SMITHKLINE HIGHLIGHTS NICODERM CQ "STEPPED" DOSAGE, 24-HOUR RELEASE in television ads supporting the launch of the new Rx-to-OTC switch nicotine patch. Developed by New York-based Jordan, McGrath, Case & Taylor, the ads began airing on Aug. 16. Teaser ads for NicoDerm CQ began running on Aug. 12.
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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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.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.
