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 ...

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 ...

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 ...

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

Digital twins function as synchronized, real-time operational mirrors, where divergence from the physical process triggers ...

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

Legacy web forms used for clinical trial recruitment, adverse event reporting, laboratory data collection, and regulatory ...

Laboratory testing validates low migration, low odor, and low VOC in clean, sustainable secondary packaging. Even paperboard ...

PRAC-triggered post-authorization actions for cenobamate will cascade across SmPC, PIL, and controlled regulatory materials, ...

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

EMA states that reduction in animal testing will be gradual. The first qualification opinion for a NAM used in toxicity ...