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Roche's Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
GlobeNewswire News Room· 2025-06-20 15:45
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx1This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community careThese data demonstrate Roche's commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma Basel, 20 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNM ...
专家热议:促进“产学研医资政”深度融合 加速创新科研成果落地转化
Ren Min Wang· 2025-06-20 09:02
Core Viewpoint - The 2025 CACA East China Integrated Oncology Conference highlighted the importance of deep integration of "industry, academia, research, medical, finance, and government" resources to accelerate the translation of cancer prevention and treatment research into clinical applications [1][2] Group 1: Innovation and Research - Eight innovative research projects in fields such as liver cancer, breast cancer, lung cancer, and lymphoma were presented at the conference [1] - The director of the China Anti-Cancer Association's Industry-Academia-Research Transformation Committee emphasized the need to streamline the entire chain of "industry, academia, research, medical, finance, and government" to promote digital medical innovation and research results [2] Group 2: AI Technology in Clinical Applications - AI technology is recognized as a key driver for new productivity and an important tool for promoting precision medicine [3] - AI can integrate various data types, such as pathological images and genetic information, to assist clinicians in improving diagnostic efficiency and providing personalized treatment plans [3][4] Group 3: Clinical Decision Support and Patient Management - The "Smart Medical Incubator" project aims to discover valuable clinical innovations and research data to address public health needs [5] - Clinical Decision Support Systems (CDSS) are being developed to integrate patient imaging data and drug efficacy prediction models, enhancing patient benefit rates [5]
Roche: Despite Venclexta Study Failure, PD Program Is Another Growth Avenue
Seeking Alpha· 2025-06-16 21:05
Group 1 - Roche Holding's subsidiary Genentech and AbbVie announced an update on the phase 3 VERONA study, which evaluates the use of Venclexta (venetoclax) [2] - The study is part of a global randomized trial aimed at assessing the efficacy of the drug in specific patient populations [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of pharmaceutical companies, including a library of over 600 articles and a model portfolio of small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings [1]
RHHBY to Advance Parkinson's Disease Drug to Late-Stage Development
ZACKS· 2025-06-16 14:50
Core Insights - Roche (RHHBY) is advancing its pipeline candidate prasinezumab into phase III development for early-stage Parkinson's disease based on data from phase IIb PADOVA study and ongoing open-label extensions [1][7] - The candidate is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson's disease progression [3] - Year-to-date, Roche's shares have increased by 20.9%, outperforming the industry growth of 4% [1] Development Details - The PADOVA study evaluated prasinezumab's safety and efficacy in 586 randomized patients, although it missed its primary endpoint of time to confirmed motor progression [4][5] - Despite missing statistical significance, positive trends toward reduced motor progression were observed at 104 weeks, with expectations of sustained effects based on additional open-label extension data [5][6] - The ongoing PASADENA and PADOVA open-label studies are assessing the long-term safety and efficacy of prasinezumab in over 750 individuals with early-stage Parkinson's disease [3] Licensing and Financials - Roche holds exclusive rights to prasinezumab under a licensing agreement with Prothena (PRTA) established in December 2013, which includes paying double-digit teen royalties on net sales [7][9] - Prothena has earned $135 million to date, with potential for up to $620 million in additional milestone payments [9] Industry Context - Developing treatments for Parkinson's disease is challenging due to its chronic and progressive nature, with both motor and non-motor symptoms [10] - Other companies, such as UCB and Novartis, are also working on treatments, with UCB's recent investigational drug failing to meet clinical endpoints [11]
Giant-Cell Arteritis Market Heats up with AbbVie's RINVOQ Approval | DelveInsight
GlobeNewswire News Room· 2025-06-12 17:00
Core Insights - AbbVie's RINVOQ (upadacitinib) has received FDA approval for the treatment of giant cell arteritis, marking it as the first oral JAK inhibitor approved for this condition in Western countries, and the ninth indication for the drug [1][6] Group 1: Market Dynamics - The approval of RINVOQ has intensified competition among pharmaceutical companies in the giant cell arteritis market [1] - DelveInsight estimates the giant cell arteritis market size to grow from USD 960 million in 2023 at a significant CAGR by 2034, driven by factors such as an increasing geriatric population and rising prevalence of cardiovascular disorders [14] Group 2: Treatment Landscape - The primary treatment for giant cell arteritis has traditionally involved high doses of corticosteroids like prednisone, with the aim of preventing serious complications such as blindness [3] - ACTEMRA/ROACTEMRA (tocilizumab) was the first approved treatment for giant cell arteritis in Europe, with its approval supported by the Phase III GiACTA study demonstrating improved remission rates [4][7] - RINVOQ's pivotal Phase 3 SELECT-GCA trial showed that 46.4% of patients achieved sustained remission with RINVOQ compared to 29.0% on placebo [7] Group 3: Emerging Therapies - Companies like Novartis and CSL/Kiniksa Pharmaceuticals are conducting clinical trials for new treatment options, indicating a need for more effective therapies in the giant cell arteritis space [10][12] - The anticipated launch of emerging therapies is expected to transform the market landscape, offering new standards of care and opportunities for innovation [13]
Access Medical Labs, a Subsidiary of Empresas Aries, Completes Historic Lab Expansion with Roche Diagnostics Systems
GlobeNewswire News Room· 2025-06-10 16:10
Core Insights - Access Medical Labs has successfully transitioned from Siemens to Roche Diagnostics systems in under 6 months, a significant achievement in the clinical laboratory industry [1][4] - The integration has increased Access's daily diagnostic capacity fivefold, enabling faster and more comprehensive results for health providers nationwide [2] - The transition was facilitated by effective collaboration between Roche's U.S. and Mexico divisions, showcasing the benefits of international cooperation in medical innovation [4] Company Developments - The transformation is seen as a major step forward for the industry, with Access Medical Labs positioning itself as one of the most advanced diagnostic labs in the nation [4][5] - Access Medical Labs is expanding its workforce by 35% by the end of 2025, creating high-impact jobs in various sectors including lab science and logistics [6][7] - The company emphasizes its commitment to personalized medicine, aiming to make it more practical and accessible through innovative testing solutions [7] Industry Trends - There is a growing focus on preventive and personalized healthcare in the U.S., with Access Medical Labs supporting thousands of physicians in this area [5][6] - The nomination of Dr. Casey Means as U.S. surgeon general highlights the increasing national emphasis on proactive, data-driven medicine [6]
Green Steel Industry Report 2025-2029 with Profiles of Leading Players - F. Hoffmann-La Roche.
GlobeNewswire News Room· 2025-06-10 09:44
Dublin, June 10, 2025 (GLOBE NEWSWIRE) -- The "Green Steel Market 2025" report has been added to ResearchAndMarkets.com's offering.The Green Steel Market was valued at USD 7.4 Billion in 2024, and is projected to reach USD 19.4 Billion by 2029, rising at a CAGR of 21.4% This report is a descriptive study providing future opportunities for manufacturing green steel and offer in-depth insights with a comprehensive and qualitative analysis, along with trends and opportunities prevailing in the market that can ...
Roche's Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy (SMA)
GlobeNewswire News Room· 2025-06-04 05:00
Core Viewpoint - Roche has received approval from the European Commission for a new room-temperature stable tablet formulation of Evrysdi® (risdiplam) for the treatment of spinal muscular atrophy (SMA), enhancing treatment flexibility and convenience for patients [1][2]. Company Overview - Roche is a leading biotechnology company focused on developing innovative medicines and diagnostics, with a strong emphasis on neuroscience and chronic disease management [10][12]. Product Details - The new 5mg Evrysdi tablet can be taken with or without food, does not require refrigeration, and is suitable for individuals aged two years and older who weigh at least 20kg (44 lbs) [1][4]. - Evrysdi is designed to increase and sustain the production of SMN protein, critical for maintaining healthy motor neurons, thereby improving the course of SMA [2][6]. Clinical Development - The approval of the tablet formulation is based on a bioequivalence study demonstrating that it provides the same efficacy and safety as the original oral solution [3][8]. - Over 18,000 individuals with SMA have been treated with Evrysdi globally, highlighting its established efficacy and safety profile [2][7]. Industry Context - SMA is a severe neuromuscular disease affecting approximately one in 10,000 babies, leading to significant muscle weakness and potential fatality [9]. - Roche's commitment to neuroscience includes investigating multiple treatments for various neurological disorders, including SMA [11].
Roche's Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer
GlobeNewswire News Room· 2025-06-03 05:00
Core Insights - Roche announced positive results from the Phase III IMforte study, demonstrating that the combination of Tecentriq and lurbinectedin significantly improves survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) [1][5] - The combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [1][5] - The study's findings were presented at the 2025 ASCO Annual Meeting and published in The Lancet, indicating a potential practice-changing option for a disease with high unmet medical needs [1][5] Study Details - The IMforte study is a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients in the maintenance phase [2] - Patients received induction therapy with Tecentriq, carboplatin, and etoposide for four cycles before being randomized to maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone [2] - The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by independent review [2] Treatment Efficacy - The median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] - No new safety signals were observed, confirming the safety profiles of both Tecentriq and lurbinectedin [1][2] About Tecentriq - Tecentriq is a monoclonal antibody that targets PD-L1, designed to enhance T cell activation against tumors [3] - It is approved for various aggressive cancer types, including small cell lung cancer and hepatocellular carcinoma, and is available in both intravenous and subcutaneous forms [4][6] Roche's Commitment - Roche is a leader in cancer immunotherapy and aims to improve patient outcomes through innovative treatments [7] - The company has a long-standing commitment to sustainability and aims to achieve net zero by 2045 [8]
New data show Roche's Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer
GlobeNewswire News Room· 2025-05-31 12:05
Core Insights - Roche announced positive final results from the phase III INAVO120 study, demonstrating that Itovebi (inavolisib) in combination with palbociclib and fulvestrant reduced the risk of death by over 30% compared to palbociclib and fulvestrant alone, indicating a significant improvement in overall survival for patients with specific breast cancer subtypes [1][3][4] Group 1: Study Results - The Itovebi-based regimen showed a median overall survival (OS) of 34.0 months compared to 27.0 months for the control group, with a stratified hazard ratio (HR) of 0.67 and a p-value of 0.0190 [1][4] - The regimen also demonstrated a median progression-free survival (PFS) of 17.2 months versus 7.3 months in the comparator arm, with a stratified HR of 0.42 [1][4] - Objective response rates improved significantly, and the time to chemotherapy was delayed by approximately two years, with a stratified HR of 0.43 [1][4] Group 2: Drug and Mechanism - Itovebi is an oral, targeted treatment specifically designed for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, which is often associated with poor prognosis [3][4] - The drug targets the PI3K alpha isoform, offering a unique mechanism of action that facilitates the degradation of mutated PI3K alpha, differentiating it from other PI3K inhibitors [4][3] Group 3: Regulatory Status and Future Studies - Itovebi is already approved in several countries, including the United States, Canada, and China, and has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use [1][4] - Additional phase III studies (INAVO121, INAVO122, INAVO123) are ongoing to explore Itovebi in various combinations for PIK3CA-mutated breast cancer [2][4]