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 challenges a...
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 expected from ...
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 par...
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 arm. ...
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 results ...
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-throughput co...
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 for Tr...
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 and fre...
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 (ACTRIM S) a...
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 member ...
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 verification and description of clinical benefit in a confirmatory t...
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 test is p...
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 MS,...
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 determine a person’s HI...
Source: Roche Media News - September 1, 2020 Category: Pharmaceuticals Source Type: news