[Ad hoc announcement pursuant to Art. 53 LR] Roche announces EMBARK trial in Duchenne muscular dystrophy (DMD) did not reach primary endpoint, but shows positive efficacy outcomes on all timed functional key endpoints
This study is ongoing.Study 301 (EMBARK), a Phase 3 global, randomised, double-blinded and placebo-controlled study of Elevidys in ambulatory Duchenne patients aged 4-<8 years old.The ENVOL trial (Study 302) a Phase 2 study in children with Duchenne. The study aims to enrol 21 participants who are under 4 years of age, including newborns. Not yet started.The ENVISION trial (Study 303), a Phase 3 study in older ambulatory/non-ambulatory patients which is now recruiting.The EXPEDITION long-term (5 year) follow up study (Study 305) of participants who have received Elevidys in a previous clinical study, which is not yet re...
Source: Roche Investor Update - October 31, 2023 Category: Pharmaceuticals Source Type: news
Sony ’s PlayStation Access controller offers a new social lifeline for gamers with disabilities
Grant Stoner said that he has loved playing video games his entire life, and that his earliest memory is of playing Super Nintendo in his parents’ bedroom at roughly 3 years old. “Gaming, for me, has always been a social activity,” Stoner, a Pittsburgh native who has spinal muscular atrophy type…#grantstoner #supernintendo #stoner #pittsburgh #popsicle #paulamadeuslane #sony #playstation #xbox #adaptivecontroller (Source: Reuters: Health)
Source: Reuters: Health - October 24, 2023 Category: Consumer Health News Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth despite decline in demand for COVID-19 products
Basel, 19 October 2023Groupsales grow by 1%1at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products,Group salesincrease by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division ’s base businessincreases by 7%;overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlightsin the third quarter of 2023:EU approval ofEvrysdifor babies under two months old with spinal muscular atrophyFirst approval of subcutaneous form of cancer immunotherapyTecen...
Source: Roche Media News - October 19, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth despite decline in demand for COVID-19 products
Groupsales grow by 1%1at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products,Group salesincrease by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division ’s base businessincreases by 7%;overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlightsin the third quarter of 2023:EU approval ofEvrysdifor babies under two months old with spinal muscular atrophyFirst approval of subcutaneous form of cancer immunotherapyTecentriqPositive phase III...
Source: Roche Investor Update - October 19, 2023 Category: Pharmaceuticals Source Type: news
Late-breaking data for Roche ’s BTK inhibitor fenebrutinib show brain penetration and significant reduction in lesions in patients with relapsing multiple sclerosis
New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS)More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at 8 weeksThe safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,500 people to dateBasel, 13 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from the Phase II FENopta study showing that inve...
Source: Roche Media News - October 13, 2023 Category: Pharmaceuticals Source Type: news
Late-breaking data for Roche ’s BTK inhibitor fenebrutinib show brain penetration and significant reduction in lesions in patients with relapsing multiple sclerosis
New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS)More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at 8 weeksThe safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,500 people to dateBasel, 13 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from the Phase II FENopta study showing that inve...
Source: Roche Investor Update - October 13, 2023 Category: Pharmaceuticals Source Type: news
New data for Roche ’s OCREVUS show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided
10-year efficacy data highlight OCREVUS ’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS)10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of OCREVUSMore than 3,200 women with MS treated with OCREVUS reported no increased risk in adverse pregnancy and infant outcomes with real-world analyses showing low risk of relapse during and after pregnancyOCREVUS controlled disease activity and progression over one year in Black and Hispanic / Latinx people with MSBasel, 12 October 2023 - Roch...
Source: Roche Media News - October 12, 2023 Category: Pharmaceuticals Source Type: news
New data for Roche ’s OCREVUS show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided
10-year efficacy data highlight OCREVUS ’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS)10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of OCREVUSMore than 3,200 women with MS treated with OCREVUS reported no increased risk in adverse pregnancy and infant outcomes with real-world analyses showing low risk of relapse during and after pregnancyOCREVUS controlled disease activity and progression over one year in Black and Hispanic / Latinx people with MSBasel, 12 October 2023 - Roch...
Source: Roche Investor Update - October 12, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions
Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeksOCREVUS subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeksThe safety profile of OCREVUS subcutaneous injection was consistent with the well-established safety profile of OCREVUS IV infusionThe 10-minute subcutaneous injection has potential to improve the treatment experience and expand usage for people with multiple sclerosis (MS) in centres...
Source: Roche Media News - October 11, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions
Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeksOCREVUS subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeksThe safety profile of OCREVUS subcutaneous injection was consistent with the well-established safety profile of OCREVUS IV infusionThe 10-minute subcutaneous injection has potential to improve the treatment experience and expand usage for people with multiple sclerosis (MS) in centres...
Source: Roche Investor Update - October 11, 2023 Category: Pharmaceuticals Source Type: news
Majority of newborn babies with spinal muscular atrophy (SMA) treated with Roche ’s Evrysdi able to sit independently after 1 year of treatment
RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least five seconds after 1 year of Evrysdi treatment – without treatment these babies would never be able to sitAll babies were able to swallow and feed orally and none required permanent ventilationEvrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globallyBasel, 04 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi ® (risdi...
Source: Roche Media News - October 4, 2023 Category: Pharmaceuticals Source Type: news
Majority of newborn babies with spinal muscular atrophy (SMA) treated with Roche ’s Evrysdi able to sit independently after 1 year of treatment
RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least five seconds after 1 year of Evrysdi treatment – without treatment these babies would never be able to sitAll babies were able to swallow and feed orally and none required permanent ventilationEvrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globallyBasel, 04 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi ® (risdi...
Source: Roche Investor Update - October 4, 2023 Category: Pharmaceuticals Source Type: news
Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD
Late-breaking results from Phase III trial of OCREVUS (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitorfenebrutinib in multiple sclerosis (MS) will be presented10-year OCREVUS efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MSAdditional OCREVUS real-world and clinical data show impact for underrepresented populations including more than 3,200 pregnant women and Black and Hispanic/Latinx patients with MSLonger-term safety data and late-breaking efficacy data from Phase III trial of ENSPRYNG (satralizumab) inneurom...
Source: Roche Media News - October 2, 2023 Category: Pharmaceuticals Source Type: news
Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD
Late-breaking results from Phase III trial of OCREVUS (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitorfenebrutinib in multiple sclerosis (MS) will be presented10-year OCREVUS efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MSAdditional OCREVUS real-world and clinical data show impact for underrepresented populations including more than 3,200 pregnant women and Black and Hispanic/Latinx patients with MSLonger-term safety data and late-breaking efficacy data from Phase III trial of ENSPRYNG (satralizumab) inneurom...
Source: Roche Investor Update - October 2, 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
