A graphical depiction of outgoing FDA Chief Counsel Stacy Cline Amin's list.
A graphical depiction of outgoing FDA Chief Counsel Stacy Cline Amin's list.
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Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.
CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.
Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.
Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
