MannKind's Uphill Climb to Partner Inhaled Insulin

MannKind no longer expects to land a partner for its inhaled insulin Afresa until FDA approval is in hand. Its not surprising that potential partners are skeptical given the regulatory and commercial challenges--but investors were disappointed nevertheless. Does MannKind know something other diabetes companies don't?

By Emily Hayes

MannKind's plans to partner inhaled insulin are on hold until the Food & Drug Administration completes its review of the...

More from Archive

More from Pink Sheet

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By 

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By 

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.