Roche to present scientific progress across Alzheimer ’s disease pharmaceutical and diagnostic portfolio at 2022 AAIC Annual Meeting
Overview of two decades of research to be presented, including development ofgantenerumabDetailed results from phase II study evaluatingcrenezumab in autosomal dominant Alzheimer ' s diseaseData around biomarker selection for theElecsys Amyloid Plasma Panel, a blood-based biomarker test to aid in the detection of people with amyloid pathology, recently granted FDA Breakthrough Device DesignationBasel, 28 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from 41 abstracts across its portfolio of Alzheimer ’s disease pharmaceuticals and diagnostics will be presented at the 2022 Alzheimer’s Associat...
Source: Roche Media News - July 28, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that driveneovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE innAMD at year one, and YOSEMITE and RHINE in DME up to two yearsThe totality of the data across all studies innAMD and DME available to date showed that over 60% of people treated withVabysmo were able to extend treatment to every four months, while improving and maintaining visionIf approved,Vabysmo would offer the first new mechanism of action in ...
Source: Roche Media News - July 22, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Board of Directors and Corporate Executive Committee in Spring 2023
Christoph Franz has decided not to seek re-election to the Board of Directors at the Annual General Meeting (AGM) in March 2023The Board of Directors intends to proposeSeverin Schwan as new Chairman at the Annual General MeetingThe Board of Directors has appointed ThomasSchinecker as the new Roche CEO effective 15 March 2023Basel, 21 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Christoph Franz has decided not to seek re-election to the Board of Directors at the AGM in March 2023. The Board of Directors intends to propose Severin Schwan as new Chairman at the AGM and has appointed Thomas Schinecker as...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news

Roche's Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer ’s disease
The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in symptomatic patients who are being evaluated for Alzheimer ' s disease and other causes of cognitive decline.The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.This minimally invasive blood-based biomarker test can help to streamline a patient ' s journey, improving access to diagnosis and helping them better plan for the future.Basel, 19 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)...
Source: Roche Media News - July 19, 2022 Category: Pharmaceuticals Source Type: news

Roche launches innovative dual antigen and antibody diagnostic test supporting the fight to eliminate the hepatitis C virus
Elecsys HCV Duo is the first commercially available immunoassay that allows the simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status.TheElecsys HCVDuo immunoassay enables significantly earlier diagnosis of active HCV infection, making it possible to get patients appropriate care sooner to stop both the disease progression and transmission.Basel, 18 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys ® HCV Duo immunoassay in countries that accept the CE Mark. Elecsys HCV Duo is the first available immunoassay that allows the simultaneous ...
Source: Roche Media News - July 18, 2022 Category: Pharmaceuticals Source Type: news

Eight-year data from APHINITY study show Roche ’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer
Discussion on the Optimal Primary Breast Cancer Treatment. Breast Care 2019;14:103-10.[11] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited June 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.[12] European Medicines Agency. Phesgo. [Internet; cited June 2022]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo.[13] World Health Organization. Cancer. [Internet; cited June 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.[14] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (H...
Source: Roche Media News - July 14, 2022 Category: Pharmaceuticals Source Type: news

New two-year data confirm Roche ’s Vabysmo improves vision with fewer treatments for people with neovascular age-related macular degeneration
In the TENAYA and LUCERNE studies, more than 60% ofVabysmo patientscould be treated every four months at two years. This represents an increase from 45% at year onePatients treated withVabysmo received a median number of 10 injections over the two years versus 15 injections for those treated withaflibercept, potentially decreasing the number of injectionsNo new safety signals were identified andVabysmo continued to be well tolerated, with afavourable benefit-risk profileBasel, 14 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term...
Source: Roche Media News - July 14, 2022 Category: Pharmaceuticals Source Type: news

New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche ’s Hemlibra in people with moderate or mild haemophilia A
Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mildhaemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]New data also reinforceHemlibra ’sfavourable safety profile, with no new safety signals observed [1]There is limited information and treatment guidance on moderate and mildhaemophilia A, which can lead to delayed or missed diagnoses of bleeding episodes [2]Hemlibra is approved to treat people of all ages withhaemophilia A with factor VIII inhibitors in more than 110 countries and for people of all ages without factor VIII in...
Source: Roche Media News - July 11, 2022 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphomaApplication is based on results from the pivotal phase I/II study showingLunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapiesLunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient settingBasel, 6 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s B...
Source: Roche Media News - July 6, 2022 Category: Pharmaceuticals Source Type: news

Roche launches new BenchMark ULTRA PLUS system for cancer diagnostics enabling timely, targeted patient care
TheBenchMark ULTRA PLUS tissue staining system, withoptimised workflow, testing efficiency and environmentally sustainable features, enables pathologists to provide high-quality, time-critical results to doctors and patients.With laboratory diagnostics involved in more than two-thirds of healthcaredecision making, innovative laboratory solutions that enable an accurate and timely diagnosis are crucial to successful treatment.About 17 million new cases of cancer are diagnosed worldwide each year, and nearly 10 million people die from the disease.1Basel, 29 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the l...
Source: Roche Media News - June 29, 2022 Category: Pharmaceuticals Source Type: news

Roche launches the VENTANA DP 600 slide scanner for digital pathology, enhancing patient care with precision diagnostics
The VENTANA DP 600 is Roche ’s new, high-capacity slide scanner that creates high-resolution, digital images of stained tissue samples that help to diagnose cancer and determine a patient’s treatment.Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths.1 Many cancers can be cured if detected early and treated effectively.1The Roche Digital Pathology solution helps empower the digital transformation of pathology and enable better, morepersonalised healthcare.Basel, 28 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE launch of the ...
Source: Roche Media News - June 28, 2022 Category: Pharmaceuticals Source Type: news

Roche launches human papillomavirus (HPV) self-sampling solution, expanding cervical cancer screening options
Every year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, caused by infection with Human Papillomavirus (HPV).1Nearly nine out of 10 women who die from cervical cancer live in low- and middle-income countries.2For patients living in areas with limited healthcare resources, increasing access to screening and decreasing barriers to sample collection are keys to ultimately preventing this disease.Roche ’s HPV self sampling solution expands access to HPV screening options by enabling patients to privately collect their sample while at a healthcare...
Source: Roche Media News - June 16, 2022 Category: Pharmaceuticals Source Type: news

Roche provides update on Alzheimer ’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease
Crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer ’s diseaseFor more than a decade Roche has been working in collaboration with Banner Alzheimer ’s Institute, the University of Antioquia in Colombia and the National Institute on Aging on this pioneering prevention studyInitial data will be presented at the upcoming Alzheimer ' s Association International ConferenceBasel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimer ’s Institute, today announced results from the Alzheimer’s Prevention Initiative (API...
Source: Roche Media News - June 16, 2022 Category: Pharmaceuticals Source Type: news

Roche receives FDA EUA for cobas SARS-CoV-2 Duo, the first PCR test to simultaneously detect COVID-19 and quantitatively measure viral load levels of COVID-19
Thecobas SARS-CoV-2 Duo test combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19.Potential benefits of thecobas SARS-CoV-2 Duo test aim to help the healthcare community with contact tracing, patient triage and the approach to medical care.Since the start of pandemic, Roche has focused on bringing effective diagnostic solutions to healthcare communities worldwide in the fight against COVID-19Basel, 15  June 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration...
Source: Roche Media News - June 15, 2022 Category: Pharmaceuticals Source Type: news