April 2020

Three classes of facilities to be set up for various categories of COVID-19 patients: Health Ministry’s guidance document for managing COVID-19, Government strategy for cluster containment and for managing outbreaks yielding positive results in some areas : Union Health Ministry

The first published data from the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) study supports the hypothesis that higher levels of the amyloid protein in the brain represent an early stage of Alzheimer’s disease. Results of an analysis of participant screening data for the study, published April 6 in JAMA Neurology, also show that amyloid burden in clinically normal older adults is associated with a family history of disease, lower cognitive test scores, and reports of declines in daily cognitive function. Major funding was provided by the National Institute on Aging (NIA), part of the National Institutes of Health; all data is now freely available to the broader research community.

The continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic.

In a dedicated COVID-19 workshop, organised by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed how data generated during clinical practice could complement evidence from clinical trials with potential therapeutics or vaccines against COVID-19. Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission acknowledged the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorisation and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials.