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Vertex

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Latest Headlines

UPDATED: Vertex's Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.

Bye-bye, Incivek: Sovaldi forces Vertex drug off hep C market

Just three years after nabbing the "fastest drug launch ever" award, Vertex is discontinuing hepatitis C med Incivek on withering demand, it said in a recent letter to healthcare providers.

Sovaldi forces Incivek off the hep C market as Vertex calls it quits

Bye-bye, Incivek. Just three years after nabbing the "fastest drug launch ever" award, maker Vertex is discontinuing the hepatitis C med on withering demand. For that, the Cambridge-based company has Gilead Sciences--owner of the new fastest drug launch ever--to thank.

Vertex scores 250 new Kalydeco patients with EMA approval

Vertex' patient pool for cystic fibrosis drug Kalydeco is getting wider--250 patients wider, to be specific. The European Medicines Agency has green-lighted the drug--originally approved for CF patients with at least one copy of the G551D mutation--for 8 additional mutations, spelling new revenue potential for the orphan drugmaker.

Vertex could snag 250 more Kalydeco patients with EMA nod

Back in February, the FDA green-lighted Kalydeco to treat cystic fibrosis in patients with one of 8 distinct gating mutations, dramatically swelling the orphan drug's patient pool.

Vertex, once king of hep C category, bows out as new drugs eclipse Incivek

Biotech Vertex has pulled the plug on work in the hepatitis C arena, an area it was expected to dominate with its Incivek until Gilead Sciences redefined the category with Sovaldi, a drug now expected to become the top seller of all time.

Vertex eyes another $45 million in sales as FDA swells Kalydeco's patient pool

Any drugmaker knows that no matter what a drug's sticker price, its sales can only go as far as its patient pool will take it. So for Vertex, whose cystic fibrosis med Kalydeco had reached nearly all eligible patients in the U.S. and Europe, a new FDA approval to treat more CF sufferers is pretty significant.

Vertex profits on one-time gain despite plummeting Incivek sales

Hepatitis C drugs like Vertex's Incivek are quickly becoming a thing of the past. A new generation of easier-to-tolerate, interferon-free treatments like Gilead's Sovaldi is moving in, and Vertex's fourth-quarter revenues showed it. But a hefty one-time royalty payment helped the company turn a profit, even despite plummeting sales of Incivek--one of just two drugs it currently has on the market.

Vertex's Incivek unseats Celebrex as fastest drug launch ever

A new report starkly illustrates how quickly things can change in the pharma industry, showing how a drug darling becomes a market dud.