Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) 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 Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys ® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the ...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra ®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Investor Update - September 17, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s 3rd Quarter Sales 2020 Webinar
Roche will publish its Sales Results for the 3rd Quarter of 2020 prior to the opening of the Swiss Stock Exchange on Thursday, October 15th, 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - September 16, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-thr...
Source: Roche Investor Update - September 16, 2020 Category: Pharmaceuticals Source Type: news

New data further reinforce Roche ’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis
Basel, 11 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data that show OCREVUS® (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Subgroup analys is from the two-year open-label Phase IIIb CASTING study also demonstrates that patients benefit across a wide range of disease related and demographic subgroups, regardless of prior treatment background. Findings will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee...
Source: Roche Investor Update - September 11, 2020 Category: Pharmaceuticals Source Type: news

New data show Roche ’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)
Basel, 10 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG ® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting, in addition to longer-term efficacy data supporting the continued effect of ENSPRYNG on reducing the risk of NMOSD relapse, as well as its favourable benefit:risk profile.“The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity ...
Source: Roche Investor Update - September 10, 2020 Category: Pharmaceuticals Source Type: news

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)
Basel, 9 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of an innovative Phase III clinical trial programme for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose Phase III clinical trial programme for OCREVUS® (ocrelizumab) and a distinct O CREVUS trial specifically to support African-American and Hispanic- and Latinx-American patients with MS. Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTR...
Source: Roche Investor Update - September 9, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
Basel, 8 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas ® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can he lp healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options. BK virus (BKV) is a m...
Source: Roche Investor Update - September 8, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Virtual Pharma Day - Monday, 14th September 2020
The Investor Relations team would like to invite you to Roche ’s Virtual Pharma Day 2020 that will take place as a live video webcast (Source: Roche Investor Update)
Source: Roche Investor Update - September 7, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
             Basel, 7 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verifica...
Source: Roche Investor Update - September 7, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems
Basel, 04 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® SARS-CoV-2& Influenza A/B Test for use on the cobas ® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.“With the approaching flu season, this new...
Source: Roche Investor Update - September 4, 2020 Category: Pharmaceuticals Source Type: news

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020
Basel, 3 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) data will be presented at MSVirtual2020, the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) - European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting from 11-13 September 2020.“While conditions of the nervous system are some of the most complex to understand and treat, we are committed to following the science to reduce relapses in NMOSD and slow and eventually stop disease progression in ...
Source: Roche Investor Update - September 3, 2020 Category: Pharmaceuticals Source Type: news

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care
Basel, 1 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.1 In addition, it serves as a valuable initial screening test f...
Source: Roche Investor Update - September 1, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
Basel, 1 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas ® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO Roche Diagnostics. “Being able to reliably determi...
Source: Roche Investor Update - September 1, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test
Basel, 28 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne ®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cance r is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and...
Source: Roche Investor Update - August 28, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Virtual Pharma Day - Monday, 14th September 2020
The Investor Relations team would like to invite you to Roche ’s Virtual Pharma Day 2020 that will take place as a live video webcast (Source: Roche Investor Update)
Source: Roche Investor Update - August 19, 2020 Category: Pharmaceuticals Source Type: news

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19
Basel, 19 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron ’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and ...
Source: Roche Investor Update - August 19, 2020 Category: Pharmaceuticals Source Type: news

FDA Approves Roche ’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Roche announced today that the US Food and Drug Administration (FDA) has approved ENSPRYNG ™ (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). (Source: Roche Investor Update)
Source: Roche Investor Update - August 17, 2020 Category: Pharmaceuticals Source Type: news

FDA accepts application for Xolair (omalizumab) prefilled syringe for self-administration across all indications
Basel, 13 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) accepted the company ’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021. In the US, Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only a...
Source: Roche Investor Update - August 13, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi ™ (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older. (Source: Roche Investor Update)
Source: Roche Investor Update - August 10, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis
Basel, 10 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo. In the HIBISCUS I induction study, in people without prior anti-tumour ...
Source: Roche Investor Update - August 10, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoi...
Source: Roche Investor Update - August 6, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
Basel, 5 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas ® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing t he ability to run a large number of patient tests for this virus in a short period of time.“Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threat...
Source: Roche Investor Update - August 5, 2020 Category: Pharmaceuticals Source Type: news

Rozlytrek, Roche ’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer
             Basel, 03 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted conditional marketing authorisation for Rozlytrek®(entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory t...
Source: Roche Investor Update - August 3, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma
Basel, 31 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.  The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The supplemental Biologics License Application (sBLA) for Tecentriq was granted under priority review.   The review was also conducted under Project Orbis, an initiative of the FDA On...
Source: Roche Investor Update - July 31, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabl...
Source: Roche Investor Update - July 29, 2020 Category: Pharmaceuticals Source Type: news

Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
Basel, 29 July - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III COVACTA study of Actemra ®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial resul...
Source: Roche Investor Update - July 29, 2020 Category: Pharmaceuticals Source Type: news

Sarepta Therapeutics Receives Fast Track Designation for SRP-9001 Micro-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy
Dear Investor, Please find attached a press release by Sarepta Therapeutics:https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-receives-fast-track-designation-srp-9001 Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - July 24, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Virtual Pharma Day - Monday, 14th September 2020
The Investor Relations team would like to invite you to Roche ’s Virtual Pharma Day 2020 that will take place as a live video webcast (Source: Roche Investor Update)
Source: Roche Investor Update - July 24, 2020 Category: Pharmaceuticals Source Type: news

First half of the year with 1% growth at constant exchange rates, significant impact of COVID-19 pandemic
Group sales increase 1% at constant exchange rates and decline 4% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies (Source: Roche Investor Update)
Source: Roche Investor Update - July 23, 2020 Category: Pharmaceuticals Source Type: news

Phase III data show Roche ’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration
Basel, 22 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from the phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of blindness globally.1 In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. In the study, PDS was generally well-tolerated, with a favourable benefit...
Source: Roche Investor Update - July 22, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s virtual event on key ophthalmology data presented at the American Society of Retina Specialists 38th Annual Meeting
We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Monday, 27 July, 2020, highlighting Roche data accepted for presentation via the ASRS 2020 Virtual Scientific Program July 24-26, 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - July 16, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Half Year Results 2020 Live Video Webcast and Conference Call
Roche will publish its Half Year Results of 2020 prior to the opening of the Swiss Stock Exchange on Thursday, 23rd July 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - July 16, 2020 Category: Pharmaceuticals Source Type: news

Reminder: New Format and E-Mail Address for Roche Investor Updates
This is to inform you that, as of 20 July 2020, Roche will send its Investor Updates from a new e-mail account with a new format as a joint-release with our Media Relations department.Please make sure the following e-mail addresses are added to your ‘safe sender’ list:roche.investor-relations@roche.com andglobal.news@roche.com. (Source: Roche Investor Update)
Source: Roche Investor Update - July 15, 2020 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Therapy Designation for Roche ’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies.“We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data for this molecule and the remaining unmet need in follicular lymphoma,” said Levi Gar...
Source: Roche Investor Update - July 14, 2020 Category: Pharmaceuticals Source Type: news

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other t...
Source: Roche Investor Update - July 14, 2020 Category: Pharmaceuticals Source Type: news

Spark Therapeutics Announces Updated Data on SPK-8011 from Phase 1/2 Clinical Trial in Hemophilia A at ISTH 2020 Virtual Congress
Dear Investor, Please find attached a press release by Spark Therapeutics:https://sparktx.com/press_releases/isth2020/ Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - July 13, 2020 Category: Pharmaceuticals Source Type: news

New data from phase IIIb study reinforces safety profile of Roche ’s Hemlibra in people with haemophilia A
Basel, 13 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the second interim analysis of the phase IIIb STASEY study, which reinforce the safety profile of Hemlibra ® (emicizumab) characterised in the phase III HAVEN clinical programme.1,2,3 In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with haemophilia A with factor VIII inhibitors, which was consistent with previous safety observations.1 Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophy...
Source: Roche Investor Update - July 13, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer
Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer. Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.“Ovarian cancer remains one of the most aggressive cancers a...
Source: Roche Investor Update - July 13, 2020 Category: Pharmaceuticals Source Type: news

New Format and E-Mail Address for Roche Investor Updates
This is to inform you that, as of 20 July 2020, Roche will send its Investor Updates from a new e-mail account with a new format as a joint-release with our Media Relations department.Please make sure the following e-mail addresses are added to your ‘safe sender’ list:roche.investor-relations@roche.com andglobal.news@roche.com. (Source: Roche Investor Update)
Source: Roche Investor Update - July 6, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s virtual event on key ophthalmology data presented at the American Society of Retina Specialists 38th Annual Meeting
We are pleased to invite investors and analysts to participate in a live video webcast and conference call onMonday, 27 July, 2020, highlighting Roche data accepted for presentation via the ASRS 2020 Virtual Scientific Program July 24-26, 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - July 1, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo ™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC i...
Source: Roche Investor Update - June 29, 2020 Category: Pharmaceuticals Source Type: news

Roche announces new data at the ISTH 2020 Congress, demonstrating ongoing commitment to advancing care for people with haemophilia A
Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress on 12-14 July 2020. Data will include updated safety results from the phase IIIb STASEY study of Hemlibra ® (emicizumab) and new results from the phase III HAVEN 5 study of Hemlibra. Data will also include insights into the impact of living with haemophilia A. Spark Therapeutics (a member of the Roche Group) will also present data from the initial dose cohorts of its phase I/II SPK-8011 gene ther...
Source: Roche Investor Update - June 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan ’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and s ignificantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to ...
Source: Roche Investor Update - June 29, 2020 Category: Pharmaceuticals Source Type: news

Roche improves speed and accuracy of non-small cell lung cancer diagnosis with launch of automated digital pathology algorithm
             Basel, June 26, 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 (SP263) image analysis for non-small cell lung cancer (NSCLC). The algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible and have the potential to aid diagnosis and, ultimately, targeted treatment options for patients. Validated on the VENTANA PD-L1 (SP263) Assay, the algorithm is ready-to-use and integrated within the Roche uPath ...
Source: Roche Investor Update - June 26, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Half Year Results 2020 Live Video Webcast and Conference Call
Roche will publish its Half Year Results of 2020 prior to the opening of the Swiss Stock Exchange on Thursday, 23rd July 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - June 25, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints
Basel, 19 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss. In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overal...
Source: Roche Investor Update - June 19, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer
Basel, 18 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion031 study, evaluating Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chem otherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression. (Source: Roche Investor Update)
Source: Roche Investor Update - June 18, 2020 Category: Pharmaceuticals Source Type: news