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 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.
What happened? A new wave of hepatitis C treatments, led by Gilead Sciences' sofosbuvir. Heartily backed by an FDA advisory panel Friday, sofosbuvir is first in a class of treatments aimed at shortening hep C treatment, boosting its effectiveness and easing its notorious side effects. The coming all-oral drug cocktails will shut out interferon--and shunt Incivek aside.
AbbVie has inked a $405 million deal with Belgium's Galapagos to target genetic mutations in patients with cystic fibrosis.
A day after AbbVie unveiled an $840 million tie-up to develop a new anti-inflammatory therapy, the pharma company is continuing its deal spree today with a $405 million discovery pact on cystic fibrosis with Belgium's Galapagos.
University of Wisconsin researchers have undertaken a genomic study involving patients with cystic fibrosis, aiming to uncover data that explain variation in symptoms among those afflicted with the genetic lung disease. And researchers believe that bioinformatics and other new resources give them an "edge" in the fight to improve treatments, according to the university's release.
Bright and early this morning Insmed ($INSM) announced that its inhaled antibiotic Arikace hit its primary endpoint in a Phase III study and was awarded fast-track status at the FDA.
The biotech says it will cut 48 jobs, or about a third of its workforce, as it gets ready to try to satisfy regulators with another study of the therapy, which is marketed in Europe.
Vertex Pharmaceuticals jolted Wall Street with a fresh batch of midstage data on one of its combo therapies against cystic fibrosis.
The FDA approved Novartis' ($NVS) cystic fibrosis treatment that fights bacterial infection via a powder solution inhaled from a handheld device, the first of its kind to do so.