FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Rethinking Clinical Trials

JUNE 7, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS) appeared first on Rethinking Clinical Trials.

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Scienmag

AUGUST 16, 2020

The […].

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XTalks

FEBRUARY 12, 2025

For instance, in the LIBerate-HeFH trial in patients with HeFH, the treatment led to mean placebo-adjusted LDL-C reductions of 65% at 24 weeks, with approximately 68% of patients achieving LDL-C reductions of 50% or more, meeting European Society of Cardiology guideline-recommended targets.

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Velocity Clinical Research

NOVEMBER 21, 2023

“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. To keep the cost down, we are thinking about how to use vaccine clinics. Key Points.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Rethinking Clinical Trials

APRIL 13, 2023

Nudges and other behavioral interventions are prevalent in industries like business and entertainment, but there is an opportunity for nudges in medicine and health care delivery. Launched in 2016, the Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within a health system.

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Rethinking Clinical Trials

JULY 19, 2023

Distinguished Professor of Medicine Professor of Nursing Duke University Neha J. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies.

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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Scienmag

DECEMBER 3, 2020

In a randomized, controlled clinical trial, researchers found that patients who received genetic test results about the side effects of cholesterol-lowering medications did not have worse outcomes after one year A person’s genetic make-up can influence whether they might experience side effects from certain medications.

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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales. Continue to STAT+ to read the full story…

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Medical Xpress

APRIL 3, 2023

A randomized clinical trial of Black patients eligible for an implantable cardioverter-defibrillator (ICD) has found that the use of a video-based decision support tool increased knowledge of but not assent to ICD implantation. The findings are published in Annals of Internal Medicine.

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The Pharma Data

NOVEMBER 12, 2020

The data were released as one of the “10 Highly Anticipated Late-Breaking Clinical Trial Releases” during the VIVA 2020 Virtual Conference.

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pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects.

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Scienmag

NOVEMBER 13, 2020

Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.

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Scienmag

NOVEMBER 20, 2020

AHA, ACC issue updated guidance for the evaluation and management of people with HCM The American Heart Association and the American College of Cardiology today released an updated guideline for managing patients with hypertrophic cardiomyopathy (HCM).

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Scienmag

MARCH 10, 2021

Credit: AlphaMed Press Durham, NC – Results of a clinical trial released in STEM CELLS Translational Medicine provide evidence that treating patients with an injection of bone marrow cells may lead to a reduction in brain injury after a stroke. The study was conducted by Muhammad E. Haque, Ph.D., Savitz, M.D.,

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Velocity Clinical Research

MARCH 7, 2024

It’s easy to hear the enthusiasm for clinical trials when William Cromwell, MD, FAHA, FNLA , Principal Investigator and a leader of the Velocity Cardiometabolic CARE Council , discusses their importance to patients yesterday, today, and tomorrow. You can also do that by researching, publishing and teaching.

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The Pharma Data

NOVEMBER 8, 2021

In the FIGARO-DKD study, presented at ESC Congress 2021 and published in the New England Journal of Medicine, the prevalence of the first secondary endpoint, a compound of time to order failure, a sustained drop of estimated glomerular filtration rate (eGFR) ? cases in the finerenone arm and 395 (10.8)

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Scienmag

MAY 16, 2021

A unique commission that today issued major new recommendations aimed at fully understanding and reducing the global burden of heart disease in women was led by Roxana Mehran, MD, Professor of Medicine, and Population Health Science and Policy, and Director of Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine (..)

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The Pharma Data

MARCH 22, 2022

New data, including two late-breaking clinical trial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease. PRINCETON, N.J.–(BUSINESS 22), taking place in Washington, DC, and virtually, from April 2-4, 2022.

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Velocity Clinical Research

DECEMBER 6, 2023

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. As a result, Sponsors and CROs can benefit from simplified access to international clinical research capabilities. and Europe.

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ACRP blog

JANUARY 24, 2023

Raising Community Awareness to Optimize Impact Nevada’s first integrated health system was created in June 2021 when an affiliation agreement was signed between Renown Health and the University of Nevada, Reno, School of Medicine. Significant progress was achieved.

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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Scienmag

OCTOBER 30, 2020

That is the conclusion of a study published in the October 2020 issue of Academic Emergency Medicine (AEM), […]. Credit: KIRSTY CHALLEN, B.SC., MBCHB, MRES, PH.D.,

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Scienmag

APRIL 2, 2021

Formerly the ICD Registry, the new name reflects expanded offerings and aligns with other quality programs Effective immediately, the American College of Cardiology is offering the EP Device Implant Registry, which will include data on ICD and CRT-D procedures previously captured in the NCDR ICD Registry as well as provide the flexibility to capture (..)

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Scienmag

NOVEMBER 15, 2020

In a clinical trial of 60 patients, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 90 per cent of symptoms experienced by patients whilst taking statins were all present when they took placebo pills. […].

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Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

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Velocity Clinical Research

JANUARY 3, 2024

The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinical trials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinical research. and Europe.

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The Pharma Data

JUNE 28, 2021

The approval is based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020. Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinical trials.”. Verquvo (vericiguat) 2.5

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XTalks

JANUARY 3, 2025

XTALKS WEBINAR: Environmental Sustainability and the Supply of Medicines for Clinical Trials Live and On-Demand: Thursday, January 16, 2025, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how major pharma companies are working towards environmental sustainability and reducing their environmental impact.

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Scienmag

OCTOBER 5, 2020

Annual scientific symposium of CRF will take place virtually October 14-18 WHAT: The TCT Connect agenda is now available online at [link] TCT, the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine, will take place online October 14-18.

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

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Scienmag

APRIL 26, 2021

International, multi-center clinical trial results provide new hope for patients even years after a stroke Credit: Courtesy of MicroTransponder Inc. LOS ANGELES — Every year, more than 795,000 people in the United States have a stroke.

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pharmaphorum

OCTOBER 2, 2020

The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects.

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