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Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
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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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Roche and Zealand Pharma Collaborate to Develop Petrelintide for Weight Management
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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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Roche and JD Healthcare Collaborate on Influenza Prevention with Xofluza (Baloxavir Marboxil)
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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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Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
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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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Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
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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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Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
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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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Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
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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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Roche Transfers InterMune and Esbriet to Legacy Pharma in IP Deal
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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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Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
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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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Roche Reports 7% Growth in Full-Year Sales, Strength in Pharmaceuticals
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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 Reports 7% Revenue Growth in 2024, Driven by Oncology and Ophthalmology
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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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Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
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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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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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Roche’s VENTANA Kappa and Lambda Dual ISH Test Gains FDA Clearance
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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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Roche Gains FDA 510(k) Clearance for Roche Digital Pathology Dx with VENTANA DP 600
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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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Innovent Biologics Strikes Licensing Deal with Roche for IBI3009 ADC
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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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Bio-Thera Solutions Enters Licensing Agreement with Tabuk Pharmaceutical for BAT2206 in Saudi Arabia
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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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Roche’s Lunsumio Receives NMPA Approval for R/R Follicular Lymphoma Treatment
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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…
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Roche’s Prasinezumab Shows Promise in Phase IIb PADOVA Study for Early-Stage Parkinson’s Disease
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Swiss pharmaceutical giant Roche (SWX: ROG) has published results from the Phase IIb PADOVA study for its investigational monoclonal antibody, prasinezumab, in patients with early-stage Parkinson’s disease (PD). The study aimed to assess the drug’s impact on the primary endpoint of time to confirmed motor progression, with a hazard ratio…
