2025 Pharmacokinetics Small Molecule 
The Premier Consulting Blog
AUGUST 8, 2024
On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.
The Pharma Data
SEPTEMBER 15, 2020
27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. mg/dL at doses of 15, 70 and 120 mg respectively, compared to a -24.8
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New Drug Approvals
SEPTEMBER 13, 2024
2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] Aticaprant is taken by mouth. [1]
The Pharma Data
JANUARY 10, 2021
In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. .
Agency IQ
JULY 26, 2024
In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.” Any CMC changes (e.g.,
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