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and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs.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.
Vessi Medical Ltd. has scooped up $1.7 million in series A funding to move forward with a first-in-human study of its minimally invasive bladder cancer device. The trial is set to launch in the first quarter of 2021. Leading the funding round are the Trendlines Group Ltd. and Agriline Ltd. The Trendlines Group already counts Misgav, Israel-based Vessi Medical as part of its portfolio of medical startups.
CAPS Medical, of Netanya, Israel, closed a $3.5 million series A round led by Chasing Value Asset Management and the Los Angeles-based Israel Investment Fund Group. The new funds will be used to enable CAPS to undertake its first clinical trial for its minimally invasive, nonthermal plasma device for cancer treatment and further develop its portfolio for the treatment of solid tumors.
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
TORONTO – Imagin Medical Inc., which has a presence near Boston and in Vancouver, British Columbia, will have verified and built a device in early January that meets all functional, electrical safety and radiated emission requirements for a new way of visualizing bladder cancer. Jim Hutchens, Imagin Medical’s president and CEO, said the i/blue imaging system should dramatically improve surgeons’ ability to visualize cancerous bladder cells by producing higher quality images more quickly compared with current methods.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
The “remarkably appealing” route of administration and every-three-month dosing put Ferring Pharmaceuticals SA’s nadofaragene firadenovec (rAd-IFN/Syn3, also known as Instiladrin) in strong position for approval in high-grade Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC).
TEL AVIV, Israel – With shares now listed in the U.S. and data from a pivotal trial for its key bladder cancer therapy coming soon, Anchiano Therapeutics Ltd. is poised to ride the wave of interest in gene therapy.
