"It's amazing with this consumer empowerment how fast that market is growing," biopharma industry veteran Fred Hassan remarks. "Coming up with good products, scientifically validated, supported by doctors and approaching consumers with proper claims, it's a huge opportunity."
Private equity firms continue their investment spree in the consumer health products sector, keeping it a hotbed for mergers and acquisitions, says private equity manager Slava Leykind. Investors' interest remains high because drug firms are selling some lines as they prioritize around top-selling brands.
Pharma industry veteran executive Fred Hassan, now a partner and managing director at private equity firm Warburg Pincus and CEO...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
