It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
Philochem AG’s ligand-targeting approach drew to the table Bristol Myers Squibb Co. in a potential $1.35 billion agreement granting BMS subsidiary Rayzebio Inc. exclusive worldwide rights to OncoACP3, a diagnostic and therapeutic candidate targeting prostate cancer.
Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO for very long. Continuing the brisk pace seen so far this year, Caris Life Sciences Inc. is hot on its heels with a road show in progress leading up to its expected debut on the Nasdaq next week.
The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.
GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
Researchers at North China Electric Power University and collaborators have developed novel radiolabels for the membrane-bound monoamine oxidase-B that feature a coumarin core.
In what represents their first patenting, researchers from New York’s Stony Brook University filed for protection for development of a system and method that uses computer vision to analyze microscale facial movements in order to objectively help diagnose, monitor, and treat disorders of consciousness.
Being able to detect and monitor the aggregation of α-synuclein in situ could lead to more objective, earlier diagnosis of Parkinson’s disease as well as allow real-time monitoring of whether patients are responding to treatment.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
RSS
