By Kate Rawson
For Big Pharma, there may be nothing more dangerous than a House Democrat 12 years out of power and itching...
Part D Pricing and Subpoena Power: What the November Elections Could Mean for Wall Street
The pharmaceutical industry has a lot riding on the mid-term elections: the Democrats only need to take back one chamber of Congress to do damage on Wall Street.
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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.
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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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
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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.