The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empowered Diagnostics.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Another biopharma consultant got on the wrong side of the U.S. SEC for insider trading. To resolve the allegations, Hugh Lee Sweeney, a longtime consultant for Catabasis Pharmaceutical Inc., agreed to a cease-and-desist order, disgorgement of $57,931 and prejudgment interest of $2,499.71, and civil penalties of $57,931.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Annovis, Bausch + Lomb, Clovis, Diamedica, Innocare, Pfizer, Xortx.
The U.S. FDA has applied a class I designation to the recall of Flow-c and Flow-e anesthesia systems manufactured by Getinge AB of Gothenburg, Sweden, due to reports of faulty on-off switches, which could lead to a failure to provide the needed suction. While no injuries or fatalities have been reported in connection with the problem, the FDA said one possible consequence of device failure is pulmonary obstruction that could ultimately lead to death.
The U.S. Securities and Exchange Commission (SEC) filed insider trading charges against Doron Tavlin, formerly the vice president of business development for Mazor Robotics Ltd., of Caesarea, Israel, over a transaction that took place four years ago. The SEC is charging Tavlin with disclosing the then-impending acquisition of Mazor by Dublin-based Medtronic plc. to a personal friend, but these types of activities are becoming easier to detect thanks to analytics used by the SEC.
A few weeks ago, the odds of the deeply divided U.S. Congress passing drug pricing reforms that would allow direct Medicare negotiation seemed pretty slim. But those odds improved significantly July 6 when Senate Democrats reached a compromise on their version of the pricing provisions included in the Build Back Better bill, H.R. 5376, passed by the House last November.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
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