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Stopping, blocking and dampening how Aussie drugs in the pipeline could treat COVID-19 – The Conversation AU

By daniellenierenberg

While widespread vaccination is key in our fight against COVID-19, people who are infected still need better treatment to improve their chance of survival and making a full recovery.

Early on, the world had high hopes for a range of repurposed medications which had previously been approved to treat other conditions including hydroxychloroquine, remdesivir and ivermectin to treat COVID-19. But the results have been disappointing.

Diseases caused by viruses are among the most difficult to treat, due to their ability to invade and repurpose infected cells. This limits the ability for drugs to directly act on the virus.

Read more: Developing antiviral drugs is not easy here's why

Yet researchers around the world are finding ways to overcome these barriers and directly target the coronavirus, including in Australia. So whats being developed here and how do they work?

Researchers at Queenslands Menzies Health Institute, in collaboration with scientists from the United States, have developed a novel treatment which targets key genes of the coronavirus, stopping the viruss ability to replicate.

The treatment uses an engineered particle called a small interfering RNA (si-RNA), which detects and binds to areas of the hosts genome, where the virus resides.

The si-RNA is encased in a nanoparticle to protect it as it travels through the bloodstream. It enters all cells in the hosts body, but will only act on the cells infected by the virus.

Read more: Have Australian researchers developed an effective COVID-19 treatment? Potentially, but we need to wait for human trials

Studies in mice showed the treatment reduced the amount of the virus in the lungs by more than 90%.

Its unclear if the results will translate to humans, but if they do, it could potentially protect infected people from severe disease and make them less likely to transmit the illness to others.

If it is successful, the researchers estimate the treatment could be available in 2023.

Another strategy is to block the virus from invading all together.

A number of research teams across Australia are working on engineered antibody treatments, which hunt out and bind to the virus before it enters a cell, effectively blocking it out.

Researchers at the Garvan and Kirby institutes in New South Wales are building on research developed after the 2003 SARS outbreak to create treatments using monoclonal antibodies. These antibodies are generated in the lab and mimic the immune system response to infection.

Once these monoclonal antibodies are injected into an infected person, they bind to the virus and stop it from invading host cells. They also mark it for destruction by the other immune cells.

While this research is in the pre-clinical (lab testing) phase, the researchers at Garvan are already working with clinicians at the Kirby institute to identify the best antibodies and move them through to human clinical trials.

As monoclonal antibody treatments are widely used in a range of diseases, these could potentially be deployed quickly for patients with COVID-19, or to protect people who have been exposed to the virus, to stop them getting sick and becoming infectious.

Another team at the Walter and Elizabeth Hall Institute in Melbourne is harnessing unique nanobodies, which are significantly smaller than human antibodies, derived from the immune system of alpacas.

These nanobodies have powerful and specific binding capacity. By vaccinating the alpacas with a synthetic component of the SARS-CoV-2 virus, nanobodies targeting the virus can be identified and synthesised for human use.

While these treatments are in the very early stages of development, they could prove revolutionary for all kinds of infectious and non-infectious diseases.

While some treatments aim to neutralise the virus, others are being developed to protect patients from the consequences of COVID-19.

One of the most severe reactions to an infection with the coronavirus is a widespread inflammatory reaction known as a cytokine storm, causing severe damage to the lungs.

While potent anti-inflammatory drugs such as hydrocortisone can help to prevent this response, they also can have severe side-effects such as bone weakening, immune system weakening, psychiatric symptoms and insomnia.

Researchers at the Victor Chang Cardiac Institute and St Vincents hospital in Sydney are proposing to trial a novel stem cell therapy, in an attempt to counteract this inflammatory storm.

While they havent disclosed specifically which cells they are planning to use, human studies show stem cell treatments can suppress inflammatory responses from the immune system.

The researchers are seeking approval for clinical studies and are using a stem cell that has been used in humans previously potentially speeding the pathway to clinical use.

Read more: Could a simple pill beat COVID-19? Pfizer is giving it a go

Another anti-inflammatory drug to control the damaging levels of immune response to the viral infection is being developed by Implicit Bioscience.

Its drug has already shown promising preliminary results in small trials for acute lung injury and amyotrophic lateral sclerosis (AML, a rare neurological disease also known as motor neurone disease), with phase 2 trials for AML due to be completed in 2021.

Two trials at major medical centres, one led by the US National Institutes of Health and the other by Quantum Leap Healthcare Collaborative, are now underway to test whether the drug is effective in patients with severe COVID-19.

Australian biotech company Ena Respiratory is developing a nasal spray to fight COVID-19.

These nasal sprays contain a compound designed to trigger a rapid immune response in the upper airways. This allows the immune system to destroy the virus and infected cells before serious disease can occur.

Ena Respiratorys product, called INNA-051, has produced promising results in animal models, with up to a 96% decrease in SARS-CoV-2 virus replication.

The next step is to see if these results translate to humans.

Australia has a long history of strong performance on the world stage in research. Fortunately, this has continued through the COVID-19 pandemic, with a number of key developments and innovations as described, which show promise for translation to human clinical trials.

Developments are continuing, including research by Vasso and her team into novel re-purposed and experimental drugs aimed at stopping coronavirus replication. This is a collaboration between Victoria University and researchers from the United States and Greece, and the team hopes to be able to report on its progress soon.

Read more: I'm a lung doctor testing the blood plasma from COVID-19 survivors as a treatment for the sick a century-old idea that could be a fast track to treatment

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Stem Cell Manufacturing Market Global Industry Analysis , Scope, Opportunity and Forecast 2020 to 2030 The Courier – The Courier

By daniellenierenberg

Global Stem Cell Manufacturing Market: Overview

Stem cells refer to special cells created by bone marrow of an individual. The key specialty of these cells is their ability to turn into various types of blood cells. Stem cells are gaining immense impetus owing to their key role in effectual disease management and specialized research activities including genomic testing and personalized medicine. Owing to these factors, the global stem cell manufacturing market is likely to register promising growth trajectory throughout the forecast period 20202030.

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The present research report performs segmentation of all the data gathered from the global stem cell manufacturing market into different sections. This segmentation is carried out based on many crucial parameters such application, product, end user, and region. Based on product, the market for stem cell manufacturing is classified into consumables, stem cell lines, and instruments.

Global Stem Cell Manufacturing Market: Growth Dynamics

Stem cells are used for various purposes such as clinical application, research applications, and cell and tissue banking applications. Thus, increased demand for the product from various end users including academic institutes, pharmaceutical and biotechnology companies, hospitals and surgical centers, cell and tissue banks, and research laboratories and contract research organizations is likely to generate lucrative avenues for vendors in the global stem cell manufacturing market in the years ahead.

Over the period of past few years, there is extensive growth in awareness pertaining to the therapeutic effectiveness of stem cells. This factor is working in favor of the expansion of the global stem cell manufacturing market. Owing to the restricted therapeutic treatment options for orphan diseases, there is considerable growth in investments toward stem cell-based technologies development by private as well as public stakeholders. This scenario is expected to help in rapid growth of the global stem cell manufacturing market in the years to come.

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Global Stem Cell Manufacturing Market: Competitive Analysis

Owing to presence of many active players, the nature of stem cell manufacturing market seems to be highly fragmented. It also denotes the high level of competition in the market for stem cell manufacturing. Thus to sustain in this high competitive scenario, enterprises are executing different strategic moves including collaborations, partnerships, mergers, acquisitions, agreements, joint ventures, and new product launches. Apart from growing financial support toward research and development activities, many players working in the stem cell manufacturing market are strengthening their production capabilities. On the back of all these moves, we can conclude that the global stem cell manufacturing market will expand at moderate pace throughout the assessment period 20202030.

Global Stem Cell Manufacturing Market: Notable Development

In May 2021, University of California, San Francisco and Thermo Fisher Scientific entered into strategic alliance. The main motive of this alliance was to open cell therapy cGMP manufacturing and collaboration center.The list of important players in the global stem cell manufacturing market includes:

Merck MilliporeThermo Fisher ScientificDanaher CorporationLonza Group AGBio-Rad LaboratoriesSartorius AGStemcell TechnologiesMiltenyi BiotecFujifilm Holdings CorporationCellgenix GMBHGlobal Stem Cell Manufacturing Market: Regional Assessment

In terms of region, the global stem cell manufacturing market is spread across many regions such as Europe, North America, Latin America, the Middle East and Africa, and Asia Pacific. Of these regions, North America is one of the prominent regions in the market for stem cell manufacturing. Key factor supporting this growth include extensive research and development in the region together with increased financial support by government as well as no-government organizations for the study of stem cell applications.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Manufacturing Market Global Industry Analysis , Scope, Opportunity and Forecast 2020 to 2030 The Courier - The Courier

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Actinium Activates Radiation Inside the Body for Target Conditioning of Cancer Cells – Yahoo Finance

By daniellenierenberg

Actinium Pharmaceuticals Inc. (NYSE: ATNM), a clinical-stage biopharmaceutical company, is developing antibody radiation-conjugates (ARCs) to combine the targeting ability of antibodies with the cell-killing ability of radiation. The Company is a leader in the targeted radiotherapy field for cancer patients who cant tolerate chemotherapy and radiation. Actiniums lead asset, Iomab-B, is currently being studied in a pivotal Phase 3 clinical trial.

Standing out in the Field of Target Conditioning

What makes Actinium unique is in its novel approach to treatment options for cancer patients. According to the National Cancer Institute (NCI) a conditioning regimen may include chemotherapy, monoclonal antibody therapy and radiation to the entire body. It supports the patient's body to make room in the bone marrow for new blood stem cells to grow, helps prevent the body from rejecting the transplanted cells and assists with killing any cancerous cells. Actiniums targeted radiotherapies are intended to be focused missiles that hit cancer directly as opposed to a broader chemoradiation therapy that can hit many other areas that do not need to be attacked with such harsh treatments.

Among its competitors, Actinium remains the only company with a pivotal Phase 3 trial for a targeting conditioning agent and the only anti-CD45 ARC in clinical development.

Multiphase Clinical Trials and the Success of Iomab-B

In the ongoing Phase 3 SIERRA trial, Actiniums lead asset lomab-B acts as an induction and conditioning agent in patients over the age of 55 with relapsed or refractory acute myeloid leukemia (AML) prior to receiving a bone marrow transplant, also known as a hematopoietic stem cell transplant.

This multicenter trial is being conducted at over 20 leading transplant centers in the U.S., including MD Anderson, Memorial Sloan Kettering and Mayo Clinic.

Of all patients who received a therapeutic dose of Iomab-B, 100% proceeded to bone marrow transplant and engrafted, which is the first sign of success in contrast to the control arm, where only 18% of patients were able to go to transplant and engraft. Its a clear, marked difference, commented Actinium CFO Steve O'Loughlin.

Story continues

Additionally, Iomab-B was very well-tolerated. Minimal adverse effects and minimal nonrelapse transplant mortality were reported compared to the control arm, OLoughlin concluded.

In addition to Iomab-B, Actiniums drug development pipeline features Iomab-ACT, a lower dose of Iomab-B that is being studied for target conditioning in advance of CAR-T, a form of cellular therapy that weaponizes patients immune cells to attack and kill their cancer. Actinium is collaborating with Sloan Kettering to study Iomab-ACT with the institutes CD19 CAR-T therapy 19-28z in a Phase 1 trial in patients with relapsed or refractory leukemia. Actinium and Sloan Kettering have been jointly awarded grant funding from the National Institute of Health via its STTR Fast Track program.

Actiniums other clinical program, Actimab-A, which has been studied in a Phase 2 clinical trial, is now being studied in two Phase 1 combination trials: one with the salvage chemotherapy regimen CLAG-M and the other with Ventoclax, a targeted therapy jointly developed and marketed by AbbVie and Roche. Actinium is focused on continuing to expand its drug development pipeline by leveraging its Antibody Warhead Enabling (AWE) technology platform.

The AWE Technology Platform

Actinium is the leader in Ac-225-based therapies, the most powerful medical-grade radioisotope. This is a result of the Companys clinical experience, technology, intellectual property and know-how. The clinical experience encompasses over 500 patients who have been treated with Actiniums ARCs and through its clinical trials.

Actinium's AWE technology platform is used to produce ARCs, a highly potent and selective form of targeted radiotherapy. ARCs enable the precision targeting of radiation to tumors and its synergistic potential with other therapeutic modalities that cannot be matched by traditional external beam radiation, cytotoxic chemotherapy or biologic therapies.

AWE-enabled ARCs exploit the use of highly-selective targeted biological agents such as monoclonal antibodies that can seek out and bind cancer antigens found on the tumor cell surface. They deliver potent radioisotopes that are capable of producing double-strand DNA breaks for which there are currently no known resistance or repair mechanisms.

Actinium announced a collaborative research partnership with Astellas Pharma in 2018 to leverage Actiniums AWE technology platform with select Astellas targeting agents. In 2021, Astellas announced this collaboration will be focused on leveraging its select targeting agents to both image and diagnose cancers. The goal is to treat patients with Actiniums AWE technology platform using the Ac-225 radioisotope warhead.

2021 and Beyond

In 2020, Actinium became a fully-integrated, targeted radiotherapy development company by securing laboratory facilities in New York City. These new research facilities function under the guidance of Dale Ludwig, Ph.D., the Company's chief scientific and technology officer, who has over 25 years of oncology discovery research and development experience.

Currently, the SIERRA trial is being conducted at preeminent transplant centers in the U.S., and the Company has begun patient enrollment in the Phase I study of Iomab-ACT for targeted conditioning before treatment in collaboration with Memorial Sloan Kettering Cancer Center. Additionally, Actinium completed enrollment of a second dose cohort in its Actimab-A Venetoclax combination trial for patients with R/R AML, making this a very exciting year for the Company.

Actinium has an IP portfolio of over 140 patents. As of March 31, 2021, the Company had a cash balance of $72 million and as of May 18, 2021, it had a market cap of approximately $156 million. Visit https://www.actiniumpharma.com/ for current news and more information.

Actinium is a partner of Benzinga. The information in this article does not represent the investment advice of Benzinga or its writers.

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2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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Hematopoietic Stem Cell Transplantation (HSCT) Market Competitive Analysis with Global Trends and Demand 2021 to 2028:ViaCord Inc, Cryo-Save AG, CBR…

By daniellenierenberg

Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size, Status And Forecast 2021-2028

MarketInsightsReports, a leading global market research firm, is pleased to announce its new report on Hematopoietic Stem Cell Transplantation (HSCT) market, forecast for 2021-2028, covering all aspects of the market and providing up-to-date data on current trends.

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis. The report also includes a detailed study of key companies to provide insights into business strategies adopted by various players in order to sustain competition in this highly competitive environment.

(Special Offer: Available Flat 30% Discount for a limited time only):Get a Free Sample Copy of the Report:https://www.marketinsightsreports.com/reports/06022956528/2016-2028-global-hematopoietic-stem-cell-transplantation-hsct-industry-market-research-report-segment-by-player-type-application-marketing-channel-and-region/inquiry?mode=dj

With our Hematopoietic Stem Cell Transplantation (HSCT) market research reports, we offer a comprehensive overview of this sector and its dynamics. We have done extensive research on this topic and are confident that our findings will be helpful for anyone who needs some guidance or direction when making important decisions related to their companys future growth strategy.

Top Companies in the Global Hematopoietic Stem Cell Transplantation (HSCT) Market: ViaCord Inc, Cryo-Save AG, CBR Systems Inc, Pluristem Therapeutics Inc, China Cord Blood Corp, Lonza Group Ltd, Escape Therapeutics Inc, Regen Biopharma Inc

This report segments the global Hematopoietic Stem Cell Transplantation (HSCT) market on the basis of Types are:

On the basis of Application, the Global Hematopoietic Stem Cell Transplantation (HSCT) market is segmented into:

For comprehensive understanding of market dynamics, the global Hematopoietic Stem Cell Transplantation (HSCT) market is analyzed across key geographies namely: United States, China, Europe, Japan, South-east Asia, India and others. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Key Takeaways from Hematopoietic Stem Cell Transplantation (HSCT) Report

Browse the report description and TOC: https://www.marketinsightsreports.com/reports/06022956528/2016-2028-global-hematopoietic-stem-cell-transplantation-hsct-industry-market-research-report-segment-by-player-type-application-marketing-channel-and-region?mode=dj

-Key Strategic Developments: The study also includes the key strategic developments of the market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.

-Key Market Features: The report evaluates key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin. In addition, the study offers a comprehensive study of the key market dynamics and their latest trends, along with pertinent market segments and sub-segments.

-Analytical Tools: The Global Hematopoietic Stem Cell Transplantation (HSCT) Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porters five forces analysis, SWOT analysis, feasibility study, and investment return analysis have been used to analyze the growth of the key players operating in the market.

Customization of the Report: This report can be customized as per your needs for additional data up to 3 companies or countries or 40 analyst hours.

MarketInsightsReports provides syndicated market research on industry verticals including Healthcare, Information and Communication Technology (ICT), Technology and Media, Chemicals, Materials, Energy, Heavy Industry, etc.MarketInsightsReports provides global and regional market intelligence coverage, a 360-degree market view which includes statistical forecasts, competitive landscape, detailed segmentation, key trends, and strategic recommendations.

How we have factored the effect of Covid-19 in our report:

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Brave Nathaniel Nabena, 9, all smiles as he has life-saving procedure – thanks to you – The Mirror

By daniellenierenberg

Brave Nathaniel Nabena smiles from his hospital bed moments before a life-saving procedure.

The nine-year-old had a vital stem cell transplant at Great Ormond Street Hospital on Wednesday after Sunday People readers helped raised more than 215,000.

Nathaniel, battling acute myeloid leukaemia, was on a drip for 30 minutes as umbilical cord stem cells were fed into his body.

Afterwards, dad Ebi said: Nathaniel is very happy. It was amazing to finally get to this point we have all been waiting for.

The youngster was admitted a fortnight ago and had five doses of chemo over ten days to prepare him for the procedure.

How brave has Nathaniel been? Have your say in comments below

Mum Modupe, 38, was able to spend time with him before his transplant.

Consultants warn he faces weeks of sickness as his body reacts to the new cells with symptoms including vomiting and a fever.

Ebi, 45, said: His doctors hope to see improvements after five weeks. It is so hard to see him so exhausted but I dont have a choice. We are grateful to have this done. Our fingers are crossed to see what happens.

For now, Nathaniel has a compromised immune system and is susceptible to falling ill, so he will be staying on the ward.

Stars including Simon Cowell, David Walliams, Katie Price and JLS singer Aston Merrygold rallied to support him after we told of the desperate race to fund treatment.

Nathaniels left eye was removed in his home country of Nigeria a year ago, due to myeloid sarcoma cancer. He was diagnosed with AML in the UK in November after coming here to have a prosthetic eye fitted.

Nathaniel was told a stem-cell transplant was his only hope for survival but it would cost 201,000 as he is not a British citizen. Ebi and Modupe were initially told it could cost as much as 825,000 but the figure was revised after doctors waived their fees and offered to treat him in their own time.

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The lad was admitted to GOSH on May 24 after generous Brits rushed to help the family raise cash.

Business analyst Ebi, who is staying at the hospitals family quarters, said: Ive been there the whole time. When he is not sleeping he is passing the time playing his games.

We sometimes talk about when he gets better and how exciting that will be. This is a difficult thing for him to go through, but Nathaniel is being brave, he is well in himself.

In acute myeloid leukaemia, unhealthy blood-forming stem cells grow quickly in the bone marrow.

This prevents it from making normal red blood cells, white blood cells and platelets meaning the body cannot fight infections or stop bleeding.

A stem cell transplant, also known as a bone marrow transplant, can help AML patients stimulate new bone marrow growth and restore the immune system.

Before treatment, patients need high doses of chemo and sometimes radiotherapy.

This destroys existing cancer and bone marrow cells and stops the immune system working, to cut the risk of transplant rejection.

In an allogeneic transplant, stem cells are taken from a family member, unrelated donor or umbilical cord blood. In Nathaniels case, it was from a cord.

They are then passed into the patients body through a line inserted in a large, central vein, in a process that takes up to two hours.

You can also remove stem cells from the patients body and transplant them later, after any damaged or diseased cells have been removed this is called an autologous transplant.

The survival rate after a transplant for patients with acute leukaemia in remission and using related donors is 55% to 68%, according to Medicine Net. If the donor is unrelated, it is 26% to 50%.

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BioRestorative Therapies to Present at the Emerging Growth Conference on June 9, 2021 – StreetInsider.com

By daniellenierenberg

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BioRestorative Therapies invites individual and institutional investors, as well as advisors and analysts, to attend its real-time, interactive presentation at the online Emerging Growth Conference.

MELVILLE, N.Y., June 07, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company or BioRestorative) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, is pleased to announce that it is has been invited to present at the online Emerging Growth Conference on June 9, 2021.

The Emerging Growth Conference will be held on June 9, 2021. This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Companys CEO, Lance Alstodt, and Vice President of Research and Development, Francisco Silva, in real time.

Mr. Alstodt will make a presentation and answer questions. Please ask your questions during the event and Mr. Alstodt will try to respond to as many as possible.

BioRestorative Therapies will be presenting at 10:45 AM Eastern time for 45 minutes.

Please register here to ensure you are able to attend the conference and receive any updates that are released:

https://goto.webcasts.com/starthere.jsp?ei=1469230&tp_key=f8b5116237&sti=brtx

If attendees are unable to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com, and the Company will also release a link to that site after the event.

About the Emerging Growth Conference

The Emerging Growth Conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conferences focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products and services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individuals and institutional investors, as well as investment advisors and analysts.

All sessions will be conducted through video webcasts and will take place in the Eastern time zone.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. Any forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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Regenerative medicine: moving next-gen treatments from lab to clinic – Pharmaceutical Technology

By daniellenierenberg

The investment in bolstering defences in virtual space also remains a top priority, as the pharmaceutical industry is extremely susceptible to cyber-attacks due to the involvement of sensitive and valuable data.

Several pharmaceutical companies and research institutes including Hammersmith Medicines Research in the UK, the University of California, San Francisco (UCSF), and US-based clinical services company eResearch Technology (ERT) remained targets for cyberattacks due to their involvement in the development of COVID-19 vaccines.

GlobalData conducted to survey to assess to extent to which emerging technologies such as cybersecurity will help a company survive through the Covid-19 pandemic.

Analysis of the results found that 54% of the respondents opined that cybersecurity would play a significant role in helping companies to pull through the crisis created by the pandemic.

Cybersecuritys Role During COVID-19 Crisis

Another 33% of the surveyed companies expect cybersecurity to play a minor role during the COVID-19 crisis.

Further, 10% of the companies stated that cybersecurity will play no role during the pandemic, while 3% of the respondents were unaware of the impact of cybersecurity.

The analysis is based on responses received in GlobalData, Emerging Technologies Survey 2020 fielded between 29 May and 09 July 2020.

Customised Viral Vectors for Cell Modelling, Gene Therapy, and Vaccination Research and Development

28 Aug 2020

Pharmaceutical-Grade Water Purification Systems for the Pharmaceutical and Biopharma Markets

28 Aug 2020

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Regenerative medicine: moving next-gen treatments from lab to clinic - Pharmaceutical Technology

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5 potential benefits of exosome treatment – AZ Big Media

By daniellenierenberg

For the better part of the 2000s, stem cell therapy ruled the public health conversation in the United States. The only thing that came close to supplanting it as the most controversial science and health topic was cloning.

These days, its normalized enough that people line up for treatments involving stem cells without giving it a second thought. Exosome treatment is one of the more popular varieties, and theres no wonder why. It has a broad range of benefits, many of which youll learn about if you read on.

Before COVID-19, the opioid epidemic was the biggest public health issue in the United States. As important as solving that issue is, it cut the number of options available to chronic pain patients.

Without effective treatment and accommodation, chronic pain affects mobility, mood, and relationships. It makes daily life and employment difficult. Suffering from it and the ensuing struggles can even lead to suicide.

The good news is that exosome therapy and other stem cell treatments lend some hope.

Arthritis is a common immune condition that causes great pain for many. Immune system disorders often involve miscommunication between cells. Exosomes primary function is communication, solving that issue, and boosting the immune system.

Joint inflammation is a key symptom of arthritis but exists in other forms, as well. Inflamed joints after injuries can end athletes seasons without proper treatment. Exosome therapy treats joint inflammation and pain, whatever the cause.

Surgery solves an endless range of ailments and helps achieve appearance goals. In terms of risk, theres never been a better time to get surgery. Laparoscopy, lasers, and robots are a few of many tools that reduce tissue damage.

Todays post-surgery therapies have folks back to regular activity faster than we imagined possible even a decade ago. Exosome treatment and other stem cell therapies are one way to restore function sooner than later.

No matter how advanced surgery gets or how effective rehab becomes, there are always risks. Issues with anesthesia, infections, and even freak accidents like surgeons sewing their equipment into patients bodies are all too common. The only way to remove these concerns is by avoiding surgery.

Exosome therapy is a non-invasive substitute for some operations. It doesnt come with the same risks or recovery period. Its also a great option for elderly people who cant risk surgery and folks with conditions that make it impossible.

Exosomes can turn around someones quality of life by solving a painful condition or restoring mobility. Theyre also useful for less pressing matters, such as restoring youthful looks.

Treatments like Botox and collagen injections arent long-lasting and can lead to adverse reactions. Because exosome therapy stimulates cell production, the body fills in wrinkles and restores skin elasticity. It doesnt come with the infamous stiffness of Botox and wont droop as dermal fillers can.

Anti-aging therapies arent a must for everyone, but they are for some, making this extra important.

Whether you think its right or not, we have high expectations for entertainers and models. Showing your age in some professions can push you out of your field. Using exosomes to reverse the aging process has a less artificial look than some other procedures and lasts longer, extending careers.

Medication is the most popular treatment for erectile dysfunction (ED), to the point that solutions have nicknames like the little blue pill. Despite pills popularity, they have several downsides.

The most popular ED meds have no long-term benefits: You rely on them for each sexual encounter. They can interact with other drugs and arent recommended for patients with certain conditions, such as heart disease and both high and low blood pressure.

ED pills also come with ugly side effects, including headaches and gastrointestinal distress.

Exosomes, on the other hand, have long-lasting results and no major side effects. Rather than providing a temporary fix, they help heal damaged nerves and tissues. This can increase how long erections last. For some, the method also boosts penile length and girth.

The treatment also helps people with conditions such as Peyronies disease, also known as PD. The main symptom is built-up scar tissue that results in a curved penis. Some PD patients cant have sex due to erectile dysfunction and/or pain.

That all can change for PD patients who undergo exosome therapy. The healing process awakens dormant cells and improves blood flow. It makes enjoyable sex possible again.

Bald is beautiful, but its not everyones cup of tea. Those who have a lot of pride in their hair may see their self-confidence tank when they go bald. It affects some folks sex lives, whether thats because their significant others dislike it or because they dont feel attractive and struggle to get in the mood.

For all of these reasons, theres an infinite range of treatments and has been pretty much since the beginning of recorded history. The grand majority of them never amounted to much, and some were downright nasty!

If youve tried everything from hair plugs to superstitious treatments without success, dont despair.

Exosome treatment is a modern solution for hair restoration, and its effective. Its not like treatments that try to mask hair loss or graft hairs from one part of the head to another. Instead, exosomes restore follicles so hair can grow again.

Expect to hear more and more about exosome treatment in the coming years. Its one of the most modern medical treatments available and continues growing due to its wide range of benefits.

If you want to learn about more of the latest and greatest science to make your life better and info to propel you to success, youre on the right website. Our articles are sure to inform and entertain, so click on another one and pick up new knowledge today.

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Scientists Working On Robot That Can Detect All Kinds Of Emotions In Hopes Of Helping Patients With Mental Health Disorders – CBS Miami

By daniellenierenberg

MIAMI (CBSMiami) Scientists are working to create a robot that can detect all kinds of emotions. They say the benefits could help patients with a range of mental health disorders.

The robot is called Abel, and it is learning to smile, snarl, and frown. Twenty motors under his artificial skin give the robot emotions just like us. Engineers hope someday Abel will be a friend for people with behavioral, social, or cognitive disorders like autism or Alzheimers.

We want Abel to know how people are feeling to keep them healthy, not just physically, but mentally and emotionally, researcher Lorenzo Cominelli said.

To make Abel look eerily real, engineers teamed up with special effects artist Gustav Hoegen. His company has created animatronics for Hollywood hits Star Wars and Jurassic Park.

Right now, someone has to wear sensors for the robot to recognize their emotions. The next step may seem like something out of science fiction. Researchers say they want to give Abel a human brain with the help of tissue taken from stem cells.

Organoids are basically an aggregate of stem cells which self-assemble and self-organize to resemble the structure and function of a mini-human organ, researcher Arti Ahluwalia said.

Scientists say that would allow Abel to read our expressions all on his own. And if theyre successful, expect the team and Abel to look a bit smug.

Researchers acknowledge they are years away from their goal, but they believe Abel will one day not only be able to recognize emotions on his own but be able feel them too.

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Scientists Working On Robot That Can Detect All Kinds Of Emotions In Hopes Of Helping Patients With Mental Health Disorders - CBS Miami

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Embryo research law requires updating to match up with science – Cleveland American

By daniellenierenberg

In March, Australian scientists announced a worldwide important model of an early human Embryo, blastoids, using skin cells. The finding was crucial because it enables researchers to explore the reasons for infertility, developmental abnormalities, and miscarriage in a period of human development that is not yet accessible without human embryos. The International Stem Cell Science Organization published.

In the past week of May, new criteria for early human life research are to be conducted. The International Stem Cell Research Society guidelines include current progress such as the iBlastoid models and offer several recommendations that assist scientists in understanding more about the early phases of human life. The procedures also include: There are also apparent indications, such as genetic tampering, of what should not be permitted.

The most significant proposal is to modify the 14-day limit, a regulatory line-in-the-sand that scientists cannot experiment with human embryos in Australia and nearly a dozen nations. The 14-day limit stems from the 1980s when human seeds could not be grown longer than roughly six days after fertilization. Although modern technology currently allows scientists to cultivate embryos beyond 14 days in the laboratory, the rule is that research to take them further has not taken place.

Why fourteen days? On day 14, a human embryo is no longer a cell ball. It develops the primitive stripe, the beginning of the neural cord, eventually leading to the central nervous system. At a period when embryo research was a reasonably novel notion with the twin advantage of creating confidence while at the same time allowing space for early human development study, the deadline offered total certainty. Since scientists can cultivate human embryos for longer, revisions to these standards have been called for a long time.

What restrictions can instead be established to manage research on human embryos? The recommendations suggest that researchers who wish to develop human briefings above the two-week mark should assess their project by case to determine when they have to terminate investigations, subject to many rounds of assessment. The recommendation of the ISSCR for embryos or models from human stem cells, like the blastoids produced by Professor Jose Polo with his colleagues at Monash University, is of particular relevance to Australian science.

The new rules declare because most laws worldwide do not regard such embryo models to be identical to human embryos that they are not subject to the 14-day rule limitations. This statement directly contradicts the guidelines with the Australian law of 2002, which defines an embryo not only as an egg and sperm product. But as an embryo created by any other process that initiates organized development of a biological entity with a human nuclear genome or an altering human nuclear genome that may develop.

iBlastoids can simulate several elements of embryo development, making it a fantastic study tool. However, they have sufficient molecular and cellular composition modifications that scientists see as differing from human embryos. However, under Australian laws, iBlastoids are subject to existing human embryo research regulations, including a research license and the fourteen-day limit, as the National Health and Medical Research Council decided. Australian iBlastoid research will require discussion on the concept of a human embryo and maybe regulatory reform under the latest international principles.

To identify reasons for ingratitude, developmental anomalies, and malfunction, we have operated with human embryos and human embryo models ethically and responsibly. A timely reminder is made of the complete and bold ISSCR standards, which frequently need a change in the legislation to comply with science and allow advances such as IVF to occur.

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The Creamiest, Dreamiest Way To Wash Your Face: 13 Must-Try Cleansing Balms – mindbodygreen.com

By daniellenierenberg

Every skin care fanatic has a favorite step of their routinethe layer of the ritual that brings them the most joy. And while I love the tender act of massaging in a dense face cream or slipping on an oil at night, there is nothing I appreciate more than washing my face. Yes, it's a semi-controversial skin care take (as controversial as those can be), but it's true: I love the ritual of cleaning my skin.

But face washes are a deceptively tricky category. For some time, the reigning options were of the strip-your-face variety. (You know the ones: Those sudsy numbers that left you feeling squeaky and dry.) But now, there are so many that experiment with textures, infuse deliciously hydrating actives, and elevate sensorial experiencesand finally, they're getting due attention.

There's no better example of this than the cleansing balm. (Even saying "cleansing balm" feels like slipping into a cashmere sweater.) The subcategory of face washes is marked by their thick, gel-cream texture and hydrating benefits; of course, there are subtle differences between them that make them unique, but that's the throughline.

Now, if all of the above has you thinking you need to get your hands on one, here are our favorites for you to try. Enjoy, won't you?

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Humanoid robot has super realistic facial expressions and it’s kind of eerie – KHOU.com

By daniellenierenberg

Abel has 20 motors under his human-like skin that allow him to show feelings just like us.

LONDON, UK Scientists in Italy are working to create a robot that can detect all kinds of emotions.

The robot is called Abel, and it is learning to smile, snarl, and frown. Twenty motors under his artificial skin give the robot "emotions" just like us. Engineers hope someday Abel will be a friend for people with behavioral, social, or cognitive disorders like autism or Alzheimer's.

Researcher Lorenzo Cominelli says, "We want Abel to know how people are feeling - to keep them healthy, not just physically, but mentally and emotionally."

To make Abel look eerily real, engineers teamed up with special effects artist Gustav Hoegen. His company has created animatronics for Hollywood hits "Star Wars" and "Jurassic Park."

Right now, someone has to wear sensors for the robot to recognize their emotions. The next step may seem like something out of science fiction. Researchers say they want to give Abel a human brain with the help of tissue taken from stem cells.

Researcher Arti Ahluwalia says, "Organoids are basically an aggregate of stem cells which self-assemble and self-organize to resemble the structure and function of a mini-human organ." Scientists say that would allow Abel to read our expressions all on his own. And if they're successful, expect the team and Abel to look a bit smug.

Researchers acknowledge they are years away from their goal, but they believe Abel will one day not only be able to recognize emotions on his own but be able feel them too.

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Humanoid robot has super realistic facial expressions and it's kind of eerie - KHOU.com

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Kiromic Announces Expansion of In-House Cell therapy cGMP Manufacturing Facility and the Appointment of Industry Veteran Ignacio Nez as Chief…

By daniellenierenberg

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (Nasdaq: KRBP)

Expansion of in-house cGMP manufacturing facility to provide support to the Company's clinical trials. Therapeutic doses expected to be ready for first in-human dosing in 3Q-2021.

Mr. Ignacio Nez, a 20-year industry veteran in global operations and manufacturing, is joining the Kiromic team to take the company to the next level and to scale up cGMP manufacturing capabilities internally.

Kiromic is an immuno-oncology company using Artificial Intelligence (AI) to identify critical markers in solid tumors to develop Allogeneic CAR-T cell therapy.

Kiromics CAR-T technology addresses critical efficacy and safety issues by developing switches to control T-cell activity reducing cell exhaustion and cytokine release syndrome among others.

-------------

Expansion of in-house cGMP manufacturing facility

In support of the upcoming INDs, Kiromic is expanding its HQ in Houston, TX. To their current cGMP, R&D labs, vivarium and offices, Kiromic is adding an adjacent space where more cGMP clean rooms, QC, QA and regulatory, offices and ultra-cold storage will have place.

This new expansion will add up to a total of approximately 30,000 square feet and will enable supporting Kiromic significant growth as the company approaches the clinical phase.

Appointment of Chief Operating and Manufacturing Officer

Mr. Ignacio Nez MSCHE, MBB has been appointed as Chief Operating Officer and Manufacturing Officer.

Mr. Nez will play a key role in expanding the scale up of Kiromics operations, including manufacturing, taking the company from pre-IND status to the clinical phase and eventually to commercial phase.

Mr. Nez has over 20 years of global experience in corporate functions including manufacturing, research, operational excellence and strategy. He has held senior leadership positions in companies including General Electric, Johnson & Johnson and Novartis. Most recently, he was the Executive Director of Manufacturing at the Gene Therapy Program of the University of Pennsylvania.

Before that, he was the Head of Manufacturing Strategy and Operations Excellence at Novartis, where he was charged with transforming manufacturing operations in support of the ramp up of Kymriah, the first FDA-approved CAR-T cell therapy, which was developed at the University of Pennsylvania.

Mr. Nez holds an MSC in Chemical Engineering from the University of Granada.

CEO of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs

Kiromic believes it has the key to resolve the current challenges in cell therapy and I believe we will become the reference and lead the industry going forward.

Cell Therapy Manufacturing: Autologous (patient) vs. Allogeneic (healthy donor)

The table below outlines the current cell therapy manufacturing challenges which Kiromic allogeneic cell manufacturing expects to resolve and which Mr. Nez will advance.

CAR-T technology challenges

AutologousCAR-T

KiromicAllogeneic

CAR-T

Safety

CRS

(cytokine release syndrome)

-

+

CRES

(T-cell related encephalopathy syndrome)

-

+

Efficacy

Efficacy

++

++++ (*)

Indication

BloodCancers

SolidTumors

T-cell overstimulation

-

+

T-cell exhaustion

-

+

Tumor immune suppressive microenvironment

-

+

Tumor specific antigens (shedding)

CD19

multipletargets

Manufacturing

Patients variation & manufacturing success

-

+

Lead time(autologous vs. off-the-shelf)

17-30 days

None

Cost of Manufacturing (per patient)

++++

+

Application

Order of treatment application

3rd Line

TBD

Treatment Setting

24 Daysin-patient

24 hoursin-patient (**)

(*) based upon Kiromic's pre-clinical projections, AACR posters (**) as filed in IND to the FDA (May 2021).

COMO of Kiromic, Mr. Ignacio Nez stated:

"I am impressed by Kiromics end-to-end approach to cell therapy as I believe they address almost every known issue in current cell therapies.

Expanded Kiromic in-house manufacturing capabilities are capital efficient and are optimized to deliver the capacity projections, making manufacturing a competitive advantage and not a challenge for the company.

I believe that this technology is meant to change the cell and gene therapy landscape, reshaping the future approach to cancer treatment.

I am humbled to join the team at this critical juncture."

CMO of Kiromic, Scott Dahlbeck, MD, PharmD stated:

Kiromic is pleased to obtain the clinical manufacturing expertise of Mr. Nez, whose expertise and biopharmaceutical background I believe will serve to capitalize on the cellular therapy production capabilities of Kiromic, leading to a new era in immuno-oncology treatments for solid tumors."

CSIO of Kiromic, Mr. Gianluca Rotino stated:

"I believe all of our cell therapy manufacturing is novel and resolves key industry challenges.

It is my opinion, that our manufacturing technology will be very much sought after by pharma companies and cell therapy industry players.

Our cell therapy IPs portfolio is very strong.

This manufacturing expansion and bringing Mr. Nunez to Kiromic are strategically important milestones that makes us ready to face the challenges of the clinical trials and puts us on the path of commercial viability of our novel therapy."

CFO of Kiromic, Mr. Tony Tontat stated:

"Capital efficiency is what we strove to deliver with our investments as we were building out our cGMP facility.

We are happy to receive this additional validation of capital efficiency from an industry veteran like Mr. Nez."

How Our KB-PD1 Live Cell Therapy CAR-T Improves CAR-T Market:

Marketed andtraditional CAR-T

Kiromic KB-PD1

Malignancies(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous

Live Cells from

pre-treatment patients

Allogeneic

Live Cells from

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Kiromic Announces Expansion of In-House Cell therapy cGMP Manufacturing Facility and the Appointment of Industry Veteran Ignacio Nez as Chief...

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Cryopreservation Media helps in Development of a Cell Therapy for Parkinson’s Disease – Microbioz India

By daniellenierenberg

AMSBIO reports upon a publication** that cites how its STEM-CELLBANKER animal-free cryopreservation media has played a role in the development of a cell therapy for Parkinsons Disease that will soon be going into clinical trials.

Parkinsons disease is one of the most common neurodegenerative diseases worldwide. Its main features include motor symptoms such as bradykinesia, rigidity, resting tremor, and postural instability, though non-motor symptoms are often also present. Currently the main therapy for Parkinsons disease consists of augmentation of dopamine levels in the brain via dopamine supplements or agonists or by inhibiting dopamine degradation. Treatment using this methodology is symptomatic but not long-lasting, and unfortunately has no neuroprotective effect. Cell therapy with grafts of human fetal tissue from the ventral mesencephalon have been carried out successfully, with multiple reports of long-term benefits.

A pioneering study from the Centre for Stem Cell Biology at the Memorial Sloan Kettering Cancer Centre (USA) has focused on developing stem cell-derived midbrain dopamine progenitors for the treatment of Parkinsons Disease. This study highlighted, amongst other things, that scientists have been able to demonstrate the efficacy of STEM-CELLBANKER to store, thaw and then recover these manufactured cells for clinical use in patients.

STEM-CELLBANKER is a ready-to-use, chemically defined, animal-free freezing medium manufactured under GMP conditions. It is optimized for embryonic stem (ES) and induced pluripotent stem (iPS) cell storage, as well as being a suitable solution for the cryopreservation of other fragile cell types. Containing only European or US Pharmacopoeia graded ingredients, STEM-CELLBANKER is the optimal choice for storage of cells developed for cell therapy applications. It is also available as a DMSO free formulation. STEM-CELLBANKER significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability after freeze-thaw. STEM-CELLBANKER is ready-to-use and requires no special devices, such as a controlled rate freezer, in order to achieve consistently high viabilities following resuscitation from cryopreservation, even over extended long-term storage.

To read the Parkinsons Disease cell therapy paper in full please visithttps://bit.ly/3eYwZ5L. For further information including a video introduction to STEM-CELLBANKER please visithttps://www.amsbio.com/stem-cell-cryopreservation/or contact AMSBIO on +44-1235-828200 / +1-617-945-5033 /info@amsbio.com.

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22nd Century Announces $40 Million Common Stock Registered Direct Offering

By Dr. Matthew Watson

Financing Provides Support to the Company’s Strategic Objectives Across All Its Plant Franchises. Financing Provides Support to the Company’s Strategic Objectives Across All Its Plant Franchises.

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BetterLife Closes $2.61 Million Marketed Public Offering

By Dr. Matthew Watson

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES

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22nd Century Advances Initiatives to Strengthen and Maximize Revenue Opportunities in Hemp/Cannabis Franchise

By Dr. Matthew Watson

BUFFALO, N.Y., June 07, 2021 (GLOBE NEWSWIRE) --  22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and hemp/cannabis research, today announced new initiatives to strengthen and maximize revenue opportunities in its hemp/cannabis franchise. Included in these developments is the announcement of strategic partnerships with two plant breeders in the northern and southern hemispheres providing the Company with year-round growing capabilities, close partnership activities being conducted with Aurora Cannabis, and the establishment of a newly created Canadian subsidiary. These newest developments further support 22nd Century’s plans for multiple avenues of hemp/cannabis revenue that will begin to be realized in late 2021.

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Déclaration d’actions et de droits de vote de la société Valneva SE – Mai 2021

By Dr. Matthew Watson

VALNEVA

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Monthly information related to total number of voting rights and shares composing the share capital – May 31, 2021

By Dr. Matthew Watson

Monthly information related to total number of voting rights and shares composing the share capital – May 31, 2021.

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Sanofi launches its new global employee share ownership plan

By Dr. Matthew Watson

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