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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.
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
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.
BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer?AG, 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). AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of
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.
This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant. BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy.
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 clinicaltrials.”. The companies share equally the costs of the development of vericiguat.
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
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.
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.
Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.
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.
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.
Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinicaldevelopment.
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.
The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.
When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. vice president, ClinicalDevelopment & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “ The companies partake inversely the costs of the development of vericiguat. In addition to this crucial study, we’re committed to gathering farther substantiation regarding the use of vericiguat.”.
– In a new sub-analysis of the landmark EMPEROR-Preserved® phase III trial, Jardiance reduced the combined relative risk of cardiovascular death and hospitalization for heart failure and slowed kidney function decline – Jardiance consistently improved outcomes across the full range of kidney function down to an eGFR of 20 mL/min/1.73
Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th.
(NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.
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.
– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.
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.
Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.
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.
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