The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.
So far this year the FDA has approved 27 new drugs, fewer than last year's total. But a greater focus on real medical breakthroughs will make this year's crop far more valuable than the harvest of 2012, according to EP Vantage.
Boston Scientific is ticking closer to judgment day for its much-scrutinized Watchman device, securing an FDA advisory hearing for a stroke-fighting implant that has faced doubts throughout its development.
The FDA has applied its most serious label to Atossa Genetics' recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.
Despite fewer drug approvals overall compared to last year, this year will have turned out a new crop of blockbusters whose combined revenues 5 years out are forecast to reach $18.7 billion, besting last year's record of $16.4 billion in projected sales, according to a report released today by EP Vantage.
The National Institute for Health and Care Excellence nixed Johnson & Johnson's Velcade as too expensive in comparison with the current standard therapies--at least as far as the current data can show.
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.