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Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced a strategic exclusive collaboration and licensing agreement with Denmark-based Zealand Pharma (CPH: ZEAL). The partnership aims to develop and commercialize petrelintide, Zealand Pharma’s amylin analog, both as a standalone therapy and in a fixed-dose combination with Roche’s lead incretin asset CT-388.…
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Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston. This new facility aims to strengthen longstanding partnerships in disease biology, engineering, and artificial intelligence/machine learning. CVRM Hub and AI IntegrationThe center will serve as Roche’s…
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Swiss giant Roche’s (SWX: ROG, OTCMKTS: RHHBY) China unit has entered into a collaboration agreement with JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD). This partnership aims to enhance the prevention and control of influenza in China through the innovative “medicine+Internet medicine” model, making Xofluza (baloxavir marboxil)…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing…
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China-based health services and distribution giant Baheal Pharmaceutical Group (SHE: 301015) last month reached an accord with Roche (SWX: ROG, OTCMKTS: RHHBY), securing exclusive market promotion rights to the Swiss giant’s MabThera (rituximab) in mainland China. Drug ProfileMabThera, the world’s first anti-CD20 monoclonal antibody (mAb), is used to treat Hodgkin…
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Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic agent TNKase (tenecteplase) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS) in adults. Drug ProfileTNKase, a tissue plasminogen activator, is administered as a single…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced the presentation of its proprietary sequencing by expansion (SBX) technology, marking a significant advancement in next-generation sequencing (NGS). Technology OverviewSBX integrates innovative sensor modules to provide ultra-fast and high-throughput sequencing solutions. The technology is designed with broad flexibility and scalability, making…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co., Ltd. (TYO: 4519) announced that the Ministry of Health, Labour and Welfare of Japan has approved Tecentriq (atezolizumab) for the treatment of unresectable alveolar soft part sarcoma. This marks the first approval of an immune…
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Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds). Drug DetailsEvrysdi is a survival…
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Swiss pharma giant Roche (SWX: ROG) has transferred US-based InterMune, Inc., acquired for USD 8 billion in 2014, and the intellectual property (IP) rights to Esbriet (pirfenidone) in the US to Legacy Pharma Inc. SEZC. Financial terms were undisclosed. FinancialsEsbriet, an idiopathic pulmonary fibrosis (IPF) drug, saw peak sales of…
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Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q4 and full-year 2024 financials, reporting a strong year with 7% year-on-year (YOY) growth across the group at constant exchange rates. Total sales reached CHF 60.495 billion ($66.34 billion), while overall group revenues were CHF 62.395 billion ($68.42 billion), also up 7%.…
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Roche (SWX: ROG) released its 2024 annual financial report on January 30, showing a 7% year-on-year increase in revenue to CHF 60.495 billion (USD 68.892 billion), calculated based on the average exchange rate of 2024 (1 CHF = USD 1.1388). The company’s R&D expenditure reached CHF 13.042 billion (USD 14.852…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US Food and Drug Administration (FDA) and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. This marks a significant advancement in rapid diagnostic capabilities…
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. This follows the test’s CE Mark approval in…
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Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced an additional 510(k) clearance from the US FDA for its Roche Digital Pathology Dx, a whole slide imaging system that now includes the VENTANA DP 600 slide scanner. This clearance expands the capabilities of Roche’s digital pathology solutions, enhancing the diagnostic…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a significant licensing agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The agreement grants Roche global exclusive development, manufacturing, and commercialization rights to Innovent’s IBI3009, a DLL3-targeted antibody drug conjugate (ADC) that is anticipated to offer new treatment options for patients with…
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China-based Bio-Thera Solutions (SHA: 688177) has announced a licensing agreement with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and North Africa (MENA) region. The agreement pertains to BAT2206, Bio-Thera’s biosimilar version of Roche’s (SWX: ROG) Stelara (Ustekinumab).…
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb), Lunsumio (mosunetuzumab). This therapy targets CD20 and CD3 and is designed to treat adult patients with recurrent or refractory follicular lymphoma (R/R FL) who…