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BioWorld - Wednesday, January 14, 2026
Home » Topics » Clinical

Clinical
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3D heart illustration showing tricuspid and bicuspid valves
ACC 2022 Scientific Sessions

One-year data for Edwards’ Pascal support improvements in mortality numbers

April 5, 2022
By Mark McCarty
The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.
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Artery and plaque

Astrazeneca, Ionis take aim at PCSK9 rivals with strong cholesterol readout from midstage hopeful AZD-8233

April 5, 2022
By Richard Staines
Astrazeneca plc and Ionis Pharmaceuticals Inc. have unveiled some eye-catching figures from their cholesterol drug, AZD-8233, in a phase IIb trial, taking aim at the PCSK9 inhibitor market where Novartis AG, Sanofi SA/Regeneron Inc. and Amgen Inc. are vying for supremacy.
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mRNA on digital background

Sunshine Biopharma continues its move into mRNA cancer treatment

April 5, 2022
By Lee Landenberger
Preclinical data on two newly designed mRNA molecules from Sunshine Biopharma Inc., of Montreal, showed they are effective at killing cancer cells grown in culture. Tests were performed on a variety of cancer cells, including multidrug-resistant breast cancer cells, ovarian adenocarcinoma cells and pancreatic cancer cells, while toxicology studies using normal human cells showed that the mRNA molecules had little or no cytotoxic effects.
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Image from GI Genius intelligent endoscopy module

Medtronic’s GI Genius in study for detecting adenomas during colonoscopy

April 4, 2022
By Nuala Moran
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
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Tablet, health professional, EHR/medical icons
ACC 2022 Scientific Sessions

Study hints electronic health records may change trajectory of heart failure outcomes

April 4, 2022
By Mark McCarty
There has been some skepticism about the value of electronic health records (EHRs) beyond their role as a source of income for EHR developers, but an April 3 presentation at the 2022 America College of Cardiology scientific sessions being held in Washington suggests this type of software offers some real value for heart failure patients. Tariq Ahmad of Yale School of Medicine said a study of EHRs suggests their power lay in part in prompting compliance with heart failure medication regimes, an application of this type of software that can both save lives and cut costs for the Medicare program and Medicare beneficiaries.
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3D heart in chest
ACC 2022 Scientific Sessions

Mavacamten, ablation poised to clash over treatment of hypertrophic cardiomyopathy

April 4, 2022
By Mark McCarty
Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.
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Patient death leads to a partial clinical hold for Curis

April 4, 2022
By Lee Landenberger
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
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IV drip

‘Plant’-ing a stake in Fabry, Protalix regains Balance with positive phase III

April 4, 2022
By Randy Osborne
The fortunes of Protalix Biotherapeutics Inc. improved dramatically with phase III results from the Fabry disease study called Balance, and a resubmission of the BLA for pegunigalsidase alfa (PRX–102) is planned for the second half of this year. In February, an MAA for PRX-102 was submitted to the EMA.
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Illustration of Sonocloud in brain

Carthera demonstrates potential of Sonocloud for lowering amyloid load in Alzheimer’s patients

April 1, 2022
By Bernard Banga
Carthera SA reported results from a pilot clinical trial to evaluate the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease (AD). The results, published in Alzheimer’s Research and Therapy, show early promise of the treatment in reducing the amyloid load of AD and potentially other neurological conditions as well as to stimulate neurogenesis and improve cognitive performance.
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Map of Europe

EU issuing wartime advice on clinical trials

April 1, 2022
By Mari Serebrov
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
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