Nosebleed

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

Retrieved on: 
Montag, Mai 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.

TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Montag, April 29, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, PFS, Congress, Pfizer, Peripheral neuropathy, Priority review, Risk, Woman, Food, Progression-free survival, Nausea, Survival, Death, Pneumonitis, Hazard, ESMO, Gynecologic Oncology (journal), OS, Disease, ADC, Patient, PFE, Bleeding, Fatigue, Toxicity, Diagnosis, Constipation, Clinical trial, Mount Sinai Medical Center, Cervical cancer, Nosebleed, Pharmaceutical industry

This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.

Key Points: 
  • This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.
  • TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated overall survival data to be granted full FDA approval in this patient population.
  • The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial ( NCT04697628 ), in which TIVDAK met its primary endpoint of overall survival (OS) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
  • “Treatment options for patients with advanced or recurrent cervical cancer are limited.

FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Montag, April 29, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, PFS, Congress, Pfizer, Peripheral neuropathy, Priority review, Risk, Woman, Food, Progression-free survival, Nausea, Survival, Death, Pneumonitis, ESMO, Gynecologic Oncology (journal), OS, Disease, Patient, PFE, Bleeding, Fatigue, Toxicity, Constipation, Diagnosis, Inc., Clinical trial, Mount Sinai Medical Center, Cervical cancer, Nosebleed, Pharmaceutical industry

"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer.

Key Points: 
  • "Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer.
  • Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met.
  • Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7].
  • “Treatment options for patients with advanced or recurrent cervical cancer are limited.

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.

Internist Shirin Peters, M.D. of Bethany Medical Clinic, Shares Top Tips for the Challenges of Winter Allergies

Retrieved on: 
Donnerstag, Februar 15, 2024
Other Consumer, Home Goods, Women, Other Health, Seniors, Retail, Teens, Pets, Parenting, Men, Children, Baby, Maternity, Family, Consumer, Veterinary, General Health, Other Retail, Health, Allergy, Pet, Atmosphere, Dust, Dry, Polyp (medicine), Diet, Sneeze, Inflammation, Filter (signal processing), Rash, Skin, HEPA, Risk, Honey, Allergen, Bacteria, MITES, Common, Nosebleed, Rosacea, Arm, Asthma, Zinc acetate, Nose, Immune system, Vaccine

has identified at-home recommendations to combat winter allergy symptoms, helping allergy sufferers manage triggers, ease concerns, and avoid future flare-ups.

Key Points: 
  • has identified at-home recommendations to combat winter allergy symptoms, helping allergy sufferers manage triggers, ease concerns, and avoid future flare-ups.
  • “Many associate seasonal allergies just with spring but winter presents a different challenge to allergy sufferers.
  • Moreover, simple lifestyle changes and at-home tips can help manage symptoms and bring some relief during these cooler months,” says Dr. Peters, with Bethany Medical Clinic.
  • Dr. Peters shares preventative measures to decrease your chances of winter and indoor allergies and lower your risk of developing sinusitis and nasal polyps.

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Freitag, Februar 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Optinose Announces the Publication of ReOpen Phase 3 Clinical Trial Program Evaluating XHANCE in the Journal of Allergy and Clinical Immunology: In Practice

Retrieved on: 
Donnerstag, Januar 18, 2024
Senior, Chronic pain, Patient, Sciatica, Ear, Incidence, Polyp (medicine), ENT, Nosebleed, Sinusitis, Doctor of Pharmacy, Migraine, Randomness, Heart, OPTN, Quality of life, Medicine, Nose, Journal, Disease, Pressure, Drainage, FDA, Inflammation, MPH, Headache, Fluticasone, Pharmaceutical industry

YARDLEY, Pa., Jan. 18, 2024 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice1.

Key Points: 
  • The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis (chronic rhinosinusitis).
  • “Patients with chronic sinusitis often suffer for years and may use multiple over-the-counter treatments in a search for ways to alleviate their symptoms.
  • Chronic sinusitis is also common: data suggests it is one of the top diagnoses in adult outpatient physician visits.
  • The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile.

Octapharma to present clinical and scientific data that advances our understanding and treatment of bleeding disorders at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), which takes place in Frankfurt, Ge

Retrieved on: 
Mittwoch, Januar 17, 2024
Factor VIII, Senior, Octapharma, Patient, Research, Nosebleed, SLAM, VWD, Trial of the century, Pharmaceutical industry

The study shows that wilate® prophylaxis is highly effective at reducing bleeding rates in children and adults with all types of VWD and across examined bleeding sites.

Key Points: 
  • The study shows that wilate® prophylaxis is highly effective at reducing bleeding rates in children and adults with all types of VWD and across examined bleeding sites.
  • The results provide compelling evidence for the use of regular prophylaxis in people with VWD.
  • "The new data from the WIL-31 study provide strong evidence for the use of wilate® prophylaxis in people with all types of VWD.
  • In such instances, indirect treatment comparisons can be used to compare the effects of different treatments.

uniQure Announces Update on Phase I/II Clinical Trials of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease

Retrieved on: 
Dienstag, Dezember 19, 2023
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The U.S. study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of five years for treated patients.

Key Points: 
  • The U.S. study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of five years for treated patients.
  • Six patients were treated with AMT-130 in the initial low-dose cohort and seven patients were treated in the subsequent high-dose cohort.
  • The cohort includes 31 patients that met the uniQure clinical trial inclusion criteria of Total Functional Capacity, Diagnostic Classification Level and minimum striatal volumes.
  • In mid-2024, uniQure expects to present another clinical update from the ongoing Phase I/II studies of AMT-130, including additional follow-up data from the treated patients in the U.S. and European trials.

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Montag, Dezember 11, 2023
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Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.