The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
In every case, FierceBiotech has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.
The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.
1. Benlysta - Human Genome Sciences and GlaxoSmithKline
2. Bydureon - Eli Lilly, Amylin Pharmaceuticals, Alkermes
3. Brilinta - AstraZeneca
4. Pradaxa - Boeringer Ingelheim
5. Qnexa - Vivus
6. Contrave - Orexigen
7. Ipilimumab - Bristol-Myers Squibb
8. Cladribine - Merck KGaA
9. Linjeta - Biodel
10. Afrezza - MannKind