Vertex has so far had a lot of success widening the patient pool for orphan drug Kalydeco. But in its latest quest for a label expansion, the FDA has stopped it in its tracks.
SAN FRANCISCO-- Cystic fibrosis specialist Vertex announced 2015 Kalydeco sales that topped analyst expectations, in advance of a presentation at the annual J.P. Morgan Healthcare Conference. But that's where the beat ended.
Vertex Pharmaceuticals has turned to Genomics to support its attempts to understand the genetic basis of drug targets and diseases. The deal gives Vertex access to an integrated database and analysis tools developed by Genomics, resources it sees advancing its work to validate disease mechanisms.
Big Biotechs Gilead Sciences and Biogen may both need to make acquisitions soon. But Vertex Pharmaceuticals is determined not to be one of their targets.
Vertex had a pretty good idea that drug pricing critics wouldn't be so keen on its $259,000-per-year tag for cystic fibrosis med Orkambi. And sure enough, less than three weeks after the combo med won the FDA's green light, the pushback is here.
Vertex Pharmaceuticals' long-awaited cystic fibrosis approval is here--and the combo med Orkambi is just as pricey as analysts expected.
U.S. payers are striking out at drug spending again, highlighting the cost to taxpayers. According to a commissioned report, 10 hot new "breakthrough" meds are expected to cost publicly funded healthcare plans more than $50 billion over the next decade.
HBO premiered an award-winning short documentary about Huntington's disease, a rare, hereditary neurological malady, on Monday night. The film follows actress and filmmaker Marianne Palka as she finds out the results of her genetic test. If someone has a parent with the disease as she did, they have a 50/50 chance of getting the disease. The missing voice? Pharma.
Vertex Pharmaceuticals wants to expand its cystic fibrosis market tenfold, and on Tuesday, it got one step closer. An FDA advisory committee voted 12 to 1 in favor of a new combo drug Orkambi, which marries current CF star Kalydeco with an experimental med, lumacaftor.
Vertex is looking to expand its market for cystic fibrosis drug Kalydeco tenfold, but to do that, it needs the FDA's backing. On Tuesday, it got one step closer, grabbing an advisory committee nod for a new Kalydeco combo.