The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first microRNA-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
Researchers at Thomas Jefferson University have found that using ultrasound to pop microbubbles already present in a contrast agent nearly doubled liver tumor response to transarterial radioembolization. The procedure raised no safety concerns and increased the likelihood of patients receiving a liver transplant.
Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of GT-90001 (ascrinvacumab) and Opdivo (nivolumab) for advanced hepatocellular carcinoma.
HONG KONG – Takeda Pharmaceutical Co. Ltd. has received Chinese approval for Takhzyro (lanadelumab), its fully human monoclonal antibody, delivered via subcutaneous injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 and older.
Suzhou, China-based Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of its angiogenesis inhibitor, GT-90001 (ascrinvacumab), and Opdivo (nivolumab) for advanced hepatocellular carcinoma (HCC) after preliminary data showed 40% of patients given the combo so far had partial remissions.
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.
