In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.

Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court.

Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.

Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.

The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.

Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.

Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.

In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis.

Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority.