New clinical and real-world data for Roche ’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss
Late-breaking post-hoc data indicateVabysmo leads to less fibrosis, which may negatively impact vision, thanaflibercept in people with diabetic macular edema (DME)Real-world data reinforce that first-lineVabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people withneovascular or ‘wet’ age-related macular degeneration (nAMD) and DMEClinical data reiterateVabysmo ’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid controlVabysmo is currently approved in over 70 countries to treatnAMD and DME, with...
Source: Roche Investor Update - July 20, 2023 Category: Pharmaceuticals Source Type: news
Positive Phase III results for Roche ’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis
Phase III OCARINA II trial met primary and secondary endpointsOCREVUS twice a year, 10-minute injection has the potential to further improve the treatment experience and expand OCREVUS usage in MS centres with IV capacity limitations or without IV infrastructureOCREVUS remains the first and only therapy approved for both RMS and PPMS, and more than 300,000 people have been treated globallyBasel, 13 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III OCARINA II trial evaluating OCREVUS ® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in...
Source: Roche Investor Update - July 13, 2023 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphomaApproval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free periodBasel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) ha...
Source: Roche Investor Update - July 11, 2023 Category: Pharmaceuticals Source Type: news
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
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile ofEvrysdi in children with Type 1 SMANinety-one percent of children were alive at month 48More than 95% maintained the ability to swallow- without treatment they would have required feeding support and majority would have died within 2 yearsEvrysdi is now approved in 99 countries with more than 8,500 patients treated globallyBasel, 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 an...
Source: Roche Investor Update - June 30, 2023 Category: Pharmaceuticals Source Type: news
Invitation to Roche ’s Half Year Results 2023 Webinar
Roche will publish its Half Year Results of 2023 prior to the opening of the Swiss Stock Exchange onThursday, 27 July 2023. 07:00 CEST / 06:00BST / 01:00 AM EDT / 10:00 PM PDT (evening before)Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here 14:00 – 15:30 CEST / 13:00 – 14:30 BST08:00 – 09:30 AM EDT / 05:00 - 06:30 AM PDTThe webinar will start with presentations by senior management,followed by a Q&A session.Presenters:Thomas Schinecker, CEO Roche GroupTeresa Graham, CEO Roche PharmaceuticalsMatt Sause, CEO Roche...
Source: Roche Investor Update - June 27, 2023 Category: Pharmaceuticals Source Type: news
Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the First Gene Therapy to Treat Duchenne Muscular Dystrophy
Dear Investor,Please find attached a press release from our partner Sarepta Therapeutics:https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-fda-approval-elevidys-first-geneFor further information please also have a look at the attached Roche statement on the accelerated approval of Elevidys™ granted by the FDA.Do not hesitate to contact us for any further questions.With best regards,Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail:bruno.eschli@roche.com Dr. Sabine Borngr äberPhone: +41 61 68-88027e-mail:sabine.borngraeber@roche.com ...
Source: Roche Investor Update - June 23, 2023 Category: Pharmaceuticals Source Type: news
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
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1.5 years (18.4 months)1Given over a fixed period of time,Columvi provides patients with a treatment end date and potential time off treatmentColumvi is part of Roche ' s industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approvedLunsumioto treat follicular lymphomaBasel, 16 June 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved ...
Source: Roche Investor Update - June 16, 2023 Category: Pharmaceuticals Source Type: news
Roche awarded WHO prequalification for the cobas ® HPV test, increasing access to cervical cancer screening tools in low and lower-middle income countries
Every year, over 600,000 women worldwideare diagnosed with cervical cancer and over 340,000 die from this preventable disease, caused by infection with human papillomavirus (HPV). Nine out of 10 women who die from cervical cancer live in low- and lower-middle income countries (LMICs).1WHO prequalification enables LMICs to use thecobas® HPV test in their national cervical cancer elimination programs, increasing access to the patients who need it most.Establishing screening programs helps prevent and detect cervical cancer, which is especially important in areas with limited healthcare resources where patientsare often diag...
Source: Roche Investor Update - June 13, 2023 Category: Pharmaceuticals Source Type: news
New data show Roche ’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH)
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors1Monthly self-administration of subcutaneous crovalimab has the potential to address the high burden of a disease that requires lifelong treatment including in settings where access to currentC5 inhibitors is limited1,2The COMMODORE 1 study in people switching from currently approved C5 inhibitors supported the consistent benefit-risk profile of crovalimab as seen in the COMMODORE 2 study3Basel, 09 June 2023 - Roche (SIX: RO, ROG; ...
Source: Roche Investor Update - June 9, 2023 Category: Pharmaceuticals Source Type: news
Reminder: Invitation to Roche ’s virtual EHA 2023 event: Crovalimab in Hematology and Nephrology
We are pleased to invite investors and analysts to participate in our virtual event onMonday,12 June2023, highlighting crovalimab data presented during the congress scientific program on June 9, 2023, and our hematology and nephrology portfolio.16:30 – 17:30 CEST / 15:30 - 16:30BST10:30 – 11:30 amEDT / 7:30 – 8:30 am PDT The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for downloadat 15:30 CEST on the day of the event.>click here AgendaWelcomeBruno Eschli, Head of Investor RelationsRoche hematology franchise andcrovalimab deep...
Source: Roche Investor Update - June 5, 2023 Category: Pharmaceuticals Source Type: news
Roche to present new data in blood cancers and solid tumours from its broad portfolio at ASCO 2023
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. Highlights include new data spanning treatments for lymphoma and hepatocellular carcinoma (HCC):Developing new treatment options for people with blood cancersExtended follow-up data for Columvi ® (glofitamab) of almost two years (20 months) from the pivotal phase II NP30179 study, further investigating the potential of fixed-duration Columvi to provide durable responses in people...
Source: Roche Investor Update - May 26, 2023 Category: Pharmaceuticals Source Type: news
Invitation to Roche ’s virtual EHA 2023 event: Crovalimab in Hematology and Nephrology
We are pleased to invite investors and analysts to participate in our virtual event onMonday,12 June2023, highlighting crovalimab data presented during the congress scientific program on June 10, 2023, and our hematology and nephrology portfolio. 16:30 – 17:30 CEST / 15:30 - 16:30BST10:30 – 11:30 amEDT / 7:30 – 8:30 am PDT The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for downloadat 15:30 CEST on the day of the event. >clickhere Access to virtual event (pre-registration required)Please pre-register for our webi...
Source: Roche Investor Update - May 17, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis
Fenebrutinib is an investigational, potent and highly selective oralBruton ’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trialsPhase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placeboThe safety profile offenebrutinib was consistent with previous and ongoing clinical trials across more than 2,400 people to dateBasel, 17 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today p...
Source: Roche Investor Update - May 17, 2023 Category: Pharmaceuticals Source Type: news
Reminder: Invitation to Roche ’s virtual ESG event: Environmental Sustainability
We are pleased to invite investors and analysts to participate in our virtual event onTuesday, 23 May 2023.The event will focus on Roche ’s efforts to address environmental sustainability challenges and highlight initiatives across the entire organization and value chain.15:30 – 17:00 CEST / 14:30– 16:00 BST9:30 – 11:00 am EDT / 6:30 – 8:00 am PDTThe webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at14:30 CEST on the day of the event.>click hereAgendaWelcomeBruno Eschli, Head of Investor RelationsWhy does ESG matt...
Source: Roche Investor Update - May 15, 2023 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY...
Source: Roche Investor Update - May 9, 2023 Category: Pharmaceuticals Source Type: news
