A FDA advisory panel has voted 14-2 to recommend that the developers of diabetes drugs specifically demonstrate that their experimental therapies don't increase cardiovascular risks. And if as expected the agency follows the recommendation, developers in the diabetes field are looking at more complex trial demands that are likely to add significant cost to the trials process. The Wall Street Journal nominates AstraZeneca and Bristol-Myers Squibb as the first two biopharma companies to face the new standard. Their diabetes drug saxagliptin is headed to the FDA for a review.
- read the report in the Wall Street Journal