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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 vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing. The FDA has set October 26, 2023, as the Prescription Drug User Fee Act (PDUFA) target action date.
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Bringing more control to temperature-sensitive logistics

UPS Supply Chain Solutions

By 2016, world sales of cold-chain drugs and biologics such as vaccines and blood plasma products will near $240 billion1. The increase has led to a surge in discussion about how to protect these products throughout the transportation logistics cycle. Industry experts are recommending that the term “cold chain” be eliminated from rules, guidance and best-practice documents. “Cold chain” now includes a broader spectrum of temperature ranges, such as controlled room temperature (CRT). This white paper focuses on the initial steps required to establish a temperature-sensitive supply chain.
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