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Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
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BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a long-acting erythropoietin (EPO) product, rhEPO-Fc, developed by Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), for review. The product is intended for the treatment of anemia associated with chronic kidney disease (CKD). Anemia is a common…
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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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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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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 Genentech Terminates Relay Therapeutics Collaboration for SHP2 Inhibitor
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In a recent development, Roche Inc.’s subsidiary Genentech has given notice of termination for a license and collaboration agreement with Relay Therapeutics Inc., affecting the development of an oral small-molecule Src homology region 2 domain-containing phosphatase-2 (SHP2) inhibitor, RLY-1971, now known as migoprotafib or GDC-1971 . The termination, effective 180…
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Roche’s Susvimo Implant Cleared for Relaunch in US After Voluntary Recall
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced the conclusion of the voluntary recall of its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant in the U.S. market. The implant, indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), has received approval from the U.S. Food and Drug Administration…
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Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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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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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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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 Extends Long-Standing Partnership with Hitachi High-Tech to Innovate Diagnostic Solutions
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Roche (SWX: RO), a major Swiss pharmaceutical company, has renewed its 46-year partnership with Japan’s Hitachi High-Tech (TYO: 6501) for an additional 10 years to develop innovative diagnostic solutions. This long-standing collaboration has led to an annual impact of over 21 billion in-vitro diagnostic tests, facilitated by more than 84,000…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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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…
