Topic:

Regulatory

Latest Headlines

Latest Headlines

WSJ: FBI probes J&J over morcellator safety risks

How much did Johnson & Johnson know about the risks of power morcellators--now suspended on safety concerns--before it pulled them from the market last year? That's the subject of a new investigation, headed up by the FBI's Newark, NJ, office,  The Wall Street Journal 's sources say.

FTC scores hefty $1.2B settlement in Teva pay-for-delay case

After pursuing a pay-for-delay case against Teva's Cephalon unit for years, the Federal Trade Commission has forced the drugmaker to hand over $1.2 billion in past profits.

GI dealmaking pays off for Valeant, Actavis with same-day FDA nods in IBS

When it comes to go-aheads in irritable bowel syndrome, the FDA was busy Wednesday, approving the indication for a pair of drugs. And now, it looks as if recent M&A moves to acquire those drugs are about to pay off for Valeant and Actavis.

Actavis and Valeant go head-to-head on IBS as FDA OKs 2 new drugs

A little more than a year after Forest Labs bought out Furiex and its experimental irritable bowel syndrome drug eluxadoline in a $1.5 billion deal, Brent Saunders and Forest-buyer Actavis have scored an FDA approval that should surprise no one. And the agency paired the approval with a green light for Valeant's Xifaxan (rifaximin) in IBS, another drug that's been changing hands lately in the frenzy of M&A deals that has been changing the face of the industry.

World Health Assembly passes resolution on vaccine pricing, transparency

The World Health Assembly passed a resolution Monday calling for improved vaccine pricing transparency and for more affordable vaccines, with more than 60 countries expressing support.

Aurobindo Pharma submits abbreviated application to FDA for HIV drug production

India's Aurobindo Pharma has submitted an abbreviated new drug application (ANDA) to the FDA for the treatment of HIV as part of the country's pharmaceutical industry's efforts to ramp up production of drugs to treat HIV/AIDS.

China to charge $102K for drug, device registration in first hike in two years

It is going to cost more than $100,000 to register a drug or medical device in China. The government plans a hike in registration fees for those two products, the first in two years.

EMA still wants 700 GVK-related drugs off the market

The European Medicines Agency has affirmed its January recommendation, calling for the suspension of more than 700 products tied to improprieties at a GVK Biosciences facility in India.

Japan's cabinet tells health minister to dig deeper on costs

Not good enough, go back and do better, a fellow member of Japan's cabinet told Health Minister Yasuhisa Shiozaki, in charge of reducing drug costs. The scene was a meeting of the Council on Economic Fiscal Policy, which has been at work recommending cost cuts.

Report: Claris Lifesciences injectables sale may hit roadblock by FDA Form 483

The Business Standard of India reports plans by Claris Lifesciences to sell its generic sterile injectables business may be thwarted by an adverse observation letter the company is reported to have gotten from the FDA.