FDA Grants Fast Track Designation for FARXIGA in Heart Failure

Posted in Biotech by Medtech[y] Staff

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 by Medtech[y] Staff

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 by Medtech[y] Staff

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) ...

Apple announces three groundbreaking health studies

Posted in Future of Healthcare by Medtech[y] Staff

September 12, 2019 • 2 min read

Apple today announced three unprecedented medical studies, in partnership with leading academic and research institutions, that will reach more participants than has ever been possible. The studies will be available on the new Research app,1 which democratizes how medical research is conducted by bringing together academic medical institutions...