The European Medicines Agency is set to decide whether to back EU marketing approval for eight new drugs.
Eli Lilly/Almirall could this week learn whether the European Medicines Agency will recommend in favor of pan-EU marketing approval for lebrikizumab, their investigational treatment for moderate-to-severe atopic dermatitis and potential rival to Sanofi/Regeneron Pharmaceuticals’ blockbuster drug Dupixent (dupilimumab).
Lebrikizumab is among eight new products for which initial EU marketing authorization applications (MAAs) are listed as being up for...
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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.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.
