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House of Representatives Approves Bipartisan 21st Century Cures Legislation
The House of Representatives has approved the bipartisan 21st Century Cures legislation, which includes funding for innovative research and provisions to speed up the drug approval process.
By a vote of 392-26, the House approved the 21st Century Cures Act. The House had passed an earlier version of the bill in July 2015 but continued to revise and update it, releasing the most recent draft of the bill last week. These updates included provisions for mental health, substance abuse, and child and family services.
Members of both political parties have been vocal in their support of the legislation, often citing its passage as a top priority during the lame-duck Congressional session. Prior to the election, Senate Majority Leader Mitch McConnell, R-Kentucky, had said it “could end up being the most significant piece of legislation we pass in the whole Congress."
Read more here.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
