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Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD
GlobeNewswire News Room· 2024-09-27 13:35
Dupixent approved in the US as the first-ever biologic medicine for patients with COPD Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placeboDupixen ...
Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD
GlobeNewswire News Room· 2024-09-27 13:35
Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo Dupixent is the leading biologic medicine for all of its FDA ...
Press Release: Dupixent approved in China as the first-ever biologic medicine for patients with COPD
GlobeNewswire News Room· 2024-09-27 11:00
Dupixent approved in China as the first-ever biologic medicine for patients with COPD Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of lifeCOPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now a ...
Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD)
GlobeNewswire News Room· 2024-09-27 11:00
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China TA ...
Regeneron to Report Third Quarter 2024 Financial and Operating Results and Host Conference Call and Webcast on October 31, 2024
GlobeNewswire News Room· 2024-09-26 20:05
TARRYTOWN, N.Y., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at ht ...
Why Is Regeneron Pharmaceuticals Stock Trading Lower On Tuesday?
Benzinga· 2024-09-24 18:21
Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.‘s REGN effort to prevent the sale of Amgen Inc‘s AMGN Eylea biosimilar.Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.The appeal is from the Order issued on September 23, 2024, which denied Regeneron’s request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.Reuters highlighted that an Amgen spokesperson express ...
Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
GlobeNewswire News Room· 2024-09-20 11:45
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescentsIf approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Paris and Tarrytown, NY, September 20, 2024. The European Medicines ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic Esophagitis (EoE) in Children as Young as 1 Year Old
GlobeNewswire News Room· 2024-09-20 11:45
Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group TARRYTOWN, N.Y. and PARIS, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for ...
Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
GlobeNewswire News Room· 2024-09-13 16:15
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food an ...
EYLEA HD® (aflibercept) Injection 8 mg Data at EURETINA Reinforce Long-term Durability, Sustained Fluid Control and Safety Profile
GlobeNewswire News Room· 2024-09-11 11:00
Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new analyses of EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injec ...