A little less than a year ago The Medicines Co. said its third late-stage trial of cangrelor managed to do something that the first two had failed at: Conclusively demonstrate the superiority of its blood thinner over Plavix.
Federal prosecutors are eyeing Teva Pharmaceutical Industries for potential marketing violations.
Late last year, FDA Commissioner Margaret Hamburg's first official trip to India was postponed for undisclosed reasons. It was rescheduled and now happens to coincide with actions designed to put ultimate pressure on India over its low regard for patents on drugs that it thinks are too expensive.
India made some noise last year with news that it wants to modernize its regulation of medical devices and drugs. Now The Economic Times is reporting that the government plans to take its time getting there.
What if every drug in a class posed a risk to the heart--all except one? That's the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world.
Beth Noveck's mission has been to apply the transparency and collaboration of the open-source movement to government. Noveck has now left the White House, but the ideas she brought are still percolating through the governmental machine. In 2014, the thinking is set to lead to a new, more open FDA.
The highly publicized insider trading case against SAC Capital Advisors trader Mathew Martoma has finally come to a conclusion--at least for now.
New Jersey-based Celgene in 2011 tucked a notice into a financial report that a U.S. Attorney in California was investigating its marketing of its cancer meds Revlimid and Thalomid. Nothing more was said until Thursday when the company divulged that the probe was tied to lawsuits filed against it by whistleblowers.
Over the past few years, the FDA has unveiled a spate of new approval pathways in hopes of getting much-needed treatments on the market faster. But in the rush to accelerate drug development, the agency has wound up putting patients at risk, according to one congresswoman, fast-tracking unproven therapies despite serious safety concerns.
The risks of women developing a blood clot while using certain contraceptives are well known and have spawned thousands of lawsuits and resulted in billions of dollars in payments. Now it is Merck's turn to pony up, with a $100 million settlement that some say lets it off cheap.