Sinusitis

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

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水曜日, 12月 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.

Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE

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水曜日, 12月 6, 2023
Fluticasone, Food, Shanda, FDA, PDUFA, Disease, Drainage, Nose, EDS, Polyp (medicine), ENT, MPH, Diagnosis, Patient, Ear, OPTN, Security (finance), Sinusitis, Pharmaceutical industry

YARDLEY, Pa., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.

Key Points: 
  • The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.
  • On November 15, 2023, as part of the ongoing sNDA review, the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1.
  • On December 4, 2023, the FDA notified Optinose that it will require additional time to review this submission (which the FDA deemed a major amendment), and that the PDUFA goal date would be extended to March 16, 2024.
  • The EDS is designed to uniquely deliver drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.

FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results

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火曜日, 12月 19, 2023
Men, Research, General Health, Pharmaceutical, Consumer, Parenting, Clinical Trials, Science, Children, Biotechnology, Women, FDA, Health, Phase, DSMB, Roche, Food, Anaphylaxis, Priority review, Infection, NIAID, Novartis, Allergy, Food allergy, Milk, Prevalence, Ageing, Swelling, ROG, Peanut, Bangladesh Technical Education Board, CSU, Polyp (medicine), NIH, Patient, Asthma, Data monitoring committee, Sinusitis, Pharmaceutical industry

If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”).

Key Points: 
  • If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”).
  • The filing acceptance is based on positive interim analysis results from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods.
  • If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
  • “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study.

Bundle up to spend flexible spending account (FSA) dollars before the December 31 use-it-or-lose-it deadline with 10 exclusive product bundles from FSA Store

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火曜日, 12月 26, 2023
Sinusitis, Allergy, Pain, Health, Commerce, Neutrogena, Pedialyte, Motion, Tylenol, Aura, Calendar, Acne, FSA, Myalgia, Massage, Travel, Ship, Pressure, Medicine cabinet, Skin, Life

DALLAS, Dec. 26, 2023 /PRNewswire-PRWeb/ -- Giving gifts to loved ones is a highlight of the holiday season, but the end of the year is also an opportunity for shoppers to give themselves the gift of better health while protecting their tax-free healthcare funds. For the millions of flexible spending account (FSA) users who face a December 31 use-it-or-use it deadline, this is the time to manage last-minute spending and avoid forfeiting an average of $300 to a missed deadline. FSA Store® makes it easy and efficient to spend FSA funds by offering exclusive product bundles that allow consumers to find and buy related products that are grouped according to popular themes or needs.

Key Points: 
  • For the millions of flexible spending account (FSA) users who face a December 31 use-it-or-use it deadline, this is the time to manage last-minute spending and avoid forfeiting an average of $300 to a missed deadline.
  • FSA Store ® makes it easy and efficient to spend FSA funds by offering exclusive product bundles that allow consumers to find and buy related products that are grouped according to popular themes or needs.
  • Our exclusive product bundles are the perfect way to spend funds – whether you have $20 or $200 in your FSA – on items that you will use every day.
  • To learn more about the FSA deadline and how to spend funds before Dec. 31, visit FSAstore.com and the FSA Learning Center .

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

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月曜日, 11月 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.

US WorldMeds Announces FDA Approval of IWILFIN™ (eflornithine) to Strengthen Fight Against Aggressive Childhood Cancer

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木曜日, 12月 14, 2023
Children, FDA, Health, General Health, Pharmaceutical, Oncology, Research, Family, Consumer, Science, Parenting, Neuroblastoma, Tenderness, Urine, Pneumonia, Huber loss, Somatic symptom disorder, Patient, Otitis media, Diagnosis, Tiffany Aching, Bruise, Liver, Chills, Hospital, Hearing loss, Vomiting, Food, Chair, American Cancer Society, EFS, Nose, Mortality, Multimedia, Division, Hematology, Pennsylvania State University, Blood, Diarrhea, Kool-Aid, Bleeding, Nausea, Development, Skin infection, Shivering, Urinary tract infection, Cough, Consortium, Risk, Sinusitis, Humble, Texas, Pain, Skin, Eflornithine, Hope, Upper respiratory tract infection, Disease, Abdomen, Tablet, Pediatric Hematology and Oncology, Sneeze, MD, Death, Immunotherapy, Pharmaceutical industry, Medical device, Nursing, Birth control, Phosphorus, Fever, USWM

High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.

Key Points: 
  • High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.
  • US WorldMeds partnered with the Beat Childhood Cancer Research Consortium at Penn State University, which conducted the preclinical and clinical research to help advance this vital therapy.
  • The Consortium represents a group of over 50 hospitals that offer collaboration through a network of childhood cancer clinical trials.
  • “We are thankful for the dedication of our partners, specifically the Beat Childhood Cancer Research Consortium, who work tirelessly to improve treatment outcomes for pediatric cancer patients.

Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults

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水曜日, 12月 6, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, JD, PGA, Neck, Itch, Safety, Head, Scalp, Ageing, Incidence, Headache, Sinusitis, Face, Irritation, Folliculitis, Nose, Common, Rash, Psoriasis, Stinger, Patient, Week, Global Assessment of Functioning, Body surface area, FDA, Prescription, Therapy, PSQ, LTS, Success, Pain, Swelling, PSO, Quality of life, FAAD, Pharmaceutical industry, Silviculture, Cosmetics, Birth control, MD, PASI

“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body.

Key Points: 
  • “Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body.
  • DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multi-center study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region.
  • The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the U.S.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Ondine Biomedical’s nasal photodisinfection named as leading photonics biomedical technology for its potential to safely combat AMR

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月曜日, 11月 13, 2023
Medical Devices, Health, Infectious Diseases, Hospitals, Health Technology, Biotechnology, Ventilator-associated pneumonia, Incidence, Nose, Reactive oxygen species, Patient, Fungus, Infection, Death, Sinusitis, Disinfectant, Christianity in Singapore, SPIE, Bacteria, AMR, Virus, Burns, Hospital, Fungal infection, Vaccine

Ondine Biomedical’s Steriwave nasal photodisinfection technology has been shortlisted in the biomedical category of the 2024 international society for optics and photonics SPIE Prism Awards.

Key Points: 
  • Ondine Biomedical’s Steriwave nasal photodisinfection technology has been shortlisted in the biomedical category of the 2024 international society for optics and photonics SPIE Prism Awards.
  • Nasal photodisinfection is a painless, five-minute treatment that uses a patented photosensitive agent and specific, non-UV light to trigger photochemical reactions that produce reactive oxygen species.
  • Ondine CEO, Carolyn Cross, comments, “It is fantastic to see photodisinfection receiving wider recognition as a technology that will be transformative for the future of healthcare.
  • I’m looking forward to congratulating all the finalists and winners at our celebration at Photonics West in January.”

Analysis Group Researchers Evaluated Long-Term Patient Experience with Dupilumab Using Groundbreaking Method for Generating Real-World Data

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火曜日, 12月 12, 2023
Regeneron Pharmaceuticals, JAMA Dermatology, Analysis Group, Atopic dermatitis, LEAP, Physician, Gold, Pros, Clinical trial, Yale school, RWD, Sinusitis, Harvard Medical School, Polyp (medicine), Yale School of Medicine, Area studies, JAMA, Nursing, Pharmaceutical industry, Sanofi, Dermatology, Patient

The study, published in the journal Dermatology and Therapy , extends the one-year results of the previously published RELIEVE-AD study in JAMA Dermatology , which was based on a groundbreaking method for generating real-world data (RWD).

Key Points: 
  • The study, published in the journal Dermatology and Therapy , extends the one-year results of the previously published RELIEVE-AD study in JAMA Dermatology , which was based on a groundbreaking method for generating real-world data (RWD).
  • This approach provides a true baseline against which to compare longitudinal data over time.
  • "Generating real-world data is particularly challenging for conditions like atopic dermatitis that require long-term therapy extending beyond the initial study period.
  • "Leveraging manufacturers' programs, such as patient support programs, has proven to be a breakthrough solution for generating early and long-term high-quality RWD."

Chronic Rhinosinusitis with Nasal Polyps Market to Witness Upsurge in Growth at a CAGR of 10.03% During the Study Period (2019-2032), Examines DelveInsight

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木曜日, 12月 7, 2023
Pressure, Nonsteroidal anti-inflammatory drug, Polyp (medicine), AstraZeneca, Inflammation, Face, Budesonide, Omalizumab, CRS, Eosinophilic granulomatosis with polyangiitis, Disease, Network congestion, PROPEL, Sleep apnea, Patient, Snoring, EU4, Sinusitis, Polyp, Allergic rhinitis, Fluticasone, Endoscopy, Smell, Nasal administration, Aspirin, Ibuprofen, Diagnosis, Cystic fibrosis, Tezepelumab, Risk, Growth, Glucocorticoid, Recurrence, Rhinorrhea, Mometasone, Physician, Asthma, LAS, Taste, GSK plc, Paranasal sinuses, Amgen, Pharmaceutical industry, Nursing

LAS VEGAS, Dec. 7, 2023 /PRNewswire/ -- DelveInsight's Chronic Rhinosinusitis with Nasal Polyps Market Insights report includes a comprehensive understanding of current treatment practices, chronic rhinosinusitis with nasal polyps emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • Leading chronic rhinosinusitis with nasal polyps companies such as AstraZeneca, Amgen, GlaxoSmithKline, Keymed Biosciences, Biohaven Pharmaceuticals, and others are developing novel chronic rhinosinusitis with nasal polyps drugs that can be available in the chronic rhinosinusitis with nasal polyps market in the coming years.
  • The promising chronic rhinosinusitis with nasal polyps therapies in the pipeline include FASENRA (benralizumab), TEZSPIRE (tezepelumab), Depemokimab/GSK3511294, CM310, NURTEC (rimegepant), and others.
  • Chronic rhinosinusitis is an inflammatory disease of the paranasal sinuses and nasal tube lining that lasts for more than 4 to 12 weeks.
  • To know more about chronic rhinosinusitis with nasal polyps treatment guidelines, visit @ Chronic Rhinosinusitis with Nasal Polyps Management