Block Drug has acquired Salisbury, N.C.-based Stanback Company, the maker of Stanback headache powders and Chap-et lip balms. Terms of the deal, completed Jan. 4, were not released. Block already markets the other two major headache powders, Goody's, which it purchased in 1994, and BC, acquired in the 1960s. All three headache powder brands are sold primarily in the southeastern U.S.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
