US Biotech posts strong second quarter gain, says Burrill

Anyone attending the 2011 BIO International Convention in Washington DC, which concluded last week, would have noted several key themes for the industry - groundbreaking innovations rising from the confluence of technology and science driving personalized medicine and digital health; US pharmaceutical companies reporting that are increasingly looking to foreign markets to introduce their products, and mounting concerns about the US Food and Drug Administration’s ability to approve new medicines efficiently.

At the Convention the biotechnology industry released a blueprint for a “21st century FDA” which proposes a fundamental overhaul of the FDA to help accelerate the approval of lifesaving medicines. On average, the FDA takes 37 months to approve a drug and only half of product applications are approved during the first review cycle.

Regulatory clouds looming