Drug Discovery World

JANUARY 23, 2023

Implementation of the EU Clinical Trials Regulation The way clinical trials (CTs) are conducted in the European Union (EU) underwent a major change when the Clinical Trial Regulation (CTR) EU No 536/2014 came into force on 31 January 2022.

Clinical Trials 130

Clinical Trials FDA Drug Development Compliance 130

The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., RII, which resulted in an increased risk of thrombosis. Structure. 9(4):321-9.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

FDA Law Blog: Drug Discovery

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. For example, objective response rate is often used as a single-arm trial endpoint in oncology given the established understanding that tumor shrinkage rarely occurs without an intervention.”

Trials 49

Trials Clinical Trials FDA Treatment 49

Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Moreover, the US Food and Drug Administration (FDA) granted breakthrough therapy status to psilocybin in 2018 for treatment-resistant depression, and in 2019 for major depressive disorder 4.

Clinical Trials 130

Clinical Trials Treatment Regulations Trials 130

Drug Discovery World

AUGUST 2, 2023

Based on this data, ezurpimtrostat completed a first-in-human clinical trial for patients with advanced cancer 5 showing sustained stabilisation in heavily pre- treated patient with mild toxicity. Recent studies have suggested that palmitoylation can regulate the expression and activity of PD-L1 6. Front Mol Biosci 2021;8:659861.

Small Molecule 130

Small Molecule Immune Response Clinical Trials International 130

The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role. Ther Innov Regul Sci. Trends Neurosci.

Drugs 111

Drugs FDA Disease Animal Testing 111

Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” This is due, in part, to perceptions of public safety, and by extension, regulation.

Research 119

Research Engineering Science Disease 119