Following the validation of MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review to determine whether regadenoson
The open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of the locally administered product in a total of 22 patients with primary or recurrent non-muscle invasive
Orphan drug designation for AIP allows AMT to market in Europe for ten years, following marketing approval for AMT-021 from the European Union. Sander van Deventer, CEO, AMT,
The trial aims to further build on data from the Phase III SHARP trial, which demonstrated that Nexavar significantly extended overall survival in patients with unresectable liver cancer
Shimmer Research vice president Kieran Daly said, “We have 30 to 40% of our business in the US, and the majority of that is in the northeast corridor.
The kits will run on a high-throughput multiplex PCR platform which allows processing of large numbers of samples and detecting multiple pathogens in one single run. The highly
Under the agreement, Sanofi Aventis will have a worldwide licence to XL147, an oral PI3K inhibitor, and XL765, an oral dual inhibitor of PI3K and mTOR. Both the
The modification is based on the analysis of data from the recently completed Phase II clinical trial (MN-221-CL-006), which evaluated MN-221 at planned escalating doses in patients with
“The spectrum that has been provided should be adequate for the foreseeable future for implantable medical devices,” Knapp said. “However, new applications for medical technology that uses radio
The FDA’s approval was based on the review of two clinical studies involving approximately 2000 kidney transplant recipients. A phase III, multi-center, open-label clinical trial was conducted where
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