Regeneron Applies For Emergency FDA Approval Of Antibody Cocktail Given To Trump
Regeneron submitted an application to the FDA for emergency use authorization of REGN-COV2, its experimental monoclonal antibody coronavirus therapy. The biotech says it only has enough doses now for 50,000 people currently and that the government would be responsible for distribution.
CNN:
Regeneron Asks FDA For Emergency Authorization Of Its Covid-19 Antibody Therapy That Was Given To Trump Last Week
Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus. The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night. (Erdman, 10/8)
The New York Times:
Regeneron Asks F.D.A. For Emergency Approval For Drug That Trump Claimed Cured Him
The news of Regeneron’s application on the same day that Mr. Trump effusively praised the unproven drug is likely to intensify fears that the president is pressuring federal health agencies to make decisions aimed at benefiting him politically. In the video, Mr. Trump repeated his desire to get a vaccine approved before the election, even though the vaccine makers themselves have said that is highly unlikely. (Thomas, 10/7)
CNBC:
Regeneron Requests EUA From The FDA For Coronavirus Treatment
The biotech company published a statement Wednesday noting that “if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.” At this time, there are doses available for approximately 50,000 patients, Regeneron said, “and we expect to have doses available for 300,000 patients in total within the next few months.” (Ellyatt, 10/8)
Also —
Reuters:
Regeneron Antibodies In Demand After Trump Treatment, Doctors Seek More Data
Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc, and on Wednesday he promised to make it free to Americans while touting its benefits. Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed. (Beasley, 10/7)
MIT Technology Review:
Trump’s Antibody Treatment Was Tested Using Cells Originally Derived From An Abortion
This week, President Donald Trump extolled the cutting-edge coronavirus treatments he received as “miracles coming down from God.” If that’s true, then God employs cell lines derived from human fetal tissue. The emergency antibody that Trump received last week was developed with the use of a cell line originally derived from abortion tissue, according to Regeneron Pharmaceuticals, the company that developed the experimental drug. (Regalado, 10/7)
Stat:
Regeneron, And The Pugnacious Pair Who Run It, Take Center Stage
On Friday morning, President Trump received an experimental treatment for Covid-19 developed by Regeneron. At the time, it had only been provided to fewer than 10 patients outside of clinical trials, under so-called compassionate use. Data for the drug had been presented for the first time earlier that week on a company conference call. It was, to put it mildly, an unusual situation. (Herper, 10/8)
