Entasis Scores! The FDA's anti-infectives advisory board unanimously recommended approval of Entasis sulbactam-durlobactam for the treatment of hospital and ventilator-acquired pneumonia, caused by resistant strains of Acinetobacter. Wonderful news. But will the company survive?
antibiotic discovery
Nabriva, an antibiotic biotech, recently announced that they were winding down its operations. While this is sad, it may not be so much a market failure problem in this particular case.
The US congress is considering enacting a market incentive to incentivize the research and development of new and needed antibiotics. They are balking at spending a few billion dollars over several years in spite of rising antibiotic resistance and a paltry pipeline of new antibiotics. Without this money, we will watch any hope of fighting the onslaught of resistance whither and die. But our senators and congresspersons are getting cold feet. You have got to be kidding!
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Antibiotic R&D is hard. Getting to approval is harder. Surviving the commercialization step today is almost impossible. Government-based funding to fix the broken antibiotic market is essential to stop this march of the lemmings. Private investment will follow a government incentive and amplify its effect.
Pull incentives to fix the broken antibiotic marketplace – like a subscription payment of several billion dollars per needed antibiotic – are finally going to be implemented in 2032. What happens then? But before we get there … a brief word about blogging on Google’s Blogger.
Will there be pull incentives to support the broken antibiotics market? Where is Biden?
Europe, as opposed to various national authorities, is well poised to provide funds to support the broken antibiotic market. If this ever comes to be, how will products deserving of such support be chosen? Separately, will European regulators continue their slide back to requiring infeasible clinical trials and thereby limiting access to new antibiotics in Europe or will they wake up?
When it comes to antibiotic research, what does the word "innovation" mean? It's a bit different for antibiotics. Dr. David Shlaes argues that a difference in clinical utility is a better measure, even when a new drug or combination of drugs may be structurally similar to older drugs. This, from his blog "Antibiotics, the Perfect Storm."
Antibiotic resistance is spotty. If you are hospitalized in New York and you acquire a Gram-negative infection in the hospital, there is a reasonable chance it will be caused by a highly resistant pathogen. If you go to a hospital in New Hampshire or Vermont, there is almost no chance for that to happen. ACSH advisor Dr. David Shlaes explains.