A panel of FDA advisers voted in favor of Vertex Pharmaceuticals' closely watched combination treatment for cystic fibrosis, looking past some efficacy doubts and setting the stage for a likely approval.
FDA reviewers plan to put Vertex's cystic fibrosis team to the test on Tuesday. In a review of the big biotech's data for its closely watched combination therapy for CF, the reviewers raised doubts about the efficacy of the drug, posing a challenge to a program that is crucial to Vertex's future.
Corbus Pharmaceuticals, which has an upcoming Phase II study for its sole clinical asset, an anti-inflammatory for cystic fibrosis called Resunab, is being feted in a glowing piece from Reuters portraying the company as a rival to Vertex.
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.
Dutch drug developer ProQR Therapeutics is swinging for a $75 million Wall Street debut to fund its work on a treatment for cystic fibrosis, looking to compete with market leader Vertex Pharmaceuticals.
There's no mistaking Geoffrey Porges' opinion on Vertex's chances of success with its combo study of VX-809 and Kalydeco. After spending the weekend at the European Cystic Fibrosis Society meeting in Sweden, the prominent Bernstein analyst came away even more soured on the experimental CF drug's potential, with pivotal data for the combo looming on the horizon.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share. So here's my pick of the likely big winners >>
Novartis notched an FDA approval on Friday for a dry-powder formulation of an antibiotic that fights a type of bacterial infection in patients with cystic fibrosis (CF).
Cambridge, MA-based Vertex Pharmaceuticals says it nailed solid mid-stage data for VX-787, an experimental influenza drug in a new class of medications that promises to prevent the virus from replicating. And the biotech added that it will be in hot pursuit of a new collaboration on the drug.
The evolution of hepatitis C treatment threatens to leave today's dominant companies with fossilized offerings. Vertex and Merck have the state-of-the-art approved drugs against the virus, but both companies are chasing after Gilead Sciences, Abbott Laboratories and others with programs that could be the first to win market approval with pill-only options. Read the full report >>