When Roche rumbles
The "Street" shakes. Mid-day April 21 announcement by Roche in Basel of a press conference on Monday, April 24 to "announce measures which are of considerable significance" sent analysts scurrying in search of march-in targets. Syntex has been a favorite rumor; but Roche announcement was apologetically rushed ("we beg for your understanding about the short term of this announcement"), and there isn't any ostensible reason for rushing a move on the California company. The window for breaking up the SmithKline-Beecham deal is more limited.
You may also be interested in...
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.”