Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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Fitness Coalition, LI Law Firm Spearhead Lawsuit Against Cuomo

SYOSSET, NY —Two weeks after Michigan’s Supreme Court overturned the continued emergency executive orders of Gov. Whitmer, a coalition of business owners on Long Island are hoping their own lawsuit will achieve the same result in New York.

The New York Fitness Coalition, an advocacy group of gym owners who came together during the coronavirus pandemic, is leading the class-action lawsuit. A news conference to announce the lawsuit is being held Wednesday at the Sysosset office of The Mermigas Law Group, P.C.

Charlie Cassara founded the New York Fitness Coalition, which sued Gov. Cuomo in July, seeking an injunction of Cuomo’s orders in order for gyms to reopen. This lawsuit, Cassara, says is a broader effort to declare the extended emergency executive orders that Cuomo uses to mandate the COVID-19 business and school regulations as unconstitutional and illegal.

“This wasn’t his job,” Cassara told Patch. Once the original aims of the state of emergency were fulfilled in the early months of the pandemic, the unilateral executive authority of the governor’s emergency powers were no longer needed, or legal, he says.

Cassara owns a health club, SC Fitness, with two Long Island locations. He tells Patch that the regulations his industry has to operate under are “unsurvivable.”

“33 percent capacity is a joke, and then you add six feet, contact tracing—We can’t live under these orders.”

Representatives from other industries including restaurant owners, as well as teachers and parents concerned about the impact of the mandates on education, are also involved in the suit, Cassara says.

“Now regular citizens of New York can jump on board. Cuomo keeps saying he is going to give the authority back to the state [legislatures] and local executives, but every week there is a new excuse.”

A similar legal challenge was raised against Pennsylvania Gov. Wolf, which initially was won before being overturned in federal appeals court.

This article originally appeared on the Syosset Patch

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A Canadian spin studio followed public health guidelines. But 61 people still caught the covid-19.

Now, despite appearing to have complied with public health regulations, at least 61 people linked to the studio have tested positive for the novel coronavirus.

“They had done all sorts of things to remove the potential for spread,” Richardson told reporters. “Unfortunately, gyms are a higher-risk place because of the fact that generally people are taking off their masks, they’re breathing at a higher rate.”

Although Hamilton requires masks to be worn in most public settings, the law includes an exemption for anyone “actively engaged in an athletic or fitness activity.” In keeping with that policy, the studio, SPINCO, allowed riders to remove their masks once clipped into their bikes, and told them to cover up again before dismounting.

In a recent Instagram post, SPINCO’s owners said that they had been “hesitant” to reopen after getting the green light in July, and would not resume classes “until it is safe to do so.” Health officials have said that the studio is temporarily closed and cooperating fully with the investigation.

“We took all the measures public health offered, even added a few, and still the pandemic struck us again!’” the owners wrote. SPINCO has more than a dozen locations across Canada.

As of Tuesday, 44 cases linked to specific classes were detected, Richardson said. An additional 17 instances of “secondary cases” were found among other contacts.

The city will reexamine gym protocols, Richardson added Tuesday, but in the meantime, “what seems to be the case is that you need to wear that mask” even though government guidelines do not strictly require it.

“It’s still a good idea to do it, in terms of keeping others safe,” she said.

People should also avoid “classes where you’ve got that kind of yelling or coaching over music.”

She declined to use the term “superspreader” to describe the event but said it is a “very large outbreak.”

“It is concerning that it is extended beyond the initial cases who were related to the classes but gone into of course their household contacts and other contacts,” she said. “We continue to look at what does it mean, what do we need to understand about exercise classes?”

The outbreak offers further evidence of the dangers of people gathering indoors without masks, as health experts warn that cases could spike further in the coming months as winter weather sets in and outdoor gatherings and exercise classes will be harder to maintain.

In August, South Korea confirmed dozens of cases linked to a single Starbucks in the city of Paju where many customers did not wear masks. The store employees, who wore masks, were not infected. The outbreak prompted Starbucks to limit its indoor seating in the country and encourage masks among patrons.

In other instances, mask usage has been credited with preventing potential outbreaks. In May, after the reopening of a hair salon in Missouri that required masks, two stylists — who had worked with more than 100 clients — tested positive for the virus. But masks were

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Is it safe to travel for the holidays in 2020 during the pandemic?

The end of the year is sneaking up, and people are weighing travel plans to join friends and family for the holidays — all against the backdrop of a deadly pandemic.



a group of people walking down the street: There's a lot more to consider when planning holiday travel in 2020.


© Daniel Slim/AFP/Getty Images
There’s a lot more to consider when planning holiday travel in 2020.

Gathering with others — probably the most universal holiday tradition — has never required so much meticulous forethought.

Should you travel for the holidays in 2020? What precautions will make it safer? Who will be there and how careful have they been?

The US Centers for Disease Control and Prevention says that travel increases the chances of contracting and spreading Covid-19. Staying home is the best way to protect against getting and spreading the virus, yet many people are likely to travel before the year is over.



a sign on the side of a snow covered car in a parking lot: Driving is not without risks, but your interactions with others can be more easily controlled than with air travel.


© Jason Connolly/AFP/Getty Images
Driving is not without risks, but your interactions with others can be more easily controlled than with air travel.

CNN spoke with medical experts on how to reduce the risks around holiday travel and when you really should skip it altogether.

Should you travel for the holidays this year?

“Probably not, if you are anxious or vulnerable,” says Dr. Richard Dawood, a travel medicine specialist and director at Fleet Street Clinic in London.

But traveling is fine if you’re willing to be cautious, follow the rules and adapt easily to changes of plan, he said.

“I think the threshold for travel at this time should still be higher than before the pandemic,” says Dr. Henry Wu, director of Emory TravelWell Center and associate professor of infectious diseases at Emory University School of Medicine in Atlanta.



a statue of a man and a woman standing in front of a building: Staying in a hotel may give guests more control of their environment than staying with friends or relatives.


© Benno Schwinghammer/picture alliance/Getty Images
Staying in a hotel may give guests more control of their environment than staying with friends or relatives.

“If you do choose to travel, try to keep gatherings small and take precautions,” such as wearing a mask and practicing social distancing and good hand hygiene, Wu said.

Who should skip it?

People who are especially vulnerable to severe Covid-19 illness are safest staying home.

“Are you older, are you frail, do you have chronic underlying illnesses?” are the questions to ask, says Dr. William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center in Nashville, Tennessee.

People who are considering meeting up with vulnerable relatives or friends should really weigh the implications of introducing illness to them, Wu said.

“There are well-documented Covid-19 clusters associated with family gatherings, including ones that resulted in deaths,” he said.

Are some locations safer than others?

Gatherings are likely safer in areas around the world where infections remain low, although the standard precautions still apply.



a group of people sitting at a table: Joining hands around a crowded holiday table is best skipped this year.


© Shutterstock
Joining hands around a crowded holiday table is best skipped this year.

For example, it may be possible to have a “relatively normal” Thanksgiving gathering in parts of the United States where infections are very low, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“But in other areas of the

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U.K.’s Film and TV Charity Launches Two-Year Program For Better Mental Health in Film and TV

The U.K.’s Film and TV Charity has launched the Whole Picture Program, a two-year initiative designed to to improve the mental health and wellbeing of the 200,000 people who work behind the scenes in film, TV and cinema.

The Film and TV Charity has now secured £3 million ($3.87 million) in funding from Amazon Prime Video, Banijay U.K., BBC, BBC Studios, Channel 4, IMG, ITV, Sky, Sky Studios, Sony Pictures Entertainment, The Walt Disney Company, ViacomCBS and WarnerMedia to deliver the program that is supported by the BFI and backed by U.K. mental health charity Mind. The charity estimates that mental health problems, including staff turnover, cost the sector at least £300 million ($387 million) in losses each year.

The program will deliver a toolkit for mentally healthy productions; enhanced professional and peer support for freelancers; people skills and training guides; industry actions to improve behavior; and anti-bullying services and resources.

Alex Pumfrey, CEO of the Film and TV Charity said: “It has been a devastating year for many people in our industry, and it’s clear we cannot afford to return to ‘business as usual’. Our 2019 research showed a mental health crisis in the industry, which has only been exacerbated by the terrible effects of the pandemic.”

More than 9,000 people took part in the research last year, sharing their experiences and stories confidentially, which identified a mental health crisis within the industry. The findings revealed issues including self-harm and bullying. Since then, the pandemic has meant increased isolation and anxiety for many, and Black, Asian and minority ethnic (BAME) people in the industry have identified the effect systemic racism and discrimination has on mental health.

“The case for improving the mental health of the industry has never been stronger or more urgent,” added Pumfrey. “This program of work is designed to turn the tide on poor mental health by enhancing the available support, changing behavior and improving ways of working; but this will need to be an industry-wide effort to create sustainable change.”

The project has been on hold for six months whilst the charity has dedicated all of its resources to responding to COVID-19, raising £6.4 million ($8.2 million), and supporting thousands of workers with grants and financial and mental wellbeing services.

Emma Mamo, head of workplace wellbeing at Mind, said: “Unfortunately, self-employed people, freelancers and those in the film and TV industry are among those hit hardest by coronavirus. That’s why we’re pleased to be supporting the Whole Picture Program, which will provide much-needed resource and support to the many experiencing poor mental health in the sector.”

Industry leaders are part of the program’s mental health taskforce and they will work collaboratively to adopt and champion the work both within their own organizations and widely across the sector.

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Summit, Colorado Center for Personalized Medicine to Develop Saliva Tests for COVID, Head & Neck Cancer

AURORA, Colo., Oct. 14, 2020 /PRNewswire/ — Summit Biolabs, Inc., an early-stage molecular diagnostics company specializing in saliva-based testing for COVID-19 and head & neck cancer, and the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus announced today a broad strategic collaboration involving research, development and commercialization of saliva liquid-biopsy tests for early cancer detection and diagnosis of COVID-19 and other viral contagions.

The CCPM holds one of the largest research biobanks in the United States with clinical data from more than 8.7 million de-identified patient records and plans to integrate the data with personalized genomic information.

“This partnership brings two innovative programs together to optimize COVID testing at a time when it’s desperately needed,” says Kathleen Barnes, Ph.D., Professor and Director of CCPM at the University of Colorado Anschutz Medical Campus. “Collaborations like this are crucial in moving research forward and advancing and expanding clinical testing to as many members of our community as possible. Working with Summit Biolabs, and leveraging technology developed by our colleagues here at the Anschutz Medical Campus, will help us achieve these goals and establish a non-invasive testing process that will benefit patients in Colorado and beyond.”

Summit Biolabs is developing breakthrough tests to improve the detection of COVID-19 and to advance the early detection of human cancers, including head & neck cancer, using simple, non-invasive saliva liquid-biopsy technology developed by Dr. Shi-Long Lu and colleagues at the University of Colorado Anschutz Medical Campus. Head & neck cancer has been scientifically overlooked, yet is medically important. Summit Biolabs’ research foundation and competency in head & neck cancer diagnosis enabled the company’s pivot to saliva-based testing for coronavirus, COVID-19.

“We are excited to collaborate with CCPM to develop and commercialize Summit Biolabs’ portfolio of developmental saliva or non-blood liquid-biopsy tests.” said Bob Blomquist, Chief Executive Officer at Summit Biolabs. “This collaboration broadens and strengthens Summit Biolabs’ ability to bring to market life-changing saliva liquid-biopsy tests that ultimately enable better treatment and improved outcomes for patients.”

About Summit Biolabs

Summit Biolabs is harnessing the power of saliva-based diagnostics to address critical challenges in COVID-19 and head & neck cancer testing. Founded on the discoveries of Dr. Shi-Long Lu, Associate Professor of Otolaryngology, Summit Biolabs is being spun out from the University of Colorado Anschutz Medical Campus.

Summit Biolabs is pioneering early detection of head & neck cancer recurrence using a first of its kind saliva liquid-biopsy test, HNKlear. HNKlear is a proprietary, non-invasive saliva test that provides more effective, more accurate, and earlier detection of head and neck cancer recurrence than traditional diagnostic methods. Summit Biolabs is leveraging its core competencies in saliva-based molecular diagnostics and viral nucleic acid testing (i.e., oral oncogenic human papillomavirus detection) to diagnose COVID-19. Along with our clinical and laboratory partners, Summit Biolabs is developing the first comprehensive panel of highly-accurate saliva-based tests for COVID-19 infection, quantitation, and immune response. Summit Biolabs is headquartered in Aurora, Colorado.

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Facebook to crack down on ads that discourage vaccines

The social media giant, however, stopped short of banning anti-vax content.

The post added that while they already don’t allow ads featuring vaccine hoaxes, “Now, if an ad explicitly discourages someone from getting a vaccine, we’ll reject it.”

Moreover, the social media giant announced the launch of a new campaign to provide information about flu vaccines to users, and pledged to work with “global health partners on campaigns to increase immunization rates,” Jin and Leathern said.

PHOTO: The Facebook logo is displayed on a mobile phone in this picture illustration taken Dec. 2, 2019.

The Facebook logo is displayed on a mobile phone in this picture illustration taken Dec. 2, 2019.

Facebook’s policy, however, stops short of banning posts or other types of content on the platform that discourages vaccines. It also does not ban political ads that “advocate for or against legislation or government policies around vaccines — including a COVID-19 vaccine,” Jin and Leathern wrote.

“We’ll continue to require anyone running these ads to get authorized and include a ‘Paid for by’ label so people can see who is behind them,” the blog post stated.

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Council Rock North Shuts Down Athletics Amid Rising COVID Cases

NEWTOWN, PA — All athletics and activity programs for Council Rock North High School students are shut down until further notice, Principal Susan C. McCarthy told parents in an email Tuesday afternoon.

The move comes one day after the high school decided to cancel in-person classes for the week after three students reportedly tested positive for COVID-19.

Superintendent Robert Fraser’s decision to close the school went against the advice of Bucks County Health Director David Damsker, who did not recommend closing school.

The health department will only recommend closing a school when there is a clear indication that the district’s health and safety plan isn’t working, Damsker told Patch, and there’s no evidence at this point that transmission is happening within schools.

“School closures are very disruptive and don’t help stop people from getting sick outside of school,” Damsker said. “If people continue to have parties and gather, closing school won’t stop any of that from occurring.”

In a follow-up email sent late Tuesday afternoon, McCarthy said two people “from our Council Rock High School North community” reported testing positive for COVID-19, bringing the total number of cases this week to five.

The district is working with the Bucks County Department of Health to identify close contacts of the individuals who tested positive as part of the contact tracing process, she added.

“As always, please continue to monitor your health and that of your children,” McCarthy said. “If you notice a fever, cough, shortness of breath, or other symptoms of COVID-19, please remain home and contact your medical provider. Moreover, if you feel uncomfortable, you may keep your children home, and during this time your children may continue to access the classroom and curriculum through interactive livestream.”

Between Aug. 31 and Oct. 13, there have been 131 cases of COVID-19 throughout the 13 public school districts and private schools in Bucks County, Damsker said, with many of those cases linked to activities outside of school.

Parents or guardians concerned about family members are encouraged to contact their child’s physician or the county health department, she said.

This article originally appeared on the Newtown Patch

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Zoom is releasing a new tool to let paid users charge for admission to online events like conferences or fitness classes



Eric S. Yuan standing in front of a sign: Eric Yuan, CEO of Zoom Video Communications takes part in a bell ringing ceremony at the NASDAQ MarketSite in New York Reuters


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Eric Yuan, CEO of Zoom Video Communications takes part in a bell ringing ceremony at the NASDAQ MarketSite in New York Reuters

  • Zoom is introducing OnZoom, a new way to host events — free and paid — using the popular videoconferencing tool.
  • Zoom has come to be used to host all kinds of events amid the pandemic, from board meetings and conferences to fitness classes and concerts. The new OnZoom platform includes the ability to charge for tickets, as well as a directory of public event listings.
  • Zoom is also launching a new kind of app integration, called a Zapp, that can bring information from productivity tools like Dropbox, Slack, or Asana directly into a video chat.
  • Facebook launched its own features for paid videoconferencing events over the summer.
  • Visit Business Insider’s homepage for more stories.

As the pandemic drags on, Zoom is releasing a new way to host online events — importantly, now including paid events — as well as new types of apps that integrate outside business and productivity tools like Slack, Dropbox, and Asana directly into Zoom meetings, the company announced Wednesday. 

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Zoom has become a household name amid shelter in place and social distancing mandates, with users turning to the videoconferencing app to host events from board meetings and conferences to yoga classes and concerts. It’s led Zoom’s business to skyrocket, but also forced the company to rethink its ambitions beyond its original enterprise approach. 

The online event platform, called OnZoom, adds features to Zoom that make it easier to host online events — notably, by allowing event organizers to sell tickets for paid events on Zoom, thanks to an integration with PayPal. There will also be an event marketplace, where people can find and sign up for public events, free and paid.

At launch, the events platform is only available to US users, but will be available more globally next year. There’s no additional fee for paid users to try out OnZoom through the end of 2020, but Zoom says that it plans to revisit the possibility of taking a cut of ticket sales next year. 

Notably, Facebook announced something similar earlier this year, allowing businesses, creators, educators and media publishers to host paid events on Facebook Live or its Messenger Rooms app. Facebook has said it won’t collect fees from tickets sales until at least August 2021.

The catch is that you will have to be a paid Zoom user to set up events with OnZoom, with a capacity ranging from 100 attendees, up to 1,000 for enterprise users. For anything larger, users can livestream the event with a Zoom Webinar license. 

OnZoom is actually getting its first public test right out in the open: Zoom is using it to host its annual Zoomtopia user conference this week. The company bills it as being well-suited for other companies to host their own conferences, for fitness instructors to hold paid lessons, for nonprofits to set up fundraising events

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As virus surges anew, Milan hospitals under pressure again

MILAN (AP) — Coronavirus infections are surging anew in the northern Italian region where the pandemic first took hold in Europe, putting pressure again on hospitals and health care workers.

At Milan’s San Paolo hospital, a ward dedicated to coronavirus patients and outfitted with breathing machines reopened this weekend, a sign that the city and the surrounding area is entering a new emergency phase of the pandemic.

For the medical personnel who fought the virus in Italy’s hardest-hit region of Lombardy in the spring, the long-predicted resurgence came too soon.


“On a psychological level, I have to say I still have not recovered,’’ said nurse Cristina Settembrese, referring to last March and April when Lombardy accounted for nearly half of the dead and one-third of the nation’s coronavirus cases.

“In the last five days, I am seeing many people who are hospitalized who need breathing support,” Settembrese said. “I am reliving the nightmare, with the difference that the virus is less lethal.”

Months after Italy eased one of the globe’s toughest lockdowns, the country is now recording well over 5,000 new infections a day — eerily close to the highs of the spring — as the weather cools and a remarkably relaxed summer of travel and socializing fades into memory. Lombardy is again leading the nation in case numbers, an echo of the trauma of March and April when ambulance sirens pierced the silence of stilled cities.

So far, Italy’s death toll remains significantly below the spring heights, hovering recently around 50 per day nationwide, a handful in Lombardy. That compares with over 900 dead nationwide one day in March.

In response to the new surge, Premier Giuseppe Conte’s government twice tightened nationwide restrictions inside a week. Starting Thursday, Italians cannot play casual pickup sports, bars and restaurants face a midnight curfew, and private celebrations in public venues are banned. Masks are mandatory outdoors as of last week.

But there is also growing concern among doctors that Italy squandered the gains it made during its 10-week lockdown and didn’t move quick enough to reimpose restrictions. Concerns persist that the rising stress on hospitals will force scheduled surgeries and screenings to be postponed — creating a parallel health emergency, as happened in the spring.

Italy is not the only European country seeing a resurgence — and, in fact, is faring better than its neighbors this time around. Italy’s cases per 100,000 residents have doubled in the last two weeks to nearly 87 — a rate well below countries like Belgium, the Netherlands, France, Spain and Britain that are seeing between around 300 to around 500 per 100,000. Those countries have also started to impose new restrictions.

This time, Milan is bearing the brunt. With Lombardy recording more than 1,000 cases a day, the regional capital and its surroundings account for as many as half of that total. Bergamo — which was hardest hit last time and has been seared into collective memory by images of army trucks transporting the dead to

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