Japan announces new confidentiality agreements with EU, Canada
This article was originally published in SRA
Japan’s Ministry of Health, Labour and Welfare and its Pharmaceuticals and Medical Devices Agency have announced new information-sharing arrangements with the European Commission and Health Canada1. The agreements, which cover the regulation of medical devices, were concluded through an exchange of letters dated 28 October (European Commission) and 9 October (Health Canada) respectively.
You may also be interested in...
HemaQuest, a US biotech focused on developing small-molecule therapeutics for haemoglobin diseases, has expanded the Phase II programme for its lead compound, HQK-1001, in sickle cell disease with a new trial aimed at establishing safety and tolerability at higher dose levels and over a longer course of therapy.
Novartis' efforts to revive its COX-2 inhibitor lumiracoxib under a new brand name, and with the risk of hepatotoxicity that killed the drug in its original incarnation muted by a companion diagnostic, have stumbled in Europe after the company withdrew an application for centralised approval of what is now known as Joicela.
Crystallics, a new contract research organisation specialising in solid-state research and pre-formulation activities for the pharmaceutical, biotechnology and agrochemical industries, has been established in the Netherlands through a management buyout of the former Avantium Pharma business from its parent company, Avantium Holding.