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Latest From Prestwick Pharmaceuticals Inc.

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.

Neurology Drug Approval Standards

Teva's Huntington's Rejection May Be Neurocrine's Good Fortune

Teva Pharmaceutical Industries Ltd.'s bad luck in getting its experimental Huntington's disease drug deutetrabenazine (SD-809) across the FDA's finish line may be Neurocrine Bioscience's good fortune for its investigational agent valbenazine in another indication – tardive dyskinesia, a condition for which both companies are expected to file applications for their respective products in the US.

Companies Approvals

Revisiting Xenazine’s Extraordinary Review: A Study In FDA Flexibility

Unmet need is high in Huntington’s disease and the protracted review of Xenazine – the only drug cleared for the disease by FDA – suggests regulatory precedent for approval based on just one efficacy endpoint and with lots of development and safety baggage.

Clinical Trials Regulation

Yaupon unveils new management team

Less than three months after taking over as chairman and CEO of Yaupon Therapeutics, Steve Tullman has tapped up former Ception Therapeutics colleagues to make key appointments to his management team. Dr Tim Henkel, formerly VP of R&D at Ception will be VP of R&D; Doug Gessl, previously CFO at Ception, is appointed COO and CFO; Dr Jeffrey Wilkins, formerly Ception's VP of clinical development is appointed CMO. Rounding out the new management team: Dr Evan Dick, previously Ception's VP of discovery medicine & operations will be SVP of business development; Kelly Copeland, formerly Ception's VP of business development and product strategy is appointed VP of product strategy; Dr Jeffrey Shaver, who was Ception's VP of project management, alliances and information, will be VP of project management and operations; also a former Ception employee, Dr Jim Dowell has been appointed VP of biopharmaceutics. Other key hires include: Dr Martin Stogniew, formerly VP and CTO of Prestwick Pharmaceuticals, as VP of pharmaceutical sciences; and Dr Lisa Wittmer, previously VP and GM of Shire Pharmaceuticals' Emerging Products business unit, as VP of regulatory affairs. Ception Therapeutics was acquired by Cephalon in 2010.

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