Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA provides new guidance to replace animal testing in early drug studies
- According to Reuters, the U.S. Food and Drug Administration issued new draft guidance encouraging drug developers to reduce reliance on traditional animal studies and adopt modern non‑animal testing tools, including computer simulations and organ‑mimicking devices.
- The draft guidance promotes new approach methodologies such as lab‑based cell tests, organoids and other human‑relevant models aimed at improving efficiency, lowering cost and addressing ethical concerns associated with animal testing.
Strait of Hormuz closure could affect U.S. generic drug supply
- Nearly half of U.S. generic prescriptions come from India, which relies heavily on the Strait of Hormuz for both petroleum‑based inputs used in drug manufacturing and for shipping finished medicines to the U.S.
- CNBC reports that while distributors maintain 30 to 60 days of buffer stock, sustained disruption could trigger shortages within four to six weeks for high‑volume generics such as diabetes, hypertension, statin and antibiotic medications.
NIH announces investment in human-based research
- The National Institutes of Health plans to invest more than $150 million to help accelerate the development of human‑based research methods that could reduce reliance on animal models.
- The program will establish technology development centers, a data hub, and a validation and qualification network to support predictive disease modeling.
EPA proposes weakening ethylene oxide emission regulations
- Per MedTech Dive, the U.S. Environmental Protection Agency has proposed weaker limits on ethylene oxide (EtO) emissions, revising its 2024 rule that had aimed to cut emissions from commercial sterilizers by about 90% and reduce cancer risks for nearby communities.
- The EPA states the updated proposal is intended to help protect the medical device supply chain, as EtO is used to sterilize roughly half of all U.S. medical devices, though public health groups warn the move intensifies risk concerns for residents living near sterilization facilities.
Patent expirations signal a tougher year for major biopharmas
- Major biopharma companies are bracing for a more difficult 2026 as the loss of patent protection on several blockbuster drugs could slow revenue growth or drive declines, reports FiercePharma.
- The report highlights that only a small subset of the world’s largest drugmakers expect faster growth next year.
For more insights in life sciences, check out RSM’s industry outlook.
