Cough

MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

Retrieved on: 
Lunedì, Maggio 6, 2024
FDA, QIDP, Fast Track, Safety, Infection, Woman, Food, Prevalence, Bacteria, Cough, Water, NTM, Environment, MAC, Patient, Doctor of Pharmacy, Fatigue, Bronchiectasis, Medicine, Soil, MannKind Corporation, Mycobacterium avium complex, Asthma, COPD, Pharmaceutical industry

Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need.
  • “We are pleased with the FDA’s decision to grant Fast Track designation for Clofazimine Inhalation Suspension, providing us an opportunity to accelerate our efforts to potentially bring an important medicine to patients living with NTM,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation.
  • The U.S. FDA previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.
  • NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent.

iHealth Unveils Breakthrough 3-in-1 At-Home 15-Minute Antigen Test for COVID-19 and Flu A&B

Retrieved on: 
Mercoledì, Maggio 8, 2024
FDA, Physician, Public, National library, COVID, Safety, Food, Uncertainty, Health, Emergency Use Authorization, Parent, Cough, Federation, Family, Fatigue, Face, Virus, Sneeze, Infection, Child, Fever, COVID-19, Ageing, Pharmaceutical industry

With the launch of the 3-in-1 COVID-19/Flu A&B Rapid Test, iHealth, one of the leading suppliers of at-home COVID tests to the federal government, ushers in a new era of at-home testing post-pandemic that will enable consumers to stop guessing what illness they may have when symptoms emerge. According to infectious disease physicians, it's important to know if you have COVID or the flu as they have different treatments--although they have similar symptoms. 

Key Points: 
  • As one of the first over-the-counter rapid antigen tests for COVID-19 and influenza (commonly known as the flu) A & B in the US, the 3-in-1 test offers a convenient and fast at-home testing experience.
  • The 3-in-1 test inherits the same user-friendly steps of iHealth's stand-alone at-home COVID test.
  • The difference lies in squeezing 5 drops onto a test card, compared to the previous 3 drops.
  • For more information on the iHealth COVID-19/Flu A&B 3-in-1 Antigen Rapid Test, visit the product page on the www.ihealthlabs.com website.

EQS-News: Marinomed Biotech AG announces results for the 2023 financial year and reports progress with Marinosolv and Carragelose assets

Retrieved on: 
Venerdì, Maggio 3, 2024
European Investment Bank, CFO, EIB, P&G, News, Map, Area studies, Partnership, Growth, EUR, BofA Securities, Cough, Research, Immunology, Clinical trial, Cryptocurrency

Cash and cash equivalents decreased to EUR 2.6 million (2022: EUR 8.2 million), with no major financing cash-inflows in the 2023 financial year contributing to the cash position.

Key Points: 
  • Cash and cash equivalents decreased to EUR 2.6 million (2022: EUR 8.2 million), with no major financing cash-inflows in the 2023 financial year contributing to the cash position.
  • “In 2023, we made important progress for both our Marinosolv and Carragelose assets.
  • However, the commercialization process for our Marinosolv assets takes longer than expected, causing Marinomed to fall short of expectations,” Andreas Grassauer, CEO of Marinomed, comments.
  • Our focus now is on near-term cash generation, including further license deals for Budesolv and expanding our Carragelose business.

Revive Therapeutics Announces Type C Meeting Request Granted by FDA for Clinical Study of Bucillamine to Treat Long COVID

Retrieved on: 
Martedì, Aprile 23, 2024
RVV, FDA, COVID, Safety, Economics, CDC, Infection, Death, Trial of the century, Doctor of Philosophy, Research, Cough, Heart rate, Therapy, Patient, Hospital, Fever, COVID-19, Harvard University, Pharmaceutical industry

The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.

Key Points: 
  • The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.
  • Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID.
  • The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.
  • Additional analyses of the Study data may suggest Bucillamine’s potential for long COVID.

Liberate Medical Announces PREVENT Study with $6.5M Grant Funding from the US DoD – Enrolls First Patients Globally

Retrieved on: 
Martedì, Aprile 30, 2024
Technology, Research, Medical Devices, FDA, Clinical Trials, Hardware, Health, General Health, Science, University, Radboud University Medical Center, Risk, Fungal infection, Death, Cough, Intensive care medicine, ICU, European, Patient, Acquisition, PI, Assistant, Quality of life, Baylor University, Critical Care Medicine (journal), CE

Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death.

Key Points: 
  • Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death.
  • PREVENT is a global collaborative effort that plans to enroll 272 patients from 25 centers across the US, EU and Australia.
  • Liberate Medical extends its deepest gratitude and congratulations to these institutions for their commitment and swift implementation of the PREVENT study.
  • "The initiation of patient enrollment in the PREVENT trial is a landmark event for Liberate Medical and innovation in critical care medicine.

P&G Announces Fiscal Year 2024 Third Quarter Results

Retrieved on: 
Venerdì, Aprile 19, 2024
Other Retail, Supermarket, Specialty, Food, Beverage, Consumer, Discount, Variety, Other Consumer, Retail, SK-II, P&G, Child, Cough, Home care, Incidence, Health care, EPS, Skin, Groom, GAAP, Growth

Operating margin for the quarter increased 90 basis points versus the prior year, 220 basis points on a currency-neutral basis.

Key Points: 
  • Operating margin for the quarter increased 90 basis points versus the prior year, 220 basis points on a currency-neutral basis.
  • The Company now expects a benefit of approximately $900 million after tax from favorable commodity costs for fiscal year 2024.
  • P&G now expects a core effective tax rate of 20% to 21% in fiscal 2024.
  • Capital spending is estimated to be approximately 4% of fiscal 2024 net sales.

Cedars-Sinai Launches Virtual Healthcare for Children and Spanish Speakers

Retrieved on: 
Mercoledì, Aprile 10, 2024
Software, General Health, Hispanic, Family, Telemedicine, Virtual Medicine, Consumer, Apps, Applications, Technology, Artificial Intelligence, Health Technology, Parenting, Children, Health, Pain, Language, AI, MD, Partnership, Cough, Parent, Depression, Obesity, Patient, Rash, Child, Anxiety, Connect, Nursing

Cedars-Sinai is expanding virtual healthcare for children and Spanish speakers in California through its mobile app Cedars-Sinai Connect , a fast-growing online option that allows patients to quickly access top healthcare professionals for acute, chronic and preventive care.

Key Points: 
  • Cedars-Sinai is expanding virtual healthcare for children and Spanish speakers in California through its mobile app Cedars-Sinai Connect , a fast-growing online option that allows patients to quickly access top healthcare professionals for acute, chronic and preventive care.
  • Parents of children 3 to 17 years old can now access Cedars-Sinai healthcare providers for urgent issues, including cough, cold, flu or rash.
  • Spanish-speaking healthcare providers are available for scheduled visits 7 a.m.-9 p.m. on weekdays and 8 a.m.-4 p.m. on weekends.
  • These patients also gain access to our broad network of specialists through referrals when appropriate.”
    The new care options for children and Spanish speakers build on Cedars-Sinai Connect’s initial success.

Revive Therapeutics Submits Type C Meeting Request Package to FDA for Clinical Study of Bucillamine to Treat Long COVID

Retrieved on: 
Mercoledì, Marzo 27, 2024
COVID, Type, COVID-19, Patient, Heart rate, Research, RVV, Death, Doctor of Philosophy, Trial of the century, Cough, CDC, Harvard University, Fever, Safety, Therapy, Disorder, FDA, Economics, Hospital, Pharmaceutical industry

Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

Key Points: 
  • Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
  • The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.
  • Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID.
  • The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Martedì, Marzo 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Sabato, Aprile 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.