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The U.S. Food and Drug Administration (FDA) has, for the first time, approved a monoclonal antibody to treat COVID-19 in hospitalized patients.Healthcare company Roche’s Actemra (tocilizumab) intravenous (IV) was approved by the FDA to treat severe COVID-19 in adults, the company announced on Wednesday.Specifically, the drug is approved in cases where the patient is hospitalized and is receiving systemic corticosteroids, as well as requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.It is the first FDA-approved monoclonal antibody to treat COVID-19, the company stated.Monoclonal antibodies are laboratory-created proteins that mimic natural antibodies the body produces to fight...

On January 24, 2022, The FDA revoked Emergency Use Authorizations (EUAs) for two COVID monoclonal antibody (McAb) treatments, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), made by Eli Lilly and Regeneron respectively. Again on March 25, the FDA revoked the EUA for sotrovimab, which is no longer authorized for use at this time in specified states and territories due to its ineffectiveness against the prevalence of Omicron sub-variants, such as BA.2 in those regions, brought in from overseas. Even these state-of-the-art McAbs can’t keep up with the rapidly mutating, highly transmissible COVID-19 variants. In doing so, the...

President Joe Biden’s administration has ordered 14 additional states to stop using a COVID-19 treatment made by GlaxoSmithKline and Vir Biotechnology. The Department of Health and Human Services (HHS) said March 30 it has paused shipments of the drug, sotrovimab, to the states, bringing the total number of states that are no longer receiving doses to 22. The states are Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin in the midwest; Arizona, California, Idaho, Oregon, and Washington state in the west; and Alaska and Hawaii. Previously, eight states in the northeast U.S. stopped receiving shipments of sotrovimab. The U.S. government purchased...

The monoclonal antibody treatment from GlaxoSmithKline (GSK) and Vir BioTechnology protects well against the Omicron subvariant that is becoming more prevalent in the United States, the companies said Feb. 10.Preclinical data suggest that sotrovimab, the monoclonal, “retains neutralizing activity against the BA.2 subvariant of Omicron ,” the companies said in a press release.The data, based on pseudovirus and pharmacokinetic testing, was not made public. A Vir spokesperson didn’t respond when asked why. The companies said the results are being shared with government authorities around the world and that they plan on publishing them on the preprint server bioRxiv in the...

Indiana-based Eli Lilly and Company reported on February 3, 2022, it recently submitted a request for Emergency Use Authorization to the U.S. FDA for bebtelovimab, an investigational anti-SARS-CoV-2 Monoclonal Antibody (mAbs). Bebtelovimab, which neutralizes the SARS-CoV-2 spike glycoprotein receptor-binding domain-specific antibody, is being evaluated to treat mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older. Lilly's recent financial disclosure says 'authentic virus analysis of bebtelovimab confirmed earlier pseudovirus findings, which demonstrated bebtelovimab neutralizes coronavirus variants of concern, including Omicron.' The U.S. NIH's OpenData Portal Therapeutic Activity Explorer separately confirmed bebtelovimab's effectiveness against Omicron as of February...

People over age 65 at the highest risk for severe COVID-19 have often been the least likely to receive monoclonal antibodies (mAbs)—a highly effective treatment for the disease—both across and within U.S. "Monoclonal antibodies should first go to patients at the highest risk of death from COVID-19, but the opposite happened—the healthiest patients were the most likely to get treatment. Monoclonal antibodies are very effective at treating mild to moderate COVID-19 infection among non-hospitalized patients. But during the pandemic, mAbs have been in short supply. Federal guidelines prioritize patients at higher risk of being hospitalized or dying from COVID-19, including...

Is Joe Biden trying to top the vile, cruel record of blue-state governors such as New York's Andrew Cuomo, who seeded COVID patients into the nursing homes?It sure looks like it, given his strange, sudden, and absolute shutdown of monoclonal antibody treatments on patients who are being successfully being treated with the therapy in Florida. For vulnerable, sick people waiting in line for it, including those right up to the date of scheduled treatment, tough luck, go to the back of the line and see if you can find some other treatment, and hope your COVID does not progress to...

The U.S. Food and Drug Administration Monday rescinded its authorization for Covid-19 monoclonal antibody treatments made by Regeneron Pharmaceuticals and Eli Lilly after those treatments proved ineffective against the omicron variant, over a month after some hospitals voluntarily decided to stop offering the drugs. Monoclonal antibody treatments can prevent serious illness or hospitalization among high-risk Covid-19 patients by reinforcing the body’s natural immune response. Though Regeneron and Eli Lilly’s treatments worked against previous variants of the virus, omicron’s mutation in a spike protein targeted by the treatments all but eliminated their effectiveness. Over a month prior to the FDA’s Monday...

Gov. Ron DeSantis declared he is “committed” to ensuring new COVID-19 monoclonal antibody treatment will be administered to vulnerable Floridians. The long-acting AstraZeneca therapy known as Evusheld will be available to moderately to severely immunocompromised people like cancer patients, he said. “We are committed to doing the monoclonal,” DeSantis said Friday during a news conference, according to ABC affiliate Local 10. “We will make sure the dose sites are available.” The Sunshine State has just 3,100 doses of the antibody drug, favored by opponents COVID-19 vaccines, which will be given to the state’s hospitals and clinics that are performing such...

The Food and Drug Administration (FDA) closed Florida's monoclonal antibody treatment sites on Monday after the federal government abruptly removed the treatments from Emergency Use Authorizations.

Monoclonal antibody sites throughout Florida will be closed after the Food and Drug Administration adjusted its authorization for the COVID-19 treatment.The new FDA policy only allows those "likely to have been infected with or exposed to a variant that is susceptible to these treatments" to receive the new medication, despite Florida's leadership advocating for its use among the populace."This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives," Florida Gov. Ron DeSantis said in a Monday statement. "There are real-world implications to Biden's medical authoritarianism — Americans' access to treatments is...

The Food and Drug Administration on Monday significantly restricted the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron. The agency said the therapies made by Eli Lilly and Regeneron should only be used in patients that have been infected with or exposed to a variant that is susceptible to the treatments.

The federal government slashed in half the number of doses of the monoclonal antibodies therapy shipped to Florida from 30,000 to 15,000 this week, according to Gov. Ron DeSantis (R).DeSantis said the 15,000 dozen received would be “immediately utilized to support new monoclonal antibody sites.”“But for the federal government’s decision to restrict supply of monoclonal antibody treatment to Florida, my administration would have already opened additional monoclonal antibody treatment sites throughout the state,” DeSantis said in a press release.The governor said that before the Biden administration “seized control of the monoclonal supply” Florida was administering 30,000 doses per week to...

The Biden administration is delivering an additional 30,000 monoclonal antibody (mAbs) doses to Florida. And another 15,000 doses of Regeneron have been secured for Floridians to support new monoclonal antibody sites, Gov. Ron DeSantis announced. DeSantis has demanded that the Biden administration “get out of the way” of Florida’s efforts to provide early treatment for the coronavirus and release more monoclonal antibody drugs to Florida. When discussing coronavirus efforts with other governors on Monday, President Joe Biden said, "My message to the governors is simple. If you need something, say something. We're going to have your back any way we...

Despite being the only authorized outpatient medical therapy for preventing the worsening of COVID-19 symptoms in high-risk patients, there remains no steady supply of monoclonal antibodies from the federal government a year after its approval for use by medical regulators.Dr. Aldo Calvo, Medical Director of Family Medicine at Broward Health, shows a Regeneron monoclonal antibody infusion bag during a news conference at the Hospital in Fort Lauderdale, Fla., on Aug. 19, 2021. (Joe Cavaretta/South Florida Sun-Sentinel via AP)Rolled out in the same month as the COVID-19 vaccines, monoclonal antibody therapies have not gotten the attention that vaccine treatments have after...

Cruz's bill comes after Biden admin's decision to control distribution of monoclonal antibody therapeutics Sen. Ted Cruz, R-Texas has introduced legislation to remove federal barriers to states purchasing coronavirus treatments amid concerns that his state and others are approaching government-induced shortages.

A third scientist employed by GlaxoSmithKline pleaded guilty to stealing trade secrets – including the science behind COVID-19 treatments – to boost a competing, state-funded Chinese pharmaceutical company.Lucy Xi, along with three co-defendants, established the Chinese pharmaceutical company Renopharma with funding from the Chinese Communist Party to supposedly research and develop anti-cancer drugs. The team, however, used the company as a vessel to steal information from GlaxoSmithKline (GSK) in the United States.Xi and her colleagues worked at a GSK facility in Upper Merion, Pennsylvania.In January 2015, she sent co-conspirator Yan Mei a GSK document containing “confidential and trade secret data...

Jeff Kuhner of the Kuhner Report is recovering from Covid (Delta) Fill in Sandy Shack updated his listeners. He will return on Monday January 10th, 2022Sandy also noted he was treated with Ivermectin and MonoClonal Antibodies.

Florida GOP Gov. Ron DeSantis on Monday continued his direct challenge to President Joe Biden, calling on the White House to permit his state to provide monoclonal antibody treatments to COVID-19 patients. At a news conference to hit Biden administration restrictions on Florida's ability to provide monoclonal antibody treatments, DeSantis offered up some stinging criticism. "We're past the point now where we're able to get it directly from any of these companies," DeSantis told the reporters. "The federal government has cornered the entire market. They basically took control of the supply in September." The Biden administration has required states to...

White people infected with COVID in New York State - the hardest hit state in the country - are in jeopardy of being turned away from potential lifesaving treatments in favor of other more at-risk races because of a national shortage of two promising types of medical treatments. In a shocking memo sent out by the state's Health Department, white residents were told not to bother trying to get Pfizer's Paxlovid pill or monoclonal antibody treatments. 'Non-white race or Hispanic/Latino ethnicity should be considered a risk factor as longstanding systemic health and social inequities have contributed to an increased risk...