Pirtobrutinib approval, animal-test alternatives and laboratory investments

1. Pirtobrutinib gains a first-line CLL/SLL indication¹

The FDA expanded pirtobrutinib’s approval on 2 October to adults with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma without known chromosome 17p deletion. In the 282-patient BRUIN CLL-313 trial, progression-free survival favoured pirtobrutinib over bendamustine plus rituximab: the hazard ratio was 0.20, with a 95% confidence interval of 0.11–0.37. Overall-survival data remained immature at the primary analysis. The decision brings the drug into an earlier treatment setting while preserving an important evidence boundary: the comparator and patient population define the demonstrated benefit. Serious adverse reactions occurred in 28% of patients receiving pirtobrutinib.¹

2. Regulators call for validated alternatives to animal testing²

International medicines regulators issued a joint call on 1 October to advance scientifically valid alternatives to animal testing throughout medicine development and quality control. The ICMRA statement identifies batch-release testing as an especially consequential opportunity and asks regulators to challenge animal tests when equivalent or superior non-animal methods exist. It also supports clearer international expectations for new approaches, including cell-based systems and computational methods. This is a shared regulatory direction, not a blanket exemption from evidence requirements: scientific validity and regulatory acceptability remain necessary, and the statement anticipates a gradual transition at different speeds across jurisdictions.²

3. DOE selects mining and critical-mineral research projects³

The US Department of Energy selected 17 national-laboratory projects for $29.5 million in proposed support on 30 September, targeting mining and critical-mineral processing. The selections include induction-heated extraction from mine waste, artificial-intelligence-assisted ore characterisation, and systems that combine imaging with predictive models to adjust underground extraction. Other projects explore biological and electrochemical routes for recovering minerals from tailings. The announcement places funding behind chemical processing, sensing and modelling work with direct relevance to materials supply. DOE specifies that the projects are entering award negotiations; the announced performance improvements are research goals, not results already achieved.³

4. DaltonTx launches an integrated antibody-discovery workflow⁴

DaltonTx announced new antibody-discovery capabilities on 1 October, combining design, structure prediction and validation tools in one workflow. The company says its chat interface records why candidates were discarded or prioritised, while an ontology connects those decisions with the antibodies and experimental observations involved. It reports folding a 2.6-million-sequence paired antibody collection at 87,000 structures per hour. For discovery teams, the practical development is the integration of modelling and decision records across a campaign. These are company-reported capabilities: computational throughput does not establish binding, developability or clinical success, and candidates still require scientific review and experimental testing.⁴

5. EMA sets priorities for women’s health in drug development⁵

EMA announced plans for a women’s-health regulatory roadmap following a 28–29 September workshop that identified ten priority actions. The proposed agenda includes better enrolment of women in clinical trials, sex-disaggregated reporting, and support for including pregnant and breastfeeding participants. It also calls for stronger real-world-data infrastructure, clearer communication of benefits and risks, and measurable progress indicators. For pharmacology and drug-development researchers, the priorities point toward more representative evidence across life stages. The roadmap and workshop report are planned for publication by the end of 2026; the proposals are not yet a completed programme or new binding trial rules.⁵