Hannah Clarke

Associate Editor at MJH Life Sciences

Editor, MJH Life Sciences | MPH candidate at Johns Hopkins University | views expressed are my own

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Articles

FDA awards Regenerative Medicine Advanced Therapy Designation to CAN-2409 for prostate cancer

1 week ago | urologytimes.com | Hannah Clarke

The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) Designation to aglatimagene besadenovec (CAN-2409), an investigational off-the-shelf, replication-defective adenovirus for newly diagnosed intermediate- to high-risk localized prostate cancer, Candel Therapeutics announced in a news release.1The therapeutic was previously awarded a Fast Track Designation for the same indication.
Intraprostatic drug elution therapy shows promise for BPH-related LUTS

1 week ago | urologytimes.com | Hannah Clarke

Paclitaxel eluting bioabsorbable implants demonstrated encouraging efficacy and appeared to be safe and feasible in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to 6-month data from a phase 1 first-in-human study (NCT06136819).1The bioabsorbable implants are a novel office-based, minimally invasive form of intraprostatic drug elution (IPDE) therapy.
Subcutaneous nivolumab approved in EU, Canada for solid tumors

1 week ago | urologytimes.com | Hannah Clarke

The European Commission (EC) and Health Canada have approved the subcutaneous (SC) formulation of nivolumab (Opdivo), co-formulated with recombinant human hyaluronidase (rHuPH20; Enhanze), across several previously approved solid tumor indications.1,2,3This includes nivolumab as a monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib (Cabometyx).
Phase 3 trial of tebipenem HBr for cUTI stopped early for efficacy

1 week ago | urologytimes.com | Hannah Clarke

GSK and Spero Therapeutics announced that the pivotal phase 3 PIVOT-PO trial (NCT06059846) of tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infection (cUTI) has been stopped early following an interim analysis of the data showing that the trial met its primary end point.1The decision was made based on a recommendation from the Independent Data Monitoring Committee (IDMC), which conducted an analysis of the first 1690 patients in the study.
Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

1 week ago | urologytimes.com | Hannah Clarke

Visby Medical has submitted an application to the FDA seeking 510(k) clearance and a clinical laboratory improvement amendments (CLIA) waiver for their point-of-care (POC) Men’s Sexual Health Test, the company shared in a news release.1The single-use, instrument-free test is designed to deliver polymerase chain reaction (PCR) diagnostic results for chlamydia and gonorrhea in approximately 30 minutes using male urine samples. The test can be conducted in men with or without symptoms.
Combination therapy linked to longer OS vs ADT in veterans with mHSPC

1 week ago | urologytimes.com | Hannah Clarke

Data published in JAMA Network Open suggest that use of combination therapy in veterans with de novo metastatic-hormone sensitive prostate cancer (mHSPC) has increased over time and is associated with significantly longer overall survival (OS) vs androgen-deprivation therapy (ADT) monotherapy.1,2“The increased use of combination therapy over time is expected, as implementation of novel therapies typically occurs over several years,” the authors noted.
Expert discusses the promise of emerging MISTs for BPH

2 weeks ago | urologytimes.com | James Ulchaker |Hannah Clarke

In recent years, the treatment landscape for benign prostatic hyperplasia (BPH) has rapidly evolved with the rise of minimally invasive surgical therapies (MISTs). These innovative options not only offer greater convenience for patients, but also place a strong emphasis on preserving sexual function and enhancing overall quality of life. As the number of available MISTs continues to grow, treatment plans are becoming increasingly tailored to meet each patient’s unique needs.
Live updates: FDA Advisory Committee on talazoparib plus enzalutamide for mCRPC

2 weeks ago | urologytimes.com | Hannah Clarke

The FDA’s Oncologic Drugs Advisory Committee (ODAC) is set to meet on May 21, 2025 to discuss the submitted supplemental new drug application (sNDA) for talazoparib (Talzenna) in combination with enzalutamide (Xtandi) for the proposed indication of adult patients with metastatic castration-resistant prostate cancer (mCRPC) unselected for homologous recombination repair (HRR) gene alterations.1 The FDA previously approved talazoparib in combination with enzalutamide for patients with...
Live updates: FDA Advisory Committee meeting on UGN-102 for LG-IR-NMIBC

2 weeks ago | urologytimes.com | Hannah Clarke

The FDA’s Oncologic Drugs Advisory Committee (ODAC) is set to meet on May 21, 2025 to discuss the submitted new drug application (NDA) for UGN-102 (mitomycin) intravesical solution for the proposed indication of adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).1The recommended dose level for UGN-102 is 75 mg (56 mL) instilled once weekly for 6 weeks. Approval of UGN-102 would mark the first FDA-approved treatment for LG-IR-NMIBC.
Pivotal trial launches of 64Cu-SAR-bisPSMA in BCR of prostate cancer

2 weeks ago | urologytimes.com | Hannah Clarke

The first clinical trial site has been initiated in the pivotal phase 3 AMPLIFY trial (NCT06970847), evaluating the efficacy and safety of 64Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer, Clarity Pharmaceuticals announced in a news release.1 64Cu-SAR-bisPSMA was granted a fast track designation from the FDA in January 2025 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with BCR of prostate cancer following initial...