Allendale Pharmaceuticals forms partnership with Access Sales and Marketing (Chester, N.J.) to facilitate the U.S. reintroduction of the OTC contraceptive. Today has been off the market since 1995, when American Home Products withdrew the product after deciding not to spend resources to address quality control problems. Access' principles are five former AHP execs. In March, Allendale, N.J.-based Allendale announced plans to return the nonoxynol-9 contraceptive sponge to the market ("The Tan Sheet" March 15, p. 14). The company says a pilot batch of Today Sponges will roll off the line at the end of June
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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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Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”