A rule change restricting access to prescription drugs under the new expanded Medicaid programs has a group of 81 patient advocacy organizations demanding some changes of their own.
The FDA is getting ready to take its Secure Supply Chain Pilot Program (SSCPP) out for a two-year test flight, and it's looking for up to 100 drugmakers to sign on for the ride.
An attempt to lift California's 6-year-old ban on compensating women for donating human eggs for medical research ended this week with a veto by Gov. Jerry Brown.
Drugmakers that are doing nothing to prepare for California's track-and-trace requirements in the hope that Congress passes legislation to preempt the state law could be taking a big gamble.
Sponsors developing drugs in competitive spaces may find themselves between a rock and a hard spot going forward if a federal court ruling on what information the FDA must release under a Freedom of Information Act (FOIA) request is allowed to stand.
The FDA jumped the gun on clocking the five-year exclusivity of Belviq from the date it granted approval – a move that would rob the obesity drug of nearly a year of exclusivity, Eisai Inc. claimed in a recent citizen petition that asks the agency to reset the clock.
When it comes to the National Institutes of Health's (NIH) funding for medical research, it's not a matter of truth or consequences. It's more like truth and unintended consequences.
While some universities may still be spinning their wheels in the red ink spewing from the Bayh-Dole Act, Emory University has built a vehicle it can use to drive promising science across the valley of death into full-scale drug development.
Hoping to stanch the red ink spewing forth from the double-edge sword of the Bayh-Dole Act, several research universities are looking for better ways to triage the value of their faculty's scientific and technological discoveries.
