article thumbnail

Clinical Trial Data: Navigating Audit Trail Data Regulations and Accessibility Challenges 

VirTrial

The data highlights fast or slow recruitment and how the drug supply is managed. Study data is always subject to scrutiny by regulators, which further highlights its importance. Given the industry is a highly regulated one, there are always new regulations being issued.

article thumbnail

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

Drugs 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Chemotherapy Drug Shortage: An Unprecedented Crisis

XTalks

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

Drugs 98
article thumbnail

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

This promise and growth are expected to continue as CGT, which have the potential to cover 70% of oncology drugs, are being developed to treat further disease types such as solid tumors. CGT drugs fall into two major categories: autologous and allogeneic. Differences in CGT vs traditional trials supply chain.

article thumbnail

MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., In July 2020, the U.S. View source version on accesswire.com: [link].

article thumbnail

Why and How Will Ecommerce Transform the Interactive Response Technology (IRT) User Experience?

XTalks

IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management. He also shared how modern software development concepts are impacting IRT platforms and transforming the user experience in clinical trials. How is Modern Software Impacting IRT Platforms?

article thumbnail

Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

Repercussions of the Covid-19 pandemic The idea that the Covid-19 pandemic dramatically affected the CGT supply chain and upturned CGT manufacturing has dominated the conversation in the biotech sector 3. But now, the increased efficiency is likely making drug development cheaper. So what bottlenecks are making CGT so inaccessible?