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.
Despite their "conceptual parallels," biosimilars are in no way, shape or form to be confused with generics. That's the message the Australian Therapeutics Goods Administration (TGA) sent out repeatedly in its latest guidance on follow-on biologics as it made it clear there would be no automatic substitution down under for biosimilars.
With drug-resistant superbugs outracing the pace of today's antibiotic development, medical experts are pushing Congress to create a regulatory superhighway specifically for drugs intended to head off the worst of the worst bugs.
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. Cheered on by prominent researchers, the NIH has embarked on an all-out campaign to spread the word about the consequences sequestration is having on its ability to fund grants and the long-term impact those consequences are likely to have on the basic research that’s the foundation of drug discovery. The $1.6 billion the NIH expects to lose from its 2013 fiscal budget because of the sequester will translate into a loss...
From here on out, drugmakers can bet their bottom dollar the sun'll be shining on their financial dealings with doctors and teaching hospitals, but there are still a lot of cobwebs that need to be cleared away as the Physician Payment Sunshine Act goes into effect today.
While the stars are aligning for the makers of medical countermeasures (MCMs), the space still has a lot of black holes as sponsors await more regulatory direction and try to anticipate what a next-generation program might look like.
If the FDA wants innovators to share their risk evaluation and management strategies (REMS) with competitors, it needs to come up with guidance, and possibly incentives, to ensure fair play, a former FDA attorney told the agency Thursday as it kicked off a two-day public meeting on how best to standardize and evaluate REMS.
