The Arkansas Supreme Court is being asked to overturn the $1.2 billion penalty assessed against Janssen Pharmaceuticals Inc. in a case that could open other drugmakers to hefty penalties when the state decides FDA-approved labeling is inadequate.
An appellate court's ruling Wednesday against Pfizer Inc. paints the way forward for more racketeering claims against drugmakers who plead guilty to criminal off-label promotion charges as part of a government settlement.
Raising fees is not the way to reduce a growing backlog of requests for continued examination (RCEs), several patent attorneys told the Patent and Trademark Office (PTO) Wednesday.
Recognizing the global impact its decision could have, the Supreme Court of India denied an appeal by Novartis AG, ending the company's 15-year quest for a patent for its cancer drug Gleevec/Glivec.
Much to-do has been made about the FDA's draft guidance on developing drugs for early stage Alzheimer's disease (AD), but some people are missing the point, especially if they think the agency is "loosening" its standards for Alzheimer's treatments, according to an FDA official.
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.
