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Equipping the Immune System to Fight Against COVID-19 – BioSpace

The coronavirus that causes COVID-19 has one major advantage over us it is a new human virus. Most people have not encountered the virus before, meaning their immune system is not primed and ready to fight it. When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

It essentially becomes a race between how fast your immune system can clear the virus and how quickly the virus can replicate and induce damage, Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences at AlloVir, told BioSpace.

To develop an effective treatment or vaccine for COVID-19, scientists must understand how the immune system is impacted during the disease. One type of immune cell that is particularly important in the bodys response to COVID-19 is T-cells. T-cells perform many functions, including recognizing invading viruses such as the coronavirus that causes COVID-19.

Multiple studies from Wuhan, China reported that COVID-19 patients had very low T-cell counts; the sicker the patient, the lower their T-cell count. Lower T-cell counts were correlated with poorer outcomes (including higher risk of death) and T-cells isolated from COVID-19 patients also showed signs of exhaustion.

The elderly, patients with low T-cell numbers, and patients who express exhaustion markers on their T-cells are high risk groups in which nave cell responses (responses against a virus they have never seen before) may be deficient or delayed, thus allowing the virus to induce a large amount of damage, Dr. Melian explained. These patients may, therefore, benefit from AlloVirs approach which is designed to restore natural T-cell immunity in high risk patients.

Could giving high-risk COVID-19 patients functional T-cells against the coronavirus boost their immune system and help them recover? This is the question AlloVir aims to answer.

AlloVir creates allogeneic (off-the-shelf) virus-specific T-cells designed to treat common and devastating viral-associated diseases in vulnerable patients, such as those who are immunocompromised or patients who received an organ or stem cell transplant. Now, they are expanding their anti-viral T-cell arsenal and taking aim at COVID-19.

We believe AlloVirs technology is well positioned to treat patients with COVID-19 because our technology is designed to provide SARS-CoV-2 specific T-cell immunity while leaving non-infected cells intact, Dr. Melian commented. Our virus-specific T-cell candidates have been used to treat more than 275 immunocompromised patients with life-threatening viral infections and diseases and we believe it our approach may also have promise in treating COVID-19.

Fighting viruses with T-cells in immunocompromised patients

When you get infected with a virus, your immune system responds to the foreign threat by making specific T-cells that can recognize the virus. These specific T-cells prompt your immune system to destroy any cells infected by the virus.

However, if you have a T-cell deficiency, your immune system cannot robustly protect you. This is a major problem because an otherwise innocuous virus can become a serious infection, causing complications, and possibly even be life-threatening.

That is where AlloVir comes in. They address the underlying problem the weakened immune system. A weakened immune system can be beefed up by giving patients with T-cell deficiencies off-the-shelf virus-specific T-cells (VSTs) originally taken from healthy people. This restores their natural T-cell immunity and helps their immune system fight off the viruses.

At AlloVir, we are a leading innovator in discovering and developing allogeneic, virus-specific T-cell immunotherapies, Dr. Melian said. We are now excited to be applying our capabilities in discovering and developing SARS-CoV-2 specific T-cells to join the fight in developing a COVID-19 program for patients at high risk of severe and devastating disease.

AlloVirs virus-specific T-cell platform

To create AlloVirs T-cell therapies, the target virus is first studied carefully to identify its specific antigens (unique molecules on the outside of each virus that are specific to the virus and alert the immune system). The best antigens those that induce a strong T-cell response are used to create the therapy.

Next, blood is taken from healthy donors who have been exposed to the virus of interest and T-cells are isolated from the blood. The T-cells are activated in the lab they are trained to recognize the identified viral antigens, enabling the T-cells to selectively recognize only the desired virus.

After the T-cells have learned to recognize the specific virus, they are expanded to generate multitudes of cells. Once the activated, specific T-cells are created, they can be cryopreserved and kept for a long time, making them readily available as soon as a patient needs them. The entire process, from antigen selection to donor to ready-to-go T-cell treatment, can be completed in a matter of weeks. This process can be seen in the visual below.

Source: AlloVir

Patients are matched using the companys proprietary human leukocyte antigen (HLA)-matching formula. HLAs are proteins on the surface of cells that regulate the immune system.

Our proprietary donor selection algorithm, known as Cytokin enables us to cover >95 percent of patients in our target population from cells derived from a small number of donors, Dr. Melian said. This proprietary process of prospectively manufacturing cells for off-the-shelf use enables us to study our allogeneic cell therapies in large numbers of patients that suffer from global health crises, like seasonal influenza and, as we are discussing, the COVID-19 pandemic.

These T-cells are advantageous because they are active against a single virus or multiple viruses, are not patient-specific (so they are readily available) and are a single treatment that provides lasting protection. The biggest bonus is the immediate off-the-shelf use for time-sensitive infections in vulnerable populations, added Dr. Melian.

In addition to developing their COVID-19 therapy (called ALVR109), AlloVir has two other multi-virus specific T-cell therapies in development: Viralym-M (ALVR105) and ALVR106. Both therapies focus on treating viral diseases common to stem cell and solid organ transplant patients and other vulnerable populations.

Viralym-M targets six common viruses: BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV, also called human herpesvirus 4), human herpesvirus 6, and JC virus (also called human polyomavirus 2). Although these viruses are widespread and infect most people, they only cause severe problems in people with weakened immune systems due to age, organ or stem cell transplant, or disease (such as diabetes or AIDS). In a Phase 2 study, 93 percent of 38 allogeneic stem cell transplant patients had a clinical response to Viralym-M treatment and functional Viralym-M cells lasted up to 12 weeks in the patients.

ALVR106 targets four common respiratory viruses: influenza, parainfluenza virus, respiratory syncytial virus (RSV), and human meta-pneumovirus (HMPV). While these viruses tend to cause mild to moderate respiratory illnesses, they can cause severe, life-threatening illness, especially in people with weakened immune systems. ALVR106 is still in preclinical development but clinical trials are expected to begin this year. Overall, AlloVir expects to have three new proof-of-concept (POC) Phase 1b/2 and three pivotal Phase 3 studies started over the next 6-18 months.

Off-the-shelf T-cells against COVID-19

While AlloVir originally designed their T-cell therapies for transplant patients, their platform can potentially be applied to any virus to create virus-specific T-cells. This versatility allowed AlloVir to pivot and create T-cells against SARS-CoV-2, the virus that causes COVID-19. This new investigational therapy, called ALVR109, is being developed as a stand-alone treatment, though it may also be incorporated into their ALVR106 respiratory virus therapy at some point in the future.

Normally, the body would make virus-specific T-cells on their own and these would clear the virus, commented Dr. Melian. We enable that process in patients who otherwise would be T-cell deficient to restore T-cell immunity by giving ex vivo expanded cells that come from patients who already have demonstrated a potent immune response and have cleared the infection.

The process of creating coronavirus-specific T-cells is the same as creating their other virus-specific T-cell therapies. First, blood is taken from people who have recovered from COVID-19 and the T-cells are isolated. Then, the cells are stimulated with viral antigens in the lab, expanded, and cryopreserved.

We purposely choose a broad range of viral antigens to stimulate the T-cells to ensure the virus cant circumvent the virus-specific T-cell therapy by mutating or developing resistance, Dr. Melian said. Working with a wide spectrum of viral activity is different than other approaches that just focus on one viral antigen.

An open-label Phase 1 trial (called BAT IT) is anticipated to start within the next few months. Initial clinical studies of ALVR109 aim to treat high-risk COVID-19 patients, such as the elderly, to prevent organ damage. Prophylaxis studies, where the T-cells could be given to high-risk or immunocompromised patients who are not currently sick with COVID-19, may be considered later.

Coronavirus-specific T-cells vs. COVID-19 convalescent plasma

You may be wondering if another treatment that uses blood from COVID-19 survivors, called convalescent plasma therapy, is similar to AlloVirs T-cell therapy. In convalescent plasma treatment, antibodies from COVID-19 survivors are isolated from their blood by separating out their plasma (the liquid part of the blood). The plasma is given to COVID-19 patients to help their immune system fight off the infection.

Although convalescent plasma and AlloVirs coronavirus-specific T-cell treatments are both derived from COVID-19 survivors blood, the two treatments are fundamentally different.

Antibodies and T-cells work in different areas of the immune system, explained Dr. Melian. Antibodies can go after viruses in circulating blood but cant necessarily see viruses in infected cells. On the other hand, T-cells are pleotropic and directly attack virally infected cells, turning off the viral factories. T-cells are interesting because it is a live therapy they can home to virally-infected cells and direct the immune system.

Dr. Melian went on to explain that T-cell approach may be more comprehensive because they can support other immune cells that work against viruses, such as B-cells that make viral-specific antibodies. T-cells can also stimulate cytokines including interferon (a group of signaling proteins the immune system uses to respond to viruses), which further activates the bodys antiviral response.

Providing virus-specific antibodies may be beneficial and protective for some viral infections, Dr. Melian added. We dont know how these antibodies affect COVID-19 patients yet, but COVID-19 has a high mortality rate despite standard of care treatment. In this respect, it is important that all viable approaches to treatment be evaluated and I am very pleased to see these therapies have entered clinical testing.

Convalescent plasma and AlloVirs coronavirus-specific T-cell therapies are not mutually exclusive, so they could even be used together.

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Our Son Wanted to Be Vegetarian, and We’re Proud He Stood Up For What He Believes In – Yahoo Lifestyle

Child is eating vegetables. He is very happy.

I'll never forget the day my son became a vegetarian. He had just finished first grade and celebrated his seventh birthday, and he didn't even know what the word meant. It was Monday, and I - in the time-honored tradition of parents everywhere - had made one of the 10 or so dishes I knew my child would eat: lemon pepper chicken with broccoli and rice. "This is chicken, right? Like the animal?" my son asked. "Yes. It's chicken like the animal." My suspicion was already rising. He had just read Charlotte's Web, and the discussion of what a smokehouse meant to Wilbur had caused some angst. My husband and I exchanged a glance across the table. What now, the look said. He put down his fork. "I don't want to eat it. I love animals. Why would I eat them?"

"Just eat your chicken. You can be a vegetarian tomorrow." I hadn't planned on a dinner fight. We had kissed those days goodbye years ago. "What's a vegetarian?" he asked. I explained: someone who doesn't eat meat. "I want to be a vegetarian," he declared. My husband tried as well. "This is what's for dinner. Tomorrow we'll make something else."

The fork remained down, and I could tell my son was struggling. His face looked tragic, near tears. He generally does what we ask without complaint, and I could see the conflict in him: listen to Mom and Dad or stand up for his beliefs - something Mom and Dad had also told him to do. That look told me everything . . . and broke my heart.

Related: Want to Talk to Your Kids About Their Weight? We Asked an Expert For Tips

With one more silent conversation with my husband, a parenting survival skill I hadn't known about before having my own kid, we gave in. "OK," I sighed. "But if you are going to be a vegetarian, you have to eat vegetables, not just, like, macaroni and cheese." My son happily agreed and proved his commitment by finishing all of his broccoli and rice.

Now, three years later, we've become experts on vegetarian meals - cooking them, ordering them, making them delicious. I've also become an expert on fielding the usual questions or comments. "Aren't you worried about protein?" "It's just a phase." "What do you even eat?" "I hate tofu."

Story continues

Here's the thing: I also hated tofu three years ago before I learned to cook it. And yes, we do eat tofu, and seitan and beans and pasta and vegetables and mushrooms and a host of other foods you might find you like as much as or more than chicken, pork, and beef. It does help that I am a culinary professional, and as soon as I accepted the new way of life, I found it fun to learn to cook vegetarian meals and, increasingly, vegan. And no, it wasn't a phase. Or if it is, it's been long enough that it has become an era in our lives that has enriched our eating habits.

But it's the protein question that gets me. It's my least favorite question, partly because people often don't really want an answer (they want to imply something) and partly because it's the obvious question, one we asked right away. I became something of a protein pro in the early days of our vegetarianism. In addition to researching nutrition intake needs for children the old-fashioned way, I reached out to a friend who happens to be a registered dietitian. The summary of what she said is this: As a country, we are overly obsessed with protein. If he is eating enough food, he is almost definitely getting enough protein. But we have to watch out for his iron intake now. Luckily, he likes spinach, and I can add it into most dishes. We also switched his vitamins to the kind with extra iron.

Related: Wondering If It's OK to Raise Your Kid Vegetarian? We Asked the Experts For Advice

Now when someone asks me about his protein intake, I answer with the question, "I have a lot of information about this. Do you want to hear it?" Usually they give me some kind of no. Sometimes they just keep suggesting vegetarian foods that have protein as though I am a recording secretary with a notepad at the ready.

The 10 or so recipes we have in our rotation now are a little different, but not much. We eat tacos still, but we use seitan and spinach as the filling. Our lasagna is a pesto spinach concoction we all love so much that we never have any leftovers. And the lemon pepper chicken has become lemon pepper tofu with broccoli and green peppers (for iron), which I do enjoy now that I learned to cook that product properly in self-defense.

I've even started teaching plant-forward cooking classes in addition to my work as a bakery chef, so my son's choices have been good for my career as well as our health and the planet.

Most importantly to us, my son has learned that he can stand up for what he thinks is right. He ignores the teasing he sometimes gets from friends (and not-friends), he donates time and sometimes money to animal-rights causes, he is maybe the only 10-year-old with subscriptions to Catster and Dogster, and - the thing I am most glad of - he stood up to authority figures who wanted him to do something that made him uncomfortable. I am so proud of him for disobeying his parents that day.

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CS Lewis and Critical Reactions to Transhumanism – Discovery Institute

Image: Screen shot from That Hideous Strength: C.S. Lewis's Prophetic Warning against the Abuse of Science.

Editors note: Published on August 16, 1945,C. S. LewissThat Hideous Strengthis a dystopian novel that eerily reflects the realities of 2020, putting into a memorable fictional form ideas expressed in Lewiss non-fiction work, The Abolition of Man. To mark the former books three-quarter century anniversary,Evolution Newspresents a series of essays, reflections, and videos about its themes and legacy.

James A. Herrick is the Guy Vander Jagt Professor of Communication at Hope College in Holland, MI. His books include The Making of the New Spirituality: The Eclipse of the Western Religious Tradition.

This post is adapted from Chapter 10 ofThe Magicians Twin: C. S. Lewis on Science, Scientism, and Society, edited by John G. West. See also,

Not surprisingly, contemporary Transhumanism has attracted a number of informed critics. I will briefly review two prominent voices in the opposition camp who reflect concerns at the heart of C. S. Lewiss own case. Hava Tirosh-Samuelson, a skeptic as regards the Transhumanist vision, echoes one of the central arguments of The Abolition of Man biotechnology now threatens to exercise control of nature itself:

Due to genetic engineering, humans are now able not only to redesign themselves but also to redesign future generations, thereby affecting the evolutionary process itself. As a result, a new posthuman phase in the evolution of the human species will emerge, in which humans will live longer, will possess new physical and cognitive abilities, and will be liberated from suffering and pain due to aging and diseases. In the posthuman age, humans will no longer be controlled by nature; instead, they will be the controllers of nature.1

The question of altering human nature also remains at the center of the developing case against Transhumanism and related proposals. Famed historian Francis Fukuyama, for example, has argued that contemporary biotechnology raises the possibility that it will alter human nature and thereby move us into a posthuman stage of history. This possibility poses a real danger to individual rights and threatens the foundation of democratic institutions:

This is important because human nature exists, is a meaningful concept, and has provided a stable continuity to our experience as a species. It is, conjointly with religion, what defines our most basic values. Human nature shapes and constrains the possible kinds of political regimes, so a technology powerful enough to reshape what we are will have possibly malign consequences for liberal democracy and the nature of politics itself.2

Though the deeper dangers of biotechnological alterations of humans have not yet manifested themselves, Fukuyama adds, one of the reasons I am not quite so sanguine is that biotechnology, in contrast to many other scientific advances, mixes obvious benefits with subtle harms in one seamless package.3 The essential correctness of Lewiss case is evident in the duration of major components in his rebuttal to Bernal, Stapledon, Haldane, Shaw and other enhancement proponents of his own day.

C. S. Lewis exhibited remarkable prescience in The Abolition of Man. Was there anything that he failed to see? Writing in the war years of the early 1940s, Lewiss perspective was understandably shaped by present circumstance and personal experience. As a result, he did not anticipate certain cultural and historical developments that have become critical to the rise of posthumanity thinking.

As noted, Lewis harbored a deep antipathy for faceless state institutions where atrocities are plotted out according to cost-benefit pragmatism and inhuman schemes are hatched in dingy meeting rooms. In such settings was the banality of evil expressed in war-torn Europe. Lewis does not appear to have anticipated the postwar power of the large corporation, the modern research university, and sophisticated mass media. Such shapers of 21st-century American culture, not the cumbersome state agencies of mid-century Europe, have taken the lead in developing the biotechnologies, educational techniques and persuasive prowess Lewis cautioned against. The user-friendly smile of the high-tech firm, not the icy stare of a government department, is the face of the new humanity. Moreover, justifications for enhancement research are not hammered out in centralized planning meetings, but tested on focus groups and winsomely presented in entertaining public lectures. Financial support for posthumanity comes not come from Big Brother bureaucracies but from Silicon Valley boardrooms.

The scope of research related to human enhancement is incomprehensibly vast and accelerating at an incalculable rate. Hundreds and perhaps thousands of university and corporate research facilities around the world are involved in developing artificial intelligence, regenerative medicine, life-extension strategies, and pharmaceutical enhancements of cognitive performance. An ever-increasing number of media products including movies, video games and novels promote Transhumanist and evolutionist themes. Each technological breakthrough is promoted as a matter of consumerist necessity despite the fact that personal electronic devices and the companies marketing them are increasingly intrusive and corrosive of personal freedoms. Innovative educational organizations such as Singularity University are forming around the Transhumanist ideal. Indeed, so immense, diverse and well-funded is the research network developing enhancement technologies that the collective financial and intellectual clout of all related projects is beyond calculating. Suffice it to say that the enhancement juggernaut is astonishingly large and powerful.

Tomorrow, Science and Scientism: The Prophetic Vision of C. S. Lewis.

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Nanomedicine Market Revolutionary Trends 2025 The News Brok – The News Brok

Nanomedicine Market Scope of the Report:

Factors and Nanomedicine Market execution are analyzed using quantitative and qualitative approaches to give a consistent picture of current and future trends in the boom. The study also allows for a detailed market analysis focused primarily on geographic locations. The Global Nanomedicine Market Report offers statistical graphs, estimates, and collateral that explain the state of specific trade within the local and global scenarios.

The worldwide market for Nanomedicine is expected to grow at a CAGR of roughly xx% over the next five years, will reach xx million US$ in 2025, from xx million US$ in 2018, according to a new study.

This report focuses on the Nanomedicine in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.

For more insights into the Market, request a sample of this report (Including Full TOC, List of Tables & Figures, Chart) @ https://www.researchmoz.com/enquiry.php?type=S&repid=2734725&source=atm

segment by Type, the product can be split intoQuantum dotsNanoparticlesNanoshellsNanotubesNanodevicesMarket segment by Application, split intooncologyInfectious diseasesCardiologyOrthopedicsOthers

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

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Reasons to Purchase this Nanomedicine Market Report:

* Analyzing the outlook of the market with the recent trends and SWOT analysis

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* Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.

* Market value (USD Million) and volume (Units Million) data for each segment and sub-segment

* Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years

* Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

* 1-year analyst support, along with the data support in excel format.

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The Nanomedicine Market report has 150 tables and figures browse the report description and TOC:

Table of Contents

1 Study Coverage

1.1 Nanomedicine Product

1.2 Key Market Segments in This Study

1.3 Key Manufacturers Covered

1.4 Market by Type

1.4.1 Global Nanomedicine Market Size Growth Rate by Type

1.5 Market by Application

1.5.1 Global Nanomedicine Market Size Growth Rate by Application

2 Executive Summary

2.1 Global Nanomedicine Market Size

2.1.1 Global Nanomedicine Revenue 2014-2025

2.1.2 Global Nanomedicine Production 2014-2025

2.2 Nanomedicine Growth Rate (CAGR) 2019-2025

2.3 Analysis of Competitive Landscape

2.3.1 Manufacturers Market Concentration Ratio (CR5 and HHI)

2.3.2 Key Nanomedicine Manufacturers

2.3.2.1 Nanomedicine Manufacturing Base Distribution, Headquarters

2.3.2.2 Manufacturers Nanomedicine Product Offered

2.3.2.3 Date of Manufacturers Enter into Nanomedicine Market

2.4 Key Trends for Nanomedicine Markets & Products

3 Market Size by Manufacturers

3.1 Nanomedicine Production by Manufacturers

3.1.1 Nanomedicine Production by Manufacturers

3.1.2 Nanomedicine Production Market Share by Manufacturers

3.2 Nanomedicine Revenue by Manufacturers

3.2.1 Nanomedicine Revenue by Manufacturers (2019-2025)

3.2.2 Nanomedicine Revenue Share by Manufacturers (2019-2025)

3.3 Nanomedicine Price by Manufacturers

3.4 Mergers & Acquisitions, Expansion Plans

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Covid-19 impact on Healthcare Nanotechnology (Nanomedicine) Market New Trends, Growth, Outlook, Overview, Application and Forecast 2020 to 2025:…

Healthcare Nanotechnology (Nanomedicine) Market 2020: Latest Analysis

Los Angeles, United States:-The report titled GlobalHealthcare Nanotechnology (Nanomedicine) Market is one of the most comprehensive and important additions toLimra Global Market Researcharchive of market research studies. It offers detailed research and analysis of key aspects of the global Healthcare Nanotechnology (Nanomedicine) Market . The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Healthcare Nanotechnology (Nanomedicine) Market . Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Healthcare Nanotechnology (Nanomedicine) Market is carefully analyzed and researched about by the market analysts.

Top Players of Healthcare Nanotechnology (Nanomedicine) Market are Studied: Amgen, Teva Pharmaceuticals, Abbott, UCB, Roche, Celgene, Sanofi, Merck & Co, Biogen, Stryker, Gilead Sciences, Pfizer, 3M Company, Johnson & Johnson, SmitH& Nephew, Leadiant Biosciences, Kyowa Hakko Kirin, Takeda, Ipsen, Endo International

Download Free Sample PDF (including full TOC, Tables, and Figures) of Healthcare Nanotechnology (Nanomedicine) Market Research 2020-2026: https://www.limraglobalmarketresearch.com/request-a-sample/?pid=17043

Global Healthcare Nanotechnology (Nanomedicine) Market is estimated to reach xxx million USD in 2020 and projected to grow at the CAGR of xx% during 2020-2026. According to the latest report added to the online repository of Limra Global Market Research the Healthcare Nanotechnology (Nanomedicine) Market has witnessed an unprecedented growth till 2020. The extrapolated future growth is expected to continue at higher rates by 2026.

Our exploration specialists acutely ascertain the significant aspects of the global Healthcare Nanotechnology (Nanomedicine) Market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Healthcare Nanotechnology (Nanomedicine) Market situation. In this Healthcare Nanotechnology (Nanomedicine) Market report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Healthcare Nanotechnology (Nanomedicine) Market report comprises of primary and secondary data which is exemplified in the form of pie outlines, Healthcare Nanotechnology (Nanomedicine) Market tables, analytical figures, and reference diagrams. The Healthcare Nanotechnology (Nanomedicine) Market report is presented in an efficient way that involves basic dialect, basic Healthcare Nanotechnology (Nanomedicine) Market outline, agreements, and certain facts as per solace and comprehension.

NOTE:Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Healthcare Nanotechnology (Nanomedicine) Market which would mention How the Covid-19 is Affecting the Healthcare Nanotechnology (Nanomedicine) Market, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Healthcare Nanotechnology (Nanomedicine) Market Players to Combat Covid-19 Impact.

The Essential Content Covered in the GlobalHealthcare Nanotechnology (Nanomedicine) Market Report:

* Top Key Company Profiles.* Main Business and Rival Information* SWOT Analysis and PESTEL Analysis* Production, Sales, Revenue, Price and Gross Margin* Market Share and Size

The report provides a 6-year forecast (2020-2026) assessed based on how the Healthcare Nanotechnology (Nanomedicine) Market is predicted to grow in major regions like USA, Europe, Japan, China, India, Southeast Asia, South America, South Africa, Others.

Key Questions Answered In this Report:

What is the overall market size in 2019? What will be the market growth during the forecast period i.e. 2020-2026?

Which region would have high demand for product in the upcoming years?

What are the factors driving the growth of the market?

Which sub-market will make the most significant contribution to the market?

What are the market opportunities for existing and entry-level players?

What are various long-term and short-term strategies adopted by the market players?

What are the key business strategies being adopted by new entrants in the Healthcare Nanotechnology (Nanomedicine) Market ?

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Table of Contents

Market Overview:This is the first section of the report that includes an overview of the scope of products offered in the global Healthcare Nanotechnology (Nanomedicine) Market , segments by product and application, and market size.

Market Competition by Player:Here, the report shows how the competition in the global Healthcare Nanotechnology (Nanomedicine) Market is growing or decreasing based on deep analysis of market concentrate rate, competitive situations and trends, expansions, merger and acquisition deals, and other subjects. It also shows how different companies are progressing in the global Healthcare Nanotechnology (Nanomedicine) Market in terms of revenue, production, sales, and market share.

Company Profiles and Sales Data:This part of the report is very important as it gives statistical as well as other types of analysis of leading manufacturers in the global Healthcare Nanotechnology (Nanomedicine) Market . It assesses each and every player studied in the report on the basis of main business, gross margin, revenue, sales, price, competitors, manufacturing base, product specification, product application, and product category.

Market Status and Outlook by Region:The report studies the status and outlook of different regional markets such as Europe, North America, the MEA, Asia Pacific, and South America. All of the regional markets researched about in the report are examined based on price, gross margin, revenue, production, and sales. Here, the size and CAGR of the regional markets are also provided.

Market by Product:This section carefully analyzes all product segments of the global Healthcare Nanotechnology (Nanomedicine) Market .

Market by Application:Here, various application segments of the global Healthcare Nanotechnology (Nanomedicine) Market are taken into account for research study.

Market Forecast:It starts with revenue forecast and then continues with sales, sales growth rate, and revenue growth rate forecasts of the global Healthcare Nanotechnology (Nanomedicine) Market . The forecasts are also provided taking into consideration product, application, and regional segments of the global Healthcare Nanotechnology (Nanomedicine) Market .

Upstream Raw Materials:This section includes industrial chain analysis, manufacturing cost structure analysis, and key raw materials analysis of the global Healthcare Nanotechnology (Nanomedicine) Market .

Marketing Strategy Analysis, Distributors:Here, the research study digs deep into behavior and other factors of downstream customers, distributors, development trends of marketing channels, and marketing channels such as indirect marketing and direct marketing.

Research Findings and Conclusion:This section is solely dedicated to the conclusion and findings of the research study on the global Healthcare Nanotechnology (Nanomedicine) Market .

Appendix:This is the last section of the report that focuses on data sources, viz. primary and secondary sources, market breakdown and data triangulation, market size estimation, research programs and design, research approach and methodology, and the publishers disclaimer.

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Testosterone Replacement Therapy Sales Market Still Has Room to Grow With Emerging Players 2027 – The Daily Chronicle

(Augest 2020) SMI published a business research report on Testosterone Replacement Therapy Sales Market: Global Industry Analysis, Size, Share, Growth,Trends, and Forecasts 20202027. Research reportwith 110+ pages on market data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand detailed analysis. The information is gathered based on modern floats and requests identified with the administrations and items.

Key players are expected to enhance their marketing capabilities over the forecast period owing to certain market conditions. The report presents certain elements that will reflect whats and hows of such changes in the market. Further, the report studies various aspects of the global market such as upstream raw materials, downstream demand, and production value of leading players subject to market growth.

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Geographical segmentation of the Testosterone Replacement Therapy Sales Market involves the regional outlook which further covers the United States, China, Europe, Japan, Southeast Asia and Middle East & Africa. This report categorizes the market based on manufacturers, regions, type and applications.

Testosterone Replacement Therapy Sales Market: Competitive Landscape

Leading players operating in the global Testosterone Replacement Therapy Sales market include AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals.

Scope of the Report:

The key features of the Testosterone Replacement Therapy Sales Market report 2020-2027 are the organization, extensive amount of analysis and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the Testosterone Replacement Therapy Sales Market. The structure of the Testosterone Replacement Therapy Sales Market by identifying its various segments and sub-segments to help to understand the report.

Testosterone Replacement Therapy Sales Market is growing at a High CAGR during the forecast period 2020-2026. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.

As the report proceeds further, it covers the analysis of key market participants paired with development plans and policies, production techniques, price structure of the market. The report also identifies the other essential elements such as product overview, supply chain relationship, raw material supply and demand statistics, expected developments, profit and consumption ratio.

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Important Data Available In This Report:

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms, and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus.

Customer Experience Analysis:

The study offers an in-depth assessment of various customers journeys pertinent to the market and its segments. It offers various customer impressions about products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

How will the report assist your business to grow?

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Testosterone Replacement Therapy Sales Market Still Has Room to Grow With Emerging Players 2027 - The Daily Chronicle

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Global Testosterone Replacement Therapy Market 2020 Growth Analysis, Opportunities, Revenue and sales, Trends and Developments, Forecast by 2025 – Red…

MarketsandResearch.biz has newly added a new research report titled Global Testosterone Replacement Therapy Market 2020 by Manufacturers, Type and Application, Forecast to 2025 which is known to provide comprehensive and detailed information about the market for the projected period from 2020 to 2025. The report inspects the crucial data related to the market. The report focuses on different components of the market including market trends, regional outlook, competitive landscape, key players, business approaches. The report determines the global Testosterone Replacement Therapy market growth and market share for the estimated forecast period. The research report has made through several data exploratory techniques which include primary and secondary research.

The reports objective is to show the development in key regions. The global Testosterone Replacement Therapy market is a database mechanism developed for analysis and access to a large volume of unstructured data. The study analyzes market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, player profiles. The research report investigates the whole growth dynamics of the industry as well as market evaluation, manufacturing approach across distinct topologies and competitive landscape analysis.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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Market Segmentation:

The global Testosterone Replacement Therapy market is analyzed for different segments to arrive at an insightful analysis. Such segmentation has been done based on type, application, and region.

The study encompasses profiles of major companies operating in the global market. Key players profiled in the report include: AbbVie, Teva, Pfizer, Endo International, Novartis, Eli lilly, Upsher-Smith, Bayer, Actavis (Allergan), Mylan, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

The report provides in-depth comprehensive analysis for regional segments that covers North America (United States, Canada and Mexico), Europe (Germany, France, United Kingdom, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), Middle East & Africa (Saudi Arabia, UAE, Egypt and South Africa) in the global Testosterone Replacement Therapy report with market definitions, classifications, manufacturing processes, cost structures, development policies, and plans.

Market segment by type, the product can be split into: Gels, Injections, Patches, Other

Market segment by regions/countries, this report covers: Hospitals, Clinics, Others

Moreover in the report, other data models include vendor positioning grid, market timeline analysis, global Testosterone Replacement Therapy market overview, and guide, company positioning grid, company market share analysis, standards of measurement, top to bottom analysis and vendor share analysis. Market players can effortlessly implement strategies with all the data provided to gain a dominant position and beat the competition in the market.

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Questions Answered By The Global Testosterone Replacement Therapy Market Report With Regards To The Geographical Spectrum of The Market:

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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 – StartupNG

The report is an all-inclusive research study of the global Testosterone Replacement Therapy market taking into account the growth factors, recent trends, developments, opportunities, and competitive landscape. The market analysts and researchers have done extensive analysis of the global Testosterone Replacement Therapy market with the help of research methodologies such as PESTLE and Porters Five Forces analysis. They have provided accurate and reliable market data and useful recommendations with an aim to help the players gain an insight into the overall present and future market scenario. The Testosterone Replacement Therapy report comprises in-depth study of the potential segments including product type, application, and end user and their contribution to the overall market size.

The Testosterone Replacement Therapy Market carries out financial changes that occur year by years in market, with information about upcoming opportunities and risk to keeps you ahead of competitors. The report also describes top company profiles that present in market with trends worldwide. This research guided you for extending business.

The Testosterone Replacement Therapy Market research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data and statistically-supported and industry-validated market data and projections with a suitable set of assumptions and methodology. It provides analysis and information by categories such as market segments, regions, and product type and distribution channels.

For more insights into the Market, request a sample of this report (Including Full TOC, List of Tables & Figures, Chart) @ https://www.researchmoz.com/enquiry.php?type=S&repid=2746283&source=atm

Segment by Type, the Testosterone Replacement Therapy market is segmented intoGelsInjectionsPatchesOther

Segment by Application, the Testosterone Replacement Therapy market is segmented intoHospitalsClinicsOthers

Regional and Country-level Analysis:North AmericaUnited StatesCanadaAsia-PacificChinaJapanSouth KoreaIndiaSoutheast AsiaAustraliaRest of Asia-PacificEuropeGermanyFranceU.K.ItalyRussiaNordic CountriesRest of EuropeLatin AmericaMexicoBrazilRest of Latin AmericaMiddle East & AfricaTurkeySaudi ArabiaUAERest of MEA

Competitive Landscape and Testosterone Replacement Therapy Market Share AnalysisTestosterone Replacement Therapy market competitive landscape provides details and data information by companies. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on sale and revenue by players for the period 2015-2020. Details included are company description, major business, Testosterone Replacement Therapy product introduction, recent developments, Testosterone Replacement Therapy sales by region, type, application and by sales channel.

The major companies include:AbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals

A proper understanding of the Testosterone Replacement Therapy Market dynamics and their inter-relations helps in gauging the performance of the industry. The growth and revenue patterns can be revised and new strategic decisions taken by companies to avoid obstacles and roadblocks. It could also help in changing the patterns using which the market will generate revenues. The analysis includes an assessment of the production chain, supply chain, end user preferences, associated industries, proper availability of resources, and other indexes to help boost revenues.

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Market Segmentation based On Type, Application and Region:

The global Testosterone Replacement Therapy is analyzed for different segments to arrive at an insightful analysis. Such segmentation has been done based on type, application and Region.

Global Testosterone Replacement Therapy market is presented to the readers as a holistic snapshot of the competitive landscape within the given forecast period. It presents a comparative detailed analysis of the all regional and player segments, offering readers a better knowledge of where areas in which they can place their existing resources and gauging the priority of a particular region in order to boost their standing in the global market.

The Global Testosterone Replacement Therapy Market is gaining pace and businesses have started understanding the benefits of analytics in the present day highly dynamic business environment. The market has witnessed several important developments over the past few years, with mounting volumes of business data and the shift from traditional data analysis platforms to self-service business analytics being some of the most prominent ones.

For the future period, sound forecasts on market value and volume are offered for each type and application. In the same period, the report also provides a detailed analysis of market value and consumption for each region. These insights are helpful in devising strategies for the future and take necessary steps. New project investment feasibility analysis and SWOT analysis are offered along with insights on industry barriers. Research findings and conclusions are mentioned at the end.

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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 - StartupNG

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LPCN: Tlando: Target Action Date This Friday – Zacks Small Cap Research

By John Vandermosten

NASDAQ:LPCN

READ THE FULL LPCN RESEARCH REPORT

Up and Coming Milestones

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Second Quarter 2020 Operational and Financial Results

On August 6, 2020 Lipocine (NASDAQ:LPCN) filed its second quarter 2020 10-Q and posted its earnings release for the three month period ending June 30, 2020. The company reported zero revenues and a net loss per share of ($0.13) compared to prior year revenues of zero and loss of ($0.14) per share. Activity during the second quarter revolved around several items including presentation at the American Urological Association (AUA) conference, demonstration of treatment potential for LPCN 1144, investigational new drug clearance for LPCN 1148, affirmation of the USPTO decision and the dismissal of a shareholder lawsuit. The companys shares also exceeded $1.00 in June, and have remained above this level, allowing Lipocine to regain compliance with NASDAQ minimum bid requirements. The most important item on the calendar is the FDAs response to Tlandos NDA submission, which is expected on or before August 28th.

We anticipate that upon approval, Lipocine will find a partner to commercialize Tlando and use associated upfront and milestone payments to further develop the existing portfolio, especially LPCN 1144 and LPCN 1148. Potential licensees are waiting until approval is granted before performing their due diligence. This suggests that a deal would be announced in the fourth quarter of 2020 rather than in the weeks following an assumed approval.

Operational expenses for 2Q:20 were $4.2 million, up 26% and net loss totaled ($6.4) million or ($0.13) per share. Research and development expenses totaled $2.5 million. The 16% rise over prior year amounts reflects increased costs related to the LiFT study and higher personnel expenditures offset by a decrease in amounts related to the ABPM study, lower spend on the Tlando XR program and a fall in manufacturing costs for LPCN 1107. General and administrative costs rose 41% over last years second quarter to $2.0 million on an expansion in legal expenditures related to the Clarus dispute and an increase in personnel costs offset by lower marketing expenses, administrative travel and other expenses. A rise in the share price increased the warrant liability and required the recognition of a $2.1 million non-cash loss in other income.

Cash and marketable securities balance was $18.2 million as of June 30, 2020. There is another $5 million of restricted1 cash which will remain on hold until Tlando is approved. Current and non-current debt is carried on the balance sheet at $6.3 million. Cash burn for 2Q:20 was approximately ($4.1) million and net cash provided by financing was $11.7 million representing a stock offering and warrant proceeds partially offset by a small amount of debt repayment.

Tlando

On November 11 of last year, Lipocine announced that it had received a complete response letter (CRL) for Tlando. The CRL identified one deficiency stating that the trial did not meet one of the three secondary endpoints for maximal testosterone concentrations (Cmax). No deficiencies related to chemistry, manufacturing and controls were noted. FDA guidelines call for 85% of subjects to achieve a Cmax below 1500 ng/dL and no more than 5% of subjects presenting a Cmax between 1800 ng/dL and 2500 ng/dL and 0% above 2500 ng/dL. In the most recent dosing validation (DV) study, 85% of subjects were below 1500 ng/dL and 7% were between 1800 ng/dL and 2500 ng/dL. Although there were small variations from the FDA guidelines in the original SOAR study for subjects above 2500 ng/dL, the FDA did not identify these as a deficiency during the original New Drug Application (NDA) submission.

Following the Post Action meeting with the FDA, Lipocine was advised to address the outstanding deficiencies with a reanalysis of existing data. This recommendation relieved Lipocine of the time and cost of an additional trial and also allowed the resubmission of the Tlando NDA in February. A target action date of August 28th was provided. While the resubmission is a positive, Tlando has faced significant hurdles gaining the favor of the FDA. We published a note on February 25th that discussed details regarding the resubmission.

LPCN 1144

Lipocine announced in August 2018 the pursuit of a new indication in nonalcoholic steatohepatitis (NASH). We discuss the indication and Lipocines efforts in an earlier piece that can be accessed here. Full enrollment of 36 subjects was achieved in November 2018.

In January 2019, Lipocine announced meaningful liver fat reduction in patients participating in its Liver Fat Study and informed investors that the company had filed an investigational new drug (IND) application to begin a Phase II study for NASH. Since LPCN 1144 is the same molecule as TLANDO, for which there were numerous safety studies completed, LPCN was allowed to perform a proof of concept (POC) clinical study under the original IND to assess liver fat changes. This 36-person study was conducted in hypogonadal men at risk of developing non-alcoholic steatohepatitis (NASH) and results were measured using the magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique. Topline results were announced in 1Q:19 demonstrating a 4.0% to 8.2% percentage point reduction in liver fat depending on baseline liver fat category. We discussed the results in further detail in our NASH Topline article.

Lipocine launched its Phase II clinical study for LPCN 1144 and dosed its first patient last September. Prior to the start of the trial, Lipocine announced that the FDA would allow the Phase II LiFT trial to enroll eugonadal patients in addition to the NASH patients that were initially targeted. This expansion was based on research that we discussed in a July 29th note. The study is anticipated to last for 18 months and cost approximately $8 million.

LiFT, an acronym of Liver Fat intervention with oral Testosterone, is a paired biopsy Phase II study in NASH subjects. The study design will employ a three-arm, double-blind, placebo-controlled structure and enroll approximately 75 biopsy confirmed male NASH subjects with a NAS2 score of greater or equal to four. The primary endpoint for the study is 12-week MRI-PDFF liver fat reduction and the first patient was enrolled in 3Q:19. As for the anticipated timeline, Lipocine expects top line liver fat reduction data in 4Q:20 as measured by MRI-PDFF at 12 weeks. Biopsy data at 36 weeks is expected to be available in the second quarter of 2021.

Exhibit I LiFT Study Timeline3

NASH Environment

A lot has happened in the NASH space in 2020. Genfit (GNFT) announced that it will halt development of elafibranor after it failed to distinguish itself compared to placebo earlier this year. CymaBay (CBAY) announced that the FDA had lifted the hold on seladelpars Phase II study last month. No evidence was found for liver injury for the drug and the trial is expected to resume. Intercepts (ICPT) OCA received a complete response letter from the FDA in late June noting that the agency remains uncertain that the benefits of the drug outweigh the risks. Viking (VKTX) is conducting the Phase IIb VOYAGE trial for VK2809 which is still ongoing. A bright spot in the space has been results from Akeros (AKRO) Phase IIb trial for efruxifermin in NASH which were announced June 30. The study found that 48% of patients had fibrosis improvement of at least one stage with a 62% response rate. Fibrosis improved by at least two stages for 28% of the group with a 38% response rate and 48% experienced NASH resolution without worsening of fibrosis across all dose groups.

LPCN 1148

Lipocine is preparing to develop its testosterone molecule to treat NASH cirrhosis patients. While the target market is smaller than that of pre-cirrhotic NASH, there are no other FDA approved products available. The inverse relationship between testosterone and sarcopenia and the increased risks of advancing NASH cirrhosis validates this pursuit. Pending funding, Lipocine plans to initiate a proof of concept trial to evaluate the potential of this candidate. The companys Investigational New Drug (IND) application was cleared by the FDA in May 2020. We anticipate Lipocine will launch the Phase II trial after the start of commercialization of Tlando and upon availability of sufficient capital to fund it. Management has guided to a 4Q:20 or 1Q:21 start.

Exhibit II Lipocine Pipeline4

Markman Hearing

On March 26th, Lipocine announced the outcome of the Markman Hearing, also known as a claim construction hearing. This meeting is an important precursor to a patent infringement lawsuit and provides the definitions of terms critical for a jurys determination on whether or not a patent has value. A patent should not be too specific, as it provides insufficient protection to an invention, or too broad, in which case a court may rule it indefinite. In the hearing order5, Judge Bryson did not agree with most of Clarus claims and sided with Lipocine on the majority of definitions and clarifications. While the terms and definitions are subject to an evolving construction, the order is favorable to Lipocines dispute against Clarus. While this order could be appealed again, it is unlikely in the opinion of Lipocines counsel. Lipocine and Clarus are currently engaged in the fact discovery phase of the lawsuit and the jury trial is anticipated to take place in February 2021. Lipocine need only prevail on one claim to merit damages, which places them in a strong position to succeed in the trial or provide incentive for Clarus to settle.

USPTO Decision Affirmed

The US Court of Appeals affirmed the decision of the USPTO in April 2020 to grant Lipocines Priority Motion in the interference case that cancelled Clarus claims to the 428 patent in January 2019. The USPTO, through its Patent Trial and Appeal Board (PTAB), had granted Lipocines priority motion in the related interference case and entered adverse judgment against Clarus. As we have previously shared, this outcome was expected as it is rare for a federal court to overturn a USPTO ruling. As a reminder, in 2Q:19 Lipocinefiled suitagainst Clarus alleging that Jatenzo infringed on six of Lipocines patents. The injunction filing may slow down commercialization of Jatenzo and force Clarus to come to the table to negotiate a settlement. While the cost of pursuing such legal action could be high, we anticipate by the time the case works its way through the courts, cash flow from Tlando could be sufficient to support the legal efforts.

Publications and Abstracts

Results from Lipocines Liver Fat Study were published in Hepatology Communications in an article entitled LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease In Hypogonadal Males." The study served to identify the prevalence of non-alcoholic fatty liver disease (NAFLD) in hypogonadal males and quantify the beneficial impact of LPCN 1144 on hypogonadism. 36 hypogonadal males were evaluated using MRI-PDFF measurements for liver fat. 81% of those with baseline liver fat equal to or greater than 5% showed improvement in liver fat content and NAFLD resolved in one-third of the group at six weeks and 48% after 16 weeks. The paper concluded that treatment with LPCN 1144 resolved NAFLD in about half of affected patients without any safety signals.

Lipocine submitted several abstracts to the American Urological Association (AUA) Virtual Experience, which took place from May 15 to 17, 2020. Three titles were presented.

Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk was presented by Dr. Mohit Khera which investigated the chronic use of testosterone replacement therapy (TRT) on cardiovascular risk. Jatenzo, Xyosted and Tlando were assessed in their impact on blood pressure and cardiovascular risk in hypogonadal men. Marginal increases in blood pressure were observed and no meaningful impact on cardiovascular risk was noted.

A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration was presented by Dr. Martin Miner and highlights the shortcomings of dose titration when prescribing TRT. The abstract concluded that fixed dose Tlando normalizes testosterone levels in hypogonadal patients while avoiding the potential problems associated with titrated TRT.

Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver was presented by Dr. Irwin Goldstein and compares oral methyltestosterone (MT) with TRT in males deficient in endogenous testosterone. The study results suggested that unlike MT, Tlando has no adverse effects on liver and can be used for an extended period to potentially reduce liver fat.

Milestones

Tlando CRL November 9, 2019

Tlando FDA post action meeting January 2020

Resubmission of Tlando NDA February 2020

Investigational New Drug (IND) clearance for LPCN 1148 May 2020

Wajda v. Patel shareholder suit dismissed July 2020

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Summary

Since our previous update, Lipocine has participated in scientific conferences, published an article in the journal Hepatology Communications and advanced several months towards the upcoming August 28 PDUFA date for Tlando. Assuming a favorable outcome for the application, Lipocine will seek a commercialization partner and should receive upfront and milestone proceeds in conjunction with a deal. The Phase II LiFT trial continues to be a bright spot for the company and is potentially able to address a large unmet need in NASH patients in contrast to other programs which have met with difficulty. Management has guided towards a year-end readout of LiFT trial results. Lipocine is also developing LPCN 1148 for cirrhosis patients which was recently given clearance to begin a Phase II study. While we do not see this program entering the clinic until sufficient capital is available, we do think it will advance if Phase II data for LPCN 1144 are positive.

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DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks provides and Zacks receives quarterly payments totaling a maximum fee of $40,000 annually for these services. Full Disclaimer HERE.

________________________

1. Tlando was not approved by the FDA by May 31, 2018, and therefore Lipocine is required to maintain $5.0 million of cash collateral at Silicon Valley Bank (the lender) until such time as it is approved by the FDA.

2. NAS: NAFLD (Non-alcoholic fatty liver disease) Activity Score. Discussion of the metric can be found here.

3. Source: Lipocine Corporate Presentation May 2020.

4. Source: Lipocine Corporate Presentation July 2020.

5. A link to the Markman Hearing Order can be found on this page: https://ir.lipocine.com/presentations

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Testosterone Replacement Therapy Market Industry: By Type, Application, Regional outlook, Manufactures & Forecast to 2029 – The News Brok

Testosterone Replacement Therapy Market contain SWOT analysis of ramp up growth of industry in supply chain, demand, sales with overall portfolio management along with geographical condition. It also have an investigation on manufactures with vary in trends of market along with future scope by 2020-2029

Get Sample Copy at https://www.orianresearch.com/request-sample/1658804

This report provides detailed historical analysis of global market for Testosterone Replacement Therapy from 2014-2019, and provides extensive market forecasts from 2020-2029 by region/country and subsectors. It covers the sales volume, price, revenue, gross margin, historical growth and future perspectives in the Testosterone Replacement Therapy market.

Development policies and plans are discussed as well as manufacturing processes and cost structures. This report also states import/export, supply and consumption figures as well as cost, price, revenue and gross margin by regions North America, Europe, Japan, China, and other regions (India, Southeast Asia, Central & South America, and Middle East & Africa) and other regions can be added.

This report analyses the impact of COVID-19 on this industry. COVID-19 can affect the global market in 3 ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on enterprises and financial markets.

Key Companies Analyzed in this Report are:

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Global Testosterone Replacement Therapy report has been compiled through extensive primary research (through analytical research, market survey and observations) and secondary research. The report also features a complete qualitative and quantitative assessment by analyzing data gathered from industry analysts and market participants across key points in the industrys value chain.

The Report Segments for Testosterone Replacement Therapy Market Analysis & Forecast 20202029 are as:

Market segment by Type, the product can be split into

Gels

Injections

Patches

Other

Market segment by Application, split into

Hospitals

Clinics

Others

Market split by Sales Channel, can be divided into:

Direct Channel

Distribution Channel

Market segment by Regions/Countries, this report covers

North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Spain etc.)

Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.)

South America Brazil, Argentina, Colombia and Chile etc.)

Middle East & Africa (South Africa, Egypt, Nigeria and Saudi Arabia etc.)

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If you have any special requirement, please let us know and we can provide you the report as your requirement.

Reasons to get this report:

In an insight outlook, this research report has dedicated to several quantities of analysis industry research (global industry trends) and Testosterone Replacement Therapy market share analysis of high players, along with company profiles, and which collectively include about the fundamental opinions regarding the market landscape, emerging and high-growth sections of Testosterone Replacement Therapy market, high-growth regions, and market drivers, restraints, and also market chances.

The analysis covers Testosterone Replacement Therapy market and its advancements across different industry verticals as well as regions. It targets estimating the current market size and growth potential of the global Testosterone Replacement Therapy Market across sections such as also application and representatives.

Additionally, the analysis also has a comprehensive review of the crucial players on the Testosterone Replacement Therapy market together side their company profiles, SWOT analysis, latest advancements, and business plans.

Major Points Covered in Table of Contents:

Chapter 1 Testosterone Replacement Therapy Market Overview

Chapter 2 Testosterone Replacement Therapy Market Segment Analysis by Player

Chapter 3 Testosterone Replacement Therapy Market Segment Analysis by Type

Chapter 4 Testosterone Replacement Therapy Market Segment Analysis by Application

Chapter 5 Testosterone Replacement Therapy Market Segment Analysis by Sales Channel

Chapter 6 Testosterone Replacement Therapy Market Segment Analysis by Region

Chapter 7 Profile of Leading Testosterone Replacement Therapy Players

Chapter 8 Upstream and Downstream Analysis of Testosterone Replacement Therapy

Chapter 9 Development Trend of Testosterone Replacement Therapy (2020-2029)

Chapter 10 Appendix

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Testosterone Replacement Therapy Market Industry: By Type, Application, Regional outlook, Manufactures & Forecast to 2029 - The News Brok

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