When it comes to the compounding of drugs, the one thing everyone agrees on is that something needs to be done to ensure the safety of the products. But how to do that is another matter.
Despite an increase in transparency and collaboration in China, the safety of drugs and other products imported from the country remains a concern in the U.S.
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.