Sinusitis

AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio

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Mittwoch, Mai 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Mortality, FDA, Risk, ICS, Death, Weight loss, Growth, Gastrointestinal tract, Rash, TSLP, Formoterol, Biopharmaceutical, AstraZeneca, LABA, Inflammation, Salbutamol, Skin, Tezepelumab, Approval, EGPA, AMG, Allergy, Polyp (medicine), Bronchitis, Chronic obstructive pulmonary disease, Patient, Eosinophilic, Sinusitis, Rheumatology, Heart, Atmosphere, Fatigue, Immunology, Budesonide, Lung, Chronic pain, Asthma, COPD, Gastroenterology, Emphysema, Disease, Science, Conditional sentence, Dermatology, Pharmaceutical industry

In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.

Key Points: 
  • In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.
  • Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
  • With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas.
  • AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

FASENRA approved for treatment of children aged 6 to 11 with severe asthma

Retrieved on: 
Donnerstag, April 11, 2024
Health, FDA, General Health, Research, Science, Pharmaceutical, Biotechnology, Efficacy, Safety, Gastroenterology, HES, Chronic obstructive pulmonary disease, Sinusitis, Social media, Polyp (medicine), Pharmacokinetics, Rheumatology, Conference call, Asthma, TATE, AstraZeneca, FY, Hypereosinophilic syndrome, Death, ClinicalTrials.gov, Dermatology, Conference, COPD, Webcast, Growth, Disease, Vasculitis, Respiratory Medicine, EGPA, Immunology, Metabolism, Diagnosis, Biomarker, PD, Biopharmaceutical, Ageing, Pharmaceutical industry

TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.

Key Points: 
  • TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.
  • The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.
  • Benralizumab in children with severe eosinophilic asthma: pharmacokinetics and long-term safety (TATE study).
  • Severe uncontrolled asthma in children: practical approach on diagnosis and management.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sonntag, April 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

OM1 and Medtronic Partner on Propel Study to Assess Long-term Outcomes for Patients With Chronic Rhinosinusitis

Retrieved on: 
Dienstag, April 9, 2024
Data Management, Technology, Other Health, Health, General Health, Pharmaceutical, Health Technology, Research, Artificial Intelligence, Surgery, Science, University Challenge 2013–14, Partnership, Physician, Inflammation, Patient, American Academy, Standard of care, CRS, AI, Medtronic, PROPEL, ENT, Sinusitis, ESS, Adhesion, Pharmaceutical industry

The study focused on healthcare resource use (HCRU) and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS).

Key Points: 
  • The study focused on healthcare resource use (HCRU) and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS).
  • The study found that PROPEL devices are associated with lower HCRU and revision surgery during a 24-month follow-up period after ESS.
  • Thus, the use of PROPEL devices may lead to payer savings from reduced healthcare resource utilization.
  • “The results of this study demonstrate a rare win-win-win within healthcare,” said Amy Van Sach, president of Medtronic ENT.

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

Retrieved on: 
Freitag, März 22, 2024
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, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

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.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • 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 Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Freitag, März 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.

Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Donnerstag, März 21, 2024
Research, LYRA, Common, Bronchitis, Disease, MF, New Drug Application, COVID-19, Patient, Smell, Network congestion, CRS, United, Nasal cavity, Pharmacotherapy, Investment, Clinical trial, Therapy, Safety, Sinusitis, ESS, FDA, Food, Pharmaceutical industry

WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.  

Key Points: 
  • WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
  • LYR-220, a larger insert, is designed for CRS patients whose nasal cavity is enlarged due to previous ESS.
  • Cash, cash equivalents and short-term investments were $102.8 million as of December 31, 2023, compared to $102.6 million as of September 30, 2023.
  • The Company recorded an impairment charge of $1.6 million related to long-lived assets for the year ended December 31, 2023.

XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

Retrieved on: 
Freitag, März 15, 2024
Nosebleed, Research, Polyp (medicine), Vanderbilt University, Sciatica, Fluticasone, Education, Drainage, Disease, Incidence, Headache, Inflammation, Patient, Conditional sentence, Chronic obstructive pulmonary disease, Sinusitis, CRS, Standard of care, Quality of life, Migraine, Nasal cavity, Ear, ENT, Service, MPH, Nose, OPTN, FDA, Frustration, Food, Pharmaceutical industry

YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.

Key Points: 
  • Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States.
  • Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine.
  • Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine.
  • Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually.

Upstream Bio Announces Appointment of Rand Sutherland as CEO and Additions to Leadership Team

Retrieved on: 
Dienstag, April 2, 2024
Professional Services, Health, Human Resources, Clinical Trials, Pharmaceutical, Biotechnology, Polyp (medicine), Organization, University, Internal medicine, Growth, UCSF, Immunotherapy, CFO, Critical Care Medicine (journal), Business, Inflammation, Patient, Roche, TSLP, Acquisition, Bryant University, MD, Senior, MBA, Biology, Asthma, Therapy, Ithaca College, National Jewish Health, Sinusitis, Eli Lilly and Company, Genzyme, Ironwood Pharmaceuticals, Babson College, Management

Upstream Bio , a clinical-stage biotech company advancing verekitug (UPB-101) for respiratory disorders, today announced strategic leadership changes including the appointment of Rand Sutherland, MD, as Chief Executive Officer.

Key Points: 
  • Upstream Bio , a clinical-stage biotech company advancing verekitug (UPB-101) for respiratory disorders, today announced strategic leadership changes including the appointment of Rand Sutherland, MD, as Chief Executive Officer.
  • “I am thrilled to join Upstream Bio as CEO.
  • By evolving and building our leadership team with these additions, we are further positioning Upstream Bio to become a leader in the immunotherapy landscape.
  • I am pleased to welcome Rand, Mike and Lisa to the Upstream Bio team.”
    Dr. Sutherland joins Upstream Bio with more than 25 years of business and clinical experience, having most recently served as CEO of Seeker Biologics, and before that as President of Translate Bio prior to its acquisition by Sanofi.

Ketolides Market Expects Robust Growth With Rising Infectious Disease Prevalence - ResearchAndMarkets.com

Retrieved on: 
Dienstag, März 26, 2024
Infectious Diseases, Pharmaceutical, Health, Ketolide, Sinusitis, Pharmacy, Infection, Urinary tract infection, Hospital, Prevalence, Antimicrobial stewardship, Tuberculosis, Pharmaceutical industry

The global ketolides market is poised for steady expansion, driven by the growing need for effective treatments for infectious diseases and an upsurge in healthcare investments.

Key Points: 
  • The global ketolides market is poised for steady expansion, driven by the growing need for effective treatments for infectious diseases and an upsurge in healthcare investments.
  • According to the latest market research report, the ketolides market showcases a promising compound annual growth rate (CAGR), signaling a positive trajectory from $3.07 billion in 2023 to a projected value of $3.82 billion by 2028.
  • It also identifies emerging trends in targeted therapies and advancements in diagnostic procedures that are augmenting the ketolides market landscape.
  • The report underscores North America's dominance in the ketolides arena, attributable to robust healthcare infrastructure, comprehensive screening programs, and a heightened focus on infectious disease control.