• Delaware: AstraZeneca has petitioned the U.S. Supreme Court to hear its case challenging the Inflation Reduction Act's Medicare Drug Price Negotiation Program. According to The Hill, two of AstraZeneca's drugs have been selected for drug price negotiations, with the first being the diabetes medication Farxiga and the second being the mantle cell lymphoma treatment Calquence. "This case concerns the fate of a new government program that will overhaul the $600-billion prescription drug market and affect the lives and health of the 68 million Americans enrolled in Medicare," the company wrote in its petition. "Contrary to its statutory name, it involves no genuine 'negotiation.' Rather, it compels pharmaceutical manufacturers to sell their most innovative and widely used medicines at prices unilaterally chosen by [CMS] on behalf of [HHS]." Several other drugmakers and trade groups have filed lawsuits against Medicare drug price negotiation, but they have been consistently shot down in federal court, with judges ruling that the law is not unconstitutional. "After 14 courtroom defeats to date, this latest appeal is just another attempt by the industry to restrict the government's power to secure a better deal for patients and delay the inevitable," said Merith Basey, executive director of Patients For Affordable Drugs. (Choi, The Hill, 9/25)
• Maryland: FDA recently approved a new form of Merck's cancer immunotherapy drug Keytruda. According to MedCity News, Keytruda is Merck's top revenue generator, accounting for $15.1 billion in sales during the first half of 2025 alone. However, its patent is set to expire in 2028, allowing cheaper biosimilars to enter the market. Instead of being administered intravenously, the new product, which is called Keytruda Qlex, is an injectable medication. FDA approved the use of Keytruda Qlex for children and adults ages 12 and older for 38 solid tumor indications. Patients can either receive a one-minute injection every three weeks or a two-minute injection every six weeks. "As part of supporting patients and families through their cancer journeys, we are excited to see patient-focused developments in subcutaneous cancer treatment that shorten administration time and may allow for more patients to receive treatment in multiple health care settings," said Sally Warner, CEO of the Cancer Support Community. (Vinluan, MedCity News, 9/21)
• New York: Pfizer has agreed to acquire biotech company Metsera in a deal valued at $4.9 billion. The acquisition will allow Pfizer to access Metsera's pipeline of oral and injectable weight-loss treatments, including a GLP-1 drug that led to significant and sustained weight loss in a Phase 1 trial and an amylin-targeting drug that has also shown potential. According to STAT, Pfizer has struggled to break into the obesity care market, especially after it discontinued development of its lead obesity candidate danuglipron due to safety concerns. "The proposed acquisition of Metsera aligns with our focus on directing our investments to the most impactful opportunities and propels Pfizer into this key therapeutic area," said Pfizer CEO Albert Bourla. "We are excited to apply our deep cardiometabolic experience and manufacturing and commercial infrastructure to accelerate a portfolio that includes potential best-in-class injectables." (Joseph, STAT+ [subscription required], 9/22)

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