Two Deaths From Liver Failure Linked to Spinal Muscular Atrophy Drug Two Deaths From Liver Failure Linked to Spinal Muscular Atrophy Drug
Two children have died 5-6 weeks after infusion with the gene therapy drug onasemnogene abeparvovec (Zolgensma), a treatment for spinal muscular atrophy, its manufacturer reports.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - August 12, 2022 Category: Gastroenterology Tags: Neurology & Neurosurgery News Source Type: news

Roche to present scientific progress across Alzheimer ’s disease pharmaceutical and diagnostic portfolio at 2022 AAIC Annual Meeting
Overview of two decades of research to be presented, including development ofgantenerumabDetailed results from phase II study evaluatingcrenezumab in autosomal dominant Alzheimer ' s diseaseData around biomarker selection for theElecsys Amyloid Plasma Panel, a blood-based biomarker test to aid in the detection of people with amyloid pathology, recently granted FDA Breakthrough Device DesignationBasel, 28 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from 41 abstracts across its portfolio of Alzheimer ’s disease pharmaceuticals and diagnostics will be presented at the 2022 Alzheimer’s Associat...
Source: Roche Media News - July 28, 2022 Category: Pharmaceuticals Source Type: news

New tests may speed diagnoses of muscular disorder in infants, UTIs in kids
New tests could speed the diagnosis of spinal muscular atrophy, a rare but deadly progressive muscle-wasting disorder in infants, and urinary tract infections in children. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 26, 2022 Category: Consumer Health News Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follicular lymphoma) andT...
Source: Roche Investor Update - July 21, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news

Roche provides update on Alzheimer ’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease
Crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer ’s diseaseFor more than a decade Roche has been working in collaboration with Banner Alzheimer ’s Institute, the University of Antioquia in Colombia and the National Institute on Aging on this pioneering prevention studyInitial data will be presented at the upcoming Alzheimer ' s Association International ConferenceBasel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimer ’s Institute, today announced results from the Alzheimer’s Prevention Initiative (API...
Source: Roche Media News - June 16, 2022 Category: Pharmaceuticals Source Type: news

Early Identification Cuts Costs for Spinal Muscular Atrophy
TUESDAY, June 14, 2022 -- Early identification and treatment of patients with spinal muscular atrophy can reduce the total associated financial costs, according to a study published online June 8 in Developmental Medicine& Child... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 14, 2022 Category: Pharmaceuticals Source Type: news

FDA Approves Label Extension for Evrysdi for Infants with Spinal Muscular Atrophy Under 2 Months Old
SOUTH PLAINFIELD, N.J., May 31, 2022 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi (risdiplam) to include infants under 2 months old... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Expands Indication for Spinal Muscular Atrophy Drug FDA Expands Indication for Spinal Muscular Atrophy Drug
Originally approved for children with spinal muscular atrophy aged 2 months and older, risdiplam is now indicated for presymptomatic children younger than 2 months.FDA Approvals (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - May 31, 2022 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA approves Roche ’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
Approval based on interim RAINBOWFISH data which show pre-symptomatic babies treated withEvrysdi for at least one year were able to sit, stand and walkPrescribing information updated with FIREFISH data showing the majority of symptomatic babies treated withEvrysdi for at least two years could sit for at least five secondsEvrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to dateBasel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under...
Source: Roche Media News - May 31, 2022 Category: Pharmaceuticals Source Type: news

Burst of FDA Approvals; Monkeypox Poses 'Moderate' Threat; Hep A in Strawberries?
(MedPage Today) -- Note that some links may require registration or subscription. The FDA expanded the indication for risdiplam (Evrysdi) to include treatment of spinal muscular atrophy in infants under 2 months of age, drugmaker Roche announced... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - May 31, 2022 Category: American Health Source Type: news

FDA approves Roche ’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
Approval based on interim RAINBOWFISH data which show pre-symptomatic babies treated withEvrysdi for at least one year were able to sit, stand and walkPrescribing information updated with FIREFISH data showing the majority of symptomatic babies treated withEvrysdi for at least two years could sit for at least five secondsEvrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to dateBasel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under...
Source: Roche Investor Update - May 31, 2022 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. (Source: World Pharma News)
Source: World Pharma News - May 31, 2022 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

New three-year data for Roche ’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
91% of infants treated withEvrysdi in the FIREFISH study were still alive at three yearsInfants treated withEvrysdi maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 secondsEvrysdi has proven efficacy in infants and adults, with over 5,000 patients treated to dateBasel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi ® (risdiplam) in infants with symptomatic Type 1 spinal mu...
Source: Roche Media News - April 29, 2022 Category: Pharmaceuticals Source Type: news

New three-year data for Roche ’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
91% of infants treated withEvrysdi in the FIREFISH study were still alive at three yearsInfants treated withEvrysdi maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 secondsEvrysdi has proven efficacy in infants and adults, with over 5,000 patients treated to dateBasel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi ® (risdiplam) in infants with symptomatic Type 1 spinal mu...
Source: Roche Investor Update - April 29, 2022 Category: Pharmaceuticals Source Type: news