[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 2% (CER) in first quarter with both divisions growing in high single digit ex COVID-19
Group sales grew by 2%1 at constant exchange rates (CER) (-6% in CHF), driven by the strong growth of newer medicines and diagnostics. Excluding COVID-19-related products, sales increased by 7%. Going forward, there will be no further material impact of COVID-19 sales declineDue to the appreciation of the Swiss franc against most currencies,saleswere 6% lower when reported in CHFPharmaceuticals Divisionbase business2 grew by 7%, driven by strong sales of medicines to treat severe diseases, such as Vabysmo (eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A...
Source: Roche Media News - April 24, 2024 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)1This approval helps address an urgent unmet need, with abouthalf of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy2TheNational Comprehensive Cancer Network ® (NCCN®)Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selectionBasel, 19 April 2024 - Roche (SIX: RO,...
Source: Roche Media News - April 19, 2024 Category: Pharmaceuticals Source Type: news
Roche ’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeksThe twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitationsU.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III...
Source: Roche Media News - April 17, 2024 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meetingBasel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates fo...
Source: Roche Media News - April 15, 2024 Category: Pharmaceuticals Source Type: news
Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis
The Elecsys ® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and CompanyOnce approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer ’s diseaseRoche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer ’s diagnosisBasel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed ...
Source: Roche Media News - April 11, 2024 Category: Pharmaceuticals Source Type: news
Roche receives FDA approval for the first molecular test to screen for malaria in blood donors
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malariaMalaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusionRoche is dedicated to saving patients ’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseasesBasel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of the cobas® Malaria test for use on the cobas® 6800/8800 Systems. This approved test ca...
Source: Roche Media News - March 26, 2024 Category: Pharmaceuticals Source Type: news
Roche Annual General Meeting 2024
All proposals of the Board of Directors approvedSeverin Schwan re-elected as Chairman of the Board of Directors; all other Board members standing for election confirmed37th consecutive dividend increase to CHF 9.60 per shareBasel, 12 March 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders had approved all proposals of the Board of Directors at its Annual General Meeting. The 635 shareholders in attendance, who represented 77.02% of the total 106,691,000 shares, approved the Annual Financial Statements and Co nsolidated Financial Statements for 2023, the Remuneration Report and the Sustainabi...
Source: Roche Media News - March 12, 2024 Category: Pharmaceuticals Source Type: news
Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care
KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month threeZilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosingRoche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular riskKARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Ca...
Source: Roche Media News - March 5, 2024 Category: Pharmaceuticals Source Type: news
New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions across multiple foods in people with food allergies
Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reactionThe U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergiesAllergic reactions can be life-threatening and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year1-3Basel, 25 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from Stage 1 of the N...
Source: Roche Media News - February 25, 2024 Category: Pharmaceuticals Source Type: news
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 Media News - February 16, 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 Media News - 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 Media News - February 1, 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 Media News - 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 Media News - 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 Media News - December 19, 2023 Category: Pharmaceuticals Source Type: news
