President Barack Obama issued an executive order pledging U.S. support and cooperation to furthering the 2014 Global Health Security Agenda (GHSA), which aims to protect against global threats from emerging infectious diseases. The order establishes long-term policy objectives and memorializes a comprehensive framework for the U.S. to use common targets to measure progress on the agenda. It specifically calls on federal agencies to work with other governments and organizations to advance the GHSA and directs the National Security Council to convene a GHSA Interagency Review Council.
The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) declined to institute an inter partes review (IPR) petition submitted by Coherus Biosciences Inc. The petition challenged a formulation patent on North Chicago-based Abbvie Inc.'s blockbuster Humira (adalimumab). Coherus has said it plans to file a BLA for its Humira biosimilar late this year or early next year.
The FDA issued a final rule to clarify regulations about the submission of citizen petitions and petitions for stay of action (PSAs) involving a request for the agency to take an action that could delay approval of generics, biosimilars and 505(b)(2) drugs. The rule clarifies that a PSA, like a citizen petition, may be supplemented, amended or withdrawn by the petitioner. Other changes in the rule reflect that the FDA commissioner may dismiss a petition if it has been rendered moot by changes in law, facts or circumstances that occurred after it was submitted.