Like the troll of yore demanding his pound of goat flesh as the toll for using his bridge, patent trolls are threatening to swallow up biotech start-ups – just as they have other businesses that strayed too close to the vague boundary lines of their intellectual property.
The pulse of the National Institutes of Health (NIH) could weaken without a healthy injection of money to fund future innovations and the scientists who form the core of biomedical research.
A U.S. appellate court blocked Genentech Inc.'s end run around foreign arbitration that could give Sanofi SA a share of the royalties on blockbuster biologic Rituxan.
When is a drug compounder a manufacturer vs. a pharmacy? That's the question the Senate Health, Education, Labor and Pensions Committee grappled with Thursday as it closed in on a bill it can send to the Senate floor that would better regulate compounding pharmacies without opening a loophole around the drug approval process.
Responding to drugmakers' growing interest in pediatric trials, the Biotechnology Industry Organization (BIO) is teaming up with the ViS Research Institute on a two-phase initiative to tackle the biggest challenge in conducting the trials – finding qualified sites that can recruit pediatric subjects.
Generic drugmakers appear to be winning in the showdown with biologics makers over state legislation that would limit the automatic substitution of future biosimilars.
After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class.
Despite moving testimony from patients stressing the need for more options to treat advanced kidney cancer, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 13-1 Thursday against the adequacy of AVEO Oncology Inc.'s single Phase III trial to support the approval of tivozanib.
