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Eli Lilly in the News: COVID-19, Q2 results, and Ad Drama

Eli Lilly is in the news for positive Olumiant data in Covid-19, a drop in Covid-19 product sales for second-quarter 2021, and a protest of one of the company’s ads.

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Eli Lilly in the News: COVID-19, Q2 and Ad Drama

 

Eli Lilly and Company is in the news with positive Olumiant data in COVID-19, a drop in COVID-19 product sales for the quarter and a protest of one of their ads. Here’s a look.

Lilly and Incyte’s Olumiant Decreases Deaths in COVID-19 Patients

Eli Lilly and Incyte announced data from an extra cohort of 101 adults from the COV-BARRIER clinical study. In this sub-study, COVID-19 patients on mechanical ventilation or receiving extracorporeal membrane oxygenation (ECMO) who were dosed with Olumiant (baricitinib) and standard of care treatment were 46% less likely to die by Day 28 compared to patients on standard of care who received placebo. 

Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved in the U.S. and more than 75 other countries for moderate to severe rheumatoid arthritis and specific hospitalized COVID-19 patients in Japan.

“As additional data from COV-BARRIER become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic,” said E. Wesley Ely, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center and co-principal investigator of COV-BARRIER.

Lilly Stock Dips 1.4% After Missing Q2 Profit Expectations

At its second-quarter financial report, Lilly’s quarterly profits were slightly below expectations because of weaker sales of its COVID-19 therapies, essentially its antibody cocktail. The cocktail, made up of bamlanivimab and etesivimab, was paused in late June after lab studies suggested it was not effective against variants first seen in Brazil (Gamma) and South Africa (Beta). 

Bamlanivimab alone was dropped after studies shown it did not respond well to variants. Sales of the antibody treatments were $148.9 million in the quarter compared to $810.1 million in the first quarter. Shares dipped 1.4% in premarket trading at the news.

Cristina Arias/Cover/Getty Images

Otherwise, the company demonstrated a strong quarter.

David A. Ricks, Lilly’s chairman and chief executive officer, stated, “We delivered strong perfornace this quarter, with volume-driven growth across our core business and most major geographies. We accelerated use of our newest medicines around the world with solid sequential growth versus first-quarter 2021.”

One Million Moms Organization Protests Lilly Advertisement Promoting Diversity

Ultra-conservative Christian organization One Million Moms is protesting a one-minute advertisement Eli Lily ran to promote diversity. The ad’s tagline is “We make medicine, not just for some, but for everyone.” The ad includes people of color, people with disabilities, and members of the LGBTQ community, and according to The Christian Post, “a woman with double mastectomy scars wearing an open shirt and identifying as a man.”

The One Million Moms protest, LGBTQ Nation notes, “The group deliberately misgenders the transgender people depicted in the ad touting diversity.” 

Their petition states, “While there are a number of concerning elements in the commercial, including a transgender [woman] wearing flashy makeup, one of the most heartbreaking and confusing parts of the ad is this statement: ‘Because the body you are randomly assigned at birth shouldn’t determine how well you are cared for.’ This voice-over is heard while showing a [man] with double mastectomy scars wearing an open robe and identifying as a man.”

Previous protests by the group include articles and petitions about lesbians in Toy Story 4, a gay character in the live-action Beauty and the Beast, and a children’s book that mentions a child’s same-sex parents. One Million Moms is part of the fundamentalist Christian American Family Association. The Southern Poverty Law Center has designated the Christian American Family Association an anti-LGBTQ hate group.

 

BioSpace source:

https://www.biospace.com/article/eli-lilly-olumiant-in-covid-19-q2-results-and-advertising-protest

 

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Potential COVID-19 Treatment Found in Llama Antibodies

The need to uncover effective COVID-19 treatments remains imperative, as case counts remain steady eighteen months into the pandemic. Recent findings point to unique antibodies produced by llamas—nanobodies—as a promising treatment. The small, stable,…

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A significant milestone in the COVID-19 pandemic was crossed this week. The number of deaths in the United States due to COVID-19—more than 675,000—has surpassed the number of deaths that occurred during the 1918 flu pandemic. In addition, there are still roughly 150,000 new cases every day. Eighteen months into the pandemic, the need for effective treatments against COVID-19 remains as great as ever.

One possible treatment, neutralizing single domain antibodies (nanobodies), has significant potential. The unique antibody produced by llamas is small, stable, and could possibly be administered as a nasal spray—an important characteristic as the antibody treatments currently in use require administration by infusion in the hospital. Now, new research shows that nanobodies can effectively target the SARS-CoV-2 virus.

The team from the Rosalind Franklin Institute found that short chains of the molecules, which can be produced in large quantities, showed “potent therapeutic efficacy in the Syrian hamster model of COVID-19 and separately, effective prophylaxis.”

This work is published in Nature Communications in the paper, “A potent SARS-CoV-2 neutralizing nanobody shows therapeutic efficacy in the Syrian golden hamster model of COVID-19.

The nanobodies, which bind tightly to the SARS-CoV-2 virus, neutralizing it in cell culture, could provide a cheaper and easier to use alternative to human antibodies taken from patients who have recovered from COVID-19.

“Nanobodies have a number of advantages over human antibodies,” said Ray Owens, PhD, head of protein production at the Rosalind Franklin Institute. “They are cheaper to produce and can be delivered directly to the airways through a nebulizer or nasal spray, so can be self-administered at home rather than needing an injection. This could have benefits in terms of ease of use by patients but it also gets the treatment directly to the site of infection in the respiratory tract.”

Credit: Rosalind Franklin Institute

The research team was able to generate the nanobodies by injecting a portion of the SARS-CoV-2 spike protein into a llama called Fifi, who is part of the antibody production facility at the University of Reading. They were able to purify four nanobodies capable of binding to SARS-CoV-2. Four nanobodies (C5, H3, C1, F2) engineered as homotrimers had pmolar affinity for the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. Crystal structures showed that C5 and H3 overlap the ACE2 epitope, while C1 and F2 bind to a different epitope.

Regarding their effectiveness against variants, the C1, H3, and C5 nanobodies all neutralized the Victoria strain, and the highly transmissible Alpha (B.1.1.7 first identified in Kent, U.K.) strain. In addition, C1 neutralizes the Beta (B.1.35, first identified in South Africa).

When one of the nanobody chains was administered to hamsters infected with SARS-CoV-2, the animals showed a marked reduction in disease, losing far less weight after seven days than those who remained untreated. Hamsters that received the nanobody treatment also had a lower viral load in their lungs and airways after seven days than untreated animals.

“Because we can see every atom of the nanobody bound to the spike, we understand what makes these agents so special,” said James Naismith, PhD, director of the Rosalind Franklin Institute. If successful and approved, nanobodies could provide an important treatment around the world as they are easier to produce than human antibodies and don’t need to be stored in cold storage facilities, added Naismith.

“Having medications that can treat the virus,” noted Naismith, “is still going to be very important, particularly as not all of the world is being vaccinated at the same speed and there remains a risk of new variants capable of bypassing vaccine immunity emerging.”

The researchers also hope the nanobody technology they have developed could form a so-called “platform technology” that can be rapidly adapted to fight other diseases.

The post Potential COVID-19 Treatment Found in Llama Antibodies appeared first on GEN - Genetic Engineering and Biotechnology News.

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Addressing the HIV epidemic in Eastern Europe and Central Asia

Working in partnership will be key, says Alex Kalomparis, vice president, public affairs, international at Gilead Sciences. 2021
The post Addressing the HIV epidemic in Eastern Europe and Central Asia appeared first on .

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Working in partnership will be key, says Alex Kalomparis, vice president, public affairs, international at Gilead Sciences.

2021 marks 40 years since the first cases of HIV were reported. In that time, over 79 million people have been diagnosed with HIV, with more than 36 million dying from AIDS-related illnesses, more than any other infectious disease.

While there has been incredible progress in the HIV response, nearly 38 million people are living with HIV, with more than a million new cases every year, jeopardising the goal to end AIDS as a public health threat by 2030.

HIV places enormous burdens on the communities it affects most, straining health systems and government budgets. In the era of the global COVID-19 pandemic, where health systems are already stretched to breaking, it is tempting to cut costs in other areas, including HIV. If commitment to the HIV response wanes, the progress we have made is at risk, leading to increases in new infections in regions that can least afford to tackle them.

“An epidemic somewhere is an epidemic everywhere”

Throughout the COVID-19 pandemic, we have seen the temptation to focus on one’s own backyard, isolate oneself from the rest of the world, and believe one is safe and protected. We know now that this protection is an illusion. Regardless of the protections we erect in our own countries, allowing public health crises to persist in other parts of the world threatens our own progress and safety.

The message is clear: an epidemic somewhere is an epidemic everywhere. To find our way out of a pandemic, we must broaden our ideas of how to respond, and address the problems and inequities that allow diseases to thrive in other parts of the world. To be effective, our response must be global.

The same is true for HIV. HIV has persisted for 40 years, and is still here because root problems continue to drive the epidemic: stigma and discrimination, poverty, lack of access to services and treatments, lack of access to education, and the marginalisation of the people and communities most at risk of HIV. These are not issues that can be addressed by any one government, group, or company. They can be addressed only in partnership with one another, and by engaging those key marginalised communities in our effort to end the HIV epidemic.

Whilst the global community has the tools it needs to meaningfully address new HIV infections, HIV is on the rise in Eastern Europe and Central Asia (EECA). Unlike other regions in the world, rates of HIV in EECA have increased, with infections up by 72 per cent, and AIDS-related deaths up by 24 per cent since 2010.

Working with the Elton John AIDS Foundation

However, across EECA, a range of community partners are making significant contributions in the fight against HIV, such as the first wave of the RADIAN ‘Unmet Need’ fund and Model City grantees, previously announced in 2020. In the first nine months of the programme, these partners have already reached more than 12,000 people from vulnerable communities directly with services, initiating life-saving care in over 2,000 people living with HIV.

RADIAN, a ground-breaking partnership between Gilead Sciences and the Elton John AIDS Foundation, works with local experts to target new HIV infections and deaths from AIDS-related illnesses in EECA in the communities most vulnerable to HIV.

Focusing on the groups most affected by HIV in EECA (eg men who have sex with men, transgender people, sex workers, and people who use drugs), RADIAN engages with groups led by these communities and are sensitive to the difficulties unique to the region.

“We all have one common goal: ending HIV”

Anne Aslett, CEO of the Elton John AIDS Foundation, is clear that for the partnership to reach its goals, it’s crucial to listen to and amplify the voices of people for whom HIV is a tangible, daily reality.

“They understand better than anyone the challenges associated with the virus, and what works to stop it. No matter where we are in the world, we must partner with them, and follow their leadership. We are proud of our RADIAN partnership with Gilead, to champion the vital work of communities to bring an end to the AIDS epidemic in Eastern Europe and Central Asia.”

Companies like Gilead Sciences provide industry leading expertise, while Governments bring an understanding of health systems and funding, developing an infrastructure that enables access.

However, these efforts need community leadership because they know best how to ensure people can access those systems to get tested, and adhere to medication. They understand the fears and sensitivities, the strengths and stigma within those communities, the nuances that make the difference in linking their members to the care they need. No two regions of the world experience the ‘same’ HIV epidemic. People living with HIV are critical to the success of any HIV response.

This autumn, RADIAN will launch a campaign telling the inspirational stories of ordinary, yet remarkable, community members who are taking action to turn the tide of the HIV epidemic in EECA.

We all have one common goal: ending HIV. It is crucial that we all understand the role we can play to achieve this. Our access to global networks of public health expertise, government funding, and innovative HIV treatments are meaningless unless they are used in service of people living with, and at risk of, HIV. They are the core of any successful response, regardless of country or region. Working in partnership with them is the key to ending HIV. By respecting them as leaders and giving them the seat at the head of the table, we make our work more effective and responsive to local needs, bringing us closer to the end of the HIV epidemic globally.

About the author 

Alex Kalomparis is vice president, public affairs, international at Gilead Sciences. He joined the company in January 2017 and is responsible for all communications and patient advocacy activities across Africa, Asia, Australia, Canada, Europe, Latin America and the Middle East. Prior to that Alex held senior communication roles with a number of consumer and pharmaceutical companies, including Unilever, Rolls Royce, Novartis, Roche, AstraZeneca and GlaxoSmithKline.

The post Addressing the HIV epidemic in Eastern Europe and Central Asia appeared first on .

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Evidence shows that, yes, masks prevent COVID-19 – and surgical masks are the way to go

Since the coronaviurs first began spreading around the globe, people have debated how effective masks are at preventing COVID-19. A year and a half in, what does the evidence show?

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What type of mask is best? Brais Seara/Moment via Getty Images

Do masks work? And if so, should you reach for an N95, a surgical mask, a cloth mask or a gaiter?

Over the past year and a half, researchers have produced a lot of laboratory, model-based and observational evidence on the effectiveness of masks. For many people it has understandably been hard to keep track of what works and what doesn’t.

I’m an assistant professor of environmental health sciences. I, too, have wondered about the answers to these questions, and earlier this year I led a study that examined the research about which materials are best.

Recently, I was part of the largest randomized controlled trial to date testing the effectiveness of mask-wearing. The study has yet to be peer reviewed but has been well received by the medical community. What we found provides gold-standard evidence that confirms previous research: Wearing masks, particularly surgical masks, prevents COVID-19.

Laboratory studies help scientists understand the physics of masks and spread.

Lab and observational studies

People have been using masks to protect themselves from contracting diseases since the Manchurian outbreak of plague in 1910.

During the coronavirus pandemic, the focus has been on masks as a way of preventing infected persons from contaminating the air around them – called source control. Recent laboratory evidence supports this idea. In April 2020, researchers showed that people infected with a coronavirus – but not SARS-CoV-2 – exhaled less coronavirus RNA into the air around them if they wore a mask. A number of additional laboratory studies have also supported the efficacy of masks.

Out in the real world, many epidemiologists have examined the impact of masking and mask policies to see if masks help slow the spread of COVID-19. One observational study – meaning it was not a controlled study with people wearing or not wearing masks – published in late 2020 looked at demographics, testing, lockdowns and mask-wearing in 196 countries. The researchers found that after controlling for other factors, countries with cultural norms or policies that supported mask-wearing saw weekly per capita coronavirus mortality increase 16% during outbreaks, compared with a 62% weekly increase in countries without mask-wearing norms.

A man wearing a surgical mask handing a mask to a woman working at a vegetable stand.
Researchers gave surgical masks to adults in 200 villages in Bangladesh to test whether they reduce COVID-19. Innovations for Poverty Action, CC BY-ND

Large-scale randomized mask-wearing

Laboratory, observational and modeling studies, have consistently supported the value of many types of masks. But these approaches are not as strong as large-scale randomized controlled trials among the general public, which compare groups after the intervention has been implemented in some randomly selected groups and not implemented in comparison groups. One such study done in Denmark in early 2020 was inconclusive, but it was relatively small and relied on participants to self-report mask-wearing.

From November 2020 to April 2021, my colleagues Jason Abaluck, Ahmed Mushfiq Mobarak, Stephen P. Luby, Ashley Styczynski and I – in close collaboration with partners in the Bangladeshi government and the research nonprofit Innovations for Poverty Action – conducted a large-scale randomized controlled trial on masking in Bangladesh. Our goals were to learn the best ways to increase mask-wearing without a mandate, understand the effect of mask-wearing on COVID-19, and compare cloth masks and surgical masks.

The study involved 341,126 adults in 600 villages in rural Bangladesh. In 300 villages we did not promote masks, and people continued wearing masks, or not, as they had before. In 200 villages we promoted the use of surgical masks, and in 100 villages we promoted cloth masks, testing a number of different outreach strategies in each group.

Over the course of eight weeks, our team distributed free masks to each adult in the mask groups at their homes, provided information about the risks of COVID-19 and the value of mask-wearing. We also worked with community and religious leaders to model and promote mask-wearing and hired staff to walk around the village and politely ask people who were not wearing a mask to put one on. Plainclothes staff recorded whether people wore masks properly over their mouth and nose, improperly or not at all.

Both five weeks and nine weeks after starting the study, we collected data from all adults on symptoms of COVID-19 during the study period. If a person reported any symptoms of COVID-19, we took and tested a blood sample for evidence of infection.

A woman exiting a store with signs showing mask requirements on the door.
Based on current evidence, many places across the U.S. have some form of mask requirements. AP Photo/LM Otero

Mask-wearing reduced COVID-19

The first question my colleagues and I needed to answer was whether our efforts led to increased mask-wearing. Mask usage more than tripled, from 13% in the group that wasn’t given masks to 42% in the group that was. Interestingly, physical distancing also increased by 5% in the villages where we promoted masks.

In the 300 villages where we distributed any type of mask, we saw a 9% reduction in COVID-19 compared with villages where we did not promote masks. Because of the small number of villages where we promoted cloth masks, we were not able to tell whether cloth or surgical masks were better at reducing COVID-19.

We did have a large enough sample size to determine that in villages where we distributed surgical masks, COVID-19 fell by 12%. In those villages COVID-19 fell by 35% for people 60 years and older and 23% for people 50-60 years old. When looking at COVID-19-like symptoms we found that both surgical and cloth masks resulted in a 12% reduction.

The body of evidence supports masks

Before this study there was a lack of gold-standard evidence on the effectiveness of masks to reduce COVID-19 in daily life. Our study provides strong real-world evidence that surgical masks reduce COVID-19, particularly for older adults who face higher rates of death and disability if they get infected.

Policymakers and public health officials now have evidence from laboratories, models, observations and real-world trials that support mask-wearing to reduce respiratory diseases, including COVID-19. Given that COVID-19 can so easily spread from person to person, if more people wear masks the benefits increase.

So next time you are wondering if you should wear a mask, the answer is yes. Cloth masks are likely better than nothing, but high-quality surgical masks or masks with even higher filtration efficiency and better fit – such as KF94s, KN95s and N95s – are the most effective at preventing COVID-19.

Laura (Layla) H. Kwong does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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