The Pharma Data

MARCH 26, 2021

The adverse reactions observed in BLISS-LN were consistent with the known safety profile of Benlysta administered intravenously plus standard therapy in patients with SLE. Belimumab was approved as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in adults in November 2017. About the BLISS-LN study.

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The Pharma Data

MAY 5, 2021

GlaxoSmithKline plc (GSK) today announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE).

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The Pharma Data

APRIL 28, 2021

1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). ClinicalTrials.gov.

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The Pharma Data

JUNE 18, 2021

The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR). The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. NORTH CHICAGO, Ill. ,

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The Pharma Data

JUNE 18, 2021

The objective of this Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderate to severe Crohn’s disease who responded to risankizumab IV induction treatment in the ADVANCE and MOTIVATE studies.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Current vaccines and medicines work by intervening against these life phases. Miller and Su published an article on Tu’s story in Cell in 2011.

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