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Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
…as breathing, swallowing, speaking and walking. Left untreated, a baby’s muscles become progressively weaker eventually leading to paralysis or death, in most cases by his or her second birthday. Delivered…
Read MorePTC Therapeutics and Spinal Muscular Atrophy Foundation Announce $8.5 million Small Molecule Development Collaboration
…is a biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary, small-molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing…
Read MoreScholar Rock shares community update on SAPPHIRE, a clinical trial evaluating apitegromab in non-ambulatory patients with Type 2 and 3 SMA
…(FDA) or any other health authority. Questions and Answers: What is Myostatin? Myostatin is a protein found primarily in skeletal muscle (muscles that connect to your bones) cells. Higher than…
Read MoreSMA Foundation Announces Collaboration with PTC Therapeutics
…discovery and development of orally administered, proprietary small-molecule drugs that target post-transcriptional control processes. Posttranscriptional control processes regulate the rate and timing of protein production and are of central importance…
Read MoreDrug Development Process
…Application (BLA) can be submitted to the FDA for approval of the drug for marketing. Phase IV Trials: Post-marketing (i.e. post-approval) studies designed to provide additional information on the drug…
Read MoreIonis and Biogen Win Prestigious Prix Galien Best Biotechnology Product Award for SPINRAZA
The SMA Foundation congratulates Ionis and Biogen for being awarded the Prix Galien USA Award for the Best Biotechnology Product in 2017 for SPINRAZA® (nusinersen). The Prix Galien USA Award…
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