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18.10.25 - 07:03
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Roche′s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer (GlobeNewswire EN)
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Basel, 18 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus.1 The evERA study is evaluating the investigational giredestrant combination in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy.2 This is the first positive head-to-head phase III trial investigating a selective oestrogen receptor degrader-containing regimen versus a standard-of-care combination.2 The results are being presented in an oral session at the European Society for Medi...
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17.10.25 - 22:24
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Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss (GlobeNewswire EN)
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Basel, 17 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from two phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME).1 UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory condition of the eye, that can result in vision loss.2 Across both studies, the primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment.1 The data were presented at the American Academy of Ophthalmology annual meeting (AAO 2025) in Orlando, Florida, United States....
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17.10.25 - 12:33
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CHMP recommends EU approval of Roche′s Gazyva/Gazyvaro for lupus nephritis (GlobeNewswire EN)
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Basel, 17 October, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications describe the extent and nature of damage to the kidneys and renal function. A final decision from the European Commission is expected in the near future....
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17.10.25 - 07:12
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Hansoh and Leads Biolabs clinch US$2.5 billion in global drug licensing deals (SCMP)
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Two Chinese drug developers have signed licensing deals that could yield as much as US$2.5 billion in performance-based payments, underscoring growing international confidence in China's life sciences sector.
Hansoh Pharmaceutical Group has agreed to license global rights – excluding mainland China, Hong Kong, Macau and Taiwan – to develop and market a colon cancer drug candidate to F Hoffmann-La Roche, a unit of Swiss-based biotech giant Roche.
Hansoh, a major psychotropic and cancer drugs......
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