FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Is Global Regulatory Gridlock Slowing Modernization?
Author(s)Agnes Shanley
PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.
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PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology. Fewer pharmaceutical companies even do “technology scouting” today.
Maik Jornitz, who chaired the aging facilities taskforce during its first year, discusses challenges and what is required for change.
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Articles in this issue
almost 10 years ago
Extending QMS to Contract Partnersalmost 10 years ago
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?almost 10 years ago
Ensuring Quality in Pharmaceutical Raw Materialsalmost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
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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.
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 article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
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.
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