When SEC Chairwoman Mary Jo White testified before a Senate Appropriations subcommittee this week, it wasn't to make excuses for missed deadlines under the Jumpstart Our Business Startups (JOBS) Act or promise when those long overdue rules would be released.
Although PDUFA V has been in effect for just nine months, the biopharma industry already is setting up the ironing board for the next round of user fee negotiations with the FDA.
When it comes to generic drugs, and possibly biosimilars in the future, federal law is the law of the land, the Supreme Court reiterated Monday, overturning a $21 million jury award based on state design-defect claims.
The Federal Circuit raised the bar a few notches on patent claims for methods of using drugs in combination, especially if one of the drugs is used in other combination therapies.
The longer timelines the FDA is proposing for biosimilar meetings and reviews add insult to the injury of expecting sponsors of the follow-on biologics (FOBs) to pay user fees up front, according to several generic drugmakers.
Biologics are innovative drugs, biosimilars are copies, and never the twain shall meet. That's the underlying message brand drugmakers sent to the FDA as they urged it to maintain the distinctions between the 351(a) and 351(k) approval paths.
Tacking toward the middle, the Supreme Court gave the FTC some berth Monday in challenging pay-for-delay settlements between generic and brand drugmakers, but it closed the hatch on a "quick look" approach that would presume all such agreements are unlawful.
In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible.
The FDA etched a distinct line between orphan drug designation and exclusivity in a final rule released Wednesday, making it clear that getting the designation doesn't guarantee seven years of market exclusivity.
It's not every day that a multimillion-dollar market suddenly opens up, inviting all comers to the ground floor of competition. But that's exactly what happened when the FDA put out its "open for business" sign for biosimilars.
