Remove 2016 Remove Clinical Development Remove Pharmacokinetics
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The rising impact of biomarkers in early clinical development

Drug Target Review

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Biomarkers can play a crucial role throughout clinical development, especially in early phases. 21(10):3517.

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ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies?

LifeSciVC

Anti-TIGIT antibodies have been clinically evaluated since 2016, and an absence of single-agent data has left a void in the scientific community’s understanding of the mechanism. Changes in both proximal measures of CBL-B inhibition and downstream measures of its ability to activate the immune system.

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SRP-001: redefining pain treatment with a safer, non-opioid analgesic

Drug Target Review

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. He is spearheading the scientific and clinical development and fundraising of South Rampart Pharma and technology development efforts.

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Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. Drug metabolism and drug transport of the 100 most prescribed oral drugs. Basic Clin Pharmacol Toxicol. 131(5): 311- 324. link] [13] Eng et al.,

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Advances in the Battle Against Autoimmune Disease

The Pharma Data

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. The primary endpoint of the trial will be NASH resolution with no worsening of fibrosis assessed on histology. Source link.

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