery, Department of Urology, University of Virginia, HPI, University of Connecticut School of Medicine, Health, Hospital, System, Female, Prostate cancer, Nursing, Medical imaging, Urology

MECHANICSBURG, Pa., June 16, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Joe Littlejohn, Jr. is acknowledged as a Top Pinnacle Professional for his contributions to the field of Medical Technology and Urology.

Key Points: 
  • MECHANICSBURG, Pa., June 16, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Joe Littlejohn, Jr. is acknowledged as a Top Pinnacle Professional for his contributions to the field of Medical Technology and Urology.
  • According to the doctor, urology is the branch of medicine that focuses on surgical and medical diseases of the male and female urinary-tract system and the male reproductive organs.
  • Aside from his medical career, Dr. Littlejohn, Jr. serves as an Assistant Professor of Surgery within the Department of Urology at Penn State Health Milton S. Hershey Medical Center.
  • The doctor offers his services at Penn State Health Surgery Specialties (Hershey Pennsylvania) & Penn State Health Medical Group Camp Hill Specialties.

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Ureter, American Urological Association, Society, Investment, Software, AUA, New Drug Application, Clinical trial, NDA, RNU, SUO, Mitomycins, UTUC, Patient, OLYMPUS, Physician, Guideline, RTW, Webcast, Growth, LG, Neoplasm, Conference, Safety, ATLAS, Pharmaceutical industry, Medical imaging, Video game, Bank, Mitomycin C

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.
  • Generated net product revenue of $17.2 million for the first quarter of 2023, representing ~27% growth over the first quarter of 2022.
  • Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, while repeat accounts on May 1, 2023 were 235, compared to 214 on March 1, 2023.
  • First Quarter 2022 Financial Results:
    Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2023 of $17.2 million, compared to $13.6 million in the first quarter of 2022.

New Retrospective Study Presented at AUA 2023 Provides Evidence of Similar Outcomes Utilizing JELMYTO® in the Treatment of UTUC of the Ureter and Renal Pelvis  

Retrieved on: 
Sunday, April 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Ureter, Urine, Stenosis, Safety, Neoplasm, Efficacy, American Urological Association, Mitomycins, UTUC, State University of New York Upstate Medical University, OLYMPUS, Patient, Kidney, LG, Abstract, Treatment, Pharmaceutical industry, Medical imaging

The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors.

Key Points: 
  • The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors.
  • The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs. renal pelvis) (p=0.644).
  • JELMYTO is approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
  • “These data are promising for LG-UTUC patients with ureteral tumors,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen.

American Urological Association Releases Non-Metastatic Upper Tract Urothelial Carcinoma Guideline

Retrieved on: 
Tuesday, April 25, 2023
Ureter, Survival, UTUC, Diagnosis, Cancer, Mortality, Bladder cancer, Estate (law), Patient, MD, Memorial Sloan Kettering Cancer Center, Guideline, Disease, Pharmaceutical industry, Medical device

UTUC is a rare disease, posing unique challenges to clinical management and significant risks to patients – both from the disease and treatment forms.

Key Points: 
  • UTUC is a rare disease, posing unique challenges to clinical management and significant risks to patients – both from the disease and treatment forms.
  • UTUC is a cancer in either the inner lining of the ureter, calyces, or renal pelvis.
  • Clinicians will not only learn how to evaluate patients, but they will get the most up to date information on treatment, surveillance, survivorship and more."
  • This guideline has 38 recommendations and serves as a useful reference on the effective evidence-based diagnosis and management of non-metastatic UTUC.

National Multicenter Trial Opens to Study ImmunityBio’s Tri-Ad5 Cancer Vaccines Plus N-803 to Prevent Cancer in People with Lynch Syndrome

Retrieved on: 
Tuesday, April 25, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Vaccine, Ureter, Medicine, Hereditary nonpolyposis colorectal cancer, Clinical trial, DCP, Pancreas, Cancer, NK, Brain, Large intestine, Bangladesh Technical Education Board, Stomach, Colorectal cancer, National Cancer Institute, Protein, Endometrial cancer, TTY, Patient, Risk, Immune system, Diagnosis, Adenoviridae, Biliary tract, NCI, B cell, Pharmaceutical industry, ImmunityBio COVID-19 vaccine

This Phase 2b trial ( NCT05419011 ) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants.

Key Points: 
  • This Phase 2b trial ( NCT05419011 ) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants.
  • Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.
  • “Lynch syndrome affects tens of thousands of people each year and the average age of cancer diagnosis for them is just 44.
  • We hope to change that with this innovative study developed by the NCI.”
    Lynch syndrome is one of the most common hereditary cancer syndromes.

UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 10, 2022
Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, Adult, Clothing, Risk, Transitional epithelium, Patient Information Advisory Group, Stomach, Company, Pharmakon—Danish College of Pharmacy Practice, Kidney, Recurrence, Blood, Ureter, Swelling, Birth, Urination, Urinary tract infection, SEC, NMIBC, Water, Time, Cancer, Orphan drug, Neoplasm, Patient, UTUC, Urine, COVID-19, Vomiting, Private Securities Litigation Reform Act, Sodium bicarbonate, Bone marrow, Medicine, Clinical trial, Breast milk, Fatigue, Skin, Growth, Abdomen, Nausea, Perforation, NDA, FDA, Trial of the century, Urinary bladder, Fever, Technology, View, Man, Safety, Female, Pain, Transitional cell carcinoma, Nephrectomy, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221110005284/en/