Follow sourced scientific, clinical, partnership, capacity, and financial developments. Factual summaries and business interpretations are presented separately.
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Acuitas summarized World Vaccine Congress Europe data showing enhanced mRNA vaccine immune responses with ALC-315 in animal tumor models, alongside improved potency of newer lipids in an influenza vaccine model. The release describes preclinical tumor, survival, and immune-response findings. These results should not be read as demonstrated clinical efficacy or a human safety advantage.
Cosette announced FDA approval of EVOXAC cevimeline hydrochloride oral solution for dry-mouth symptoms in adults with Sjögren’s disease. The liquid formulation offers an alternative for patients who have difficulty swallowing capsules. Developed internally, it used an application pathway relying partly on existing capsule safety and efficacy data, with U.S. commercial availability expected by the end of 2026.
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.
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.
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.
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.
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.
Catalent and Mantra have signed a commercial supply agreement covering single-serve over-the-counter oral gels. Catalent will provide formulation development, manufacturing, and packaging at its St. Petersburg, Florida, facility for products addressing occasional sleeplessness, pain, and menstrual discomfort. The announcement establishes a development and supply relationship; it does not report new clinical efficacy data or regulatory approvals for the portfolio.
Teva announced FDA approval of WELTRUZA, a monthly subcutaneous extended-release olanzapine suspension for adults with schizophrenia. The formulation uses Medincell’s SteadyTeq copolymer technology and requires no loading dose, oral supplementation, or post-injection monitoring. Supported by the Phase 3 SOLARIS trial, it retains important olanzapine safety considerations, including weight gain and metabolic effects, rather than eliminating systemic drug risks.
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.
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.
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.
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