Investor updates Suchbegriff Suchen Löschen 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 Published on: 18 September 2019 FDA grants Breakthrough Therapy Designation for Roche’s Gazyva (obinutuzumab) in Lupus Nephritis Roche today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for adults with lupus nephritis. mehr Published on: 16 September 2019 Roche zum elften Mal in Folge als eines der nachhaltigsten Gesundheitsunternehmen im Dow Jones Sustainability Index ausgezeichnet Roche wurde erneut zu einem der nachhaltigsten Unternehmen innerhalb der Pharmabranche im Dow Jones Sustainability Index (DJSI) gekürt. mehr Published on: 16 September 2019 Roche receives FDA clearance for cobas pro integrated solutions designed to help labs deliver faster results to patients Roche Diagnostics announced today that the US Food and Drug Administration (FDA) has cleared its cobas pro® integrated solutions, a new generation of Serum Work Area (clinical chemistry and ... mehr Published on: 13 September 2019 Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis Roche today announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously ... mehr Published on: 13 September 2019 Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer Roche today announced the phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), ... mehr Published on: 12 September 2019 Roche’s satralizumab significantly reduced relapse risk in second positive phase III study for neuromyelitis optica spectrum Roche presented today full pivotal phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. mehr Published on: 12 September 2019 Roche’s Tecentriq as a first-line monotherapy helped certain people with advanced non-small cell lung cancer live longer compared with chemotherapy Roche today announced positive data from the Phase III IMpower110 study evaluating Tecentriq® (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and ... mehr Published on: 11 September 2019 Reminder: Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr Published on: 10 September 2019 Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS Roche today announced new data from OCREVUS® (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS). mehr Published on: 6 September 2019 European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer Roche today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the ... mehr Published on: 6 September 2019 European Commission approves Roche’s new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer Roche today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® ... mehr Published on: 4 September 2019 Reminder: Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr Published on: 4 September 2019 Roche to present pivotal data for satralizumab in neuromyelitis optica spectrum disorder and six-year OCREVUS data in multiple sclerosis at ECTRIMS Roche announced today that new data across its neuroscience portfolio will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from ... mehr Published on: 3 September 2019 Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common ... mehr Published on: 2 September 2019 Positive phase III results show Xofluza reduces risk of developing flu after contact with an infected person by 86% Roche today announced that the phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk ... mehr Published on: 2 September 2019 Roche presents positive phase III study results for one-dose Xofluza in children with flu Roche today announced that the phase III MINISTONE-2 study showed that one-dose XofluzaTM (baloxavir marboxil) was a well-tolerated and effective potential treatment for flu in otherwise healthy ... mehr Published on: 29 August 2019 Roche launches VENTANA PD-L1 (SP142) Assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq Roche today announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer ... mehr Published on: 29 August 2019 European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); ... mehr Published on: 22 August 2019 Tecentriq, an Anti-PD-L1 Antibody, Receives Approval for Additional Indication of Extensive-Stage Small Cell Lung Cancer mehr Published on: 16 August 2019 FDA approves Roche’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours Roche today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). mehr Published on: 5 August 2019 Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr Published on: 5 August 2019 Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer Roche today announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS). mehr Published on: 31 Juli 2019 Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding ... mehr Published on: 26 Juli 2019 Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with ... mehr Published on: 26 Juli 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with ... mehr Published on: 25 Juli 2019 Roche reports very strong performance in the first half of 2019 – Outlook raised Group sales increase 9% at constant exchange rates and 8% in Swiss francs mehr Published on: 22 Juli 2019 Roche erweitert globales Zugangsprogramm über HIV hinaus auf diagnostische Tests für Tuberkulose, Hepatitis und humanes Papillomavirus Roche gab heute bekannt, dass ihr globales Zugangsprogramm über HIV hinaus ausgeweitet wird auf Mycobacterium tuberculosis (MTB), Hepatitis B und C (HBV und HCV) sowie humanes Papillomavirus (HPV). mehr Published on: 19 Juli 2019 Reminder: Invitation to Roche’s Half Year Results 2019 Thursday, 25 July 2019 – Live video webcast and conference call Roche will publish its Half Year Results for 2019 prior to the opening of the Swiss Stock Exchange on Thursday, 25th July 2019. mehr Published on: 9 Juli 2019 Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress Roche today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on ... mehr Published on: 3 Juli 2019 Roche announces positive results for first global phase III study investigating one-dose Xofluza (baloxavir marboxil) in children with flu Roche today announced that the phase III MINISTONE-2 study met its primary endpoint, demonstrating that XofluzaTM (baloxavir marboxil) was well tolerated in children with flu. mehr Published on: 28 Juni 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy ... mehr Published on: 27 Juni 2019 Chugai Obtains Approval of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic for Rozlytrek mehr Published on: 27 Juni 2019 Invitation to Roche’s Half Year Results 2019 Thursday, 25 July 2019 – Live video webcast and conference call Roche will publish its Half Year Results for 2019 prior to the opening of the Swiss Stock Exchange on Thursday, 25th July 2019. mehr Published on: 18 Juni 2019 Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek Roche today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine ... mehr Published on: 13 Juni 2019 Phase III PEMPHIX study showed that Roche’s Mabthera/Rituxan (rituximab) is superior to standard of care in achieving sustained remission in patients with pemphigus vulgaris Roche today announced positive topline results from the Roche-sponsored phase III PEMPHIX study, evaluating the efficacy and safety of MabThera®/Rituxan® (rituximab) compared to mycophenolate mofetil ... mehr Published on: 12 Juni 2019 FDA grants priority review to Roche’s Mabthera/Rituxan (rituximab) in children with two rare blood vessel disorders 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 ... mehr Published on: 11 Juni 2019 Roche’s Gazyva (obinutuzumab) delivers positive topline results for phase II lupus nephritis study Roche today announced positive topline results for NOBILITY, a phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. mehr Published on: 11 Juni 2019 FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) ... mehr Published on: 11 Juni 2019 Änderungen im Verwaltungsrat und in der Konzernleitung von Roche Roche gab heute bekannt, dass sich Peter Voser (61), seit 2011 Mitglied des Verwaltungsrates der Roche Holding AG, entschieden hat, aufgrund seiner zusätzlichen Aufgabe als interimistischer CEO von ... mehr Published on: 10 Juni 2019 Roche and Spark Therapeutics, Inc. receive Request for Additional Information from FTC under Hart-Scott-Rodino Act and announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that they have each received a request for additional information and documentary material (the “Second Request”) from the U.S. Federal ... mehr Published on: 7 Juni 2019 Save the date: Roche Pharma Day - Monday, 16 September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16 September 2019, starting at 9:30am local time. mehr Published on: 4 Juni 2019 Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine Roche today announced results from the pivotal phase III CLL14 study in previously untreated chronic lymphocytic leukaemia (CLL) showing that Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® ... mehr Published on: 4 Juni 2019 Phase III study showed Xofluza (baloxavir marboxil) is effective at preventing influenza infection Roche today announced that the phase III BLOCKSTONE study, conducted by Shionogi & Co., Ltd., met its primary endpoint showing that people exposed to a household member with influenza (flu) and ... mehr Published on: 3 Juni 2019 Chugai Launches Genomic Mutation Analysis Program mehr Published on: 3 Juni 2019 Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies Roche today announced positive topline data from two Phase III multicenter studies evaluating Xolair® (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) ... mehr Published on: 3 Juni 2019 Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting Roche presents new and updated results from a number of abstracts highlighting studies including the treatment of both PD-L1-positive triple-negative and HER2-positive breast cancer at the 2019 ASCO ... mehr Published on: 2 Juni 2019 Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer shows positive data in those with liver metastases Roche today announced positive additional results of a prespecified exploratory analysis from the Phase III IMpower150 study, which demonstrated that the combination of Tecentriq® (atezolizumab), ... mehr Published on: 31 Mai 2019 Roche and GE Healthcare launch NAVIFY Tumor Board with medical imaging capabilities to enable more personalised treatment decisions in cancer care Roche announced today the release of NAVIFY Tumor Board 2.0, the first collaboration product from our partnership with GE Healthcare. mehr Published on: 23 Mai 2019 Reminder: Invitation to Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr Published on: 16 Mai 2019 Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia Roche today announced that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously ... mehr Published on: 16 Mai 2019 Roche’s personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents Roche today announced positive data from the Phase I/II STARTRK-NG study, evaluating the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours ... mehr Published on: 14 Mai 2019 New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting antimicrobial resistance within the world’s leading cause of infectious disease deaths Roche today announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. mehr Published on: 14 Mai 2019 Roche and Spark Therapeutics, Inc. announce expected refiling date of Premerger Notification and Report Forms under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche and Spark intend to refile on or about 23 May 2019 their respective Premerger Notification and Report Forms under the ... mehr Published on: 10 Mai 2019 Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 ... mehr Published on: 8 Mai 2019 Roche stellt am AAN-Kongress neue Daten zu OCREVUS (Ocrelizumab) vor, die bei schubförmiger und primär progredienter MS eine signifikante Abnahme des Fortschreitens der Erkrankung belegen Roche gab heute bekannt, dass an der 71. Jahrestagung der Academy of Neurology (AAN) vom 4. bis 10. Mai in Philadelphia, Pennsylvania, neue Daten zu OCREVUS® (Ocrelizumab) bei schubförmiger und ... mehr Published on: 7 Mai 2019 Roche presents data from the risdiplam pivotal FIREFISH and SUNFISH studies in spinal muscular atrophy at the 2019 AAN Annual Meeting Roche today announced new data from the dose-finding Part 1 of the pivotal FIREFISH trial showing infants with Type 1 spinal muscular atrophy (SMA) achieved key motor milestones after one year of ... mehr Published on: 6 Mai 2019 Reminder: Invitation to Roche's live audio webcast on data presented at AAN 2019 - 13 May 2019 We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 13 May 2019, highlighting Roche data presented at the American Academy of ... mehr Published on: 6 Mai 2019 FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment Roche today announced that the US Food and Drug Administration (FDA) has approved Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast ... mehr Published on: 29 April 2019 Invitation to Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr Published on: 29 April 2019 New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio Roche today announced new data for its approved and investigational medicines for the treatment of neurological conditions will be presented at the 71st American Academy of Neurology (AAN) Annual ... mehr Published on: 26 April 2019 Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Act (the “HSR Act”) in ... mehr Published on: 23 April 2019 Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy Roche today announced the launch of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer. mehr Published on: 17 April 2019 Roche reports a strong start in 2019 and raises the outlook for the full-year Group sales increase 8% at constant exchange rates and 9% in Swiss francs Pharmaceuticals Division sales up 10%, driven mainly by Ocrevus, Perjeta, Hemlibra and Tecentriq Diagnostics Division sales ... mehr Published on: 11 April 2019 Reminder: Invitation to Roche's First Quarter Sales 2019 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2019 prior to the opening of the Swiss Stock Exchange on Wednesday, April 17th, 2019 mehr Published on: 3 April 2019 Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Act (the “HSR Act”) in connection with ... mehr Published on: 1 April 2019 Invitation to Roche's live audio webcast on data presented at AAN 2019 - 13 May 2019 We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 13 May 2019, highlighting Roche data presented at the American Academy of ... mehr Published on: 1 April 2019 Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial Roche will today present the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel or ... mehr Published on: 19 März 2019 FDA approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer Roche today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) ... mehr Published on: 18 März 2019 Invitation to Roche's First Quarter Sales 2019 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2019 prior to the opening of the Swiss Stock Exchange on Wednesday, April 17th, 2019 mehr Published on: 18 März 2019 Roche to present results of the largest safety study of its kind with Tecentriq (atezolizumab) in patients with metastatic bladder cancer Roche today announced first results from SAUL, a Phase IIIb study evaluating the safety of Tecentriq® in approximately 1000 patients with locally advanced or metastatic urothelial carcinoma (mUC) ... mehr Published on: 15 März 2019 European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease Roche today announced that the European Commission has approved MabThera® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by ... mehr Published on: 14 März 2019 European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors Roche today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII ... mehr Published on: 11 März 2019 Roche’s VENTANA PD-L1 (SP142) Assay approved as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq in combination with Abraxane Roche today announced US Food and Drug Administration approval of the VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients ... mehr Published on: 11 März 2019 FDA grants Roche’s Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for ... mehr Published on: 8 März 2019 European Commission 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 European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and ... mehr Published on: 7 März 2019 Roche commences tender offer for all shares of Spark Therapeutics, Inc. for US$ 114.50 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 Spark Therapeutics, Inc. (NASDAQ: ONCE) at a price of US$ 114.50 per share. mehr Published on: 7 März 2019 Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions Roche today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in ... mehr Published on: 6 März 2019 FDA accepts Roche’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications Roche today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) as a single-dose, oral ... mehr Published on: 5 März 2019 Roche Generalversammlung 2019 Roche gab heute bekannt, dass ihre ordentliche Generalversammlung allen Anträgen des Verwaltungsrates zugestimmt hat. Die anwesenden 840 Aktionärinnen und Aktionäre, die 86.73% der total 160'000'000 ... mehr Published on: 4 März 2019 Save the date: Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr Published on: 28 Februar 2019 FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers Roche today announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment ... mehr Published on: 25 Februar 2019 Roche und Spark Therapeutics schliessen verbindliche Übernahmevereinbarung Roche und Spark Therapeutics, Inc. (NASDAQ: ONCE) gaben heute den Abschluss einer verbindlichen Übernahmevereinbarung bekannt. Roche übernimmt Spark Therapeutics vollständig in einer reinen ... mehr Published on: 19 Februar 2019 FDA grants Priority Review to Roche’s personalised medicine entrectinib Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and ... mehr Published on: 19 Februar 2019 FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in ... mehr Published on: 5 Februar 2019 Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla® (trastuzumab emtansine) for adjuvant (after ... mehr Published on: 1 Februar 2019 CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII 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 adults ... mehr Published on: 1 Februar 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with ... mehr Published on: 31 Januar 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs mehr Published on: 30 Januar 2019 Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) - other company programmes in AD continue - Roche today announced the decision to discontinue CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early ... mehr Published on: 23 Januar 2019 Reminder: Invitation to Roche's Full Year Results 2018 Presentation Roche will publish its Full Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 31 January 2019. mehr Published on: 17 Januar 2019 FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-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) for Tecentriq® (atezolizumab) in combination with ... mehr Published on: 7 Januar 2019 Invitation to Roche's Full Year Results 2018 Presentation Roche will publish its Full Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 31 January 2019. mehr
Published on: 18 September 2019 FDA grants Breakthrough Therapy Designation for Roche’s Gazyva (obinutuzumab) in Lupus Nephritis Roche today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for adults with lupus nephritis. mehr
Published on: 16 September 2019 Roche zum elften Mal in Folge als eines der nachhaltigsten Gesundheitsunternehmen im Dow Jones Sustainability Index ausgezeichnet Roche wurde erneut zu einem der nachhaltigsten Unternehmen innerhalb der Pharmabranche im Dow Jones Sustainability Index (DJSI) gekürt. mehr
Published on: 16 September 2019 Roche receives FDA clearance for cobas pro integrated solutions designed to help labs deliver faster results to patients Roche Diagnostics announced today that the US Food and Drug Administration (FDA) has cleared its cobas pro® integrated solutions, a new generation of Serum Work Area (clinical chemistry and ... mehr
Published on: 13 September 2019 Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis Roche today announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously ... mehr
Published on: 13 September 2019 Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer Roche today announced the phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), ... mehr
Published on: 12 September 2019 Roche’s satralizumab significantly reduced relapse risk in second positive phase III study for neuromyelitis optica spectrum Roche presented today full pivotal phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. mehr
Published on: 12 September 2019 Roche’s Tecentriq as a first-line monotherapy helped certain people with advanced non-small cell lung cancer live longer compared with chemotherapy Roche today announced positive data from the Phase III IMpower110 study evaluating Tecentriq® (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and ... mehr
Published on: 11 September 2019 Reminder: Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr
Published on: 10 September 2019 Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS Roche today announced new data from OCREVUS® (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS). mehr
Published on: 6 September 2019 European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer Roche today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the ... mehr
Published on: 6 September 2019 European Commission approves Roche’s new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer Roche today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® ... mehr
Published on: 4 September 2019 Reminder: Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr
Published on: 4 September 2019 Roche to present pivotal data for satralizumab in neuromyelitis optica spectrum disorder and six-year OCREVUS data in multiple sclerosis at ECTRIMS Roche announced today that new data across its neuroscience portfolio will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from ... mehr
Published on: 3 September 2019 Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common ... mehr
Published on: 2 September 2019 Positive phase III results show Xofluza reduces risk of developing flu after contact with an infected person by 86% Roche today announced that the phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk ... mehr
Published on: 2 September 2019 Roche presents positive phase III study results for one-dose Xofluza in children with flu Roche today announced that the phase III MINISTONE-2 study showed that one-dose XofluzaTM (baloxavir marboxil) was a well-tolerated and effective potential treatment for flu in otherwise healthy ... mehr
Published on: 29 August 2019 Roche launches VENTANA PD-L1 (SP142) Assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq Roche today announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer ... mehr
Published on: 29 August 2019 European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); ... mehr
Published on: 22 August 2019 Tecentriq, an Anti-PD-L1 Antibody, Receives Approval for Additional Indication of Extensive-Stage Small Cell Lung Cancer mehr
Published on: 16 August 2019 FDA approves Roche’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours Roche today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). mehr
Published on: 5 August 2019 Invitation to Roche’s Pharma Day - Monday, 16th September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16th September 2019, starting at 9:30am local time. mehr
Published on: 5 August 2019 Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer Roche today announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS). mehr
Published on: 31 Juli 2019 Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding ... mehr
Published on: 26 Juli 2019 Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with ... mehr
Published on: 26 Juli 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with ... mehr
Published on: 25 Juli 2019 Roche reports very strong performance in the first half of 2019 – Outlook raised Group sales increase 9% at constant exchange rates and 8% in Swiss francs mehr
Published on: 22 Juli 2019 Roche erweitert globales Zugangsprogramm über HIV hinaus auf diagnostische Tests für Tuberkulose, Hepatitis und humanes Papillomavirus Roche gab heute bekannt, dass ihr globales Zugangsprogramm über HIV hinaus ausgeweitet wird auf Mycobacterium tuberculosis (MTB), Hepatitis B und C (HBV und HCV) sowie humanes Papillomavirus (HPV). mehr
Published on: 19 Juli 2019 Reminder: Invitation to Roche’s Half Year Results 2019 Thursday, 25 July 2019 – Live video webcast and conference call Roche will publish its Half Year Results for 2019 prior to the opening of the Swiss Stock Exchange on Thursday, 25th July 2019. mehr
Published on: 9 Juli 2019 Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress Roche today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on ... mehr
Published on: 3 Juli 2019 Roche announces positive results for first global phase III study investigating one-dose Xofluza (baloxavir marboxil) in children with flu Roche today announced that the phase III MINISTONE-2 study met its primary endpoint, demonstrating that XofluzaTM (baloxavir marboxil) was well tolerated in children with flu. mehr
Published on: 28 Juni 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy ... mehr
Published on: 27 Juni 2019 Chugai Obtains Approval of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic for Rozlytrek mehr
Published on: 27 Juni 2019 Invitation to Roche’s Half Year Results 2019 Thursday, 25 July 2019 – Live video webcast and conference call Roche will publish its Half Year Results for 2019 prior to the opening of the Swiss Stock Exchange on Thursday, 25th July 2019. mehr
Published on: 18 Juni 2019 Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek Roche today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine ... mehr
Published on: 13 Juni 2019 Phase III PEMPHIX study showed that Roche’s Mabthera/Rituxan (rituximab) is superior to standard of care in achieving sustained remission in patients with pemphigus vulgaris Roche today announced positive topline results from the Roche-sponsored phase III PEMPHIX study, evaluating the efficacy and safety of MabThera®/Rituxan® (rituximab) compared to mycophenolate mofetil ... mehr
Published on: 12 Juni 2019 FDA grants priority review to Roche’s Mabthera/Rituxan (rituximab) in children with two rare blood vessel disorders 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 ... mehr
Published on: 11 Juni 2019 Roche’s Gazyva (obinutuzumab) delivers positive topline results for phase II lupus nephritis study Roche today announced positive topline results for NOBILITY, a phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. mehr
Published on: 11 Juni 2019 FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) ... mehr
Published on: 11 Juni 2019 Änderungen im Verwaltungsrat und in der Konzernleitung von Roche Roche gab heute bekannt, dass sich Peter Voser (61), seit 2011 Mitglied des Verwaltungsrates der Roche Holding AG, entschieden hat, aufgrund seiner zusätzlichen Aufgabe als interimistischer CEO von ... mehr
Published on: 10 Juni 2019 Roche and Spark Therapeutics, Inc. receive Request for Additional Information from FTC under Hart-Scott-Rodino Act and announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that they have each received a request for additional information and documentary material (the “Second Request”) from the U.S. Federal ... mehr
Published on: 7 Juni 2019 Save the date: Roche Pharma Day - Monday, 16 September 2019 The Roche Investor Relations team would like to invite you to the Roche Pharma Day that will take place in London on Monday, 16 September 2019, starting at 9:30am local time. mehr
Published on: 4 Juni 2019 Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine Roche today announced results from the pivotal phase III CLL14 study in previously untreated chronic lymphocytic leukaemia (CLL) showing that Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® ... mehr
Published on: 4 Juni 2019 Phase III study showed Xofluza (baloxavir marboxil) is effective at preventing influenza infection Roche today announced that the phase III BLOCKSTONE study, conducted by Shionogi & Co., Ltd., met its primary endpoint showing that people exposed to a household member with influenza (flu) and ... mehr
Published on: 3 Juni 2019 Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies Roche today announced positive topline data from two Phase III multicenter studies evaluating Xolair® (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) ... mehr
Published on: 3 Juni 2019 Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting Roche presents new and updated results from a number of abstracts highlighting studies including the treatment of both PD-L1-positive triple-negative and HER2-positive breast cancer at the 2019 ASCO ... mehr
Published on: 2 Juni 2019 Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer shows positive data in those with liver metastases Roche today announced positive additional results of a prespecified exploratory analysis from the Phase III IMpower150 study, which demonstrated that the combination of Tecentriq® (atezolizumab), ... mehr
Published on: 31 Mai 2019 Roche and GE Healthcare launch NAVIFY Tumor Board with medical imaging capabilities to enable more personalised treatment decisions in cancer care Roche announced today the release of NAVIFY Tumor Board 2.0, the first collaboration product from our partnership with GE Healthcare. mehr
Published on: 23 Mai 2019 Reminder: Invitation to Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr
Published on: 16 Mai 2019 Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia Roche today announced that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously ... mehr
Published on: 16 Mai 2019 Roche’s personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents Roche today announced positive data from the Phase I/II STARTRK-NG study, evaluating the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours ... mehr
Published on: 14 Mai 2019 New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting antimicrobial resistance within the world’s leading cause of infectious disease deaths Roche today announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. mehr
Published on: 14 Mai 2019 Roche and Spark Therapeutics, Inc. announce expected refiling date of Premerger Notification and Report Forms under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche and Spark intend to refile on or about 23 May 2019 their respective Premerger Notification and Report Forms under the ... mehr
Published on: 10 Mai 2019 Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting Roche today announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 ... mehr
Published on: 8 Mai 2019 Roche stellt am AAN-Kongress neue Daten zu OCREVUS (Ocrelizumab) vor, die bei schubförmiger und primär progredienter MS eine signifikante Abnahme des Fortschreitens der Erkrankung belegen Roche gab heute bekannt, dass an der 71. Jahrestagung der Academy of Neurology (AAN) vom 4. bis 10. Mai in Philadelphia, Pennsylvania, neue Daten zu OCREVUS® (Ocrelizumab) bei schubförmiger und ... mehr
Published on: 7 Mai 2019 Roche presents data from the risdiplam pivotal FIREFISH and SUNFISH studies in spinal muscular atrophy at the 2019 AAN Annual Meeting Roche today announced new data from the dose-finding Part 1 of the pivotal FIREFISH trial showing infants with Type 1 spinal muscular atrophy (SMA) achieved key motor milestones after one year of ... mehr
Published on: 6 Mai 2019 Reminder: Invitation to Roche's live audio webcast on data presented at AAN 2019 - 13 May 2019 We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 13 May 2019, highlighting Roche data presented at the American Academy of ... mehr
Published on: 6 Mai 2019 FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment Roche today announced that the US Food and Drug Administration (FDA) has approved Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast ... mehr
Published on: 29 April 2019 Invitation to Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr
Published on: 29 April 2019 New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio Roche today announced new data for its approved and investigational medicines for the treatment of neurological conditions will be presented at the 71st American Academy of Neurology (AAN) Annual ... mehr
Published on: 26 April 2019 Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Act (the “HSR Act”) in ... mehr
Published on: 23 April 2019 Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy Roche today announced the launch of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer. mehr
Published on: 17 April 2019 Roche reports a strong start in 2019 and raises the outlook for the full-year Group sales increase 8% at constant exchange rates and 9% in Swiss francs Pharmaceuticals Division sales up 10%, driven mainly by Ocrevus, Perjeta, Hemlibra and Tecentriq Diagnostics Division sales ... mehr
Published on: 11 April 2019 Reminder: Invitation to Roche's First Quarter Sales 2019 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2019 prior to the opening of the Swiss Stock Exchange on Wednesday, April 17th, 2019 mehr
Published on: 3 April 2019 Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche and Spark Therapeutics, Inc. (“Spark”) today announced that Roche has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Act (the “HSR Act”) in connection with ... mehr
Published on: 1 April 2019 Invitation to Roche's live audio webcast on data presented at AAN 2019 - 13 May 2019 We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 13 May 2019, highlighting Roche data presented at the American Academy of ... mehr
Published on: 1 April 2019 Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial Roche will today present the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel or ... mehr
Published on: 19 März 2019 FDA approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer Roche today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) ... mehr
Published on: 18 März 2019 Invitation to Roche's First Quarter Sales 2019 Audio Webcast and Conference Call Roche will publish its Sales Results for the 1st Quarter of 2019 prior to the opening of the Swiss Stock Exchange on Wednesday, April 17th, 2019 mehr
Published on: 18 März 2019 Roche to present results of the largest safety study of its kind with Tecentriq (atezolizumab) in patients with metastatic bladder cancer Roche today announced first results from SAUL, a Phase IIIb study evaluating the safety of Tecentriq® in approximately 1000 patients with locally advanced or metastatic urothelial carcinoma (mUC) ... mehr
Published on: 15 März 2019 European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease Roche today announced that the European Commission has approved MabThera® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by ... mehr
Published on: 14 März 2019 European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors Roche today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII ... mehr
Published on: 11 März 2019 Roche’s VENTANA PD-L1 (SP142) Assay approved as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq in combination with Abraxane Roche today announced US Food and Drug Administration approval of the VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients ... mehr
Published on: 11 März 2019 FDA grants Roche’s Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for ... mehr
Published on: 8 März 2019 European Commission 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 European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and ... mehr
Published on: 7 März 2019 Roche commences tender offer for all shares of Spark Therapeutics, Inc. for US$ 114.50 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 Spark Therapeutics, Inc. (NASDAQ: ONCE) at a price of US$ 114.50 per share. mehr
Published on: 7 März 2019 Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions Roche today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in ... mehr
Published on: 6 März 2019 FDA accepts Roche’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications Roche today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) as a single-dose, oral ... mehr
Published on: 5 März 2019 Roche Generalversammlung 2019 Roche gab heute bekannt, dass ihre ordentliche Generalversammlung allen Anträgen des Verwaltungsrates zugestimmt hat. Die anwesenden 840 Aktionärinnen und Aktionäre, die 86.73% der total 160'000'000 ... mehr
Published on: 4 März 2019 Save the date: Roche Analyst Event at ASCO 2019 - Monday, 3 June 2019 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 ... mehr
Published on: 28 Februar 2019 FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers Roche today announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment ... mehr
Published on: 25 Februar 2019 Roche und Spark Therapeutics schliessen verbindliche Übernahmevereinbarung Roche und Spark Therapeutics, Inc. (NASDAQ: ONCE) gaben heute den Abschluss einer verbindlichen Übernahmevereinbarung bekannt. Roche übernimmt Spark Therapeutics vollständig in einer reinen ... mehr
Published on: 19 Februar 2019 FDA grants Priority Review to Roche’s personalised medicine entrectinib Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and ... mehr
Published on: 19 Februar 2019 FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in ... mehr
Published on: 5 Februar 2019 Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla® (trastuzumab emtansine) for adjuvant (after ... mehr
Published on: 1 Februar 2019 CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII 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 adults ... mehr
Published on: 1 Februar 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with ... mehr
Published on: 31 Januar 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs mehr
Published on: 30 Januar 2019 Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) - other company programmes in AD continue - Roche today announced the decision to discontinue CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early ... mehr
Published on: 23 Januar 2019 Reminder: Invitation to Roche's Full Year Results 2018 Presentation Roche will publish its Full Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 31 January 2019. mehr
Published on: 17 Januar 2019 FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-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) for Tecentriq® (atezolizumab) in combination with ... mehr
Published on: 7 Januar 2019 Invitation to Roche's Full Year Results 2018 Presentation Roche will publish its Full Year Results for 2018 prior to the opening of the Swiss Stock Exchange on Thursday, 31 January 2019. mehr