The patent lawsuit of Athena v. Mayo revisits previous case law where patent subject matter eligibility is concerned, and numerous parties have weighed in urging the Supreme Court to hear the case. However, the U.S. Solicitor General has not responded with its own friend-of-the-court brief, an omission that would seem to take some of the pressure off the Supreme Court to hear the case.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
The impending resumption of the 2.3% tax on medical devices has industry actively seeking at least a new suspension. Now, the Tax Foundation, of Washington, has issued a report saying that the tax would cost more than 21,000 Americans their jobs and impose a $1.7 billion hit on the U.S. economy.
The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.
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