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Celltrion
NEWS

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

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Estrella
NEWS

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

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Teva and Alvotech
NEWS

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

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Akesobio
NEWS

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

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 Mayne Pharma
NEWS

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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Incyte & Genesis Therapeutics
NEWS

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

Shots: Incyte has partnered with Genesis to advance research, discovery, & development of novel small molecules using GEMS (Genesis Exploration of Molecular Space) AI platform, initially focusing on targets selected by Incyte As per the agreement, Incyte will gain exclusive rights to develop & commercialize products arising from this deal in exchange for $30M…
February 21, 2025

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Harbour BioMed &  Insilico Medicine
NEWS

Harbour BioMed Enters into a Collaboration with Insilico Medicine to Advance AI-Driven Antibody Discovery and Development

Shots: Harbour BioMed has entered into a strategic collaboration with Insilico Medicine to accelerate therapeutic antibody development, combining their expertise in antibody discovery and artificial intelligence The companies will also collaborate on early-stage drug discovery targeting novel antibodies, leveraging Insilico's AI expertise and Harbour BioMed's wet lab capabilities for immunology, oncology, and neuroscience, aiming…
February 20, 2025

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