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Kalydeco

Latest Headlines

Latest Headlines

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.

Vertex's new data on CF drug cocktail doesn't disappoint

Vertex Pharmaceuticals ($VRTX) kept hopes alive for treating cystic fibrosis patients with the most common genetic mutation behind the lung disease, with new data from a mid-stage study showing improved lung function in patients on a combination of its approved drug Kalydeco and the experimental compound VX-809.

FDA flags cataract risk in kids using Vertex's Kalydeco

Vertex Pharmaceuticals ($VRTX) has hit an unexpected snag with its cystic fibrosis pill Kalydeco. The FDA is raising questions about a potential risk of cataracts in children using the drug, and asked the drugmaker to conduct a two-year study to assess that risk.

Europeans notch approvals for Vertex, Novartis drugs

Regulators gave their final blessing to Vertex Pharmaceuticals' cystic fibrosis treatment Kalydeco, Almirall's lung drug Eklira Genuair, and Eisai's Fycompa seizure drug. And they granted Novartis dispensation to market its cancer drug Afinitor for breast cancer.