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At INTERPHEX 2026, MasterControl CEO Dave Edwards details how AI tools are boosting efficiency and compliance in pharma quality and manufacturing without replacing human oversight.

Maria Batalha, Valgenesis, discusses how her team assited a comapny in centralizing drug substance data, standardize processes, and unlock powerful AI-driven insights.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

Winners in 8 categories were announced at ISPE’s Europe Annual Conference.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

Drug shortages are rising. Learn what's breaking the pharmaceutical supply chain, and what industry leaders are doing to fix it.

Ranjit Deshmukh, Principal, BiologixCMC, discusses how contract manufacturers can optimize their processes and plan for the future by optimizing facility design.

Asahi Kasei acquires Aicuris, adding three antiviral assets targeting immunocompromised patients, with combined revenue projected at $500M by 2030.

Rohan Kumar, laboratory analyst at CS Analytical, discusses how sustainability in pharmaceutical packaging can be improved.

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.

FDA grants full approval to sparsentan for FSGS, the first-ever treatment for the rare kidney disease, backed by Phase III data showing 48% proteinuria reduction.

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.

FDA rejects Replimune's melanoma therapy despite breakthrough designation, raising urgent questions about regulatory consistency and accelerated approval pathway reliability.

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