FDA Warning Letter To Xanodyne Cites Risk Info Omissions In Brochure
An FDA warning letter to Xanodyne Pharmacal cites a lack of product risk information in a corporate brochure
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SHIRE TO GAIN U.S. MARKETING ARM THROUGH $185.7 MIL. RICHWOOD PURCHASE if the deal is approved by Shire shareholders Aug. 20, Hampshire, England-based Shire Pharmaceuticals said. The company announced Aug. 4 the proposed acquisition of Florence, Ky.-based Richwood Pharmaceuticals for $145.8 mil. in stock (31% of Shire's equity), $15 mil. in cash, and 7.2 mil. options valued at $24.9 mil. Richwood will be Shire's second acquisition this year: the company acquired the Gaithersburg, Md.-based drug delivery company Pharmavene in February for $90.5 mil.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials