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Samsung Bioepis, Biogen Announce FDA Filing Acceptance of Lucentis Biosimilar americanpharmaceuticalreview
December 04, 2020
Samsung Bioepis and Biogen announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).
FDA to review Samsung Bioepis and Biogen’s biosimilar SB11 pharmaceutical-technology
November 20, 2020
The US Food and Drug Administration (FDA) has accepted Samsung Bioepis and Biogen’s biologics licence application to review the use of SB11 as a biosimilar referencing Lucentis (ranibizumab).
French authority orders €444m fine on Novartis, Roche over Lucentis pharmaceutical-technology
September 24, 2020
The French competition authority has imposed a total fine of €444m on Novartis, Roche and Genentech for allegedly following abusive practices to push more sales of eye disease drug Lucentis than a cheaper drug.
Neovascularization inhibitor sales will near $7 bn in diabetic retinopathy market in 2029: GlobalData expresspharma
September 18, 2020
This increase is expected to be driven by the demonstrable efficacy of these products in reducing the rate of angiogenesis and sight loss in diseases such as DR, diabetic macular oedema and retinal vein occlusion.
Novartis Resolves Legacy FCPA Investigations americanpharmaceuticalreview
July 07, 2020
Novartis has reached settlements with the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the Company and its subsidiaries.
Novartis to file Lucentis for rare sight condition in premature babies pharmatimes
September 27, 2018
Novartis has revealed its intent to file anti-VEGF therapy Lucentis for retinopathy of prematurity (ROP), a rare disease...
Roche’s bags new US approvals for Tecentriq, Lucentis pharmatimes
April 19, 2017
The US Food and Drug Administration has expanded the approval of Roche’s Tecentriq so that it can be used to treat a wider range of patients with bladder cancer.