The United States and Russia are currently engaged in a Cold War-like feud over cystic Fibrosis research, with the United States demanding to know if its new drug candidate, Bexsero, is safe and effective for cystic and other forms of CF, and Russia demanding to be assured that it is.
The two countries signed a $1 billion contract for the development of Bexerol for CF last year.
A joint study by the American and Russian National Institutes of Health and the National Center for Cystic Fibrotic Disorders and the International Federation of Cystic Disease Registries (IFCDR) has yet to be completed, and the two sides are still negotiating over the results.
The American CF researchers have said the drug will be “a game changer” in the field, while the Russian CF researchers are more cautious, saying that they’re “hoping that there’s a little bit of an edge” in Bexero that could make it more effective.
The battle has been heating up since President Donald Trump announced in January that he was “open” to a new, cheaper, and more effective drug, and he also said he would “look at a lot of new ideas.”
Last week, the National Academies of Sciences, Engineering, and Medicine announced that the drugs could be available within the next five years.
However, the American CF team says that Bexercol is not as safe as it is being made out to be, and it has called on Congress to ensure that BExerol is “safe, effective, and inexpensive.”
They also have called on President Trump to make sure that BEXERO is approved by the FDA before he leaves office in January 2021, or else the new drug may not even be approved for human use.
The United States has been trying to get more funding to speed up research on Bexeraol.
In 2017, it proposed the creation of the National Institutes for Allergy and Infectious Diseases (NIH) to coordinate drug development.
The proposed NIH-NIH program would have funded the development and production of BExercol, the only approved CF drug approved by FDA in the United State.
The United Kingdom also had been trying since 2015 to create a similar program, but that effort was derailed by political disagreements over the price.
“There’s not a lot we can do at this point.
If they want to go after us, they should go after our scientists and put up a little more of a fight,” said Dr. Daniel L. Pascual, a professor at the University of Maryland and an expert on CF.”
The goal is to be the first to do this.
We don’t want to be first, we want to make this work,” he added.
Bexerciol was approved by European regulators last year for treatment of CF.
The drug was also approved by American authorities, which have also tested it in the clinical trials for Bexralea.
The new drug will cost the United Kingdom about $6 billion, according to the IFCDR, and will be the only drug approved for CF by the U,S.
But there are still questions about the safety and effectiveness of BEXercol.
The first study of Baxel is not expected until 2019, and Dr. Pascal said that the American study is “not going to be that good.”
“You’re talking about a drug that is only tested in a fraction of the patients that we tested,” he said.
“There’s a very small number of patients that are going to benefit, and that’s not going to change the results.”
The National Institutes say that there are now 1,926 CF patients receiving Bexcerol, which is more than twice as many as were receiving Cymbalta before the drug was approved.
The number of people with CF who received Cymbaloa treatment has been growing over the past several years, and by 2020, more than 100,000 people will be receiving the drug.
“If we don’t get the research going in the next two years, then we’re not going see this progress at all,” said Pascu.
The European CF researchers said that Baxer has the potential to become the first drug approved in the U of S. to be able to treat all forms of cystic CF.
But the drug has yet (at least) to be tested in humans, and there are no indications that Bxl has any clinical benefit over Cymba.
“Baxer is the only treatment that we’re testing, and we’re going to make it available in the second half of 2019,” said one of the researchers, Dr. Sajid Jafari.
“We don’t know if Baxar will be effective, or if we will get better results from it.
But it’s certainly a