Roche to present new data from its expanding neuromuscular disease portfolio at World Muscle Society 2022
New positive data fromEvrysdi, a treatment for spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatalData from the gene therapyprogramme forDuchenne muscular dystrophy (DMD), a progressive disease that leads to premature death, reinforce confidence in the most advanced Phase 3 study currently underwayStudy designs of two new trials ingeneralised myasthenia gravis (gMG), a rare chronic autoimmune disease, andfacioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorderBasel, 05 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its industry-leading n...
Source: Roche Media News - October 5, 2022 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. These patients with HER2 low status may now be eligible for a targeted treatment, which could significantly improve their outcomes.1,2The PATHWAY anti-HER2 (4B5) test is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients. These patients may now consider ENHERTU as a treatment option based on the results of the Phase 3 DESTINY-Breast04 trial.3Basel, 4 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug ...
Source: Roche Media News - October 4, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Corporate Executive Committee in January 2023
Basel, 3 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Matt Sause (45), currently Head of Roche Diagnostics ’ North America Region, will become CEO Roche Diagnostics and a member of the Corporate Executive Committee effective 1 January 2023.Thomas Schinecker, the incumbent CEO of the Diagnostics Division and new Roche CEO as of 15 March 2023: “Matt Sause’s career at Roche has spanned twenty years in multiple countries across Asia, Latin America, Europe and North America in both the Diagnostics and Pharma divisions. His combination of scientific knowledge with commercial experience makes him a...
Source: Roche Media News - October 3, 2022 Category: Pharmaceuticals Source Type: news

Change in the Roche Board of Directors
Basel, 26 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Julie Brown has notified the Board that she will step down as a member of the Roche Board of Directors as she has accepted a management role at another pharmaceutical company. This change will be effective from today.Ms. Brown was elected to the Board of Directors in March 2016 and has since been the Chairwoman of the Audit Committee. Dr. Patrick Frost will chair the Audit Committee on an interim basis until the Annual General Meeting in March 2023.Roche Chairman Christoph Franz: " As a Board member and Chairwoman of the Audit Committee, Jul...
Source: Roche Media News - September 26, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Media News - September 19, 2022 Category: Pharmaceuticals Source Type: news

Roche launches a digital PCR system, a powerful new diagnostics platform in the fight against cancer and other diseases
The DigitalLightCycler System is a next-generation digital PCR system that helps clinicalresearchers better understand the nature of a patient ’s cancer, genetic disease or infection.The newsystem has the potential to find and quantify ultra-rare, hard to detect mutations, leading to early diagnosis and treatment strategies.The DigitalLightCycler Systemis designed for laboratories performing highly sensitive and precise DNA and RNA analysis in areas such as oncology and infectious diseases.Basel, 23 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Digital LightCycler Ⓡ System, Roche’...
Source: Roche Media News - August 23, 2022 Category: Pharmaceuticals Source Type: news

FDA accepts supplemental Biologics License Application for Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphomaApplication is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced therisk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company ' s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoingBasel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the compan...
Source: Roche Media News - August 16, 2022 Category: Pharmaceuticals Source Type: news

Roche launches new diagnostic test for the better understanding of immune response to SARS-CoV-2
Elecsys IGRA SARS-CoV-2 testsupports the better understanding of immuneresponse to SARS-CoV-2 infection or vaccinationThe test detects T-cell response, which may play an important role in determining if immune protection has been achievedThenew diagnostic testmayprovide clinical care guidance, particularly forimmunocompromised and high-risk patient groupsBasel, 15 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys ® IGRA SARS-CoV-2 test in countries that accept the CE Mark1. The Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection...
Source: Roche Media News - August 15, 2022 Category: Pharmaceuticals Source Type: news

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of ageThe FDA also approved Xofluza to prevent influenza in children aged five years and older following contact with an infected personBasel, 12 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years o...
Source: Roche Media News - August 12, 2022 Category: Pharmaceuticals Source Type: news

Roche ’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results
IMscin001 study showed non-inferior levels of cancer immunotherapyTecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancerAdministered under the skin, the subcutaneous formulation reduces time spent receiving treatment to just minutes, compared with up to an hour for IV infusionData will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines AgencyBasel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous form...
Source: Roche Media News - August 2, 2022 Category: Pharmaceuticals Source Type: news

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