Tags : Positive Opinion

Sanofi’s Supemtek Receives CHMP’s Positive Opinion for Approval to Prevent

Shots: The CHMP’s recommendation is based on two P-III studies demonstrating the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000+ patients aged ≥18yrs. The company expects EC’s decision in Q4’20 Supemtek is the first and only influenza vaccine to rely on recombinant manufacturing technology and is available in the US since 2017 […]Read More

Alexion’s Ultomiris (ravulizumab) Receives the CHMP’s Positive Opinion for its

Shots: The CHMP has adopted a positive opinion recommending marketing authorization in the EU for a new 100 mg/mL (IV) advanced formulation of Ultomiris (ravulizumab). The positive opinion is based on CMC submission and a supplementary clinical data set showing that the safety, PK, and immunogenicity following administration of Ultomiris (10mg/mL & 100mg/mL) were comparable […]Read More

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for

Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Equidacent will be available as 25 mg/ml as the […]Read More

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02

Shots: The EMA’s CHMP has granted a positive opinion, recommending marketing authorization for HLX02 to treat HER2+ early breast cancer, HER2+ metastatic breast cancer & previously untreated HER2+ metastatic adenocarcinoma of the stomach or gastro-esophageal junction EC will now review the CHMP’s positive opinion, with the expected regulatory decision in next 2-3mos. Once approved, a […]Read More

Mylan and Lupin Receive CHMP’s Positive Opinion for Nepexton (biosimilar,

Shots: The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO The positive opinion is based on bio similarity assessment which included pre/ clinical studies demonstrating bioequivalence […]Read More