Skip to content Skip to footer
Subscribe Now
NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots: The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

Read more

VIEWPOINTS_Dr. Mourad Farouk Rezk1_2023
VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots :Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022)He also spoke about the results of the 48-week analysis of the PROPER trial evaluating   adalimumab biosimilar, Imraldi, in patients with autoimmune diseasesThe interview highlights Biogen's…
June 27, 2023

Read more

VIEWPOINTS_Gina Fusaro_2023
VIEWPOINTS

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots:Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanomaShe also spoke on the epidemiology of melanoma and…
May 16, 2023

Read more

Viewpoints_Dr. Volker Knappertz
VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots:Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNISThe interview gives an understanding of how Aurinia…
December 7, 2022

Read more