Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA warns against fraudulent data in medical device premarket submissions
- The U.S. Food and Drug Administration is alerting medical device manufacturers about the rise in fraudulent and unreliable laboratory testing data from third-party labs, particularly emphasizing the need for thorough scrutiny and verification of such data before submissions.
- Highlighting a trend of data integrity issues, including instances of data fabrication and duplication, the FDA stresses the importance of device firms qualifying third-party labs and ensuring accurate, reliable data to maintain patient safety and product efficacy.
NodThera’s NLRP3 inhibitors show promise in obesity and heart health
- NodThera’s clinical-stage drug for Parkinson’s demonstrates significant weight loss and cardiovascular benefits in obese mice, nearly matching the effects of Wegovy, a leading obesity drug.
- According to Fierce Biotech, the study reveals the potential of NLRP3 inhibitors to offer a dual approach to obesity management and cardiovascular health improvement, emphasizing their unique position in treating inflammation-related conditions.
Senators call for enhanced FDA oversight on direct-to-consumer pharmaceutical ads
- Senators have expressed concerns to the FDA about insufficient regulation of direct-to-consumer pharmaceutical advertising, particularly on digital platforms, urging stronger oversight.
- This push for regulatory reform, according to Fierce Pharma, aims to protect consumers from potentially misleading drug promotions, emphasizing the importance of accurate health information in the rapidly evolving landscape of digital advertising.
The rise of radiopharmaceuticals in cancer treatment
- Big Pharma is investing heavily in radiopharmaceuticals, a promising cancer treatment method that targets tumors more precisely with radioactive particles, indicating a significant shift towards more targeted cancer therapies.
- The field has seen rapid growth, reports The Wall Street Journal, with major acquisitions and increased venture capital, highlighting its potential to complement or replace traditional treatments like chemotherapy and external radiation, despite challenges in supply chain and manufacturing.
Strengthening cybersecurity in medtech
- This Med City News article discusses the increasing focus on cybersecurity for connected medical devices, highlighting the adoption of security-by-design strategies to protect against cyberthreats without compromising device functionality.
- The article outlines recent regulatory and legislative efforts to improve the security of the Internet of Medical Things, emphasizing the need for standards, Internet of Things security enhancements, and a multi-layered security approach.
For more insights in life sciences, check out RSM’s industry outlook.
