Europe
Detailed results from the JAVELIN Lung 200 trial will be submitted for presentation at an upcoming medical congress.
The news was revealed in a filing with the SEC.
The company is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January,
Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug.
The company plans to build two new cleanrooms and a sterilisation suite at its manufacturing base at Inchinnan.
The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents.
The Dutch healthcare giant said that it also plans to invest in a service training program in Cleveland.
But the biotech swiftly indicated that it doesn’t expect the halt to last for long.
Axovant shares plunged after Hung abruptly resigned as CEO and also stepped down from his seat on the company board of directors.
With the deal in hand, Roivant has stepped into the world of metabolic diseases.
PRESS RELEASES