2010: Another blah year at FDA as new drug approvals slip

2010 will not go down in biotech history as a particularly fruitful year for new drug approvals. Developers managed to gain an FDA approval on only 21 new drugs last year, a drop from the anemic records established in 2008 and 2009. And it only barely edged out the 17 new approvals recorded in 2007--the historic low water mark in biopharma history.

There were 25 new approvals to report in 2009, up just a tad from 2008's 24 new approvals, according to tallies kept by Bloomberg and the Wall Street Journal. And with new restrictions on drugs like Avandia and the disappearance of Meridia, as well as fresh action targeting Avastin for breast cancer, analysts note that regulators show signs of continually raising the bar on new approvals.

"There's a sense that the FDA is being more cautious," Les Funtleyder, a fund manager at Miller Tabak & Co., told Bloomberg. "If the rules get too onerous, it could potentially keep innovative drugs out of U.S. hands."

The bad news in 2010 was spread far and wide. Eli Lilly ($LLY) and its partners were handed a fresh setback on Bydureon and AstraZeneca ($AZN) has to wait on Brilinta as well. And big pharma companies like Pfizer were handed a series of stinging clinical failures for top drug prospects. None of that bodes well for 2011 as the drug development industry continues its hunt for a more effective business model.

- read the story from the Wall Street Journal
- see the Bloomberg report

BD&L Summit

Deal-Making Insights for the Life Sciences Industry

Bringing together key deal-makers and serving as an open forum for cross-functional business development and legal teams to share valuable insights and actionable strategies on successfully managing alliances, licensing agreements, and M&A deals.