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Vertex

Latest Headlines

Latest Headlines

Vertex's big plans for Kalydeco sales just got bigger

Vertex is already awaiting the FDA's decision on a Kalydeco combo that could exponentially amp up its cystic fibrosis patient pool. But in the meantime, it announced Sunday evening, it's starting in on a Phase III program for yet another Kalydeco pairing.

Vertex gets 500-patient boost with FDA's newest Kalydeco nod

Vertex will start the new year with a group of new eligible patients for cystic fibrosis drug Kalydeco, thanks to a Monday green light from the FDA. The agency has OK'd the med in patients with the R117H mutation, a nod analysts say will boost Kalydeco in the present and also bodes well for its future.

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.