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...
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
