Tags : marketing approval

Voluntis’ Oleena Digital Application Receives FDA’s Marketing Approval to Self-Manage

Shots: The US FDA has completed its regulatory review of Oleena software which is a Class II medical device facilitating oncology-related symptoms management and remote patient monitoring Oleena is embedded with clinical algorithms offerings real-time personalized insights and actionable recommendations to the patients for managing their own symptoms while monitoring remote patients will improve clinical […]Read More

Fresenius Kabi’s Idacio (adalimumab, biosimilar) Receives EU’s Marketing Approval in

Shots: The approval is based on its non-inferiority data consisting of its PK, efficacy, safety, immunogenicity data with the reference product in analytical, preclinical and clinical data trials Fresenius Kabi has a portfolio consisting of generic drugs, infusion therapies, biosimilars, and clinical nutrition products focusing on multiple therapy areas Idacio (adalimumab, biosimilar) is a mAb […]Read More

Exelixis and Daiichi Sankyo’s Minnebro (Esaxerenone) Receives MHLW Marketing Approval

Shots: The approval is based on P-III ESAX-HTN study assessing esaxerenone vs eplerenone for 12wks. in patients with essential hypertension, 1EP as SBP / DBP In 2006, Exelixis and Daiichi Sankyo collaborated to develop and commercialize and Esaxerenone tablets. Exelixis will receive $20M milestone on sales and has received additional $20M as on regulatory milestones in […]Read More

Coherus Biosciences’ Udenyca (Pegfilgrastim Biosimilar) Receives EU Marketing Approval for

Shots: Udenyca’s (Pegfilgrastim biosimilar) EU approval is based on the data demonstrating its PK and PD, for reducing the chances of infection by febrile neutropenia This biosimilar is currently under the US FDA inspection and has provided a PDUFA date 3 Nov, 2018. Udenyca is currently not available for commercial sale Udenyca (pegfilgrastim-cbqv/CHS-1701), is a […]Read More

Pharmacosmos’ Monoferric 1000 mg IV Receives Health Canada Marketing Approval

Shots:  Monoferric is being approved for anaemic adult patients intolerant or unresponsive to iron oral therapy with an expection to reach market by Nov 2018 In 2015, Pharmacosmos signed Canada commercialization rights of Monoferric to Pfizer Canada Monoferric IV has a novel matrix structure of linear isomaltoside chains interspersed with Fe3+ and already being marketed […]Read More

Celltrion’s Herzuma (Herceptin biosimilar) Receives Marketing Approval in Australia

Shots: Herzuma is first biosimilar approved in Australia for the treatment of early breast cancer, locally advanced or metastatic or advance gastric cancer Including Herzuma Celltrion has three biosimilar for Australia, Remsima for autoimmune disease, Truxima for blood cancer approved in Aug 2015 and April 2018 respectively Celltrion plans to launch Herzuma in Australia after […]Read More