Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease
Zilebesiran met primary endpoint demonstrating greater than 15 mmHg reduction of systolic blood pressure at three months of treatment compared to placeboStudy met key secondary endpoints showing consistent and sustained reductions of systolic blood pressure at six monthsZilebesiran demonstrated an encouraging safety and tolerability profile in adult patients with mild-to-moderate hypertensionFull study results to be presented at an upcoming scientific conferenceBasel, 7 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi the...
Source: Roche Media News - September 7, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecens...
Source: Roche Media News - September 1, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes
Tecentriq subcutaneous (SC) is now approved in Great Britain for all indications of intravenousTecentriq, including certain types of lung, bladder, breast and liver cancer, offering a faster, more convenient option to receive treatmentAdministered under the skin within approx. seven minutes,Tecentriq SC saves time for patients and helps conserve resources in healthcare systems1Evaluations by the FDA, EMA and other health authorities globally are ongoingBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq ® SC (atezolizumab) has been approved by the Medicines and Healthcare products Reg...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Evrysdi available to treat people of all ages with SMA in the European Union, including babies from birth1Approval is based on interim data from ongoing RAINBOWFISH trial showing majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment2,3Evrysdi is the only non-invasive SMA therapy and is approved in 100 countries with more than 11,000 patients treated globallyBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi ® (risdiplam) European Union (EU) marketing ...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III Skyscraper-01 study in PD-L1-high metastatic non-small cell lung cancer
Basel, 23 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq ® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators. We are continuing the study until the final analysis for overall survival. All other stud...
Source: Roche Media News - August 23, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in both divisions ’ base business; Group sales and profit reflect declining demand for COVID-19 products
Basel, 27 July 2023Excluding COVID-19 products,Groupsales increase strongly by 8%1at constant exchange rates (CER)In line with the expected declining demand for COVID-19 products,Groupsales decrease 2% (-8% in Swiss francs)Pharmaceuticals Division sales grow strongly by 8% due to continued high demand for newer medicines; new eye medicine Vabysmo is the strongest growth driverDiagnostics Division ’s base businesscontinues its good growth momentum with an increase of 6%, while total divisional sales are 23% lower due to exceptionally high demand for COVID-19 tests in the first half of 2022Core earnings per share decrease ...
Source: Roche Media News - July 27, 2023 Category: Pharmaceuticals Source Type: news
Roche enters partnership with Alnylam to co-develop and co-commercialise RNAi therapeutic zilebesiran to treat hypertension in patients with high cardiovascular risk
Partnership combines Roche ’s proven track record of successfully developing and launching innovative medicines worldwide withAlnylam ’s leadership in RNAi therapeuticsZilebesiran, a Phase 2 RNAi therapeutic, has best-in-disease potential for patients with hypertension at high risk of cardiovascular morbidity and mortality, by robustly and durably lowering blood pressureHypertension, the leading cause of cardiovascular disease, affects more than 1.2 billion adults worldwide. While several therapies exist, a significant unmet need, especially for high risk patients, remains.1Basel, 24 July 2023 - Roche (SIX: RO, ROG; OT...
Source: Roche Media News - July 24, 2023 Category: Pharmaceuticals Source Type: news
CHMP recommends Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment1,2If approved by the European Commission,Evrysdi will be available to treat people of all ages with SMA in the European Union, including babies from birthEvrysdi is now approved in 100 countries with more than 8,500 patients treated globallyBasel, 21 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive o...
Source: Roche Media News - July 21, 2023 Category: Pharmaceuticals Source Type: news
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 Media News - 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 Media News - 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 Media News - 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 Media News - June 30, 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 Media News - June 27, 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 Media News - 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 Media News - June 9, 2023 Category: Pharmaceuticals Source Type: news
