Entera Bio Shares Rise After Concluding FDA Meeting on Osteoporosis Treatment

 Entera Bio Ltd. said it has concluded its end-of-Phase 2 meeting with the U.S. Food and Drug Administration on EB613, its oral formulation of human parathyroid hormone for the treatment of osteoporosis.

Entera Bio shares were up 19% to $3.85 in premarket trading.

The company said the meeting defined the path for Phase 3 development of EB613, confirming that a fracture study won't be necessary and that lumbar spine bone mineral density at 12 months can be the primary endpoint.

The meeting followed completion of its Phase 2 clinical trial, which met its endpoints, including increases in lumbar spine, femoral, neck and hip bone mineral density versus placebo after six months of treatment, and demonstrated a safety profile consistent with subcutaneous PTH.

Based on FDA feedback at the meeting, Entera said that it is currently proceeding with its plans for a Phase 3 registration study of EB613 this year.

The company said the FDA confirmed that a comparison of Entera's EB613 dosed at 2.5 mg versus subcutaneous PTH with a lumbar spine BMD increase at 12 months as the primary endpoint for the trial would be acceptable. The company may rely on marketed drugs as part of a 505(b)(2) regulatory approval pathway. The FDA's 505(b)(2) new drug application pathway helps avoid unnecessary duplication of studies already performed on previously approved drugs.

If approved, EB613 would be the first oral anabolic agent for the treatment of osteoporosis. Entera said it expects to begin enrollment in its Phase 3 study in 2022.

https://www.marketscreener.com/quote/stock/ENTERA-BIO-LTD-40311507/news/Entera-Bio-Shares-Rise-After-Concluding-FDA-Meeting-on-Osteoporosis-Treatment-37462592/

Bharat Biotech gets approval to test nasal COVID-19 shot as booster - report

 

India's drug regulator on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to a Mint report, which cited ANI.

The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

"DCGI's Subject Expert Committee has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval," according to the report on Wednesday.

Bharat Biotech and DCGI did not immediately respond to Reuters requests for comment.

As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of COVID-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from Jan. 10.

The country is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 received regulatory approval for mid- to late-stage trials. Local media had reported the mid-stage trial has completed.

India's inoculation drive so far has been dominated by a domestically produced version of the AstraZeneca COVID-19 shot by Serum Institute of India and Bharat Biotech's inactivated vaccine Covaxin, both administered through injections.

On Wednesday, the country reported 58,097 new coronavirus cases, twice the number seen only four days ago, taking its total caseload to over 35 million.

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Indian health experts urge preparations for new wave of COVID-19

 

New COVID-19 cases in India surged to 58,097 on Wednesday, a doubling of the daily tally over the past four days, as health experts called for preparations to ensure hospitals are not overwhelmed by a new wave of patients.

While doctors fretted, politicians, including Prime Minister Narendra Modi, appeared less concerned by the rising case numbers with many of them holding rallies ahead of assembly elections in several states.

Infections have been increasing sharply in cities, with the fast-spreading Omicron variant of the virus becoming dominant in places like New Delhi, authorities said.

India has confirmed nearly 2,000 cases of the variant with many more expected, lending an urgency to calls for hospitals to get ready.

"With infections expected to be skyrocketing we need: clear communication about self-care to prevent panic-driven trips to the hospitals," Bhramar Mukherjee, professor of epidemiology at the University of Michigan, wrote on Twitter.

"Scale up hospital capacity and optimise care to those who really need it," she said.

New Delhi's premier All India Institute of Medical Sciences cancelled a winter holiday for staff between Jan. 5 and 10. Many doctors and nurses have contracted the virus in recent days.

"Ensure maximum preparedness against a possible surge in cases," the health ministry told state authorities on Tuesday.

Authorities, especially in Delhi, have repeatedly said only those who actually need round-the-clock monitoring should go to hospital while others should recover at home.

Delhi tightened up virus mitigation measures on Tuesday, ordering people to stay on the weekends, in addition to a night curfew.

Many other cities have announced curfews but politicians have not called off their election rallies, at which few people wear masks.

Such gatherings last March and April helped the Delta coronavirus variant infect millions of people in India, killing tens of thousands of them.

Delhi Chief Minister Arvind Kejriwal said on Tuesday he had tested positive a day after attending an election rally where none of the people on a dais, including him, could be seen wearing a mask.

Modi will on Wednesday attend the inauguration of various projects in Punjab state, his latest visit to several states holding elections in coming weeks.

Health ministry officials have said COVID-safety measures such as mask-wearing and social distancing apply to all, including politicians, though few seem to heed the advice.

India has had more than 35 million cases, the second highest tally after the United States

The health ministry reported 534 new deaths on Wednesday, taking that toll to 482,551.

https://www.marketscreener.com/news/latest/Indian-health-experts-urge-preparations-for-new-wave-of-COVID-19--37466456/

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’

 

Joe Biden sat on a panel alongside Elizabeth Holmes in July 2015.MediaNews Group via Getty Images
Count President Joe Biden among the political elites who fell under the spell of Theranos and its founder Elizabeth Holmes, the former Silicon Valley star who was convicted of defrauding investors on Monday. 

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. 

“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. 

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 was once embraced by powerful politicians and media outlets.

Getty Imageshttps://nypost.com/2022/01/04/joe-biden-visited-theranos-called-elizabeth-holmes-inspiring/