"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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Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.
As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.