Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA issues warnings on plastic syringes from China
- According to MedTech Dive, the U.S. Food and Drug Administration has issued three warning letters as part of its investigation into plastic syringes made in China, advising U.S. suppliers, consumers and health care organizations to immediately stop using products from two specific Chinese companies due to widespread quality issues.
- The investigation, which began late last year after reports of leaks, breaks and other quality problems with Chinese-made plastic syringes, has led to the discovery of unauthorized syringes being marketed and distributed in the U.S., with nearly 60 models identified as being sold without proper clearance or approval.
Deal forged for ALS therapy development
- Ferrer has committed to over €112.5 million ($121.7 million) in upfront and potential milestone payments for the ex-U.S. rights to Verge Genomics’ ALS drug VRG50635, which is in a phase 1b trial, reports Fierce Biotech.
- VRG50635, discovered and developed using an artificial intelligence-enabled platform, represents a significant step in ALS treatment and confidence in Verge’s AI-driven research and development capabilities.
Congress reengages in laboratory developed tests regulation
- Amid discussions on the FDA’s proposed rule to regulate laboratory developed tests (LDTs) as medical devices, Congress revisited the debate, highlighting concerns over regulatory overreach and the potential impact on innovation and patient care, reports Medtech Insight.
- The debate underscores a bipartisan acknowledgment of the need for LDT oversight but reveals a divide on the approach, with some lawmakers criticizing the FDA’s proposed rule for potentially stifling innovation and increasing costs.
National Institutes of Health’s contribution to the U.S. economy and job market
- United for Medical Research’s 2024 update reports that in fiscal year 2023, the National Institutes of Health awarded $37.81 billion to researchers across the U.S., supporting 412,041 jobs and generating $92.89 billion in economic activity, highlighting the agency’s pivotal role in fueling both scientific advancement and economic growth.
- The NIH’s investment in research not only advances medical science and innovation but also significantly affects local economies by creating jobs and stimulating economic activity, with over 80% of its budget awarded to external researchers, underscoring the broad and beneficial economic impact of federal funding for biomedical research.
Veeda’s strategic expansion through acquisition of European CRO
- Veeda Clinical Research, based in India, has acquired Heads, a European contract research organization (CRO) with 25 locations across Europe, North America and the Asia Pacific region, marking a significant step in Veeda’s expansion into international markets, reports Fierce Biotech.
- This acquisition enables Veeda to enhance its capabilities in conducting large-scale, multi-geography clinical trials, particularly benefiting from Heads’ expertise in hematology and oncology, as well as its consulting services for anti-cancer drug development.
For more insights in life sciences, check out RSM’s industry outlook.
