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NEWS

Innovent
Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer
Shots: China’s NMPA has accepted NDA & granted priority review to ipilimumab (IBI310) + sintilimab as neoadj. treatment of operable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer Submission was based on P-III (NeoShot) trial assessing safety & efficacy of ipilimumab + sintilimab vs direct radical surgery in MSI-H/dMMR colon cancer pts …
February 24, 2025
bluebird Bio
Carlyle & SK Capital to Acquire Bluebird Bio
Shots: Carlyle & SK Capital have entered into definitive agreement to acquire Bluebird Bio for $3/share in cash, delisting it from public market. Acquisition will fund Bluebird’s commercial delivery of gene therapies for SCD, β-thalassemia, & cerebral adrenoleukodystrophy, with closing expected in H1’25 As per the deal, Bluebird stockholders will get $3/share & contingent…
February 24, 2025
Biocon Biologics
Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US
Shots: Biocon Biologics has launched Yesintek (ustekinumab- kfce), a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial The approval was…
February 24, 2025
Celltrion
Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)
Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025
Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)
Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025
Estrella
Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study
Shots: Estrella reported the successful completion of its first dose cohort in the P-I/II (STARLIGHT-1) study assessing the safety, tolerability, PK, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) Preliminary data demonstrated a favorable safety profile, with no dose-limiting toxicities or treatment-related SAEs, based on this Data and…
February 24, 2025
Teva and Alvotech
Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US
Shots: Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…
February 24, 2025
BMS
BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS) 
Shots:   The positive opinion was supported by the P-III (COMMANDS) study assessing the safety & efficacy of Reblozyl (1.0mg/kg, titration ~1.75mg/kg, Q3W) vs epoetin alfa (450 IU/kg, titration ~1050IU/kg, QW) for ≥24 wks. to treat transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) MDS in patients naïve to erythropoiesis-stimulating agent  The data, as…
February 23, 2025
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