Topic:

Regulatory

Latest Headlines

Latest Headlines

Documents reveal FDA's use of computer forensics to uncover data falsification

In 2011, a Sun Pharma technician gave into temptation, hit the delete key and generated new, positive data from another sample within the same batch. In 2013, the FDA uncovered what had happened and tasked its computer forensics experts with finding other such events. The team discovered 5,301 more deleted chromatography results from the same facility.

EU nations yank drugs over GVK data scandal

Some European Union states have suspended the approvals of drugs tied to a data falsification scandal at CRO GVK Biosciences, and the European Medicines Agency is investigating whether to recommend a continental halt.

Report: New FDA policy on animal antibiotics has loopholes

The Pew Charitable Trust has released a report revealing that significant gaps in labeling of some products effectively allow farmers to give antibiotics to their animals under the guise of "disease prevention," when they're really using the drugs for growth promotion.

Long-acting Copaxone to launch early next year in Europe, Teva says

Teva has already surprised analysts with the success it's had converting patients from multiple sclerosis star Copaxone to a new, long-acting version. And now, the company is preparing to take the med to Europe.

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.