• District of Columbia: The Federal Trade Commission (FTC) has filed a lawsuit to block Edward LifeSciences' acquisition of JenaValve Technology. According to FTC, the acquisition would negatively impact innovation in treatments for aortic regurgitation (AR), a serious heart condition where blood leaks into the heart chamber. Because there are few treatment options for AR, FTC says the merger would reduce competition. "The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards' JC Medical subsidiary continue competing to innovate, expand treatment eligibility, and keep down costs," said Daniel Guarnera, director of the FTC's Bureau of Competition. In response, Edwards said it disagrees with FTC's decision and argued that the acquisition will "accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR." The company said it plans to continue seeking regulatory approval for the acquisition and expects a final decision to be made by the end of the first quarter of 2026. JenaValve also said it remains committed to completing the deal and will join Edwards to argue their case in court. (Murphy, Becker's Hospital Review, 8/7; Kelly, MedTech Dive, 8/6)
• Maryland: Last week, FDA announced the launch of a new program called "FDA PreCheck" to help expedite approval of new U.S. drug manufacturing facilities. According to FDA, streamlining the regulatory approval process for pharmaceutical plants will make it easier to build drug manufacturing sites in the United States and help bolster the domestic pharmaceutical supply chain. The PreCheck program includes more frequent communication between FDA and manufacturers during the development stages, including facility design, construction, and preproduction. The program also offers manufacturers preapplication meetings and early feedback on how a drug will be manufactured and controlled. "Our gradual overreliance on foreign drug manufacturing has created national security risks," said FDA Commissioner Marty Makary. "The FDA PreCheck initiative is one of the many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply." (O'Connell-Domenech, The Hill, 8/7; Twenter, Becker's Hospital Review, 8/7)
• New Hampshire: Gov. Kelly Ayotte (R) last week signed two bills banning gender-affirming care for minors in New Hampshire, making it the first Northeastern state to do so. The bill H.B. 377 prohibits doctors from administering puberty blockers and hormones for transgender youth, and the bill H.B. 172 expands on the state's existing restrictions on gender-affirming surgery. Both bills are scheduled to go into effect in January. In a statement, Ayotte said that "[m]edical decisions made at a young age can carry lifelong consequences, and these bills represent a balanced, bipartisan effort to protect children." However, LGBTQ rights groups have heavily criticized the bills and said that they ignore testimony from transgender youth who have benefited from gender-affirming care, as well as statements from major medical associations saying that such care is medically necessary and can be lifesaving for transgender children and adults. According to Linds Jakows, founder of the state LGBTQ rights group 603 Equality, transgender young people in the state "are not only tangibly losing access to life-saving healthcare — but also receiving a disturbing message of rejection from their state government." (Migdon, The Hill, 8/4)

In a rapidly changing pharmaceutical landscape, three foundational forces are set to shape the industry's future: artificial intelligence and machine learning in drug development, the urgent need for health equity, and the role of patient-reported outcomes. Discover why these forces are critical for manufacturers to consider in their strategic planning for 2025 and beyond.