Regulatory Sourcebook 2021

Onshoring pharmaceutical manufacturing can be made more practical by collaborating with CDMOs that have gray space, supported by strong relationships with used equipment dealers and OEMs.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains how her team managed the study’s strict −80 °C handling requirement, quality release, and site readiness, and how the Almac Adapt approach can apply beyond this program.

The PharmTech AI Pulse Check panel discusses why MHRA and FDA oversight of pharma AI continues past go-live, and who validates the regulators' own AI.

The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.

USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.

Boehringer, AbbVie, ASKA, and Evommune license ADC, IBD, thyroid eye disease, and degrader assets, raising tech transfer demands for manufacturers.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains the benefits and challenges of the company’s just-in-time manufacturing solution.

Vivek Gupta of Duquesne University explains at AAPS PharmSci 360 why device decisions can't wait and why excipient makers must test beyond drug molecules.