Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA issues draft guidance on platform technology designation
- The Food and Drug Administration has released a draft guidance aimed at providing a framework for the designation of platform technologies, which can be used to develop multiple products efficiently.
- According to the Regulatory Affairs Professionals Society, this initiative is expected to streamline the regulatory process for innovative technologies, benefiting manufacturers and patients alike.
UK agencies propose new medtech evaluation and roll-out pathway
- UK government agencies have proposed a new framework to streamline the evaluation and adoption of innovative medical technologies within the National Health Service.
- As reported by Med-Tech News, the initiative aims to enhance patient outcomes and drive cost efficiencies, with public consultation open until August 15.
New male contraceptive found safe, effective and reversible in testing
- Scientists have developed a non-hormonal male contraceptive that targets the STK33 protein, essential for sperm formation, showing promising results in mice studies.
- According to The Independent, this contraceptive method demonstrated reversible effects, with treated mice regaining fertility after discontinuation of the drug, suggesting potential for human application.
Decentralized clinical trials play important role in life sciences development process
- Clinical Trials Arena reports that the COVID-19 pandemic accelerated the adoption of decentralized clinical trial (DCT) solutions, allowing research to continue virtually and remotely. DCT solutions have become an integral part of the clinical trial process, widening participant opportunities and enhancing data collection efficiency.
- Integration of wearable health tech with Bluetooth and Internet of Things technologies further enhances clinical trial data quantity and accuracy while improving participant retention and reducing trial costs. However, challenges remain in implementing DCTs, necessitating a hybrid approach that optimizes trial quality and efficiency.
Revenue forecast for weight loss drugs continues to increase
- According to Reuters, experts have raised annual global sales forecasts for two leading weight-loss drugs to about $150 billion by the early 2030s, driven by increasing supplies, wider usage and potential new competitors. Previous estimates were around $100 billion.
- Despite most insurers not covering these therapies, unprecedented consumer demand and willingness to make significant out-of-pocket payments have driven the market.
For more insights in life sciences, check out RSM’s industry outlook.
