Potential Cialis switch and the pending addition of Boehringer Ingelheim's consumer business are the revenue drivers highlighted by company execs on earnings call; second-quarter consumer health product revenues slipped 4.3% to $886.4m as a mild allergy season in the US and economic chaos in Venezuela drag down sales.
Sanofi is working to "fine-tune" an application to make erectile dysfunction drug Cialis available OTC in the US, marking another potential boost for its consumer health care segment on top of adding Boehringer Ingelheim GMBH's consumer business.
After Sanofi's second-quarter consumer health product revenues slipped 4.3% to €800m ($886.4m) as a mild allergy season in the US...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
