Regulations for the development of medical devices in Japan, China, and the UK will come under scrutiny
Regulations for the development of medical devices in Japan, China, and the UK will come under scrutiny during a workshop to be held in London on March 20.
The Asia-Pacific Technology Network is organizing the event, with the support of Global Regulatory Services (GRS). Among the speakers will be David Jefferys, MD, Senior Vice-President of Eisai Medical Research and the former Chief Executive and Director of the UK Medical Devices Agency of the Department of Health. He will discuss medical device regulations in Japan, including recent developments and combination products.
By 2017, the global medical device market will be worth around US $434.4 billion, amounting to an annual average growth of 7.1% from 2012, and increasing numbers of devices are hybrids, which combine a device with a medicine, according to the organizers. Pre-filled syringes are an example of a combination product.
“Pharma companies can no longer rely on discovering the next blockbuster, and they are being forced to diversify in order to remain viable; therefore, many are now turning to devices as their next revenue stream. Increasing healthcare costs are helping to drive the growing medical device industry,” they noted in a statement.
For further details on the workshop, contact [email protected]
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.