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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dariohealth, Geneoscopy, Sequana Medical, Teleflex.
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.
HONG KONG – Helio Health Inc. has new data that demonstrate the high accuracy and screening value of its cell-free DNA (cfDNA) methylation blood test for the detection of hepatocellular carcinoma (HCC).
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