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FDA Issued Complete Response Letter to AstraZeneca Regarding Supplemental Biologics License Application for Fasenra for Patients with Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyps

By Charles Gross
Today, 10:40 AM
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

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AstraZeneca Announced Nirsevimab Showed 74.5% Efficacy Against Medically Attended Lower Respiratory Tract Infections Caused by Respiratory Syncytial Virus in Healthy Infants

By Charles Gross
Today, 10:40 AM
Detailed results from the positive MELODY Phase III trial showed a single dose of AstraZeneca and Sanofi's nirsevimab met the primary efficacy endpoint reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) by 74.5% (95% CI 49.6, 87.1; p<0.001), compared to placebo.1-2

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AstraZeneca and Neurimmune Close Exclusive Global Collaboration and Licence Agreement to Develop and Commercialize NI006

By Charles Gross
Today, 10:40 AM
Alexion, AstraZeneca's Rare Disease group, has closed an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within f

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