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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 &…
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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…
GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)
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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)…
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Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the IndiaÂ
Tishtha will be available in 100 mg and 40 mg strengthsÂ
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 Â
Ref: Zydus | Image: Zydus |  Press ReleaseÂ
Related News: Shanghai Henlius Receives the US FDA…
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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…
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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…
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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)…
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J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228Â 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;…
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The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review
MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
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HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025
Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…

