BC Week In Review | Dec 19, 2011
Clinical News

Adderall and Adderall XR amphetamine neurology data

Researchers at Kaiser Permanente and colleagues reported data from a pair of retrospective cohort studies in a total of 443,198 adults aged 25-64 years from 4 healthcare claims databases showing that there was no evidence...
BC Week In Review | Nov 7, 2011
Clinical News

Adderall and Adderall XR amphetamine neurology data

The study is the first of 3 studies sponsored by FDA and the U.S. Department of Health and Human Service's Agency for Healthcare Research and Quality (AHRQ). The studies are part of a safety review...
BC Week In Review | Nov 22, 2010
Clinical News

Intuniv guanfacine extended release: Additional Phase III data

Additional data from a 9-week, double-blind, U.S. Phase III trial in 455 patients ages 6-17 showed that up to 4 mg once-daily Intuniv in the morning or evening plus long-acting oral stimulants met the secondary...
BC Week In Review | May 31, 2010
Clinical News

Guanfacine extended release: Phase III data

A double-blind U.S. Phase III trial in 455 patients ages 6-17 showed that up to 4 mg once-daily Intuniv in the morning or evening plus long-acting oral stimulants met the primary endpoint of significantly improving...
BC Week In Review | Feb 23, 2009
Company News

Shire, UCB sales and marketing update

Shire will acquire exclusive, worldwide rights to UCB's ADHD drug Equasym methylphenidate IR and XL for an upfront cash payment of €55 million ($70.1 million). The deal excludes the U.S., Canada and Barbados. Outside of...
BC Week In Review | Feb 2, 2009
Clinical News

Focalin XR dexmethylphenidate: Post-marketing study data

Researchers from FDA's Office of Surveillance and Epidemiology and HHS's Health Resources and Services Administration published in Pediatrics a review of data on incidences of psychosis or mania from placebo-controlled trials and post-marketing adverse-event reports...
BioCentury | Oct 8, 2007
Politics, Policy & Law

NICE's balance sheet 2006-07

NICE's balance sheet 2006-07 NICE's balance sheet 2006-07 Of 28 appraisals issued in 2006 and 2007, NICE recommended 40 treatments for coverage on the NHS and seven were rejected. However, of the drugs recommended, only...
BioCentury | Feb 26, 2007
Strategy

Development deficit

Development deficit Development deficit Given the number of marketed ADHD drugs, the dearth of new compounds in the clinic is not surprising. Aside from the two Shire compounds awaiting approval, the next one up would...
BC Week In Review | May 29, 2006
Clinical News

Equasym XL methylphenidate extended-release capsules regulatory update

UCB completed the European Mutual Recognition Procedure (MRP) for Equasym XL to treat symptoms of attention deficit hyperactivity disorder (ADHD). The U.K. acted as the reference member state. The company expects national marketing authorizations to...
BioCentury | Feb 7, 2005
Strategy

The ADHD crowd

The ADHD crowd Shire's pipeline Product Description Status Shire Adderall XR Extended release formulation of Adderall Mkt Noven/Shire MethyPatch Once daily transdermal methylphenidate patch Not approvable (A) New River/Shire NRP104 Prodrug of amphetamine Ph III...
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