Pixium Vision, which had its IPO in June, is ready to head to European regulators with a retinal implant.
Analysts in March foresaw Incyte's Jakafi easily topping the blockbuster mark when it met its goals in a Phase II trial in certain patients with a rare type of bone marrow disease. Now, with the FDA's official green light, it's time for Incyte to get working on turning those predictions into reality.
To address the European Commission's concerns about its proposed $13.4 billion acquisition of Biomet, Zimmer Holdings has proposed the divestiture of "one unicompartmental knee brand and one elbow brand" in the European Economic Areas as well as "one total knee brand" in two European countries.
Six years after the FDA banned products from a Ranbaxy Laboratories plant in Dewas, India, the European Commission and Germany have restricted imports of sterile drugs from the facility.
iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.
At least a dozen drugmakers with operations in India were accused by the FDA last year of routinely throwing out negative test results of bad batches of pharmaceuticals, some of which eventually made it to U.S. consumers.
The FDA approved Amgen's new leukemia treatment more than 5 months ahead of schedule, green-lighting the first contender among a new class of immunotherapies that promise to change the standard of care in blood cancer.
Seemingly hand in hand with the U.S., German regulators have banned Ranbaxy Laboratories from exporting the antibiotic cephalosporin to their country following an inspection earlier this year of the company's plant in central India.
Bayer plans to submit its new hemophilia A treatment to regulators by year's end, following through on a roughly $700 million commitment to roll out next-generation treatments for the bleeding disease.
Physicians can add another tool to their arsenal that targets chronic back pain locally, without requiring surgery or an external device. The FDA has cleared Stimwave's Freedom Spinal Cord Stimulation System, which the company says is the smallest available neuromodulation device.