Topic:

Regulatory

Latest Headlines

Latest Headlines

Fallout from India's GVK means $1B lost in drug exports by March 2016

The fallout from a European Union-wide ban on more than 700 drugs that were bioequivalency-tested by India's GVK BioSciences could cost India at least $1 billion in exports by the end of the fiscal year in March 2016, the Economic Times reports.

Innovative drugmakers take note, China plans national serious illness insurance rollout this year

Last week, China approved the rollout of medical insurance on serious illness nationwide, said Liang Wannian, vice-director of the medical reform office under the State Council and a senior official with China's National Health and Family Planning Commission, at a July 24 policy briefing.

FDA uses previous trial data to design faster study of certain ablation devices

Lately, strengthening the clinical trial enterprise has been the one of the main goals of the FDA's device arm (CDRH). It appears to be making some progress, as judged by the faster than expected approval of the latest generation of TAVRs made by Medtronic and Edwards Lifesciences.

Will marketing make the difference in approval of Sprout's 'pink pill' for women?

In the next few weeks, the FDA will rule again on a prescription treatment for female sexual dysfunction. This is the third time the FDA has considered Sprout Pharmaceuticals' drug flibanserin, which has been rejected twice. This time, however, it has its best chance yet of getting approved, having already gained an FDA advisory panel nod in June.

Bristol-Myers snags a hep C approval to piggyback on Gilead's blockbuster

Bristol-Myers Squibb, playing catch-up in hepatitis C, picked up FDA approval for a virus-blocking agent to be used in tandem with Sovaldi, Gilead Sciences' blockbuster success.

Abbott execs detail prospects in China, nutrition products

For the second quarter, top executives from Abbott came on the July 22 earnings call with Miles White, chairman and CEO, following fellow chiefs from Novartis and Johnson & Johnson in highlighting concerns about China--though at the same time emphasizing actual growth in the country and good prospects across the company's divisions.

Novartis wins an early approval for a new skin cancer drug

Novartis won accelerated approval for a promising oncology drug, gearing up to launch a new treatment for an advanced form of the most common type of skin cancer.

Glaxo's malaria vaccine gets EMA green light

GlaxoSmithKline's malaria vaccine, RTS,S or Mosquirix, has won a positive opinion from the EMA's Committee for Medicinal Products for Human Use for use in children aged 6 weeks to 17 months outside the European Union, the agency said in a statement.

UPDATED: Sanofi and Regeneron pick up a blockbuster cardio approval--with a catch

Sanofi and Regeneron won an expected FDA approval for the first of a new class of cholesterol drugs expected to alter the landscape in cardiology, but regulators stopped short of giving the treatment the wide label its makers wanted.

Sanofi and Regeneron line up for second place in EU cardio race

Sanofi and Regeneron may be on pace to win the first U.S. approval for a new type of cholesterol treatment, but the pair trails rival Amgen in Europe in a race to make good on blockbuster sales predictions.