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
Combination Products Raise Manufacturing Challenges
Author(s)Jill Wechsler
New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.
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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 SystemsAdvertisement
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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.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
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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