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Roche s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition Swiss Stock Exchange:RO

Systemic sclerosis (SSc) is a rare disease that affects about 2.5 million people worldwide Approximately 80% of SSc patients may be affected by.

United statesNathalie meetzClin rheumatolLevi garrawayDaniel grotzkyActemra roactemraPatrick barthKarsten kleineChugai pharmaceutical co ltdDrug administrationHead of global product developmentUniversity of michigan healthRoche groupPharmaceuticals industryRoche group media relationsPriority review

Investegate |F Hoffmann-La Roche Ltd Announcements | F Hoffmann-La Roche Ltd: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

Investegate announcements from F. Hoffmann-La Roche Ltd, EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

United statesUnited kingdomNathalie meetzLevi garrawayDaniel grotzkyPatrick barthKarsten kleineUs department of healthHuman servicesBiomedical advanced researchDrug administrationHead of global product developmentDevelopment authorityEuropean medicines agencyRoche groupOffice of the

Press Release: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

(2) Press Release: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19 CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab; Roche will be responsible for distribution in Europe and other countries outside the US Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed

United kingdomKostenloser wertpapierhandelLevi garrawayMark rocheUs department of healthHuman servicesBiomedical advanced researchDrug administrationHead of global product developmentDevelopment authorityEuropean medicines agencyOffice of theCommittee for medicinal products human usePress releaseHuman useChief medical officer

F Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older

F. Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings Evrysdi is approved in seven countries, submitted in 30 more Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease. SMA causes progressive muscle weakness and atrophy, and significant unmet need remains, particu

United statesSouth koreaNathalie meetzJon kaspar bayardLevi garrawayDaniel grotzkyKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLoren kalmLisa tuomiPatrick barthKarsten kleineToddler development

F Hoffmann-La Roche Ltd: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

F Hoffmann-La Roche Ltd: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
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United statesUnited kingdomNathalie meetzLevi garrawayDaniel grotzkyJon kaspar bayardKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLisa tuomiLoren kalmPatrick barthKarsten kleineUs department of health