Dark Days In Diabetes

Diabetes has long been one of the most "investable" diseases, with a host of pharmaceutical, biotech, and medical device plays on this serious (and increasingly common) condition. Recent weeks have not been kind to the sector, though, as a range of problems and challenges have sent investors to the sidelines.   

FDA - Don't Call Us, We'll Call You
Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration.


Roche (Nasdaq:RHHBY) has essentially been sent back to the drawing board on its weekly GLP-1 drug taspoglutide, and there is a good chance that the side-effect problems that halted a Phase 3 study will prove insurmountable. Another would-be long-acting GLP-1 drug (to be marketed by Eli Lilly (NYSE:LLY) was surprisingly rejected due to FDA worries about safety and a demand for a new study.

Biodel (Nasdaq:BIOD) recently saw its application for a new formulation of insulin rejected due to sample handling and patient drop-out problems, and the FDA's unwillingness to brook a post-hoc analysis of the data. Both Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA) saw their obesity drugs rejected (obesity is a leading cause of Type 2 diabetes), though the FDA left a sliver of hope for both companies (particularly Vivus).

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