FDA approves Xolair as first and only medicine for children and adults with one or more food allergies
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placeboMore than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2   Detailed OUtMATCH results will be featured in a late-breaking symposiumat the 2024 AAAAI Annual MeetingBasel, 16  February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food ...
Source: Roche Investor Update - February 16, 2024 Category: Pharmaceuticals Source Type: news

Save the date: Roche Diagnostics Investor Day 2024
  The Roche Investor Relations team would like to invite you to the Roche Diagnostics Investor Day that will take place in London on Wednesday, 22 May 2024, starting at 12:00 BST local time and will finish at 15:30 BST with a reception.The Roche Diagnostics Investor Day will address the following topics:Mass spectrometryContinuous glucose monitoringNext generation sequencingPoint of careUpcoming molecular diagnostics launchesNeurology biomarkers in developmentMeeting information:Date/Time (BST):Wednesday, 22 May 202412:00 - 13:00 Registration and lunch13:00 - 15:30 Presentations& Q&A15:30 - 16:15 ReceptionVenu...
Source: Roche Investor Update - February 13, 2024 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Virtual Neurology Investor Event
  We are pleased to invite investors and analysts to participate in our virtual event onMonday,11 March 2024, highlighting key data presented at 2024 Muscular Dystrophy Association (MDA) and Alzheimer ' s& Parkinson ' s Diseases (AD/PD) conferences. 15:00 – 16:30 CET / 14:00 – 15:30 GMT10:00 – 11:30 AM EDT / 07:00 – 08:30 AM PDT The webinar will start with presentations, followed by a Q&A session (live access to the speakers). The slides will be available for download at 14:00 CET on the day of the event.>click here Access to virtual event (pre-registration required)Please pre-register for our webin...
Source: Roche Investor Update - February 12, 2024 Category: Pharmaceuticals Source Type: news

New long-term data for Roche ’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO)
Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry visionUp to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apartDetailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024Vabysmo is approved in the US for RVO, and in more than 90 countries around the world for people living with nAMD and DMEBasel, 1 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) i...
Source: Roche Investor Update - February 1, 2024 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
Group salesgrow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidanceExcluding COVID-19 products,Group sales increase by 8%Pharmaceuticals Divisionsalesincrease by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)Diagnostics Division salesare 13% lower due to high demand for COVID-19 tests in 2022; strong ...
Source: Roche Investor Update - February 1, 2024 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Full Year Results 2023 Presentation
Roche will publish its Full Year Results of 2023 prior to the opening of the Swiss Stock Exchange onThursday,1 February 2024.07:00 CET / 06:00 GMT / 01:00 AM EST / 10:00 PM PST (evening before)Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here14:00 – 16:00 CET / 13:00 – 15:00 GMT08:00 – 10:00 AM EST / 05:00 - 07:00 AM PSTThe webinar  will start with presentations by senior management, followed by a Q&A session.Presenters:Thomas Schinecker, CEO Roche GroupTeresa Graham, CEO Roche PharmaceuticalsMatt Sause, CEO Roche D...
Source: Roche Investor Update - January 25, 2024 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patients,  nurses and physicians1-5Tecentriq SC reduces treatment time by approximately 80%, compared with standard IV infusion6Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq SC as quickly as possibleBasel, 16 January 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq ® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer...
Source: Roche Investor Update - January 16, 2024 Category: Pharmaceuticals Source Type: news

Roche enters into a definitive agreement to acquire LumiraDx's Point of Care technology combining multiple diagnostic modalities on a single platform
The transformative point of care solution will complement Roche ’s centralised diagnostics portfolio across Clinical Chemistry, Immunochemistry, Coagulation and Molecular, and across multiple disease areasLumiraDx ’s technology integrates multiple Point of Care tests on a simple to use single instrument and brings more affordable and accessible testing to patients worldwideUnder the terms of the agreement, Rochewill pay a purchase price of USD 295 million and an additional payment of up to USD 55 millionBasel, 29 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive agreement to...
Source: Roche Investor Update - December 30, 2023 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposureInterim analysis results from first-of-its-kind phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2,3Basel, 19 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration ...
Source: Roche Investor Update - December 19, 2023 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Full Year Results 2023 Presentation
  Roche will publish its Full Year Results of 2023 prior to the opening of the Swiss Stock Exchange onThursday,1 February 2024.07:00 CET / 06:00 GMT / 01:00 AM EST / 10:00 PM PST (evening before)Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here14:00 – 16:00 CET / 13:00 – 15:00 GMT08:00 – 10:00 AM EST / 05:00 - 07:00 AM PSTThe webinar  will start with presentations by senior management, followed by a Q&A session.Presenters:Thomas Schinecker, CEO Roche GroupTeresa Graham, CEO Roche PharmaceuticalsMatt Sause, CEO Roch...
Source: Roche Investor Update - December 19, 2023 Category: Pharmaceuticals Source Type: news

Roche named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices
The ranking acknowledges Roche ’s commitment to sustainability as an integral part of its business strategyRoche performed particularly well in innovation management, access to healthcare, greenhouse gas emissions, water management, resource efficiency and circularity, labour practice indicators and human rightsThis marks the 15th consecutive year that Roche has maintained its leading rankingBasel, 15 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). Roche ranked third, Chugai P...
Source: Roche Investor Update - December 15, 2023 Category: Pharmaceuticals Source Type: news

New data for Roche ’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma
Longer-term data from pivotal studies of fixed-duration Columvi and Lunsumio continue to show durable responses in people with heavily pre-treated lymphomas1,2New data reinforce the potential of combination regimens in earlier treatment settings and add to the robust body of evidence supporting ongoing Phase III studies3,4,5,6Basel, 11 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting& Exposition, 9-12 December ...
Source: Roche Investor Update - December 11, 2023 Category: Pharmaceuticals Source Type: news

New data reinforce the benefit of early preventative treatment with Roche ’s Hemlibra for babies with severe haemophilia A
Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth1At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma1Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed1The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with ha...
Source: Roche Investor Update - December 9, 2023 Category: Pharmaceuticals Source Type: news

Roche's Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment
Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date1,2Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study2These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press programmeBasel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (e...
Source: Roche Investor Update - December 8, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Inavolisib in combination with palbociclib and fulvestrant more than doubled progression-free survival compared to palbociclib and fulvestrant alone1The inavolisib combination has the potential to address resistance to treatment and poor prognosis associated with PIK3CA mutations2-5These new data are being presented today in an oral presentation at the 2023 San Antonio Breast Cancer Symposium and shared with health authoritiesBasel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance ®) and fu...
Source: Roche Investor Update - December 8, 2023 Category: Pharmaceuticals Source Type: news