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.
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.
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.
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.
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.
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.
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.
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.
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.
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.