The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . The SGLT2 inhibitor was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise. . New indications. The application was granted priority review. .

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

New Drug Approvals

OCTOBER 24, 2023

2014, 5, 12, 1313–1317 Publication Date:November 4, 2014 [link] APD334 was discovered as part of our internal effort to identify potent, centrally available, functional antagonists of the S1P 1 receptor for use as next generation therapeutics for treating multiple sclerosis (MS) and other autoimmune diseases. . 11] SYN ACS Med.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] February 2014). September 2014). October 2014). Jump up to: a b Urbano M, Guerrero M, Rosen H, Roberts E (May 2014). 2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

The Pharma Data

JULY 6, 2021

Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014. Population pharmacokinetic and pharmacodynamic modeling data to characterize the antithrombin (AT) lowering dynamics in hemophilia patients treated with fitusiran will be shared in a poster presentation.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

Metabolite Tales Blog

DECEMBER 13, 2023

Paine and Aleksandra Galetin (2014). 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. Figure 4: Optimisation of an IDO1 inhibitor incorporating installation of a gem-dimethyl group to control glucuronidation of a key hydroxyl group. Polli, Mary F.

Small Molecule 59

Small Molecule Metabolic Stability Treatment Drugs 59

Molecular Design

MAY 11, 2019

Design decisions in lead optimization are typically supported by assays for a range of properties such as solubility, permeability, metabolic stability and off-target activity as well as pharmacokinetic studies.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Pharmaceuticals Drugs 52