Search jobs 16-Dec-2020 Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
EAST HANOVER, December 15, 2020 /PRNewswire/ Novartis today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto
® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fra
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled,
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses i