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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Flare Therapeutics and Roche Enter Strategic Collaboration for Oncology Drug Discovery
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US-based Flare Therapeutics Inc., a clinical-stage biotech company specializing in cancer therapies through the use of transcription factors, has announced a strategic discovery collaboration agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The partnership will utilize Flare Therapeutics’ expertise in proteomics and mass spectrometry, along with its proprietary library of…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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AstraZeneca China President Leon Wang Involved in Chinese Investigation Amid Industry Probes
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Leon Wang, Executive Vice President International and AstraZeneca (AZ, NASDAQ: AZN) China President, is cooperating with an investigation by Chinese authorities, as stated by the UK pharmaceutical major. During this period, AstraZeneca China General Manager Lai Minglong will ensure business continuity. This development follows a series of media reports about…
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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
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Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Regor Therapeutics Strikes Deal with Genentech for CDK Inhibitors, Fetching USD 850 Million Upfront
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Regor Therapeutics Group, a US-based biotech with significant ties to China, has entered into a licensing agreement with Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG; OTCMKTS: RHHBY) . Under the agreement, Genentech will acquire the rights to develop, manufacture, and commercialize Regor’s next-generation CDK inhibitors, including the…
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Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
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Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Roche’s Ocrevus Zunovo Receives FDA Nod as First Twice-Yearly MS Treatment
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Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment…
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Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
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The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma…
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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…
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Roche Secures NMPA Approval for Rozlytrek to Treat Pediatric NTRK Fusion-Positive Tumors
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Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approval allows the treatment of pediatric patients aged at least one month with NTRK fusion-positive solid tumors. Entrectinib is a TRK/ROS1 tyrosine kinase inhibitor known…
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Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
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Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
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Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
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Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
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Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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Merck In-Licenses Inspirna’s Ompenaclid for Advanced Colorectal Cancer, Eyes Market Potential
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Germany-based Merck (NYSE: MRK) has in-licensed the potential first-in-class candidate ompenaclid from U.S. firm Inspirna, aimed at inhibiting the creatine transport channel SLC6A8. The drug is currently undergoing Phase II trials for RAS-mutated advanced or metastatic colorectal cancer (mCRC). The agreement also encompasses additional follow-on compounds targeting SLC6A8. In return…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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Roche to Expand Diagnostics Portfolio with Acquisition of LumiraDx Technology
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Pharmaceutical giant Roche (SWX: ROG), based in Switzerland, has announced an agreement to acquire innovative diagnostic technology from UK-headquartered LumiraDx (OTCMKTS: LMDXF). The transaction, expected to close in mid-2024, involves an upfront payment of $295 million, complemented by up to an additional $55 million to support LumiraDx’s point-of-care business during…
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Roche Secures Diagnostics Deal with LumiraDx for $295M
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Switzerland’s pharmaceutical giant Roche (SWX: ROG) has sealed a deal to acquire innovative diagnostics technology from UK-based LumiraDx. The transaction, valued at $295 million, is anticipated to conclude in mid-2024, with an additional payment of up to $55 million to cover LumiraDx’s point-of-care business expenses until the deal’s closure. The…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
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The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
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Roche Diagnostics and Beijing Strong Biotechnologies Deepen Ties to Innovate in Hemostasis Diagnostics
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Roche Diagnostics (SWX: ROG), the Swiss diagnostics heavyweight, has furthered its collaboration with Beijing Strong Biotechnologies Inc. (SHE: 300406), a Chinese partner, to craft more holistic and pioneering laboratory solutions for hemostasis and thrombotic disorders. Building on their initial partnership established in 2016, which focused on biochemical reagents and resulted…
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Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Roche Expands Beyond Oncology with USD 2.7 Billion Carmot Therapeutics Acquisition
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Swiss pharmaceutical giant Roche (SWX: ROG) has entered into an agreement to acquire U.S. biotech firm Carmot Therapeutics, a specialist in anti-obesity and diabetes drugs, in a transaction valued at USD 2.7 billion with potential milestone payments of up to USD 400 million. The acquisition is expected to close in…
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Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
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The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL)…
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FDA Raises Concerns Over Research Conditions at Roche’s Genentech Trial Site
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The US Food and Drug Administration (FDA) has voiced concerns regarding the research conditions at a clinical site involved in a Phase III trial evaluating Genentech’s antiviral Xofluza (baloxavir marboxil), a unit of Switzerland-based Roche (SWX: ROG), for the reduction of household transmission of influenza. While the concerns appear to…
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Genentech and NVIDIA Collaborate to Advance Drug Discovery with AI
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has entered into a collaboration agreement with semiconductor manufacturer NVIDIA (NASDAQ: NVDA) to expedite drug discovery and development. This partnership aims to harness the power of artificial intelligence (AI) by integrating Genentech’s biological and molecular datasets with NVIDIA’s advanced supercomputing…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its gene transfer therapy Elevidys (delandistrogene moxeparvovec) did not meet its primary endpoint in Duchenne muscular dystrophy (DMD) ambulatory patients aged 4 to 7 years. The trial aimed to measure the change from baseline in motor…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings, a biotechnology firm co-owned by UK’s Roivant Sciences (NASDAQ: ROIV) and US-based Pfizer (NYSE: PFE). The acquisition will grant Roche rights to RVT-3101, a potential best-in-class and first-in-class anti-TL1A subcutaneous antibody, in the US and…
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Roche’s Q3 2023 Report Shows 1% Global Growth Amid Lower COVID-19 Product Demand
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2023 report, indicating that a reduced demand for COVID-19 products impacted global growth, resulting in a 1% year-on-year (YOY) increase at constant exchange rates over the first nine months, with total sales amounting to CHF 44.1 billion (USD 49.4 billion). Excluding…
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Alebund Pharmaceuticals Secures Exclusive Rights to Roche’s Mircera in China
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Shanghai-based Alebund Pharmaceuticals has entered into a commercialization agreement with Swiss pharmaceutical giant Roche (SWX: ROG), securing exclusive promotion rights to Mircera (methoxy polyethylene glycol-epoetin beta) in mainland China. The financial terms of the deal remain undisclosed, highlighting the strategic nature of the partnership without revealing specific monetary details. Mircera:…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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Roche’s Ocrevus Demonstrates Long-Term Efficacy in Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has presented compelling long-term efficacy data for its selective immunosuppressant Ocrevus (ocrelizumab) in the treatment of multiple sclerosis (MS). The 10-year results from a Phase III extension study provide significant insights into the drug’s sustained impact on patients with relapsing and primary progressive forms…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Roche Secures Global Rights to Ionis Pharmaceuticals’ Alzheimer’s and Huntington’s Disease Candidates
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced the acquisition of global rights to develop, manufacture, and commercialize two early-stage drug candidates for Alzheimer’s disease (AD) and Huntington’s disease (HD) from Ionis Pharmaceuticals (NASDAQ: IONS). This strategic move is set to bolster Roche’s pipeline in central nervous system (CNS) disorders…
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Roche’s Genentech Partners with Orionis Biosciences for Molecular Glue Therapies
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has announced a partnership with Belgium-based Orionis Biosciences to discover molecular glue-class small-molecule treatments in oncology and neurodegeneration. This strategic collaboration aims to leverage Orionis’s proprietary platform for high-throughput discovery, rational design, and optimization of candidates that modulate intermolecular interactions,…
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Roche’s Genentech Partners with Peptidream for First-in-Class PDCs in Radioisotope Therapy
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has announced a partnership with Japan’s peptide-based therapeutics and diagnostics specialist, Peptidream (TYO: 4587). The collaboration aims to discover and develop potential first-in-class peptide-drug conjugates (PDCs) for the targeted delivery of radioisotopes against specific disease targets. Details of the PartnershipUnder the terms…
