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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 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 anti-viral 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.

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 first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.

Monoclonal antibody treatments hit the headlines this month after news broke

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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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”



a person sitting on a table: Trump sparks new FDA concerns with praise of 'miracle' treatment


© Getty Images
Trump sparks new FDA concerns with praise of ‘miracle’ treatment

Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at a crucial time.

The pressure threatens to undermine confidence in government regulators and turn the science of drug evaluation into yet another political dispute, confusing Americans and sowing distrust about helpful therapies.

Former FDA Commissioner Scott Gottlieb said the agency should grant emergency authorization to antibody treatments like the one Trump took, and people shouldn’t be so quick to attack such a promising therapy.

“I hope people don’t shoot at these drugs because there’s this political veneer over access to this. We should just look at the scientific merits,” Gottlieb said Friday on CNBC.

Gottlieb also said the safety bar for antibody treatments is lower than it is for vaccines because the science for antibodies is better understood.

“These drugs, based on the data we’ve seen publicly, probably meet the bar for an emergency use authorization. They’re different from a vaccine, a vaccine you’re going to have a much higher threshold for safety,” Gottlieb said.

Two companies have filed for emergency use authorization for antibody drugs in the past week: Regeneron and Eli Lilly. The treatment from Eli Lilly consists of a single monoclonal antibody, while the treatment from Regeneron consists of a cocktail of antibodies.

Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.

Video: Pfizer breast cancer drug fails late-stage test (Reuters)

Pfizer breast cancer drug fails late-stage test

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Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine, but have cautioned that the results to date are very preliminary and longer studies are needed.

“I think there’s an efficacy signal here. But it’s a very selective part of the patient population,” said Jesse Goodman, a professor at Georgetown University who was FDA’s chief scientific officer during the Obama administration.

Regeneron issued a press release touting its preliminary results, but has not publicly released any data. According to the company, a high dose of its drug led to reduced levels of the virus in non-hospitalized patients with mild to moderate symptoms.

Eli Lilly’s submission was based on studies showing that its antibody

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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Rudy Giuliani taking hydroxychloroquine to fend off COVID-19 despite safety concerns

NEW YORK — Rudy Giuliani will apparently never get off the hydroxychloroquine train.

The ex-New York mayor told the New York Daily News on Wednesday that he’s taking the anti-malarial drug as a preventative measure against COVID-19 — even though U.S. regulators advise against it over concerns that the medication can cause serious side effects.

Giuliani, 76, stressed that he has tested negative for the virus several times in the past few days, but said his doctor recommended the hydroxychloroquine regimen since he spent considerable time last week with President Donald Trump and others who have since tested positive.

“All negative so far and no symptoms but I am taking hydroxychloroquine and zinc as a prophylactic,” said Giuliani, who’s these days best known as Trump’s combative personal lawyer. “A study in Italy showed exceptional results.”

Despite Giuliani’s claim that he’s not experiencing symptoms, a source familiar with the matter told The News that the ex-mayor was openly coughing while having dinner Tuesday night at Amata’s in Midtown.

“He really should be in quarantine,” the source said.

Giuliani did not outright deny the source’s observation.

“I am negative and I don’t think I coughed and I was 20 feet away from anyone and wore my mask when the waiter served me,” he said.

The Food and Drug Administration issued guidance in July advising doctors against prescribing hydroxychloroquine to any COVID-19 patients because the drug had not proved effective in treating or preventing the virus.

The FDA also said the drug could cause “abnormal heart rhythms,” especially in patients with preexisting heart or kidney conditions.

But Giuliani claimed the FDA guidance “was all political.”

“It’s a very effective early-stage cure per NYU, French, Italian, Chinese, Brazilian studies,” Giuliani said.

Like Giuliani, Trump has pushed hydroxychloroquine as a COVID-19 miracle cure for months.

Nonetheless, the president’s medical team did not prescribe the anti-malarial drug during his hospitalization at Walter Reed Medical Center this past weekend.

Giuliani traveled with Trump onboard Air Force One last week for his first debate against Joe Biden in Cleveland.

Hope Hicks, Chris Christie, Kayleigh McEnany, Stephen Miller and dozens of other White House staffers and associates of the president have also tested positive for COVID-19.

Giuliani told The News that he doesn’t believe he’s totally out of the woods yet.

“It’s been seven full days now so let’s hope,” he said. “I’ll take another test tomorrow or Friday.”

———

©2020 New York Daily News

Visit New York Daily News at www.nydailynews.com

Distributed by Tribune Content Agency, LLC.

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Trump trip to greet supporters outside hospital raises concerns

Washington — While he continues to receive treatment for COVID-19 at Walter Reed Medical Center, President Trump made a surprise trip out of the hospital on Sunday evening to greet well-wishers who have flocked to the medical facility, a move that came amid questions about the severity of his illness and the risk of infection to those around him.

Riding in the back of a black SUV and donning a mask, Mr. Trump was seen waving to his supporters during the brief jaunt, which he teased as a “little surprise” in a video on Twitter before departing the Maryland hospital. 

“It’s been a very interesting journey,” Mr. Trump said in his video. “I learned a lot about Covid.”

The president’s short trip prompted questions as to what precautions were taken to ensure the safety of Mr. Trump and those in the vehicle with him. Judd Deere, a White House spokesman, said Mr. Trump’s doctors approved the outing and “appropriate precautions were taken in the execution of this movement to protect the president and all those supporting it, including PPE.”

Supporters Of President Trump Outside Walter Reed Medical Center
President Trump wears a protective mask while waving as he is driven in a motorcade past supporters outside of Walter Reed National Military Medical Center in Bethesda, Maryland, on Sunday, October 4, 2020.

Bloomberg/Getty Images


The president’s drive-by came hours after his medical team attempted to clear up confusion about his condition after providing limited — and conflicting — information Saturday. While his doctors said the president could be discharged for continued treatment at the White House as early as Monday, questions remain as to the severity of Mr. Trump’s health status, as his doctors revealed he was given a dose of dexamethasone, a steroid, on Saturday after two episodes in which his oxygen levels dropped.

Dexamethasone is recommended by the World Health Organization for COVID-19 patients who are “critically ill.” Mr. Trump also remains on the five-day course of remdesivir, which has been found to shorten recovery time for patients hospitalized with the coronavirus.

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Hand Sanitizers Packed Like Food And Beverage Pouches Recalled Over Safety Concerns

KEY POINTS

  • A company voluntarily recalled hand sanitizers that resembled food and beverage pouches
  • The pouches also had children’s characters on them
  • Ingesting hand sanitizer is not safe, especially for children
  • The confusing packaging could lead to accidental hand sanitizer ingestion

A company has voluntarily recalled several of its hand sanitizer products with packages that look rather like food or drink pouches. Such products may lead to accidental ingestion, which is potentially harmful to health.

On Oct. 2, the FDA released a company announcement from Ashtel Studios voluntarily recalling several 25-milliliter containers of hand sanitizers that are packaged in what looks like food or beverage pouches and, even have children’s characters displayed on them.

The recall affects the following products, all of which are packaged in 25 ml pouches:

  • PAW Patrol Hand Sanitizer (NDC 70108-042-01 )
  • JoJo Siwa Hand Sanitizer (NDC 70108-044-01 )
  • Hot Wheels Hand Sanitizer (NDC 70108-045-01 )
  • Barbie Hand Sanitizer (NDC 70108-046-01 )
  • Trolls Hand Sanitizer (NDC 70108-047-01 )
  • Minions Hand Sanitizer (NDC 70108-043-01 )

Photos of the affected products, which were distributed in various retailers in the U.S. and Canada, are available at the FDA website. The company has since notified the retailers about the recall and is advising anyone who may have purchased the said products to immediately destroy them.

The danger in these products lies in the possibility that people may accidentally ingest the hand sanitizers since they are packed like food or beverages. This is particularly problematic in children, who may easily mistake the packaging for food and experience adverse effects even after ingesting just a small amount of hand sanitizer.

“Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal,” the FDA recall notes.

Back in August, the FDA warned the public against buying such products, including those that have food flavors, because they may lead to serious injury if accidentally ingested. At the time, there were already reports of a hand sanitizer being mistaken for a drinking water bottle and others that were packed rather like children’s snacks.

“These products could confuse consumers into accidentally ingesting a potentially deadly product,” FDA Commissioner Stephen M. Hahn, M.D. said in the August news release. “It’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning.”

The company has not received any reports of adverse effects related to the products but anyone who experiences any problems with them may report to the FDA online or via mail or fax. Those with questions about the recall may contact Ashtel Studios at 866-Ashtel-1 or 909-434-0911 (international).

hand sanitizer packaging Representational photo of hand sanitizer. Photo: Harvey Boyd – Pixabay

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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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