Hot on the heels of news that two vaccines for COVID-19 are nearing market readiness, two companies have broken away from the pack of assay manufacturers to offer quantitative antibody tests that can verify whether the vaccines provide effective, lasting protection. Siemens Healthineers and Imanis Life Sciences both claim to be first to develop scalable, quantitative neutralizing antibody tests. Read More
Varian Medical Systems Inc. revealed that the first clinical trial of FLASH therapy has kicked off, with the initial treatment taking place at the Cincinnati Children's/UC Health Proton Therapy Center. The study, which saw the first patient treated this week, involves the investigational use of Varian's Probeam particle accelerator modified to enable radiation therapy delivery at ultra-high dose rates. Read More
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy. Read More
Sequana Medical NV scored a U.S. FDA breakthrough device designation last year for its fully implanted wireless device that automatically pumps fluids from the abdomen into the bladder. Now, it has released positive interim safety and efficacy data on that device, known as Alfapump, in the treatment of patients with recurrent or refractory ascites due to liver cirrhosis. Read More
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading. Testifying in a Nov. 17 hearing before the Senate Banking Committee, SEC Chair Jay Clayton suggested a mandatory period of four to six months between implementing or materially changing a 10b5-1 plan and the first allowed stock sale. He added that the cooling-off period should at least cover a full quarter. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dariohealth, Geneoscopy, Sequana Medical, Teleflex. Read More
Keeping you up to date on recent developments in diagnostics, including: Imaging methods reveal underlying cause of unexplained heart attack; Questionnaire predicts people at high risk for heart disease; Bias skews tally on imaging diagnostic test accuracy studies. Read More
