Skip to content Skip to footer

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)…

Read more

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…

Read more

Akesobio

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…

Read more

J&J

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;…

Read more

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

Shots: 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…

Read more

Hutchmed

HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: 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…

Read more