Halfway into fiscal 2013, the FDA is finally looking at a budget that allows it to use the new and increased user fees that were approved as part of PDUFA V last year.
The FDA raised another safety flag over the continued off-label use of Avastin Wednesday when it issued a MedWatch alerting physicians of a recall of the compounded cancer drug intended as an unapproved treatment for wet age-related macular degeneration (AMD). While that's bad news for compounders, it could be good news for Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y.
A lot of eyes were on the Supreme Court Tuesday as it considered arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that could further define generic drug preemption or pave the way for more liability for all drugmakers.
With sequestration swinging its two-edged blade through the funding for the National Institutes of Health (NIH) and other government research-focused programs, a lot has been said about its impact on the future pipeline of medical researchers. But federal funding isn't the only factor leading to a growing talent drain in the field.
Weighing in on a drug preemption case that could impact the future liability of makers of biosimilars, the author of the Hatch-Waxman Amendments told the Supreme Court that the law, which opened the floodgates to generics, was intended to speed access to cheaper drugs – not to protect generic drugmakers from patient lawsuits arising from injuries caused by their drugs.
The reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), coupled with the government's intent to purchase a large order of drugs to stockpile against the threat of a radiological/nuclear attack, should make it easier for biotechs developing medical countermeasures (MCMs) to attract investors.
The taming of the Wild West of social media has begun, with the FTC reinforcing its role as sheriff. To keep the peace and help drugmakers and other industries ride through the new digital territories unscathed, the FTC updated its 13-year-old ".com Disclosures" guidance.
Despite the continuing grip of sequestration, the FDA will breathe easier if a bipartisan Senate appropriations proposal becomes part of a hybrid spending package intended to fund the government for the remainder of fiscal 2013.
In the days before the sequester tightened Washington’s belt, the National Institutes of Health (NIH) and several other federal agencies sent up warning shots of just what was at stake. Under the automatic budget cuts intended to put the national deficit on a strict diet, the NIH expected to lose $1.6 billion from its 2013 fiscal budget. If the sequester stayed in place, NIH Director Francis Collins said the agency would give "hundreds and hundreds" fewer grants than it would have awarded otherwise, slowing down important research. Speaking at a news conference, Collins said the NIH was trying to avoid...
