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Vertex's Cystic Fibrosis Drug Kalydeco Could See Speedy Review

This article was originally published in The Pink Sheet Daily

Executive Summary

High unmet medical need, a genetically targeted patient population and the drug's biological rationale could combine for a faster-than-six-month approval for the novel, disease-modifying therapy.

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Early Success For Kalydeco Is Just The Beginning For Vertex’s CF Drug

Kalydeco is expected to be a game-changer in cystic fibrosis, but its current label is applicable to only 4% of the patient population. Vertex, however, has an ongoing plan to expand Kalydeco’s label as both a monotherapy and in combination with other experimental CF agents.

Vertex Gets Quick FDA Approval Of Kalydeco; Prices New CF Drug At $294,000 Per Year

Kalydeco, an oral CFTR potentiator, becomes the first approved drug to address the underlying cause of cystic fibrosis, rather than just treating the disease’s symptoms.

In One Day, Change At Biotechs: Leiden To Replace Emmens At Vertex And At Amgen, Bradway Will Become CEO

Board member Jeffrey Leiden, who oversaw the commercialization of Humira at Abbott, will succeed Matthew Emmens as Vertex CEO next February.

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