May 21, 2013 | Vol. 12 No. 100 | Full Issue in PDF Format
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Following weeks of speculation, Actavis said Monday it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion.
Late-stage clinical trial data for Merck’s insomnia drug suvorexant “clearly” show that the candidate is effective, but safety data raise “significant” dose-related concerns, FDA reviews say.
The FDA is hiring two new executives to restructure its Office of Information Technology and address criticism by government auditors that its efforts to integrate its vast IT system have taken far too long.
HIV is the topic of the FDA’s second meeting intended to further its patient-centered research push; in a Federal Register notice today, the agency lists a series of questions it plans to ask HIV patients and advocates, including whether they have qualms about participating in cure research.
XenoPort’s pivotal Phase III trial of arbaclofen placarbil (AP) to treat spasticity in patients with multiple sclerosis (MS) did not meet its co-primary endpoints, prompting the drugmaker to halt development of the drug.
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