Fluticasone

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

Retrieved on: 
Donnerstag, 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.

Mundipharma and Vectura announce plans to reformulate flutiform® (fluticasone propionate/formoterol fumarate) pressurised metered-dose inhaler (pMDI) as a commitment to reducing the product’s carbon footprint

Retrieved on: 
Dienstag, April 16, 2024
Biotechnology, General Health, Other Health, Health, Pharmaceutical, Medication package insert, Climate change, NHS, Isocyanate, EEA, European, European Parliament, Carbon, Life, Climate, Environment, Council, Patient, World Asthma Day, Medicine, Fluticasone, Multimedia, HFA, Gas, NHS England, Asthma, Pharmaceutical industry

Mundipharma and Vectura will now progress development of the reformulation of flutiform® (fluticasone propionate/formoterol fumarate) following long-term collaboration, planning and lab-scale development work.

Key Points: 
  • Mundipharma and Vectura will now progress development of the reformulation of flutiform® (fluticasone propionate/formoterol fumarate) following long-term collaboration, planning and lab-scale development work.
  • The reformulation will ultimately ensure a comparable effective product for patients and further reduce its impact on the environment.
  • This new collaboration will revitalise the efforts to identify and switch to a more environmentally friendly propellant.
  • “At Vectura, our priority is to ensure that patients prescribed fluticasone propionate/formoterol fumarate pMDI can continue to have access to this treatment.

Eupraxia Pharmaceuticals Announces Upcoming Presentations at the Osteoarthritis Research Society International World Congress 2024

Retrieved on: 
Donnerstag, April 11, 2024
OA, Fluticasone, Pain, Patient, Knee, Randomness, OARSI, Osteoarthritis Research Society International, Osteoarthritis, Abstract, TSX, Pharmacokinetics, MRI, Diabetes, World Congress, Pharmaceutical industry

VICTORIA, BC, April 11, 2024 /PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize drug delivery for applications with significant unmet need, today announced that the Company will present two abstracts at the upcoming Osteoarthritis Research Society International ("OARSI") World Congress 2024.

Key Points: 
  • VICTORIA, BC, April 11, 2024 /PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize drug delivery for applications with significant unmet need, today announced that the Company will present two abstracts at the upcoming Osteoarthritis Research Society International ("OARSI") World Congress 2024.
  • The meeting is being held in Vienna, Austria from April 18-21, 2024.
  • In combination with our pre-clinical and MRI results, these data suggest a potential best-in-class candidate in terms of managing cartilage health."
  • Poster Title: Pharmacokinetics of EP-104IAR Long-lasting Fluticasone Propionate for Intra Articular Injection in 163 Subjects from SPRINGBOARD, a Phase 2 Study in Knee Osteoarthritis.

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.

Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024

Retrieved on: 
Mittwoch, März 13, 2024
Mont Blanc, IOP, OCT, Whistler, Glaucoma, Ocular hypertension, Fluticasone, Database, Intraocular pressure, NCX, COVID-19, Patient, NDA, BlackRock, Sale, Bausch & Lomb, Therapy, Retina, Allergic conjunctivitis, Safety, Patent, Telecanthus, FDA, Corporation, Food, Pharmaceutical industry

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.

Key Points: 
  • “Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.
  • We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations.
  • In January 2024, Nicox expanded the territory of the exclusive licensing agreement with Harrow, Inc., to include Canada.
  • The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470.

Clinical Collaboration Agreement between Teva and Launch Therapeutics to Accelerate Development of Dual-Action Asthma Rescue Inhaler (ICS-SABA/TEV-’248) Respiratory Program; Teva and Abingworth Enter Strategic Development Funding Agreement

Retrieved on: 
Montag, April 1, 2024
Other Health, Research, Professional Services, Pharmaceutical, Medical Devices, Clinical Trials, Science, Biotechnology, Medical Supplies, Finance, Other Science, Health, TEVA, U.S. FDA, MDPI, Fluticasone, Patient, Doctor of Philosophy, MD, Asthma, Therapy, Teva, Pharmaceutical industry

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Launch Therapeutics, Inc., today announced a clinical collaboration agreement to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-‘248).

Key Points: 
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Launch Therapeutics, Inc., today announced a clinical collaboration agreement to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-‘248).
  • As part of the clinical collaboration agreement, Launch Therapeutics, a clinical development company backed by Abingworth and Carlyle, will have the lead role in the operational execution and management of the planned clinical trials, focused on accelerating Teva’s ICS-SABA (TEV-‘248) clinical research program.
  • Teva will recognize the funding as a reduction in research and development expenses and will retain full rights to the Company’s ICS/SABA program.
  • “Bridging together Teva's deep therapeutic expertise with Launch Therapeutics' profound clinical and operational expertise generates value to execute and accelerate this program.

Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

Retrieved on: 
Donnerstag, März 7, 2024
Conference call, Fluticasone, Sinusitis, Telephone, Inflammation, FDA, Food, Shanda, Conference, Ear, Safety, OPTN, ENT, Webcast, Patient, Journal, MPH, Medicine, Research, Nose, Pharmaceutical industry

YARDLEY, Pa., March 07, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2023, and provided recent operational highlights.

Key Points: 
  • In addition, during 2023 we worked hard to prepare our organization to make the most of the new opportunity.
  • For the three-month and twelve-month periods ended December 31, 2023, research and development expenses were $1.3 million and $5.3 million, respectively.
  • The net loss for the three-month period ended December 31, 2023 was $10.0 million, or $0.09 per share (basic and diluted).
  • The net loss for the twelve-month period ended December 31, 2023 was $35.5 million, or $0.32 per share (basic and diluted).

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.

Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

Retrieved on: 
Dienstag, Januar 2, 2024
Atmosphere, Patient, Medical Subject Headings, Quality of life, Fluticasone, Marketing, Sinusitis, Agency, INN, Fever, Lower respiratory tract infection, Immunoglobulin E, Allergy, ATC, Chronic pain, Pain, International, Headache, Ageing, Nose, Blood, Language, MITES, Pharyngitis, Swelling, Inflammation, Dizziness, Red, European Medicines Agency, Polyp (medicine), Select, Overalls, Anatomy, Arthralgia, IIA, Pollen, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 49, Status: Authorised

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

Retrieved on: 
Mittwoch, Dezember 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.