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Roche ’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1 The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (C...
Source: Roche Media News - November 14, 2023 Category: Pharmaceuticals Source Type: news

Roche & #039;s subcutaneous injection of Tecentriq recommended by the EU & #039;s CHMP for multiple cancer types
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers. (Source: World Pharma News)
Source: World Pharma News - November 14, 2023 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

[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 Media News - October 31, 2023 Category: Pharmaceuticals Source Type: news

[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

A chikungunya vaccine is nearing approval. Who will get it?
The first vaccine against the mosquito-borne viral disease chikungunya will likely come to market next month. With the debilitating disease now afflicting more than half the countries in the world and threatening to spread further, the imminent U.S. Food and Drug Administration (FDA) approval of the vaccine is “great news,” says Scott Weaver, a virologist at the University of Texas Medical Branch whose own lab started to work on a chikungunya vaccine nearly 2 decades ago. The vaccine, made by the French company Valneva, will likely be recommended mainly to U.S. travelers at first. But many expect an FDA approval ...
Source: ScienceNOW - October 30, 2023 Category: Science Source Type: news

Wegovy and Thyroid Cancer; Maine Shooter's Mental Health; 469 Heat Deaths
(MedPage Today) -- Note that some links may require registration or subscription. No causal connection exists between GLP-1 agonists such as semaglutide (Ozempic, Wegovy) and thyroid cancer, a safety panel for the European Medicines Agency concluded... (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - October 30, 2023 Category: Psychiatry Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaApproval is based on two phase III studies demonstrating early and sustained vision improvements that were non-inferior to afliberceptVabysmo also demonstrated rapid and robust drying of retinal fluidAdditional U.S. label update across indications includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion; reporting rate isin line withother broadly used intravitreal treatmentsBasel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) an...
Source: Roche Investor Update - October 27, 2023 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaApproval is based on two phase III studies demonstrating early and sustained vision improvements that were non-inferior to afliberceptVabysmo also demonstrated rapid and robust drying of retinal fluidAdditional U.S. label update across indications includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion; reporting rate isin line withother broadly used intravitreal treatmentsBasel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) an...
Source: Roche Media News - October 27, 2023 Category: Pharmaceuticals Source Type: news

French Regulator Approves Charcot Disease Treatment French Regulator Approves Charcot Disease Treatment
The French National Agency for Medicines and Health Products Safety has conditionally authorized a treatment previously rejected by the European Medicines Agency back in June.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - October 23, 2023 Category: Internal Medicine Tags: Neurology & Neurosurgery News Source Type: news

Roche ’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer
These Phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC)With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy,1 more effective treatment options are urgently needed to provide the best chance for cure2Data are being presented as a late-breaking oral during the ESMO 2023 Presidential SymposiumBasel, 18 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the primary analysis of the Phase III ALINA study demonstratin...
Source: Roche Investor Update - October 18, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer
These Phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC)With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy,1 more effective treatment options are urgently needed to provide the best chance for cure2Data are being presented as a late-breaking oral during the ESMO 2023 Presidential SymposiumBasel, 18 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the primary analysis of the Phase III ALINA study demonstratin...
Source: Roche Media News - October 18, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Vabysmo maintained vision improvements with extended treatment intervals up to four months for people with retinal vein occlusion (RVO) in phase III studies
Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous studiesRegulatory applications for Vabysmo in RVO are under review by health authorities around the world; if approved, RVO would be the third indication in addition to nAMD and DMEVabysmo is the first and only treatment that targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditionsBasel, 10 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline long-term results from the global phase III BALATON and COMINO studies, evaluating extended tre...
Source: Roche Media News - October 10, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Vabysmo maintained vision improvements with extended treatment intervals up to four months for people with retinal vein occlusion (RVO) in phase III studies
Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous studiesRegulatory applications for Vabysmo in RVO are under review by health authorities around the world; if approved, RVO would be the third indication in addition to nAMD and DMEVabysmo is the first and only treatment that targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditionsBasel, 10 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline long-term results from the global phase III BALATON and COMINO studies, evaluating extended tre...
Source: Roche Investor Update - October 10, 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