If an appellate court allows a shareholder suit alleging fraud to proceed against Genzyme Corp., it will encourage more such frivolous lawsuits to be filed against drugmakers, a public interest law and policy center said in filing an amicus brief this week on behalf of Genzyme.
The FDA is working on revisions to its labeling regulations that could revoke the free pass the Supreme Court has handed generic drugmakers when it comes to state failure-to-warn claims.
The days of reading European tea leaves to predict the future for biosimilars in the U.S. may be coming to an end as the U.S. regulatory path for the follow-on biologics brews its own distinct flavor.
With some neglected tropical diseases (NTDs) making inroads in the U.S., the government must find ways to incentivize R&D for vaccines, diagnostics and treatments for the diseases, Rep. Christopher Smith (R-N.J.) said in opening a House subcommittee hearing on addressing the NTD gap.
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.
