|
|
|
|
|
|
|
M T W Th Fri |
|
21 November, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Merck was the first to file suit against Medicare drug price negotiations, and it may be the last to get a decision. Teva lost its IRA challenge in district court yesterday, so now Merck’s case (filed in 2023!) is the only one left at the lower court level. We’re also still waiting on the Fifth Circuit to decide on PhRMA’s appeal in a separate IRA case. It remains to be seen if the Supreme Court will wade into any of these lawsuits. |
|
|
|
Alexis Kramer |
Editor, Endpoints News
|
|
|
|
|
|
|
by Max Bayer
|
A close confidant and aide of FDA Commissioner Marty Makary won't be forced to resign after running afoul of the White House, but also won't be promoted into a senior role at the regulator. Makary had planned to appoint Sanjula Jain-Nagpal, who had been serving as his director of policy and research strategy, as his deputy chief of staff. Jain-Nagpal
used the new title during a Nov. 12 call with agency stakeholders. But the White House had never signed off, according to a White House official, who spoke with Endpoints News Friday on condition of anonymity. That led to a perception that she was being insubordinate, and the White House asked for her resignation. It pulled back that demand, the official said, but it also denied Jain-Nagpal's promotion. | |
|
|
|
 |
|
AstraZeneca’s site that will be expanded in Frederick, MD (Courtesy AstraZeneca) |
|
|
|
by Anna Brown
|
AstraZeneca will invest $2 billion to expand its presence in Maryland, its latest move to boost US manufacturing as part of a larger $50 billion pledge, the company announced Friday. The UK-based drugmaker will use the funds to onshore its rare disease portfolio to the US for the first time. It plans to expand its biologics facility in
Frederick, MD, and nearly double the factory’s commercial capacity. AstraZeneca will also build a new factory in Gaithersburg, MD, which will manufacture assets for clinical trials, the UK drugmaker said. Around 300 new jobs will be created across both the Gaithersburg and Frederick sites. The pharma giant announced its larger $50 billion pledge
in July as part of the Trump administration’s onshoring push. | |
|
|
|
|
|
|
by Nicole DeFeudis
|
Teva’s challenge against Medicare negotiations fell flat in DC federal court, marking another loss for the pharma industry. US District Judge Sparkle Sooknanan said Thursday that Teva’s
constitutional and statutory claims against the negotiation process “either fail on the merits or are unripe.” Teva has already filed a notice of appeal, and a company spokesperson said it “stands behind the merits” of the case. Its challenge will be one of two appeals cases left undecided in the pharma industry’s long-running legal battle against the Inflation Reduction Act. A decision could come any day for industry trade group PhRMA in the Fifth Circuit. Meanwhile, Merck is still
waiting on a decision in DC district court, and AstraZeneca petitioned its case to the US Supreme Court in September. | |
|
|
|
|
|
|
|
|
by Lydia Ramsey Pflanzer
|
Building on the growing success of offering cheaper cash-pay prices to consumers for their GLP-1 weight loss drugs, Novo Nordisk and Eli Lilly are setting up programs to work directly with employers. Waltz Health, an Eversana company that brings payors and pharma directly together, is working with Lilly and Novo to power the approach. Through Waltz, there will be a fixed price for the medications, though the companies haven’t shared what that price will be. Only about 20% of employers with more than 200 employees in 2025 offer coverage for GLP-1s for weight loss. Rather than covering the medications through the traditional pharmacy benefit manager formulary, employers have been considering alternative models. That way, the employer could offer some obesity medicine benefits. Many Americans get health benefits through their employer. | |
|
|
|