Sinusitis

First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

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onsdag, maj 22, 2024
ATP, ACL, Risk, Molina Healthcare, Ageing, Agent handling, Adverse event, CVD, Esperion Therapeutics, Back pain, Angioedema, Cholesterol, Gout, Kidney, Constipation, Treatment, Civil service commission, European Commission, Fetus, Anaphylaxis, Hypersensitivity, Moyamoya disease, Bempedoic acid, Urinary tract infection, Anemia, Hypercholesterolemia, Upper respiratory tract infection, Safety, Ezetimibe, CLEAR, Incidence, Bronchitis, Excipient, Diet, Gallstone, Rash, Patient, Cardiovascular disease, Diarrhea, Abdominal pain, Uric acid, Spasm, University, University of Milan, Therapy, Arthralgia, Sinusitis, Pregnancy, European, Stroke, Health, Common, Death, FDC, Fatigue, Myocardial infarction, Tablet, Rupture, Pain, CHMP, Dietary supplement

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

Key Points: 
  • Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
  • Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
  • “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Upstream Bio Presents Results from a Dose Ranging Study of Verekitug (UPB-101) in Adults with Asthma at the American Thoracic Society International Conference

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onsdag, maj 22, 2024
Patient, Thymic stromal lymphopoietin, Risk, Headache, Sinusitis, Polyp (medicine), Asthma, Conference, FENO, Inflammation, TSLP, Pharmaceutical industry

WALTHAM, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Upstream Bio, Inc., a clinical-stage company focused on the development of verekitug, a potential first-in-class antagonist of the Thymic Stromal Lymphopoietin (TSLP) receptor that may deliver best-in-class efficacy for people with severe asthma and related diseases, today presented clinical data from its dose-ranging study of verekitug (UPB-101) in adults with asthma, at the American Thoracic Society International Conference being held in San Diego, CA.

Key Points: 
  • As a result, a substantial reduction of FENO within 2 weeks after the first dose was observed in all doses of verekitug.
  • With 100 mg of verekitug, a 54% reduction of FENO from baseline that was sustained for up to 24 weeks after the last dose was observed.
  • Similar rapid, substantial and sustained reductions were observed in blood eosinophils, a type of white blood cell found in increased numbers in many patients with asthma.
  • Verekitug was well-tolerated at all dose levels tested; the most common treatment emergent adverse event was headaches.

Lyra Therapeutics Announces Cost-Cutting Measures to Preserve Capital

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tisdag, maj 21, 2024
Sinusitis, Workforce, Investment, Patient, Lyra, Therapy, LYRA, CRS, Pharmaceutical industry

WATERTOWN, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced that it is advancing its goal to preserve capital by implementing a layoff of approximately 75% of its workforce, in addition to other cost-cutting measures.

Key Points: 
  • WATERTOWN, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced that it is advancing its goal to preserve capital by implementing a layoff of approximately 75% of its workforce, in addition to other cost-cutting measures.
  • In the near term, Lyra Therapeutics will focus on the two ongoing ENLIGHTEN Phase 3 trials evaluating LYR-210, a bioabsorbable sinonasal implant for the treatment of chronic rhinosinusitis (CRS).
  • Lyra continues to analyze the data from the ENLIGHTEN 1 trial, which did not meet its 24-week primary endpoint.
  • “As we streamline our operations to focus on our ongoing clinical trials, we are taking aggressive measures to extend our cash runway,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics.

Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe

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fredag, maj 24, 2024
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Infliximab, Patient, Omalizumab, Pharmacokinetics, Immunology, Food, Sinusitis, European Medicines Agency, FDA, Polyp (medicine), Safety, Marketing, Asthma, Civil service commission, European Commission, CSU, EMA, Allergy, Committee, Biosimilar, CHMP, Pharmaceutical industry

Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.

Key Points: 
  • Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.
  • Omlyclo® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment.
  • Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar bevacizumab).

Optinose Announces $55 Million Registered Direct Offering

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torsdag, maj 9, 2024
Sale, FDA, Prospectus, Sinusitis, ENT, Nose, OPTN, Patient, MPH, Ear, Polyp (medicine), Security (finance)

YARDLEY, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that it has entered into agreements for the sale of approximately $55 million of its common stock and pre-funded common stock warrants to a group of existing and new institutional investors in a registered direct offering.

Key Points: 
  • The gross proceeds from the offering are expected to be approximately $55 million, before deducting estimated offering expenses.
  • The registered direct offering is expected to close on or about May 10, 2024, subject to the satisfaction of customary closing conditions.
  • We expect the post-offering cash and cash equivalents of approximately $100 million to fund operations and debt service obligations through 2025.
  • A preliminary prospectus supplement relating to the offering was filed with the SEC on May 9, 2024 and is available on the SEC’s website at www.sec.gov.

Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis

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måndag, maj 6, 2024
Sinusitis, CRS, LYRA, Network congestion, Data, Workforce, ITT, Therapy, Nosebleed

WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at 24 weeks. ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).

Key Points: 
  • WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS).
  • ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).
  • “We are surprised and disappointed by the ENLIGHTEN 1 topline results,” said Maria Palasis, Ph.D., President and Chief Executive Officer, Lyra Therapeutics.
  • The ENLIGHTEN 1 trial is ongoing and data from the 52-week extension phase are expected in Q4 2024.

Optinose Provides Corporate Update on XHANCE Launch and Outlook and Announces Preliminary First Quarter 2024 XHANCE Net Revenue of $14.9 million

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torsdag, april 25, 2024
FDA, Sinusitis, CS, ENT, Nose, Webcast, OPTN, Patient, MPH, Physician, Fluticasone, Ear, Telephone, Polyp (medicine), GAAP, Growth, Pharmaceutical industry

The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook.

Key Points: 
  • The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook.
  • In addition, the Company announced preliminary XHANCE net product revenue of $14.9 million for the three months ended March 31, 2024, representing growth of approximately 26% over the first quarter of 2023.
  • “The recent FDA approval of XHANCE as the first and only approved drug treatment for chronic sinusitis (CS) is a landmark achievement,” said Ramy Mahmoud, MD, MPH, CEO of Optinose.
  • In addition, a replay of the webcast will be available on the Company website for 60 days following the event.

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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onsdag, maj 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

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torsdag, 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

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söndag, 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.