Topic:

Regulatory

Latest Headlines

Latest Headlines

Regulators in Europe propose bans on plants in China and India

According to reports posted on the EudraGMDP site, regulators from Italy recommended bans on specific products made by Jinan Jinda Pharmaceutical in Shandong Province in China and Wuxi Jida Pharmaceutical in Jiangsu City, China, as well as Parabolic Drugs in Haryana, India.

Edwards ups TAVR guidance on Sapien 3 launch, looks to expand indication in 2016

Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.

Indian drugmaker in hot water with FDA over forged records

FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.

FDA clears devices to reduce snoring in patients without sleep apnea

InSleep Health just received FDA clearance for its Cloud9 Anti-Snoring System, which deploys continuous low positive airway pressure to help snorers (and their annoyed partners). The prescription-only device consists of an air-flow unit and headgear worn around the head that delivers oxygen into the nose. The two components are connected via a hose.

Pfizer drops effort to make Lipitor an OTC med

Millions of Americans take statins to help control their cholesterol and try to stay heart healthy. You just can't count on them to handle that on their own, Pfizer has found. And so the maker of Lipitor, the most successful statin of them all, has given up on its efforts to move the drug to an over-the-counter treatment.

Bio-Rad Labs grabs FDA approval for next-gen HIV test

Bio-Rad Laboratories snagged FDA approval for its next-generation HIV Ag-Ab test for early detection of the virus. The Hercules, CA-based company's BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 and HIV-2 markers in human blood samples, making it the first diagnostic approved by the agency that can differentiate the infections.

Progenics' orphan cancer drug picks up the FDA's 'breakthrough' tag

Progenics Pharmaceuticals' in-development treatment for an ultrarare form of cancer secured the FDA's breakthrough-therapy designation, promising a smoother path through the regulatory process.

EU ban on more than 700 drugs set for Aug. 21

The European Union will impose a ban starting Aug. 21 on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences after inspectors raised questions about its procedures.

EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences

A European Union-wide ban on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts.

AbbVie CEO: Viekira approval expected this year in Japan

For the second quarter AbbVie on a July 24 earnings call saw Rick Gonzalez, chairman and CEO, put Bristol-Myers Squibb and Gilead on notice that approval for hepatitis C therapy in Japan is expected in the second half of the year.