Hypercholesterolemia

NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results

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torsdag, maj 9, 2024
Congress, American College, Investment, Risk, ASCVD, CVD, Research, Moyamoya disease, Research and development, Partnership, Conference, PCSK9, Hypercholesterolemia, History, Growth, Administration, Cardiology, Patient, Physician, LDL, Cardiovascular disease, NAMS, Standard of care, Phase 3, Clinical trial, Biomarker, Drug discovery, Partner, Pharmaceutical industry

-- Strong financial position; ending the quarter with $481.1 million in cash --

Key Points: 
  • Driven by strong patient and physician interest globally, NewAmsterdam extended enrollment to the end of April and randomized over 9,500 patients.
  • In January 2024, NewAmsterdam appointed William H. Lewis, J.D., M.B.A as Chair of its Board of Directors.
  • NewAmsterdam currently expects to achieve the following upcoming milestones:
    Announce topline data from the Phase 3 BROOKLYN trial for obicetrapib monotherapy in the third quarter of 2024.
  • Revenue: NewAmsterdam recognized $1.4 million in revenue for the quarter ended March 31, 2024, compared to $8.6 million in the same period in 2023.

Valbiotis publishes its annual accounts 2023

Retrieved on: 
fredag, maj 3, 2024
FDA, Sales management, Partnership, Hypercholesterolemia, Sleep, INSIGHT, Prevalence, Insulin resistance, Inflammation, DSM-IV codes, Food, Communication, Cholecalciferol, Executive Committee, Pharmacist, Pharmacy, Volunteering, INAF, Phase, Practitioner, Incretin, EFSA, Safety, Omega-3 fatty acid, Agonal respiration, Human, LDL, Marketing, Prediabetes, NAFLD, Endocrine gland, NDI, Food and Drug Administration, Meal, Commercial, Dietary supplement, Blood pressure, Patient, Statutory auditor, Metabolism, Hypertension, Cardiovascular disease, Bank statement, Pharmaceutical industry

Sébastien PELTIER, Chairman of the Executive Committee and Co-Founder of Valbiotis, comments: ‘’2023 was one of Valbiotis' most productive years since the Company was founded just ten years ago.

Key Points: 
  • Sébastien PELTIER, Chairman of the Executive Committee and Co-Founder of Valbiotis, comments: ‘’2023 was one of Valbiotis' most productive years since the Company was founded just ten years ago.
  • By accelerating its structuring, Valbiotis also laid the foundations for 2024, which promises to be particularly fruitful.
  • The Company's 2023 financial statements, drawn up in accordance with IFRS, were approved by the Board of Directors on April 23, 2024.
  • They have been audited by the Statutory Auditor and are available on the Valbiotis website: www.valbiotis.com/en (investors section).

Using clinical-led AI, Truveta expands clinical notes and medical images available to advance research

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torsdag, maj 2, 2024
Migraine, Roger Hawkins (drummer), Metadata, Hospital, Cardiology, Nuclear medicine, EHR, MD, Research, Pathology, Hypercholesterolemia, Seizure, Cancer, Disease, Exercise, NASH, Documentation, Patient, Diet, Medicine, MRI, Health, Catheter, Algorithm, Cardiac catheterization, Heart failure, Medical imaging

By providing a complete view of the patient journey, Truveta enables researchers to accelerate therapy adoption, improve clinical trials and enhance patient care.

Key Points: 
  • By providing a complete view of the patient journey, Truveta enables researchers to accelerate therapy adoption, improve clinical trials and enhance patient care.
  • Using the most advanced, award-winning AI technology , Truveta extracts the data from these notes and cleans it to enable research.
  • Medical images are updated daily, cleaned with clinical expert-led AI, and de-identified with industry-leading privacy and security technology.
  • Images can be analyzed in notebooks in Truveta Studio and included in studies for scientifically rigorous research.

Valbiotis to launch its 100% natural dietary supplement for the management of hypercholesterolemia on the French market in May

Retrieved on: 
onsdag, april 10, 2024
Cholecalciferol, LDL, CRM, Cholesterol, Cardiovascular disease, Medicine, Digital, Dietary supplement, Business, Risk, Patient, Pharmacy, DSM-IV codes, ERP, Research, Stroke, Pharmacist, Business development, Executive Committee, HEART, Artery, Research and development, Omega-3 fatty acid, Safety, Enterocyte, Lipid metabolism, General practitioner, Marketing, Practitioner, Sleep, Hypercholesterolemia, Pharmaceutical industry

The natural and innovative characteristics of this product clearly position Valbiotis®PRO Cholestérol as a leader in the lifestyle and dietary management of hypercholesterolemia, a major risk factor for cardiovascular disease."

Key Points: 
  • The natural and innovative characteristics of this product clearly position Valbiotis®PRO Cholestérol as a leader in the lifestyle and dietary management of hypercholesterolemia, a major risk factor for cardiovascular disease."
  • Available behind the counter in pharmacies, the dietary supplement will also be sold without a prescription with a pharmacist’s recommendation.
  • It comprises a new generation of dietary supplements with active ingredients of natural origin, acting on several targets for comprehensive management.
  • A principal mechanism controls intestinal cholesterol absorption, while a complementary mechanism acts on hepatic metabolism for a comprehensive approach to the management of hypercholesterolemia.

NewAmsterdam Pharma Enrolls Over 9,000 Patients in Pivotal Phase 3 PREVAIL Global Cardiovascular Outcome Trial Evaluating the Effect of Obicetrapib in Patients with Established Atherosclerotic Cardiovascular Disease

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tisdag, april 9, 2024
Disability, Cardiovascular disease, Myocardial infarction, CVD, Risk, Patient, Stroke, NAMS, History, Mortality, Death, FESC, Moyamoya disease, Phase 3, Monash University, MACE, ASCVD, Hypercholesterolemia, Pharmaceutical industry

Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.

Key Points: 
  • Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.
  • “PREVAIL, our pivotal CVOT, will potentially demonstrate that obicetrapib’s lowering of LDL-C will reduce major adverse cardiac events (“MACE”).
  • The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.
  • “Despite widespread availability of statin therapies, CVD-related deaths are on the rise, and many patients are not at their risk-based LDL-C goals.

Verve Therapeutics Announces Updates on its PCSK9 Program

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tisdag, april 2, 2024
LDLR, Cardiovascular disease, Gene editing, PCSK9, ALT, Patient, RNA, Health care, Health Canada, IND, N-Acetylgalactosamine, MHRA, Asialoglycoprotein receptor, Clinical trial, CTAS, Therapy, Bleeding, Safety, Moyamoya disease, DSMB, FDA, Liver, ASCVD, LNP, Medsafe, Hypercholesterolemia, Food, Pharmaceutical industry

BOSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced updates from the Heart-1 Phase 1b clinical trial of VERVE-101 and clearance of its Clinical Trial Applications (CTAs) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada for VERVE-102, with the Heart-2 Phase 1b clinical trial expected to initiate in the second quarter of this year.

Key Points: 
  • Six participants have been dosed at 0.45 mg/kg of VERVE-101, with a total of 13 participants dosed in the study.
  • Verve is conducting an investigation into the laboratory abnormalities and based on those results, expects to work with regulatory authorities to define a path forward for VERVE-101.
  • Verve is now prioritizing the development of VERVE-102 and the initiation of the Heart-2 clinical trial.
  • VERVE-102 uses the same base editor and guide RNA for PCSK9 but a different lipid nanoparticle (LNP) delivery system than VERVE-101.

Vaxxinity Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Updates

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onsdag, mars 27, 2024
Research, Neurodegenerative disease, Notifiable disease, LDL, Obesity, University, Comparison, PCSK9, Central Florida, Translational research, COVID-19, PD, CSF, Diabetes, Amprion, Patient, CNS, Mayo Clinic, Vaccine, Journal, Biomarker, Travel, Myostatin, Hope, SARS-CoV-2, D&O, Investment, Solid lipid nanoparticle, MDS, Marketing, Parkinson's disease, Hypercholesterolemia

CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
  • We also seek to advance UB-311, our anti-Aβ Alzheimer’s candidate, as we resume dialogue with regulatory authorities and partners.
  • General and administrative expenses were $3.4 million and $7.7 million for the three months ended December 31, 2023, and 2022, respectively.
  • General and administrative expenses were $22.4 million and $28.4 million for the years ended December 31, 2023, and 2022, respectively.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

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fredag, mars 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing cardiovascular events

Retrieved on: 
fredag, mars 22, 2024
Health, Biometrics, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Hypercholesterolemia, European Commission, Bempedoic acid, Risk, Patient, Tablet, Committee, ACL, Ageing, Agent handling, Esperion Therapeutics, EMA, Death, European Medicines Agency, Ezetimibe, Therapy, Moyamoya disease, ATP, FDC, CHMP, Apolipoprotein, Pharmaceutical industry

“The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.

Key Points: 
  • “The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.
  • This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.

Summary of opinion: Nustendi, 21/03/2024 Positive

Retrieved on: 
onsdag, april 3, 2024
Civil service commission, Hypercholesterolemia, Bempedoic acid, Patient, Tablet, Committee, Risk, Medication package insert, Diet, Ezetimibe, Moyamoya disease, European Commission, Cardiovascular disease, Marketing, CHMP, Pharmaceutical industry

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nustendi.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nustendi.
  • The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH.
  • For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
  • For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.