Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar […]Read More
The 2020 JP Morgan Healthcare Conference was loaded with insights from key pharma companies. An analysis of events and catalysts that were announced or updated at the conference these days are included. Our PharmaShots team summarized the key deals which were presented during the updates from companies from Jan 13 to Jan 16, 2020. Date […]Read More
1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, FDA, Fast Track Designation, Treat, Patients, Decompensated Heart 2. Charles River Collaborates with Fios Genomics for Bioinformatics-Driven Drug Discovery and Safety Assessment Published: Jan 16, 2020 | Tags: Charles River, Collaborates, Fios Genomics, […]Read More
Shots: Innovent to receive $45M as upfront, development & regulatory milestone and royalties on sales of the therapy in the licensed territories while Coherus plans to file BLA to the US FDA in H2’20 or H1’21. Additionally, Coherus get an option to commercialize Innovent’s biosimilar to Rituxan (rituximab) in the US and Canada If option […]Read More
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar […]Read More
1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell Lymphoma 2. Janssen Reports Submission of MAA to EMA for its Investigational Ebola Vaccine Regimen to Prevent Ebola Virus Disease Published: Nov 07, 2019 | Tags: […]Read More
Shots: Bioeq to receive up front, regulatory and launch milestones with equal profit sharing. Coherus to get exclusive rights to commercialize biosimilar candidate referencing Genentech’s Lucentis with its anticipated launch in 2021 in the US Bioeq will be responsible for product delivery to the Coherus and will submit BLA to the US FDA in Q4’19 […]Read More
Shots: Post EU Approval, Udenyca has received FDA approval on basis of non-inferiority data including its PK, PD and immunogenicity in 600 healthy patients, receiving myelosuppressive CT having cancer Udenyca novel pegfilgrastim-cbqv biosimilar, has received its EU approval on 21 Sep, 2018. In 2017, Pegfilgrastim had $4.5B sales worldwide Udenyca (formerly CHS-1701) is a PEGylated […]Read More
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