Zachary Zubulake

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.

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.

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

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.

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.

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.

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.

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

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

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.

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

Merck acquires Terns Pharmaceuticals for $6.7B, gaining TERN-701, a promising oral CML therapy with a novel mechanism and early Phase I/II clinical data.

Olon is expanding global biologics and high-potency manufacturing capacity across four countries, with major ADC chain investments completing in 2026.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses how IRA negotiations, Most Favored Nation pricing, US manufacturing push, and new FDA biosimilar guidance are reshaping the industry.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses drug supply chain vulnerabilities tied to China dependence, urging resilience through mapping, nearshoring, and manufacturing reform.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology advocates clinically relevant PDX models to bridge preclinical and clinical gaps for radiopharmaceutical success.

Pharma companies reveal capacity expansions and strategic pivots at DCAT Week 2026, signaling where supply chain investment is heading.

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.