Amylin Plans Cardiac Safety Study By The Book After Bydureon Rejection
This article was originally published in Pharmaceutical Approvals Monthly
There’s more than meets the eye to the story of the seemingly surprising “complete response” letter for Amylin’s ultra-high-profile once-weekly diabetes injectable Bydureon.
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Analysts still expect an approval and launch by year end of long-acting exenatide, now branded as Bydureon.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.