Researchers from the U.K.’s University of Birmingham have filed for protection of an implantable device for targeted drug delivery in patients who have undergone surgery, particularly surgery to remove one or more tumors.

The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.

Finding an effective medication for patients with major depressive disorder is notoriously difficult, with 70% of patients failing to respond to the first drug prescribed and 30% not responding to the first four medications. Complicating matters, genetic mutations can increase psychotropic drug-related adverse events, including hospitalizations. A recent study indicates Myriad Genetics Inc.’s Genesight test can help minimize the risk of these negative events, with a reduction of nearly 40% in psychiatric-related hospitalizations and prescription of medications with significant gene-drug interactions.

Eli Lilly and Co. continues its development of an oral drug delivery device that can successfully deliver a drug that would otherwise be ineffective when taken orally.

Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements.