Media releases Keyword Search Clear 2019 2018 2017 2016 2015 2014 2013 2012 2011 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 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