Skip to content Skip to footer
Subscribe Now
NEWS
Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation
Shots: Hansa Biopharma has reported topline P-III (ConfIdeS) trial data assessing imlifidase vs control for 12mos. in 64 kidney transplant pts (cPRA ≥99.9%) across 25 US sites Trial met its 1EP of improved kidney function at 12mos. per mean eGFR, with pts achieving eGFR of 51.5 mL/min/1.73m2 vs 19.3 mL/min/1.73m2, plus reached statistical significance in…
September 25, 20250Comments
NEWS
Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer
Shots: The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC) Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…
September 25, 20250Comments
NEWS
Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada
Shots: Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to market Pexegra & Filra in Canada, with Kashiv’s facilities supporting JAMP’s commercialization efforts Pexegra (6mg/0.6mL) & Filra (300mcg/0.5mL & 480mcg/0.8mL) help treat CT-induced neutropenia by…
September 25, 20250Comments
NEWS
Solid Biosciences & Kinea Bio Partner to Advance KNA-155 Using AAV-SLB101 for Dysferlin-Related Limb-Girdle Muscular Dystrophy
Shots: Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsid As per the deal, Kinea Bio will receive a non-exclusive global license to utilize AAV-SLB101 for the delivery of KNA-155, which will enter IND-enabling studies…
September 24, 20250Comments
NEWS
Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases
Shots: The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…
September 24, 20250Comments
Astrazeneca & Daiichi Sankyo
NEWS
Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer
Shots: The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026) sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…
September 24, 20250Comments
BMS
NEWS
BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat R/R Multiple Myeloma
Shots: BMS has reported the P-III (EXCALIBER-RRMM) trial data assessing iberdomide + daratumumab + dexamethasone (IberDd) vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma The trial has 2 stages: Stage 1 randomized ~200 pts to iberdomide (1, 1.3, or 1.6mg) plus daratumumab & dexamethasone, identifying 1mg as the selected dose; Stage…
September 24, 20250Comments