Clinical Trials

As part of its continued efforts to streamline operations through digitisation, the Central Drugs Standard Control Organisation (CDSCO) has transitioned from offline to online acceptance of clinical trial applications for cell and gene therapies products (CGTP). The agency has also...

Randomised controlled trials (RCTs) have long been the gold standard of clinical trials, with the most robust evidence of safety and effectiveness of new medicines. But the traditional RCT model—characterised by strict protocols, predetermined sample sizes, and rigid timelines—is...

In the years that have gone by, the big data integration within clinical trials has gone on to emerge as a very transformative force within the healthcare industry, especially in Asia. As Asia continues to experience fast economic growth, advancement...

The market for clinical trial supplies is about to change a lot because there is a growing need for new ways to help people with their health and because medical research is making progress. As the world changes, the...

In a time characterized by accelerated innovation and ever-more complicated clinical environments, Asia is witnessing an invigorating shift in the role of Contract Research Organizations (CROs). Once seen as service organizations that assist in the pharmaceutical and biotech product...

When it comes to the pharmaceutical sector, choosing the correct contract development and manufacturing organization (CDMO) is essential to having a successful trip through the process of making a pharmaceutical product. This choice is dependent on two crucial aspects:...

Alnylam Pharmaceuticals, Inc., a global leader in RNAi therapeutics, has announced U.S. FDA approval of AMVUTTRA® (vutrisiran) for the treatment of cardiomyopathy associated with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. This approval makes AMVUTTRA the first and...