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March 02, 2023
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
February 28, 2023
Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.
February 21, 2023
In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.
February 17, 2023
In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
February 15, 2023
Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.
The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.
February 13, 2023
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
February 07, 2023
The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.
February 03, 2023
