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Ritedose has opened an analytical chemistry laboratory alongside expanded microbiology facilities, tripling its laboratory footprint through an investment exceeding $17 million. Capabilities include extractables and leachables, nitrosamine testing, drug product characterization, and ten qualified ICH stability chambers. The infrastructure supports development, regulatory submissions, release testing, and lifecycle management for its sterile blow-fill-seal ophthalmic and respiratory manufacturing programs.
Roche entered a research collaboration and licensing agreement with Hangzhou-based Defand Therapeutics to discover molecular glue degraders for oncology and immunology targets. Defand will contribute its screening platform, with Roche taking responsibility for subsequent development and exclusive global commercialization. The announcement did not disclose upfront payment amounts, milestone thresholds, or royalty rates.
Nurix announced the first patient enrollment in NX-5948-203, a Phase 1b/2 trial combining the investigational BTK degrader bexobrutideg with venetoclax in chronic lymphocytic leukemia. Initial enrollment focuses on relapsed or refractory disease. Conducted under the Roche collaboration, the study will assess safety, tolerability, and clinical activity to inform potential combination development across treatment settings.
Arvinas presented final Phase 1 findings for its brain-penetrant LRRK2 degrader ARV-102 in 24 patients with Parkinson’s disease treated for 28 days. Exploratory changes in eye movement measurements correlated with reductions in cerebrospinal fluid LRRK2 and changes in pathway biomarkers. The trial was not designed to establish clinical efficacy or effects on disease progression.
Researchers characterized PSIRC3, an irreversible covalent BTK PROTAC that produced rapid, selective degradation in cellular experiments and target reduction in vivo. Activity required engagement of BTK Cys481 and was lost against the C481S mutant. Modeling supported a balance between target and E3 ligase affinities, challenging the assumption that catalytic turnover is required for potent degradation.
Researchers studied flurbiprofen–polyvinylpyrrolidone amorphous solid dispersions using controlled nucleation and real-time synchrotron X-ray diffraction after contact with water. Higher nucleation density shortened the lag before crystallization and accelerated drug crystallization. The work proposes that evaluating latent nuclei is important to maintaining supersaturation, rather than assuming the absence of visible crystals demonstrates a robust amorphous formulation.
GEA has introduced the ConsiGma FC Flex, a production-scale film coater for tablets, capsules, and pellets. It processes approximately nine-kilogram sub-batches in six-minute cycles and retains the laboratory system’s drum diameter while changing drum depth and nozzle count. Standard containment targets OEB 4, with an optional cleaning upgrade supporting OEB 5–6 applications, according to the supplier.
Viking began an exploratory study evaluating oral and less frequent injectable VK2735 maintenance strategies after initial weekly injections. Approximately 195 adults are expected to participate, with maintenance evaluated through Week 33 and results anticipated in 2027. This adjacent oral peptide delivery study has not established successful weight maintenance; a later correction clarified the oral dosing schedule.
Piramal announced that its new Lexington microbiology laboratory entered routine GMP use on September 11, with the sterility suite subsequently conditionally approved. The lab expands testing space and adds a Grade A isolator intended to double sterility-testing capacity. It is an early component of an $85 million sterile-injectables expansion; the remaining manufacturing capacity is expected in late 2027.
Sensible announced a $47 million financing package comprising an Oxford Science Enterprises-led Series A and up to $20 million in non-dilutive funding. Transaction adviser DLA Piper confirmed that proceeds will support VECTOR platform scale-up, AI-enabled sequence design, high-throughput screening, and clinical-grade manufacturing capabilities. The $47 million figure is not a disclosed equity-only round size.
Screening eight ionizable lipids identified a lead formulation that delivered reporter RNA to several immune-cell types. Researchers then used it to engineer primary human T cells expressing a MUC1-directed CAR, with cytotoxic activity against antigen-positive tumor cells in vitro. Animal reporter experiments supported delivery feasibility, but the study does not demonstrate therapeutic CAR-T generation inside patients or animals.
Nurix and Gilead agreed to extend research on an undisclosed oncology program by another two years, marking the program’s second extension. Their collaboration uses E3 ligases to induce degradation of selected targets. Nurix retains options, subject to restrictions, to share development, commercialization, and profits and losses equally in the United States for up to two programs.
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