Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
Before filing financial statements with the U.S. SEC, public companies will need to think about how their business has been impacted by Russia’s invasion of Ukraine and, perhaps, update filings they’ve already submitted.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cathvision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acrotech, Bayer, Belite, Cellics, Depymed, Idorsia, Exelixis, Petros, Regeneron, Sapience, Taysha.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
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