The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).

Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.

The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.

A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.

The major players in electrophysiology – Boston Scientific Corp., Johnson & Johnson, Medtronic plc, Abbot Laboratories – showed up in force at the 2024 Heart Rhythm Society annual meeting in Boston May 16-19 to tout their pulsed field ablation devices and study results.

Shares of Dyne Therapeutics Inc. (NASDAQ:DYN) closed May 20 at $35.38, up $7.70, or 28%, on word of positive data from the phase I/II Achieve trial of DYNE-101 in myotonic dystrophy type 1 (DM1) and the phase I/II Deliver effort with DYNE-251 in Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping. CEO John Cox, who joined Waltham, Mass.-based Dyne eight weeks ago, said he “couldn’t be more proud to be part of this team.” Studies are ongoing, but new data with regard to DM1 as well as DMD showed a “compelling” impact, Dyne said, plus satisfying safety profiles.

U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.