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Roche’s Alzheimer’s Disease Diagnostic Kits Gain Approval in Hainan, Set for Use in Shanghai Ruijin Hospital
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical Products Administration for its suite of Alzheimer’s disease (AD) cerebrospinal fluid diagnostic kits. The approved products include Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho Tau (181P) CSF, Elecsys Total Tau CSF detection reagents, along with…
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Roche Completes Acquisition of LumiraDx’s Point-of-Care Solutions Business
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG, OTCMKTS: RHHBY, SWX: RO) has announced the completion of its acquisition of the point-of-care (POC) solutions business from UK-based diagnostics firm LumiraDx, following all necessary antitrust and regulatory approvals. Initially announced at the end of 2023, the acquisition involved an upfront payment…
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Roche’s H1’24 Financials Show 5% Growth, Eye Care and Cancer Therapies Drive Sales
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Roche (SWX: ROG, OTCMKTS: RHHBY, SWX: RO), the Swiss pharmaceutical and diagnostics giant, has reported its financial results for the first half of 2024, with group sales remaining stable in Swiss franc terms. However, on a constant exchange rate basis, sales increased by 5% year-on-year to CHF 29.85 billion (USD…
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Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Roche Secures RNA Exon Editing Tech for Neurological Diseases with Ascidian Deal
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Roche (SWX: ROG; OTCMKTS: RHHBY), a Swiss pharmaceutical giant, is expanding its footprint in the RNA drug development sector through a strategic partnership and licensing agreement with Ascidian Therapeutics, a U.S.-based biotechnology company. The collaboration aims to discover and develop RNA exon editing therapeutics for the treatment of neurological disorders.…
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Roche’s Genentech Gets Green Light for Vixarelimab UC Clinical Trial in China
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Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
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Roche’s CT-388 Shows Significant Weight Loss in Phase I Clinical Trial for Obesity
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Switzerland-based healthcare giant Roche (SWX: ROG) has announced preliminary results from a Phase I study of its investigational dual GLP-1/GIP receptor agonist, CT-388. The study is assessing the drug’s effects in obese adults, both healthy and those with type 2 diabetes (T2D). Initial data from the healthy cohort showed that…
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Roche Marks 30 Years in China with Commitment to Boost Investments and Local Manufacturing
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has reaffirmed its long-term commitment to the Chinese market with plans to significantly increase investments across the medical industry value chain. This strategic expansion was announced during the company’s 30-year anniversary celebration in China, highlighting its dedication to the region. The company’s novel…
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Roche and Genprex Initiate Phase I Trial Combining Tecentriq and Reqorsa for ES-SCLC
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Switzerland-based Roche (SWX: ROG) is advancing the evaluation of its anti-PD-L1 drug, Tecentriq (atezolizumab), in combination with Genprex’s (NASDAQ: GNPX) gene therapy, Reqorsa (quaratusugene ozeplasmid), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Genprex has initiated the dose escalation phase of a Phase I clinical trial, with the…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Roche’s Q1 2024 Turnover Rises 2% YOY, Driven by New Medicines and Diagnostics
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has reported a 2% year-on-year (YOY) increase in turnover at constant exchange rates (CER) for the first quarter of 2024, reaching CHF 14.4 billion (USD 15.7 billion). The growth was modest but steady, driven by newer medicines and diagnostics, which compensated for…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Roche China’s Talent and Culture Vice President Chen Yanli Departs for New Opportunities
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the departure of Chen Yanli, who served as Vice President of Talent and Organizational Culture at Roche China and Head of the Chinese Market Access Hospital Key Account Management Department. Chen has decided to leave Roche to pursue external development opportunities.…
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Roche and Eli Lilly’s Elecsys pTau217 Blood Test Earns FDA Breakthrough Designation for Alzheimer’s Detection
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The U.S. Food and Drug Administration (FDA) has granted a breakthrough device designation for Elecsys pTau217, a blood test co-developed by Roche (SWX: ROG) and Eli Lilly (NYSE: LLY), aimed at detecting amyloid pathology, a hallmark of Alzheimer’s disease. This designation is significant in the context of the growing global…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
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Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
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Immune-Onc Therapeutics Partners with Roche for Phase Ib/II Study of IO-108 in Liver Cancer
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Immune-Onc Therapeutics Inc., based in the U.S., is entering into a collaboration with Roche (SWX: ROG) to conduct a Phase Ib/II clinical study evaluating its LILRB2 (ILT4) monoclonal antibody (mAb) IO-108 in combination with Roche’s PD-L1 mAb atezolizumab and VEGF mAb bevacizumab. This study aims to target first-line localized advanced,…
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Roche’s Xolair Gains FDA Approval to Combat IgE-Mediated Food Allergies in Patients Aged 1 and Up
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Roche (SWX: ROG) has announced that the U.S. Food and Drug Administration (FDA) has granted a new indication for Xolair (omalizumab) to mitigate allergic reactions, including anaphylaxis, associated with IgE-mediated food allergies in both adult and pediatric patients aged 1 and older. While Xolair is designed to reduce the risk…
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Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
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The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment…
