FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

Biocon Biologics’ retinal disorder medication Yesafili gets public funding in Canada

Yesafili, available in vial and prefilled syringe presentations (2 mg/0.05 mL), was the first biosimilar to Eylea approved by Health Canada

Lupin partners with Sadoz to commercialise Ranibizumab biosimilar

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data

Lupin and SteinCares ink agreement for Ranibizumab in Latin America

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study

Demonstrates vision gains with extended treatment intervals in retinal vein occlusion

Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study

Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU