Tag Archives: Fierce Biotech

Docs to FDA: Biosimilars should have different names than branded drugs

shutterstock_1092009

Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , ,

Looking Ahead to the 2014 BIO Investor Forum, Biotech IPO Hopefuls Continue to Seek Funding

partnering1

As mentioned in Fierce Biotech, a new crop of biotech IPO hopefuls have recently thrown their hats into the ring. These three biotechs are targeting $175M in IPO cash, hoping to secure funding for oncology, pain, and rare diseases. In fact, there have been 96 IPOs since the passage of the JOBS Act in April of 2012. One important provision of the Act is the ability for emerging growth companies to conduct “testing the waters” meetings with Read More >

Events  |  Leave a comment  |  Email This Post
Tags: , , , , ,