WASHINGTON – In vacating a preliminary injunction that protected Momenta Pharmaceuticals Inc.'s $1 billion a year monopoly on generic Lovenox, the Federal Circuit gave the makers of generic drugs a much wider safe harbor under Hatch-Waxman.
WASHINGTON – Optimer Pharmaceuticals Inc.'s Dificid hit the market a few years too soon to take advantage of the exclusivity offered for new antibiotics under the FDA Safety and Innovation Act (FDASIA), but the Clostridium difficile-fighting drug is getting a regulatory hand up from another agency.
In the heat of the race for an interferon-free treatment for hepatitis C virus (HCV), Bristol-Myers Squibb Co. (BMS) stumbled over a serious safety issue in a Phase IIb trial of BMS-986094.
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.
