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Biosapce.com | January 15, 2019

Shares of Alameda, Calif.-based Exelixis are climbing after the U.S. Food and Drug Administration (FDA) approved its hepatocellular carcinoma (HCC) treatment Cabometyx (cabozantinib). It was previously approved for the treatment of patients with advanced renal cell carcinoma. The approval came despite a partial government shutdown that will likely delay a number of potential approvals unless funding is restored to the regulatory agency. Exelixis’ Cabometyx was approved for HCC patients who...

pharmatimes | June 26, 2019

Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical significance for its primary endpoint of overall survival. The news isn’t all negative, however, as a clear trend was demonstrated towards improvement in overall survival for patients treated with Opd...

Pharmaphorum Media Limited | August 23, 2018

AstraZeneca has said it is analyzing “inconsistent” results after a late-stage trial of its Bevespi Aerosphere inhaler in chronic obstructive pulmonary disease (COPD) failed to match the performance of GlaxoSmithKline’s rival. Already approved in the US and on the market since early last year, Bevespi (glycopyrronium/formoterol fumarate) is under review in Europe. While trials used as a basis for approval in the US and Asia have tested Bevespi against placebo, the latest trial,...

Medgadget | January 02, 2019

Edwards Lifesciences received FDA approval to introduce its SAPIEN 3 Ultra transcatheter aortic heart valve in the U.S. Specifically, the device is indicated for cases of severe, symptomatic aortic stenosis identified to be at the intermediate or greater risk of open-heart surgery. The SAPIEN 3 Ultra has some modifications that make it appropriate to a wider range of patients that would otherwise not be able to get a transcatheter aortic valve. And a brand new delivery system and sheath make the...