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BioWorld - Tuesday, May 24, 2022
Home » Topics » Clinical

Clinical
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Tacticath

Abbott’s Tacticath scores high in persistent atrial fibrillation study

May 4, 2022
By Meg Bryant
No Comments
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
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Connect seeks to partner S1P drug after phase II falls short

May 4, 2022
By Jennifer Boggs
No Comments
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
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Esophageal cancer

Beigene’s tislelizumab meets primary survival endpoint in first-line advanced esophageal cancer

May 4, 2022
By Tamra Sami
No Comments
Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
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Pro2cool device

Tectraum completes Pro2cool concussion therapy study

May 4, 2022
By Meg Bryant
No Comments
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.
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Axess device and logo

Xeltis touts preliminary data for restorative hemodialysis access graft

May 4, 2022
By Catherine Longworth
No Comments
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
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Shionogi releases positive results, back on track for COVID-19 treatment

May 3, 2022
By Gina Lee
No Comments
New trial results presented by Shionogi & Co. Ltd. at the 32nd European Congress of Clinical Microbiology and Infectious Diseases showed the company’s 3CL protease inhibitor, S-217622, was well-tolerated, with the potential to rapidly clear SARS-CoV-2, Simon Portsmouth, executive medical director at Shionogi, told BioWorld.
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Map of Australia as blue circuit board, digital network

Australia to begin routine GCP inspections for clinical trial sites

May 3, 2022
By Tamra Sami
No Comments
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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Australia to begin routine GCP inspections for clinical trial sites

April 29, 2022
By Tamra Sami
No Comments
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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Back and shoulder

As LS tree line rises, Timber stacked for success?

April 29, 2022
By Randy Osborne
No Comments
A handful of developers are advancing drug prospects in the localized scleroderma (LS) space, with candidate mechanisms that range from cell-based gene therapy to IL-4 or IL-6 antagonism to PDE4 blocking, and with efforts that involve approved as well as experimental compounds.
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Arecor eyes fast development for concentrated insulin product after phase I readout

April 28, 2022
By Richard Staines
No Comments
Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
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