As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
A recent report written by SVB Leerink analysts that looked at eight companies and their research-and-development portfolios found that in the past five years, they progressed only 24 percent of their new molecular entities to approval.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
Among the industry group PhRMA’s findings was that overall R&D spending was at an all-time high in 2017, hitting $71.4 billion, up from $65.5 billion in 2016 and from $29.8 billion in 2001.
Nektar Therapeutics announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the new molecular entity NKTR-181, a mu-opioid agonist for pain relief. The company also inked a non-exclusive clinical collaboration deal with Syndax Pharmaceuticals to develop Nektar’s NKTR-214, a CD122-biased agonist in combination with entinostat, Syndax’s HDAC inhibitor in metastatic melanoma.
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.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
A shift from traditional project management practices, EPC is designed to accelerate drugs to market.