Antibiotics With Bacteria-Specific, Rather Than Site-Specific, Indication Headed To US FDA
Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.
You may also be interested in...
Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.
Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected.
Gilead’s tie-up with Google’s Verily will explore the immunological underpinnings of rheumatoid arthritis, lupus and GI disorders. Janssen acquires BeneVir and its oncolytic virus expertise, while United Therapeutics buys out SteadyMed.