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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

The Pharma Data

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. It is not currently approved for use in COPD anywhere in the world.

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Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). They expect to launch a Phase III trial of the drug in the first quarter of 2021. . Other Industry News.

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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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First Single-Shot Vaccine in Fight Against Global Pandemic

The Pharma Data

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021. “We The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Phase 3 ENSEMBLE Study Design.

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FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

If approved, Dupixent would be the first medicine available in the U.S. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. Dupilumab Development Program.

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FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

The Pharma Data

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In children younger than 12 years of age, Dupixent should be administered by a caregiver.

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FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

The Pharma Data

baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. It is approved in the U.S.

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