Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
Lantheus Holdings Inc. has snagged FDA approval for Pylarify (piflufolastat F 18), a PET imaging agent for the identification of suspected metastasis or recurrence of prostate cancer. The company said the product will be available immediately in the mid-Atlantic and southern regions, with availability across the U.S. by the end of 2021.
HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform.
A check up by Khosla Ventures determined that Docbot Inc. was healthy enough for the prominent biotech investor to take the lead in a $4 million series A round. The new funds bring the artificial intelligence company to a total of $8.5 million in capital raised to date. Other participants included Bold Capital Partners, Collaborative Fund and Boutique Venture Partners.
Veriskin Inc. has emerged from stealth mode with a noninvasive technology for skin cancer diagnosis and screening. The hand-held device, called Truscore, is designed to help nonexpert users quickly ascertain if a suspicious skin lesion is cancerous. Truscore works by detecting and interpreting force-induced hemodynamic differences between normal and malignant skin sores. It uses a proprietary artificial neural network-based artificial intelligence algorithm and protocols to differentiate skin cancers from other harmless skin conditions.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
The U.S. Preventive Services Task Force (USPSTF) has updated its recommendations for lung cancer screening, which expands the age group for screening to include those aged 50-54 years. The change has forced CMS to reopen the national coverage memo for low-dose CT screening for lung cancer, which appears to be set to add millions to the number of Americans who are eligible for annual screening procedures.
While saying "white rabbit, white rabbit" on the first of the month may be a luck-bringing superstition, Whiterabbit.ai aims to take luck out of the equation in identifying early breast malignancies. The Santa Clara, Calif.-based company emerged from stealth mode with FDA clearance for its Wrdensity tool, two other products, and more than $49 million in funding to date.
Caris Life Sciences Inc. raised $830 million in a capital growth round led by Sixth Street Partners, the latest show of private investors’ zeal for backing precision medicine ventures. The infusion, which includes $235 million in equity financing, will be used for continued commercial expansion and to advance its liquid biopsy platform. T.R. Price Associates Inc., Silver Lake, Fidelity Management & Research Co. LLC were significant contributors in the round.
Avenda Health Inc. has taken a page out of the breast cancer book with a new technology that offers very localized treatment of prostate tumors in a procedure the company refers to as a prostate cancer lumpectomy. The FDA granted breakthrough device designation to the product based on its potential to transform care for one of the most common cancers.