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.

Using patent intelligence data from the FounderNest platform, alongside funding, partnership, and deployment signals across the market, Felix Gonzalez highlights where AI and digital technologies are gaining traction in pharmaceutical development and manufacturing, and what it means for competition this year.

The FDA approved a high-dose nusinersen regimen for spinal muscular atrophy, offering pharma teams key insights into dose optimization and lifecycle management.

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

Excipients contribute to more sustainable practices throughout the life cycle of a drug.

FDA’s Project Optimus shifts oncology dosing from MTD to balancing efficacy and safety via metrics like Net Treatment Benefit to pick doses.

This article explores key engineering strategies that support this transformation, including hybrid reactor design, clean-in-place optimization, automation architecture, and modular scalability.

Michelle Dennis at MilliporeSigma explores how biofluorescent particle counting and RFID traceability are transforming real-time environmental monitoring.

This week, three core themes have emerged: the digital transformation of quality systems through AI and hybrid cloud architectures; the pursuit of supply chain resilience via onshoring and advanced mapping; and a regulatory push toward real-time data and flexible approval pathways.

EMA approved Johnson & Johnson’s daratumumab SC for self-administration, Europe’s first oncology injectable to offer this treatment flexibility.

Tony Lakavage, USP, outlines pharma disruptions, pricing shifts, supply chain risks. As well as greening standards to build a resilient supply chain.

FDA approves first therapy for Hunter syndrome's neurologic symptoms via surrogate endpoint, signaling evolving rare disease development standards.

Richard Jaenisch explains how digitally interactive SOPs and Human-AI Training Parallelization help build, measure, and continuously improve AI-era workforce skills.

Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental monitoring in pharma manufacturing.

New legislation will improve patient access to innovative medicines in Europe and the United Kingdom.