Upper respiratory tract infection

Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024

Retrieved on: 
Sunday, February 25, 2024
Allergy, Ophthalmology, AAAAI, Omalizumab, Upper respiratory tract infection, Dermatology, Allergic rhinitis, Season, Hematology, Rhinitis, Immunology, Patient, Autoimmunity, Clinical trial, PPP, SOC, Asthma, Insurance, American Academy, Pharmaceutical industry

The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.

Key Points: 
  • The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.
  • This Phase II study shows that 100mg LP-003 significantly improved nasal symptoms (TNSS score) of uncontrolled seasonal allergic rhinitis patients despite SoC treatment.
  • We are honored to unveiled the exciting Phase II results of LP-003, the first registrational clinical trial of anti-IgE antibody for AR conducted in China."
  • As Longbio Pharma charts its course forward, the successful Phase II study of LP-003 in allergic rhinitis represents a pivotal milestone in advancing the treatment landscape for allergic diseases.

Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Thursday, January 11, 2024
Biotechnology, FDA, Men, Health, Family, Consumer, Pharmaceutical, Other Science, Research, Children, General Health, Science, Women, Clinical Trials, Swelling, Patient, Șaeș, Atopic dermatitis, Stinger, Itch, Incidence, MD, Shanda, Rash, MCR, Folliculitis, Irritation, Skin, Aes, Body surface area, Food, Nose, Psoriasis, Disease, Safety, Caregiver, Therapy, Pain, Upper respiratory tract infection, Headache, Pharmaceutical industry

The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.

Key Points: 
  • The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.
  • In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.
  • “Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Medical Subject Headings, Common, Diarrhea, Marketing, HIV-1, European Commission, Agency, Protease, HIV, INN, Immune system, Upper respiratory tract infection, ATC, Nelfinavir, Depression, EMA, AIDS, International, Capsule, European, Ageing, Nausea, Blood, Language, European Medicines Agency, Infection, Food, Ritonavir, Tablet, Reproduction, Select, Patient, Human, Liver disease, Anatomy, Medicine, IIA, Lopinavir, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

Retrieved on: 
Wednesday, December 13, 2023
PDUFA date, Constipation, Risk, Tendon rupture, Moyamoya disease, FDA, Fatigue, Health, Bempedoic acid, Fetus, Back pain, Agent handling, Sinusitis, Pain, PDUFA, Diet, Uric acid, CLEAR, ATP, Safety, Kidney, Bronchitis, Food, Pregnancy, Mortality, Angioedema, Therapy, CVD, ANN, Esperies, Tablet, Patient, Ezetimibe, Spasm, Anaphylaxis, Upper respiratory tract infection, Diarrhea, Anemia, Disease, ESPR, Rupture, Incidence, Abdominal pain, Urinary tract infection, Gout, Hypersensitivity, Use, Esperion Therapeutics, Arthralgia, Rash, Pharmaceutical industry

ANN ARBOR, Mich., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has not been determined” has also been removed.

Key Points: 
  • These applications were accepted by the FDA which issued a PDUFA, or action, date of March 31, 2024.
  • The Company’s EMA applications also remain on track, with anticipated approval in the first half of 2024.
  • 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.

Dupixent® (dupilumab) Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for This Serious Disease

Retrieved on: 
Monday, November 27, 2023
Patient, Regeneron Pharmaceuticals, Food, Smoker, Aes, Breakthrough therapy, Death, Upper respiratory tract infection, Diarrhea, FDA, Hypertension, Headache, Common, Inflammation, COVID-19, European Medicines Agency, Doctor of Philosophy, International development, Back pain, Phenotype, Safety, History, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) showed that Dupixent significantly reduced (34%) exacerbations, confirming positive results from the landmark Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks.

Key Points: 
  • “These results demonstrate the important role of type 2 inflammation in yet another chronic and debilitating disease, and the ability of Dupixent to address this inflammation.
  • Patients receiving Dupixent compared to placebo experienced:
    34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
  • BOREAS results showed:
    30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

Press Release: Dupixent® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease

Retrieved on: 
Monday, November 27, 2023
Patient, Regeneron Pharmaceuticals, Sanofi, Food, Smoker, Death, Aes, Breakthrough therapy, Upper respiratory tract infection, Diarrhea, FDA, Hypertension, Headache, Disease, Common, Inflammation, COVID-19, European Medicines Agency, Back pain, Phenotype, Safety, History, Pharmaceutical industry

The second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial.

Key Points: 
  • The second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial.
  • These results were from an interim analysis and, given the overwhelming positive efficacy of the primary endpoint, will be considered the primary analysis of the trial.
  • Patients receiving Dupixent compared to placebo experienced:
    34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)

Retrieved on: 
Friday, December 22, 2023
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Exposition, Food, Death, Upper respiratory tract infection, Physician, Lymphocytosis, BGNE, TP53, Hypertension, Mantle cell lymphoma, Neutropenia, Society, ASH, BTK, Patient, Safety, PFS, Pharmaceutical industry

PFS benefit is consistent across multiple sensitivity analyses, demonstrating that PFS advantage with BRUKINSA was primarily driven by efficacy and not tolerability.

Key Points: 
  • PFS benefit is consistent across multiple sensitivity analyses, demonstrating that PFS advantage with BRUKINSA was primarily driven by efficacy and not tolerability.
  • The overall safety and tolerability profile was consistent with previous ALPINE analyses, including persistently lower rates of cardiovascular events reported with BRUKINSA.
  • The most commonly reported treatment emergent adverse events (≥20%) with BRUKINSA were COVID-19-related, neutropenia, hypertension, and upper respiratory tract infection.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023

Retrieved on: 
Monday, November 13, 2023
Disease, Esperion Therapeutics, Rash, Abdominal pain, AHA, Membrane protein, Patient, Bempedoic acid, PCSK9, CVD, Anemia, Angioedema, Rupture, Inflammation, Diet, Atherosclerosis, Safety, Incidence, FAHA, Mortality, Tablet, Health, Tendon rupture, Diarrhea, Harvard Medical School, Ezetimibe, Urinary tract infection, Fetus, Hypersensitivity, Arthralgia, Gout, American Heart Association, ESPR, Therapy, Sinusitis, Risk, Spasm, Constipation, MACE, Anaphylaxis, Pain, Moyamoya disease, Back pain, Upper respiratory tract infection, FACC, Flexner Report, CLEAR, Fatigue, Pregnancy, Kidney, Uric acid, MPH, ATP, Bronchitis, Hospital, Dietary supplement, Pharmaceutical industry, Vaccine, Common, Esperies, Brigham, Hyperuricemia, MD, Cholesterol

ANN ARBOR, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. Results were also simultaneously published in Circulation which can be accessed here.

Key Points: 
  • “In the future, it can be anticipated that virtually all atherosclerosis patients will receive aggressive inflammation inhibition along with aggressive cholesterol reduction,” Ridker added.
  • In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a 21.6% reduction in hsCRP compared to placebo at 6 months.
  • 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.

ARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, November 9, 2023
NDA, SAN, ARS, European Medicines Agency, D, Pediatrics, Upper respiratory tract infection, Investment, Asthma, MAA, EMA, Patient, Journal, Research, U.S. FDA, FDA, American College, G&A, Caregiver, Anaphylaxis, BMI, Trial of the century, CRL, Symantec Endpoint Protection, Adrenaline, R, Human, ACAAI, Vaccine, Fine chemical, Pharmaceutical industry, Allergy

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the third quarter of 2023.

Key Points: 
  • ARS Pharma expects to report its findings from this study in the first quarter of 2024.
  • R&D Expenses: Research and development (R&D) expenses were $3.0 million for the quarter ended September 30, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $15.0 million for the quarter ended September 30, 2023.
  • Net Loss: Net loss was $14.9 million for the quarter ended September 30, 2023.