Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis […]readmore
Shots: The P-III study evaluates TX05 (biosimilar, trastuzumab) vs Herceptin in 809 patients with HER2-positive early-stage breast cancer The results showed that the proportions of patients that meet pCR criteria […]readmore
Shots: The EMA’s CHMP has recommended the approval of Alvotech‘s AVT02 (100 mg/mL), a proposed biosimilar to Humira (adalimumab) to treat AD in the EU The EC has been assigned to discuss […]readmore
Shots: The P-III study evaluates the efficacy, safety & immunogenicity of BCD-021 (q3w for 6 cycles) vs reference Avastin + paclitaxel & carboplatin in 357 patients with stage IIIB or IV nonsq. […]readmore
Shots: The P-III study evaluates the cardiac safety profiles & efficacy of Ontruzant vs reference trastuzumab in 367 patients with HER2 positive early or LA BC for 4yrs. after randomization […]readmore
Shots: The AVT02-GL-302 study evaluates AVT02 in 568 patients at ~30 centers in the EU. Patients were randomized into either of the two arms of the switching module: The first […]readmore
Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline […]readmore
Shots: Bio-Thera to receive an up front, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706 Sandoz to get rights for […]readmore
Shots: The 1st P-I study evaluates MSB11456 as SC formulation vs US-Actemra/EU-RoActemra & 2nd P-I study evaluate MSB11456 vs Actemra as IV formulation in patients with moderately to severely active RA […]readmore
Shots: DCGI has granted a EUA for tocilizumab in India for the treatment of COVID-19 in hospitalized adults who receives systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical […]readmore