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HCO News MURFREESBORO, Tenn. —Nashville-based healthcare real estate development firm Oman-Gibson Associates (OGA) has broken ground on a new ambulatory surgery center (ASC) and medical office building (MOB) in the city of Murfreesboro, located 30 miles southeast of Tennessee’s capital city. OGA is developing the ASC in concert with United Surgical Partners International (USPI), whose home offices are in Dallas. The healthcare construction project, which will be sited adjacent to the existing Ascension/St. Thomas medical facility, will entail nearly 30,000 square feet of medical use space...

Novartis International AG: Novartis receives complete response letter from U.S. FDA for inclisiran The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditions No onsite inspection was conducted of the single third-party facility in question. If a facility inspection is needed, FDA will define an approach once safe travel may resume based on public health need and other factors Novartis will work with FDA and the third-party manufacturing facilit...

NOVARTIS AG CHF0.50(REGD) Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFr...

(2) The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators 1,2 HFpEF patients currently have no approved treatment options and face worsening symptoms that result in frequent HF hospitalizations, emergency room a...

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 Entrest...