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Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
drugs
May 31, 2021
AMGN today announced its partner AZN submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma.
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Tezepelumab significantly reduces exacerbations of severe asthma
europeanpharmaceuticalreview
March 02, 2021
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
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Tezepelumab Trial Does Not Meet Primary Endpoint
americanpharmaceuticalreview
January 08, 2021
Amgen and AstraZeneca announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo.
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Tezepelumab Trial Meets Primary Endpoint
americanpharmaceuticalreview
November 20, 2020
Amgen and AstraZeneca announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe ...
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Bayer Receives FDA Approval of myBETAapp and BETACONNECT Navigator
biospectrumasia
June 01, 2017
With this software in relapsing-remitting multiple sclerosis, patients can use Bluetooth technology to connect their current autoinjector to the new myBETAapp on their mobile device or computer.