Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast bringing you the latest insights shaping patient access, regulatory policy, and healthcare innovation. I'm your host, and let's get into today's headlines.
First up, the Trump administration has expanded its government-backed pharmaceutical portal, TrumpRx.gov, to now feature more than 600 generic medication, a significant increase from its original 74 branded offerings. Rather than functioning as a direct pharmacy, the platform acts as a price aggregator, pulling cash-pay pricing from Amazon Pharmacy, GoodRx, and Mark Cuban's Cost Plus Drugs to bypass traditional PBM frameworks. To secure these listings, the administration offered three-year tariff exemptions to 17 manufacturers in exchange for aligning US prices with those in other developed nations, with the administration projecting $64.3 billion in federal and state savings over the next decade.
Next, the US Supreme Court has declined to hear appeals from pharmaceutical companies, including AstraZeneca and Janssen, challenging the federal government's authority to negotiate Medicare drug prices under the Inflation Reduction Act. The Court's refusal, issued without comment, leaves intact lower-court rulings that rejected manufacturers' Fifth and First Amendment arguments, with courts noting that companies retain the option to exit Medicare and Medicaid markets and therefore cannot block the government from setting pricing terms as a condition of participation. The government has now negotiated prices for 25 drugs, including GLP-1s like Ozempic and Wegovy, with a third round underway—and because the statute has no end date, stopping the program could require an act of Congress.
In M&A news, Eli Lilly has entered into an agreement to acquire Engage Biologics Inc. in a deal valued at up to $202 million, combining Engage's proprietary non-viral DNA delivery platform with Lilly's expanding genetic medicines portfolio. At the center of the deal is Engage's Tethosome platform, a novel system engineered to co-formulate a DNA expression vector and an mRNA strand in a lipid nanoparticle—enabling sustained gene expression in target cells while reducing the immune activation and re-dosing limitations that have constrained competing approaches. Early preclinical work has focused on hepatic delivery in models of hemophilia A and hepatocellular carcinoma, and for Lilly, adding the technology at this stage offers the opportunity to shape its development trajectory alongside existing internal capabilities in target discovery, manufacturing, and clinical operations.
And finally, the FDA's leadership upheaval continued this week with the removal of the acting directors of its two primary product review centers following Commissioner Marty Makary's resignation earlier this month. Tracy Beth Høeg, who had been serving as acting CDER director, stated publicly that she was fired, while Katherine Szarama has departed as acting CBER director; Michael Davis has been named acting head of CDER, and Karim Mikhail, a former pharmaceutical executive, takes over at CBER. Chief of Staff Jim Traficant was also removed, with Lowell Zeta named acting chief of staff—leaving the agency without permanent leadership at the commissioner level or at either of its two most consequential review centers.
That's it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access, visit pharmaceuticalcommerce.com. Thanks for listening—until next time, stay well and stay informed.
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