Mckesson Corp. has brought together several oncology organizations, life sciences companies, and patient advocacy groups to increase understanding of non-small-cell lung cancer (NSCLC) and leverage targeted therapies to improve outcomes. The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) study will observe and analyze 12,000 community-based, metastatic NSCLC patients to learn more about barriers to molecular testing for targeted therapies, how those therapies are being used, and to expand opportunities for participation in clinical trials.
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.
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.
Becton, Dickinson and Co. (BD) reported revenue of $4.32 billion for the first quarter of fiscal year 2021, up 25.8% on a reported basis and 24.3% on a currency neutral basis. COVID-19 testing contributed 20.5% of that growth, totaling $867 million for the period, including $688 million in Veritor Plus system sales.
Chinese heart valve specialist Microport Cardioflow Medtech Corp. (HKEX:2160) launched an IPO in Hong Kong on Feb. 4, raising HK$2.5 billion (US$324 million) by issuing 205.62 million shares at HK$12.20 apiece. With J.P. Morgan, Citi and CICC backing the IPO, the stock opened at HK$21.50, up 76% from the offer price. The pre-revenue med-tech firm, spun off from Microport Scientific Corp. in 2020, develops transcatheter aortic valve implantation (TAVI) products for valvular heart diseases, and is especially known for its Vitaflow series.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CEO tells patients their deaths were impending for profit; DeGette, Bucshon ink new testing legislation; NICE: Acupath’s URO17 test needs more data.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B-Secur, Claronav Kolahi, RapidAI, Precision Biomonitoring, Precision Spine.