Chronic obstructive pulmonary disease

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
воскресенье, июня 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

Summary of opinion: Dupixent, 30/05/2024 Positive

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
воскресенье, июня 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
воскресенье, июня 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation

Retrieved on: 
пятница, мая 31, 2024
Patient, Food, FDA, Safety, Regeneron Pharmaceuticals, EMA, COPD, Chronic obstructive pulmonary disease, Committee, European, CHMP, Pharmaceutical industry

The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

Key Points: 
  • The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
  • The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.
  • Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union (EU) and China.
  • The potential use of Dupixent in COPD is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD

Retrieved on: 
пятница, мая 31, 2024
Patient, Headache, Diarrhea, Risk, Cough, COVID-19, Priority, Respiratory disease, Smoking, Food, Depression, FDA, Anxiety, Disease, Safety, Health, Mucus, Common, Hospital, Death, European Commission, COPD, Back pain, Chronic obstructive pulmonary disease, Regeneron Pharmaceuticals, Priority review, European, CHMP, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • COPD is a respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide.
  • COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization.
  • The use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.

Press Release: Dupixent recommended for EU approval by the CHMP to treat patients with COPD

Retrieved on: 
пятница, мая 31, 2024
Patient, Headache, Diarrhea, Risk, Cough, COVID-19, Priority, Respiratory disease, Smoking, Food, Depression, FDA, Anxiety, Disease, Safety, Health, Mucus, Common, Hospital, Death, European Commission, COPD, Back pain, Chronic obstructive pulmonary disease, Priority review, European, CHMP

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • COPD is a respiratory disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide.
  • Safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications.
  • The use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.

Press Release: Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation

Retrieved on: 
пятница, мая 31, 2024
Sanofi, Patient, Food, FDA, Safety, Regeneron Pharmaceuticals, EMA, COPD, Chronic obstructive pulmonary disease, Committee, European, CHMP, Pharmaceutical industry

The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

Key Points: 
  • The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
  • The FDA had requested additional efficacy analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.
  • Sanofi and Regeneron are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
  • Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union and China.

JJP Biologics Announces Positive Decision to Execute a First-in-Human Clinical Trial of Anti-Inflammatory mAb JJP-1212 (anti-CD89)

Retrieved on: 
среда, мая 29, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, JJP, Patient, EudraCT, Biology, Blister, Immunoglobulin G, European Medicines Agency, Clinical trial, Linear IgA bullous dermatosis, Doctor of Philosophy, Immunoglobulin M, Trial of the century, Autoimmunity, Disease, Safety, Henoch–Schönlein purpura, Autoantibody, Fatty liver disease, IgA nephropathy, Trust, Civil service commission, European Commission, Idiopathic pulmonary fibrosis, Cancer, CSO, Axial spondyloarthritis, Lupus, Biomarker, Incidence, Chronic obstructive pulmonary disease, Volunteering, Cystic fibrosis, Hidradenitis suppurativa, Linearity, European, Paratriathlon, Rheumatoid arthritis, Immunoglobulin A, Pharmaceutical industry

Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.

Key Points: 
  • Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.
  • According to Paweł Szczepański, COO and Management Board Member at JJP Biologics - “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland.
  • JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212.
  • JJP Biologics pursues the development of its product candidates as well as projects executed in cooperation with scientific partners.

HKTDC kicks off third International Healthcare Week

Retrieved on: 
четверг, мая 16, 2024
Information technology, HK, Ministry, Investment, IHW, HKSTP, Research, I&T, Therapy, Nan Fung Group, Global Health, Intelligence, Hong Kong Polytechnic University, Medtronic, Silver, Health, HKSAR, National Health Commission, Robotics, Fair, Hip, Perception, Traditional Chinese medicine, Policy, Attention, WHO, Rehabilitation, Chronic obstructive pulmonary disease, HKTDC, AstraZeneca, Republic, AI, Speech, Summit, Structural biology, Biotechnology, Medical device

HONG KONG, May 16, 2024 - (ACN Newswire) - The third International Healthcare Week (IHW), organised by the Hong Kong Trade Development Council (HKTDC), opened yesterday, featuring two flagship events.

Key Points: 
  • HONG KONG, May 16, 2024 - (ACN Newswire) - The third International Healthcare Week (IHW), organised by the Hong Kong Trade Development Council (HKTDC), opened yesterday, featuring two flagship events.
  • The 15th edition of the Hong Kong International Medical and Healthcare Fair (Medical Fair) runs from today to 18 May.
  • With Hong Kong being an international finance and business centre and on its way to becoming a health and medical innovation hub, it is fitting for the HKTDC to organise International Healthcare Week, with the Asia Summit on Global Health and Hong Kong International Medical and Healthcare Fair as flagship events, to bring together major industry players from Asia and beyond in our city to foster collaboration and accelerate the development of Asia's medical and healthcare industry."
  • ASGH gathers more than 80 global leaders in healthcare, including business executives, investors, international research and medical experts and health officials, to discuss diverse industry issues, such as medical and healthcare innovations, healthcare development in China and healthcare investment prospects.

Apogee Therapeutics Expands Board of Directors with the Appointment of Lisa Bollinger, MD

Retrieved on: 
вторник, мая 28, 2024
CDER, Research and development, Hospital, Amgen, Food, Drug development, Pediatrics, University, Atopic dermatitis, FDA, Therapy, Safety, Book, SAN, Publication, Asthma, I&I, MD, Outline of health sciences, Regulatory affairs, COPD, Division, Chronic obstructive pulmonary disease, Research, Physiology

Dr. Bollinger’s over 30 years of experience in drug development, with deep regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the Apogee board of directors’ selection decision.

Key Points: 
  • Dr. Bollinger’s over 30 years of experience in drug development, with deep regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the Apogee board of directors’ selection decision.
  • “With extensive experience in the pharmaceutical and regulatory industries, coupled with her background as a practicing pediatric physician, Lisa brings an impressive skill set to our board of directors,” said Michael Henderson, MD, Chief Executive Officer of Apogee.
  • “We have several exciting milestones ahead at Apogee in 2024 with two programs now in clinical development and a third expected in the second half of the year.
  • I am excited to partner with this exceptional team and board of directors to advance programs that I strongly believe could offer a number of advantages over today’s standard of care options.”