FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|March 2, 2005
- Pharmaceutical Technology-03-02-2005
- Volume 29
- Issue 3
IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients
Author(s)Pharmaceutical Technology Editors
IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.
Articles in this issue
over 21 years ago
March 2005over 21 years ago
Packaging Becomes Part of the Prescriptionover 21 years ago
Appraisal of the Laser Diffraction Particle-Sizing Techniqueover 21 years ago
Optimism Taking Over in Pharmaceutical Chemicalsover 21 years ago
In the Spotlight - March 2005over 21 years ago
A “Disclosure Defense” in Liability Lawover 21 years ago
Managing Aseptic Interventionsover 21 years ago
Validating Automated Systemsover 21 years ago
Combination Products Raise Manufacturing ChallengesRelated to this article
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
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