By Emily Hayes
MannKind's plans to partner inhaled insulin are on hold until the Food & Drug Administration completes its review of the...
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...
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.
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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
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.