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Kalydeco

Latest Headlines

Latest Headlines

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.

Arkansas stiff-arms CF patients seeking Vertex's $300K drug Kalydeco: WSJ

The drug-pricing battle continues, but this time, Gilead Sciences' Sovaldi isn't at the center.  That dubious honor goes to Vertex Pharmaceuticals' cystic fibrosis treatment Kalydeco. According to a lawsuit filed by three CF patients, Arkansas Medicaid officials are locking them out of Kalydeco treatment.

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 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 Kalydeco flunks a Phase III for cystic fibrosis

Vertex Pharmaceuticals' piecemeal approach to the world's cystic fibrosis sufferers took a hit as Kalydeco failed to meet its primary endpoint in a Phase III trial on patients with one form of the disease, sending the company's shares down as much as 6% premarket on Thursday morning before an eventual rebound.

Top 15 Drug Launch Superstars

Herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge--one we weren't exactly expecting, based on previous experience. Read the full report >>

Vertex asks FDA to expand market for CF drug Kalydeco

Vertex Pharmaceuticals asked the FDA to approve broader use of its cystic fibrosis drug Kalydeco. Already marketed for patients with a G551 "gateway" mutation, Kalydeco could be approved to treat patients with at least one non-G551 mutation.

Top 20 orphan drugs by 2018

For a long time, pharma companies have looked to large disease populations as the biggest potential revenue streams. But those days are long gone. That perception has shifted, especially with the prescription drug market stagnating in the U.S. and Europe. Orphan drugs--pharmaceutical treatments for rare diseases or disorders--have proven themselves as viable moneymakers, and the industry has taken note. Read the report >>

UPDATED: Vertex skyrockets on positive Ph2 combo study in cystic fibrosis

Vertex Pharmaceuticals jolted Wall Street with a fresh batch of midstage data on one of its combo therapies against cystic fibrosis.