Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Source: Drug Industry Daily
Artelo Biosciences and the NEOMED Institute announced today that they have entered into an exclusive global option and license agreement for NEO1940. Source: BioSpace
With 2018 expected to be a big year for mergers and acquisitions in the biopharma industry, analysts and investors are considering who the top targets might be. Source: BioSpace
The SEC filed a suit against “one or more unknown traders” while it seeks to identify the perpetrators. Source: BioSpace
The startup is working to develop pharmaceutical technology born out of Johns Hopkins University. Source: BioSpace
DMD Therapeutics is based in Seattle, although at present it is a virtual company, and, as its name suggests, is focused on developing therapeutics for DMD. Source: BioSpace
Rare disease giant Shire plunked down an undisclosed sum to get its hands on a preclinical autoimmune drug candidate being developed by AB Biosciences. Source: BioSpace
BridgeBio stepped in to take over the drug and also launch a subsidiary, QED Therapeutics, to drive the development of infigratinib. Source: BioSpace
Since 2013, Dr. Perlmutter has served as executive vice president of Merck and president of Merck Research Laboratories. Source: BioSpace
A look at three intriguing biotech stocks that are seeing big insider buying from top-ranked insiders right now. Source: BioSpace