Each week we highlight five things affecting the life sciences industry. Here’s the latest.
UK becomes first European country to approve oral GLP-1 medicine
- The UK Medicines and Healthcare products Regulatory Agency approved an oral GLP-1 agonist for weight management and type 2 diabetes, making the UK the first country in Europe to authorize the medicine, reports Pharmaphorum.
- The treatment provides a new oral option for obesity and is the second in its class to be green lit for use this year.
FDA proposes onshoring incentives and new meeting pathways under GDUFA IV
- The U.S. Food and Drug Administration proposed the Generic Drug User Fee Amendment (GDUFA) IV framework which largely preserves existing generic drug review timelines, but also adds initiatives aimed at accelerating complex generic approvals and encouraging U.S.-based manufacturing.
- The proposed amendment includes a key change that would allow certain domestic facilities to voluntarily request FDA surveillance inspections up to 24 months before review submission, potentially helping reduce approval delays tied to inspection readiness, reports Endpoints News. The proposal also introduces four new FDA meeting types to facilitate scientific discussions on complex development issues, including: study design, novel formulation data, response to complete response letter deficiencies and platform-wide issues affecting multiple products.
Senate reintroduces BINSA renewing pressure on China biotech deal scrutiny
- A bipartisan group of U.S. senators reintroduced the Biotech Investment National Security Act (BINSA). The legislation would direct the Treasury Department to more closely scrutinize U.S. investments, licensing deals and joint ventures involving Chinese biotech companies by adding biotechnology to the sectors covered under the Comprehensive Outbound Investment National Security Act.
- According to Endpoints News, the proposal increases pressure on Treasury as it develops outbound investment screening regulations, while industry groups argue that broad restrictions on China biotech partnerships could hinder innovation and weaken the competitiveness of the life sciences industry.
Medical device company expands Big Ten blood donation campaign amid U.S. supply shortage
- A large medical device company is launching the third year of its “We Give Blood” competition with the Big Ten Conference, offering a $1 million prize to the university that generates the most blood donations.
- According to Fierce Pharma, the program aims to address a growing imbalance in donor demographics by increasing participation among younger donors as older adults account for a much larger share of blood donations. The effort comes shortly after the American Red Cross declared its second-ever national blood supply crisis following a sharp decline in donations.
CMS proposes accelerated Medicare coverage pathway for breakthrough devices
- The Centers for Medicare and Medicaid Services (CMS)is seeking feedback on a proposed Regulatory Alignment for Predictable and Immediate Device, or RAPID, pathway that could significantly shorten the time between FDA authorization and Medicare coverage for certain breakthrough medical devices. National coverage could begin as soon as 60 days after FDA approval.
- According to Medtech Dive, the proposal would align FDA and CMS reviews earlier in the development process to streamline reimbursement decisions for eligible breakthrough devices; in vitro diagnostics and devices beyond the pre-submission stage would not qualify.
For more insights in life sciences, check out RSM’s industry outlook.
