International regulators make dementia plans
This article was originally published in Scrip
The conclusions of a workshop involving 10 medicines regulators held in Geneva in November 2014 have been published by the UK's MHRA, which noted that the meeting was the first time the regulators had met globally to discuss dementia. With the aim of providing a supportive environment for drug development in this area of high unmet need, six areas were identified in which regulators and other clinical and scientific experts and analysts will collaborate to find a solution to the problem. These included analysing the factors behind the termination of development programs over the past 10-15 years; considering how to make clinical trials more efficient; composite endpoints and benefit-risk balance including exploring expedited approval procedures. Participants in the initial workshop included the European Medicines Agency and regulators from several countries including the US, Japan, Germany, Italy, Denmark, the UK, the Netherlands, Canada and Switzerland. The meeting was convened by the UK government, which is also supporting the World Health Organization's first ministerial conference on global action against dementia in Geneva on 16-17 March.
You may also be interested in...
The Chinese government's plan to reduce tariffs it imposed on a slew of US exports is expected to have minimal impact on the overall medtech industry. See what Ralph Ives, AdvaMed's executive VP for global strategy, said about it here.
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.
While the global health threat from the now officially named SARS-CoV-2 coronavirus has grown since the start of the quarterly earnings season in early February, even many of the companies reporting more recently do not appear overly concerned about potential business impact at this stage.