UW spinout raises over $5M to target neuromuscular diseases
Myosana's first target is Duchenne muscular dystrophy, a genetic disorder that leads to muscle degeneration. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 31, 2023 Category: Biotechnology Authors: Rick Morgan Source Type: news

Rockville biotech RegenxBio launches clinical trial in muscular dystrophy
It's one of a series of treatments RegenxBio is developing as it aims to bring multiple products to market by 2025. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - January 24, 2023 Category: American Health Authors: Sara Gilgore Source Type: news

Rockville biotech RegenxBio launches clinical trial in muscular dystrophy
It's one of a series of treatments the company is developing as it aims to bring multiple products to market by 2025. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 23, 2023 Category: Biotechnology Authors: Sara Gilgore Source Type: news

Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 9, 2023 Category: Drugs & Pharmacology Source Type: news

Drug Trial Snapshot: AMONDYS 45
AMONDYS 45 is a drug for the treatment of a particular type of Duchenne muscular dystrophy (DMD). It is to be used only in patients who have a specific mutation of the dystrophin gene. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 2, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Sarepta Therapeutics Announces That U.S. FDA has Accepted Filing and Granted Priority Review for the Biologics License Application for SRP-9001, Sarepta ’s Gene Therapy for Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
Dear Investor,Please find attached a press release by Sarepta Therapeutics regarding the FDA acceptance of filing and priority review  of our partnered DMD asset:https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-us-fda-has-accepted-filing-andDo not hesitate to contact us for any further questions.With best regards,Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail:bruno.eschli@roche.com Dr. Sabine Borngr äberPhone: +41 61 68-88027e-mail:sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail:birgit.masjost@roche.comDr. Gerard ...
Source: Roche Investor Update - November 28, 2022 Category: Pharmaceuticals Source Type: news

Sarepta Surges As It Nears The Finish Line With A Muscular Dystrophy Gene Therapy
The Food and Drug Administration said Monday it will perform a speedy review of Sarepta Therapeutics' (SRPT) muscular dystrophy gene therapy, and SRPT stock jumped.X Sarepta filed for approval based on three clinical studies of the gene therapy, SRP-9001. But one study, called Embark, is still…#sareptatherapeutics #sarepta #genetherapy #srpt #gene #sareptagene #therapeutics #therapy #fda #embark (Source: Reuters: Health)
Source: Reuters: Health - November 28, 2022 Category: Consumer Health News Source Type: news

Sarepta Therapeutics Announces That U.S. FDA has Accepted for Filing and Granted Priority Review for the Biologics License Application for SRP-9001, Sarepta ’s Gene Therapy for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
Regulatory action date of May 29, 2023 SRP-9001 would be the first gene therapy for Duchenne, a one-time treatment designed to treat the underlying cause of DMD by delivering a functional shortened dystrophin to muscle CAMBRIDGE, Mass., Nov.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 28, 2022 Category: Drugs & Pharmacology Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer ’s disease
Phase III GRADUATE studies did not meet their primary endpoints of slowing clinical decline in people with early Alzheimer ’sThe level of beta-amyloid removal by gantenerumab was lower than expectedTopline data will be presented at the Clinical Trials on Alzheimer ’s Disease (CTAD) ConferenceRoche is committed to the Alzheimer ’s community and will continue to develop novel diagnostics and potential treatments for Alzheimer’sBasel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) du...
Source: Roche Investor Update - November 14, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer ’s disease
Phase III GRADUATE studies did not meet their primary endpoints of slowing clinical decline in people with early Alzheimer ’sThe level of beta-amyloid removal bygantenerumab was lower than expectedTopline data will be presented at the Clinical Trials on Alzheimer ’s Disease (CTAD) ConferenceRoche is committed to the Alzheimer ’s community and will continue to develop novel diagnostics and potential treatments for Alzheimer ’sBasel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) du...
Source: Roche Investor Update - November 14, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer ’s disease
Phase III GRADUATE studies did not meet their primary endpoints of slowing clinical decline in people with early Alzheimer ’sThe level of beta-amyloid removal bygantenerumab was lower than expectedTopline data will be presented at the Clinical Trials on Alzheimer ’s Disease (CTAD) ConferenceRoche is committed to the Alzheimer ’s community and will continue to develop novel diagnostics and potential treatments for Alzheimer ’sBasel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) du...
Source: Roche Media News - November 14, 2022 Category: Pharmaceuticals Source Type: news

News at a glance: A new antibiotic, COVID-19 in Antarctica, and a Venus mission deferred
CLIMATE SCIENCE Space station carbon mapper faces demise An orbiting fridge-size sensor that uses lasers to map forest structure—key to understanding how much carbon trees sequester—is set to plummet to a fiery destruction in the atmosphere in 2023 unless NASA extends its tenure. Researchers and some U.S. Congress members are lobbying the agency to reconsider its plan to jettison the Global Ecosystem Dynamics Investigation (GEDI) instrument from the International Space Station to make way for a Department of Defense sensor. GEDI measures the height of trees and the quality of habitat they provide...
Source: ScienceNOW - November 10, 2022 Category: Science Source Type: news

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, October 27, 2022– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2022 Category: Drugs & Pharmacology Source Type: news

Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile
77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients who had not received prior treatment achieved no evidence of disease activity (NEDA) at two yearsInitiation of OCREVUS as first-line treatment reduces relapses,hospitalisations and costs compared with using OCREVUS in second-line settingNine-year long-term safety data for OCREVUS further reinforcefavourable benefit-risk profile; more than 250,000 people have been treated globallyPregnancy outcomes reported for more than 2,000 women with multiple sclerosis (MS) treated with OCREVUS do not suggest an increased risk of adverse pregnancy and infant outco...
Source: Roche Media News - October 26, 2022 Category: Pharmaceuticals Source Type: news

Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile
77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients who had not received prior treatment achieved no evidence of disease activity (NEDA) at two yearsInitiation of OCREVUS as first-line treatment reduces relapses,hospitalisations and costs compared with using OCREVUS in second-line settingNine-year long-term safety data for OCREVUS further reinforcefavourable benefit-risk profile; more than 250,000 people have been treated globallyPregnancy outcomes reported for more than 2,000 women with multiple sclerosis (MS) treated with OCREVUS do not suggest an increased risk of adverse pregnancy and infant outco...
Source: Roche Investor Update - October 26, 2022 Category: Pharmaceuticals Source Type: news