Each week we highlight five things affecting the life sciences industry. Here’s the latest.
UK government backs AI healthcare reform to accelerate safe adoption of medical AI
- The UK government has formally accepted all 44 recommendations from the National Commission into the Regulation of Artificial Intelligence in Healthcare, committing to a new, clearer lifecycle-based regulatory framework designed to support innovation and investment while maintaining patient safety and public trust.
- This development is expected to make it easier for life sciences companies, digital health businesses and medical device developers to bring AI-enabled products to market.
U.S. government joins Biohub and tech giants to commit to build AI-ready biology data
- Biohub, the National Institutes of Health, the U.S. Department of Energy and technology industry partners announced a coordinated $1.8 billion commitment to create large-scale, open AI-ready biological datasets that can support predictive models of biology and accelerate disease research and drug discovery.
- The initiative aims to build a “virtual cell” by generating standardized, multimodal biological data at unprecedented scale, enabling researchers to digitally model how cells respond to interventions and potentially shorten the path to new medical breakthroughs.
Asia’s next wave of biotech innovation
- An investment firm is launching a $600 million Asia-focused life sciences fund to invest in biotech companies across the region, reflecting the growing importance of Asia, particularly China, as a source of innovative drug discovery.
- According to Fierce Biotech, the investment firm aims to apply the same investment strategy that worked in the U.S. and Europe to emerging Asian biotechs.
PhRMA challenges CMS’s new global drug pricing model
- Pharmaceutical Research and Manufacturers of America (PhRMA) has filed a lawsuit that challenges the Centers of Medicare & Medicaid Services’ (CMS) new Global Benchmark for Efficient Drug Pricing model. The industry group argues that CMS lacks the legal authority to implement the policy, which would use international drug pricing benchmarks to calculate Medicare Part B inflation rebates, and that its attempt to do so amounts to unauthorized government price setting.
- PhRMA also argues the policy could harm innovation and patient access, claiming it would deliver limited savings to beneficiaries while discouraging U.S. biopharma research and development investment. CMS, however, maintains that the model will reduce out-of-pocket costs for Medicare patients without compromising quality of care, according to Fierce Pharma.
FDA clears first expandable heart valve designed to grow with children
- The U.S. Food and Drug Administration has approved the first pediatric heart valve designed to expand as a child grows, potentially reducing the need for multiple open-heart surgeries in children with congenital pulmonary valve disease. The device can be enlarged over time using a balloon catheter, allowing it to grow from toddler-sized to adult-sized dimensions.
- The valve is also the first FDA-approved heart valve to use synthetic polymer leaflets instead of animal-derived tissue, which may improve durability in children. One-year follow-up data showed promising performance, and the approval marks the first pediatric authorization under the FDA’s Total Product Life Cycle Advisory Program, according to Fierce Biotech.
