相关临床试验
12
6 进行中
药物批准
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监管机构
0
监管机构数
成立时间
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进行中（未招募）
6
50.0%
已完成
4
33.3%
招募中
2
16.7%
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- The FDA approved obinutuzumab (Gazyva, Genentech) to reduce relapse risk in adults and children aged 2 years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in remission. - The decision is supported by the phase 3 INSHORE trial, which randomized 85 patients to intravenous obinutuzumab or twice-daily oral mycophenolate mofetil. - Obinutuzumab was given on days 1 and 15 and at weeks 24 and 26, with the primary endpoint assessed at week 52. - A significantly greater proportion of obinutuzumab-treated patients achieved a first morning urine protein-creatinine ratio of 0.2 g/g or less without relapse from week 8 to week 52.
- Roche will pay Atavistik $70 million upfront with up to $1.9 billion in milestones plus royalties for small molecules designed against several disease targets. - Genentech will pay Earendil $55 million upfront for multiple bispecific antibodies in cancer, in a deal worth over $1.5 billion with royalties. - The agreements are Roche's fourth and fifth announced biotech partnerships in less than a month, following ADC, trispecific and bispecific deals.
- Earendil Labs will receive a $55 million upfront payment under a research collaboration with Genentech to discover and develop bispecific antibodies in oncology. - Total potential deal value, including development, regulatory and sales milestones plus tiered royalties, exceeds $1.5 billion, with the transaction subject to customary closing conditions. - Earendil leads antibody discovery and research through early clinical development for pre-agreed target combinations, after which Genentech takes over global development and commercialization. - The deal extends Earendil's AI-enabled biologics partnering strategy, following Sanofi collaborations and a $787 million raise to expand a pipeline of more than 40 programs.
- Merck's remigromig met the primary endpoint in the Brunello phase 2b/3 trial, showing noninferiority to ranibizumab on best-corrected visual acuity at Week 52. - The trispecific drug agonizes the Wnt signaling pathway by mimicking norrin, offering a non-VEGF mechanism for diabetic macular edema patients. - Remigromig was well tolerated, but proliferative diabetic retinopathy, vitreous hemorrhage and adverse event-related discontinuations occurred more often than with ranibizumab. - Merck acquired remigromig in its $1.3 billion upfront EyeBio takeover and will present the data at the American Academy of Ophthalmology meeting.
- Japan's PMDA has approved Natera's Signatera test as a companion diagnostic to guide adjuvant atezolizumab decisions in muscle-invasive bladder cancer. - The approval was supported by the randomized, double-blind phase III IMvigor011 trial, which included more than 20 participating sites in Japan. - It is Signatera's second PMDA authorization in three months, following colorectal cancer approval in June 2026, and the first PMDA-approved CDx in MRD-guided care. - Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, pending final reimbursement and pricing.
- Genentech reported positive topline Phase II results for enicepatide, a once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes and overweight or obesity. - At the 24 mg dose, enicepatide reduced HbA1c by 2.65% and body weight by 15.5% at 48 weeks, meeting both dual primary endpoints. - Ninety percent of patients on 24 mg reached HbA1c of 6.5% or below and 62% achieved normoglycemia, while patients with baseline HbA1c above 8.5% saw a 4.13% reduction. - Treatment discontinuation due to adverse events was 2.0% in enicepatide arms versus 0.0% on placebo, with mostly mild-to-moderate gastrointestinal events.
- The European Commission has approved Susvimo (ranibizumab 100 mg/mL) for adults with neovascular age-related macular degeneration, Roche's continuous-delivery treatment option. - Approval rests on the pivotal Phase III Archway trial plus the Phase II Ladder study and the open-label long-term extension Portal study. - In Archway, Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, with Portal showing vision maintained up to seven years. - With two refills per year, approximately 95% of Susvimo-treated patients needed no supplemental anti-VEGF treatment, and the therapy was generally well tolerated long term.
- Roche and Genentech opened the Roche Genentech Innovation Center in Boston's Allston neighborhood at Harvard's Enterprise Research Campus on Thursday. - The site will serve as Roche's cardiovascular, renal and metabolism hub, spanning basic research, clinical development, artificial intelligence and scientific data work. - A 10-year lease covers 95,000 square meters, with capacity for up to 500 specialists in research, clinical development and data science roles. - The investment is part of Roche's $50 billion commitment to US manufacturing and research, building on sites in North Carolina and Oregon.
- The EMA's CHMP recommended approval of intravenous Ocrevus (ocrelizumab) for patients aged 10 years and older with relapsing forms of multiple sclerosis. - The positive opinion rests on the Phase 3 OPERETTA 2 trial, which tested Ocrevus against fingolimod, the current standard treatment for pediatric MS. - Ocrevus was non-inferior to fingolimod on relapse control and cut relapse risk by 48%, with 48% fewer new or enlarging T2 lesions. - The safety profile in children and adolescents matched the established adult profile, and no OPERETTA 2 participants discontinued treatment for adverse events.
- Genentech reported that Lunsumio plus lenalidomide significantly improved progression-free survival versus rituximab plus lenalidomide in relapsed or refractory follicular lymphoma. - The Phase III CELESTIMO trial met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful reduction in disease progression risk. - CELESTIMO is a confirmatory study intended to convert Lunsumio's accelerated third-line approval to full approval and secure a second-line or later indication. - Overall survival data were immature, no new safety signals emerged, and full results including the hazard ratio are awaited at an upcoming medical meeting.
