FDA Grants Fast Track Designation for FARXIGA in Heart Failure

Posted in Biotech

September 16, 2019 • 2 min read

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF)....

National Lipid Association’s New Position Statement on Use of Icosapent Ethyl in High and Very-High-Risk Patients Recognizes Importance of Addressing Residual Cardiovascular Risk in Patients on Statins

Posted in Biotech

September 16, 2019 • 2 min read

​Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that the National Lipid Association (NLA) has issued a position statement recognizing the cardiovascular risk-lowering effects of icosapent ethyl based on the landmark REDUCE-IT cardiovascular outcomes study....

Celgene Announces Phase 3 QUAZAR AML-001 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Met Primary and Key Secondary Endpoints

Posted in Biotech

September 13, 2019 • 2 min read

Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) ...

AVEO Oncology Announces Updated Overall Survival Hazard Ratio of 0.99 in Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma

Posted in Biotech

September 10, 2019 • 2 min read

AVEO Oncology (NASDAQ: AVEO) today announced results from the second prespecified analysis of overall survival (OS) in the TIVO-3 trial. TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib (FOTIVDA) to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma (RCC)....

Ipsen and Servier announce initial Phase II/III clinical data evaluating investigational ONIVYDE as a second-line treatment for small cell lung cancer at the IASLC 2019 World Conference on Lung Cancer

Posted in Biotech

September 09, 2019 • 0 min read

– 44% of patients achieved a response and nearly half (48%) maintained disease control at week 12 (efficacy as secondary endpoint). Treatment emergent adverse events Grade 3 or higher were reported by 10 of 25 patients (safety as primary endpoint)....