While names may not matter to a rose, the naming of biosimilars continues to be a thorny issue for regulators across the globe. And the World Health Organization (WHO) expects it to get a whole lot thornier over the next decade as biosimilar prescriptions begin to outnumber those for the original reference biologics.
While the government continues to spend billions of dollars on more drugs everyone hopes will never be used, it has yet to safeguard or account for the growing number of high-containment laboratories where those medical countermeasures (MCMs) are being developed, the Government Accountability Office (GAO) said in a new report that echoes an alarm the office first sounded three years ago.
Adamant that pay-for-delay settlements between brand- and generic drugmakers are anticompetitive, the FTC is leaving no stone unturned in its efforts to get the settlements outlawed.
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.
