The presidential campaign is about to begin in earnest, and for biopharma companies, the biggest question is what the outcome will mean for the pricing climate in the US. It isn’t an easy question to answer.
With the Democratic National Convention getting under way in Philadelphia, the presidential campaign is ready to begin in earnest. Hillary Clinton and Donald Trump will officially start campaigning as the formal nominees of the Democratic and Republican parties, and in just over three months, one of them will be elected President of the United States.
For the biopharma industry, there is one question that dominates the discussion of the upcoming election: what will the result...
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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.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.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
