Drug Target Review
JULY 4, 2023
These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules.
thought leadership
SEPTEMBER 20, 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. Since these products share specific aspects of biologics and small molecule drugs, this new guidance provides specific recommendations to address the special characteristics of these drugs.
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The Premier Consulting Blog
JULY 31, 2024
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.
Drug Target Review
APRIL 7, 2025
The emergence and adoption of clinically relevant biomarkers is gradually presenting alternatives to MTD, particularly around therapies such as cell and gene therapy (CGT) and immunotherapy. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Rodrigues AD. 113:9861002.
New Drug Approvals
SEPTEMBER 10, 2024
g/mol 1929519-13-0 NBI-1065846 or TAK-041 Phase 2 (S)-2-(4-oxobenzo[d][1,2,3]triazin-3(4H)-yl)-N-(1-(4-(trifluoromethoxy)phenyl)ethyl)acetamide Zelatriazin ( NBI-1065846 or TAK-041 ) is a small-molecule agonist of GPR139. Zelatriazin, C 18 H 15 F 3 N 4 O 3 , 392.3 88 (8): 3872–3882. doi : 10.1111/bcp.15305. PMC 9544063. PMID 35277995.
The Pharma Data
NOVEMBER 1, 2020
The Company has built a leading platform for the discovery and development of first-in-class, small molecule drugs that selectively target deubiquitylating enzymes (DUBs) – an emerging drug class that is attracting significant commercial interest in the area of protein homeostasis.
The Premier Consulting Blog
SEPTEMBER 11, 2024
The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to.
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