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Tuesday, January 4, 2022

New COVID-19 variant named IHU discovered in France

 A new COVID-19 variant has been detected in France.  The variant has been named IHU.

It was found to have infected 12 people living in an area near Marseilles, a port city in southern France.

Health officials found that IHU has 46 mutations. That is even more mutations than were found in omicron.

The cases have been linked to travel to the African country Cameroon.

The new strain has not been spotted in other countries yet and the World Health Organization (WHO) has not labeled the new strain a variant under investigation. It has not put any strains on the list since it added omicron in November 2021.

The WHO considers variants of concern ones that increase in transmissibility or increase in virulence or decrease vaccine effectiveness.

Experts say new variants keep emerging but it does not mean they will be more dangerous than previous strains.

According to a paper posted on medRxiv, the strain carries the E484K and N501Y mutations which can make it more resistant to vaccines and can make it more transmissible but it is unclear if either of those things will happen with it.

New York has seen a surge in cases fueled by the omicron variant.  The silver lining has been that many New Yorkers appear to be coming down with a less-severe form of the disease.

Across the U.S., new COVID-19 cases have tripled in the past two weeks to over 400,000 a day, the highest level on record, amid a rush by many Americans to get tested. The high infection rates and resulting worker shortages are putting a heavy burden on employers large and small. Thousands of airline flights have been canceled in recent days. Many companies have shelved return-to-work plans.

Omicron accounted for 95% of new coronavirus infections in the U.S. last week, according to the CDC. The number of new cases in the U.S. topped 1 million on Monday.

https://www.fox6now.com/news/new-covid-19-variant-named-ihu-discovered-in-france

Study: Men More Likely to Experience Damaging Antibodies after COVID-19 Illness

 As SARS-CoV-2 continues to disrupt our world with surging cases, the illness does more than cause a week or two of symptoms for many. As many as 30% of COVID-19 patients experience extended side effects for months—“long COVID.” Recent studies have found that the antibodies produced by our immune systems are the likely culprit.  

A new study from a team in California dug in deeper, examining the differences between the sexes in the long-hauler response to SARS-CoV-2 infection. While women are more statistically susceptible to autoimmune diseases, the research found that men with at least a mild COVID-19 infection had far more autoantibody (AAB) reactivity. Yet, in asymptomatic cases, women showed a higher AAB reactivity rate than men. Disease-associated AABs are important biomarkers used to diagnose autoimmune disease. 

The team studied 3,688 healthcare employees in Los Angeles County who had symptoms related to COVID-19 in the previous six months. Of that group, 177, or 5%, showed positive for the antibody to the nucleocapsid protein of SARS-CoV-2. The study showed that even when the initial illness was not severe, a broad AAB response was seen, triggering lingering side effects for the patients.  

Elevated autoantibody levels in these patients led to attacks on organs and tissues, resulting in chronic inflammation and injuries to the joints and nervous system.  

“We would not normally expect to see such a diverse array of autoantibodies elevated in these individuals or stay elevated for as long six months after full clinical recovery,” said Dr. Susan Cheng, M.D., of the Cedars-Sinai Smidt Heart Institute in Los Angeles. 

Previous research found that the lingering antibodies attack the angiotensin-converting enzyme 2 (ACE2), which helps regulate the body’s response to the virus. The research team believes this antibody attack on ACE2 is a probable cause of long COVID.  

Long COVID has caused a host of lasting issues for patients affected, including extreme fatigue, breathlessness, chest pain, difficulty concentrating and more. Studies suggest that vaccines reduce the risk of long COVID first by preventing infection and decreasing the risk of lingering implications for breakthrough cases.  

The LA team continues to review their data to study the link between autoantibody elevations and long COVID, including new variants of the virus, to see if the mutations have impacted these findings. 

“We don’t yet know how much longer, beyond six months, the antibodies will stay elevated and/or lead to any important clinical symptoms,” Cheng said. “It will be essential to monitor individuals moving forward.” 

SARS-CoV-2 has caused over 293 million cases of COVID-19 worldwide and claimed more than 5.45 million lives.  

https://www.biospace.com/article/men-more-likely-to-experience-damaging-antibodies-after-covid-19-illness-/

4th Scientist Pleads Guilty to Stealing GSK Information for China

 Ex-GlaxoSmithKline researcher Lucy Xi has pled guilty to conspiracy to steal trade secrets from her former company to help a rival firm launch a business in China. She is the fourth person to plead guilty to the offense. 

In a press release posted by the U.S. Department of Justice, Xi and co-defendants Yan Mei, Yu Xue, Yan Mei, and Tao Li created Renopharma in the guise of conducting research and development of ant-cancer therapies. However, it was found that Renopharma had been operating as a repository of stolen GSK information and was receiving compensation and subsidies from the People's Republic of China to do so. 

During this time, Yu Xue and Lucy Xi (married to Yan Mei) were employees of GSK's Upper Merion laboratory in Pennsylvania, where products valued at least $1 billion were being evaluated and created. The underground collaboration reportedly started in January 2015, when Lucy Xi sent Yan Mei confidential information and GSK trade secrets about ongoing research on monoclonal antibodies. The scientist allegedly told Yan Mei that the data sent could "help you in your future business," pertaining to Renopharma. 

The indictment against the scientists point in specific to GSK's code of conduct, which prohibits any company information from being shared externally without approval. 

"The lifeblood of companies like GSK is its intellectual property, and when that property is stolen and transferred to a foreign country, it threatens thousands of American jobs and jeopardizes the strategic benefits brought about through research and development. Such criminal behavior must be prosecuted to the fullest extent of the law," said U.S. Attorney Jennifer Arbittier Williams in a statement.

So far, Tao Li, Tian Xue, and Yu Xue (Lucy Xi's sister) have pled guilty to conspiracy. Yan Mei is currently at large and is believed to be hiding in China. Xue, who has admitted to the charge earlier, faces a $250,000 fine, up to 10 years in jail, and possibly more fines if the court requires that she pay for the value of the trade secrets knowingly leaked, which industry observers estimate to be worth $2 billion. 

"When individuals steal valuable trade secrets concerning one of these drugs, it's a threat both to that firm and beyond. After all, innovation like this propels the U.S. economy. The FBI is committed to enforcing laws that protect the nation's businesses from such theft. We will not permit American research and development to be scavenged for the benefit of other companies or countries," commented Jacqueline Maguire, the special agent in charge of the Federal Bureau of Investigation's Philadelphia unit. 

U.S. District Judge Joel Slomsky has set April 12, 2022, as Lucy Xi's sentencing date.

https://www.biospace.com/article/fourth-scientist-pleads-guilty-to-conspiracy-in-leaking-confidential-gsk-research-to-rival-chinese-company/

Joe Biden visited Theranos, called Elizabeth Holmes ‘inspiring’

 Elizabeth Holmes and Joe Biden

Then-Vice President Biden visited Theranos’ California headquarters in 2015, sitting next to its turtlenecked founder during a roundtable and christening the facility the “laboratory of the future.” 

“Talk about being inspired,” Biden gushed, according to a Theranos press release published after the visit. “This is inspiration. It is amazing to me, Elizabeth, what you’ve been able to do.” 

Biden’s visit came just months before the Wall Street Journal published an exposé revealing that Holmes had misled investors and patients about its blood testing technology. The company, which was once valued at $9 billion, dissolved by 2018 and Holmes was found guilty of three wire fraud charges and one conspiracy charge on Monday.

But before Holmes’ hogwash was revealed, Biden said that the Obama administration considered Theranos to be the future of medicine. 

Elizabeth Holmes and Joe Biden
“This is the laboratory of the future,” Biden said.
MediaNews Group via Getty Images

“This is the laboratory of the future,” Biden said. “What’s most impressive to me is you’re not only making these lab tests more accessible, you’re charging historically low prices, which is a small fraction of what is charged now, while maintaining the highest standards, and empowering people whether they live in the barrio or a mansion, putting them in a position to help take control of their own health.”

Biden also told Holmes that he and then-President Barack Obama “share your vision of a health care paradigm focused on prevention.”

Both the vice president’s office and Theranos documented the visit in extensive tweets that were recently unearthed by the Washington Examiner

Biden was far from the only powerful man to embrace Theranos. The company’s board members included former secretaries of state Henry Kissinger and George Shultz, former defense secretaries James Mattis and William Perry and former Senators Bill Frist and Sam Nunn. 

Other prominent investors who sank millions into Theranos include the Walmart-founding Walton family, the billionaire DeVos family — which includes Trump administration education secretary Betsy DeVos — and Rupert Murdoch, who owns the parent company of The Post and The Wall Street Journal. 

Prior to the Journal exposé, Holmes was also embraced by the media, gracing the covers of magazines like Fortune, Forbes and Inc. 

Shortly after Biden’s visit, the White House’s YouTube channel posted a short video of Holmes talking about her work “empowering women in science, technology, mathematics and business as well as working on breakthroughs in global health.” 

Holmes was also invited to a 2015 White House dinner in honor of the prime minister of Japan, according to an invitation unearthed by the Washington Examiner. 

Elizabeth Holmes
Holmes was convicted of fraud on Monday.
Bloomberg via Getty Images

The jury in Holmes’ trial found that she defrauded some investors by lying about the potential of Theranos’ blood testing technology. However, the jury also cleared her of an additional three fraud and one conspiracy charge and failed to reach a verdict on another three charges

Holmes faces up to 20 years in prison for each of the four charges, though most court-watchers say her sentence will almost surely be shorter. 

Ramesh “Sonny” Balwani, Holmes’ ex-boyfriend and number-two at Theranos, is set to face the same charges as Holmes in a separate trial later this year

Elizabeth Holmes
Elizabeth Holmes was once embraced by powerful politicians and media outlets.
Getty Imageshttps://nypost.com/2022/01/04/joe-biden-visited-theranos-called-elizabeth-holmes-inspiring/

FDA cautions against throat swab for at-home COVID tests

 The FDA is warning people to follow the instructions of at-home Covid-19 rapid tests and only swab their noses — pushing back against viral reports that the tests are more accurate when users also swab their throats.

The at-home rapid antigen tests currently available in the US were only developed and studied using nasal swabs. Swabbing your throat along with your nose could actually contaminate your sample, the FDA said.

“The FDA advises that COVID-19 tests should be used as authorized, including following their instructions for use regarding obtaining the sample for testing,” the agency, which approves Covid tests, told the Post in statement.

The FDA said it has also “noted safety concerns regarding self-collection of throat swabs,” which can harm a patient if done incorrectly and should be collected by a trained professional.

Despite the FDA recommendations, people are swabbing their throats because they don’t feel confident in the accuracy of at-home tests and think the Omicron variant, which often lives in the upper airways, might be more commonly found in throat.

Dr. Roy Gulick, chief of infectious diseases at Weill Cornell Medicine and NewYork-Presbyterian, said he isn’t surprised to hear people who experimented with at-home tests have found different results, but advised against “coloring outside the lines” when self-testing.

A throat swab is taken from a patient to test for COVID-19 at a facility in Soweto, South Africa, Dec. 2, 2021.
The FDA has warned at-home testing users to not swab their throats as it could contaminate the sample.
AP Photo/Denis Farrell, File

“The FDA has cautioned that the at-home tests can be less sensitive to pick up the Omicron variant,” he said “But that doesn’t mean they’re worthless.”

PCR tests remain the gold standard in the industry, but Gulick said early tests are an important starting points if available.

“Always start with a home test, and if it’s positive, certainly believe the result,” he said. “If it’s negative and you have classic covid symptoms or were in contact with someone who had Covid, the best thing to do is not to swab your throat but to go in and get the PCR test.”

An at home Covid-19 test shows up positive in a Memphis, Tennessee household over the Christmas Holiday.
The FDA has issued a stern warning after many social media users recommended swabbing throats for more accurate testing results.
Karen Focht/ZUMA Press Wire

Covid “is not a do-it-yourself disease,” Gulick said, and if you’re worried about accuracy, ignoring clinical instructions won’t help.

If anything, it’s this scramble to ensure accurate test results that emphasizes the importance of easy access to PCR testing.

“Early on when you’re not showing symptoms, you likely don’t have a lot of virus in your system, and rapid tests can’t pick up those low levels of virus,” Kara Cannon, the operations manager of Enzo Clinical Labs, which runs labs in the New York area that do Covid testing, previously told the Post. PCR tests, meanwhile, do take longer to process and require a lab but are able to capture smaller amounts of the virus.

A health worker collects a swab sample from a person for COVID-19 testing at a mobile COVID-19 testing site in midtown Manhattan.
Infectious diseases expert Dr. Roy Gulick argues the PCR COVID-19 test is the most accurate for detecting the bug.
Shawn Goldberg / SOPA Images/Sipa USA

Abbott, which manufactures the popular BinaxNow test, told the Post its tests remain “highly accurate” and said if users want to “ensure accurate test results, is important to follow the instruction for use” — stressing the test is only authorized by the FDA to work for a nasal sample.

But not everyone thinks a throat swab is a bad idea. Dr. Purvi Parikh, an immunologist at NYU Langone, thinks the throat swab is a good “add-on” to the nose swab.

“I would do both: nose first and then throat,” Parikh said. “If you’re sending out for a PCR and you’re able to do both, that’s helpful.”

A BinaxNOW COVID-19 at-home test.
Manufacturer Abbott says their at-home rapid test only works with a nasal sample.
William Farrington

Parikh says her suggestion stems from concerns that people aren’t swabbing themselves properly, failing to go deep enough in their nasal cavity and missing the virus.

Post-nasal drip from congestion might mean the virus will find its way into your throat, making it a useful site for sampling, she said.

For Brooklyn resident Jocelyn Silver, 29, a throat swab made the difference.

Silver, the managing editor at the website Gawker, began feeling sick on Monday but tested negative on a rapid antigen test. On Tuesday, a friend sent her a TikTok from a journalist suggesting you swab both your nose and your throat. Silver tried the method and tested positive.

“I can’t be making my medical decisions based on TikTok and I’m still planning on getting a PCR, but it seems like there’s some validity to it,” she said.

Still, she gets why the FDA is worried about people swabbing their own throats.

“It did make me gag and it was awful…I fully cried,” she said. “My landlord lives downstairs and she texted me and asked if everything okay.”

https://nypost.com/2022/01/04/fda-cautions-against-throat-swab-for-at-home-covid-tests/

Cullinan Oncology Gets FDA Breakthrough Tag for Lung Cancer Med

 Cullinan Oncology Inc. on Tuesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to CLN-081 for the treatment of certain patients with non-small cell lung cancer.

The Cambridge, Mass., biopharmaceutical company said the designation covers CLN-081 in patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients harboring exon 20 mutations whose disease has progressed on or after prior therapy.

https://www.marketscreener.com/quote/stock/CULLINAN-ONCOLOGY-INC-117317644/news/Cullinan-Oncology-Gets-FDA-Breakthrough-Designation-for-CLN-081-37460353/

Spero Therapeutics Says FDA Lifts Clinical Hold on SPR720 Phase 2 Trial

 Spero Therapeutics Inc. said the U.S. Food and Drug Administration has lifted the clinical hold on the Phase 2 trial of SPR720, its investigational oral product candidate being developed for nontuberculous mycobacterial disease.

The SPR720 program was placed on a clinical hold by the FDA following a review of data from a non-human primate toxicology study in which mortalities with inconclusive causality to treatment were observed.

The company said the FDA's decision to lift the hold follows Spero's submission of a comprehensive study report with detailed analyses from the NHP toxicology study.

Spero plans on engaging with the FDA in the first quarter of 2022 to discuss the re-initiation of the SPR720 Phase 2 trial for NTM-pulmonary disease patients, with an expected study start date commencing in the second half of 2022.

https://www.marketscreener.com/quote/stock/SPERO-THERAPEUTICS-INC-38533873/news/Spero-Therapeutics-Says-FDA-Lifts-Clinical-Hold-on-SPR720-Phase-2-Trial-37461183/