In a decision that gives at least some merit to Amgen Inc.'s interpretation of the patent dance laid out in the Biologic Price Competition and Innovation Act (BPCIA), the Federal Circuit this week granted the innovator biologics maker an injunction preventing, for the time being, the launch of the first FDA-approved biosimilar.
On the heels of the first sequencing of the human genome, Francis Collins recommended a prospective genetics cohort of patients to provide the foundation for a new approach to health care – precision medicine.
The handling of prescription drug patents in Canadian courts in recent years helped earn Canada the dubious distinction of being the only developed country included on this year's U.S. Trade Representative's (USTR) list of trade partners that need to get their act together.
Patients have come a long way to get a say in the drug development and approval process. But there’s still some ground to cover if they’re going to move from the passive subject role to a 50-50 partnership that reminds researchers, drugmakers and regulators that, “Hey, this is all about us!” While major drugmakers have been hiring senior-level staff to connect and interact with patients and to incorporate the patient perspective into their R&D for a while now, the regulatory field is making slim – albeit positive – advances in that direction. In the past, patients often testified during the...
A recent bidding war on a government tender in Norway for an infliximab biosimilar resulted in a 69 percent discount from the innovator and a rapid market uptake of the follow-on, proving that physicians and patients will flock to a biosimilar – if the price is right.
Despite the challenges of being a biologic pioneer, Amgen Inc.'s melanoma drug, talimogene laherparepvec, or T-vec, garnered the support of two FDA advisory committees – with some caveats.
After months of bipartisan negotiations, a House subcommittee yesterday released its 2.0 discussion draft of the 21st Century Cures Act that fills one of the holes in the first version released in January – provisions to bolster funding for the National Institutes of Health (NIH).
