Recently showcased on local media, North Platte Nebraska’s Great Plains Health (GPH) has treated at least 20 patients with Aviptadil (RLF-100), an investigational product recently submitted for emergency use authorization in late September. One of those surviving...
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Patient’s Fiancé Tries to get Memorial Baptist Hospital to Treat her Future Husband with RLF-100
Leticia Pacheco’s fiancé is battling for his life against COVID-19. The family has heard that Aviptadil (RLF-100), not yet approved by the U.S. Food and Drug Administration (FDA), but purported to work, is currently an investigational drug used in clinical trials at...
FDA Issues Guidance for IRBs to Help them Review Individual Expanded Access Submissions for COVID-19 Therapies
COVID-19 ushered in an unprecedented public health crisis. America’s drug and device regulatory, the U.S. Food and Drug Administration (FDA), recently released new guidance for Institutional Review Board (IRB) and clinical investigators to confront individual patient...
AMA Position on How to Discuss Clinical Trial Participation with a Patient
Physicians frequently get asked by patients how to participate in a clinical trial. They may face a life-threatening or life-limiting condition reports Timothy M. Smith, Senior News Writer with the American Medical Association (AMA). Smith reports that for those...
FDA Issues Draft Guidance for Amyotrophic Lateral Sclerosis Treatments
The FDA has witnessed unprecedented and advanced medical breakthroughs over the past decade. However, progress for complex neurological diseases, such as amyotrophic lateral sclerosis (ALS), has been challenging due to complexity and the fact that the underlying...
Baby Pia Denied Compassionate Use: Something ‘Ain’t’ Right in Basel
Novartis just can’t keep out of bad news. They have denied a request from the Belgian federal government to make the most expensive drug in the world (Zolgensma at $2 million) available to a Belgian toddler named Pia who suffers from spinal muscular atrophy, despite...