Twenty-nine state attorneys general filed a lawsuit against Bristol-Myers Squibb June 4 alleging the company illegally prevented sales of generic Taxol (paclitaxel). According to the states, sales of Taxol total over $5.4 bil. since 1998 when Hatch-Waxman marketing exclusivity for the drug ended...
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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.”