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

Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting
Long-term data at the European Hematology Association (EHA) 2022 congress expands understanding of the impact of Roche medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatmentUpdated data from phase III CLL14 study of Venclexta ®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1]Final analysis of phase III GALLIUM study showed meaningful improvement in progression-free survival was main...
Source: Roche Media News - June 10, 2022 Category: Pharmaceuticals Source Type: news

U.S. FDA approves Foundation Medicine ’s FoundationOne®CDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib)
FoundationOneCDx can now be used to identify patients with ROS1 fusion-positive non-small cell lung cancer or patients with NTRK fusion-positive solidtumours for whom treatment withRozlytrek may be appropriateThis approval marks the first and only companion diagnostic indication forRozlytrek, and another important milestone intumour-agnostic approaches for people living with rare cancersRoche is a leader in drivingpersonalised healthcare around the world through validated diagnostic tools, genomic insights and a continued focus on drug developmentBasel, 9 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that ...
Source: Roche Media News - June 9, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer
In the Phase III IMpower010 trial, adjuvantTecentriq reduced the risk of disease recurrence or death by 57% in people with PD-L1 high resected Stage II-III NSCLC, compared with best supportive careTecentriq is now the firstand only cancer immunotherapy available for certain people with early-stage NSCLC in EuropeToday ’s approval marksTecentriq ’s sixth lung cancer indication in EuropeBasel, 09 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adu...
Source: Roche Media News - June 9, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
Lunsumio® (mosunetuzumab) is the first CD20xCD3 T-cell engaging bispecific antibody available to treat the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma (FL)Lunsumio represents a new type of immunotherapy that is a chemotherapy-free, off-the-shelf, fixed-duration treatment option that could improve outcomes for people who have relapsed or are refractory to multiple previous treatmentsApproval is based on the phase I/II GO29781 study, whereLunsumio induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pre-treated FLBa...
Source: Roche Media News - June 8, 2022 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
Approval based on interim RAINBOWFISH data which show pre-symptomatic babies treated withEvrysdi for at least one year were able to sit, stand and walkPrescribing information updated with FIREFISH data showing the majority of symptomatic babies treated withEvrysdi for at least two years could sit for at least five secondsEvrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to dateBasel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under...
Source: Roche Media News - May 31, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma ¹ Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and preferences of people with blood cancers Basel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new p...
Source: Roche Media News - May 27, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 showglofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma1Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody developmentprogramme, which aims to address the diverse needs and preferences of people with blood cancersBasel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on i...
Source: Roche Media News - May 27, 2022 Category: Pharmaceuticals Source Type: news

Roche ’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
First new treatment option in more than 20 years to show a clinically meaningful improvement in progression-free survival is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL)Approval is based on pivotal data from the phase III POLARIX study, where Polivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOPFirst-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression ¹Basel, 25 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today anno...
Source: Roche Media News - May 25, 2022 Category: Pharmaceuticals Source Type: news