The Supreme Court needed only a few months to determine Prometheus Laboratories Inc.'s process claims weren't patent eligible, but it could take the biopharma industry years to figure out how to live within the new line the court has drawn for process patents, especially those covering diagnostics that advance personalized medicine.
WASHINGTON – Ariad Pharmaceuticals Inc. will have a lot on the line Tuesday when an FDA advisory committee takes a hard look at the data for its sarcoma drug Taltorivc. But for the FDA, it all comes down to one question – do the risks outweigh the benefits?
WASHINGTON – As more and more drugs fall off patent, Congress may need to reset the scales to maintain the proper balance of lower drug prices through access to generics and an environment that encourages innovation.
While other drugmakers are spending billions of dollars in pursuit of the next-generation hepatitis C treatment, Okairos AG is on a quest for the holy grail – a preventive hepatitis C virus (HCV) vaccine.
The game is probably not over for anti-nerve growth factor (NGF) painkillers, but they may have to take a few steps backward before they can go forward.
WASHINGTON – Stop searching for the perfect way and just do it, a coalition of drugmaker, distributor and pharmacy groups told a House subcommittee last week as it pushed for a uniform, nationwide track-and-trace system for prescription drugs that's practical and feasible.
WASHINGTON – The practice of accelerated approval needs to live up to what the law allows, a House subcommittee was told Thursday as it considered a number of issues riding the coattails of PDUFA.
Hoping to unlock much-needed access to the public market for emerging growth companies, the House expects to pass a legislative package later this week that would remove some of the barriers that have all but shut the initial public offering (IPO) door to small biotechs.
