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Celgene’s Pomalidomide Faces Review, With Confirmatory Trial Waiting In Wings

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Oncologic Drugs Advisory Committee is set to consider next-generation immunomodulator pomalidomide based on Phase II data. But the company is planning to launch a Phase III confirmatory trial by the end of 2012, which may help smooth the review.

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How Kyprolis Overcame Serious Safety Fears To Reach Myeloma Market With Clean Label

FDA had flagged life-threatening safety issues that could have delayed approval of Onyx’s myeloma drug Kyprolis. But in the end, the agency instead opted for explicit instructions in the label to avoid risks, stopping short of a boxed warning, and a sub-study in a Phase III trial to fully assess cardiac and pulmonary risks.

Rare Disease Roundtable: Dealing With Pricing Pressure

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.

Rare Disease Roundtable: How Rare Is Too Rare?

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.


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