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. Read More
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. Read More
As with most common diseases of the developed world, aging is the major risk factor for developing cancer. Most of the half-dozen hallmarks of precancer that were published last week by investigators from Vanderbilt University and the Fred Hutchinson Cancer Research Center are also hallmarks of aging.
Unfortunately, scientists reported at the American Association for Cancer Research’s (AACR) 2024 annual meeting this week that accelerated aging is increasing, and may be driving an increase in early-onset cancers. Read More
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. Read More
The U.S. FDA thinks using minimal residual disease as an endpoint for accelerated approval in new therapies to treat multiple myeloma (MM) might just be an idea whose time has come. The FDA now wants to know what its Oncologic Drugs Advisory Committee thinks about it, so the agency has convened a meeting of the committee for a deep dive into the subject on April 12. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ablative Solutions, SHL Telemedicine, Neuronetics, Nico, Paragonix, Sight Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axena, Bosch, Dexcom, MD Revolution, Randox, Radnet, Ricoh, Simbiosys. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Simpson Interventions. Read More
