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This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
In key registration-enabling, placebo-controlled trials, patients received once-monthly doses of lerodalcibep for up to 52 weeks. Results from the trials demonstrated that lerodalcibep achieved significant reductions in LDL-C levels. Over 2,400 patients have continued in the 72-week open-label extension trial.
The approval is grounded in data from five randomized, double-blind, placebo-controlled trials involving 317 adults. He expressed optimism about the therapy’s potential to enhance outcomes for patients in the US.
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.
The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. Participants were randomized to receive acoramidis or placebo over 30 months.
Since its introduction, it has become a cornerstone therapy for heart failure patients, particularly after receiving a Class 1 recommendation from the American College of Cardiology (ACC) and the American Heart Association (AHA) in 2016. The trial found that the primary composite endpoint was reduced by 40% with selexipag compared to placebo.
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial Management.
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. The webinar will also cover: What the NPRCs’ franchise model means for research delivery.
One such study, the PREVAMIC trial conducted in Spain , found that cardiac amyloidosis was present in 20.1 Cardiac amyloidosis can significantly shorten survival times if not diagnosed early. Patients with heart failure and preserved ejection fraction — a population particularly at risk — often go undiagnosed, compounding the issue.
Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). While HELIOS-A focused on nerve damage, HELIOS-B expands vutrisiran’s use to cardiomyopathy.
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.
the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of F.C.A.H.S. (PI)
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.
a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc., It is then efficiently metabolized by the body.
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. The webinar will also cover: What the NPRCs’ franchise model means for research delivery.
Late-stage clinical trial failures are largely to blame for the lack of effective treatment options for patients with HFpEF, and poor five-year survival rates make this an area of great unmet need. And by validating a drug target before further developing target compounds, late-stage clinical trial attrition could be greatly decreased.
Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.
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. In July, finerenone was approved under the name Kerendia® by the us (U.S.)
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.
This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. There was a record 34 approvals in major markets, and late-stage trials are commencing for medications including camizestrant, datopotamab deruxtecan and volrustomig.
The FDA’s approval is based on positive results from the AGENT IDE trial , a multicenter, prospective, randomized controlled study, which demonstrated the statistical superiority of Agent DCB over uncoated balloon angioplasty in preventing target lesion failure (TLF) at 12 months.
“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research (CDER).
Liz Paulson, Associate Vice President, LifeSciences for the Healthcare Business of LexisNexis® Risk Solutions, is recognized with HBA’s Strategic Transformation Achievement Recognition (STAR) volunteer honor. Christi Shaw, Chief Executive Officer, Kite, a Gilead Company, was selected as the 2023 Woman of the Year.
We did not get a Class II certification for diabetes only, or orthopedics or cardiology; we got a disease-agnostic certification. Now, as we develop new predictive algorithms, whether that is in diabetes, cardiology, respiratory or oncology, we can bring those algorithms to our platform because it is disease-agnostic.
For healthcare professionals and stakeholders in the lifesciences sector, understanding the top-performing cardiovascular drugs is not just about recognizing their financial success. Recent trial data shows bentracimab can rapidly reverse the blood-thinning and antiplatelet effects of Brilinta in as little as five minutes.
Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, lifesciences and pharmaceutical sectors. The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were investigated in various clinical trials. billion in 2022.
Currently, several alpha particle emitters are being investigated in clinical trials. Radiobiological Considerations of Alpha Emitters: No Two Are the Same While Xofigo (Ra-223) remains the only FDA-approved alpha emitter, several others are being investigated in both clinical trials and preclinical studies. Radiotherapy and Oncology.
In recent years, the landscape of women’s health clinical trials has begun to shift. Read on to learn more about the historical challenges, recent advancements, clinical considerations, and the future of women’s health clinical trials, as detailed by Medpace’s women’s health experts. Health disparities add to these challenges.
We live in a diverse world and our teams, clinical trial participants, customers, and key opinion leaders (KOLs) should reflect this. Diversity in clinical trials. Racial disparities are still commonplace in most clinical trials. A notable example is the relative lack of Black participants in cardiologytrials.
NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinical trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. The TANDEM trial enrolled 407 participants with baseline LDL-C levels averaging 97 mg/dL despite maximally tolerated statin use in 74 percent of patients.
Results from the trial of 418 patients showed that subcutaneous Rybrevant reduced the risk of death by 38 percent compared to intravenous Rybrevant. percent, including impacts from its 2023 acquisition of cardiology medtech company Laminar. If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.
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