The French regulator says that the safety issues associated with pseudoephedrine-containing medicines, and the fact that they are indicated for "benign, non-life threatening and self-resolving conditions," calls their benefit-risk balance into question.
The future of more than 300 medicines containing the decongestant pseudoephedrine is in the balance after the EU’s drug safety watchdog said it was looking into concerns raised by the French medicines agency, ANSM, about the risk of two conditions affecting the blood vessels in the brain.
ANSM said it was concerned about new data from a small number of cases of posterior reversible encephalopathy syndrome (PRES)...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
