• Kentucky: Last week, Sen. Mitch McConnell (R-Ky.) announced that he has been discharged from a rehabilitation facility after almost eight weeks of medical absence. "On the advice of my doctors, I'll maintain an intensive regimen of physical therapy from home during the state work period, and I'll continue to engage with my staff and colleagues on important Senate business," McConnell said in a statement. McConnell has been absent from Congress since mid-June after experiencing a fall and a "mild" case of pneumonia. In recent years, McConnell has experienced several health issues, including freezing during a press conference and a series of falls. In February, McConnell was hospitalized for a week after experiencing flu-like symptoms. In 2024, McConnell announced that he was stepping down as Senate Majority Leader, and in 2025, he said he would not seek re-election, ending his tenure in the Senate in January 2027. Currently, it's not clear when or if McConnell will return to the Senate when it resumes its session in September. (Diaz, New York Times, 8/6; Daniels, Politico, 8/6)
• Maryland: FDA has selected Dexcom as the first participant in a new digital health pilot called the Technology-Enabled Meaningful Patient Outcomes (TEMPO) program. The program will allow certain devices to be exempted from the agency's premarket authorization requirements while also collecting real-world data through a complementary Medicare program. According to MedTech Dive, Dexcom is planning to implement an AI-enabled glucose health program, which will help screen for prediabetes and type 2 diabetes, through the pilot. By participating in the pilot, Dexcom said it will be able to generate real-world evidence on how its glucose sensors and digital health programs can help support earlier intervention strategies. Through the pilot program, FDA will accept up to 10 manufacturers across four CMS focus areas, which cover conditions like hypertension, diabetes, heart disease, chronic kidney disease, musculoskeletal pain, anxiety, and depression. Currently, the agency is considering statements of interest from manufacturers and has not set a deadline for when it will stop accepting them. (Reuter, MedTech Dive, 7/23)
• New Jersey: Johnson & Johnson (J&J) has come to a strategic agreement with Sail Biomedicines to advance Sail's immune-mediated disease program and broader technology platform. Through the collaboration, Sail will be able to expand the application of its in vivo CAR T platform across more therapeutic targets over time. As part of the agreement, J&J will make an initial payment of $785 million, including a $465 million equity investment and additional contingent payments of $140 million if certain development goals are met. It is also granted an exclusive option to acquire Sail for $2.58 billion. According to John Reed, J&J's EVP of innovative medicine research and development, the company hopes to accelerate the development of innovative therapies by working with Sail. (Yoon, Wall Street Journal, 7/29)

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