EU Regulators Contradict Germany's Assessment Of Pfizer Anti-Depressant
A recent ruling by the European Medicines Agency that the benefit-risk profile of Pfizer Inc.'s antidepressant Endronax (reboxetine) was positive contradicts the outcome of a similar assessment a year ago by German health technology assessment body IQWiG, which had rubbished the drug as “ineffective and potentially harmful.” But it’s far from clear that Pfizer will now have any chance to resurrect the drug in Germany, however.
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<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>
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