FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
|Articles|January 2, 2011
- Pharmaceutical Technology-01-02-2011
- Volume 35
- Issue 1
Pharmaceutical Technology, January 2011 Issue (PDF)
Outlook 2011
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Articles in this issue
almost 16 years ago
Global Healthcare on the Ground: Global Health Progress Initiativealmost 16 years ago
Exploring Custom Synthesisalmost 16 years ago
Report from Europealmost 16 years ago
Inside ICH: ICH Meets in Japan to Finalize Key Documentsalmost 16 years ago
In the Spotlight January 2011almost 16 years ago
Outlook 2011almost 16 years ago
A Comparison of Three Extrusion Systemsalmost 16 years ago
Cost and Compliance Dominate Agenda for 2011almost 16 years ago
Improving the Quality of Product ReleaseAdvertisement
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Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.
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.
Science, circularity, regulation, and technology are reshaping how the industry develops packaging for medicines.
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