WASHINGTON – Hoping it will merely be an exercise in emergency planning, the FDA, National Institutes of Health (NIH) and other federal agencies are being told to begin preparing for sequestration – the across-the-board budget cuts in discretionary spending that will be triggered in January if Congress fails to trim $1.2 trillion from the national deficit.
If the FDA follows through on an advisory committee's recommendations, patients may finally have drug options to fight two conditions that can lead to permanent loss of vision.
Executives of biopharma companies got a little good news and a lot of bad news when an appeals court, in a split decision, upheld the federal exclusion of three former Purdue Frederick Co. officials, clearing the way for more corporate officers to be forced out of the industry over off-label drug promotion.
While the SEC is still trying to wrap its regulatory arms around the Jumpstart Our Business Startups (JOBS) Act, biopharma is pushing for more financial reforms to loosen the bureaucratic chokehold that threatens to strangle small biotechs.
If the FDA follows through on an advisory committee's recommendations, patients may finally have drug options to fight two conditions that can lead to permanent loss of vision.
The FDA could be facing a quandary brought on by the growing epidemic of prescription drug abuse as it tries to balance the need for tamper-resistant painkillers with the demand for access to cheaper generics.
Forget whether progression-free survival (PFS) should be a surrogate endpoint in cancer trials, the FDA said as it charged the Oncologic Drug Advisory Committee (ODAC) Tuesday to look at reducing the central review audit burden as a way to streamline cancer trials.
It will be a while before all the provisions of the Jumpstart Our Business Startups (JOBS) Act kick in, but a number of emerging growth biotechs are already queuing for an initial public offering (IPO).
WASHINGTON – It was an encore performance in the Federal Circuit Friday as the panel of judges that ruled on the Association for Molecular Pathology v. Myriad Genetics Inc. last year listened to pretty much the same arguments about the patentability of isolated DNA all over again.
WASHINGTON – Biopharma has a lot at stake as the political theater continues around the Affordable Care Act (ACA). But rather than waiting on the edge of their seats to see what happens in Congress, drugmakers need to start planning now for the consequences of the law.
