EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.
Epista's Henrik Johanning revisits his 2026 predictions on QRM, Annex 1, AI governance, and regulatory convergence: What's tracking, what isn't.
Force-displacement monitoring and LVDT verification may solve the cartridge press-fit challenge for greater than 99.5% yield.
CRB Group Fellow James Golden explains why solvent-driven hazardous-material infrastructure can become a major cost driver in oligonucleotide manufacturing facilities.
The future factory will be defined by how well automation tools work together with people, processes, and quality systems to make pharmaceutical manufacturing faster, smarter, more transparent, and more reliable.
Arcana Life Sciences' Remco Munnik revisits his 2026 predictions on EU regulatory reform, AI adoption, and data governance, and previews pharma's biggest challenges for H2 2026.
Dostarlimab monotherapy achieves sustained 12-month complete response in dMMR/MSI-H rectal cancer, potentially sparing chemo and surgery.
A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments.
FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.
Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.
Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.
Ocrelizumab biosimilar for multiple sclerosis: Teva and Polpharma Biologics sign global deal covering intravenous and subcutaneous forms.
PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.
To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.
It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies.
Advances in personalized medicine, biopharma, and digital technologies are unlocking treatments for complex and rare conditions.
FDA approves a new IgA nephropathy therapy that targets two immune cytokines at once, offering a weekly, self-administered treatment option.
EMA starts phased review of daraxonrasib for metastatic pancreatic cancer, testing a faster assessment model under reformed EU pharma rules.
PharmTech spoke with Gabriela Grasa Mannino, Senior Director, Advanced Supply Chain Solutions, US Pharmacopeia about the current state of the drug supply chain and what actions USP is taking to make supply more secure.
In a string of ADC acquisitions, Novartis agreed to acquire Myricx Bio for up to $1.5 billion, gaining an NMTi ADC payload platform designed to overcome resistance in solid tumor treatment.
An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.
FDA's 12-digit NDC rule demands industry-wide barcode, labeling, and data system overhauls, manufacturers must act now to avoid pharma's Y2K moment.
June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.
BioPhorum launches a 20-member collaboration uniting pharma, CDMOs, and regulators to address manufacturing challenges in small molecule drug production.
FDA has approved Tregzi, the first regulatory T-cell therapy shown to reduce chronic GVHD and improve survival in blood cancer transplant patients.
The company’s thyroid eye disease treatment will be the first at-home subcutaneous disease-modifying treatment if approved.
This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.
The FDA again rejected Unicycive's oxylanthanum carbonate over third-party manufacturing compliance, not safety, spotlighting CMC risk in nanoparticle drug development.
The outsourcing company is adding commercial-scale capabilities to manufacture HPAPI and ADC payload-linkers.
The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain.
