OTC private label giant agrees with Starboard, which owns around 6.7% of Perrigo's shares, to immediately add to Perrigo's board Starboard CEO Jeffrey Smith and two other members recommended by the hedge fund: former Pfizer CEO Jeffrey Kindler and Nestle USA executive Bradley Alford.
The likelihood grows that Perrigo Co. PLC will find a buyer for its Rx generic specialty topicals business as investor Starboard Value LP gains five seats on the firm's board after pressing for the sale.
The Dublin-based OTC private label giant on Feb. 7 announced an agreement with Starboard, which owns around 6.7% of the...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
