Roche (RHHBY) announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded use of Columvi (glofitamab) for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for review. The eligible population includes DLBCL patients who have received at least one prior line of treatment (second-line setting) and are not candidates for autologous stem cell transplant. A final decision from the regulatory body is expected on July 20, 2025.Please note ...

Application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival1,2 This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progressionImproving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those w ...

CLINTON, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Unity Bank proudly announces that Amanda Roche, Vice President and Finance Department Supervisor, has been recognized as a 2024 New Leader in Banking by the New Jersey Bankers Association (NJBankers). This esteemed award honors outstanding young professionals who are making significant contributions to the New Jersey banking sector. A resident of Long Valley, New Jersey, Roche is one of only 22 banking professionals under the age of 40 to receive this disting ...

On Tuesday, Roche Holdings AG RHHBY agreed to acquire Poseida Therapeutics, Inc. PSTX for an equity value of approximately $1.5 billion on a fully diluted basis.The deal consideration includes $9.00 per share in cash plus a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $4.00 per share in cash upon achievement of specific milestones.Also Read: Roche’s Q3 Sales Surge Led By Ocrevus, Vabysmo, Urges Regulators To Block Novo Holdings’ $16.5B Catalent AcquisitionThe proposed ac ...

The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE. This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year.TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received C ...

Collaboration will leverage Flare Therapeutics' proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncologyFlare Therapeutics to receive US$70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royaltiesCAMBRIDGE, Mass., Nov. 12, 2024 /PRNewswire/ -- Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcri ...

Basel, 05 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US. The data underscore Roche’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy® (polatuzumab vedotin), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab) as well as new investigation ...

Roche This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others ...

Roche Holding AG (OTCQX:RHHBY) Virtual Neurology Investor Event Conference October 31, 2024 11:00 AM ET Company Participants Bruno Eschli – Investor Relations Azad Bonni – Senior Vice President and Global Head-Neuroscience and Rare Diseases-pRED Luka Kulic – Therapeutic Area Leader-Dementia and Expert Medical Director-Neuroscience and Rare Diseases-pRED Margherita Carboni – Indication Lead, Neurology and Clinical Development Lead-Neurology, Endocrinology and OBGYN-Roche Diagnostics Hanno Svoboda – Head-Port ...

Summary of Roche Holding AG Neurology Investor Event Conference Company Overview - **Company**: Roche Holding AG (OTCQX:RHHBY) - **Event Date**: October 31, 2024 - **Focus**: Neurology pipeline updates, particularly in Alzheimer's disease and related therapies Key Points Industry and Company Focus - Roche is focusing on neurology as a significant growth area, with existing products like Ocrevus and Evrysdi, and upcoming opportunities such as Elevidys and fenebrutinib [3][4] - The company has a robust pipeline for Alzheimer's disease, including trontinemab and gamma-secretase modulators [10][11] Alzheimer's Disease Pipeline - **Trontinemab**: A novel Brainshuttle A-beta antibody designed to cross the blood-brain barrier effectively, showing promise in early studies [37][38] - **Gamma-secretase modulator (GSM)**: Aims to prevent amyloid accumulation rather than just clear existing amyloid plaques, with early positive results in human trials [26][29] Clinical Trials and Data - **Trontinemab Phase 1b/2a Study**: Ongoing with 160 participants, showing safety and biomarker data. The study includes dose escalation and expansion phases [39][43] - **Safety Profile**: No new safety concerns reported; however, a serious adverse event (cerebral macrohemorrhage) occurred in a participant with pre-existing conditions, leading to protocol amendments [46][48] - **Amyloid PET Results**: Significant reductions in amyloid plaque levels observed, with a decrease of approximately 90 centiloids at the highest dose after 12 weeks [54][61] Diagnostic Innovations - Roche Diagnostics is advancing blood-based biomarkers for Alzheimer's, including the Elecsys Amyloid Plasma Panel, which has shown high clinical performance in ruling out amyloid pathology [68][70] - Breakthrough device designations received for pTau-181 and pTau-217, enhancing diagnostic capabilities [68][69] Market Outlook - The prevalence of Alzheimer's disease is projected to reach 150 million by 2050, highlighting the urgent need for effective treatments [19] - Roche's dual approach in diagnostics and therapeutics aims to improve patient outcomes and streamline treatment pathways [23][66] Additional Insights - The company emphasizes the importance of patient journey mapping, integrating diagnostics with therapeutic interventions to enhance treatment efficacy [23][25] - The potential for oral small molecule approaches in the future is noted, aiming for more convenient administration of therapies [22] Future Developments - Roche plans to continue expanding its neurology pipeline, with pivotal Phase 3 trials for trontinemab expected to start in the second half of 2025 [7][62] - The company is committed to addressing safety concerns and optimizing treatment protocols based on ongoing trial data [48][60] Conclusion Roche Holding AG is strategically positioned in the neurology sector, with a strong focus on Alzheimer's disease through innovative therapies and diagnostics. The ongoing clinical trials and advancements in biomarker development are expected to enhance the company's market presence and address the growing public health challenge posed by neurodegenerative diseases.