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© Globe Newswire
25.04.2025
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New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission
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Basel, 25 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil).1 The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced t...
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23.04.2025
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Roche receives CE Mark for its Chest Pain Triage algorithm to enhance detection of Acute Coronary Syndrome (ACS)
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Basel, 23 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the introduction of its innovative Chest Pain Triage algorithm as part of the navifyⓇ Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately detect Acute Coronary Syndrome (ACS) in patients presenting with chest pain, one of the most common...
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22.04.2025
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Roche to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years
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Basel, 22 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche’s already significant US footprint with 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions, and are e...
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Worth to know
20.10.2025
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14.04.2025
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European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
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Basel, 14 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for a...
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Swarmalpha i/o · The Event Futures Prediction X
20.10.2025
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02.04.2025
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Roche provides update on Phase III OCREVUS high dose study in people with relapsing multiple sclerosis
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Basel, 02 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OCREVUS IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional benefit in slo...
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17.03.2025
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Roche to share latest scientific advancements from its neuromuscular portfolio at Muscular Dystrophy Association (MDA) 2025 conference
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Basel, 17 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present new data at the Muscular Dystrophy Association (MDA) conference, 16-19 March, 2025, in Dallas, Texas, from its neuromuscular portfolio, including 12 oral and poster presentations. These data demonstrate the breadth of Roche’s neuromuscular portfolio acros...
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12.03.2025
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Roche enters into an exclusive collaboration & licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity
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Basel, 12 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into an exclusive collaboration and licensing agreement with Zealand Pharma (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise petrelintide, Zealand Pharma’...
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07.03.2025
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Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston
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Basel, March 7, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning....
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05.03.2025
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FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
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Basel, 5 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the phase III REGENCY...
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02.03.2025
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Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies
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Basel, 2 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provide further evidence supporting the role of Xolair® (omalizumab) for the treatment of one or more food allergies. Stage 2 of the OUtMATCH study s...
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28.02.2025
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CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
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Basel, 28 February 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 Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) di...
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20.02.2025
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Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology
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Basel, 20 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) unveiled today its proprietary, breakthrough sequencing by expansion (SBX) technology, establishing a new category of next-generation sequencing. SBX chemistry, combined with an innovative sensor module, offers ultra-rapid, high-throughput sequencing that is both flexible and scalable for...
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20.10.2025
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07.02.2025
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New England Journal of Medicine publishes new data for Roche’s Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis
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Basel, 7 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of its phase III REGENCY trial of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine.1 The study demonstrated a statistically significant and clinically meaningful improve...
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04.02.2025
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FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
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Basel, 04 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide.1-3 Susvimo is...
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31.01.2025
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Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
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Basel, 31 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHE...
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30.01.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth
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Basel, 30 January 2025...
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29.01.2025
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Change to the Roche Enlarged Corporate Executive Committee
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Basel, 29 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Wafaa Mamilli (1967) will join the company as Chief Digital Technology Officer (CDTO), reporting to Group CEO, Thomas Schinecker, and will become a member of the enlarged Corporate Executive Committee starting 10 February 2025. She will be based at Genentech in South...
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28.01.2025
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Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer
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Basel, 28 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study investigating ItovebiTM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal g...
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27.01.2025
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Roche announces new results from EMBARK demonstrating significant sustained benefits of Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD)
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Basel, 27 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from year two of the EMBARK trial, a global, randomised, double-blind phase III study of Elevidys™ (delandistrogene moxeparvovec), the first approved gene therapy for the treatment of individuals with Duchenne muscular dystrophy. Two years after tre...
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22.01.2025
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Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
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Basel, 22 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia an...
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08.01.2025
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Roche purchases shares in tender offer for Poseida Therapeutics, Inc.
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Basel, 8 January 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX) at...
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© Globe Newswire
19.12.2024
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Roche’s Phase IIb study of prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease
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Basel, 19 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time...
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18.12.2024
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Roche transforms mass spectrometry diagnostics with launch of cobas® Mass Spec solution
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Basel, 18 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark approval for its cobas® Mass Spec solution including the cobas® i 601 analyser and the first Ionify® reagent pack of four assays for steroid hormones2. The CE mark is the first milestone in the global launch of the cobas Mass Spec solution, usi...
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13.12.2024
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Roche’s Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness
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Basel, 13 December 2024– Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein oc...
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13.12.2024
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Roche receives CE Mark for new and updated molecular cobas 6800/8800 systems, enhancing laboratory efficiency and testing capabilities
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Basel, 13 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE certification of the new cobas® 6800/8800 systems 2.0. The update significantly enhances the efficiency of laboratories by optimising resources, reducing downtime, consolidating test menus, and increasing throughput. These improvements ultimately promise a more stre...
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10.12.2024
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New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma
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Basel, 10 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, 7-10 December 2024. With more than 20 bispecific antibody abstracts a...
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09.12.2024
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Roche commences tender offer for all shares of Poseida Therapeutics, Inc. for $9.00 per share in cash, plus a non-tradeable contingent value right for up to $4.00 per share in cash
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Basel, 9 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has commenced a tender offer for all of the outstanding shares of common stock of Poseida Therapeutics, Inc. (Poseida) (NASDAQ: PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain contingent payments of u...
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08.12.2024
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Five-year results confirm Roche’s Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma
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Basel, 8 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from a five-year follow-up of the pivotal phase III POLARIX study evaluating Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (D...
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05.12.2024
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FDA accepts supplemental Biologics License Application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
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Basel, 5 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diff...
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26.11.2024
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Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies
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Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX), a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies. Based in San Diego, California, Poseida’s R&D portfo...
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26.11.2024
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Roche reports update on Phase III SKYSCRAPER-01 study results
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Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). ...
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05.11.2024
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Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024
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Basel, 05 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US. The data underscore Roche’s commitment to advance patient outcomes in lymphoma...
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31.10.2024
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Roche presents new data at CTAD, demonstrating its growing momentum in diagnostics for Alzheimer’s disease
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Basel, 31 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new late-breaking data on its Elecsys Amyloid Plasma Panel (combination of pTau181 and ApoE4), for Alzheimer’s disease, at the 17th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, Spain. Results show that the test, currently in development, could accuratel...
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31.10.2024
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New England Journal of Medicine publishes landmark phase III results for Roche’s Itovebi, showing more than doubling of progression-free survival in certain type of HR-positive advanced breast cancer
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Basel, 31 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of the positive phase III INAVO120 results, evaluating ItovebiTM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant were published in the New England Journal of Medicine.1 The United States Food and Drug Administration (FDA) rec...
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23.10.2024
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[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong sales growth of 9% (CER) continues in the third quarter of 2024; Group sales increase 6% in the first nine months
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Roche CEO Thomas Schinecker: “Our strong growth momentum continued in the third quarter, reflecting the high demand for our innovative medicines and diagnostic solutions and their positive impact on patients’ lives around the world....
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18.10.2024
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Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study
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Basel, 18 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4...
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11.10.2024
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FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
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Basel, 11 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth...
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10.10.2024
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Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
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Basel, 10 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These...
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26.09.2024
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Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis
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Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis...
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24.09.2024
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Roche launches the first test to use its breakthrough TAGS technology for high throughput, simultaneous detection of 12 respiratory viruses
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Basel, 24 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined wi...
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23.09.2024
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WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s role in pioneering cervical cancer solutions
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Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-posit...
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19.09.2024
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Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses
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Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results of the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infec...
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16.09.2024
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FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis
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Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO is the first and only twi...
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13.09.2024
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FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy
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Basel, 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be inject...
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10.09.2024
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Roche opens Pharma Research and Development Center in Basel to accelerate scientific innovation
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Basel, 10 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the opening of its new Pharma Research and Early Development (pRED) Center at its global headquarters in Basel, Switzerland. Equipped with cutting-edge technologies and housing around 1,000 state-of-the-art laboratory and office workplaces, the new center brings together...
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04.09.2024
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Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression for up to 48 weeks in patients with relapsing multiple sclerosis
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Basel, 04 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new 48-week data for the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib from the Phase II FENopta open-label extension (OLE) study at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen,...
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27.08.2024
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Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
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Basel, 27 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved PiaSky® (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria (PN...
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30.07.2024
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European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion (RVO)
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Basel, 30 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved Vabysmo® (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO). RVO is the third indication for Vabysmo in the European Union, in addition to n...
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29.07.2024
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Roche closes acquisition of LumiraDx’s Point of Care technology to expand access to diagnostic testing in primary care
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Basel, 29 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now embark on the full integration of the company’s innovative multi-assay point of care platform and the related R&a...
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© Globe Newswire
25.07.2024
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[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised
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Roche CEO Thomas Schinecker: “Our strong sales growth in the first half of 2024 reflects the high demand for our innovative medicines and diagnostics. In the second quarter, we saw an acceleration of our growth momentum as Group sales were no longer impacted by the decline in COVID-19 sales, resulting in very strong sales growth for the Group. Base...
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© Globe Newswire
18.07.2024
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New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions
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Basel, 18 July 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively, the two leading causes of vision loss in adults with diabetes.1...
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© Globe Newswire
17.07.2024
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[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase I results of its oral GLP-1 receptor agonist CT-996 for the treatment of people with obesity
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Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity.1 The data showed that treatment...
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© Globe Newswire
09.07.2024
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Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes
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Basel, 09 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the CE Mark for its Accu-Chek SmartGuide® continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin t...
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© Globe Newswire
05.07.2024
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FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss
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Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema fol...
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© Globe Newswire
04.07.2024
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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer
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Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-sq...
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© Globe Newswire
28.06.2024
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Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO)
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Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo® (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retin...
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© Globe Newswire
28.06.2024
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CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
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Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for PiaSky® (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). The CHMP has recommended PiaSky, a novel recycling monoclon...
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© Globe Newswire
27.06.2024
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Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection
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Basel, 27 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after...
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© Globe Newswire
25.06.2024
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Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
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Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same...
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© Globe Newswire
24.06.2024
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Roche launches new analytical units for cobas® pro integrated solutions delivering greater efficiency and capacity to laboratories
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Basel, 24 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cob...
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