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The U.S. Food and Drug Administration(FDA) is updating its 2015 draft guidelines for drug discovery in rare diseases, with new guidance on natural history— how disorders such as spinal muscle atrophy(SMA) run their course if untreated — the choice of “efficacy endpoints” in clinical trials, and how…

A team of Italian researchers suggests that CLN3 disease, also known as juvenile Batten disease, should be included in the differential diagnosis of people with autophagic vacuolar myopathy (AVM), after describing the case of a man who received an accurate diagnosis only after undergoing a muscle biopsy.

Cash-strapped governments across the 28-member European Union are struggling to control runaway healthcare expenditures — at exactly the same time as the promise of new but expensive therapies to treat rare diseases has never been greater. That’s the paradox faced by pharmaceutical companies as well as patient advocacy groups in…

A type of Batten disease, called CLN8 disease, is associated with the failure of important cell- signaling molecules to properly interact and engage in critical signaling pathways, according to results of a recent study. The study, “Neuronal ceroid lipofuscinosis related ER membrane protein CLN8 regulates PP2A activity and ceramide levels,”…