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BioWorld - Tuesday, December 30, 2025
Home » Topics » Clinical

Clinical
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Clinical research concept with medical icons on light bulb

Ark Bio shares positive data for first positive RSV antiviral phase III

April 8, 2022
By David Ho
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
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T cells

Ontak making a comeback with new data from Citius

April 6, 2022
By Lee Landenberger
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
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Person wearing mask, glove holding pill

Phase III proxalutamide opens door for Kintor in COVID-19

April 6, 2022
By Randy Osborne
Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors.
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Allist's furmonertinib meets primary endpoint in phase III trial to treat lung cancer

April 6, 2022
By Doris Yu
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
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3-30-Medtronic-Symplicity-Spyral.png
ACC 2022 Scientific Sessions

Renal denervation not yet prepared to move medications to the side

April 5, 2022
By Mark McCarty
As was the case with left atrial appendage closure, renal denervation (RD) as a treatment for hypertension has proven to be difficult to move along into routine clinical usage. New data for a study sponsored by Medtronic plc showed that RD offers a statistically significant improvement over sham treatment in reducing hypertension, but the data do not seem to suggest that patients will be able to drop their antihypertensive medications after RD treatment.
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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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