Tag Archives: Lundbeck

New Literacy Requirement for Physicians

“FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be … Continue reading

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http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees

Questions and Answers Regarding Advisory Committee Membership What is an FDA Advisory Committee? Advisory committees provide FDA with independent advice from outsiders and political cover in the event that something goes wrong. The committees provide advice to the Agency, but … Continue reading

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FRM-6124 Trials Halted

There is a highly credible report that the Forum Pharmaceuticals Phase III trials for encenicline/FRM-6124 are being halted due to a safety issue: Gastric hypomotility setting the stage for eventual gut perforation. FRM-6124 is a program that NIR has long … Continue reading

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Of Persistence and Ethics in Phase III

Persistence paid off for Lundbeck and Takeda, whose first Phase III program for their antidepressant Lu AA21004 failed. With revised dosing, they ran another extensive set of pivotal trials, have announced that they will be filing for regulatory approval in … Continue reading

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