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F Hoffmann-La Roche Ltd: Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine

FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the

F Hoffmann-La Roche Ltd: FDA grants Breakthrough Device Designation for Roche s Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

(2) FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer s investigational drug PF-06946860 Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death Successful cachexia treatment can potentially contribute to improved cancer treatment worldwide Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc. s (NYSE: PFE) investigational d

F Hoffmann-La Roche Ltd: Roche renews partnership with Sysmex to deliver haematology testing solutions

F. Hoffmann-La Roche Ltd: Roche renews partnership with Sysmex to deliver haematology testing solutions This successful long-running partnership continues to evolve and bring haematology testing innovations to laboratories, globally The new agreement aims to utilise the IT systems to lead to improved clinical decision making and customer experience Blood disorders have a high impact, not only for patients but for society as a whole, accounting for a third of all central laboratory tests 1 Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents.

F Hoffmann-La Roche Ltd: Roche s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration

(2) Faricimab given at intervals of up to every 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks, potentially reducing the frequency of injections and overall burden of treatment Nearly half of people were treated with faricimab every 16 weeks during the first year - the first time this level of durability has been achieved in a phase III study of an injectable eye medicine for neovascular age-related macular degeneration Faricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways - via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) - that drive a number of retinal conditions

F Hoffmann-La Roche Ltd: Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer

F. Hoffmann-La Roche Ltd: Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer 19.2 6.9 18.1 Tecentriq + Avastin (n=133) 24.0 (0.35-0.80) Median follow-up: 15.6 months. CR, complete response; DOR, duration of response; HR, hazard ratio; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression free response; PR, partial response; SD, stable disease. See below for OS data from the primary analysis. About the IMbrave150 study IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib wa

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