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FDA publishes guidance to help in developing new ALS therapies

After gathering input from patients, researchers, and advocates, the U.S Food and Drug Administration (FDA) has released new guidance on the development of therapies for amyotrophic lateral sclerosis (ALS).

Among its recommendations, it is advising more communication with companies early on in the product development process, access to experimental therapies through compassionate use or the Right to Try Act, and broader inclusion criteria in clinical trials.

Oxford Biodynamics PLC (LON:OBD) was spun out from Oxford University in June 2007 with the aim of translating fundamental scientific advances into a commercialised platform technology and a new generation of biomarkers for cancer and other diseases. OBD has been granted a substantial funding award from Innovate UK to develop and validate diagnostic, prognostic and predictive EpiSwitch™ biomarkers for ALS.

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