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., 175:1091-1101 (1992) 2 Karpusas, M et al., Structure. 9(4):321-9.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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

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.

Small Molecule 130

Small Molecule Immune Response Clinical Trials International 130

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Ther Innov Regul Sci. Rockley KL.

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Drugs FDA Disease Animal Testing 111