Investor updates

Roche’s emicizumab for haemophilia A meets primary endpoint in phase III study

Roche today announced that the primary endpoint has been met for the phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with haemophilia A and inhibitors to ...

Positive Phase III results for Roche’s investigational medicine OCREVUS® (ocrelizumab) published in New England Journal of Medicine

Roche announced today that data from three Phase III studies of its investigational medicine OCREVUS® (ocrelizumab)– the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ...

FDA extends review of application for OCREVUS™ (ocrelizumab)

Roche announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics Licence Application (BLA) of ...

CHMP recommends EU conditional approval of Roche’s Alecensa (alectinib) for people with previously treated ALK-positive NSCLC

Roche announced today that the European Medicines Agency (EMA) for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Alecensa® (alectinib) for the treatment of ...

Roche announces European approval of Venclyxto for people with hard-to-treat chronic lymphocytic leukaemia

Roche announced today that the European Commission has granted conditional marketing approval for Venclyxto™ (venetoclax) for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of ...

Roche’s Avastin (bevacizumab) plus chemotherapy receives FDA approval for platinum-sensitive recurrent ovarian cancer

Roche today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin ...

Changes in Roche Board of Directors

At its December meeting, the Board of Directors (BoD) of Roche Holding decided on first proposals for approval by the Annual General Meeting (AGM), scheduled for 14 March 2017.

Roche’s Gazyva/Gazyvaro Helped People With Previously Untreated Follicular Lymphoma Live Significantly Longer Without Their Disease Worsening Compared to MabThera/Rituxan

Roche today announced data from the positive, pivotal Phase III GALLIUM study that compared Gazyva®/Gazyvaro® (obinutuzumab) plus chemotherapy followed by Gazyva/Gazyvaro alone head-to-head against ...

Reminder: Invitation to Roche Analyst Event at ASH 2016

We are pleased to invite you to an analyst briefing to discuss data presented on Roche Group’s hematology portfolio at the American Society of Hematology Annual Meeting (ASH) in San Diego (3 – 6 ...

Roche launches imCORE, a global network of cancer immunotherapy centers of excellence

Roche today launched the global cancer immunotherapy Centers of Research Excellence (imCORE™) Network. This network brings together many of the world’s leading scientific and clinical experts in ...

Phase III GiACTA study shows Roche’s Actemra/RoActemra is superior to steroids alone in maintaining steroid-free remission for people with giant cell arteritis

Roche today announced positive results from the phase III GiACTA study, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA).

Roche announces initiation of two phase III pivotal trials in melanoma based on results of studies combining targeted and immunotherapy treatment approaches; early data presented at the International Congress of the Society for Melanoma Research

Roche announced results from two early cancer immunotherapy studies at the International Congress of the Society for Melanoma Research (SMR).

Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting

Roche announced today that more than 60 abstracts featuring nine of its approved or investigational medicines will be presented during the 58th American Society of Hematology (ASH) Annual Meeting ...

Roche to present new data on medicines for autoimmune diseases and severe inflammatory disorders at the 2016 ACR/ARHP Annual Meeting

Roche today announced that new data from Actemra®/RoActemra® and Rituxan®/MabThera® will be presented during the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health ...

Invitation to Roche Analyst Event at ASH 2016

We are pleased to invite you to an analyst briefing to discuss data presented on Roche Group’s hematology portfolio at the American Society of Hematology Annual Meeting (ASH) in San Diego (3 – 6 ...

Roche delivers good sales growth in the first nine months of 2016

Group sales increased 4% to CHF 37.5 billion. Sales in the Pharmaceuticals Division were up 4% to CHF 29.1 billion, driven by demand for breast cancer medicines Perjeta and Herceptin as well as for ...

FDA approves Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for people with a specific type of metastatic lung cancer

Roche today announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have ...

FDA approves Lucentis (ranibizumab injection) prefilled syringe

Roche today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine.

Roche announces CHMP recommendation for EU approval of Venclyxto for people with hard-to-treat chronic lymphocytic leukaemia

Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto™ (venetoclax) for the treatment of people with chronic lymphocytic ...

Reminder: Invitation to Roche’s 9 Months Sales 2016 Conference Call

Roche will publish its Sales Results for the 3rd Quarter of 2016 prior to the opening of the Swiss Stock Exchange on Thursday, 20th October 2016.

FDA grants priority review to Lucentis (ranibizumab injection) supplemental biologics license application for myopic choroidal neovascularization

Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis® (ranibizumab ...

Roche’s TECENTRIQ (atezolizumab) shows significant survival advantage compared to chemotherapy regardless of PD-L1 status in a specific type of lung cancer in Phase III study

Roche today announced data from the positive, pivotal Phase III OAK study of TECENTRIQ® (atezolizumab) at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark.

FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis, a form of vasculitis

Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra/RoActemra® (tocilizumab) for giant cell arteritis (GCA), a ...

Save the date: Roche Analyst Event at ASH 2016

We are pleased to invite you to an analyst briefing to discuss data presented on Roche Group’s hematology portfolio at the American Society of Hematology Annual Meeting (ASH) in San Diego (3 – 6 ...

US FDA grants Breakthrough Therapy Designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC

Roche announced today that it has received a second Breakthrough Therapy Designation (BTD) from the United States Food and Drug Administration (FDA) for its ALK inhibitor, Alecensa (alectinib).

First phase III data on Roche’s TECENTRIQ (atezolizumab) to feature at the 2016 European Society for Medical Oncology (ESMO) Congress

Roche today announced that new results from studies with its approved or investigational medicines across more than 20 cancer types will be presented during the European Society for Medical Oncology ...

Invitation to Roche's Third Quarter Sales 2016 Conference Call

Roche will publish its Sales Results for the 3rd Quarter of 2016 prior to the opening of the Swiss Stock Exchange on Thursday, 20th October 2016.

Phase III efficacy results of investigational medicine OCREVUS® (ocrelizumab) reinforced by exploratory analyses in two forms of multiple sclerosis

Roche announced today new analyses from the three OCREVUS® (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented ...

Roche ranked most sustainable healthcare company in the Dow Jones Sustainability Index for the eighth year running

For the eighth consecutive year, Roche has been recognised as Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry of the Dow Jones Sustainability Index ...

Phase III study showed Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) helped people with a specific type of lung cancer live significantly longer compared to chemotherapy

Roche today announced positive results for TECENTRIQ® from the Phase III study, OAK.

Anti-Cancer Agent “Xeloda®”, Obtained Approval for Additional Indication of “Adjuvant Chemotherapy for Rectal Cancer”

Roche launches innovative Accu-Chek Guide blood glucose monitoring system, which makes every step of testing easy

Roche today announced the launch of the Accu-Chek® Guide, the next-generation blood glucose monitoring system.

Roche’s emicizumab continued to show promising safety and efficacy profile in long-term study in people with severe haemophilia A

Roche announced yesterday new data for investigational haemophilia medicine emicizumab (ACE910) at the World Federation of Hemophilia 2016 World Congress.

Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2016

We are pleased to invite you to an analyst event on Tuesday, 2nd August 2016 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ...

Roche delivers continued growth in the first half of 2016

Group sales increased by 5% at constant exchange rates, 6% in Swiss francs

Reminder: Invitation to Roche Analyst Event on Diagnostics Division at AACC 2016

We are pleased to invite you to an analyst event on Tuesday, 2nd August 2016 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ...

Roche provides update on phase III study of Gazyva/Gazyvaro in people with previously untreated diffuse large B-cell lymphoma

Roche today announced that the phase III GOYA study evaluating Gazyva®/Gazyvaro® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma ...

Reminder: Invitation to Roche's Half Year Results 2016

Roche will publish its Half Year Results for 2016 prior to the opening of the Swiss Stock Exchange on 21st July, 2016.

Roche Analyst Event on Diagnostics Division at AACC 2016

We are pleased to invite you to an analyst event on Tuesday, 2nd August 2016 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ...

Roche's marketing applications for review of OCREVUS® (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA

Roche announced today that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) of OCREVUS® (ocrelizumab) for the treatment of relapsing multiple ...

Invitation to Roche's Half Year Results 2016

Roche will publish its Half Year Results for 2016 prior to the opening of the Swiss Stock Exchange on 21st July, 2016.

Roche launches the new cobas e 801 module, helping hospitals meet the demand for increased diagnostic testing

Roche announced today that its new, dedicated high-volume testing immunoassay solution, the cobas e 801 module, is now available for countries accepting the CE Mark.

Roche's Gazyvaro approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma

Roche announced today that the European Commission has approved Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular ...

Roche receives EU approval of Avastin in combination with Tarceva for patients with a specific type of advanced lung cancer

Roche announced today that the European Commission has approved the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with ...

Save the date: Roche Analyst Event on Diagnostics Division at AACC 2016

We are pleased to invite you to an analyst event on Tuesday, 2nd August 2016 to discuss Roche’s Diagnostics Division, in conjunction with the American Association for Clinical Chemistry (AACC) Annual ...

Phase III study shows Roche's Actemra/RoActemra maintained steroid-free remission in people with Giant Cell Arteritis (GCA)

Roche today announced positive results from the Phase III study known as GiACTA, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA).

Roche’s cancer immunotherapy Tecentriq (atezolizumab) shrank tumours in people with previously untreated advanced bladder cancer

Roche, today announced that in a Phase II study, IMvigor210, Tecentriq® (atezolizumab) shrank tumours (objective response rate, ORR) in 24 percent (n=28) of people with locally advanced or metastatic ...

Roche showcases three distinct combinations for cancer immunotherapy treatment across a broad range of cancers

Roche is presenting data from across its cancer immunotherapy pipeline highlighting its multipronged combination approach to cancer immunotherapy treatment.

Roche's Tecentriq® (atezolizumab) shows increasing overall survival benefit in updated clinical data analysis for people with specific type of advanced lung cancer

Roche will today present updated survival data from the phase II study POPLAR, in people with previously treated advanced non-small cell lung cancer (NSCLC).

Roche's subcutaneous formulation of MabThera receives approval in Europe for people with chronic lymphocytic leukaemia

Roche announced today that the European Commission (EC) has approved the subcutaneous (SC) formulation of MabThera® (rituximab) for people with previously untreated and relapsed/refractory chronic ...

First PT/INR home self-testing device with Bluetooth technology enabling remote care programmes for anticoagulated patients

Roche announced today that it has launched the CoaguChek® INRange system in countries accepting the CE Mark*.

Roche’s Gazyva/Gazyvaro showed superior progression-free survival compared to MabThera/Rituxan in people with previously untreated follicular lymphoma

Roche today announced positive results from the pivotal phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin ...

Reminder: Invitation to Roche Analyst Event at ASCO 2016

We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group's oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ...

Chugai announcement: Avastin approved for additional indication of advanced or recurrent cervical cancer

Phase III study of Roche’s Alecensa (alectinib) showed superior efficacy versus crizotinib in Japanese people with a specific type of lung cancer

Roche today announced that Alecensa® , an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to ...

FDA grants Roche’s cancer immunotherapy Tecentriq (atezolizumab) accelerated approval for people with a specific type of advanced bladder cancer

Roche today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people with locally advanced or metastatic ...

Roche highlights personalised medicines and cancer immunotherapies at 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

Roche today announced new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from 3rd – 7th June in ...

CHMP recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma

Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy ...

CHMP recommends EU approval for Roche's Avastin in combination with Tarceva for patients with a specific type of advanced lung cancer

Roche announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® ...

Invitation to Roche Analyst Event at ASCO 2016

We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group's oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ...

Roche reports solid sales growth in the first quarter of 2016

"We have started the year with solid growth in both our Pharmaceuticals and Diagnostics Divisions"

Roche to present new data at AAN showing superior efficacy of investigational medicine ocrelizumab versus comparators on disease activity and progression in two forms of multiple sclerosis

Roche announced today that new data from three Phase III studies of the investigational medicine OCREVUS™(ocrelizumab) will be presented during the 68th American Academy of Neurology (AAN) Annual ...

Roche announces FDA grants Venclexta(venetoclax) accelerated approval for people with hard-to-treat type of chronic lymphocytic leukemia

Roche announced today that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Venclexta™ (venetoclax) for the treatment of people with chronic lymphocytic leukemia (CLL) with ...

Reminder: Invitation to Roche's First Quarter Sales 2016 Conference Call

Roche will publish its Sales Results for the 1st Quarter of 2016 prior to the opening of the Swiss Stock Exchange on Tuesday April 19th, 2016.

FDA grants priority review for Roche's cancer immunotherapy atezolizumab in specific type of lung cancer

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 atezolizumab (anti-PDL1; ...

Roche to initiate testing for Zika virus at U.S. Blood Centres under FDA Investigational New Drug Application protocol

Roche today announced that the U.S. Food and Drug Administration (FDA) has provided approval to initiate collection and testing of blood samples for screening with the cobas® Zika assay under an ...

Invitation to Roche's First Quarter Sales 2016 Conference Call

Roche will publish its Sales Results for the 1st Quarter of 2016 prior to the opening of the Swiss Stock Exchange on Tuesday April 19th, 2016.

FDA grants Roche's Cancer Immunotherapy Atezolizumab priority review for advanced bladder cancer

Roche Group, 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 atezolizumab (anti-PDL1; ...

Roche Annual General Meeting 2016

Roche announced today that its shareholders approved all of the Board of Directors' proposals and amendments to the Articles of Incorporation at its ordinary Annual General Meeting (AGM). The 797 ...

FDA approves Roche's Gazyva (obinutuzumab) for certain people with previously treated follicular lymphoma

Roche today announced that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with ...

Roche provides update on two identical phase III studies of lebrikizumab in people with severe asthma

Roche today announced top-line results from two phase III studies. The LAVOLTA I-II studies were identical, double-blind, randomised, multicentre, placebo-controlled studies that evaluated the ...

Save the date: Roche Analyst Event at ASCO 2016

We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group's oncology products and pipeline at the American Society of Clinical Oncology Annual Meeting (ASCO) in ...

U.S. FDA grants Breakthrough Therapy Designation for Roche's investigational medicine ocrelizumab in primary progressive multiple sclerosis

Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUS ™) for the treatment of ...

Chugai's ALK Inhibitor "Alecensa" Trial Stopped Early for Benefit

Demonstrates Statistically Significant Improvement in PFS in a Japanese Phase III Head to Head Study with Crizotinib

Changes to the Roche Corporate Executive Committee

Silvia Ayyoubi (62), Head of Group Human Resources for Roche and member of the Corporate Executive Committee has decided to retire from Roche following the Annual General Meeting in March 2016.

Roche reports strong results in 2015

Commenting on the Group’s results, Roche CEO Severin Schwan said: "2015 was a successful year, with strong business results in both Pharmaceuticals and Diagnostics, driven by our newly launched ...

FDA grants breakthrough therapy designation for investigational medicine venetoclax in combination with MabThera/Rituxan in relapsed or refractory chronic lymphocytic leukaemia

Roche today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to venetoclax in combination with MabThera/Rituxan (rituximab) for the treatment of ...

Reminder: Invitation to Roche's Full Year Results 2015

Roche will publish its Full Year Results for 2015 prior to the opening of the Swiss Stock Exchange on Thursday, 28 January 2016.

FDA grants priority review for venetoclax new drug application

Roche announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for venetoclax for the treatment of people with chronic ...

Roche presents updated results for investigational cancer immunotherapy atezolizumab in advanced bladder cancer

Roche today announced updated results from the pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (MPDL3280A) in people with locally advanced or metastatic ...

Invitation to Roche's Full Year Results 2015

Roche will publish its Full Year Results for 2015 prior to the opening of the Swiss Stock Exchange on Thursday, 28 January 2016.