Mari Serebrov

With its stock price falling as much as 70% July 27, Capricor Therapeutics Inc. took the rare step of issuing a news release to explain the negative tone of the U.S. FDA's briefing document for the July 29 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss the company's BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy.

Boston Scientific Corp. came out the all-around winner July 27 when the U.S. Court of Appeals for the Federal Circuit reversed a jury verdict that found the med-tech company's drug-eluting coronary stent systems infringed a University of Texas System patent.

After repeatedly invoking the Fifth Amendment to every question asked during the July 29 hearing of the U.S. Senate Homeland Security Committee, Anthony Fauci, the now retired head of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), faces a committee vote next week on a resolution citing him for contempt.

Erica Schwartz is one step away from becoming the next director of the U.S. CDC. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-10 July 30 to favorably report her nomination to the Senate floor for confirmation. The committee also favorably reported the nomination of Sean Kaufman, on a party line vote of 12-11, to be the assistant secretary for preparedness and response (ASPR) at the Department of Health and Human Services.

Once again, medical device sponsors will see a considerable jump in their U.S. FDA user fees come Oct. 1. Across the board, MDUFA fees are increasing 10%, while the annual device establishment registration fee will see a 21% hike.

Keeping the government funded beyond Sept. 30 is the top priority on the U.S. Senate's to-do list as it races toward its August recess. The Senate's bipartisan version of a continuing resolution (CR) cleared a procedural vote Aug. 3 that could lead to a vote before the senators leave town Aug. 7. If the Senate passes the CR, it will head to the House, which passed its own CR in July on a vote of 220-205. Both versions would temporarily keep the government funded at current levels.

The U.S. Health Resources and Services Administration is moving ahead with its second attempt at establishing a 340B rebate pilot program for manufacturers with prescription drugs selected for Medicare negotiations in initial payment years 2026 and 2027.

A Senate Finance subcommittee held a brainstorming session of sorts to explore ways to spur U.S. innovation to address two of the biggest threats to growing a strong domestic biotech sector. Those threats? China and the public health crisis being spawned by increasing antimicrobial resistance.

Erica Shwartz rode to U.S. Senate confirmation on a 51-44 party-line vote Aug. 5 to become the second CDC director in the current Trump administration.

Despite several attempts by Democratic members to table a contempt resolution Aug. 6, the U.S. Senate Homeland Security Committee voted 8-5 along party lines to hold former NIH official Anthony Fauci in contempt of Congress. (Two Democrats also voted by proxy against the resolution.)