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