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 ...

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

Laboratory testing validates low migration, low odor, and low VOC in clean, sustainable secondary packaging. Even paperboard with post-consumer recycled content passed the analytical methodology and ...

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars. This week, PharmTech took a look ...

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 ...

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

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