FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|March 15, 2020
A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials
Author(s)J. Mark Wiggins, Joseph A. Albanese
This case study is based on the experience of one of the authors but is applicable to all companies across the broader industry, illustrating the potentially surprising point that some compliance difficulties may be of the company’s own making.
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Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
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