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.

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.

Michelle Dennis, MilliporeSigma, breaks down how biofluorescent particle counting and RFID traceability are improving speed, accuracy, and efficiency in pharma QC.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses siloed pharma data being a hidden risk, with AI as a possible key to connecting quality systems and seeing the full manufacturing picture.

In this Drug Digest episode, Abzena’s vice president of Regulatory Strategy, Jeff Mocny, and Cellares’ director of Regulatory Affairs, Anna McMahon, examine how evolving regulatory and quality expectations are reshaping biopharmaceutical development and manufacturing.

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

New US pharmaceutical tariffs reach up to 100%, with exemptions for companies that strike pricing deals or commit to domestic manufacturing.

Susan Schniepp, Regulatory Compliance Associates Inc., says poor quality in pharma manufacturing is costly but catching defects early can saves millions.

Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.

The FDA approves orforglipron (Foundayo), the first oral, non-peptide GLP-1 for obesity, the fastest NME approval under the new CNPV program.

ROIS acquires Bristol Myers Squibb's Phoenix sterile injectable facility, expanding its global network to 800M+ units/year with US-based high-potent fill-finish capacity.

Lilly acquires Centessa for $6.3B, gaining an orexin receptor agonist pipeline targeting narcolepsy and other sleep-wake disorders.

The agency has issued a draft qualification opinion on a new preclinical research methodology.

Contract development and manufacturing organizations can assist the sponsor company in ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

Lilly licenses Insilico's AI drug discovery platform in a deal worth up to $2.75B, signaling a shift in how novel therapeutics are identified.