Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Media News - October 29, 2020 Category: Pharmaceuticals Source Type: news

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients
Basel, 22 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea ’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. In...
Source: Roche Media News - October 22, 2020 Category: Pharmaceuticals Source Type: news

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia
             Basel, 19 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA ’s accelerated approval pro...
Source: Roche Media News - October 19, 2020 Category: Pharmaceuticals Source Type: news

First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic
Group sales increase 1% at constant exchange rates and decline 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies (Source: Roche Media News)
Source: Roche Media News - October 15, 2020 Category: Pharmaceuticals Source Type: news

Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. (Source: Roche Media News)
Source: Roche Media News - October 13, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi ™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support...
Source: Roche Media News - September 28, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020
Basel, 19 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq ® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.“While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are proud of our work to address...
Source: Roche Media News - September 19, 2020 Category: Pharmaceuticals Source Type: news

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 Media News - 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 Media News - 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 Media News - 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 Media News - September 17, 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - September 8, 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - August 28, 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 Media News - 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 Media News)
Source: Roche Media News - August 17, 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 Media News)
Source: Roche Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News - July 29, 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 Media News)
Source: Roche Media News - 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 Media News - July 22, 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 ...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news

New data from phase IIIb study reinforces safety profile of Roche ’s Hemlibra in people with haemophilia A
Roche 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. (Source: Roche Media News)
Source: Roche Media News - 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 Media News - July 13, 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 Media News - 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 Media News - 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 Media News - 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 enterprise software, a universal digital platform for case management, collabo...
Source: Roche Media News - June 26, 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
      ·Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumoursBasel, 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 (mCR...
Source: Roche Media News - 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.“Tripl...
Source: Roche Media News - June 18, 2020 Category: Pharmaceuticals Source Type: news

Positive phase III results for Venclexta/Venclyxto combination in acute myeloid leukaemia presented at EHA 2020
Basel, 13 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III VIALE-A study, evaluating Venclexta ®/Venclyxto® (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. VIALE-A results were featured in the 25th European Hematology Association Virtual Congress Press Briefing on Saturda y 13 June 2020 at 08:30 CEST and will be presented at the congress during the Late-breaking Oral Session (abstract #LB2601) on Sunday 14 June 2020.“We are very pleased to p...
Source: Roche Media News - June 13, 2020 Category: Pharmaceuticals Source Type: news

Roche announces 2-year risdiplam data from SUNFISH and new data from JEWELFISH in infants, children and adults with spinal muscular atrophy (SMA)
Basel, 12 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented two-year data from Part 1 of its pivotal SUNFISH trial in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA) at the virtual Cure SMA Annual Conference, 8-12 June, 2020. The results of an exploratory efficacy analysis show risdiplam significantly improved motor function after 24 months of treatment compared to natural history data. In addition, preliminary 12 month data from JEWELFISH, a trial in people with all types of SMA aged 6 months to 60 years previously treated with other SMA therapies, showed that treatment with risdiplam le...
Source: Roche Media News - June 12, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Elecsys IL-6 test receives FDA Emergency Use Authorization to help in identifying patients at high risk of severe inflammatory response
             Basel, 04 June 2020   - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirm ed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed...
Source: Roche Media News - June 4, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response
             Basel, 04 June 2020   - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirm ed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed...
Source: Roche Media News - June 4, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received p rior systemic therapy.“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph....
Source: Roche Media News - June 2, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
      ·Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche ’s first tumour-agnostic therapy in EuropeBasel, 29 May 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 adopted a positive opinion under 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 neurotrop...
Source: Roche Media News - May 29, 2020 Category: Pharmaceuticals Source Type: news

Updated data demonstrate Roche ’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer
Basel, 29 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented updated data from the pivotal phase III ALEX study, showing an increased five-year survival rate with Alecensa ® (alectinib), compared with crizotinib, in people living with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). These data confirm the longer-term efficacy of Alecensa already demonstrated across three phase III clinical trials. Full findings were presented at the ASCO2 0 Virtual Scientific Programme, on 29 May 2020.“These data further support Alecensa as the standard of care for people with metastatic AL...
Source: Roche Media News - May 29, 2020 Category: Pharmaceuticals Source Type: news