Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…

ByRidhi Rastogi3 days ago

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Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Shots: Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable…

ByRidhi Rastogi4 days ago

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Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Shots: Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…

ByRidhi RastogiFebruary 16, 2026

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Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

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GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…

ByRidhi RastogiFebruary 6, 2026

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Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India

Shots: Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India Tishtha will be available in 100 mg and 40 mg strengths Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma Ref: Zydus | Image: Zydus | Press Release Related News: Shanghai Henlius Receives the US FDA…

ByDipanshu DixitJanuary 22, 2026

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Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…

ByRidhi RastogiJanuary 20, 2026

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Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

Shots: Sun Pharma has reported Unloxcyt (cosibelimab-ipdl) is now available in the US for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation Approval of label update was based on long-term pivotal CK-301-101 data, showing improved ORR, including higher CR, and DoR without new…

ByDipanshu DixitJanuary 16, 2026

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Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi RastogiJanuary 12, 2026

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Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…

ByRidhi RastogiJanuary 7, 2026

Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

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