PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington ’s disease
Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company ’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). (Source: Roche Media News)
Source: Roche Media News - August 3, 2018 Category: Pharmaceuticals Source Type: news

Roche Purchases Shares in Tender Offer for FMI
Roche and Foundation Medicine, Inc. (NASDAQ:FMI) today announced that Roche ’s wholly owned subsidiary 062018 Merger Subsidiary, Inc. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Foundation Medicine not already owned by Roche or its affiliates, at a price of $137.0 0 per share in cash. (Source: Roche Media News)
Source: Roche Media News - July 31, 2018 Category: Pharmaceuticals Source Type: news

Roche reports very strong performance in the first half of 2018
Group sales increase 7% at constant exchange rates and in Swiss francs (Source: Roche Media News)
Source: Roche Media News - July 26, 2018 Category: Pharmaceuticals Source Type: news

Roche receives CE Mark for its Accu-Chek Solo micropump system
Roche announced today that it has received CE Mark for its Accu Chek ® Solo micropump system. (Source: Roche Media News)
Source: Roche Media News - July 23, 2018 Category: Pharmaceuticals Source Type: news

Roche to present new data demonstrating the breadth and depth of its Alzheimer ’s programme at the upcoming Alzheimer's Association International Conference
Roche announced today that it will present 16 new data presentations from across its Alzheimer ’s disease (AD) pipeline at this year’s Alzheimer's Association International Conference (AAIC) from 22-26 July in Chicago, Illinois. (Source: Roche Media News)
Source: Roche Media News - July 20, 2018 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer's disease
Roche announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys ® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s dis ease (AD) or other causes of dementia. (Source: Roche Media News)
Source: Roche Media News - July 20, 2018 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in the initial treatment of people with advanced lung cancer
Roche today announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq ® (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - July 19, 2018 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Therapy Designation for Roche ’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC)
Roche today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. (Source: Roche Media News)
Source: Roche Media News - July 18, 2018 Category: Pharmaceuticals Source Type: news

Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu
Roche today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study ’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or thos e who have conditions such as asthma, chronic lung disease, diabetes, or heart disease – for these people, flu can lead to hospitalisation ...
Source: Roche Media News - July 17, 2018 Category: Pharmaceuticals Source Type: news

Roche commences tender offer for all shares of Foundation Medicine, Inc. for US$ 137.00 per share in cash
Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Foundation Medicine, Inc. (NASDAQ: FMI) at a price of US$ 137.00 per share. (Source: Roche Media News)
Source: Roche Media News - July 2, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpassion130 study showed Roche ’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer
Roche today announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival (PFS). (Source: Roche Media News)
Source: Roche Media News - July 2, 2018 Category: Pharmaceuticals Source Type: news

Roche ’s TECENTRIQ in combination with chemotherapy helped people with previously-untreated extensive-stage small cell lung cancer live significantly longer compared to chemotherapy
Roche today announced that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. (Source: Roche Media News)
Source: Roche Media News - June 25, 2018 Category: Pharmaceuticals Source Type: news

Changes to the Roche Enlarged Corporate Executive Committee
Roche today announced that Sophie Kornowski-Bonnet, Head of Roche Partnering and member of the enlarged Corporate Executive Committee since 2012, has accepted a new opportunity and will be leaving the company effective 31 July 2018. (Source: Roche Media News)
Source: Roche Media News - June 22, 2018 Category: Pharmaceuticals Source Type: news

Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology
Roche and Foundation Medicine, Inc. today announced they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of FMI ’s common stock not already owned by Roche and its affiliates at a price of US$ 137.00 per share in cash. (Source: Roche Media News)
Source: Roche Media News - June 19, 2018 Category: Pharmaceuticals Source Type: news

New long-term data confirm Roche ’s Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan
Roche today announced data from the final analysis of the CLL11 study evaluating Gazyva ®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which will be presented during the Presidential Symposium at the 23rd European Hematology Association (EHA) Annual Congress, 14 - 17 June, in Stockholm. (Source: Roche Media News)
Source: Roche Media News - June 15, 2018 Category: Pharmaceuticals Source Type: news

Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis
Roche today announced that new OCREVUS (ocrelizumab) data will be presented at the 4th Congress of the European Academy of Neurology (EAN) from 16 June to 19 June in Lisbon, Portugal. (Source: Roche Media News)
Source: Roche Media News - June 14, 2018 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery
Roche today announced that the US Food and Drug Administration (FDA) has approved Avastin ® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. (Source: Roche Media News)
Source: Roche Media News - June 13, 2018 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval for Venclexta plus Rituxan for people with previously treated chronic lymphocytic leukaemia
Roche, announced today that the United States Food and Drug Administration (FDA) has approved Venclexta ® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. (Source: Roche Media News)
Source: Roche Media News - June 11, 2018 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s Hemlibra for people with haemophilia A without factor VIII inhibitors
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - June 5, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpower131 study showed Tecentriq(atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death for people with advanced squamous non-small cell lung cancer
Roche today announced that results from the Phase III IMpower131 study showed Tecentriq ® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) by 29 percent compared with chemotherapy (carboplatin and nab-paclitaxel) alone in the initial (first-line) trea tment of people with advanced squamous non-small cell lung cancer (NSCLC) (median PFS=6.3 vs. 5.6 months; hazard ratio [HR]=0.71, 95% CI: 0.60, 0.85, p=0.0001). (Source: Roche Media News)
Source: Roche Media News - June 2, 2018 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Roche today announced that the European Commission (EC) has approved Perjeta ® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. (Source: Roche Media News)
Source: Roche Media News - June 1, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpower130 study showed Roche ’s Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane) helped people with metastatic non-squamous NSCLC live significantly longer compared to chemotherapy alone
Roche today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). (Source: Roche Media News)
Source: Roche Media News - May 29, 2018 Category: Pharmaceuticals Source Type: news

Roche ’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors
Roche today announced full results from the phase III HAVEN 3 study evaluating Hemlibra ® (emicizumab) prophylaxis administered every week or every two weeks in people with haemophilia A without factor VIII inhibitors and the phase III HAVEN 4 study evaluating Hemlibra prophylaxis administered every four weeks in people with haemophilia A with or without factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - May 21, 2018 Category: Pharmaceuticals Source Type: news

Follow-up phase III data showed Roche ’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death
Roche today announced follow-up data from the phase III ALEX study, showing that, as an initial treatment, Alecensa ® (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57% (hazard ratio [HR]= 0.43, 95% CI: 0.32-0.58) compared to crizotinib after two years of follow-up in people with anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-sm all cell lung cancer (NSCLC), as assessed by the investigator. (Source: Roche Media News)
Source: Roche Media News - May 17, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpower150 study showed Roche ’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel
Roche today announced positive results from the Phase III IMpower150 study of Tecentriq ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) for the initial (first-line) treatment of chemotherapy-naïve people with metastatic non-squamous non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - May 17, 2018 Category: Pharmaceuticals Source Type: news

Roche to present new phase III data for Hemlibra in people with haemophilia A at the World Federation of Hemophilia 2018 World Congress
Roche today announced that phase III results for Hemlibra ® (emicizumab) will be presented for the first time during the World Federation of Hemophilia (WFH) 2018 World Congress from 20-24 May in Glasgow, Scotland. (Source: Roche Media News)
Source: Roche Media News - May 14, 2018 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer
Roche today announced that the Phase III IMblaze370 study evaluating the combination of Tecentriq ® (atezolizumab) and Cotellic® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intole rant to at least two systemic chemotherapy regimens. (Source: Roche Media News)
Source: Roche Media News - May 10, 2018 Category: Pharmaceuticals Source Type: news

Roche to present new data from its industry-leading oncology portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Roche today announced that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States. More than 180 abstracts have been accepted across 13 cancer types, including two “late breakers” and 15 oral presentations. (Source: Roche Media News)
Source: Roche Media News - May 8, 2018 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - May 7, 2018 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Roche today announced the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast c ancer (eBC) at high risk of recurrence. (Source: Roche Media News)
Source: Roche Media News - April 27, 2018 Category: Pharmaceuticals Source Type: news

Roche reports a strong start in 2018
Group sales increase 6% at constant exchange rates and 5% in Swiss francs. Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus and Perjeta. Diagnostics Division sales grow 5%, with increases in all business areas. (Source: Roche Media News)
Source: Roche Media News - April 26, 2018 Category: Pharmaceuticals Source Type: news

New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis
Roche announced today that new OCREVUS (ocrelizumab) data were presented at the 70th American Academy of Neurology (AAN) Annual Meeting from 21-27 April in Los Angeles, California. (Source: Roche Media News)
Source: Roche Media News - April 23, 2018 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Therapy Designation for Roche ’s Hemlibra in haemophilia A without inhibitors
Roche today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra ® (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - April 17, 2018 Category: Pharmaceuticals Source Type: news

Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline
Roche announced today that new data on its approved and investigational medicines for neurological conditions will be presented during the 70th American Academy of Neurology (AAN) Annual Meeting from 21-27 April in Los Angeles, California. (Source: Roche Media News)
Source: Roche Media News - April 16, 2018 Category: Pharmaceuticals Source Type: news

Roche completes acquisition of Flatiron Health
Roche today announced that it has completed the acquisition of Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US. Flatiron Health is a market leader in oncology-specific electronic health record (EHR) software as well as in the curation and development of real-world evidence for cancer research. With its large network of community oncology practices and academic medical centers across the US, Flatiron Health has created a technology platform designed to learn from the experience of every patient. (Source: Roche Media News)
Source: Roche Media News - April 6, 2018 Category: Pharmaceuticals Source Type: news

Roche announces Japanese court ruled in favour of Chugai in Hemlibra patent litigation
Roche today announced that a Japanese court (Tokyo District Court) ruled in favour of Chugai Pharmaceutical Co., Ltd, a member of the Roche Group, in the patent litigation case relating to Hemlibra ® (emicizumab). (Source: Roche Media News)
Source: Roche Media News - March 28, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpower150 study showed Roche ’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel helped people with advanced lung cancer live longer compared to Avastin plus carboplatin and paclitaxel
Roche today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel. (Source: Roche Media News)
Source: Roche Media News - March 26, 2018 Category: Pharmaceuticals Source Type: news

Phase III IMpower131 study showed Roche ’s TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced squamous lung cancer
Roche today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - March 20, 2018 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2018
Roche announced today that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). (Source: Roche Media News)
Source: Roche Media News - March 13, 2018 Category: Pharmaceuticals Source Type: news

Changes to the Roche Enlarged Corporate Executive Committee
Roche today announced that John C. Reed (1958), MD, PhD, Head of Roche Pharma Research and Early Development (pRED) since 2013, has decided to leave Roche for personal reasons and will return to the United States effective 2 April 2018. (Source: Roche Media News)
Source: Roche Media News - March 8, 2018 Category: Pharmaceuticals Source Type: news