Following a missed primary endpoint in its phase III study in treating anti-PD-1-refractory advanced melanoma, Idera Pharmaceuticals Inc. is considering stopping the registrational trial of its synthetic Toll-like receptor 9 (TLR9) agonist or pressing on toward the clinical trial’s second primary endpoint.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
HONG KONG – The third pre-revenue med-tech firm to list on the Hong Kong Stock Exchange in a month, New Horizon Health Technology Co. Ltd. raised HK$1.9 billion (US$245.08 million) in an IPO that began trading Thursday, Feb. 18. New Horizon placed 76.6 million shares at HK$26.66 apiece and said part of the funds will help the company commercialize its FIT-DNA test Coloclear to screen for colorectal cancer.
HONG KONG – Irvine, Calif.-based Trigr Therapeutics Inc. has signed an exclusive licensing deal with Shanghai-based Elpiscience Biopharmaceuticals Co. Ltd., known as Kewang in China. The two companies will develop and commercialize TR-009 in mainland China, Hong Kong, Macau and Taiwan.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.
The draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.
Mirati Therapeutics Inc.’s update on the phase I/II Krystal trial of the KRAS-G12C-targeting adagrasib (MRTX-849) was arguably the most eagerly awaited news, and certainly the most eagerly awaited KRAS-targeting news, to come out of the 2020 EORTC-NCI-AACR (ENA) Molecular Targets meeting. KRAS is one of the most frequently mutated oncogenes across a wide swath of solid tumors, and has been one of the toughest nuts to crack as far as druggability is concerned.
The European Society for Medical Oncology is slanted toward clinical medicine, and plenary sessions at the ESMO Virtual Congress 2020 featured phase III trials on approved drugs. But there were smaller sessions devoted to basic science as well. At one of those sessions, several researchers shared new insights into metastasis.
