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.
Drug Discovery World
JULY 11, 2024
MTX325 is a potent, selective, small molecule brain-penetrant USP30 inhibitor, which is designed to protect dopamine-producing neurons by improving mitochondrial quality and function. Patient dosing is expected to start early in 2025. The company previously raised £25.2 ($32.1)
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Drug Discovery World
FEBRUARY 22, 2024
With no in-house laboratory space, the company works closely with multiple international contract research organisations (CROs), including Axxam, which carry out all of the Libra R&D, from compound screening assays, to in vivo pharmacokinetic/pharmacodynamic and ADME work, as well as in vitro and in vivo pre-clinical safety assessments.
Drug Discovery World
APRIL 8, 2024
Alto Neuroscience has initiated a Phase II study to determine the pharmacodynamic effects of ALTO-203 in major depressive disorder (MDD) patients, as well as assess its safety, tolerability, and pharmacokinetics. To date, ALTO-203 has demonstrated positive emotional and cognitive effects in healthy participants after a single dose.
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
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
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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