Dr Reddy’s Requested a New Application, a Patent Lawsuit Against Regeneron’s ‘Antibody Cocktail’ – The Latest on the Covid-19 Vaccine


Cases of the coronavirus disease (Covid-19) have risen to more than 35 million and 1,042,679 people have died worldwide, even as the World Health Organization (WHO) said its “best estimates” indicate that the 10% of people worldwide may have been infected by the coronavirus.

Dr Michael Ryan, WHO’s chief of emergencies, said Monday that the numbers vary from urban to rural areas and between different groups, but that ultimately means that “the vast majority of the world remains at risk.” He said the pandemic will continue to evolve, but there are tools to suppress transmission and save lives. “Many deaths have been prevented and many more lives can be protected,” Ryan said.

According to Ryan, Southeast Asia faced an increase in cases, Europe and the eastern Mediterranean were experiencing an increase in deaths, while situations in Africa and the western Pacific were “significantly more positive.”

Researchers around the world are racing against time to develop a vaccine against the coronavirus disease, as several of them have done so in advanced stages of the clinical trial. Development of the vaccine generally takes years, but scientists have been racing to shorten that time.

These are the latest developments on the Covid-19 vaccine:

1. Dr. Reddy’s lab was asked to review the protocol for the Russian Covid-19 vaccine trials

Dr Reddy’s Laboratories (DRL) was instructed by the Comptroller General of Medicines of India (DCGI) panel of experts to present a revised protocol for conducting phase 2 and 3 clinical trials of the Russian Covid-19 vaccine, Sputnik V, in India. Dr. Reddy’s lab had submitted an application to the top drug regulator seeking a go-ahead to conduct clinical trials for the Russian Covid-19 vaccine in India.

“The Subject Matter Expert Committee (SEC) conducted a thorough evaluation of the application submitted by Dr. Reddy’s Lab. The SEC has sought a revised protocol from Dr. Reddy’s laboratory along with more information and now Dr. Reddy’s laboratory it has to provide a new protocol to the DCGI, ”said a government official, according to the ANI news agency.

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Dr. Reddy’s Lab has partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine, as well as its distribution. RDIF has said it will supply 100 million doses of its potential Covid-19 vaccine to Dr. Reddy’s lab.

2. Trump’s Regeneron Antibody Cocktail Faces Patent Lawsuit

According to a lawsuit by a California company that patented the technology, Regeneron Pharmaceuticals Inc’s “antibody cocktail” given to US resident Donald Trump to treat his Covid-19 symptoms was developed with the unauthorized use of a protein. fluorescent.

Allele Biotechnology and Pharmaceuticals Inc sued Regeneron Monday in White Plains, New York, seeking royalties for the use of its mNeonGreen protein in developing the experimental treatment. A separate federal lawsuit was filed in California against Pfizer Inc and BioNTech SE, partners in the race to develop a Covid-19 vaccine.

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A fluorescent protein is injected into cells so researchers can observe what is happening, to determine, for example, how a virus reacts to an antibody. The mNeonGreen patent, issued in March 2019, covers the use of the protein, which, according to Allele, scientific journals have called the “gold standard” for testing the efficacy of antibody and vaccine candidates.

3. The White House blocked stricter FDA guidelines on vaccine approval

The New York Times reported Monday that White House officials are blocking new federal guidelines for the emergency release of a coronavirus vaccine, including one that would likely ensure no vaccine can be authorized before the US presidential election. November 3.

The U.S. Food and Drug Administration submitted the guidelines to the Office of Management and Budget more than two weeks ago, but they got stuck with White House Chief of Staff Mark Meadows, the Times reported, citing people. familiar with the approval process.

According to Reuters, an administration official said the approval process was still pending and denied any connection on election day. The FDA is looking for other ways to ensure that vaccines meet the guidelines, the Times reported.

FDA Commissioner Stephen Hahn has promised that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly established standards that it works and is safe.

(With contributions from the agency)

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