Tags : EC

Regulatory

Ipsen’s Cabometyx + Opdivo Receive EC’s Approval as a 1L

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across all efficacy EPs. The trial met its 1EPs i.e. showed doubled mPFS (16.6 vs 8.3mos.); ORR (55.7% vs. 27.1%); CR (8.0% vs 4.6%); OS (40% […]Read More

Biosimilars

Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the

Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the reference product, in terms of safety, efficacy, PK/PD, and immunogenicity […]Read More

Regulatory

Vico’s VO659 Receives EC’s Orphan Drug Designation for Spinocerebellar Ataxia

Shots: The EC granted ODD for VO659 for the treatment of spinocerebellar ataxia (SCA). The ODD was based on a EMA’s COMP positive opinion The company previously received ODD in Huntington Disease The company focused on the development of RNA modulating therapies for rare neurological disorders VO659 is an antisense oligonucleotide product, designed to suppress […]Read More