Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Basel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has granted conditional marketing authorisation for Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. With this approval, Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, Columvi is designed to be given for a fixed period of time meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that people do not have to wait for cell collection and genetic engineering - a multistep process that can take several weeks - before starting treatment. This could be particularly important for patients who are at a high-risk of their disease progressing.

European Commission approves Roche's fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma

Roche's (RHHBY) SMA drug Evrysdi maintains its efficacy and safety profile in children with type 1 SMA after four years of treatment.

Roche (RHHBY) Announces Positive Long-Term Data on SMA Drug

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new long-term data for Evrysdi® (risdiplam) from the open-label extension (n=50) of the pivotal FIREFISH study, reinforcing its sustained efficacy and safety profile in children with Type 1 spinal muscular atrophy (SMA). FIREFISH is a two-part study in babies aged 1-7 months at the time of enrollment. After four years of treatment with Evrysdi, many of the babies, n.

Four-Year Follow-Up Data for Genentech's Evrysdi Show Continued Increase in Number of Children With a Severe Form of Spinal ​Muscular ​Atrophy (SMA)​ Able to Sit, Stand and Walk

Basel, 30 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new long-term data for Evrysdi® (risdiplam) from the open-label extension (n=50) of the pivotal FIREFISH study, reinforcing its sustained efficacy and safety profile in children with Type 1 spinal muscular atrophy (SMA). FIREFISH is a two-part study in babies aged 1-7 months at the time of enrolment. After four years of treatment with Evrysdi, many of the babies, now young children, continued to improve their ability to sit, stand and walk without support. All the Evrysdi-treated children who were alive at the time of the primary analysis were still alive at month 48. Additionally, the majority of infants maintained their ability to feed by mouth and swallow up to month 48. Motor function was assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III) and Hammersmith Infant Neurological Examination 2 (HINE-2) and abilities were either maintained or improved over four years of Evrysdi treatment. Without treatment, children with Type 1 SMA are not expected to live past two years of age and are never able to sit without support. These data were presented at the Cure SMA Research & Clinical Care Meeting, June 28 – 30, 2023. Among the infants treated with Evrysdi (n=58), 37 were able to sit without support for at least 5 seconds at month 48, compared to 35 at month 24 (BSID-III). In addition, 36 infants were able to sit without support for at least 30 seconds at month 48, up from 23 infants at month 24. Between month 24 and month 48, three infants gained the ability to stand alone and one infant gained the ability to walk alone. “Evrysdi's oral route of administration allows the medicine to be distributed throughout the body, systemically increasing SMN protein production, the lack of which is the underlying cause of SMA,” said Dr Giovanni Baranello, UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital, London, UK. “This has shown to help in delivering a meaningful impact on important functions of daily living including motor milestones, feeding and swallowing, which were maintained or improved in this long-term study, while also offering a tolerable safety profile.” Evrysdi is the first and only small molecule pre-mRNA splicing modifier that targets survival motor neuron-2 (SMN2) for the treatment of SMA, and can be administered at home in liquid form by mouth or by feeding tube. “The independence that comes with sitting, standing and walking is transformational for children with SMA, and their families, and we are very encouraged by how these skills increased over four years of Evrysdi treatment for many children in this study,” said Levi Garraway, M.D., Ph. D., Chief Medical Officer and Head of Global Product Development. “Nine out of 10 patients in our studies remain on Evrysdi long-term and these data underscore its importance as an option for people with SMA across a broad range of age and disease types.” No treatment-related adverse events (AEs) led to treatment discontinuation or withdrawal from the study, and the rate of AEs decreased by 71% between the first and fourth 12 month periods. The most common AEs were pyrexia (62%), upper respiratory tract infection (62%) and pneumonia (48%). The rate of hospitalisations decreased over the study period.

Four-year follow up data for Roche's Evrysdi show continued increase in number of children with a severe form of spinal muscular atrophy (SMA) able to sit, stand and walk

CHICAGO--(BUSINESS WIRE)-- #appointments--BearingPoint, an independent management and technology consulting firm with US headquarters in Chicago, announces Fabrice Roche has joined its US leadership as Partner focused on digital transformation. An industry veteran, Roche joins BearingPoint with over 20 years of experience in management consulting leading complex programs and transformation initiatives for Fortune 500 companies in the US, Canada, and Europe across multiple functions and sectors, with specific k.

BearingPoint Grows with Addition of Fabrice Roche as US Partner

The Elecsys® tTau/Abeta42 ratio helps clinicians define Alzheimer's disease (AD) biologically and expands Roche's AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's: amyloid plaques, tau tangles and neurodegeneration. Confirmation of amyloid pathology via CSF FDA-cleared Alzheimer's biomarker testing or amyloid positron emission tomography (PET) is recommended in the appropriate use recommendations for new and emerging disease-modifying therapies (DMTs) shown to slow down cognitive decline when administered in early-disease stages.

Roche receives FDA clearance for additional Alzheimer's disease Cerebrospinal Fluid (CSF) assays, supporting timely diagnosis and treatment decision-making

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Roche's (RHHBY) blood cancer portfolio gets a boost with the approval of Columvi (glofitamab-gxbm) for treating patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Roche (RHHBY) Gets FDA Approval for Blood Cancer Drug Columvi

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The U.S. Food and Drug Administration (FDA) greenlighted Roche Holding AG's experimental therapy to treat a type of advanced blood cancer, nearly a month after the approval of a rival therapy from AbbVie Inc.

Roche's cancer therapy gets US FDA nod, heating up competition with AbbVie

Basel, 16 June 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the phase I/II NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Columvi will be available in the US in the coming weeks.  “People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs.” DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the US.2 While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes.3,4 “Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” said Krish Patel, M.D., Director of the Lymphoma Program at the Swedish Cancer Institute in Seattle and investigator of the Columvi phase I/II NP30179 study. “Experience from clinical trials demonstrates that Columvi can provide patients with relapsed or refractory diffuse large B-cell lymphoma a chance for complete remission with a fixed duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”   The FDA accelerated approval is based on positive results from the phase I/II NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including about one-third (30%) who had received prior CAR T-cell therapy. Additionally, 83% were refractory to their most recent therapy. Results showed patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response (OR; 74/132 [95% confidence interval (CI): 47-65]) and 43% of patients achieving a complete response (CR; 57/132 [95% CI: 35-52]). Over two-thirds of those who responded continued to respond for at least nine months (68.5% [95% CI: 56.7-80.3]). The OR rate is the combination of CR rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response was 1.5 years (18.4 months [95% CI: 11.4-not estimable]).1 Data from the NP30179 study were recently published in the New England Journal of Medicine.  Among 145 patients who received Columvi in the study, the most common adverse events (AEs) were cytokine release syndrome (CRS; 70%), which may be serious or life-threatening, musculoskeletal pain (21%), fatigue (20%) and rash (20%). CRS was generally low grade (52% experienced Grade 1, and 14% experienced Grade 2). 1  Columvi is the first and only CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R DLBCL that is given for a defined period of time, unlike treat-to-progression approaches where treatment is given indefinitely until the cancer progresses or the therapy cannot be tolerated, whichever occurs first. Designed to be completed in approximately 8.5 months, Columvi offers people with R/R DLBCL a target end date for their course of treatment and the possibility of a treatment-free period. Additionally, Columvi is a chemotherapy-free treatment option that is off-the-shelf and ready for infusion. Columvi is part of Roche's broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme. This includes the phase III STARGLO study evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with DLBCL who have been treated with one or more previous therapies and are ineligible for autologous stem cell transplant. Roche's haematology bispecific antibody portfolio also includes Lunsumio® (mosunetuzumab), which was granted accelerated approval by the FDA in December 2022 for the treatment of adult patients with R/R follicular lymphoma (FL) after two or more lines of systemic therapy. Roche is exploring the potential of both Columvi and Lunsumio as monotherapies and in combination with other therapies, including Polivy® (polatuzumab vedotin), in earlier lines of treatment with the goal of providing patients with long-lasting outcomes. This robust development programme includes two phase III studies: CELESTIMO, investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy in 2L+ DLBCL. Columvi received its first worldwide approval in Canada, and the European Medicines Agency's Committee for Medicinal Products for Human Use recently granted a positive opinion recommending its approval. About  Columvi ® ( glofitamab-gxbm ) Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A clinical development programme for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers. About the NP30179 study The NP30179 study [ NCT03075696 ] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Columvi® (glofitamab-gxbm) in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by an independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints). About diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.2 DLBCL is an aggressive (fast-growing) type of NHL.2 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.3,4 Improving treatments earlier in the course of the disease and providing needed alternative options could help to improve long-term outcomes. Approximately 160,000 people worldwide are estimated to be diagnosed with DLBCL each year.5 About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes a T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

FDA approves Roche's Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under ac.

FDA Approves Genentech's Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Basel, 13 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation's list in making purchasing and implementation decisions.

Roche awarded WHO prequalification for the cobas® HPV test, increasing access to cervical cancer screening tools in low and lower-middle income countries

Roche (RHHBY) crovalimab achieves disease control in paroxysmal nocturnal hemoglobinuria patients in the phase III COMMODORE 1 and COMMODORE 2 studies.

Roche (RHHBY) Announces Positive Results From PNH Studies

Basel, 09 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that positive results from the global phase III COMMODORE 1 and 2 studies, evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, compared to eculizumab, a current standard of care in paroxysmal nocturnal haemoglobinuria (PNH) were presented at the European Hematology Association (EHA) Hybrid Congress, taking place in Frankfurt, Germany on 8-11 June 2023.

New data show Roche's subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that positive results from the global Phase III COMMODORE 1 and 2 studies, evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, compared to eculizumab, a current standard of care in paroxysmal nocturnal hemoglobinuria (PNH), were presented at the European Hematology Association (EHA) Hybrid Congress, taki.

New Data Show Genentech's Subcutaneously Administered Crovalimab Achieved Disease Control and Was Well-Tolerated in People With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Potentially registrational trial with Nykode's lead candidate VB10.16 and Roche's atezolizumab (Tecentriq®) in the U.S. is expected to be initiated 4Q 2023 Potentially registrational trial with Nykode's lead candidate VB10.16 and Roche's atezolizumab (Tecentriq®) in the U.S. is expected to be initiated 4Q 2023

Nykode Therapeutics Announces Expansion of Clinical Collaboration with Roche to Evaluate VB10.16 in Combination with anti-PD-L1 in the next trial in Advanced Cervical Cancer

Swiss drugmaker Roche Holding AG plans to sell or close its drug manufacturing plant in Vacaville, California, or it will shut the factory down by 2029, according to e-mailed letters to the plant's workers obtained by Reuters on Wednesday.

Roche looking to sell Vacaville, California plant

Arcus Biosciences

Shares of Arcus Biosciences surged Friday after Roche provided "meaningful" evidence for a new cancer treatment class. The post Arcus Biosciences Soars On Roche's 'Meaningful' Results In A New Cancer Drug Class appeared first on Investor's Business Daily.

Arcus Biosciences Soars On Roche's 'Meaningful' Results In A New Cancer Drug Class

Basel, 26 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will be presenting new data on six approved and investigational medicines across ten cancer types at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held 2 – 6 June.

Roche to present new data in blood cancers and solid tumours from its broad portfolio at ASCO 2023

It is expected that the market opportunity for disease-modifying therapies for MS will reach $29.8 billion in 2030; further projected that OCREVUS could generate sales of $6.3 billion by 2030. Roche Holding AG reported positive results reported from its phase 2 FENopta study, which used BTK inhibitor fenebrutinib for patients with RMS; Fenebrutinib is the only reversible BTK inhibitor in phase 3 testing for MS positive results reported from phase 2 FENopta study, which used BTK inhibitor fenebrutinib for patients with RMS; Fenebrutinib is the only reversible BTK inhibitor in phase 3 testing for MS.

Roche, With Ocrevus And Fenebrutinib Advancement, Should Be Top MS Contender

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The debt ceiling crisis is coming down to the wire. We're possibly already out of time to prevent default and just don't know it. UBS estimates a short default could create a 20% bear market and a one-month default could lead to a 44% crash.

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Roche's (RHHBY) investigational oral fenebrutinib meets its primary and secondary endpoints in the phase II FENopta study.

Roche's (RHHBY) MS Drug Meets Goals in the Phase II Study

Roche said on Wednesday that its multiple sclerosis drug candidate, part of a class of compounds that has been linked to cases of liver damage, reduced brain lesions in a mid-stage trial and that no new safety concerns emerged.

Roche says new MS drug shown to reduce brain lesions

Basel, 17 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS.

Roche's BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre.

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