Development

Certara UK’s Dr. Armin Sepp, who spoke at the 2026 AAPS National Biotechnology Conference, explains how quantitative systems pharmacology may improve CAR T-cell safety and efficacy by modeling immune activation, tumor response, and cell persistence.

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.

New analyses from Novo Nordisk’s Phase 3 OASIS 4 trial showed that adults taking oral Wegovy achieved substantial weight loss and improved physical mobility, reinforcing the potential of oral semaglutide in obesity management.

AstraZeneca reported positive Phase 3 CALYPSO data showing eneboparatide normalized serum calcium and reduced dependence on conventional supplements in adults with chronic hypoparathyroidism, supporting continued development of the investigational PTH receptor agonist.

Isomorphic Labs’ $2.1 billion financing will support expansion of its AI-driven drug discovery platform and advancement of therapeutic candidates toward clinical development.

Multi-attribute LC–MS methods improve characterization of complex bioconjugates, supporting scalable and regulatory-ready biotherapeutic development, says Agilent Technologies’ Dr. Ganesh Bala, who spoke at the 2026 AAPS National Biotechnology Conference.

Abzena’s Dr. Jeffrey C. Mocny and Cellares’ Anna McMahon discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Bristol Myers Squibb and Hengrui Pharma’s strategic collaboration supports development of investigational oncology, hematology, and immunology therapies targeting unmet patient needs.

AskBio has dosed the first participant in a Phase 1/2 clinical trial evaluating AB-1009, an investigational AAV-based gene therapy for late-onset Pompe disease.

Servier received FDA Breakthrough Therapy designation for emiltatug ledadotin, a B7-H4-targeting antibody-drug conjugate being developed for patients with advanced adenoid cystic carcinoma.

The approval of zenocutuzumab-zbco for NRG1 fusion-positive cholangiocarcinoma expands precision oncology options for patients with rare molecularly defined cancers.

Zai Lab received FDA Fast Track designation for zocilurtatug pelitecan, a DLL3-targeting antibody-drug conjugate, advancing development of a potential new treatment option for extrapulmonary neuroendocrine carcinomas.

argenx secured expanded FDA approval for efgartigimod alfa-fcab and efgartigimod alfa and hyaluronidase-qvfc broadening access to all adult patients with generalized myasthenia gravis regardless of antibody status.

Harbour BioMed has received FDA IND clearance to begin a Phase I trial of its B7H4xCD3 bispecific antibody HBM7004 for advanced solid tumors, advancing its pipeline of T cell–engaging cancer immunotherapies.

Johnson & Johnson reported Phase 2b results for its investigational dual-pathway co-antibody JNJ-4804, showing improved clinical remission and endoscopic outcomes in patients with refractory inflammatory bowel disease.

FDA’s extended review of a subcutaneous formulation of lecanemab highlights ongoing regulatory evaluation of alternative anti-amyloid delivery approaches for early Alzheimer’s disease.

Merck scientists have published a new large-scale biocatalytic manufacturing approach for enlicitide decanoate, an investigational oral PCSK9 inhibitor, potentially advancing scalable production of macrocyclic peptide therapeutics for cardiovascular disease.

Hypoimmune cell engineering may enable scalable type 1 diabetes therapies without immunosuppression, advancing regenerative medicine approaches, according to Dr. Steve Harr, president and CEO of Sana Biotechnology.

Aptevo Therapeutics reported updated Phase 1b data from its RAINIER AML study showing high remission and clinical benefit rates for mipletamig in combination with venetoclax and azacitidine in frontline acute myeloid leukemia patients.

Entrada Therapeutics reported positive topline Phase 1/2 data for ENTR-601-44 in Duchenne muscular dystrophy, showing favorable safety, increased dystrophin production, and statistically significant functional improvement in treated patients.

Kanvas Biosciences and LTZ Therapeutics raised a combined $86 million to advance novel cancer immunotherapy platforms targeting the microbiome and innate immune system, respectively.

GSK’s licensing agreement for SiranBio’s ALK7-targeting siRNA candidate expands development efforts aimed at reducing cardiometabolic risk in chronic inflammatory diseases.

Amgen and Eli Lilly and Company are expanding U.S. pharmaceutical manufacturing with multibillion-dollar investments aimed at strengthening domestic supply chains and supporting advanced therapies. The moves reflect a broader industry shift toward biologics scale-up, genetic medicine capabilities, and more resilient production infrastructure.

LTZ Therapeutics’ $38 million financing supports phase 1 development of myeloid engager therapies targeting oncology and autoimmune diseases.