Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Immune-evasive CAR-NK cells offer potential cancer treatment
- Researchers at Massachusetts Institute of Technology and Harvard engineered chimeric antigen receptor (CAR) natural killer (NK) cells that evade immune rejection, allowing them to persist in mice and eliminate lymphoma without triggering cytokine release syndrome.
- These cloaked CAR-NK cells offer a safer alternative to CAR-T therapies and could pave the way for off-the-shelf cancer treatments with improved safety and efficacy profiles, reports BioTechniques.
Orphan drug exemption could cost Medicare billions
- A provision of the One Big Beautiful Bill Act which cuts many orphan drugs from Medicare negotiations could increase Medicare spending by $8.8 billion over the next decade, according to the Congressional Budget Office.
- Per Fierce Healthcare, the exemption would limit Medicare’s ability to negotiate prices for certain rare disease treatments, raising concerns about long-term affordability and access.
Swiss pharma exports to U.S. jump in September
- Swiss exports to the U.S. rose in September 2025, driven by a 5.1% month-over-month nominal increase in chemical and pharmaceutical shipments, according to Swiss customs data.
- Per Reuters, the proposed October 1 tariff on imports of branded drugs, unless a company was building a manufacturing plant in the U.S., may have been the cause of the ramped-up acceleration of imports. The tariff has not yet been enacted.
Drug approvals drop amid staffing cuts and delays
- Drug approval rates from the U.S. Food and Drug Administration fell to 73% in the third quarter of 2025, down from an average of 87% over the previous six quarters, as leadership turnover and government shutdowns slowed reviews, according to STAT.
- Analysts warned that ongoing staff shortages and delayed inspections could extend approval timelines further, though a more lenient stance toward certain therapies offers limited optimism.
FDA awards nine priority review vouchers
- The FDA has granted nine priority review vouchers in 2025 for treatments targeting a variety of different types of products, including drugs that would help people quit e-cigarettes, address genetic deafness and address infertility.
- Per BioPharma Dive, these vouchers allow recipients to expedite FDA review timelines for products.
For more insights in life sciences, check out RSM’s industry outlook.
