Monthly Archives: May 2012

Finally-A Pivotal Role for CNS Surrogates

Pfizer’s tafamidis program for Transthyretin Familial Amyloid Polyneuropathy (acquired via the buyout of FoldRx) has reached the FDA, and the CNS Advisory Committee charged with assessing tafamidis in the treatment of this rare disease has made an equally rare, and … 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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