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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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.
Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinicaldevelopment of their DA01 cell therapy approach for Parkinson’s disease.
Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinicaltrials.”. The companies share equally the costs of the development of vericiguat. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division.
At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We
Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinicaldevelopment in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.
UK-based RHYTHM AI is to go ahead with a larger clinicaltrial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. Clinicaldevelopment of the system got off the ground last year when the company announced the closure of a £2.15m financing round.
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, ClinicalDevelopment, BlueRock Therapeutics.
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.
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.
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.
The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinicaldevelopment.
Teerlink is actively involved in many acute and chronic heart failure clinicaltrials, serving on endpoint, data safety monitoring, and steering committees for numerous international cardiovascular studies. Dr. Teerlink was profiled in The Lancet as an internationally recognized leader in heart failure.
The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.
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.
In recent years, the landscape of women’s health clinicaltrials has begun to shift. Beth Tulip, Senior Executive Director of ClinicalTrial Management at Medpace, also participated and shared key operational strategies for women’s health clinicaltrials. Health disparities add to these challenges.
“The Phase III FIDELIO-DKD trial is the first large contemporary positive outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) with a primary composite endpoint consisting exclusively of kidney-specific outcomes. The study met its primary endpoint.
Professor of Cardiology at the National and Kapodistrian University of Athens, Greece, and co-principal investigator of the FIDELIO-DKD and FIGARO-DKD Phase III clinicaltrials.
. “No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, M.D., vice president, Product Development, Lilly.
The company announced the initiation of its Phase 1b clinicaltrial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. and -50.4%
With Blackstone Life Sciences, up to €300 million (around $315 million USD) will be invested to accelerate pivotal studies and clinicaldevelopment 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 billion in 2022.
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