Phase 2 data for efdoralprin alfa demonstrate the recombinant protein maintains normal protein levels with less frequent dosing than current standards of care for patients with alpha-1 antitrypsin deficiency (AATD)-related emphysema.
Phase 2 data for efdoralprin alfa demonstrate the recombinant protein maintains normal protein levels with less frequent dosing than current standards of care for patients with alpha-1 antitrypsin deficiency (AATD)-related emphysema.
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For RSV awareness month (October), the American Lung Association is spotlighting new data that show a dramatic decrease in RSV-related hospitalizations among infants.
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Sanofi and Regeneron’s COPD drug candidate itepekimab met its primary endpoint in one phase 3 study but failed in a second trial.
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New industry support enables the team to expand their search and validation of diagnostic biomarkers to shed light on asthma with thus far unexplained causes and improve therapy.
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The FDA has updated the label for Sanofi’s Flublok influenza vaccine to include safety data from a study of over 48,000 pregnant individuals.
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The FDA has approved Dupixent for adults with inadequately controlled COPD and an eosinophilic phenotype.
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The FDA has approved Dupixent as an add-on maintenance treatment for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps, expanding its original approval for adults in 2019.
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FluGen’s investigational intranasal M2SR flu vaccine, in combination with Sanofi’s Fluzone High Dose, demonstrates superior protection and antibody response in adults aged 65-85.
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New Jersey-based Cosette Pharmaceuticals has acquired the insomnia medications Ambien and Ambien CR from Sanofi US.
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The European Commission has approved Dupixent as an add-on treatment for adults with uncontrolled COPD.
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AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.
Read MoreThe second Dupixent investigational phase 3 COPD trial has shown that Dupixent reduced exacerbations by 34%, confirming positive published results from the phase 3 BOREAS trial.
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The US CDC has issued advice for healthcare providers to navigate the shortage of nirsevimab (Beyfortus), used to immunize infants from RSV.
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Sanofi issued an advisory to notify healthcare providers and consumers of a “unprecedented” and “higher than anticipated” demand for its recently-approved RSV monoclonal antibody, nirsevimab-alip (Beyfortus).
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Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease.
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The single-dose antibody drug can be used in babies during their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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FDA panel favors approval for two RSV vaccines, ‘Tripledemic’ hits US households, and a monoclonal antibody may be ready for next season—here are five RSV stories you should check out this week.
Read MoreThe target action date for the FDA’s approval decision is set for the third quarter. If approved, nirsevimab is expected to be available in the US for the 2023/2024 RSV season.
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Sanofi and Regeneron Pharmaceuticals’ Dupixent was approved in Canada for expanded use as an add-on maintenance treatment in certain patients with severe asthma.
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The investigational long-acting monoclonal antibody Nirsevimab showed 74.5% efficacy against medically attended lower respiratory tract infections caused by RSV in healthy infants.
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Sanofi and GSK will submit data from both their booster and Phase 3 efficacy trials to the FDA and other international regulatory agencies for authorization of their Sanofi-GSK COVID-19 vaccine.
Read MoreThe FDA has approved dupilumab (Dupixent, Regeneron) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
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Adding Libtayo to chemotherapy significantly improved median overall survival in advanced non-small cell lung cancer patients from 13 to 22 months, leading to a 29% reduction in the risk of death, compared to chemotherapy alone.
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Sanofi Pasteur will increase its domestic pandemic influenza vaccine production capabilities in the US.
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