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#news #biotech Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug.Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug … Continue reading →

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Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

MyTEMP worked with patients and caregivers to develop the trial, and Kidney Patient and Family Advisory Councils guided the choice of additional outcomes. degrees Celsius. The REB approved the MyTEMP request to use an altered patient consent process because the research was deemed of minimal risk to patients.

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Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)

Rethinking Clinical Trials

Trial participants were adults ages 30-85, who tested positive for SARS-CoV-2 within 3 days, with fewer than 7 days of symptoms, no known prior infection with SARS-CoV-2, no severe kidney, liver, or heart failure. We also kept equal focus on follow-up. Learn more about COVID-OUT. pctGR, @Collaboratory1.

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Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Rethinking Clinical Trials

ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. The intervention was to facilitate delivery of guideline-based care. Pearl O’Rourke, MD; David S.

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Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Rethinking Clinical Trials

The DECODE trial used registry data to identify patients with chronic kidney disease. You can always use the system to identify potential candidates and then guide them to the local cardiology, kidney department. To keep the cost down, we are thinking about how to use vaccine clinics. Learn more. Read about DANFLU-1.

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Perfusion MRI and Other Perfusion Imaging Techniques for Clinical Trials

XTalks

For ASL MR perfusion, water molecules in arterial blood from a feeder artery are magnetically tagged and tracked until they reach the region of interest. Then, the signal difference in the region of interest between the tagged images and control images can be computed to obtain cerebral blood flow (CBF) values ( Figure 3 ).

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New Rare Disease Drugs and Research Advancements

XTalks

Recent FDA Approvals of New Rare Disease Drugs Filspari (sparsentan) for primary immunoglobulin A nephropathy (IgAN), a rare kidney disease, marking it as the first non-immunosuppressive therapy for the condition. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.