Russia’s Sputnik V vaccine gets the all-clear in India as the COVAX initiative hits the shortages speed bump. Also, two more antibody treatments are OKd for use in COVID-19 in the UK.
Coronavirus vaccine shortages are very much in the news on a global level, exacerbated by supply restrictions in India. New safety scares associated with vaccines from AstraZeneca PLC and Janssen Pharmaceutical Cos. will have done nothing to inspire confidence in the global rollout.
The European Medicines Agency said last Friday that its drug safety committee, the PRAC, was investigating not only rare and...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
