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The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)
Shots: The US FDA has approved Ennumo, a biosimilar to Neulasta (pegfilgrastim), expanding Accord’s biosimilar portfolio & supporting its goal to launch 20 biosimilars in the US by 2030 Ennumo is approved for adults & pediatric pts (newborn & older) to reduce incidence of infection in febrile neutropenia in non-myeloid malignancies receiving myelosuppressive anti-cancer drugs…
July 10, 2026
Samsung Bioepis Partners with Teva  to Commercialize Opuviz  (Biosimilar, Eylea) in Canada 
 Shots:  Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada  As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights  Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis' aflibercept biosimilar is also marketed in EU and South…
July 9, 2026
Roche
Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis
Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
July 9, 2026
iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening
Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…
July 9, 2026
AstraZeneca Inks $1.9B Exclusive Licensing Deal with Sino Biopharmaceutical for TQC3721
Shots: Sino Biopharmaceutical has entered into an exclusive license agreement with AstraZeneca for the development, manufacturing & commercialization of TQC3721, an inhaled PDE3/4 inhibitor As per the deal, AstraZeneca secured exclusive rights to develop, manufacture, & commercialize TQC3721 outside China, along with exclusive global rights to select future development programs In return, Sino will receive…
July 9, 2026
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