Shot: The P-III ORIENT-32 involves assessing of Tyvyt (sintilimab) + Byvasda (bevacizumab, biosimilar) vs sorafenib in a ratio (2:1) for 1L treatment of patients with advanced HCC The study resulted in meeting its 1EPs of PFS and OS, the safety profile is consistent with prior studies, and no new safety signals were identified. Following the […]Read More
Shots: The collaboration allows MD Anderson to conduct multiple clinical studies for multiple rare cancer indications. MD Anderson plans to develop an approach, upon commercialization in rare diseases and will receive royalties on sales of the product in the US, used it to fund for uninsured patients The focus of the collaboration is to advance […]Read More
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilar is expanding its footprints worldwide with multiple collaborations. In Jan 2020, Pfizer launched its two biosimilars [Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab)] at lowest WAC in the US Our team at PharmaShots has summarized key […]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 key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space […]Read More
Shots: The P-III study involves assessing of IBI303 (SC, 40 mg/0.8 ml, q2w) vs the reference product, Humira (adalimiumab) in 438 patients with ankylosing spondylitis across 20 hospitals in China The P-III study resulted in meeting its 1EPs, @24wks. ASAS20 response rate (75% vs 72%) & 2EPs i.e, ASAS20 @12wks., ASAS40 @24wks; ASAS partial response […]Read More
Shots: The companies collaborated to jointly assess safety and efficacy of Chipscreen’s Chidamide in combination with Innovent’s Sintilimab + IBI305 in patients with advanced colorectal carcinoma (ACC) The focus of the agreement is to explore the combination in clinical applications of immune check-point inhibitor, angiogenesis inhibitor and epigenetic modulator in ACC Chidamide is a HDAC […]Read More
Shots: The BLA is based on two P-III study results assessing efficacy, safety and PK of IBI-305 vs bevacizumab in patients with advanced non-sq NSCLC and has demonstrated in meeting 1EPs with bio-similarity Innovent has received three NMPA acceptance including IBI-305 namely Tyvyt (sintilimab injection) and IBI-303 (adalimumab, biosimilar) in H2’18 for ankylosing spondylitis (AS), […]Read More
Shots: The approval is based on ORIENT-1 study results assessing Tyvyt in patients with 2L+ Hodgkin’s lymphoma The ORIENT-1 study resulted in effective complete response rates for CT + radiotherapy in patients Tyvyt is an IgG4 mAb, which helps in binding with PD-1 in T cells further blocking PD-L1. In 2015, Innovent Biologics and Eli Lilly collaborated to […]Read More
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