Topic:

Regulatory

Latest Headlines

Latest Headlines

In wake of IPO, anti-blindness player Pixium expects to file for CE mark

Pixium Vision, which had its IPO in June, is ready to head to European regulators with a retinal implant.

Incyte's Jakafi gets a boost with FDA nod for bone marrow disease

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.

Zimmer makes a divestiture proposal to appease EU regulators in Biomet acquisition

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.

Ranbaxy now faces product bans in Europe

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 wearable cardiac monitor gets CE mark, CardioLogic partners to sell it in U.K.

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.

Some Indian drugmakers routinely toss out bad test results: Bloomberg

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.

Amgen snags a lightning-fast approval for its leukemia immunotherapy

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.

UPDATED: Germany, EU, join U.S. in banning India-made Ranbaxy products

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 tees up its new hemophilia drug for an FDA submission

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.

Startup gains FDA clearance for first tiny, injectable neuromodulation system for back pain

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.