Andrew Chang and Steven Falcone, Novo Nordisk, discuss GMP mutual recognition, real-time digital monitoring, and the future of pharma QMS.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

Andrew Chang and Steven Falcone, Novo Nordisk, share how real-time digital monitoring, smart sensors, and a globally connected manufacturing network are shaping pharma's QMS future.

CPHI Americas 2026 tackles pharma's pressing challenges such as: regulatory shifts, AI in drug discovery, biologics innovation, and supply chain resilience.

Interpack 2026 previews filling, labeling, and packaging equipment from Uhlmann Group, groninger, and HERMA designed for pharmaceutical manufacturers.

Christopher Lewis, Umoja Biopharma, shares how AI is reshaping pharma through smarter oversight, personalized training, and actionable data insights.

Christopher Lewis, Umoja Biopharma, explores how AI is revolutionizing pharma training, predicting process issues, and unlocking the value of existing data.

Regeneron and Telix announce a 50/50 radiopharma collaboration, combining antibody expertise with specialized manufacturing to develop next-generation cancer therapies.

European Biotechs are utilizing AI and precision medicines to improve the personalized treatment of cardiovascular disease.

Andrew Chang and Steven Falcone, Novo Nordisk, explain how FDA-EU GMP mutual recognition and a robust internal signal process drive global regulatory compliance.

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars.

New PRAC safety data link cenobamate to rare severe liver injury, prompting updated monitoring requirements and revised product labeling for prescribers.

Christopher Lewis, Umoja Biopharma, explores how AI can streamline compliance, cut investigation time, and free skilled workers for higher-value tasks

Modernizing technology is urgent as legacy web forms expose pharma companies to breaches averaging $5.1 Million

BMS and Oxford BioTherapeutics partner to develop tumour-selective T-cell engagers, signalling pharma's growing reliance on specialist discovery platforms.

Susan Schniepp discusses how AI and digital twins speed up pharma batch release and detect data integrity issues while maintaining human oversight.

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions.

Biocon launches two FDA-approved interchangeable denosumab biosimilars in the US, targeting osteoporosis and bone metastasis in a $5B market.

This article details what co-processed excipients are and how they are made.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks.

Gene therapy AFTX-201 advances into multinational clinical trials, targeting the genetic root cause of BAG3-associated dilated cardiomyopathy with an engineered capsid.

Susan Schniepp, Regulatory Compliance Associates Inc., shares strategies to streamline pharma quality, reduce costs via early detection, and use data to ensure safety.

Susan Schniepp, Regulatory Compliance Associates Inc., explains how flexibility, right-sized SOPs, and transparency keep compliance simple.