A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Mark it as a day to remember. Today the FDA authorized the first in vitro diagnostic test for Alzheimer’s disease, enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations.
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.
Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.
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.
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