The Petri Dish: Sarepta hit with clinical hold, Decibel stock soars
The FDA has placed a clinical hold on a Duchenne muscular dystrophy drug made by Sarepta Therapeutics Inc. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 30, 2022 Category: Pharmaceuticals Authors: Rowan Walrath 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

Human Longevity offers AMRA BCP Scan to its members
Swedish image analysis software developer AMRA Medical has signed a definitiv...Read more on AuntMinnie.comRelated Reading: AMRA gets U.S., Canadian clearance for MRI-based body composition scan AMRA Medical gets FDA clearance for MasS Scan Canada greenlights distribution of AMRA's muscle scan AMRA touts liver MRI research at AASLD show AMRA joins clinical trial on muscular dystrophy (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - June 14, 2022 Category: Radiology Source Type: news

Code Biotherapeutics expects to double in size after raising $75M to advance gene therapy candidates
The company's first two targets are Duchenne muscular dystrophy and type 1 diabetes. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 7, 2022 Category: Pharmaceuticals Authors: John George 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

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

Five New Neurology Studies: Possible Breakthroughs, Some Failures Five New Neurology Studies: Possible Breakthroughs, Some Failures
Dr Christoph Diener on promising early results in muscular dystrophy and Creutzfeldt-Jakob disease, and discouraging ones for aducanumab.Medscape Neurology (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - May 9, 2022 Category: Neurology Tags: Neurology & Neurosurgery Commentary Source Type: news

Muscular dystrophy startup goes public in $108M IPO
PepGen, a Boston-based startup developing medicine for muscular dystrophies, raised $108 million in its Wall Street debut. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - May 6, 2022 Category: Pharmaceuticals Authors: Rowan Walrath 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

Trial May Set Standard for Steroid Therapy in Duchenne Muscular Dystrophy
(MedPage Today) -- SEATTLE -- Prednisone or deflazacort given every day were superior to prednisone on a 1o-days-on, 10-days-off schedule for boys with Duchenne muscular dystrophy (DMD), a researcher reported. In the international randomized... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 27, 2022 Category: Endocrinology Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth in the first quarter of 2022
Basel, 25 April 2022Group sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francsPharmaceuticals Divisionsales up 6%; continued strong sales of new medicines for severe diseases. Impact of biosimilars decreases as expected.Diagnostics Divisionsales grow 24% due to good momentum in base business and continued high demand for COVID-19 tests. After a strong first quarter, significant decline in COVID-19-related testing expected.Highlights in the first quarter:FDA approval of Vabysmo (severe eye diseases); CHMP recommends EU approval of Polivy combination (aggressive form of blood cancer), Tecentriq (early...
Source: Roche Media News - April 25, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth in the first quarter of 2022
Group sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francsPharmaceuticals Divisionsales up 6%; continued strong sales of new medicines for severe diseases. Impact of biosimilars decreases as expected.Diagnostics Divisionsales grow 24% due to good momentum in base business and continued high demand for COVID-19 tests. After a strong first quarter, significant decline in COVID-19-related testing expected.Highlights in the first quarter:FDA approval of Vabysmo (severe eye diseases); CHMP recommends EU approval of Polivy combination (aggressive form of blood cancer), Tecentriq (early-stage non-small cel...
Source: Roche Investor Update - April 25, 2022 Category: Pharmaceuticals Source Type: news

Optimal Treatment Regimen for Muscular Dystrophy Identified? Optimal Treatment Regimen for Muscular Dystrophy Identified?
Children treated with either daily prednisone or daily deflazacort (Emflaza) have better motor function than those receiving a standard prednisone regimen.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - April 6, 2022 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

New data for Roche ’s OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis
75% of patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS) achieved no evidence of progression (NEP) in a one-year interim analysis of CONSONANCE study70% of patients with SPMS and PPMS demonstrated stable or improved cognition after one year of OCREVUS treatment in CONSONANCESeparate analysis on treatment disparities showed fewer Black and Hispanic patients with MS initiate high-efficacy treatments within two years of diagnosisData at AAN support the body of evidence for OCREVUS more than 450,000 patient years and more than 225,000 patients treated globallyBasel, 04 April 2022 -...
Source: Roche Media News - April 4, 2022 Category: Pharmaceuticals Source Type: news