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NEWS

Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots: Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26 Approval was based on pivotal P-IIb (VISION-DMD) data and EMA assessments, granting 15-year Swiss orphan drug exclusivity; Santhera retains exclusive Swiss distribution. Trial met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at…
January 15, 2026

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NEWS

Bio Usawa Receives the Ghana FDA Approval for BioUcenta (Biosimilar, Lucentis) 

   Shots:  The Ghana FDA has approved BioUcenta, a biosimilar version of Lucentis (ranibizumab) for diabetic macular edema, age-related macular degeneration, and diabetic retinopathy  The Ghana FDA approval followed a rigorous, science-based review referencing comprehensive data previously evaluated and accepted by the EMA  BioUcenta is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG  Ref: Bio Usawa  | Image: Bio Usawa |  Press Release  Related News: CuraTeQ Biologics Reports Positive P-III study…
January 12, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Reports the Health Canada’s NOC for Dyrupeg (Biosimilar, Neulasta) 

Shots:  CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)  Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia  In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar…
January 9, 2026

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NEWS

Mannkind Acquires Scpharmaceuticals to Strengthen Its Cardiometabolic and Lung Diseases Portfolio

Shots: MannKind has signed definitive merger agreement to acquire ScPharmaceuticals Under the merger agreement, MannKind will launch a tender offer to acquire all outstanding scPharmaceuticals shares for $5.35 per share in cash, plus a non-tradable CVR worth up to $1.00 per share based on regulatory and sales milestones, for total consideration of up to $6.35…
August 26, 2025

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VIEWPOINTS_Samantha Kerr_2023
VIEWPOINTS

Samantha Kerr shares insights from the topline data of Xeomin P-III studies and pivotal study evaluating Belotero Balance (+)

Shots: Samantha Kerr, Chief Scientific Officer, Merz Aesthetics shares insights from the topline data of Xeomin P-III studies and pivotal study evaluating Belotero Balance (+) Samantha says, for Belotero Balance (+), Merz Aesthetics has already submitted the data as a supplemental Premarket Approval Application (sPMA) with the FDA and plans to submit the data as…
October 5, 2023

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