The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
FTC Closes Seven-Year Adderall XR Pay-for-Delay Investigation
Given the FTC's very recent amicus brief in In re Effexor, however, the closing of the Adderall XR investigation should not be taken as an indication that the agency is abandoning its scrutiny of these provisions. Instead, this development may suggest that the FTC is carefully weighing the fact that these types of provisions can vary significantly both in form and competitive effect.
Finally, it is important to note that the Adderall XR agreements are still the subject of private litigation currently pending in federal court in the Southern District of New York.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017