Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Topic

Articles

FDA has approved Tregzi, the first regulatory T-cell therapy shown to reduce chronic GVHD and improve survival in blood cancer transplant patients.

FDA Grants First-in-Class Approval for Treg Cell Therapy in Blood Cancer Transplant Patients

The company’s thyroid eye disease treatment will be the first at-home subcutaneous disease-modifying treatment if approved.

Roche Gets Priority Review for Enspryng; Announces Sequencing Platform

Videos

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve standardization and efficiency were themes covered on PharmTech.

PharmTech Weekly Roundup—June 26, 2026

Emily Schoenthaler is the Content Producer for 

Matt Truppo is global head of Computational & AI Strategy, R&D, at Sanofi.

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

Drug Digest: How Advanced Analytics Partnerships Enhance the Biopharma Value Chain

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

Pharma Fundamentals: Biologics Quality System

The agency approved palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer.

FDA Approves Pfizer’s Breast Cancer Treatment

The FDA's revised draft guidance updates master protocol recommendations on randomization, control groups, blinding, and regulatory submissions for multi-drug trials.

FDA Updates Master Protocol: What Developers Need to Know

Merck is collaborating with Versant Ventures to establish a portfolio of treatments for rare genetic cardiomyopathies. The company also announced the winners of its 2026 Future Insight Prize and its 2026 North American Advance Biotech Grant.

Merck KGaA Launches Saturnus Bio; Announces Awards

Joseph Zeleznik is technical product director, IMCD US

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Candy Reynolds Cummings spent 15 years at GlaxoSmithKline starting as an analytical chemist and working up to QA Validation Manager in the OTC area (specifically oral care). Currently working at Evonik as the Regulatory and Product Stewardship Manager supporting the business line Silica for regulations in US, Canada, and Mexico.

Katherine L. Ulman is president of KLU Consulting.

Charlotte McIlvaine is senior manager-North America Pharma Quality at Univar Solutions. Charlotte is an analytical chemist experienced in quality control and quality assurance. Charlotte joined Univar Solutions over 9 years ago to oversee quality in 2 districts focusing on the quality needs for Univar Solutions’ pharmaceutical customers.

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

AbbVie acquires Apogee Therapeutics for $10.9 billion, gaining zumilokibart, a long-acting injectable targeting atopic dermatitis and asthma with once-quarterly dosing potential.

Drug Development

Research into Cold Cancers Heating Up

Development of Gamma-Delta T-Cell Therapies

QbD for Small-Molecule Continuous Process Development