The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs.
Some patent litigation cases don’t require a deep effort to interpret claims, but the litigation between Agilent Technologies Inc., and Dionex Softron GmbH, forced the Court of Appeals for the Federal Circuit to determine whether a written description adequately captures the use of a piston in a liquid chromatograph to avoid nullification of the claim.
Citing federal preemption, the U.S. Court of Appeals for the First Circuit tossed multidistrict litigation (MDL) involving GSK plc’s labeling of Zofran, an antiemetic approved for postoperative use and in conjunction with chemo or radiation, but that is commonly used off-label in pregnancy.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Act Genomics, Arthrex, Bactiguard, Cellmyx, Inogen, Medalliance, Micronoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biora, Cantex, Eisai, Hifibio, Ideaya, Immorna, Krystal, Neurelis, Otsuka, Phio, Revance, Santhera, Secura, SK, Tenaya.
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
The U.S. Department of Justice (DOJ) reported an indictment of three men alleged to have filed more than $100 million in genetic testing false claims directly or indirectly with the Medicare program. Two of the three defendants face as many as 65 years of incarceration if convicted, a clear sign that federal government agencies in the U.S. are more intent than ever on cracking down on fraud and abuse of federal health programs.
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