PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Drug Discovery World

JULY 11, 2024

Patient dosing is expected to start early in 2025. million to accelerate clinical trials for MTX325 and MTX652. The money will support a 28-day dosing of MTX325 in patients with early-stage PD, as part of an ongoing MTX325 Phase I programme. The company previously raised £25.2 ($32.1)

Disease 147

Disease Treatment Small Molecule Clinical Trials 147

Drug Discovery World

APRIL 11, 2024

It was announced that the next AACR Annual Meeting will take place in Chicago on 25-30 April 2025. The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research.

Biochemical Assays 130

Biochemical Assays DNA Science Pharmacokinetics 130

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. This study is planned to start in late 2024 and conclude in late 2025. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Regulations Therapies 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.] When would the guidance go into effect?

Science 40

Science FDA Production Trials 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

FDA 59

FDA Clinical Trials Disease Trials 59