"Hopefully we will be receiving the final [Reminyl] approval in a reasonable time frame," J&J CEO Ralph Larsen tells Jan. 23 analysts meeting. "We are prepared and have taken steps to introduce this important product into the U.S. very rapidly." The Alzheimer's agent galantamine has been "approvable" at FDA since July 31 (1"The Pink Sheet" Aug. 7, 2000, In Brief)
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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.’
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.
The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.
