Emily Schoenthaler

Subcutaneous infliximab may help improve treatment convenience, dosing consistency, and long-term adherence for patients with inflammatory bowel disease, according to discussions at DDW 2026. Clinicians highlighted the potential for self-administered infliximab to support sustained remission while reducing infusion-center burden and improving patient-centered care.

Kelun-Biotech reported positive Phase 3 results for sacituzumab tirumotecan in first-line metastatic triple-negative breast cancer, demonstrating a statistically significant improvement in progression-free survival versus chemotherapy. The findings further strengthen momentum behind TROP2-directed antibody-drug conjugates in oncology and highlight growing competition in the metastatic breast cancer treatment landscape.

This edition of The BioPharm Brief highlights major advances in obesity, oncology, and regenerative medicine, including Merck’s Phase 3 ADC study in metastatic colorectal cancer, Eli Lilly’s promising retatrutide obesity trial results, and manufacturing progress supporting Klotho cell therapy development. Together, these updates reflect the biopharma industry’s accelerating focus on targeted therapies, next-generation weight loss drugs, and scalable cell therapy innovation.

Circio CEO Erik Wiklund discussed how circular RNA technology may improve the safety, durability, and cost-efficiency of AAV gene therapies for cardiovascular diseases at ASGCT 2026. Early animal data suggest the platform reduces cellular stress responses while increasing gene expression, potentially expanding access to safer and more scalable gene therapy treatments.

Merck has dosed the first patient in the Phase 3 PROCEDE-CRC-03 trial evaluating investigational antibody-drug conjugate precemtabart tocentecan in metastatic colorectal cancer. The CEACAM5-targeted ADC is being studied against standard chemotherapy in previously treated patients, highlighting growing industry momentum around targeted oncology therapies and next-generation antibody-drug conjugates.

Eli Lilly’s investigational obesity drug retatrutide produced up to 28.3% average weight loss in the Phase 3 TRIUMPH-1 study, strengthening momentum behind next-generation triple agonist therapies.

New clinical trial updates highlight advances in RNA editing for alpha-1 antitrypsin deficiency, semaglutide data in MASH liver disease, and improved joint outcomes in psoriatic arthritis treatment comparisons.

Novo Nordisk presented new EASL 2026 data highlighting semaglutide’s liver safety profile and subgroup efficacy in metabolic dysfunction-associated steatohepatitis, reinforcing the growing role of GLP-1 therapies in chronic liver disease management.

UCB reported Week 16 data from the Phase 3 BE BOLD study showing Bimzelx outperformed risankizumab on the primary ACR50 endpoint in psoriatic arthritis, marking the first approved biologic to demonstrate superiority in joint outcomes in a head-to-head PsA trial.

Today’s BioPharm Brief covers how biopharma companies are leveraging next-generation platform technologies—from CNS-targeted gene therapy and AI-driven R&D to antibody-cleaving biologics partnerships—to improve therapeutic precision, reduce development barriers, and expand access to advanced medicines.

Erik Wiklund discusses how circular RNA-based AAV expression systems may improve gene therapy durability, reduce toxicity, and lower dosing requirements for next-generation therapies.

Vibha Jawa, PhD, discussed evolving approaches to preclinical development, animal use reduction, and immunogenicity assessment during an interview with BioPharm International at AAPS NBC 2026.

Preclinical ASGCT 2026 data suggest JCR Pharmaceuticals’ JUST-AAV platform may improve central nervous system delivery while reducing liver exposure in AAV-based gene therapies for rare neurodegenerative diseases.

Incyte and Edison Scientific have entered a strategic collaboration to integrate the Kosmos AI platform across Incyte’s research and development operations, reflecting the growing role of continuous-learning AI systems in biopharmaceutical drug discovery and translational medicine.

Today’s BioPharm Brief covers major developments in antibody-drug conjugates, early-stage HER2-positive breast cancer treatment, and the expanding biosimilars market.

Integra Therapeutics is advancing its FICAT gene writing platform to enable more sophisticated CAR T-cell engineering, combining CRISPR precision with high-capacity DNA integration for next-generation cancer therapies.

Regeneron’s new partnership with Parabilis Medicines underscores growing industry interest in next-generation conjugate technologies designed to reach historically “undruggable” intracellular targets through peptide-enabled delivery systems.

FDA approvals for Enhertu in both neoadjuvant and adjuvant HER2-positive early breast cancer settings mark a major expansion of antibody-drug conjugates into curative-intent treatment, supported by pivotal Phase 3 DESTINY-Breast11 and DESTINY-Breast05 data.

AstraZeneca reported encouraging bladder cancer data for Imfinzi plus BCG, Imviva shared early remission findings for allogeneic CAR-T therapy in lupus, and Biogen expanded its rare disease pipeline through its acquisition of Apellis Pharmaceuticals.

Exploratory analyses from the Phase 3 POTOMAC trial showed AstraZeneca’s Imfinzi plus BCG regimen reduced early high-risk recurrences and delayed cystectomy in patients with high-risk non-muscle-invasive bladder cancer.

New Phase 1/2 findings presented at ASGCT 2026 suggest Imviva Biotech’s investigational allogeneic CAR-T therapy CTA313 may induce durable remission and immunosuppression-free disease control in systemic lupus erythematosus.

Biogen has completed its acquisition of Apellis Pharmaceuticals, adding complement-targeting therapies Empaveli and Syfovre to its portfolio and strengthening the company’s position in nephrology and rare disease therapeutics.

Today’s BioPharm Brief covers Phase III clinical trial advances in bladder cancer from AstraZeneca , new in vivo CAR-T financing from Create Medicines, and positive Duchenne muscular dystrophy gene therapy results from REGENXBIO.

A new European Union regulatory framework known as MIDBA may streamline auto-injector approvals for biologics by reducing the need for repetitive pharmacokinetic (PK) bridging studies. Charles Theuer discussed how the model-based approach could accelerate drug-device combination development and potentially influence future FDA policy.

At AAPS NPC 2026, Charles Theuer discussed how converting biologics from intravenous (IV) infusion to subcutaneous (sub-q) administration is reshaping patient experience, safety profiles, and regulatory development strategies. The shift toward pharmacokinetic (PK)-based approvals and label extrapolation is enabling faster development of subcutaneous oncology and biologic therapies.

Emerging sequential treatment study designs may simplify and accelerate IV-to-subcutaneous biologic conversions by reducing variability and shrinking clinical trial sizes. Charles Theuer discussed how streamlined pharmacokinetic (PK)-driven regulatory pathways and evolving EU initiatives are reshaping subcutaneous biologic development.

REGENXBIO announced positive topline Phase 3 AFFINITY DUCHENNE trial results showing that investigational gene therapy RGX-202 achieved significant microdystrophin expression and demonstrated a correlation with functional improvement in patients with Duchenne muscular dystrophy.

AstraZeneca reported that the Phase 3 VOLGA trial demonstrated statistically significant improvements in event-free survival and overall survival with perioperative durvalumab plus neoadjuvant enfortumab vedotin in cisplatin-ineligible patients with muscle-invasive bladder cancer.

Yelena Ionova, Pharm.D., Redica Systems, discusses how benchmarking inspection data, strengthening sterile manufacturing controls, and adopting continuous regulatory intelligence strategies can help cell and gene therapy manufacturers improve inspection readiness and quality system performance.

Yelena Ionova, Pharm.D., Redica Systems, described how FDA and EMA standards for cell and gene therapy chemistry, manufacturing, and controls are increasingly aligned, yet manufacturers continue to struggle with basic GMP elements such as quality oversight, sterile processing, and staff training. She emphasized that newer CGT facilities have a critical opportunity to design quality systems and data integrity controls correctly from the outset to avoid costly remediation later.