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Visit 1www.ThePinkSheetDAILY.com for coverage of the latest developments in the pharmaceutical industry, including a settlement allowing Ivax to market its version of gabapentin (Pfizer's Neurontin), Sanofi's launch of the meningococcal conjugate vaccine Menactra and GlaxoSmithKline's continued manufacturing problems at its Puerto Rico facility. To sign up for a free trial of "The Pink Sheet" DAILY, visit our website or call customer service at 800-332-2181...
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Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”