Flare Therapeutics Inc. has synthesized peroxisome proliferator-activated receptor γ (PPARγ) inverse agonists reported to be useful for the treatment of bladder cancer.
Lift Biosciences Ltd. has shown that its first-in-class cell therapy destroyed on average over 90% of the tumoroid in a PDX (patient-derived xenograft) organoid across five solid tumor types, including bladder cancer, rectal cancer, colorectal cancer, gastric cancer and squamous cell non-small-cell lung cancer (NSCLC).
Nanostics Inc. launched a new trial of its Claritydx Bladder with support from Alberta Innovates to the tune of C$600,000 (US$465,690). The test uses extracellular vesicle detection technology and artificial intelligence to identify bladder cancer and could provide a valuable alternative to cystoscopy for detection of bladder cancer at earlier stages.
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found the test has a 93% sensitivity and 93% specificity for detecting bladder cancer. The test is also designed to predict whether people are more likely to respond to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer.
Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.
The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.
New evidence about the role of the RSK family of protein kinases in cancer has cut through conflicting experimental data to demonstrate they have different functions and that the RSK4 isoform is a promoter of drug resistance and metastasis in lung and bladder cancer.
TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs.
Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
