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Alvotech, Kashiv Biosciences & Advanz Pharma
News

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…
March 26, 2025

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GSK
News

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

Shots: The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…
March 3, 2025

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GSK
News

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
January 28, 2025

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