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
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More
Shots: The approval is based on P-II STARTRK-2 study assessing the efficacy of Rozyltrek in ROS1 fusion-positive NSCLC cohort while the safety is evaluated in two P-I studies (STARTRK-1 study and ALKA-372-001 study) Additionally, Chugai receives MHLW’s approval for Alecensa (alectinib hydrochloride) and Rituxan to treat r/r ALK-positive ALCL) and ATTP respectively Rozlytrek is an […]Read More
Shots: Teva and Celltrion launch Truxima (rituximab-abbs) injection as the first biosimilar referencing Roche’s Rituxan (rituximab) to be available in the US by the week of November 11, addressing the unmet medical needs of the patients in the US The approval of Truxima is based on clinical/ nonclinical, pharmacology, immunogenicity, clinical efficacy and safety data. […]Read More
Shots: The FDA’s approval is based on P-IIa PePRS study assessing MabThera/Rituxan (IV) + glucocorticoids in 25 pediatric patients with active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) aged 6-17yrs. The P-IIa PePRS study results: the achievement of PVAS remission @6mos. (56%); @12mos. (92%); @18mos. (100%); safety profile in pediatric patients with GPA & […]Read More
Shots: The P-III PEMPHIX Study (NCT02383589) involves assessing of Rituxan (1000mg, IV) vs mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris The P-III PEMPHIX study met its 1EPs & 2EPs and further demonstrated superior results to MMF in regards to sustained complete remission Rituxan (rituximab) is a mAb used to target […]Read More
Shots: The sBLA submission is based on P-IIa PePRS study results assessing Rituxan (IV) + tapering course of oral glucocorticoids in 25 patients with severe GPA or MPA aged b/w 6 to 17 years of age Rituxan has also received Priority Review Designation in combination with glucocorticoids (GCC), for treatment of granulomatosis with polyangiitis (GPA) […]Read More
Shots: The study involves assessing efficacy and safety of CT-P10 vs Rituxan (rituximab) in 140 patients in ratio (1:1) with AFL for a duration of two years P-III study results: @ 2 Year OS (93.2% vs 95.3%); PFS (75.2% vs 73.5%); relapse or disease progression (19.4% vs 21.3%); well tolerated and safe, Presented at ASH […]Read More
Shots: Halozyme to receive $25M upfront plus $160 to $165M/target milestones payments based on development, regulatory & sales in addition to royalties. Roche to get rights for ENHANZE Technology for exclusive development of clinical stage candidates for therapy areas Roche also has an option to add two additional targets within a span of four years, […]Read More
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