The latest global regulatory news, changes and updates affecting biopharma, including: Aurolife, CDC, Central Drugs Standard Control Organisation, FDA, Glaxosmithkline, National Institute of Allergy and Infectious Diseases, Sanofi, U.S. Court of Appeals, World Health Organization.
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA).
Palo Alto, Calif.-based Varian Medical Systems Inc. has won the U.S. FDA’s nod for its Ethos therapy, an artificial intelligence (AI)-driven holistic solution that is aiming to transform cancer care. This solution is designed to deliver an entire adaptive treatment in a typical 15-minute slot and is intended to put the patient at the center of care, noted Chris Toth, president of Varian Oncology Systems.
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements.
Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
The FDA has granted over-the-counter (OTC) clearance to the first noninvasive wearable to treat stress urinary incontinence. The device, known as Innovo, uses electrical stimulation to strengthen pelvic floor muscles and is integrated into fitted shorts. It was already available by physician prescription in the U.S. since an FDA clearance in early 2019.
RSS
