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XTALKS WEBINAR: Keys to Success in ClinicalTrials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinicaltrials.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinicaltrials, 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.
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.
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinicaltrial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc.,
The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
XTALKS WEBINAR: Environmental Sustainability and the Supply of Medicines for ClinicalTrials 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.
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.
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 clinicaltrial is to evaluate the safety, tolerability, and?preliminary?efficacy?of Senior Vice President, Clinical Development, BlueRock Therapeutics.
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.
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) clinicaltrials. In CV clinicaltrials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
Cardiovascular clinicaltrials 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 clinicaltrials. The Diversity of the US Population.
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinicaltrials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of ClinicalTrial Management.
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.
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinicaltrial 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.
Late-stage clinicaltrial 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. Heart failure affects about 6.2
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 clinicaltrials.
Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinicaltrial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
Currently, several alpha particle emitters are being investigated in clinicaltrials. 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 clinicaltrials and preclinical studies.
Heerspink, Professor of ClinicalTrials 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.
For healthcare professionals and stakeholders in the lifesciences sector, understanding the top-performing cardiovascular drugs is not just about recognizing their financial success. The clinical benefits and safety of Repatha have been studied for 12 years in 50 clinicaltrials with over 47,000 patients.
In recent years, the landscape of women’s health clinicaltrials has begun to shift. Read on to learn more about the historical challenges, recent advancements, clinical considerations, and the future of women’s health clinicaltrials, as detailed by Medpace’s women’s health experts.
We live in a diverse world and our teams, clinicaltrial participants, customers, and key opinion leaders (KOLs) should reflect this. Diversity in clinicaltrials. Racial disparities are still commonplace in most clinicaltrials. Are decentralised and virtual trials the answer? Diverse teams.
With Blackstone LifeSciences, up to €300 million (around $315 million USD) will be invested to accelerate pivotal studies and clinical development programs for formulating the subcutaneous delivery of the anti-CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma. billion ($3.65 billion ($2.85
NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinicaltrial, evaluating a fixed-dose combination of obicetrapib and ezetimibe.
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