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Roche gets FDA priority review for Evrysdi to treat SMA in new-borns
pharmaceutical-business-review
January 27, 2022
Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) priority review for its Evrysdi...
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Roche awarded 2022 Drug Discovery of the Year for Evrysdi®
EuropeanPharmaceuticalReview
December 07, 2021
The British Pharmacological Society has given the team of scientists who discovered and developed Evrysdi® (risdiplam) the Drug Discovery of the Year Award 2022.
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Roche’s Evrysdi significantly improves lives of babies with SMA
europeanpharmaceuticalreview
August 02, 2021
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
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Roche records 8% increase in group sales for H1 2021
pharmaceutical-technology
July 26, 2021
Roche has reported an 8% increase in group sales to $33.46bn (CHF30.71bn) at constant exchange rates (CER) in the first half (H1) of 2021, as against $31.81bn (CHF29.28bn) in H1 last year.
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NICE draft guidance does not recommend Evrysdi for SMA
pharmatimes
June 04, 2021
The UK National Institute for Health and Care Excellence (NICE) has announced that it does not recommend Roche’s Evrysdi for the treatment of spinal muscular atrophy (SMA) in draft guidance.
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Evrysdi from ROCHE gets EC nod as home treatment for spinal muscular atrophy
expresspharma
March 31, 2021
Roche announced that the European Commission (EC) has approved Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to ...
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Evrysdi Trial Demonstrates Improvement of Motor Function in SMA Patients
americanpharmaceuticalreview
March 22, 2021
PTC Therapeutics announced two-year data from Part 2 of the SUNFISH trial evaluating Evrysdi™ (risdiplam) in children and adults with Type 2 or Type 3 spinal muscular atrophy (SMA) at the 2021 Muscular Dystrophy Association (MDA) Virtual and ...
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CHMP Adopts Positive Opinion for Evrysdi for Spinal Muscular Atrophy
americanpharmaceuticalreview
March 03, 2021
PTC Therapeutics announced 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 and ...
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Evrysdi leads latest CHMP recommendations
pharmatimes
March 02, 2021
The European Medicines Agency’s (EMA) Committee for Medicines for Human Use (CHMP) has recommended six medicines for approval at its February meeting.
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PTC Therapeutics Achieves $20M Roche Milestone
contractpharma
August 28, 2020
Payment was triggered by the first commercial sale of Evrysdi in the U.S. which was approved by the FDA on August 7 to treat SMA.