Sarepta Therapeutics Inc.’s balloting March 12 from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (OTAT) in favor of gene transfer therapy SRP-9001 (delandistrogene moxeparvovec) in Duchenne muscular dystrophy (DMD) had Wall Street mulling the odds for others in the space.
Veracyte Inc. reported that its Prosigna breast cancer assay significantly reduced the use of chemotherapy in patients with high-risk, early-stage disease at the European Society for Medical Oncology 2023 in Berlin this week. The findings came from the EMIT study, a prospective, multi-year, population-based study in women in Norway that is assessing the impact of the Prosigna test on treatment decisions and outcomes.
Aidoc Medical Ltd. has just presented a study using its AI tool in the Netherlands Cancers Institute for detection and worklist prioritization to diagnose incidental pulmonary embolism at routine contrast-enhanced chest CT. The results published in Radiology: Cardiothoracic Imaging show a reduction by 15% of the missed rate of incidental pulmonary embolism and by more than 98% of the notification time for positive incidental pulmonary embolism. “Our AI system gives a response related to the interpretation, quantification and workflow management,” Elad Walach, co-founder and CEO of Aidoc Medical, told BioWorld. Due to the growing volume of radiology examinations, particularly in thoracic imaging, and the lack of supply radiologists, the delay between the CT examinations and their interpretation has increased significantly in many practices. This is particularly true for pulmonary embolism (PE).
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
A new urine test from Convergent Genomics Inc. correctly predicts bladder cancer as early as 12 years before clinical symptoms occur, new data presented at the 2023 American Urological Association annual meeting shows. The Uroamp test, which can be administered at home and in point-of-care settings, could increase survival rates and help to reduce health care costs.
Despite hitting a phase III study’s primary and key secondary endpoints for treating diabetic kidney disease, Reata Pharmaceuticals Inc. is discontinuing its bardoxolone programs for the indication. The data that disappointed Reata were, after three years of treatment, finding no separation in end-stage renal disease events between the bardoxolone and placebo groups.
Watchers of the Bruton’s kinase (BTK) inhibitor space may be casting renewed skepticism in that direction after Merck KGaA disclosed April 12 that the U.S. FDA placed a partial clinical hold on the sign-up of more patients in work testing evobrutinib in relapsing multiple sclerosis (MS) – but BTK efforts in MS continue in various quarters.
In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials to advance research in medical devices, drugs and biologics.
Fibrogen Inc. and its co-development partners for roxadustat, Astrazeneca plc and Astellas Pharma Inc., were dealt a major blow May 5 as the oral hypoxia-inducible factor prolyl hydroxylase inhibitor failed to meet its primary efficacy endpoint in a phase III trial in patients with anemia caused by transfusion-dependent lower-risk myelodysplastic syndromes (MDS).
Moleculight Inc. published a study on the impact of skin pigmentation on the clinical diagnosis of wound infection that could have profound implications for implicit or unconscious racial bias among diagnosticians. The paper in the Journal of Racial and Ethnic Health Disparities pointed to lack of clinical training and educational resources on diverse skin tones and of diagnostic tools to address unique clinical attributes of patients with darker skin tones.
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