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Recipharm has extended high-potency oral solid dose manufacturing at Leganés, Spain, to GMP pilot scale. A contained suite combines dry granulation, tableting, and coating for compounds up to OEB 5. The same pilot equipment can support clinical and small commercial batches, with larger programs transferring to commercial lines at the same site rather than another facility.
Researchers compared laboratory powder X-ray diffraction with 3D electron diffraction outcomes for 29 samples spanning 17 organic pigments. XRPD-derived domain size was the most useful screening indicator; structure solution succeeded above approximately 31 nanometers and failed below that value in this sample set. The threshold is empirical and should not be generalized to every pharmaceutical solid.
The 252-participant ANTHEM-UC Phase 2b publication found all three icotrokinra doses superior to placebo for week-12 clinical response. Remission was 30% versus 11% at 400 mg. The 200 mg remission comparison did not meet significance, stopping formal downstream testing under the prespecified sequence. These results do not establish approval for ulcerative colitis.
The CAPSULIX consortium of OZ Biosciences, ExploRNA, and Miltenyi received Eurostars support for a three-year project with a total budget of €1,518,766. It will combine novel cap-analog mRNA or self-amplifying RNA with biodegradable LNPs for nonviral CAR-T manufacturing. GMP-compatible process development and preclinical validation are objectives. The total project budget is not necessarily the amount of grant funding.
Viking announced the SUNRISE Phase 3 program for oral VK2735, a dual GLP-1/GIP agonist. Two placebo-controlled, 68-week studies each target 560 adults, with and without type 2 diabetes. This is an adjacent oral peptide delivery program rather than a confirmed cyclic peptide platform, and the announcement provides a trial start rather than Phase 3 efficacy results.
BioNTech reported that AHEAD-MERIT, a Phase 2/3 trial of BNT113 plus pembrolizumab, did not meet its progression-free survival dual primary endpoint versus pembrolizumab alone. The study enrolled patients with previously untreated, unresectable recurrent or metastatic HPV16-positive, PD-L1-expressing head and neck cancer. Overall-survival follow-up continues; under the prespecified design, a significant survival benefit could still establish a positive trial outcome.
Entera reported a post hoc analysis of its Phase 2 EB613 study and outlined a planned Phase 3 trial. Women with lower baseline bone density showed larger gains, but the relevant subgroups were small. EB613 is an oral PTH(1-34) delivery program, an adjacent noncyclic peptide approach; these exploratory findings do not establish fracture reduction.
Insilico Medicine nominated ISM9546 as a preclinical candidate for autoimmune diseases, including inflammatory bowel disease and rheumatoid arthritis. The company described an orally available, peripherally restricted VAV1 molecular glue degrader, reporting cellular degradation activity and anti-inflammatory effects in disease models. Its limited brain exposure is a design feature; human safety and efficacy have not been established.
Electron diffraction established the previously unresolved structure of buspirone hydrochloride Form 2. The study also prepared 15 multicomponent solids, including cocrystals, an ionic cocrystal, and salts, and compared conformations and thermal behavior. This expands structural knowledge of a long-marketed drug and provides a solid-form exploration example without demonstrating improved clinical performance for the newly prepared materials.
Lonza expanded its accelerated DNA-to-IND offering to bispecific antibodies, Fc-fusion proteins, and high-concentration drug product formulations. The program coordinates drug substance and drug product development and manufacturing. Lonza states that eligible programs can deliver toxicology drug substance in as little as three months and reach IND readiness in six months; these are supplier-reported timelines.
This repeat-dosing study examined whether changes in PEG chemistry, PEG concentration, RNA cargo, or administration route could overcome efficacy loss after an immunogenic nanoparticle dose. None reliably restored delivery in the tested setting, and reduced activity tracked anti-PEG antibodies. The results emphasize the interaction between ionizable lipids and innate immunity, without establishing that every PEG-containing product will behave identically.
Researchers combined a 520-member degradable lipid library with interpretable machine learning and a 10,920-member virtual design space. Independent mouse experiments identified PA97MD101 as a lead for hepatic mRNA expression, Cre-mediated recombination, and Cas9-based TTR suppression. The study links screening predictions with functional animal validation, without establishing clinical safety or efficacy.
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