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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Despite the persistence of the patent thicket, and slow uptake by the medical community, biosimilars are positioned for growth in the US.
New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?
Advances in development, data management, and automation, and closer collaboration with contract development and manufacturing partners, are pushing more therapies closer to commercialization.
A former Team Biologics' whistleblower’s complaint raises questions about FDA inspector training and support, as well as GMP noncompliance patterns at biologics facilities.