Two complaints seeking compensation for Perrigo shareholders and four motions seeking lead plaintiff designations in the litigation have been filed in US district court. Both target Perrigo's fundamental argument against Mylan's takeover bid in 2015, that the company would be stronger continuing on its own.
Perrigo Co. PLC's campaign to repel Mylan NV's hostile takeover in 2015 left shareholders holding the bag with the OTC private label giant in worse shape than it would be as part of Mylan, according to lawsuits seeking class-action certification.
Two complaints seeking compensation for Perrigo shareholders and four motions proposing certain shareholders as lead plaintiff in the litigation have...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
