Prescription Drug User Fee Act (PDUFA)

Top 10 Pipelines To Watch: 2019 Annual Report

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The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

February 13, 2019/by Andrew Humphreys

FDA Advisory Committee Votes in Favor of Waylivra for Treatment of FCS

Advisory Committees, Familial Chylomicronemia Syndrome (FCS), FDA, Prescription Drug User Fee Act (PDUFA), Recommeded for approval

Akcea Therapeutics Inc. announced that the U.S. Food and Drug Administration’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra (volanesorsen) for the treatment of people with familial chylomicronemia syndrome.

May 10, 2018/by GlobeNewswire

Aimovig Halves Length of Migraine Attacks in Study

Biologics License Application (BLA), Clinical Trials, Migraine, Prescription Drug User Fee Act (PDUFA), R&D

Amgen unveiled results from a late-stage study that shows the company’s Phase III drug Aimovig reduced monthly migraine attacks in half.

November 30, 2017/by BioSpace

Amgen Discontinues Quest for New CETP Heart Drug

Analysts, Cholesterol, Cholesteryl Ester Transfer Protein (CETP) Inhibitor, Clinical Trials, Fat Tissue, M&A, Prescription Drug User Fee Act (PDUFA), R&D

In the company’s third-quarter 2017 report, Amgen Inc. announced it scrapped internal development of AMG 899, an oral CETP inhibitor it acquired in the $1.2 billion deal for Netherlands-based Dezima Pharma BV.

October 26, 2017/by BioSpace

Eight PDUFA Dates to Watch in August 2017

Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Biotech, Blood Cancers, Cardiovascular Deaths, Glaucoma, Head & Neck Cancer, Hepatitis C, Kidney Cancer, Melanoma, Nasdaq Biotech Index, New Molecular Entities, New York Stock Exchange, Parkinson's Disease, Prescription Drug User Fee Act (PDUFA), Rabies, Stocks

The biotech industry did OK in July 2017. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August 2017.

August 1, 2017/by BioSpace