SYH-2039

Pipeline pruning at BeOneFDA pilots single-day inspectionsAnavex axes CEOTrump says MFN deals yield savings over $500BFDA consolidates AI tools under one HALO Pipeline pruning at BeOneBeOne Medicines disclosed Wednesday that it has dropped several early-stage programmes from its pipeline, including the IRAK4 chimaeric degradation activation compound (CDAC) BGB-45035, a Phase II asset that was being developed for various autoimmune disorders such as rheumatoid arthritis.A number of Phase I programmes were on the chopping block as well. These include BG-60366, a CDAC that targets EGFR to treat lung cancer; the pan-KRAS blocker BGB-53038 that was being developed for gastrointestinal and lung cancers; BGB-A3055, a CCR8-directed mAb against solid tumours; the MAT2A inhibitor BG-89894 for lung and solid tumours; and BG-68501, a CDK2 inhibitor for breast and solid tumours.-Anna BratulicFDA pilots single-day inspectionsThe FDA has shared more details on a pilot programme, launched in April and running until fiscal year-end, that will conduct one-day inspections of certain facilities in an effort to deploy resources in a more targeted and efficient manner. FDA Commissioner Marty Makary said the pilot will broaden surveillance coverage, "enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor…while minimising operational disruption."The new assessments will not replace standard FDA inspections, the agency clarified, nor will they be used in high-risk or complex factories that need "comprehensive inspectional coverage." Instead, they are an "additional tool" in the US regulator's inspections arsenal and will be deployed in sites selected based on risk criteria, such as product type, prior inspection outcomes and operational characteristics. The FDA has already completed about 46 one-day inspections, with most confirming compliance. So far, the pilot has shown flexibility, as some assessments were extended "when significant observations were identified." The agency plans to use compliance and risk data collected through the pilot to better target future oversight activities.-Elizabeth EatonAnavex axes CEOAnavex Life Sciences terminated the employment of CEO Christopher Missling on April 30 due to conduct that the company "believed was inconsistent" with its policies. Terrie Kellmeyer, an advisor to Anavex who previously served as SVP of clinical development, has been appointed as interim chief executive.While specifics on Missling's departure were not divulged by Anavex, his ouster comes shortly after the company withdrew an application for EU approval of its lead Alzheimer's drug candidate blarcamesine. That announcement at the end of March sent the drugmaker's shares tumbling more than 30%.Anavex is in discussions with the EMA on advancing blarcamesine for Alzheimer's, while the company has also engaged with US regulators about submitting an application for the once-daily oral small molecule, which is designed to act on SIGMAR1 and muscarinic receptors in order to restore cellular homeostasis.-Matt DennisTrump says MFN deals yield savings over $500BThe White House said its most-favoured nation (MFN) drug pricing framework could deliver more than $500 billion in savings over the next decade, according to a new Trump administration report.Under the policy, MFN provisions operate differently for future drugs versus existing drugs. All drugs launched after the implementation of MFN must be priced in line with levels in other high-income countries. This "prospective" MFN requirement applies across all US markets, including private insurance, and is projected to save $529 billion domestically over the next decade.Additional savings are expected from existing drugs already on the market before MFN began. In these cases, drugmakers that have signed onto the framework must extend MFN-level pricing to state Medicaid programmes, a move the report projects will reduce federal and state spending by $64.3 billion over the same period.The administration has so far secured voluntary agreements with 17 major drugmakers, most recently Regeneron Pharmaceuticals. The administration said it "expects to reach similar agreements with most manufacturers of sole-source brand name drugs and biologics in the nation." It is also working with Congress to codify those MFN agreements into law.-Anna Bratulic FDA consolidates AI tools under one HALO The FDA deepened its embrace of AI technologies on Wednesday, collating all of its application and submission data sources, systems and portals — which total more than 40 separate tools — under the Harmonized AI & Lifecycle Operations for Data (HALO) platform. Its launch came alongside the rollout of Elsa 4.0, the agency's agentic AI tool. By consolidating data within HALO — and positioning Elsa on top of that data — staffers will be able to query data and build workflows without having to manually upload documents within each chat, enabling a deeper deployment of AI capabilities within agency operations. The upgrades to Elsa include custom agents, quantitative data analysis and visualisation, and an optimised search function to find the desired information within large document repositories.-Elizabeth Eaton