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A mouse study compared LNP-delivered self-amplifying RNA and an Ad5 vaccine encoding the same RSV prefusion F antigen. Intramuscular dosing produced distinct immune patterns: saRNA favored pulmonary mucosal and tissue-resident memory responses, while Ad5 generated stronger systemic responses. The comparison concerns immune architecture, not demonstrated superiority in human protection.
Ascletis reported that ASC36o, an oral amylin receptor agonist tablet, had an approximately seven-day half-life and 6%–8% oral bioavailability in nonhuman primates. The company said a US Phase 1 study was underway, with human PK results expected by year-end 2026. The quantitative findings are preclinical and do not yet establish once-weekly oral dosing in humans.
Researchers separated the effects of circular structure, preparation quality, and nucleotide modification across two vaccine antigen systems. Cleaner circular RNA preparations caused less innate immune activation, but antibody and T-cell response levels were comparable with linear mRNA. Incorporating m6A was associated with higher antibody avidity, rather than a general increase in expression.
Researchers screened PEG-free hybrid particles containing a polylactic acid core and engineered lipid surface. A lead formulation preserved particle size and reporter activity after vibrating-mesh nebulization, outperforming the tested SM-102 reference under those conditions. Non-nebulized particles also transfected organoids and primary airway cultures. The authors identify mucus transport, aerosol deposition, and in vivo efficacy as unresolved next steps.
A laboratory study compared single-stage and two-stage MSMPR crystallization for paracetamol Form I and carbamazepine Form III at matched total active volume and residence time. Staging improved particle uniformity, reduced fouling, and shortened filtration times while preserving solid-state and chemical quality. The findings attribute the benefit to supersaturation distribution rather than additional crystallizer capacity.
Recipharm has added a sterile cream and ointment line at its Odivelas site in Portugal. The line accommodates aluminum and polyfoil tubes from 3.5 to 30 grams, with annual output of 8 million to 15 million units depending on fill volume and batch size. It complements existing multidose ophthalmic manufacturing and is ready for new customer projects.
Researchers developed HighPlay3 to balance cyclic peptide target binding and membrane permeability through iterative structural assessment and prediction. Experimental screening produced micromolar binders against MDM2 and GABARAP. Among tested active GABARAP candidates, GAB-D4 showed the highest Caco-2 apparent permeability with no apparent net efflux. These are early laboratory results, not demonstrated human oral bioavailability.
Serial blood samples from 73 vaccine recipients were analyzed using ddPCR for total and long-range-linked mRNA and LC-MS for ionizable lipids. RNA and lipid decay differed across three vaccine platforms. Cohorts differed in dose, vaccination history, and sampling schedules. Detecting circulating RNA fragments does not by itself establish continued protein expression, clinical toxicity, or comparative vaccine effectiveness.
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.
Zeitschrift für Kristallographie – Crystalline Materials
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.
New England Journal of Medicine / Johnson & Johnson
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.
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