The University of Tennessee Health Science Center (UTHSC) College of Medicine, UTHSC College of Pharmacy and Oak Ridge National Laboratory are combining efforts and expertise to create breakthrough treatments for renal (kidney) disease. This scientific and academic effort has already attracted commercial biotech interest.
Based on the recommendation of Governor Bill Lee and action by the General Assembly before it adjourned, the state funds available to match the federal grant dollars have been significantly increased. At the start of the 2019-2020 fiscal year, the funds will rise to $3 million, which is great news to Tennessee-based start-ups.
Cumberland Pharmaceuticals Inc. has entered into an agreement with a Chinese pharmaceuticals firm that will introduce two of the Nashville-based company’s brands to the world’s second-largest market for prescription medicine. The exclusive deal gives Winhealth Pharma Group the licensing rights to sell Cumberland’s drug brands Acetadote and Caldolor in China.
The medical device industry is criticizing a US Food and Drug Administration (FDA) proposal to limit the use of older predicate devices, citing misconceptions about the 510(k) pathway, hindered market access, stifled innovation and competition and more regulatory burdens. A common theme across commenters on the proposal is: There appears to be no public health reason to support limiting the use of predicates to those that are 10 years old or less, nor does there seem to be a reason to make older ones ineligible for use in demonstrating substantial equivalence to existing medical devices.