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 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.
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 >>
Vertex Pharmaceuticals jolted Wall Street with a fresh batch of midstage data on one of its combo therapies against cystic fibrosis.
Vertex Pharmaceuticals ($VRTX) kept hopes alive for treating cystic fibrosis patients with the most common genetic mutation behind the lung disease, with new data from a mid-stage study showing improved lung function in patients on a combination of its approved drug Kalydeco and the experimental compound VX-809.
Vertex Pharmaceuticals ($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.
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.
Vertex Pharmaceuticals has rolled to European approval of its pioneering cystic fibrosis drug Kalydeco as expected, following the early nod for treatment in January from the FDA to treat a subset of patients with the G551D mutation.
About 6 months after the FDA gave the nod to Vertex Pharmaceuticals' pricey drug Kalydeco, the European Commission also approved the treatment for patients with cystic fibrosis that have a certain genetic mutation.
Vertex ($VRTX) today opened the door on a key part of final results for a mid-stage combo study of its two cystic fibrosis drugs, mapping out its late-stage strategy on a program that has built up hopes for a potentially blockbuster pioneering treatment.