Expanded Access

Albireo Launches Expanded Access Program for Odevixibat for Patients in the U.S., Canada, Australia and Europe

07/26/2020

Excerpt from the Press Release: “BOSTON, July 20, 2020 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the launch of an Expanded Access Program (EAP) for investigational lead product candidate odevixibat, a highly potent and selective inhibitor of the ileal bile…

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NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19

06/24/2020

Excerpt from the press release: “RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute…

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WideTrial Partners With Oncotelic to Bring Expanded Access Platform to Cancer

06/14/2019

WideTrial , one of TrialStat’s strategic partners has partnered with Oncotelic to bring the Expanded Access Platform to Cancer. June 03, 2019 (ACCESSWIRE via COMTEX) — SAN FRANCISCO, CA / ACCESSWIRE / June 3, 2019 / WideTrial Inc., a third-party sponsor of Expanded Access programs, has begun a partnership with Oncotelic Inc., a wholly owned subsidiary…

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FDA to Launch Expanded Access Pilot ‘Project Facilitate’

06/02/2019

The goal of Project Facilitate is to make it easier for oncologists or healthcare providers without the regulatory experience or resources to navigate the single patient IND process. “Access to clinical trials and access to novel therapeutics for patients is still a problem. We know that not all oncologists or healthcare providers have the regulatory…

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

05/26/2019

In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…

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