The Handoff is a weekly roundup of neurology news covering various developments in subspecialties, the pharmaceutical industry, and the overall state of health care as it affects neurologists.
— The FDA has issued a Class I recall of the Penumbra 3D Revascularization device due to risk of the delivery wire breaking or separating during use. Attempts to recover broken-off pieces of the wire can worsen stroke cases, the FDA warned.
— Amgen’s CGRP migraine drug erenumab is the first of a handful of CGRP agents to be accepted for review by the FDA. The PDUFA date is set for May 17, 2018.
— Neuralstem’s investigational depression drug NSI-189 failed to meet the primary endpoint in a phase 2 study — the latest in a string of failures for depression treatment.
— FDA Commissioner Gottlieb plans to meet with insurers and pharmacy benefit managers to discuss how to limit opioid dispensing and bring prescribing closer to clinical guidelines. Meanwhile, the CDC plans to disperse $12 million to 23 states to support their fight against the opioid crisis.
— Researchers supported by the NIH have identified genetic mutations associated with T cell reactivity to alpha-synuclein, which accumulates in the brains of Parkinson’s patients. In another study, researchers found that volumes of free water increase in the substantia nigra during Parkinson’s disease, suggesting its association with the degeneration of neurons over time.
— An FDA panel voted 22-1 against the approval of Intellipharma’s Oxycontin bioequivalent Rexista, claiming that the company failed to demonstrate the drug’s abuse deterrent properties in humans.
— Research bias in concussion studies is finally beginning to waver, as the NIH now requires pre-clinical studies to include female animals and more evidence demonstrates differences in male and female concussion.
— Why adding a “right to try” bill could undermine the FDA’s clinical trial system.
— Genetic variations inherited from our Neanderthal ancestors may contribute to some of the neural deficits seen in patients with schizophrenia and autism spectrum disorder.