Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with ...
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ...
In this interview with PharmTech, at AAPS PharmSci 360, Johnson discusses her presentation, “Platform Formulations as Tools for Risk Redistribution and Accelerated Development,” which draws on two ...
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up ...
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, ...
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic ...
On preclinical science, Gardiner welcomes FDA’s growing flexibility, including its plausible mechanism framework. Patient-derived cell lines, humanized transgenic mice, and targeted large-animal ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
In the October 2026 episode of PharmTech’s Ask the Expert video series, Jane Zhang, co-founder and co-CEO of ETCH Sourcing, joins Susan J. Schniepp, distinguished fellow at Nelson Labs, to answer the ...
Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...
The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and ...
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