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.
You may also be interested in...
Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.
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.
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.