Tagged News
BioDlink Secures Brazil GMP Certification, Expanding Global Reach for Bevacizumab Biosimilar
• BioDlink has successfully passed its first on-site GMP inspection by Brazil's ANVISA, a PIC/S member, marking a significant regulatory milestone for the company's Suzhou manufacturing facility.
• The inspection specifically reviewed production of Pusintin® (bevacizumab), a biosimilar antibody treating non-small cell lung cancer and metastatic colorectal cancer, receiving full approval with no observations.
• With regulatory certifications now in five countries including Brazil, Indonesia, Egypt, Colombia, and Argentina, BioDlink aims to expand access to affordable oncology biologics across emerging markets.
Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial
• The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
• This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
• Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.
Faron Pharmaceuticals Appoints Ralph Hughes as Chief Business Officer to Advance Immunotherapy Pipeline
• Faron Pharmaceuticals has appointed Ralph Hughes as Chief Business Officer, bringing extensive experience in commercial strategy and market access from his previous roles at PharmaVentures, Mundipharma, and Pfizer.
• Hughes joins Faron at a critical time as the company advances its lead immunotherapy candidate bexmarilimab, currently in Phase I/II trials for acute myeloid leukemia and myelodysplastic syndrome.
• Bexmarilimab targets the Clever-1 receptor on macrophages, potentially overcoming cancer treatment resistance by reprogramming the tumor microenvironment and enhancing immune system response against cancer cells.
Triveni Bio Initiates First-in-Human Trial of TRIV-509 for Atopic Dermatitis, Targeting Novel Kallikrein Pathway
• Triveni Bio has begun dosing healthy volunteers in a Phase 1 clinical trial for TRIV-509, a dual inhibitor of kallikreins 5 and 7 (KLK5/7) designed to treat moderate-to-severe atopic dermatitis.
• Preclinical data presented at SID 2025 demonstrated TRIV-509's ability to rapidly improve skin barrier integrity, reduce epidermal thickness, and increase desmoglein-1 expression in atopic dermatitis patient explants.
• The company is also advancing TRIV-573, a next-generation bispecific antibody targeting both KLK5/7 and IL-13, currently in IND-enabling studies, expanding their novel approach to inflammatory skin disorders.
Zura Bio Launches Phase II TibuSHIELD Trial for Novel Dual-Inhibitor in Hidradenitis Suppurativa
• Zura Bio has initiated the Phase II TibuSHIELD trial evaluating tibulizumab, a first-of-its-kind dual inhibitor targeting both BAFF and IL-17A pathways in patients with moderate to severe hidradenitis suppurativa.
• The global, randomized, double-blind, placebo-controlled study will enroll approximately 180 patients across the US, Canada, and Europe, with topline efficacy results expected in Q3 2026.
• This trial represents Zura Bio's second Phase II study for tibulizumab, following the December launch of TibuSURE for systemic sclerosis, advancing their portfolio of treatments for severe inflammatory diseases.
Belimumab Shows Superior Efficacy for Systemic Lupus Erythematosus in Meta-Analysis
• A comprehensive meta-analysis of five randomized controlled trials confirms belimumab's superior efficacy over placebo in treating systemic lupus erythematosus (SLE) according to BICLA criteria.
• Patients receiving belimumab demonstrated significantly higher response rates regardless of baseline glucocorticoid dose, with particularly strong results in those with high disease activity or serologically active disease.
• The findings validate belimumab's clinical efficacy through an additional widely used responder index, supporting its use in SLE management according to current recommendations.
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
Related Clinical Trials:
Janssen Research & Development, LLC
Posted 11/7/2017
Tourmaline Bio's Heart Disease Antibody Shows Promise in Phase 2, But Shares Fall Amid Competition Concerns
• Tourmaline Bio's antibody drug pacibekitug demonstrated significant reduction in cardiovascular risk biomarkers compared to placebo in Phase 2 trials, but shares fell 18% as investors question its competitive edge against Novo Nordisk's offering.
• Schrödinger announced CFO Geoffrey Porges will leave the company amid near-record low share prices, coinciding with plans to lay off 7% of staff as part of cost-cutting measures.
• CRISPR Therapeutics is expanding its technological capabilities through a $95 million deal with Sirius Therapeutics to develop SRSD107, a novel siRNA blood thinner designed to minimize bleeding risk.
Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025
• Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma treatment.
• The company will present research on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma, addressing significant unmet medical needs.
• Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma will be featured in an oral presentation.
Related Clinical Trials:
Eisai Inc.
Posted 7/11/2019
Merck Sharp & Dohme LLC
Posted 12/30/2020
Philikos Initiates Phase 1/2 Trial of T-Guard for Diffuse Cutaneous Systemic Sclerosis
• Philikos has enrolled the first patient in a Phase 1/2 trial evaluating T-Guard for diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disorder with limited treatment options.
• The open-label study will assess safety and preliminary efficacy in 12 early-stage dcSSc patients whose disease remains refractory despite prior immunosuppressive therapy.
• T-Guard, administered as four infusions over one week, aims to provide a safer alternative to hematopoietic stem cell transplantation by selectively depleting disease-associated T cells and NK cells.