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Washington Roundup
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.
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.
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.
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