Ariad Pharmaceuticals slammed the brakes on new trial enrollment and rolled out a lower dosing schedule for patients in a slate of ongoing studies of Iclusig (ponatinib) after investigators tracked cardiovascular events among a significant group of leukemia patients.
Contract manufacturer Ash Stevens has signed on to manufacture the API for Ariad's recently approved leukemia drug.
Ariad's plan to launch its maiden commercialization effort took hard shape today as the FDA announced that it had approved ponatinib for two types of leukemia. Tapped as a likely blockbuster by a number of analysts, Ariad gained regulatory approval for the targeted treatment a full three months ahead of its regulatory deadline.
Five months after Merck's woeful application for ridaforolimus was shown the door at the FDA, the Europeans repeated the regulatory coup de grace on the other side of the Atlantic.
As Ariad, Pfizer and others make strides with their rival antileukemia compounds, Novartis aims to show how its newer therapy Tasigna helps more patients beat their cancer and stop taking the drug than Gleevec does.
The FDA has granted the company an accelerated review of the targeted cancer treatment for patients who have failed previous treatment for chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia. The speedy review comes with action date of March 27.
With its lead drug ponatinib on track to a likely approval in the U.S. and Europe, Ariad Pharmaceuticals ($ARIA) moved center stage at ESMO 2012 over the weekend with an early-stage cancer drug that produced some impressive results among a small population of non-small cell lung cancer patients.
Ariad Pharmaceuticals picked up an accelerated review for its promising leukemia drug ponatinib from the European Union's drug regulator as the Cambridge, MA-based biotech steams ahead with plans to commercialize the blockbuster hopeful over the next year.
Ariad Pharmaceuticals ($ARIA) has taken another big step toward its first big regulatory approval, shaving weeks off its schedule to file an application for ponatinib in the U.S. as it races to the market with a new leukemia treatment.
In another self-inflicted wound for Merck, the FDA has handed back its new drug application for ridaforolimus, saying the pharma giant will need to run additional clinical trials to test its effectiveness on sarcomas before it can issue an approval.