Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).
After climbing nearly 37% since the start of the week, shares of Greenwich Lifesciences Inc. (NASDAQ:GLSI) gained another 6% on April 9 as it disclosed new data bolstering the case for its cancer immunotherapy candidate, GP2. The data, to be presented at the American Association for Cancer Research annual meeting on Saturday, showed that when HER2-positive breast cancer patients had GP2 added to standard-of-care Herceptin (trastuzumab, Roche Holding AG) following breast cancer surgery, no recurrences of their cancer were observed, even after a median follow-up of five years.
Companion diagnostics-focused Celcuity Inc. CEO Brian Sullivan said the deal with Pfizer Inc. for rights to pan-PI3K/mTOR inhibitor gedatolisib was “an organically developed opportunity, because of the research we had done on gedatolisib” in the course of investigating PI3K inhibitors. “We hadn’t shifted our strategy and said, ‘Oh, let’s start in-licensing drugs.’”
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.
Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
PERTH, Australia – Wellington, New Zealand-headquartered Volpara Health Technologies Ltd. has acquired Boston-based CRA Health LLC for $18 million up front and an additional $4 million to be paid over the next 18 months in earnouts. Volpara’s digital health solutions use imaging and artificial intelligence (AI) for early detection of breast cancer. The company’s clinical functions for screening clinics provide feedback on breast density, compression, dose, and quality, while its enterprise-wide practice software management helps with productivity, compliance, reimbursement and patient tracking.
One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor.
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.
Arcus Biosciences Inc., in a presentation on the opening day of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), reported a 41% objective response rate across the first four cohorts in its phase I dose-escalation study of AB-680, a small-molecule CD73 inhibitor for treating metastatic pancreatic cancer. The data also showed 88% of patients experienced at least some shrinkage of their lesions.
