Theravance Re-Introduces Vibativ In The U.S. Independently (For Now)
This article was originally published in The Pink Sheet Daily
Executive Summary
The biotech is bringing is long-plagued antibiotic back to U.S. patients, but is still searching for another company to help with commercialization efforts. Meanwhile, plans for its split and the launch of its partnered COPD drug are on track.
You may also be interested in...
If You Think Approval Is Hard, Try Selling A New Antibiotic
Getting approval of a new antibiotic is just the first hurdle. Launching an anti-infective in the hospital setting is particularly challenging for sponsors pressured by both the requirements of antibiotic stewardship and an especially challenging reimbursement climate, as Theravance learned with Vibativ.
Actavis’ Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic
FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data but follows its advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might look like.
Actavis Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic
FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data, but follows it advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might be.