The third quarter wasn't pretty when it came to drug and pharmaceutical recalls. While the number of recalls fell nearly 30%, the number of units recalled was the highest in the last 5 quarters.
Alexion is again having problems with a contract filler, forcing it to recall two more lots of its rare-disease drug Soliris because of visible particles found in vials. It is the second time in about three months that the company has been in this situation.
The drug--designed to correct the circadian rhythms of the blind to ensure normal sleep patterns--worked as billed in the late-stage program for non-24 hour disorder, he wrote, and, given that there were no serious adverse events to consider, ought to be endorsed during an upcoming expert panel review and then approved by the agency.
In what has been one of the most hotly contested issues among biotech investors this year, many had bet big that the FDA would push through an accelerated approval for eteplirsen based on some very promising results from a mid-stage study. The study, though, only included a dozen boys, making the prospect of an early approval problematic at best.
The White House's Office of Management and Budget released a new report that sheds light on how the 16-day federal government shutdown in October impacted scientific research.
With more power comes more responsibility. And generics makers know it. If the FDA follows through on a new rule allowing them the authority to update their own labels, then they'll be on the hook if they fail to.
The FDA's probe into the safety and effectiveness of Intuitive Surgical's robotic da Vinci system points to a muddled conclusion: Surgeons said the devices have a strong benefit but point out that inconsistent training can put patients at risk.
With three year's of back-and-forth with the FDA under its belt, contract drug developer AMRI has finally closed the book on an agency warning letter tied to its Burlington, MA, plant, ending a protracted saga that has cost the company millions.
The reauthorization of PDUFA committed the FDA to giving patients a stronger voice in regulatory decisions, particularly when assessing the benefits and risks of new drugs. The FDA is planning a series of meetings, and Genetic Alliance thinks it's found a way to accelerate the gathering of patient feedback--crowdsourcing.
Topera, developer of a 3-D device and mapping tool designed to detect cardiac rhythm problems, is ramping up commercial sales of its debut technology in the U.S. and Europe now that crucial regulatory sign-offs are in place.