Investor updates Keyword Search Clear 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006 Published on: 19 December 2018 Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors more Published on: 19 December 2018 Chugai announed satralizumab receives FDA Breakthrough Therapy Designation for NMOSD more Published on: 19 December 2018 Chugai’s Satralizumab Meets Primary Endpoint in Phase III Monotherapy Study in NMOSD more Published on: 17 December 2018 PRIME designation granted by European Medicines Agency for Roche’s risdiplam for treatment of spinal muscular atrophy (SMA) Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational oral medicine risdiplam (RG7916) for the treatment ... more Published on: 10 December 2018 New member proposed for election to Roche Board of Directors Roche today announced that at its December meeting the Board of Directors (BoD) of Roche Holding Ltd decided on first proposals for approval by the Annual General Meeting (AGM), scheduled for 5 March ... more Published on: 10 December 2018 Changes to the Roche Corporate Executive Committee Roche today announced that Daniel O’Day, CEO Roche Pharmaceuticals and member of the Corporate Executive Committee, will be stepping down from his role as of 31 December 2018. more Published on: 7 December 2018 FDA approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the ... more Published on: 6 December 2018 Chugai Receives Orphan Drug Designation for TECENTRIQ® in Small cell Lung Cancer and for Entrectinib in NTRK Fusion-positive Solid Tumors more Published on: 6 December 2018 Chugai Presents Interim Analysis Data of Phase I/II Study of SKY59, anti-C5 antibody in PNH at ASH more Published on: 5 December 2018 Roche’s Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced that the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or ... more Published on: 5 December 2018 FDA grants priority review to Roche’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® ... more Published on: 4 December 2018 New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia Roche today announced new data from the Venclexta®/Venclyxto® (venetoclax) clinical development programme, including longer-term results from the phase III MURANO study in people with previously ... more Published on: 3 December 2018 Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors Roche today announced data from the primary analysis of the phase III HAVEN 2 study evaluating Hemlibra® (emicizumab) prophylaxis in children younger than 12 years of age with haemophilia A with ... more Published on: 3 December 2018 Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma Roche today announced longer-term data from the phase Ib/II GO29365 study showing that polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate (ADC), in combination with ... more Published on: 27 November 2018 Reminder: Invitation to Roche’s live audio webcast at the 2018 American Society of Hematology’s 60 th Annual Meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 4 December 2018, highlighting the results from important clinical studies which ... more Published on: 26 November 2018 FDA approves the ACTPen for Roche’s Actemra, a single-dose, prefilled autoinjector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra®(tocilizumab) as an additional formulation ... more Published on: 21 November 2018 Roche announces FDA grants Venclexta accelerated approval for people with newly-diagnosed acute myeloid leukaemia or those who are ineligible for intensive induction chemotherapy Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or ... more Published on: 13 November 2018 FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) ... more Published on: 1 November 2018 Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting Roche today announced that new data for its approved and investigational medicines across a range of blood diseases, and including several first-in-class medicines, will be presented at the 60th ... more Published on: 1 November 2018 Invitation to Roche's live audio webcast at the 2018 American Society of Hematology's 60th Annual Meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 4 December 2018, highlighting the results from important clinical studies which ... more Published on: 1 November 2018 Phase III data showed that Venclexta/Venclyxto plus Gazyva/Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities Roche announced today that the randomised phase III CLL14 study, which evaluated fixed-duration Venclexta®/Venclyxto® (venetoclax) in combination with Gazyva®/Gazyvaro® (obinutuzumab) in people with ... more Published on: 1 November 2018 Roche announces EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia Roche today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for the treatment of adult patients with chronic lymphocytic ... more Published on: 29 October 2018 New STAIRWAY study data shows potential for extended durability with Roche’s faricimab in neovascular age-related macular degeneration (nAMD) Roche today announced positive results from the phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of neovascular (“wet”) age-related macular ... more Published on: 24 October 2018 Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza Roche today announced that the US Food and Drug Administration (FDA) has approved Xofluza ™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age ... more Published on: 22 October 2018 Roche’s Alecensa (alectinib) significantly reduced the risk of disease worsening or death as a first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer Roche will today announce results from the phase III ALESIA study, showing that Alecensa® (alectinib) met its primary endpoint of investigator-assessed (INV) progression-free survival (PFS). more Published on: 22 October 2018 Roche’s Tecentriq plus chemotherapy (carboplatin and Abraxane) as an initial treatment helped people with advanced non-squamous non-small cell lung cancer live significantly longer compared to chemotherapy alone Roche today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for ... more Published on: 21 October 2018 Updated data showed that Roche's Tecentriq in combination with Avastin shrank tumours in people with unresectable or advanced hepatocellular carcinoma (HCC) Roche will today present updated data from a Phase Ib study evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable or advanced ... more Published on: 21 October 2018 Roche’s investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours Roche today announced results from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials that showed the investigational personalised medicine ... more Published on: 20 October 2018 Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer Roche today announced positive results from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial ... more Published on: 19 October 2018 FDA approves label update for Roche’s Mabthera/Rituxan (rituximab) in two rare forms of vasculitis Roche announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the MabThera/Rituxan® (rituximab) label to include information on follow up treatment of adult ... more Published on: 17 October 2018 Roche reports very strong growth in the first nine months of 2018 Group sales increase 7% at constant exchange rates and in Swiss francs. Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus, Perjeta, Alecensa and Tecentriq. Diagnostics Division sales ... more Published on: 16 October 2018 Reminder: Invitation to Roche's live audio webcast at the 2018 European Society for Medical Oncology (ESMO) Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 22 October 2018, to discuss key data presented on the Roche Group's oncology ... more Published on: 15 October 2018 Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018 more Published on: 15 October 2018 Roche launches NGS AVENIO Tumor Tissue Analysis Kits for oncology research Roche today announced the global commercial launch of three new next-generation sequencing (NGS) AVENIO Tumor Tissue Analysis Kits – the AVENIO Tumor Tissue Targeted Kit, Expanded Kit and ... more Published on: 15 October 2018 Roche’s Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death ... more Published on: 10 October 2018 Reminder: Invitation to Roche's 9 Months Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 3rd Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Wednesday, October 17th, 2018. more Published on: 10 October 2018 OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis Roche announced today that new OCREVUS® (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from 10 ... more Published on: 9 October 2018 Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress Roche today announced that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for ... more Published on: 4 October 2018 FDA approves Roche’s Hemlibra for haemophilia A without factor VIII inhibitors Roche announced today that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults ... more Published on: 4 October 2018 Invitation to Roche’s live audio webcast at the 2018 European Society for Medical Oncology (ESMO) Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 22 October 2018, to discuss key data presented on the Roche Group’s oncology ... more Published on: 4 October 2018 Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 Roche today announced that the phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time of ... more Published on: 3 October 2018 Roche announces new data for risdiplam in Spinal Muscular Atrophy (SMA) at the World Muscle Society Congress Roche today announced interim clinical data from the dose-finding parts of the pivotal FIREFISH and SUNFISH studies investigating risdiplam (RG7916) in SMA. more Published on: 2 October 2018 Roche to present five-year OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive multiple sclerosis (MS) at ECTRIMS Roche announced today that new data on OCREVUS® (ocrelizumab) in people with relapsing and primary progressive forms of MS will be presented during the 34th Congress of the European Committee for the ... more Published on: 1 October 2018 FDA grants approval of Xolair (omalizumab) prefilled syringe formulation Roche announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional ... more Published on: 25 September 2018 Roche’s Tecentriq in combination with chemotherapy helped people live significantly longer as an initial treatment for people with extensive-stage small cell lung cancer Roche today announced positive results from the Phase III IMpower133 study of Tecentriq® (atezolizumab) plus carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of people ... more Published on: 24 September 2018 Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer Roche today announced results for its investigational medicine entrectinib, from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA trials, which showed that ... more Published on: 24 September 2018 Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer Roche today announced results from the Phase III IMpower132 study of Tecentriq® (atezolizumab) plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) ... more Published on: 24 September 2018 Roche announces global availability of blood-based genomic profiling test, FoundationOne Liquid Roche announced today the global availability of FoundationOne®Liquid, a liquid biopsy test. more Published on: 21 September 2018 CHMP recommends EU approval for subcutaneous formulation of RoActemra for use in active systemic juvenile idiopathic arthritis (sJIA), a rare form of juvenile arthritis Roche announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the subcutaneous (SC) formulation of RoActemra® (tocilizumab) for the ... more Published on: 21 September 2018 Roche announces CHMP recommendation for EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for the ... more Published on: 18 September 2018 Reminder: Invitation to Roche's Virtual Pipeline Event: Key data for Roche's lung cancer portfolio to be presented at the 2018 IASLC World Conference on Lung Cancer We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 25 September 2018, highlighting the results from important clinical studies ... more Published on: 18 September 2018 Roche’s NAVIFY decision support portfolio unlocks relevant content from clinical trial and medical publication databases Roche today announced the launch of the first two NAVIFY® clinical decision support apps: The NAVIFY Clinical Trial Match and NAVIFY Publication Search apps help oncology care teams access relevant ... more Published on: 17 September 2018 Invitation to Roche's 9 Months Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 3rd Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Wednesday, October 17th, 2018. more Published on: 13 September 2018 FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis (sJIA), a rare form of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic ... more Published on: 13 September 2018 Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the tenth year running For the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). more Published on: 7 September 2018 Baloxavir Marboxil Phase II and III Studies for the Treatment of Influenza Published in the New England Journal of Medicine Please find attached a press release by Shionogi & Co., Ltd. more Published on: 6 September 2018 Roche Provides Update on Supplemental Biologics License Application (sBLA) for TECENTRIQ in First-line Metastatic Non-Squamous NSCLC On September 05 2018, Roche was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ® (atezolizumab) ... more Published on: 6 September 2018 Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC) Roche today announced that new data from its broad clinical development programme across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer ... more Published on: 3 September 2018 Reminder: Invitation to Roche's Virtual Late Stage Pipeline Event 2018 We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Thursday, 13 September 2018, highlighting development and commercial opportunities within ... more Published on: 30 August 2018 Positive phase III results for Roche’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine Roche today announced that pivotal data from the phase III HAVEN 3 study, which evaluated Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in adults and adolescents aged ... more Published on: 29 August 2018 Launch of Gazyva for treatment of CD20-positive follicular lymphoma in Japan more Published on: 28 August 2018 Changes to the Roche Corporate Executive Committee Roche today announced that Roland Diggelmann, CEO Diagnostics Division and member of the Corporate Executive Committee, will be leaving Roche to pursue his career outside of the company effective 30 ... more Published on: 22 August 2018 Invitation to Roche's Virtual Pipeline Event: Key data for Roche's lung cancer portfolio to be presented at the 2018 IASLC World Conference on Lung Cancer We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 25 September 2018, highlighting the results from important clinical studies ... more Published on: 20 August 2018 China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer Roche today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma ... more Published on: 13 August 2018 FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following ... more Published on: 3 August 2018 PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for ... more Published on: 31 July 2018 Roche Purchases Shares in Tender Offer for FMI Roche and Foundation Medicine, Inc. (NASDAQ:FMI) today announced that Roche’s wholly owned subsidiary 062018 Merger Subsidiary, Inc. has accepted for payment all shares validly tendered and not ... more Published on: 30 July 2018 Invitation to Roche's Virtual Late Stage Pipeline Event 2018 We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Thursday, 13 September 2018, highlighting development and commercial opportunities within ... more Published on: 27 July 2018 Reminder: Invitation to Roche's Virtual Pipeline Event: Phase 2 LADDER results of the Port Delivery System (PDS) with Lucentis to be presented at the 2018 ASRS annual meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Thursday, 2 August 2018, featuring data from the Phase 2 LADDER study of the Port ... more Published on: 26 July 2018 Roche presents positive phase II results for the first-ever eye implant demonstrating sustained delivery of a biologic medicine to treat people with neovascular age-related macular degeneration Roche announced positive, top-line results from the LADDER study, the first successful phase II study of a long-acting delivery device for the treatment of neovascular (“wet”) age-related macular ... more Published on: 26 July 2018 Roche reports very strong performance in the first half of 2018 In the first half of 2018, Group sales rose 7% to CHF 28.1 billion and core EPS grew 19%. Excluding the effect of the US tax reform, core EPS grew 8%, ahead of sales. Core EPS growth reflects the ... more Published on: 24 July 2018 Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more Published on: 23 July 2018 Roche receives CE Mark for its Accu-Chek Solo micropump system Roche announced today that it has received CE Mark for its Accu Chek® Solo micropump system. more Published on: 20 July 2018 Roche to present new data demonstrating the breadth and depth of its Alzheimer’s programme at the upcoming Alzheimer's Association International Conference Roche announced today that it will present 16 new data presentations from across its Alzheimer’s disease (AD) pipeline at this year’s Alzheimer's Association International Conference (AAIC) from ... more Published on: 20 July 2018 FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer's disease Roche announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in ... more Published on: 19 July 2018 Reminder: Invitation to Roche's Half Year Results 2018, Thursday 26th July 2018 - Live video webcast and conference call Roche will publish its Half Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 26th July 2018. more Published on: 19 July 2018 Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in the initial treatment of people with advanced lung cancer Roche today announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq® (atezolizumab) plus ... more Published on: 18 July 2018 FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC) Roche today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an ... more Published on: 17 July 2018 Chugai to In-license ROS1/TRK Inhibitor Entrectinib more Published on: 17 July 2018 Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more Published on: 17 July 2018 Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu Roche today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary ... more Published on: 12 July 2018 Roche announces submission of supplemental New Drug Application for Venclexta for people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy Roche today announced submission of a supplemental New Drug Application (sNDA) to the United States (U.S.) Food and Drug Administration (FDA) for Venclexta (venetoclax), in combination with a ... more Published on: 11 July 2018 Invitation to Roche's Virtual Pipeline Event: Phase 2 LADDER results of the Port Delivery System (PDS) with Lucentis to be presented at the 2018 ASRS annual meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Thursday, 2 August 2018, featuring data from the Phase 2 LADDER study of the Port ... more Published on: 3 July 2018 Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more Published on: 2 July 2018 Roche commences tender offer for all shares of Foundation Medicine, Inc. for US$ 137.00 per share in cash Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Foundation Medicine, Inc. (NASDAQ: FMI) at a price of US$ 137.00 per share. more Published on: 2 July 2018 Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer Roche today announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival (PFS). more Published on: 29 June 2018 Roche’s RoActemra gains positive CHMP opinion for CAR T-cell-induced cytokine release syndrome Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of RoActemra® (tocilizumab) for the treatment of cytokine ... more Published on: 28 June 2018 Invitation to Roche's Half Year Results 2018, Thursday 26th July 2018 - Live video webcast and conference call Roche will publish its Half Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 26th July 2018. more Published on: 26 June 2018 FDA grants Priority Review to Roche’s baloxavir marboxil for the treatment of influenza Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment ... more Published on: 25 June 2018 Roche’s TECENTRIQ in combination with chemotherapy helped people with previously-untreated extensive-stage small cell lung cancer live significantly longer compared to chemotherapy Roche today announced that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. more Published on: 22 June 2018 Changes to the Roche Enlarged Corporate Executive Committee Roche today announced that Sophie Kornowski-Bonnet, Head of Roche Partnering and member of the enlarged Corporate Executive Committee since 2012, has accepted a new opportunity and will be leaving ... more Published on: 19 June 2018 Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology Roche and Foundation Medicine, Inc. today announced they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of FMI’s common stock not already owned by Roche ... more Published on: 15 June 2018 New long-term data confirm Roche’s Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan Roche today announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which ... more Published on: 14 June 2018 Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis Roche today announced that new OCREVUS (ocrelizumab) data will be presented at the 4th Congress of the European Academy of Neurology (EAN) from 16 June to 19 June in Lisbon, Portugal. more Published on: 13 June 2018 FDA approves Roche’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery Roche today announced that the US Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single ... more Published on: 11 June 2018 Roche announces FDA approval for Venclexta plus Rituxan for people with previously treated chronic lymphocytic leukaemia Roche, announced today that the United States Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic ... more Published on: 8 June 2018 FDA approves Roche’s MabThera/Rituxan (rituximab) for pemphigus vulgaris Roche announced today that the US Food and Drug Administration (FDA) has approved MabThera/Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, ... more Published on: 5 June 2018 Save the date: Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more Published on: 5 June 2018 FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® ... more Published on: 3 June 2018 Roche presents new data across a range of blood cancers at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche presented new data from studies in several blood cancers, including diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukaemia (CLL) and acute myeloid leukaemia (AML) at the 2018 ASCO ... more Published on: 2 June 2018 Phase III IMpower131 study showed Tecentriq(atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death for people with advanced squamous non-small cell lung cancer Roche today announced that results from the Phase III IMpower131 study showed Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) ... more Published on: 1 June 2018 European Commission approves Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence Roche today announced that the European Commission (EC) has approved Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery ... more Published on: 1 June 2018 Roche to present data for TECENTRIQ (atezolizumab) from across its genitourinary and gastrointestinal cancer immunotherapy programme at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that data from across its genitourinary (GU) and gastrointestinal (GI) cancer immunotherapy development programme will be presented during the American Society of Clinical ... more Published on: 29 May 2018 Phase III IMpower130 study showed Roche’s Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane) helped people with metastatic non-squamous NSCLC live significantly longer compared to chemotherapy alone Roche today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). more Published on: 25 May 2018 Reminder: Invitation to Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more Published on: 21 May 2018 Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors Roche today announced full results from the phase III HAVEN 3 study evaluating Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in people with haemophilia A without ... more Published on: 18 May 2018 Reminder: Invitation to Roche’s Virtual Pipeline Event from WFH 2018 World Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Wednesday, 23 May 2018, from the World Federation of Hemophilia (WFH) 2018 World Congress ... more Published on: 17 May 2018 Follow-up phase III data showed Roche’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death Roche today announced follow-up data from the phase III ALEX study, showing that, as an initial treatment, Alecensa® (alectinib) significantly reduced the risk of disease progression or death ... more Published on: 17 May 2018 Phase III IMpower150 study showed Roche’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel Roche today announced positive results from the Phase III IMpower150 study of Tecentriq® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) for the initial ... more Published on: 15 May 2018 FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis (pJIA), a rare form of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile ... more Published on: 14 May 2018 Roche to present new phase III data for Hemlibra in people with haemophilia A at the World Federation of Hemophilia 2018 World Congress Roche today announced that phase III results for Hemlibra® (emicizumab) will be presented for the first time during the World Federation of Hemophilia (WFH) 2018 World Congress from 20-24 May in ... more Published on: 11 May 2018 Invitation to Roche’s Virtual Pipeline Event from WFH 2018 World Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Wednesday, 23 May 2018, from the World Federation of Hemophilia (WFH) 2018 World Congress ... more Published on: 10 May 2018 Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer Roche today announced that the Phase III IMblaze370 study evaluating the combination of Tecentriq® (atezolizumab) and Cotellic® (cobimetinib) did not meet its primary endpoint of overall survival ... more Published on: 8 May 2018 Roche to present new data from its industry-leading oncology portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of ... more Published on: 7 May 2018 FDA grants priority review to Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® ... more Published on: 27 April 2018 CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence Roche today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® ... more Published on: 26 April 2018 Roche reports a strong start in 2018 Group sales increase 6% at constant exchange rates and 5% in Swiss francs. Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus and Perjeta. Diagnostics Division sales grow 5%, with ... more Published on: 25 April 2018 Invitation to Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more Published on: 23 April 2018 New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis Roche announced today that new OCREVUS (ocrelizumab) data were presented at the 70th American Academy of Neurology (AAN) Annual Meeting from 21-27 April in Los Angeles, California. more Published on: 19 April 2018 Reminder: Invitation to Roche’s First Quarter Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Thursday April 26th, 2018. more Published on: 18 April 2018 Launch of Tecentriq in 2L+ NSCLC in Japan more Published on: 17 April 2018 FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors Roche today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII ... more Published on: 16 April 2018 Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline Roche announced today that new data on its approved and investigational medicines for neurological conditions will be presented during the 70th American Academy of Neurology (AAN) Annual Meeting from ... more Published on: 14 April 2018 Roche to present data on TECENTRIQ (Atezolizumab) and data from across its cancer immunotherapy portfolio at the 2018 American Association of Cancer Research (AACR) Annual Meeting Roche today announced that it will present data from across its broad cancer immunotherapy development programme, including approved and investigational medicines, during the American Association for ... more Published on: 6 April 2018 Roche completes acquisition of Flatiron Health Roche today announced that it has completed the acquisition of Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US. Flatiron Health is a ... more Published on: 28 March 2018 Roche announces Japanese court ruled in favour of Chugai in Hemlibra patent litigation Roche today announced that a Japanese court (Tokyo District Court) ruled in favour of Chugai Pharmaceutical Co., Ltd, a member of the Roche Group, in the patent litigation case relating to Hemlibra® ... more Published on: 27 March 2018 Invitation to Roche’s First Quarter Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Thursday April 26th, 2018. more Published on: 26 March 2018 Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel helped people with advanced lung cancer live longer compared to Avastin plus carboplatin and paclitaxel Roche today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the ... more Published on: 22 March 2018 FDA approves Lucentis (ranibizumab injection) 0.3 mg prefilled syringe for diabetic macular edema and diabetic retinopathy Roche today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to ... more Published on: 20 March 2018 Phase III IMpower131 study showed Roche’s TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced squamous lung cancer Roche today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus ... more Published on: 14 March 2018 Save the date: Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more Published on: 13 March 2018 Roche Annual General Meeting 2018 Roche announced today that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). more Published on: 8 March 2018 Changes to the Roche Enlarged Corporate Executive Committee Roche today announced that John C. Reed (1958), MD, PhD, Head of Roche Pharma Research and Early Development (pRED) since 2013, has decided to leave Roche for personal reasons and will return to the ... more Published on: 27 February 2018 European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors Roche today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. more Published on: 15 February 2018 Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer Roche and Flatiron Health, Inc. announced today that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing ... more Published on: 14 February 2018 FDA grants priority review for Roche’s MabThera/ Rituxan (rituximab) for pemphigus vulgaris Roche announced today that the US Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of ... more Published on: 12 February 2018 Phase II data support potential for Roche’s novel anti-VEGF/anti-angiopoietin-2 bispecific antibody, RG7716, for people with diabetic macular edema Roche today announced encouraging results from the Phase II BOULEVARD study. more Published on: 8 February 2018 Roche purchases shares in tender offer for Ignyta, Inc. Roche and Ignyta, Inc. today announced that Roche’s wholly owned subsidiary Abingdon Acquisition Corp., has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its ... more Published on: 6 February 2018 Reminder: Invitation to Roche's Virtual Pipeline Event We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 13 February 2018. more Published on: 6 February 2018 Phase III IMmotion151 study showed Roche's TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer Roche today announced results from the positive Phase III IMmotion151 study of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) as a first-line treatment for advanced or metastatic renal cell ... more Published on: 1 February 2018 Roche reports good results in 2017 Commenting on the Group’s results, Roche CEO Severin Schwan said: “In 2017, we made significant progress with good growth in both divisions driven by newly launched medicines and tests. I am ... more Published on: 29 January 2018 FDA grants Breakthrough Therapy Designation for Roche’s balovaptan in autism spectrum disorder Roche announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational oral medicine balovaptan (previously known as RG7314), a ... more Published on: 26 January 2018 CHMP recommends EU approval of Roche’s Hemlibra for people with haemophilia A with inhibitors Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in ... more Published on: 26 January 2018 Invitation to Roche's Virtual Pipeline Event We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 13 February 2018. more Published on: 24 January 2018 Reminder: Invitation to Roche's Full Year Results 2017 Presentation Roche will publish its Full Year Results for 2017 prior to the opening of the Swiss Stock Exchange on Thursday, 1 February 2018. more Published on: 19 January 2018 TECENTRIQ approved in Japan for the treatment of unresectable, advanced or recurrent NSCLC more Published on: 12 January 2018 Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis Roche announced today that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by ... more Published on: 10 January 2018 Roche commences tender offer for all shares of Ignyta, Inc. for US$ 27.00 per share in cash Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Ignyta, Inc. at a price of US$ 27.00 per share. more Published on: 8 January 2018 Invitation to Roche's Full Year Results 2017 Presentation Roche will publish its Full Year Results for 2017 prior to the opening of the Swiss Stock Exchange on Thursday, 1 February 2018. more Published on: 8 January 2018 Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment Roche announced today that it has entered into a strategic, long-term partnership with GE Healthcare in order to jointly develop and co-market digital clinical decision support solutions. The ... more Published on: 4 January 2018 Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas Roche announced today the launch of the cobas® Plasma Separation Card. This new solution is a stable and easy-to-use sample collection device for HIV plasma viral load testing. By providing a small ... more
Published on: 19 December 2018 Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors more
Published on: 19 December 2018 Chugai announed satralizumab receives FDA Breakthrough Therapy Designation for NMOSD more
Published on: 19 December 2018 Chugai’s Satralizumab Meets Primary Endpoint in Phase III Monotherapy Study in NMOSD more
Published on: 17 December 2018 PRIME designation granted by European Medicines Agency for Roche’s risdiplam for treatment of spinal muscular atrophy (SMA) Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational oral medicine risdiplam (RG7916) for the treatment ... more
Published on: 10 December 2018 New member proposed for election to Roche Board of Directors Roche today announced that at its December meeting the Board of Directors (BoD) of Roche Holding Ltd decided on first proposals for approval by the Annual General Meeting (AGM), scheduled for 5 March ... more
Published on: 10 December 2018 Changes to the Roche Corporate Executive Committee Roche today announced that Daniel O’Day, CEO Roche Pharmaceuticals and member of the Corporate Executive Committee, will be stepping down from his role as of 31 December 2018. more
Published on: 7 December 2018 FDA approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the ... more
Published on: 6 December 2018 Chugai Receives Orphan Drug Designation for TECENTRIQ® in Small cell Lung Cancer and for Entrectinib in NTRK Fusion-positive Solid Tumors more
Published on: 6 December 2018 Chugai Presents Interim Analysis Data of Phase I/II Study of SKY59, anti-C5 antibody in PNH at ASH more
Published on: 5 December 2018 Roche’s Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced that the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or ... more
Published on: 5 December 2018 FDA grants priority review to Roche’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® ... more
Published on: 4 December 2018 New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia Roche today announced new data from the Venclexta®/Venclyxto® (venetoclax) clinical development programme, including longer-term results from the phase III MURANO study in people with previously ... more
Published on: 3 December 2018 Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors Roche today announced data from the primary analysis of the phase III HAVEN 2 study evaluating Hemlibra® (emicizumab) prophylaxis in children younger than 12 years of age with haemophilia A with ... more
Published on: 3 December 2018 Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma Roche today announced longer-term data from the phase Ib/II GO29365 study showing that polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate (ADC), in combination with ... more
Published on: 27 November 2018 Reminder: Invitation to Roche’s live audio webcast at the 2018 American Society of Hematology’s 60 th Annual Meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 4 December 2018, highlighting the results from important clinical studies which ... more
Published on: 26 November 2018 FDA approves the ACTPen for Roche’s Actemra, a single-dose, prefilled autoinjector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra®(tocilizumab) as an additional formulation ... more
Published on: 21 November 2018 Roche announces FDA grants Venclexta accelerated approval for people with newly-diagnosed acute myeloid leukaemia or those who are ineligible for intensive induction chemotherapy Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or ... more
Published on: 13 November 2018 FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) ... more
Published on: 1 November 2018 Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting Roche today announced that new data for its approved and investigational medicines across a range of blood diseases, and including several first-in-class medicines, will be presented at the 60th ... more
Published on: 1 November 2018 Invitation to Roche's live audio webcast at the 2018 American Society of Hematology's 60th Annual Meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 4 December 2018, highlighting the results from important clinical studies which ... more
Published on: 1 November 2018 Phase III data showed that Venclexta/Venclyxto plus Gazyva/Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities Roche announced today that the randomised phase III CLL14 study, which evaluated fixed-duration Venclexta®/Venclyxto® (venetoclax) in combination with Gazyva®/Gazyvaro® (obinutuzumab) in people with ... more
Published on: 1 November 2018 Roche announces EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia Roche today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for the treatment of adult patients with chronic lymphocytic ... more
Published on: 29 October 2018 New STAIRWAY study data shows potential for extended durability with Roche’s faricimab in neovascular age-related macular degeneration (nAMD) Roche today announced positive results from the phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of neovascular (“wet”) age-related macular ... more
Published on: 24 October 2018 Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza Roche today announced that the US Food and Drug Administration (FDA) has approved Xofluza ™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age ... more
Published on: 22 October 2018 Roche’s Alecensa (alectinib) significantly reduced the risk of disease worsening or death as a first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer Roche will today announce results from the phase III ALESIA study, showing that Alecensa® (alectinib) met its primary endpoint of investigator-assessed (INV) progression-free survival (PFS). more
Published on: 22 October 2018 Roche’s Tecentriq plus chemotherapy (carboplatin and Abraxane) as an initial treatment helped people with advanced non-squamous non-small cell lung cancer live significantly longer compared to chemotherapy alone Roche today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for ... more
Published on: 21 October 2018 Updated data showed that Roche's Tecentriq in combination with Avastin shrank tumours in people with unresectable or advanced hepatocellular carcinoma (HCC) Roche will today present updated data from a Phase Ib study evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable or advanced ... more
Published on: 21 October 2018 Roche’s investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours Roche today announced results from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials that showed the investigational personalised medicine ... more
Published on: 20 October 2018 Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer Roche today announced positive results from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial ... more
Published on: 19 October 2018 FDA approves label update for Roche’s Mabthera/Rituxan (rituximab) in two rare forms of vasculitis Roche announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the MabThera/Rituxan® (rituximab) label to include information on follow up treatment of adult ... more
Published on: 17 October 2018 Roche reports very strong growth in the first nine months of 2018 Group sales increase 7% at constant exchange rates and in Swiss francs. Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus, Perjeta, Alecensa and Tecentriq. Diagnostics Division sales ... more
Published on: 16 October 2018 Reminder: Invitation to Roche's live audio webcast at the 2018 European Society for Medical Oncology (ESMO) Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 22 October 2018, to discuss key data presented on the Roche Group's oncology ... more
Published on: 15 October 2018 Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018 more
Published on: 15 October 2018 Roche launches NGS AVENIO Tumor Tissue Analysis Kits for oncology research Roche today announced the global commercial launch of three new next-generation sequencing (NGS) AVENIO Tumor Tissue Analysis Kits – the AVENIO Tumor Tissue Targeted Kit, Expanded Kit and ... more
Published on: 15 October 2018 Roche’s Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death ... more
Published on: 10 October 2018 Reminder: Invitation to Roche's 9 Months Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 3rd Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Wednesday, October 17th, 2018. more
Published on: 10 October 2018 OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis Roche announced today that new OCREVUS® (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from 10 ... more
Published on: 9 October 2018 Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress Roche today announced that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for ... more
Published on: 4 October 2018 FDA approves Roche’s Hemlibra for haemophilia A without factor VIII inhibitors Roche announced today that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults ... more
Published on: 4 October 2018 Invitation to Roche’s live audio webcast at the 2018 European Society for Medical Oncology (ESMO) Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 22 October 2018, to discuss key data presented on the Roche Group’s oncology ... more
Published on: 4 October 2018 Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 Roche today announced that the phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time of ... more
Published on: 3 October 2018 Roche announces new data for risdiplam in Spinal Muscular Atrophy (SMA) at the World Muscle Society Congress Roche today announced interim clinical data from the dose-finding parts of the pivotal FIREFISH and SUNFISH studies investigating risdiplam (RG7916) in SMA. more
Published on: 2 October 2018 Roche to present five-year OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive multiple sclerosis (MS) at ECTRIMS Roche announced today that new data on OCREVUS® (ocrelizumab) in people with relapsing and primary progressive forms of MS will be presented during the 34th Congress of the European Committee for the ... more
Published on: 1 October 2018 FDA grants approval of Xolair (omalizumab) prefilled syringe formulation Roche announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional ... more
Published on: 25 September 2018 Roche’s Tecentriq in combination with chemotherapy helped people live significantly longer as an initial treatment for people with extensive-stage small cell lung cancer Roche today announced positive results from the Phase III IMpower133 study of Tecentriq® (atezolizumab) plus carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of people ... more
Published on: 24 September 2018 Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer Roche today announced results for its investigational medicine entrectinib, from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA trials, which showed that ... more
Published on: 24 September 2018 Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer Roche today announced results from the Phase III IMpower132 study of Tecentriq® (atezolizumab) plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) ... more
Published on: 24 September 2018 Roche announces global availability of blood-based genomic profiling test, FoundationOne Liquid Roche announced today the global availability of FoundationOne®Liquid, a liquid biopsy test. more
Published on: 21 September 2018 CHMP recommends EU approval for subcutaneous formulation of RoActemra for use in active systemic juvenile idiopathic arthritis (sJIA), a rare form of juvenile arthritis Roche announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the subcutaneous (SC) formulation of RoActemra® (tocilizumab) for the ... more
Published on: 21 September 2018 Roche announces CHMP recommendation for EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for the ... more
Published on: 18 September 2018 Reminder: Invitation to Roche's Virtual Pipeline Event: Key data for Roche's lung cancer portfolio to be presented at the 2018 IASLC World Conference on Lung Cancer We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 25 September 2018, highlighting the results from important clinical studies ... more
Published on: 18 September 2018 Roche’s NAVIFY decision support portfolio unlocks relevant content from clinical trial and medical publication databases Roche today announced the launch of the first two NAVIFY® clinical decision support apps: The NAVIFY Clinical Trial Match and NAVIFY Publication Search apps help oncology care teams access relevant ... more
Published on: 17 September 2018 Invitation to Roche's 9 Months Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 3rd Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Wednesday, October 17th, 2018. more
Published on: 13 September 2018 FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis (sJIA), a rare form of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic ... more
Published on: 13 September 2018 Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the tenth year running For the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). more
Published on: 7 September 2018 Baloxavir Marboxil Phase II and III Studies for the Treatment of Influenza Published in the New England Journal of Medicine Please find attached a press release by Shionogi & Co., Ltd. more
Published on: 6 September 2018 Roche Provides Update on Supplemental Biologics License Application (sBLA) for TECENTRIQ in First-line Metastatic Non-Squamous NSCLC On September 05 2018, Roche was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ® (atezolizumab) ... more
Published on: 6 September 2018 Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC) Roche today announced that new data from its broad clinical development programme across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer ... more
Published on: 3 September 2018 Reminder: Invitation to Roche's Virtual Late Stage Pipeline Event 2018 We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Thursday, 13 September 2018, highlighting development and commercial opportunities within ... more
Published on: 30 August 2018 Positive phase III results for Roche’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine Roche today announced that pivotal data from the phase III HAVEN 3 study, which evaluated Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in adults and adolescents aged ... more
Published on: 29 August 2018 Launch of Gazyva for treatment of CD20-positive follicular lymphoma in Japan more
Published on: 28 August 2018 Changes to the Roche Corporate Executive Committee Roche today announced that Roland Diggelmann, CEO Diagnostics Division and member of the Corporate Executive Committee, will be leaving Roche to pursue his career outside of the company effective 30 ... more
Published on: 22 August 2018 Invitation to Roche's Virtual Pipeline Event: Key data for Roche's lung cancer portfolio to be presented at the 2018 IASLC World Conference on Lung Cancer We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 25 September 2018, highlighting the results from important clinical studies ... more
Published on: 20 August 2018 China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer Roche today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma ... more
Published on: 13 August 2018 FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following ... more
Published on: 3 August 2018 PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for ... more
Published on: 31 July 2018 Roche Purchases Shares in Tender Offer for FMI Roche and Foundation Medicine, Inc. (NASDAQ:FMI) today announced that Roche’s wholly owned subsidiary 062018 Merger Subsidiary, Inc. has accepted for payment all shares validly tendered and not ... more
Published on: 30 July 2018 Invitation to Roche's Virtual Late Stage Pipeline Event 2018 We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Thursday, 13 September 2018, highlighting development and commercial opportunities within ... more
Published on: 27 July 2018 Reminder: Invitation to Roche's Virtual Pipeline Event: Phase 2 LADDER results of the Port Delivery System (PDS) with Lucentis to be presented at the 2018 ASRS annual meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Thursday, 2 August 2018, featuring data from the Phase 2 LADDER study of the Port ... more
Published on: 26 July 2018 Roche presents positive phase II results for the first-ever eye implant demonstrating sustained delivery of a biologic medicine to treat people with neovascular age-related macular degeneration Roche announced positive, top-line results from the LADDER study, the first successful phase II study of a long-acting delivery device for the treatment of neovascular (“wet”) age-related macular ... more
Published on: 26 July 2018 Roche reports very strong performance in the first half of 2018 In the first half of 2018, Group sales rose 7% to CHF 28.1 billion and core EPS grew 19%. Excluding the effect of the US tax reform, core EPS grew 8%, ahead of sales. Core EPS growth reflects the ... more
Published on: 24 July 2018 Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more
Published on: 23 July 2018 Roche receives CE Mark for its Accu-Chek Solo micropump system Roche announced today that it has received CE Mark for its Accu Chek® Solo micropump system. more
Published on: 20 July 2018 Roche to present new data demonstrating the breadth and depth of its Alzheimer’s programme at the upcoming Alzheimer's Association International Conference Roche announced today that it will present 16 new data presentations from across its Alzheimer’s disease (AD) pipeline at this year’s Alzheimer's Association International Conference (AAIC) from ... more
Published on: 20 July 2018 FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer's disease Roche announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in ... more
Published on: 19 July 2018 Reminder: Invitation to Roche's Half Year Results 2018, Thursday 26th July 2018 - Live video webcast and conference call Roche will publish its Half Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 26th July 2018. more
Published on: 19 July 2018 Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in the initial treatment of people with advanced lung cancer Roche today announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq® (atezolizumab) plus ... more
Published on: 18 July 2018 FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC) Roche today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an ... more
Published on: 17 July 2018 Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more
Published on: 17 July 2018 Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu Roche today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary ... more
Published on: 12 July 2018 Roche announces submission of supplemental New Drug Application for Venclexta for people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy Roche today announced submission of a supplemental New Drug Application (sNDA) to the United States (U.S.) Food and Drug Administration (FDA) for Venclexta (venetoclax), in combination with a ... more
Published on: 11 July 2018 Invitation to Roche's Virtual Pipeline Event: Phase 2 LADDER results of the Port Delivery System (PDS) with Lucentis to be presented at the 2018 ASRS annual meeting We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Thursday, 2 August 2018, featuring data from the Phase 2 LADDER study of the Port ... more
Published on: 3 July 2018 Invitation to Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche's Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more
Published on: 2 July 2018 Roche commences tender offer for all shares of Foundation Medicine, Inc. for US$ 137.00 per share in cash Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Foundation Medicine, Inc. (NASDAQ: FMI) at a price of US$ 137.00 per share. more
Published on: 2 July 2018 Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer Roche today announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival (PFS). more
Published on: 29 June 2018 Roche’s RoActemra gains positive CHMP opinion for CAR T-cell-induced cytokine release syndrome Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of RoActemra® (tocilizumab) for the treatment of cytokine ... more
Published on: 28 June 2018 Invitation to Roche's Half Year Results 2018, Thursday 26th July 2018 - Live video webcast and conference call Roche will publish its Half Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 26th July 2018. more
Published on: 26 June 2018 FDA grants Priority Review to Roche’s baloxavir marboxil for the treatment of influenza Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment ... more
Published on: 25 June 2018 Roche’s TECENTRIQ in combination with chemotherapy helped people with previously-untreated extensive-stage small cell lung cancer live significantly longer compared to chemotherapy Roche today announced that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. more
Published on: 22 June 2018 Changes to the Roche Enlarged Corporate Executive Committee Roche today announced that Sophie Kornowski-Bonnet, Head of Roche Partnering and member of the enlarged Corporate Executive Committee since 2012, has accepted a new opportunity and will be leaving ... more
Published on: 19 June 2018 Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology Roche and Foundation Medicine, Inc. today announced they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of FMI’s common stock not already owned by Roche ... more
Published on: 15 June 2018 New long-term data confirm Roche’s Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan Roche today announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which ... more
Published on: 14 June 2018 Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis Roche today announced that new OCREVUS (ocrelizumab) data will be presented at the 4th Congress of the European Academy of Neurology (EAN) from 16 June to 19 June in Lisbon, Portugal. more
Published on: 13 June 2018 FDA approves Roche’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery Roche today announced that the US Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single ... more
Published on: 11 June 2018 Roche announces FDA approval for Venclexta plus Rituxan for people with previously treated chronic lymphocytic leukaemia Roche, announced today that the United States Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic ... more
Published on: 8 June 2018 FDA approves Roche’s MabThera/Rituxan (rituximab) for pemphigus vulgaris Roche announced today that the US Food and Drug Administration (FDA) has approved MabThera/Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, ... more
Published on: 5 June 2018 Save the date: Roche Analyst Event on Diagnostics Division at AACC 2018 We are pleased to invite you to an analyst event on Tuesday, 31st July 2018 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ... more
Published on: 5 June 2018 FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® ... more
Published on: 3 June 2018 Roche presents new data across a range of blood cancers at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche presented new data from studies in several blood cancers, including diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukaemia (CLL) and acute myeloid leukaemia (AML) at the 2018 ASCO ... more
Published on: 2 June 2018 Phase III IMpower131 study showed Tecentriq(atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death for people with advanced squamous non-small cell lung cancer Roche today announced that results from the Phase III IMpower131 study showed Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) ... more
Published on: 1 June 2018 European Commission approves Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence Roche today announced that the European Commission (EC) has approved Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery ... more
Published on: 1 June 2018 Roche to present data for TECENTRIQ (atezolizumab) from across its genitourinary and gastrointestinal cancer immunotherapy programme at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that data from across its genitourinary (GU) and gastrointestinal (GI) cancer immunotherapy development programme will be presented during the American Society of Clinical ... more
Published on: 29 May 2018 Phase III IMpower130 study showed Roche’s Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane) helped people with metastatic non-squamous NSCLC live significantly longer compared to chemotherapy alone Roche today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). more
Published on: 25 May 2018 Reminder: Invitation to Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more
Published on: 21 May 2018 Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors Roche today announced full results from the phase III HAVEN 3 study evaluating Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in people with haemophilia A without ... more
Published on: 18 May 2018 Reminder: Invitation to Roche’s Virtual Pipeline Event from WFH 2018 World Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Wednesday, 23 May 2018, from the World Federation of Hemophilia (WFH) 2018 World Congress ... more
Published on: 17 May 2018 Follow-up phase III data showed Roche’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death Roche today announced follow-up data from the phase III ALEX study, showing that, as an initial treatment, Alecensa® (alectinib) significantly reduced the risk of disease progression or death ... more
Published on: 17 May 2018 Phase III IMpower150 study showed Roche’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel Roche today announced positive results from the Phase III IMpower150 study of Tecentriq® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) for the initial ... more
Published on: 15 May 2018 FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis (pJIA), a rare form of juvenile arthritis Roche announced today that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile ... more
Published on: 14 May 2018 Roche to present new phase III data for Hemlibra in people with haemophilia A at the World Federation of Hemophilia 2018 World Congress Roche today announced that phase III results for Hemlibra® (emicizumab) will be presented for the first time during the World Federation of Hemophilia (WFH) 2018 World Congress from 20-24 May in ... more
Published on: 11 May 2018 Invitation to Roche’s Virtual Pipeline Event from WFH 2018 World Congress We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Wednesday, 23 May 2018, from the World Federation of Hemophilia (WFH) 2018 World Congress ... more
Published on: 10 May 2018 Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer Roche today announced that the Phase III IMblaze370 study evaluating the combination of Tecentriq® (atezolizumab) and Cotellic® (cobimetinib) did not meet its primary endpoint of overall survival ... more
Published on: 8 May 2018 Roche to present new data from its industry-leading oncology portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of ... more
Published on: 7 May 2018 FDA grants priority review to Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® ... more
Published on: 27 April 2018 CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence Roche today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® ... more
Published on: 26 April 2018 Roche reports a strong start in 2018 Group sales increase 6% at constant exchange rates and 5% in Swiss francs. Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus and Perjeta. Diagnostics Division sales grow 5%, with ... more
Published on: 25 April 2018 Invitation to Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more
Published on: 23 April 2018 New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis Roche announced today that new OCREVUS (ocrelizumab) data were presented at the 70th American Academy of Neurology (AAN) Annual Meeting from 21-27 April in Los Angeles, California. more
Published on: 19 April 2018 Reminder: Invitation to Roche’s First Quarter Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Thursday April 26th, 2018. more
Published on: 17 April 2018 FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors Roche today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII ... more
Published on: 16 April 2018 Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline Roche announced today that new data on its approved and investigational medicines for neurological conditions will be presented during the 70th American Academy of Neurology (AAN) Annual Meeting from ... more
Published on: 14 April 2018 Roche to present data on TECENTRIQ (Atezolizumab) and data from across its cancer immunotherapy portfolio at the 2018 American Association of Cancer Research (AACR) Annual Meeting Roche today announced that it will present data from across its broad cancer immunotherapy development programme, including approved and investigational medicines, during the American Association for ... more
Published on: 6 April 2018 Roche completes acquisition of Flatiron Health Roche today announced that it has completed the acquisition of Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US. Flatiron Health is a ... more
Published on: 28 March 2018 Roche announces Japanese court ruled in favour of Chugai in Hemlibra patent litigation Roche today announced that a Japanese court (Tokyo District Court) ruled in favour of Chugai Pharmaceutical Co., Ltd, a member of the Roche Group, in the patent litigation case relating to Hemlibra® ... more
Published on: 27 March 2018 Invitation to Roche’s First Quarter Sales 2018 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2018 prior to the opening of the Swiss Stock Exchange on Thursday April 26th, 2018. more
Published on: 26 March 2018 Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel helped people with advanced lung cancer live longer compared to Avastin plus carboplatin and paclitaxel Roche today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the ... more
Published on: 22 March 2018 FDA approves Lucentis (ranibizumab injection) 0.3 mg prefilled syringe for diabetic macular edema and diabetic retinopathy Roche today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to ... more
Published on: 20 March 2018 Phase III IMpower131 study showed Roche’s TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced squamous lung cancer Roche today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus ... more
Published on: 14 March 2018 Save the date: Roche Analyst Event at ASCO 2018 We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ... more
Published on: 13 March 2018 Roche Annual General Meeting 2018 Roche announced today that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). more
Published on: 8 March 2018 Changes to the Roche Enlarged Corporate Executive Committee Roche today announced that John C. Reed (1958), MD, PhD, Head of Roche Pharma Research and Early Development (pRED) since 2013, has decided to leave Roche for personal reasons and will return to the ... more
Published on: 27 February 2018 European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors Roche today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. more
Published on: 15 February 2018 Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer Roche and Flatiron Health, Inc. announced today that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing ... more
Published on: 14 February 2018 FDA grants priority review for Roche’s MabThera/ Rituxan (rituximab) for pemphigus vulgaris Roche announced today that the US Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of ... more
Published on: 12 February 2018 Phase II data support potential for Roche’s novel anti-VEGF/anti-angiopoietin-2 bispecific antibody, RG7716, for people with diabetic macular edema Roche today announced encouraging results from the Phase II BOULEVARD study. more
Published on: 8 February 2018 Roche purchases shares in tender offer for Ignyta, Inc. Roche and Ignyta, Inc. today announced that Roche’s wholly owned subsidiary Abingdon Acquisition Corp., has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its ... more
Published on: 6 February 2018 Reminder: Invitation to Roche's Virtual Pipeline Event We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 13 February 2018. more
Published on: 6 February 2018 Phase III IMmotion151 study showed Roche's TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer Roche today announced results from the positive Phase III IMmotion151 study of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) as a first-line treatment for advanced or metastatic renal cell ... more
Published on: 1 February 2018 Roche reports good results in 2017 Commenting on the Group’s results, Roche CEO Severin Schwan said: “In 2017, we made significant progress with good growth in both divisions driven by newly launched medicines and tests. I am ... more
Published on: 29 January 2018 FDA grants Breakthrough Therapy Designation for Roche’s balovaptan in autism spectrum disorder Roche announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational oral medicine balovaptan (previously known as RG7314), a ... more
Published on: 26 January 2018 CHMP recommends EU approval of Roche’s Hemlibra for people with haemophilia A with inhibitors Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in ... more
Published on: 26 January 2018 Invitation to Roche's Virtual Pipeline Event We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 13 February 2018. more
Published on: 24 January 2018 Reminder: Invitation to Roche's Full Year Results 2017 Presentation Roche will publish its Full Year Results for 2017 prior to the opening of the Swiss Stock Exchange on Thursday, 1 February 2018. more
Published on: 19 January 2018 TECENTRIQ approved in Japan for the treatment of unresectable, advanced or recurrent NSCLC more
Published on: 12 January 2018 Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis Roche announced today that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by ... more
Published on: 10 January 2018 Roche commences tender offer for all shares of Ignyta, Inc. for US$ 27.00 per share in cash Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Ignyta, Inc. at a price of US$ 27.00 per share. more
Published on: 8 January 2018 Invitation to Roche's Full Year Results 2017 Presentation Roche will publish its Full Year Results for 2017 prior to the opening of the Swiss Stock Exchange on Thursday, 1 February 2018. more
Published on: 8 January 2018 Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment Roche announced today that it has entered into a strategic, long-term partnership with GE Healthcare in order to jointly develop and co-market digital clinical decision support solutions. The ... more
Published on: 4 January 2018 Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas Roche announced today the launch of the cobas® Plasma Separation Card. This new solution is a stable and easy-to-use sample collection device for HIV plasma viral load testing. By providing a small ... more