International – Biogen, Harvard partner on gene therapy for eye diseases

Mutations in more than 270 genes have been implicated in inherited eye diseases like retinitis pigmentosa. Now, Biogen has formed a research pact with...
WHO drafts guidance for pharma supply chain tracking

International – WHO takes stock of global COVID-19 R&D progress

Researchers, developers and funders from across the globe attended the two half-day virtual summit on 1 and 2 July to examine the progress made...

International – Ethnic Differences, Regulatory Policies, and COVID-19

The ICH E5 guideline “Ethnic factors in the acceptability of foreign clinical data” and E17 guideline “General principles for planning and design of multi-regional clinical trials” present harmonized...

International – Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US, and Asia

Electronic labeling is the focus of many ongoing initiatives across regions. E-labeling can deliver the latest labeling information immediately and in an efficient and...

International – Improving Access to CAR T Therapy: It’s Not Just Payment

The development of chimeric antigen receptor (CAR) T therapy for patients with advanced hematological malignancies represents one of the greatest successes in bringing basic...

International – EMA and Korean Ministry of Food and Drug Safety to share confidential...

EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential information...
WHO drafts guidance for pharma supply chain tracking

International – WHO ACT-Accelerator prioritizes global vaccine approach

The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and...

International – Covid : l’OMS appelle à augmenter la production mondiale de dexaméthasone

« Le prochain défi consiste à augmenter la production et à distribuer rapidement et équitablement la dexaméthasone dans le monde entier, en se concentrant...

International – European Commission, EMA and FDA agree new priorities to strengthen their collaboration...

Senior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral...

International – WHO warns against indiscriminate use of dexamethasone

The World Health Organization (WHO) on Wednesday said a common drug shown to be effective in treating COVID-19 is meant for use only among...

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