Tag Archives: David Epstein

Novartis: FDA grants priority review designation to investigational medicine for the treatment of heart failure

Decision could speed access to LCZ696 for HFrEF patients in the US, reducing total review time from 12 to 8 months Filing is based on results from the landmark PARADIGM-HF study[1] Nearly six million people live with heart failure in … Read the full press release

Novartis signed licensing agreement with Ophthotech Corporation to market Fovista® outside the United States

Novartis acquires exclusive ex-US rights to Fovista from Ophthotech; upfront payment of USD 200 million plus potential future recruitment and other milestone payments; additionally Ophthotech to receive royalties on ex-US Fovista sales Fovista is the most advanced anti-PDGF technology in … Read the full press release

Novartis announced US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its serelaxin (RLX030) for acute heart failure

Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 … Read the full press release