The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies.
Focused on oral therapies for obesity, diabetes and rare diseases, Boston-based Syntis Bio Inc., which raised $15.5 million through seed funding last year, emerged from stealth to advance its synthetic tissue-lining technology and a pipeline of candidates.
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
Arrivent Biopharma Inc. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. have signed a development deal that leverages Alphamab’s antibody-drug conjugate (ADC) research and discovery platform and could bring Alphamab up to $615.5 million.
Australian radiopharmaceutical company Telix Pharmaceuticals Ltd. announced its IPO on the Nasdaq to raise $200 million to advance its late-stage radiopharma candidates. Headquartered in Melbourne, Telix has operations in the U.S., Europe (Belgium and Switzerland) and Japan with an extensive pipeline of theranostic radiopharmaceutical candidates.
Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.
Dublin-based Medtronic plc. has issued an urgent device correction letter to customers using the company’s Stealthstation robotic surgical system due to a software error that may provide inaccurate information about the location of the system’s surgical tip in the cranial anatomy.
Kardium Inc. landed $104 million in new financing for its Globe mapping and ablation system for atrial fibrillation, positioning it to enter the rapidly changing field in the U.S. The funds will allow the company to finish its PULSAR trial, secure FDA approval and launch its pulsed field ablation system commercially, Kardium Chief Financial Officer Koert VandenEnden told BioWorld.
The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court.
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
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