Cardiology

Atamyo Therapeutics Obtains Regulatory Authorization in Europe to Initiate a Clinical Trial for ATA-200, its Gene Therapy to Treat Limb-Girdle Muscular Dystrophy Type 2C/R5

Retrieved on: 
Tuesday, March 26, 2024
Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, CNRS, Neurology, AAV, Motivation, Environment, Scientific method, Patient, CTA, DSM-IV codes, Biomarker, Research, ANSM, University, EMA, European Medicines Agency, Clinical trial, Therapy, Muscular dystrophy, Safety, Pathology, Weakness, Cardiomyopathy, Pharmaceutical industry

This authorization was first granted by the Italian Medicines Agency (AIFA), then by the French Medicines Agency (ANSM).

Key Points: 
  • This authorization was first granted by the Italian Medicines Agency (AIFA), then by the French Medicines Agency (ANSM).
  • Giacomo Comi, Full Professor of Neurology at the University of Milan (Italy), and principal investigator of this trial.
  • ATA-200, a gene therapy candidate for LGMD2C/R5, delivers a normal copy of the gene for production of γ-sarcoglycan protein.
  • In addition to its LGMD2C/R5 gene therapy, Atamyo is developing a clinical trial with ATA-100 gene therapy for LGMD2I/R9, related to deficiencies in FKRP; and is in IND-enabling studies for LGMD2A/R1, related to deficiencies in calpain protein.

Arrowhead Pharmaceuticals Initiates Expanded Access Program for Plozasiran and Announces Upcoming Presentation of Clinical Data

Retrieved on: 
Monday, March 25, 2024
Infectious Diseases, Diabetes, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Oncology, Arrowhead, Diagnosis, PALISADE, Patient, Hypertriglyceridemia, EAP, Science, Microsoft Access, American College, Clinical trial, RNA interference, FCS, Therapy, Physician, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.
  • Arrowhead will also present new final Phase 2 clinical data from the double-blind portion of the SHASTA-2 study of plozasiran in a late-breaking oral presentation at the upcoming American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24), being held in Atlanta on April 6-8, 2024.
  • “Arrowhead is committed to supporting patients living with various lipid disorders and the physicians who treat them.
  • “Our Phase 3 PALISADE study of plozasiran in patients with FCS is nearing completion and we are further supporting the patient community by initiating an expanded access program for patients and physicians interested in receiving treatment with plozasiran outside of a clinical trial.

United Therapeutics Corporation Announces $1 Billion Accelerated Share Repurchase Program

Retrieved on: 
Monday, March 25, 2024
Biotechnology, Pharmaceutical, Health, Cardiology, UTHR, Patient, ASR, PBC, Sale, Therapy, Creativity, Citibank, Pharmaceutical industry

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its Board of Directors has authorized the company to purchase up to $1 billion of United Therapeutics’ common stock.

Key Points: 
  • United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its Board of Directors has authorized the company to purchase up to $1 billion of United Therapeutics’ common stock.
  • This program builds on United Therapeutics’ planned $400 million paydown of its revolving credit facility in 2024, of which $100 million was paid down during the first quarter of 2024.
  • To enact the program, United Therapeutics today will enter into an Accelerated Share Repurchase (ASR) agreement with Citibank, N.A.
  • At final settlement of the ASR agreement, United Therapeutics may be entitled to receive additional shares of United Therapeutics’ common stock, or, under certain limited circumstances, be required to make cash payment to Citi or, if United Therapeutics elects, deliver shares to Citi.

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

Retrieved on: 
Tuesday, March 26, 2024
General Health, Professional Services, Venture Capital, Medical Devices, Hospitals, Small Business, Clinical Trials, Cardiology, Biotechnology, Finance, FDA, Health, Brain, Boston Scientific, Growth, Aortic stenosis, Trust, Risk, Patient, Pivotal trial, Research, IDE, Doctor of Philosophy, Stanford University, CMO

Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).
  • The funding round was structured in two separate capital increases which have both been completed.
  • It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund.
  • Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio

Retrieved on: 
Monday, March 25, 2024
Health, Clinical Trials, General Health, Pharmaceutical, Cardiology, Biotechnology, BMY, Patient, Mitigation, Bristol Myers Squibb, MD, Senior, LVEF, American College, Safety, REMS, ACC, Risk, Hospital, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place April 6-8, 2024 in Atlanta, Georgia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place April 6-8, 2024 in Atlanta, Georgia.
  • These data are consistent with the clinical development program and reinforce the safety profile of CAMZYOS in clinical practice.
  • This effectiveness and safety information about ELIQUIS use in clinical practice can supplement data from randomized clinical trials.
  • Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on cardiovascular diseases.

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: 
Friday, March 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.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Global Balloon Catheter Market Analysis Report 2023-2030: Minimally Invasive Solutions and Age-Associated Cardiovascular Problems Drive Demand - ResearchAndMarkets.com

Retrieved on: 
Friday, March 22, 2024
Medical Supplies, Medical Devices, Health, Surgery, Cardiology, Biotechnology, Coronary artery disease, Balloon catheter, Neurology, Prevalence, Headache, Urbanization, Blood, Peripheral artery disease, Urology, Angioplasty, Nylon, Hospital, Restenosis, Research, Splenic infarction, Telehealth, Heart, Stroke, Artery, Safety, Prognosis, Catheter, FDA, Artificial intelligence, CAD, Ageing, Medical device

The "Global Balloon Catheter Market, Size, Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Balloon Catheter Market, Size, Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The growing prevalence of age-associated cardiovascular problems propels balloon catheter demand, significantly increasing the medical device market and enhancing the care of growing older populations globally.
  • Offering minimally invasive alternatives to conventional surgeries, balloon catheters lead to faster recuperation instances, decreased dangers, and progressed patient effects, driving market increase towards minimally invasive tactics.
  • By product type, the Global Balloon Catheter Market is divided into Normal Balloon Catheter, Drug Eluting Balloon Catheter, Cutting Balloon Catheter, Scoring Balloon Catheter, Stent Graft Balloon Catheter, and Others.

LivaNova to Announce First-Quarter 2024 Results

Retrieved on: 
Thursday, March 21, 2024
Research, General Health, Mental Health, Medical Devices, Hospitals, Health Technology, Surgery, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Health, PLC, Telephone, LIVN, LivaNova

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, will host a conference call to discuss its first-quarter 2024 results on Wednesday, May 1, 2024 at 1 p.m. London time (8 a.m. Eastern Time).

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, will host a conference call to discuss its first-quarter 2024 results on Wednesday, May 1, 2024 at 1 p.m. London time (8 a.m. Eastern Time).
  • The Company will release its first-quarter 2024 results prior to the call.
  • Listeners should log on approximately 10 minutes in advance to ensure proper setup to receive the audiocast.
  • A replay will be available on the LivaNova website for 90 days following the call.

Global Digital Biomarkers Market Outlook & Forecast 2024-2029: Rise in Digitized Virtual Clinical Research, Increasing Focus on Drug Development and Expanding Applications in Mental Health - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 21, 2024
Mobile, Wireless, Other Technology, Telecommunications, Other Science, Data Analytics, Pharmaceutical, Research, Hardware, Mental Health, Medical Devices, Data Management, Consumer Electronics, Wearables, Mobile Technology, Technology, Women, Science, Biotechnology, Seniors, Biometrics, Medical Supplies, Men, Health, Artificial Intelligence, Health Technology, Professional Services, Health Insurance, Consumer, Cardiology, Culture, Conditional sentence, Growth, Prevalence, Neurology, Digital, Vital signs, COVID-19, Patient, Heart rate, Tablet, Biomarker, Health care, Software, Diagnosis, Drug development, USD, Ageing, Medical imaging

Factors such as an aging population, increasing healthcare costs, and a shift towards value-based care have driven the adoption of digital biomarkers.

Key Points: 
  • Factors such as an aging population, increasing healthcare costs, and a shift towards value-based care have driven the adoption of digital biomarkers.
  • The rise in digitized virtual clinical research is a significant trend in the global digital biomarkers market, driven by advances in remote monitoring technologies and the need for more efficient, patient-centric clinical trials.
  • The global digital biomarkers market is witnessing a notable trend with an increasing focus on drug development.
  • A prominent trend in the global digital biomarkers market is the increasing number of vendor collaborations and partnerships.