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Takeda
NEWS

Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE

Shots: Takeda reported the EMA's approval of an additional 2 mL pre-filled pen option for Takhzyro (lanadelumab) for patients aged ≥12 with Recurrent hereditary angioedema (HAE) Currently Takhzyro is approved in 150 mg and 300 mg pre-filled syringes and 300 mg vial. The new approval is for a 300 mg pre-filled pen (2 mL…
February 25, 2025

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Innovent
NEWS

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

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bluebird Bio
NEWS

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

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Mirum Pharmaceuticals
NEWS

Mirum Pharmaceuticals Receives the US FDA Approval for Ctexli to Treat Cerebrotendinous Xanthomatosis

Shots: The US FDA has approved Ctexli (chenodiol) to treat cerebrotendinous xanthomatosis (CTX) in adults Efficacy was established in crossover withdrawal P-III (RESTORE) trial assessing Ctexli (250mg, PO, TID) vs PBO in pts for 24wks. Study showed reduced levels of plasma cholestanol & urine 23S-pentol in pts compared to PBO Ref: Prnewswire | Image: Mirum Related…
February 24, 2025

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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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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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