Abbott has avoided addressing rumors that its deal with point-of-care diagnostics maker Alere is on the rocks. But according to Alere, the Illinois med tech wants out.
Abbott said last year that it wasn't interested in St. Jude, but now, the company is changing its tune. The Illinois devicemaker will shell out $25 billion for St. Jude to gain ground in the cardiovascular and neuromodulation markets.
Abbott Laboratories was cleared by a Texas federal jury of accusations it violated the False Claims Act by wrongly marketing bile duct stents in a whistleblower case that sought more than $1 billion in damages.
Abbott's Absorb bioresorbable stent took a step closer to FDA approval, winning the overwhelming backing of an FDA advisory panel of experts, who voted 9-0 (with one abstention) to recommend approval of the device based on an analysis of its risks and rewards.
Questionable data among patients with small vessels is the dominant issue at hand during the FDA panel's consideration of Abbott's Absorb bioresorbable scaffold.
Diagnostics maker Alere seemed to have closed one chapter after agreeing to sell out to Abbott last month. But some of the company's problems are coming back to haunt it as the U.S. Department of Justice (DOJ) investigates Alere's international sales practices.
Pfizer and Abbott cut production on their popular cough medicines in India last year after officials imposed new regs to fight the smuggling of opiates into Bangladesh. Now regulators have banned the products altogether, leaving Pfizer to scramble to court Monday for an order staying the action as it tries to sort out the matter.
One of the most anticipated FDA panel meetings in years will commence in Gaithersburg, MD, on March 15, that of Abbott's Absorb BVS bioresorbable stent. The stent is a paradigm-shifting device, and the data show noninferiority to Abbott's current standard-of-care Xience drug-eluting stent.
Abbott will launch a major study of several brain injury evaluation approaches along with researchers at Hennepin County Medical Center in Minneapolis, MN, and the University of Minnesota. The goal is to evaluate a number of different tools including eye tracking, blood-based biomarkers, imaging and cognitive measures to develop a standard protocol for identifying brain injuries--including concussions.
Abbott said it will retrain implanters of its transcatheter MitraClip device for mitral valve repair following reports of procedures in which the implant could not be detached from the delivery device. All 9 reported cases resulted in surgical interventions, and one ended in postoperative death due to severe comorbidities.