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NEWS

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
FibroGen & AstraZeneca
AstraZeneca Purchases FibroGen China for ~$160M
Shots: AstraZeneca has purchased FibroGen’s China subsidiary for ~$160M ($85M enterprise value + ~$75M net cash) with closing expected in mid-2025, obtaining full rights to roxadustat in China The sale allows FibroGen to repay its Morgan Stanley Tactical Value loan & extend its cash runway to 2027 for advancing FG-3246 in P-II trial for…
February 21, 2025
Akesobio
Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China
Shots: Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308)  study of Ivonescimab + CT  for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China) The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…
February 21, 2025
 Mayne Pharma
Cosette Pharmaceuticals to Acquire Mayne Pharma for ~$430M
Shots: Cosette Pharmaceuticals to acquire Mayne Pharma Group for ~$430M, with shareholders receiving $4.71/share. Closing expected in Q2’25 Acquisition will strengthen Cosette’s dermatology & women’s health business, adding 12 patent-protected products incl. Vyleesi, Intrarosa, Nextstellis, Annovera, Bijuva, Imvexxy, & Rhofade along with multiple pipeline candidates in its product line upon closing The combined…
February 21, 2025
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