The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.

Sherlock Biosciences Inc. is on the case of the missing tests – the lack of diagnostic testing for sexually transmitted infections, that is. Sherlock’s over-the-counter molecular, disposable tests combine CRISPR and synthetic biology chemistries to provide results in 30 minutes in the privacy of the user’s home.

The U.S. FDA is keen to develop tools for oversight of artificial intelligence (AI) as demonstrated by a batch of research projects designed to inform the review of medical applications of AI. The agency’s concern is that there is a dearth of “robust evaluation methods” for evaluating AI products, thus the need for tools that will allow the agency to clear or approve such products with an assurance that these algorithms are safe and effective for their intended use.

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.

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.