Shots: The P- I/IIa study assess BI-1206 + rituximab in patients with indolent r/r B-cell NHL. The study consists of 2 parts: P- l with dose escalation cohorts using a 3+3 dose-escalation and selection of the recommended RP2D and P-IIa which is an expansion cohort at the RP2D enriched with MCL patients The results showed […]Read More
Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan […]Read More
Shots: Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly-owned subsidiary, Archigen Biotech, which was solely engaged in the development of SAIT101 (biosimilar, rituximab) Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan […]Read More
Shots: The P-III CHRONOS-3 study involves assessing of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing treatment The P-II study met its 1EP of prolonged PFS, safety is consistent with previously published data on the individual components […]Read More
Shots: NMPA has approved Halpryza for patients with DLBCL, FL, and CLL in China. The biosimilar is the fourth mAb approved in China following the approval of Tyvyt (biosimilar, sintilimab), Byvasda (biosimilar, bevacizumab) and Sulinno (biosimilar, adalimumab) The clinical efficacy and safety of rituximab in CD20 +ve NHL have been confirmed in multiple large-scale clinical […]Read More
Shots: In Jul 2020, following the pCPA agreement Riximyo is now reimbursed through Limited Use as well as the Exceptional Access Program while funding will be done by Cancer Care Ontario. Additionally, from Aug 01, 2020, the BC cancer will be responsible for reimbursement of Riximyo as per British Columbia The patient support program will […]Read More
Shots: Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20 Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung […]Read More
Shots: Celltrion has presented the result of P-II study that showed that regimen of Truxima (375mg/m2) + lenalidomide (20mg, day 1-21, qd) + acalabrutinib (100mg, day 1-28, bid) (R2A) is well-tolerated and effective in relapsed/refractory aggressive B-cell lymphoma In the 13 patients who underwent disease assessment following the R2A regimen, ORR (69%) and CR (31%), […]Read More
Shots: Health Canada has approved Ziextenzo (a biosimilar referencing Neulasta) and Riximyo (a biosimilar referencing Rituxan) for marketing in Canada Sandoz has received Health Canada’s Notice of Compliance on Apr 21, 2020, for the use of Ziextenzo to reduce the incidence of febrile neutropenia while Riximyo has received approval on Apr 28, 2020 to treat […]Read More
Shots: In Jun 2021, the company plans for the closure of supplying Truxima to the state governments and will focus on expanding its footprints with exclusively selling it in Brazil. Truxima’s safety and efficacy is proven as its prescriptions is expanded in the US, EU, and WW Additionally, on May 26th, 2020, Celltrion will launch […]Read More
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