Eli Lilly antibody trial paused over safety concerns

Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.

Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.

That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.

What’s next: The data and safety monitoring board overseeing the trial will review data again at a preplanned meeting on October 26. The board will recommend at that meeting whether or not enrollment should be resumed, according to NIAID.

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U.S. pauses Eli Lilly’s trial of a coronavirus antibody treatment over safety concerns

  • Eli Lilly’s phase three trial of its ACTIV-3 monoclonal antibody treatment for the coronavirus has been paused due to potential safety concerns.
  • The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral with emergency use authorization for the virus.
  • It’s one of several ongoing trials, as part of the National Institute of Health’s “Activ” program, designed to accelerate the development of vaccine treatments in partnership with the pharmaceutical industry.



a group of people standing around a plane: In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.


© Provided by CNBC
In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over potential safety concerns, the company confirmed to CNBC on Tuesday.

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“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” a spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The company’s shares fell by about 3% in afternoon trading after the news started to leak out over Twitter.

The news comes less than 24 hours after Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was paused after a participant reported an “adverse event” the day before.

Dr. Mathai Mammen, global head of Janssen research and development at J&J, told investors on a conference call Tuesday that the company still has “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. Preliminary information has been sent to the data safety monitoring board for review, he added.

Medical experts note that pauses in large clinical trials are not uncommon. They added it’s possible the bad reaction could be result of an unrelated illness, and not the drug itself. The review from the data and safety monitoring board will help determine that.

Video: Dr. Scott Gottlieb on remdesivir Covid-19 treatment study: ‘Results were strong’ (CNBC)

Dr. Scott Gottlieb on remdesivir Covid-19 treatment study: ‘Results were strong’

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The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ remdesivir, an anti-viral with emergency use authorization for the virus. It’s one of several ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration’s effort to manufacturer and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the

COVID-19 again? Reinfection cases raise concerns over immunity

By Kate Kelland

LONDON (Reuters) – The case of a man in the United States infected twice with COVID-19 shows there is much yet to learn about immune responses and also raises questions over vaccination, scientists said on Tuesday.

The 25-year-old from Reno, Nevada, tested positive in April after showing mild symptoms, then got sick again in late May with a more serious bout, according to a case report in the Lancet Infectious Diseases medical journal.

The report was published just hours after U.S. President Donald Trump, who was infected with COVID-19 and hospitalised earlier this month, said he believes he now has immunity and felt “so powerful”.

Scientists said that while known incidences of reinfection appear rare – and the Nevada man has now recovered – cases like his were worrying. Other isolated cases of reinfection have been reported around the world, including in Asia and Europe.

In the Netherlands, the National Institute for Public Health confirmed on Tuesday that an 89-year-old Dutch woman, also sick with a rare form of bone marrow cancer, had recently died after contracting COVID-19 for a second time.

Dutch media said this was the first known case worldwide of a death after SARS-CoV-2 coronavirus reinfection.

‘IMPLICATIONS FOR VACCINATION’

“It is becoming increasingly clear that reinfections are possible, but we can’t yet know how common this will be,” said Simon Clarke, a microbiology expert at Britain’s Reading University.

“If people can be reinfected easily, it could also have implications for vaccination programmes as well as our understanding of when and how the pandemic will end.”

The Nevada patient’s doctors, who first reported the case in a non peer-reviewed paper in August, said sophisticated testing showed that the virus strains associated with each bout of infection were genetically different.

“These findings reinforce the point that we still do not know enough about the immune response to this infection,” said Paul Hunter, a professor in medicine at Britain’s University of East Anglia.

Brendan Wren, a professor of vaccinology at the London School of Hygiene & Tropical Medicine, said the Nevada case was the fifth confirmed example of reinfection worldwide. 

“The demonstration that it is possible to be reinfected by SARS-CoV-2 may suggest that a COVID-19 vaccine may not be totally protective,” he said. “However, given the (more than) 40 million cases worldwide, these small examples of reinfection are tiny and should not deter efforts to develop vaccines.”

World Health Organization spokesman Tarik Jasarevic concurred that the U.S. case underlined what was unknown about immunity. “And this also really is an argument against what some have been advocating, and that’s building naturally what is called herd immunity. Because we don’t know,” he told a briefing.

(Reporting by Kate Kelland; Additional reporting by Anthony Deutsch in Amsterdam, Stephanie Nebehay in Geneva; Editing by Andrew Cawthorne)

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Novak Djokovic gives fitness update after Carreno Busta accuses him of feigning injury concerns



Novak Djokovic


Novak Djokovic

Pablo Carreno Busta made a startling accusation on Wednesday when he alleged that top seed Novak DJokovic was feigning injury concerns during their quarter-final meetings at French Open 2020. 17th seed Carreno Busta took the first set 6-4 only to go down in 4 sets and crash out of the competition.

Novak Djokovic seemingly wasn’t in top gear in the first set as he had headed into the match with a strap on his neck and his movements were restricted. Carreno Busta though was ruthless as he came up with spotless service games while Djokovic was struggling with it, getting only 40 percent of his first serves in.

After losing the first set, Djokovic received treatment on-court as his trainer worked on his upper-left arm. Djokovic was feeling uncomfortable but after the on-court treatment, the Serb was able to manage a strong comeback and fend off the threat from the 17th-seed Spaniard.

Djokovic needed 3 hours and 10 minutes to beat Carreno Busta 4-6, 6-2, 6-3, 6-4 but the Spaniard wasn’t happy with the treatment Djokovic received. Notably, Carreno Busta had beaten Djokovic when the Serb was defaulted during his Round of 16 match at US Open — the only loss for the World No. 1 in the ongoing season.

“Each time he is in trouble he usually does it, that means to say that he was in trouble, that he wasn’t comfortable and that I was playing at a high level and was causing him to doubt himself. Every time a match gets complicated he asks for medical assistance. He has been doing this for a long time. I already knew that. I knew it would happen at the US Open, I knew it would happen here and I know it will keep on happening,” Carreno Busta said.

“I don’t know if it’s something chronic in his shoulder or just mental, but he didn’t put me off.”

Don’t want to get into it too much: Djokovic

Meanwhile, Djokovic said he did not feel great before coming into the match but he is feeling okay after overcoming his neck and shoulder issues during the quarter-final. Djokovic will face 5th seed Stefanos Tsitsipas in the semi-final as he bids to win his 18th Grand Slam at Roland Garros this year.

“I definitely didn’t feel great coming onto the court today, a few things happened in the warm-up. I had some neck issues and some shoulder issues. I don’t really want to get too much into it. I’m feeling okay, I’m still in the tournament so I don’t want to reveal too much. As the match went on, I felt better, and didn’t feel as much pain,” Djokovic said.

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Terence Kongolo’s move to Sheffield United on the rocks after scans raised concerns over fitness

Terence Kongolo’s move to Sheffield United on the rocks after scans raised concerns over the defender’s fitness following a broken foot last season with Blades looking at other options

Terence Kongolo’s proposed move from Huddersfield Town to Sheffield United is understood to have hit a hitch following medical tests.

The 26-year-old defender has only just recovered after missing most of the year with a broken foot that required metal re-enforcement. That metal work had to be removed again before he could resume playing.

Sheffield United manager Chris Wilder confirmed his interest in signing Kongolo as a potential replacement for the injured Jack O’Connell and a deal had looked likely over the weekend. However, medical tests are understood to have raised concerns over when Kongolo was ready to play at full fitness again.

Terence Kongolo's move to Sheffield United has broken down following medical tests

Terence Kongolo’s move to Sheffield United has broken down following medical tests

The Dutchman picked up the injury while on loan at Fulham and they have also been among the clubs keen to sign him.

Talking about the injury back in February, then Huddersfield manager Danny Cowley explained: ‘Terence went on in the Blackburn game with about eight minutes to go, he jumped and won a header but when he landed on his foot there was a problem.

‘In the foot there are many, many different bones and between these there are ligaments.

‘Unfortunately, Terence took a heavy landing on one of those bones and ligaments and he’s had to have a piece of metalwork put in which, hopefully, will resolve the issue.

‘He will then need that metalwork to come out before he is able to play again, so it is going to be a lengthy one.

‘We are hoping he will be available for the start of next season – that is certainly the aim – but it is a disappointment to everyone.

‘You feel for Terence because he had just gone to Fulham, who are in a good position and he would have wanted to affect them while on loan.’

Sheffield United have also asked about Preston North End’s £10m rated defender Ben Davies.

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Florida forges ahead in lifting curbs amid virus concerns

MIAMI — As the summer coronavirus spike in Sunbelt states subsides, Florida has gone the furthest in lifting restrictions, especially on restaurants where the burden of ensuring safety has shifted to business owners and residents — raising concerns of a resurgence.

In his drive to return the state to normalcy, Republican Gov. Ron DeSantis lifted limits on indoor seating at restaurants, saying they can operate at 100% in cities and counties with no restrictions and that other local governments with some restrictions can’t limit indoor seating by more than 50%.

In some of Florida’s touristy neighborhoods, patrons have since been flocking to bars and restaurants, filling terraces, defying mask orders — drawing mixed reactions from business owners and other customers.

“We’re generally concerned that we’re going to find ourselves on the other side of an inverted curve and erasing all the progress we’ve made,” said Albert Garcia, chairman of the Wynwood Business improvement district, which represents 50 blocks of restaurants and bars in Miami’s trendy arts district.

Other Sunbelt states that have been COVID-19 hot spots over the summer haven’t gone as far. In Texas, bars have been closed since June under Republican Gov. Greg Abbott’s orders, and restaurants can hold up to 75% of their capacity, while face covers are required throughout the state. And in Arizona, restaurants and bars must run at half-capacity.

Though Florida’s governor generally wears a mask when arriving at public appearances and has allowed municipalities to impose mask rules, he has declined to impose a statewide mandate. And on Sept. 25, as the state entered a Phase 3 reopening, he barred municipalities from collecting fines for mask violations.

DeSantis says contact tracing has not shown restaurants to be substantial sources of spread.

“I am confident that these restaurants want to have safe environments,” he said earlier this week. “And I’m also confident that as a consumer, if you don’t go and you don’t think they’re taking precautions, then obviously you’re going to take your business elsewhere.”

Craig O’Keefe, managing partner for Johnnie Brown’s and Lionfish in Delray Beach, said they’re now accommodating as many people as they did before the pandemic began and he’s hired eight people in the past few days. Demand surged last weekend.

“It was like someone turned the light on,” O’Keefe said. “It was great to see people out smiling, having fun getting to see each other. It’s been a really nice thing to get people back to work.”

Shutdowns and restrictions have battered Florida’s economy, leaving hundreds of thousands unemployed in the tourist-dependent state.

Earlier this week, The Walt Disney Co. announced it would lay off 28,000 workers in its theme parks division even after the Florida parks were allowed to reopen this summer.

Florida has had more than 14,500 deaths from the pandemic, ranking 12th per capita among states. Its outbreak peaked in the summer, seeing as many as 12,000-15,000 cases added per day. New cases, positivity rates, hospitalizations and deaths have been on a downward trend for

The Latest: S. Korea Reports 64 Cases Amid Holiday Concerns | World News

SEOUL, South Korea — South Korea has reported 64 new cases of the coronavirus, the fourth straight day its increase came below 100, possibly reflecting the fewer number of tests conducted during one of the biggest holidays of the year.

The figures released by the Korea Disease Control and Prevention Agency on Sunday brought the national caseload to 24,091, including 421 deaths.

Thirty-eight of the new cases were reported from the densely populated Seoul metropolitan area, which has been at the center of a viral resurgence since August. Health workers have struggled to track transmissions tied to churches, hospitals, schools and offices.

Seventeen of the new cases were linked to international arrivals, mostly from other Asian countries such as the Philippines, India, and Bangladesh.

There are concerns that infections could rise in coming weeks because of increased travel during the five-day Chuseok harvest holiday that continues through Sunday.

HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Trump said to be improving but next 48 hours ‘critical’

— Trump’s diagnosis shows US vulnerability to the coronavirus

— Pence ordered borders closed after CDC experts refused

— South Africa and India have asked the World Trade Organization to waive some provisions in the international agreements that regulate intellectual property rights to speed up efforts to prevent, treat and contain the COVID-19 pandemic.

— Madrid has started its first day under a partial lockdown with police controlling travel in and out of the Spanish capital. The Madrid region has become Europe’s most critical hot spot in the second wave of the coronavirus.

— Pope Francis has traveled to the tomb of his nature-loving namesake to sign an encyclical laying out his vision of a post-COVID world built on solidarity, fraternity and care for the environment.

Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

HERE’S WHAT ELSE IS HAPPENING:

SANTA FE, N.M. — New Mexico officials have reported 298 additional known COVID-19 cases and three more deaths, increasing the statewide totals to 30,296 cases with 890 deaths.

The additional cases reported Saturday included 75 in Bernalillo County, 67 in Dona Ana County, 32 in Chaves County, 22 in Lea County and 20 in Curry County.

The three deaths occurred one each in Bernalillo, Curry and Dona Ana counties and involving people in their 70s or 80s with underlying conditions.

PHOENIX — Numerous inmates say Arizona’s prison system has failed to provide necessary testing, supplies and treatment during the coronavirus pandemic.

The Arizona Republic reports that dozens of letters from inmates in recent months said the Arizona Department of Corrections, Rehabilitation and Reentry wasn’t protecting staff and inmates during the outbreak.

The Republic reports inmates’ letters describing fears and frustrations, asking for help while others provided graphic details in personal narratives of surviving the virus.

A department spokesperson denied many allegations by inmates, including that sick inmates weren’t tested. Department spokesperson Judy Keane also cited health and safety protocols announced during the pandemic.

LONDON — Britain has recorded 12,872 new coronavirus infections,

Health officials urge Americans to get flu vaccine as concerns mount over possible ‘twindemic’

During the annual Influenza/Pneumococcal Disease news conference on Thursday, hosted by the National Foundation for Infectious Diseases, public health experts, including Dr. Anthony Fauci, urged the public to follow the Centers for Disease Control and Prevention recommendation for everyone to get vaccinated against flu.

“Everybody, 6 months of age or older, should get an annual flu vaccine,” asserted Fauci.

“Influenza, all by itself, is a profoundly serious viral infection, which causes hundreds of thousands of hospitalizations each year, with the major complication being pneumonia, and many thousands of deaths,” Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told ABC News.

Only 48% of U.S. adults were vaccinated against the flu during 2019-2020, leading to 38 million flu illnesses, 18 million flu-associated medical visits, 400,000 flu hospitalizations and 22,000 flu deaths, according to CDC estimates.

“We’re at greatest risk of becoming seriously ill,” Fauci said during the conference. “It’s our personal responsibility to protect ourselves. But we also have a responsibility to protect the vulnerable around us, including young children, pregnant women, adults, 65 years of age or older and those with underlying chronic health conditions.”

“First, get vaccinated,” he continued, “and take everyday preventive actions to stop the spread of germs.”

Vaccine hesitation is a major public health issue in America, but vaccines are the most effective tool in combating infectious diseases. Last year, the flu vaccine prevented 7.5 million flu illnesses, 3.7 million flu-associated medical visits, 105,000 flu hospitalizations and 6,300 flu deaths, according to the National Foundation for Infectious Diseases.

The flu vaccine is not 100% effective, thus, it may be possible for some people to get vaccinated and still get the flu. However, getting the vaccine makes the symptoms of the flu much less severe than it would have been if you never got the shot.

“Each year, we show that people who are vaccinated, and run the risk of getting influenza, are less likely to have to go to the emergency room, less likely to be hospitalized, less likely to be admitted to the intensive care unit. And they’re less likely to die,”

Texas officials: No earlier concerns after microbe found

Updated


LAKE JACKSON, Texas (AP) — Texas officials said Tuesday that water samples taken earlier this year from a Houston-area community did not raise concerns before the detection of a deadly, microscopic parasite, which doctors believe killed a 6-year-old boy.

Residents of Lake Jackson are likely to remain under orders to boil water for several weeks as the city continues purging the water supply. Lake Jackson officials said this week that three of 11 samples of the city’s water indicated preliminary positive results for the naegleria fowleri microbe.


One sample, Lake Jackson City Manager Modesto Mundo has said, came from the home of Josiah McIntyre, the 6-year-old boy whom doctors said died earlier this month after being infected with the brain-eating parasite.



Republican Gov. Greg Abbott visited Lake Jackson on Tuesday along with the state environmental regulators, who said samples through at least June raised no flags. Abbott said all indications point to the case being isolated and that the suspected problem in the boy’s death was traced back to a splashpad.

“The

Organoids Market: Growing Concerns about Systematic Treatment Solutions for Personalised Medicine to Drive the Market Growth

Global Organoids Market: An Overview

The global organoids Market is a fragmented landscape with several new players driving intense competition and rising investment in innovation. Recent advancements in Big Data, and technologies like 3D printing have opened up new skies of growth for innovation.

Organoids is a simplified and compact version of organs which depicts micro-anatomy realistically. These are usually made up of stem cells, tissues, or pluripotent stem cells. These can organize themselves in three-dimensions, which is key to its realistic representation of organism.

In 2013, the scientific community named the development in organoids as one of the biggest scientific achievement in recent times. This is not surprising as understanding real-movements of organs allows scientists to study various abnormal as well as healthy behaviour in cells, and test new drugs to bring forth solutions to challenges such as Alzheimer’s disease which are yet to be completely understood. Technologies like Big Data promise to a rapid progress in understanding cells, while 3D printing promises more realistic, and more diversification in materials used for research.

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Global Organoids Market: Trends and Opportunities

A new study published in the National Institutes of Health Journal shows that La Crosse Virus or LACV can cause inflammation of the brain in children. The study also shows that at different stages of development cycle, the cells affect children differently. The study relied on the use of organoids for the understanding the primary function of brain cells in the nervous cell system. The study and rising concerns about neurons causal relationship with LACV promise new research opportunities for end-players.

Rise in chronic diseases including most forms of cancer, and new little understood major illnesses like Alzheimer’s have rung many alarm bells in the healthcare sector. Additionally, the cost of treatment for many of these diseases remains extremely high and out of reach for many patients.

The rising population of elderly, increased investment in research for chronic illnesses, and growing burden on healthcare system are expected to drive more capital towards research and innovation. Moreover, advancements in organoids replacing conventional 2D cells with a 3D model promises new growth opportunities for researchers in return. Growing concerns about systematic treatment solutions for personalised medicine will also drive new opportunities for growth in the organoids market.

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Global Organoids Market: Regional Outlook

The global organoids market report covers all regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Among these, the North American region is likely to post highest revenues, thanks to increasing technological adoption of big data, and faster streamlining process by the FDA.  The new drive to innovation in the industry is a major trend in the region as old patents expire, and new opportunities due to a bigger push by the regulatory environment drives growth in the region. The global organoids market is also expected to register robust growth in Asia Pacific, as increasing private investments for