Clinical Pharmacology Drug Development Small Molecule 
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.
Drug Target Review
JULY 4, 2023
Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.
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The Pharma Data
NOVEMBER 1, 2020
Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. – ENDS – NOTES TO EDITORS: About Mission Therapeutics.
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.
Agency IQ
FEBRUARY 23, 2024
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
New Drug Approvals
SEPTEMBER 13, 2024
“LY2456302 is a novel, potent, orally-bioavailable small molecule kappa-selective antagonist with activity in animal models predictive of efficacy in mood and addictive disorders” Neuropharmacology. “The first implementation of the NIMH FAST-FAIL approach to psychiatric drug development” Nature Reviews.
Agency IQ
DECEMBER 11, 2023
In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drug development process as well.
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