Teva received a “package of commercial side-deals” for agreeing to halt generic competition to Cephalon’s Provigil (modafinil) throughout the EU, which it “would not have achieved without committing to staying out of the market,” according to findings by the European Commission.
Teva and its Cephalon affiliate have been handed fines totaling €60.5m ($72m) over a historic “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil) that violated EU antitrust rules and caused “substantial harm to EU patients and healthcare systems by keeping prices high.”
The fine is the culmination of a near 10-year investigation by the European Commission that began in April 2011, weeks...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
