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.
WASHINGTON – In a decision that's likely to head to the Supreme Court, a federal appellate court struck down pay-for-delay settlements between makers of brand and generic drugs, claiming they violate antitrust laws.
A hunter walks into a bar and says, “Did you hear the one about the FDA?” “You mean the time it shot itself in the foot?” the bartender responds. “The left foot or the right foot?” another hunter asks, wiping the beer froth from his mouth. “What difference does that make?” the first hunter asks. “I want to know if it’s the one I’ve heard before. Or if this is a new one.” The first rule of thumb for hunters is to know what they’re doing. Otherwise, they might shoot themselves in the foot – or worse. The second is...
WASHINGTON – While the Federal Circuit is still digesting the Supreme Court's ruling on patents involving laws of nature and natural correlations, the Patent and Trademark Office (PTO) has translated its Mayo Collaborative Services v. Prometheus Laboratories Inc. decision into temporary guidance for patent examiners.
If the FDA greenlights Vivus Inc.'s Qnexa next week, it won't just be giving the market go-ahead to a second obesity drug. It will be opening up a new lane for weight-loss drugs containing an anticonvulsant.
In the latest salvo against the growing problem of prescription drug abuse and misuse, the FDA approved a classwide risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid drugs.
WASHINGTON – Although the SEC told Congress it was doing what it could to amp up the rulemaking process to implement the Jumpstart Our Business Startups (JOBS) Act, it didn't hit its first deadline.
