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Pipeline and Product Development

FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act: One key condition: Facility generally cannot compound drugs using bulk drug substances unless that substance appears on the FDA's '503B Bulks List' (substances for which there is a demonstrated clinical need) or the compounded drug is on the FDA's active drug shortage list

Which leads to the most important part of this newsletter: Who made these drugs expensive

Investigating the Potential Role of Serotonin-2B Receptor Antagonism in the Neuronal Actions of Adjunctive Aripiprazole (M.Sc

& Bergman, R

Discussion In this study, we have identified how single amino acid substitutions to exendin-4 can dramatically enhance insulin secretion via modulation of GLP-1R binding kinetics, biased signaling, and trafficking