The FDA's Arthritis Advisory Committee struggled to flip its mind around a broad novel indication of axial spondyloarthritis (axSpA) Tuesday, voting 7-6, with one abstention, to recommend FDA approval of UCB SA's Cimzia to treat active axSpA.

It may be just a jump to the left and then a step to the right, but the time warp that forms between the evolution of clinical science and regulatory science can make the two seem worlds apart.

In what could become a textbook example of putting the cart alongside the horse, the FDA will ask its Arthritis Advisory Committee Monday to consider whether the data are sufficient to make axial spondyloarthritis (SpA), as defined by the Assessment of Spondyloarthritis International Society (ASAS) criteria, a new indication for arthritis drugs.

If a compounding pharmacy looks like a drug manufacturer, walks like a drug manufacturer and quacks like a drug manufacturer, it should be regulated like a drug manufacturer.

The brakes are on India's clinical trials industry as the country implements stiffer regulations in response to outcries that its citizens are being treated like human guinea pigs.

Many of the small biotechs that went public thanks to the Jumpstart Our Business Startups (JOBS) Act "could be left to die on the vine" unless Congress takes additional steps to help emerging growth companies (EGCs) fully access the market, a House subcommittee was told this week.

More than a year after its congressionally set deadline, the SEC voted 4-1 Wednesday to lift the ban on general solicitations for Rules 506 and 144A private offerings – one of the key provisions of the Jumpstart Our Business Startups (JOBS) Act.

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.