Media releases Keyword Search Clear 2019 2018 2017 2016 2015 2014 2013 2012 2011 Published on: 18 November 2019 Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium Roche today announced that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December ... more Published on: 15 November 2019 CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the ... more Published on: 15 November 2019 CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy® (polatuzumab vedotin) in combination with bendamustine plus ... more Published on: 11 November 2019 Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone Roche today announced data from the phase II NOBILITY study, investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis.1 The study met the primary ... more Published on: 11 November 2019 Roche’s risdiplam meets primary endpoint in pivotal SUNFISH trial in people with type 2 or 3 spinal muscular atrophy Roche today announced positive data from the pivotal Part 2 of SUNFISH, a study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). more Published on: 6 November 2019 Roche to present new data highlighting breadth of haematology portfolio and pipeline at the American Society of Hematology 2019 Annual Meeting Roche today announced new data for its approved and investigational medicines across a range of blood diseases will be presented at the 61st American Society of Hematology (ASH) Annual Meeting from 7 ... more Published on: 30 October 2019 Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA Roche announced today that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent ... more Published on: 29 October 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 ... more Published on: 21 October 2019 Roche’s Tecentriq in combination with Avastin increased overall survival and progression-free survival in people with unresectable hepatocellular carcinoma Roche today announced that the Phase III IMbrave150 study, evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular ... more Published on: 18 October 2019 Roche announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications Roche today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, ... more Published on: 16 October 2019 Roche reports very strong sales growth in the first nine months of 2019 – outlook raised Group sales increase 10% at constant exchange rates and 9% in Swiss francs, due to new products Pharmaceuticals Division sales up 12%, driven by high demand for recently launched medicines, mainly ... more Published on: 14 October 2019 Phase III PEMPHIX study shows Roche’s MabThera/Rituxan (rituximab) superior to mycophenolate mofetil in patients with pemphigus vulgaris Roche today announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of MabThera®/Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to ... more Published on: 30 September 2019 Roche presents positive Phase III results for Tecentriq® (atezolizumab) in combination with platinum-based chemotherapy in people with previously untreated advanced bladder cancer Roche today presented positive results from the Phase III IMvigor130 study evaluating Tecentriq® (atezolizumab) plus platinum-based chemotherapy versus chemotherapy alone for the first-line (initial) ... more Published on: 30 September 2019 Roche to present results of first prospective trial using blood-based next generation sequencing which successfully identifies people for treatment with Alecensa Roche will today announce positive results from a single-arm cohort of the Phase II/III Blood First Assay Screening Trial (BFAST), the first prospective study to use only blood-based next generation ... more Published on: 30 September 2019 FDA approves Roche’s Rituxan (rituximab) in children with two rare blood vessel disorders Roche today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis ... more Published on: 30 September 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 ... more Published on: 28 September 2019 Roche to present new and updated data at ESMO 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer Roche will present new data at the European Society for Medical Oncology (ESMO) 2019 congress, announcing the results of a number of studies in patients receiving Alecensa® (alectinib) for anaplastic ... more Published on: 27 September 2019 Roche's Tecentriq improves overall survival as a first-line monotherapy in certain people with advanced non-small cell lung cancer 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 ... more Published on: 27 September 2019 Roche’s Tecentriq in combination with Avastin shows encouraging results in Phase Ib study of people with unresectable hepatocellular carcinoma Roche will today present results from a Phase Ib study evaluating the efficacy and safety of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with ... more Published on: 23 September 2019 Roche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress Roche today announced that results from a number of studies across its comprehensive oncology portfolio, covering a broad range of cancers including bladder, lung and breast will be presented at the ... more Published on: 20 September 2019 FDA approves cobas Babesia, Roche’s first whole blood test for donor screening Roche today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation ... more Published on: 19 September 2019 Roche renews its commitment to the primary healthcare Phelophepa trains, marking the 25th anniversary Roche today announced its renewed support of the Phelophepa primary healthcare trains in South Africa as the main external sponsor to mark this milestone 25th anniversary. more 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. more Published on: 16 September 2019 Roche ranked as one of the most sustainable healthcare companies in the Dow Jones Sustainability Indices for the eleventh year running Roche has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). more 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 ... more 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 ... more 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), ... more 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. more 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 ... more 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). more 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 ... more 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® ... more 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 ... more 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 ... more 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 ... more 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 ... more 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 ... more 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); ... more 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). more 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). more Published on: 31 July 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 ... more Published on: 26 July 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 ... more Published on: 26 July 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 ... more Published on: 25 July 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 more Published on: 22 July 2019 Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus Roche announced today the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and ... more Published on: 9 July 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 ... more Published on: 28 June 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 ... more Published on: 18 June 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 ... more Published on: 11 June 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) ... more Published on: 11 June 2019 Changes in Roche's Board of Directors and Corporate Executive Committee Roche today announced that Peter Voser (61), a member of the Board of Directors of Roche Holding Ltd since 2011, has decided to step down as a member of the Board of Directors of Roche at the end of ... more Published on: 10 June 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 ... more Published on: 4 June 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® ... more Published on: 3 June 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 ... more Published on: 2 June 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), ... more Published on: 31 May 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. more Published on: 16 May 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 ... more Published on: 16 May 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 ... more Published on: 14 May 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. more Published on: 14 May 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 ... more Published on: 10 May 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 ... more Published on: 8 May 2019 Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting Roche today announced new OCREVUS® (ocrelizumab) data in relapsing and primary progressive multiple sclerosis (MS) were presented at the 71st American Academy of Neurology (AAN) Annual Meeting from ... more Published on: 7 May 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 ... more Published on: 6 May 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 ... more 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 ... more 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 ... more 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. more 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 ... more 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 ... more 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 ... more Published on: 19 March 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) ... more Published on: 15 March 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 ... more Published on: 14 March 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 ... more Published on: 11 March 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 ... more Published on: 11 March 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 ... more Published on: 8 March 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 ... more Published on: 7 March 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. more Published on: 7 March 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 ... more Published on: 5 March 2019 Roche Annual General Meeting 2019 Roche today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). The 840 attending shareholders, representing 86.73% of the ... more Published on: 28 February 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 ... more Published on: 25 February 2019 Roche enters into definitive merger agreement to acquire Spark Therapeutics Roche and Spark Therapeutics, Inc. today announced that they have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics at a price of US$ 114.50 per share in an ... more Published on: 19 February 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 ... more Published on: 19 February 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 ... more Published on: 6 February 2019 Roche joins the World Federation of Hemophilia Humanitarian Aid Program Roche today announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment ... more Published on: 5 February 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 ... more Published on: 1 February 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 ... more Published on: 1 February 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 ... more Published on: 31 January 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs more Published on: 30 January 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 ... more Published on: 17 January 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 ... more
Published on: 18 November 2019 Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium Roche today announced that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December ... more
Published on: 15 November 2019 CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the ... more
Published on: 15 November 2019 CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy® (polatuzumab vedotin) in combination with bendamustine plus ... more
Published on: 11 November 2019 Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone Roche today announced data from the phase II NOBILITY study, investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis.1 The study met the primary ... more
Published on: 11 November 2019 Roche’s risdiplam meets primary endpoint in pivotal SUNFISH trial in people with type 2 or 3 spinal muscular atrophy Roche today announced positive data from the pivotal Part 2 of SUNFISH, a study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). more
Published on: 6 November 2019 Roche to present new data highlighting breadth of haematology portfolio and pipeline at the American Society of Hematology 2019 Annual Meeting Roche today announced new data for its approved and investigational medicines across a range of blood diseases will be presented at the 61st American Society of Hematology (ASH) Annual Meeting from 7 ... more
Published on: 30 October 2019 Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA Roche announced today that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent ... more
Published on: 29 October 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 ... more
Published on: 21 October 2019 Roche’s Tecentriq in combination with Avastin increased overall survival and progression-free survival in people with unresectable hepatocellular carcinoma Roche today announced that the Phase III IMbrave150 study, evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular ... more
Published on: 18 October 2019 Roche announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications Roche today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, ... more
Published on: 16 October 2019 Roche reports very strong sales growth in the first nine months of 2019 – outlook raised Group sales increase 10% at constant exchange rates and 9% in Swiss francs, due to new products Pharmaceuticals Division sales up 12%, driven by high demand for recently launched medicines, mainly ... more
Published on: 14 October 2019 Phase III PEMPHIX study shows Roche’s MabThera/Rituxan (rituximab) superior to mycophenolate mofetil in patients with pemphigus vulgaris Roche today announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of MabThera®/Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to ... more
Published on: 30 September 2019 Roche presents positive Phase III results for Tecentriq® (atezolizumab) in combination with platinum-based chemotherapy in people with previously untreated advanced bladder cancer Roche today presented positive results from the Phase III IMvigor130 study evaluating Tecentriq® (atezolizumab) plus platinum-based chemotherapy versus chemotherapy alone for the first-line (initial) ... more
Published on: 30 September 2019 Roche to present results of first prospective trial using blood-based next generation sequencing which successfully identifies people for treatment with Alecensa Roche will today announce positive results from a single-arm cohort of the Phase II/III Blood First Assay Screening Trial (BFAST), the first prospective study to use only blood-based next generation ... more
Published on: 30 September 2019 FDA approves Roche’s Rituxan (rituximab) in children with two rare blood vessel disorders Roche today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis ... more
Published on: 30 September 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 ... more
Published on: 28 September 2019 Roche to present new and updated data at ESMO 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer Roche will present new data at the European Society for Medical Oncology (ESMO) 2019 congress, announcing the results of a number of studies in patients receiving Alecensa® (alectinib) for anaplastic ... more
Published on: 27 September 2019 Roche's Tecentriq improves overall survival as a first-line monotherapy in certain people with advanced non-small cell lung cancer 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 ... more
Published on: 27 September 2019 Roche’s Tecentriq in combination with Avastin shows encouraging results in Phase Ib study of people with unresectable hepatocellular carcinoma Roche will today present results from a Phase Ib study evaluating the efficacy and safety of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with ... more
Published on: 23 September 2019 Roche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress Roche today announced that results from a number of studies across its comprehensive oncology portfolio, covering a broad range of cancers including bladder, lung and breast will be presented at the ... more
Published on: 20 September 2019 FDA approves cobas Babesia, Roche’s first whole blood test for donor screening Roche today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation ... more
Published on: 19 September 2019 Roche renews its commitment to the primary healthcare Phelophepa trains, marking the 25th anniversary Roche today announced its renewed support of the Phelophepa primary healthcare trains in South Africa as the main external sponsor to mark this milestone 25th anniversary. more
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. more
Published on: 16 September 2019 Roche ranked as one of the most sustainable healthcare companies in the Dow Jones Sustainability Indices for the eleventh year running Roche has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). more
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 ... more
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 ... more
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), ... more
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. more
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 ... more
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). more
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 ... more
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® ... more
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 ... more
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 ... more
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 ... more
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 ... more
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 ... more
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); ... more
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). more
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). more
Published on: 31 July 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 ... more
Published on: 26 July 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 ... more
Published on: 26 July 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 ... more
Published on: 25 July 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 more
Published on: 22 July 2019 Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus Roche announced today the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and ... more
Published on: 9 July 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 ... more
Published on: 28 June 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 ... more
Published on: 18 June 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 ... more
Published on: 11 June 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) ... more
Published on: 11 June 2019 Changes in Roche's Board of Directors and Corporate Executive Committee Roche today announced that Peter Voser (61), a member of the Board of Directors of Roche Holding Ltd since 2011, has decided to step down as a member of the Board of Directors of Roche at the end of ... more
Published on: 10 June 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 ... more
Published on: 4 June 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® ... more
Published on: 3 June 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 ... more
Published on: 2 June 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), ... more
Published on: 31 May 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. more
Published on: 16 May 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 ... more
Published on: 16 May 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 ... more
Published on: 14 May 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. more
Published on: 14 May 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 ... more
Published on: 10 May 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 ... more
Published on: 8 May 2019 Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting Roche today announced new OCREVUS® (ocrelizumab) data in relapsing and primary progressive multiple sclerosis (MS) were presented at the 71st American Academy of Neurology (AAN) Annual Meeting from ... more
Published on: 7 May 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 ... more
Published on: 6 May 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 ... more
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 ... more
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 ... more
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. more
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 ... more
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 ... more
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 ... more
Published on: 19 March 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) ... more
Published on: 15 March 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 ... more
Published on: 14 March 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 ... more
Published on: 11 March 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 ... more
Published on: 11 March 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 ... more
Published on: 8 March 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 ... more
Published on: 7 March 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. more
Published on: 7 March 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 ... more
Published on: 5 March 2019 Roche Annual General Meeting 2019 Roche today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). The 840 attending shareholders, representing 86.73% of the ... more
Published on: 28 February 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 ... more
Published on: 25 February 2019 Roche enters into definitive merger agreement to acquire Spark Therapeutics Roche and Spark Therapeutics, Inc. today announced that they have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics at a price of US$ 114.50 per share in an ... more
Published on: 19 February 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 ... more
Published on: 19 February 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 ... more
Published on: 6 February 2019 Roche joins the World Federation of Hemophilia Humanitarian Aid Program Roche today announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment ... more
Published on: 5 February 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 ... more
Published on: 1 February 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 ... more
Published on: 1 February 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 ... more
Published on: 31 January 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs more
Published on: 30 January 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 ... more
Published on: 17 January 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 ... more