In this clip from episode 1 of Manufacturing Intelligence, Richard Jaenisch of Open Biopharma discusses step 1 in adopting AI ...
FDA rejects Replimune's melanoma therapy despite breakthrough designation, raising urgent questions about regulatory ...
Andrew Chang and Steven Falcone, Novo Nordisk, explain how FDA-EU GMP mutual recognition and a robust internal signal process drive global regulatory compliance. Andrew Chang, senior Director for ...
Fernanda Onofre, PhD, explains how the dsm-firmenich ModulaSENSE® Bitter platform and the functional application of vitamins as excipients are revolutionizing drug palatability and performance. While ...
Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.
Laboratory testing validates low migration, low odor, and low VOC in clean, sustainable secondary packaging. Even paperboard ...
This week, PharmTech took a look at the shift toward proactive, data-driven contamination control, the adoption of advanced material science to solve manufacturing hurdles, and an ...
PRAC-triggered post-authorization actions for cenobamate will cascade across SmPC, PIL, and controlled regulatory materials, ...
As a part of PDA Week 2026, Christopher Lewis, Emoja Biopharma and President of the Mountain States PDA Chapter, sat down ...
Legacy web forms used for clinical trial recruitment, adverse event reporting, laboratory data collection, and regulatory ...
On April 9, 2026, Oxford BioTherapeutics announced a multi-year collaboration with Bristol Myers Squibb focused on the discovery and development of T-cell engager therapies for solid tumors. 1 ...
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