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Why Biotechnology Companies Should Leverage Novel and Competitive Opportunities With CDMOs To Serve a Greater Population – Technology Networks
Posted: January 20, 2022 at 2:13 am
The acceleration of development and innovation in cell and gene therapy (CGT) together with greater fast-tracking of regulatory approvals has resulted in the CGT ecosystem being unable to keep pace with production, creating a global supply bottleneck. Whilst various alleviative solutions have been suggested, addressing viral vectors seems the most viable approach given the fundamental role they play in CGTs potential in particular CAR-T therapy to change lives. Indeed their true potential can only be unlocked if production and manufacturing costs are reduced, as this translates directly to lower patient costs and increased accessibility. Novel approaches must therefore be considered to ensure that patient-centricity remains the heart of the biotechnology (biotech) industry.
One such approach is to expand partnership focuses beyond incumbent contract development and manufacturing organisations (CDMOs) to explore collaborations with new market entrants. This might mean broadening horizons to less traditional production regions, such as the Asia-Pacific region. Usually smaller and nimbler, these CDMOs are more adept at innovation and reducing costs via faster, more effective processes. Strategic global positioning can also offer competitive savings and distributive advantages, making treatments more accessible not just to directly proximate regions, but worldwide. This approach would diversify geographical production areas, potentially reducing bottlenecks, and enable better fulfilment of the industrys ethos to reach, treat and heal the greatest number of people in the most efficient manner possible.
Given the complexities of vector manufacturing, there are always concerns around compromising quality when reducing costs. However, there are a few ways biotechs can alleviate these. Firstly, they can identify CDMOs which have obtained government conformity assessment certifications in environments with robust regulatory frameworks. This provides a basic guarantee of quality assurance and compliance.
Secondly, they can evaluate whether the CDMOs have a demonstrable commitment to addressing existing CGT barriers through technological innovation. For instance, some believe that early intervention initiatives at the production and manufacturing stages are key to cost reduction through embracing a process is the product approach. In doing so, they avoid the need for costly regulatory approvals for any process modifications which are also time-consuming when done downstream. Incorporating compliance into the process can therefore result in significant savings. Additionally, because cost-cutting is a priority at every stage, these CDMOs make attempts to holistically streamline their operational developments, such as using Benzonase endonuclease as an alternative to expensive enzymes traditionally used in novel suspension processes.
CDMOs which manufacture in-house (as some niche organisations do) are also able to achieve high process consistency through optimizing helper and packaging construct expression to upstream and downstream processes, all whilst maintaining high titre and high purity. With these advanced in-house capabilities, they can also support small biotechs and research institutes (who often lack these systems) to transition into the vector delivery system by designing their vectors to yield high titre products. This further enables production scaling and overcoming genetic instabilities, which can then lead to meaningful opportunities such as the ability to address commonly occurring cancers.
Some up-and-coming CDMOs have the additional ability to customize and tailor treatments to order, which ensures that product quality is maintained and even enhanced. Whilst autologous products are often associated with higher costs, these CDMOs use techniques such as first-expired-first-out (FEFO) to manage inventory and manufacture only what is needed, thus avoiding the stockpiling of pre-ordered raw materials or excess stock and reducing inventory loss by up to 40 percent. They also consistently invest in business improvements to enhance efficiency like digitalizing the management of supply chains and make procurement decisions using their subject-matter expertise, such as timing orders based on the projected shelf life of materials. This maximizes their capacity for on-time delivery, further translating into lower costs and improved treatment accessibility for patients.
A final and pertinent consideration of working with nimbler, more niche CDMOs who actively innovate at every stage of production is the speed at which they enable treatments to reach patient bedsides. Through technological innovation, they can reduce production times to two weeks instead of the industrys standard of one month or more. This is a huge advantage due to the significance of shortened time frames of treatment accessibility in saving lives, especially where chronic and serious diseases are concerned. Faster production times also translate to a reduction of manpower and consumable costs, making it both a competitive and humanitarian advantage for biotechs to work with CDMOs that possess this agility and flexibility.
Chronic diseases have been on an upward trajectory worldwide. That, along with greater healthcare awareness (especially after the pandemic), has resulted in more investments in this space globally including in CDMOs. With an expected market growth of 8.4 percent between 2021 to 2026, CDMOs are therefore well-positioned in the upcoming years to deliver patient-centric solutions and leverage geographical advantages in tandem with savvy biotechnology partners.
For example, over 4.5 billion people (59.5 percent of the global population) reside in Asia. Unsurprisingly, the region also has some of the highest numbers of chronic disease patients and deaths; in 2020, 58.3 percent of global cancer deaths are estimated to have occurred in Asia. These sombre statistics display, catalyze and heighten the urgent need for expedient and targeted treatments, along with equitable access for those that might be unable to afford it.
With larger incumbents typically based in the West, CDMOs based in the Asia-Pacific region have the competitive advantage of being able to cater to a large, underserved population on their doorstep and further enhance distributive efforts in the worlds most populous region. Besides lower transport and distribution costs, biotechnology companies can also benefit from other inherent cost-saving advantages such as these CDMOs having access to a large, skilled workforce and reduced costs in research and development This can translate to a lower cost of production and empower distribution further impacting accessibility favourably not just in underserved regions, but worldwide.
Given the projected market growth is 22.3 percent for 2021 to 2026, the promising future of CGT will play an increasingly important role in addressing some of humanitys most problematic diseases. As populations and healthcare awareness grow, it is important to democratize access for all who need it not just those who can afford it.
Biotechnology companies have a major role to play in realizing this ideal scenario. It is thus imperative for them to look beyond traditional solutions and explore partnership opportunities with smaller, more agile CDMOs, which will pave the way for them to achieve new breakthroughs in alleviating the supply bottleneck issue and enhancing patient accessibility in diverse geographical regions.
Whilst these partnerships might require a leap of faith for some biotechnology companies in venturing beyond traditional comfort zones, embracing collaborations with smaller CDMOs encourages healthy competition and accelerates industry growth. Most importantly, it moves the industry closer towards achieving its overarching mission to deliver effective treatment to patients in the most expedient and humanitarian manner possible.
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Does Clal Biotechnology Industries (TLV:CBI) Have A Healthy Balance Sheet? – Simply Wall St
Posted: January 20, 2022 at 2:13 am
Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of permanent loss is the risk I worry about... and every practical investor I know worries about.' So it might be obvious that you need to consider debt, when you think about how risky any given stock is, because too much debt can sink a company. Importantly, Clal Biotechnology Industries Ltd. (TLV:CBI) does carry debt. But the real question is whether this debt is making the company risky.
Debt and other liabilities become risky for a business when it cannot easily fulfill those obligations, either with free cash flow or by raising capital at an attractive price. Part and parcel of capitalism is the process of 'creative destruction' where failed businesses are mercilessly liquidated by their bankers. However, a more usual (but still expensive) situation is where a company must dilute shareholders at a cheap share price simply to get debt under control. Of course, plenty of companies use debt to fund growth, without any negative consequences. When we examine debt levels, we first consider both cash and debt levels, together.
View our latest analysis for Clal Biotechnology Industries
You can click the graphic below for the historical numbers, but it shows that Clal Biotechnology Industries had 40.2m of debt in September 2021, down from 42.7m, one year before. However, it does have 84.8m in cash offsetting this, leading to net cash of 44.7m.
According to the last reported balance sheet, Clal Biotechnology Industries had liabilities of 34.7m due within 12 months, and liabilities of 77.0m due beyond 12 months. Offsetting these obligations, it had cash of 84.8m as well as receivables valued at 6.54m due within 12 months. So its liabilities total 20.3m more than the combination of its cash and short-term receivables.
Given Clal Biotechnology Industries has a market capitalization of 211.4m, it's hard to believe these liabilities pose much threat. But there are sufficient liabilities that we would certainly recommend shareholders continue to monitor the balance sheet, going forward. Despite its noteworthy liabilities, Clal Biotechnology Industries boasts net cash, so it's fair to say it does not have a heavy debt load! When analysing debt levels, the balance sheet is the obvious place to start. But it is Clal Biotechnology Industries's earnings that will influence how the balance sheet holds up in the future. So when considering debt, it's definitely worth looking at the earnings trend. Click here for an interactive snapshot.
Over 12 months, Clal Biotechnology Industries reported revenue of 82m, which is a gain of 14%, although it did not report any earnings before interest and tax. That rate of growth is a bit slow for our taste, but it takes all types to make a world.
While Clal Biotechnology Industries lost money on an earnings before interest and tax (EBIT) level, it actually booked a paper profit of 59m. So when you consider it has net cash, along with the statutory profit, the stock probably isn't as risky as it might seem, at least in the short term. Until we see some positive EBIT, we're a bit cautious of the stock, not least because of the rather modest revenue growth. There's no doubt that we learn most about debt from the balance sheet. However, not all investment risk resides within the balance sheet - far from it. To that end, you should learn about the 3 warning signs we've spotted with Clal Biotechnology Industries (including 1 which is concerning) .
If you're interested in investing in businesses that can grow profits without the burden of debt, then check out this free list of growing businesses that have net cash on the balance sheet.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
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Does Clal Biotechnology Industries (TLV:CBI) Have A Healthy Balance Sheet? - Simply Wall St
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PDS BIOTECHNOLOGY CORP : Change in Directors or Principal Officers, Submission of Matters to a Vote of Security Holders, Financial Statements and…
Posted: January 20, 2022 at 2:13 am
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
PDS Biotechnology Corporation (the "Company") held a special meeting ofstockholders on January 19, 2022 (the "Special Meeting").
As previously disclosed, on December 8, 2020, the Board of Directors of theCompany (the "Board") approved the Second Amended and Restated PDS BiotechnologyCorporation 2014 Equity Inventive Plan (the "2014 Plan"), subject to stockholderapproval at the Company's 2021 annual meeting of stockholders (the "2021 AnnualMeeting of Stockholders"). The 2014 Plan was previously submitted forconsideration by the Company's stockholders at the 2021 Annual Meeting ofStockholders. At the 2021 Annual Meeting of Stockholders, the Company determinedthat the proposal to approve the 2014 Plan received the requisite number ofvotes for approval. As part of this determination, broker non-votes were treatedas having no effect on the outcome of this proposal. Following the 2021 AnnualMeeting of Stockholders, a complaint (the "Complaint") was filed in the Court ofChancery of the State of Delaware (C.A. No. 2021-0644 JRS) against the Company,certain executive officers of the Company, and the members of the Board, inwhich it was alleged that, under the voting standard contained in the Company'sbylaws in effect at the time of the 2021 Annual Meeting of Stockholders, brokernon-votes should have been treated as a vote "AGAINST" the proposal. If thebroker non-votes were treated as a vote "AGAINST," the proposal would not havebeen approved at the 2021 Annual Meeting of Stockholders.
Although the Company does not believe that the interpretation reflected in theComplaint regarding the bylaws of the Company that were in effect as of the timeof the 2021 Annual Meeting of Stockholders was correct, in an effort to resolveany ambiguity regarding the approval of the 2014 Plan at the 2021 Annual Meetingof Stockholders raised by the Complaint, the Company asked its stockholders, atthe Special Meeting, to ratify the prior approval of the 2014 Plan, which wasadopted at the 2021 Annual Meeting of Stockholders.
At the Special Meeting, the stockholders of the Company voted in favor of theratification of the prior approval of the 2014 Plan, which was adopted at the2021 Annual Meeting of Stockholders. A copy of the 2014 Plan is filed asExhibit 10.1 hereto and is incorporated by reference herein.
Item 5.07 Submission of Matters to a Vote of Security Holders.
At the Special Meeting, the following proposal was submitted to the stockholdersof the Company: a proposal to ratify the prior approval of the Second Amendedand Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan, which wasadopted at the Company's 2021 annual meeting of stockholders.
For more information about the foregoing proposal, see the Company's definitiveproxy statement on Schedule 14A filed with the United States Securities andExchange Commission on December 16, 2021. Of the 28,437,940 shares of theCompany's common stock entitled to vote at the Special Meeting, 15,698,729shares, or approximately 55.20%, were represented at the Special Meeting inperson or by proxy, constituting a quorum.
The number of votes cast for, against or withheld, as well as abstentions inrespect of the proposal is set forth below.
Proposal 1: Ratification of the prior approval of the Second Amended and Restated
The Company's stockholders ratified the prior approval of the Second Amended andRestated PDS Biotechnology Corporation 2014 Equity Incentive Plan, which wasadopted at the Company's 2021 annual meeting of stockholders. The votesregarding this proposal were as follows:
Votes For Votes Against Votes Abstaining Broker Non-Votes14,471,905 1,046,389 180,435
Item 9.01 Financial Statements and Exhibits.
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Global Biotechnology-Based Chemical Market Analysis, Opportunities and Forecast To 2021-2029 Discovery Sports Media – Discovery Sports Media
Posted: January 20, 2022 at 2:13 am
A detailed market study of the Biotechnology-Based Chemical market examines the performance of the market. It includes an in-depth study of market conditions and the global competitive landscape. This report analyzes the market potential in detail, both in the present and future prospects.
Biotechnology-Based Chemical Market Analysis to 2029 is a professional and in-depth study of the industry with a focus on the global market trends. The report aims to provide an overview of the global market with detailed market segments by product type, component, application, and region. The global market is expected to grow significantly during the forecast period. The report provides vital statistics on the market status of key market players and suggests key trends and opportunities in the market.
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First, the report provides a basic overview of the Biotechnology-Based Chemical market including definitions, applications and manufacturing technology. The market report then scrutinizes China and its leading international players. The report is segmented into key industry, region, type and application. Global Market 2021 research report covers all major regions and sub-regions across the globe and focuses on product sales, value, size and growth opportunities in those regions.
This market research report details the global Biotechnology-Based Chemical market. It highlights recent market scenarios, growth over past years, and opportunities for manufacturers in the future. The research methods and tools used to complete this study are primary and secondary studies. The study also provides details on investments initiated by several organizations, institutions, governments and non-governmental organizations.
The market grew at a steady pace in 2021, as the negative global impact of the coronavirus has already taken place, which significantly impacted the Biotechnology-Based Chemical market. However, the market is expected to grow rapidly in the post-COVID-19 period. The report further investigates and assesses the current situation in the ever-evolving business sector, as well as the current and future impact of COVID-19 on the market.
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Global Chromatography Biotechnology Instrumentation Market Research Report Forecast 2021-2029 Discovery Sports Media – Discovery Sports Media
Posted: January 20, 2022 at 2:13 am
The Global Chromatography Biotechnology Instrumentation Market Research Report Forecast 2021-2029 is a valuable source of insightful data for business strategists. It provides the Chromatography Biotechnology Instrumentation industry overview with growth analysis and historical & futuristic cost, revenue, demand and supply data (as applicable). The research analysts provide an elaborate description of the value chain and its distributor analysis. This Chromatography Biotechnology Instrumentation market study provides comprehensive data which enhances the understanding, scope and application of this report.The recently released report byMarket Research Inc on Global Chromatography Biotechnology Instrumentation Market comprises the entire market as well as the industry. The analysts carefully analyze the market scenario and provide data such as the market dynamics, qualitative and qualitative analysis, the market size, segmentation of the market, factors driving in the market, market restraints, and the major key players of the market, geographical analysis, the overall market estimations and latest developments as well as changes that have taken place in the market.Get Your Sample Report At Given Link: https://marketresearchinc.com/request-sample.php?id=5899
The research gives an idea how to aim at your targeted customers needs and wants. It also reveals how effectively a company can make their requirements. The conclusions provided in this report are of great value for the leading industry players. Every organization partaking in the global production of the Chromatography Biotechnology Instrumentation products have been mentioned in this report.List of Key Players in This Market:* Agilent Technologies* Beckman Coulter* Bio-Rad Laboratories* Gilson* HitachiBased on Region:North AmericaEuropeAsia-PacificLatin AmericaMiddle East & AfricaGrab discount on the report: https://marketresearchinc.com/ask-for-discount.php?id=5899Reasons Why You Should Buy This ReportThe report provides a deep understanding of the market drivers as well as the restraintsA reader can gain intense knowledge of the latest market trends as well developmentsThe market revenue, size as well as CAGR is provided in the reportImpact of COVID-19 as well as how the market is functioning post-CoVID-19
This research on Chromatography Biotechnology Instrumentation report provides information about market regions, which are further broken down into sub regions and countries.In addition to marketin each country and sub-region, this chapter of this report also contains information about profit opportunities. This chapter of the report mentions the share and market growth rate of each region, country, and sub-region in the estimated time period.
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Table of Contents:Introduction, Definition, Specifications, Classification and Scope the Chromatography Biotechnology Instrumentation market 2021Exclusive Summary like Industry chain structure, Manufacturer cost structure, suppliers, etcDisplays Trends, Drivers and Challenges of the Chromatography Biotechnology Instrumentation marketBy the study of SWOT analysis it displays sales analysis, investment analysis, market analysis, etcIt evaluates the market by segments, by countries and by manufacturers with revenue, share and sales by key countries in these various regions.Evaluate the leading manufacturers of the Global Chromatography Biotechnology Instrumentation market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company ProfileChromatography Biotechnology Instrumentation Research Findings and Conclusion, Appendix, system and information sourceAbout UsMarket Research Inc is farsighted in its view and covers massive ground in global research. Local or global, we keep a close check on both markets. Trends and concurrent assessments sometimes overlap and influence the other. When we say market intelligence, we mean a deep and well-informed insight into your products, market, marketing, competitors, and customers. Market research companies are leading the way in nurturing global thought leadership. We help your product/service become the best they can with our informed approach.Contact UsMarket Research Inc.Author:KevinUS Address: 51 Yerba Buena Lane, Ground Suite,Inner Sunset San Francisco, CA 94103, USACall Us:+1 (628) 225-1818Write Us:sales@marketresearchinc.com
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Vir Biotechnology Launches New Antibody Research Initiative Aimed at a Functional Cure for HIV and Prevention of Malaria – Yahoo Finance
Posted: January 20, 2022 at 2:13 am
New commitment from the Bill & Melinda Gates Foundation supports the development of Virs novel vaccinal antibody technology as another important step in the fight to address global infectious diseases
SAN FRANCISCO, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced an expansion of its partnership with the Bill & Melinda Gates Foundation to include the advancement of innovative platform technologies in the development of broadly neutralizing antibodies designed to provide a vaccinal effect for the treatment of HIV and prevention of malaria. This novel program combines Virs extensive immunologic and virologic expertise with the Gates Foundations long-standing global health leadership to address two of the worlds most challenging infectious diseases.
Virs partnership with the Bill & Melinda Gates Foundation has been a formative and essential part of our company history beginning with our T-cell vaccine program targeting HIV and tuberculosis. This expanded collaboration into a second platform technology supports our shared goal of developing innovative solutions for prevention and treatment of global infectious diseases. We look forward to applying the lessons learned thus far in COVID-19, chronic hepatitis B virus infection and influenza to advance our efforts toward curing HIV and preventing malaria, said George Scangos, Ph.D., chief executive officer of Vir Biotechnology.
The new initiative includes a clinical proof-of-concept trial designed to evaluate the potential impact of broadly neutralizing antibodies engineered to inhibit viral replication and spread in people infected with HIV, as well as their ability to confer a vaccine-like effect that could be applicable to durable antiretroviral therapy (ART)-free suppression of HIV. Additional preclinical research is planned to assess the potential role of this technology in preventing malaria. The vaccinal antibody concept is currently being applied across Virs pipeline of potential SARS-CoV-2, chronic hepatitis B virus (HBV), and influenza A product candidates, and will now be used to address other infectious diseases with high impact in low- and middle-income countries (LMICs).
Story continues
Even though HIV has gone from being a near-term fatal disease to a chronic condition for those who have access to effective antiviral therapies, there remains a significant unmet need for new advances that could enable durable antiretroviral-free suppression of HIV. The foundation is pleased to support the development of this novel vaccinal antibody technology that has the potential to result in such suppression and is committed to advancing access to this cutting-edge innovation globally, said Mike McCune, M.D., Ph.D., head of the HIV Frontiers Program at the Gates Foundation.
To support this effort, the Gates Foundation has committed a $40 million equity investment and a $10 million grant. The program-related equity investment is being made through its $2.5 billion Strategic Investment Fund (SIF), which aims to stimulate private sector-driven innovation, encourage market-driven efficiencies, and attract external capital to priority global health and development initiatives that improve the health and wellbeing of underserved people around the world. Any financial returns generated by SIF are re-invested in Gates Foundation philanthropic programs.
About Vir BiotechnologyVir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit http://www.vir.bio.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising, and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, Virs collaboration with the Bill & Melinda Gates Foundation and the potential application of Virs antibody-engineering platform technology to enhance the therapeutic and prophylactic efficacy of monoclonal antibodies for HIV and malaria. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development, and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in, or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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Institute for Bioscience and Biotechnology Research Receives $16.8 M Investment from the National Institute of Standards and Technology – PRNewswire
Posted: January 20, 2022 at 2:13 am
ROCKVILLE, Md., Jan. 13, 2022 /PRNewswire/ -- The Institute for Bioscience and Biotechnology Research (IBBR) announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology (NIST) headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino (NIST). This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges.
IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines.This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers.
"Trusting in and funding research makes it possible to find solutions to address major health and scientific challenges, and to prepare for the unknown," said Bruce E. Jarrell, MD, FACS, President of the University of Maryland, Baltimore (UMB). "UMB has invested heavily in operational support and high-end instruments for IBBR in support of the NIST relationship. I am very pleased to see that the long-standing NIST collaboration will continue."
As part of the new agreement, NIST provided state-of-the-art equipment for the "IBBR Commons"a highly sophisticated research space shared with researchers throughout Maryland and the nation.For example, NIST recently partnered with Maryland to establish the Maryland Center for Advanced Molecular Analysis (M-CAMA) that established new cryo-electron (cryoEM) instruments and facilities to be used by NIST and researchers in Maryland for the timely development of new therapies and vaccines.
"IBBR has long provided the critical link necessary to bring together researchers across disciplines to address major health challenges and help strengthen the state's economic base in bioscience and biotechnology," said Darryll J. Pines, Ph.D., President of the University of Maryland, College Park. "I am so pleased this collaboration between NIST and the University of Maryland, Baltimore and the University of Maryland, College Park remains strong, and I look forward to seeing the innovations it will lead to in the future."
IBBR was established by the University System of Maryland Board of Regents in 2010, building on and integrating previous partnerships between the University of Maryland and NIST that date back to 1984. The institute connects dozens of experts from interrelated fields of study with the common goal of accomplishing world-class interdisciplinary research that can lead to real-world advances like drug discovery, more effective vaccines, and disease prevention and treatment.
"Achieving truly groundbreaking results in fields like bioscience and biotechnology requires a wide array of resources, perspectives and expertisefrom pharmaceutical and biotech companies to academic and government institutions, to foundations and NGOs," said Jennifer King Rice, Ph.D., Senior Vice President and Provost of the University of Maryland, College Park. "What makes IBBR so unique and impactful is its ability to stand in the center of this circle of voices as the catalyst for collaborative and impactful work."
"Having this important cooperative agreement with NIST enables us to develop and share the most sophisticated and advanced instrumentation for use in the discovery, development and manufacturing of safe and effective new medicines to treat human diseaseincluding, most recently, for COVID19," said E. Albert Reece, MD, Ph.D., MBA, Executive Vice President for Medical Affairs at the University of Maryland, Baltimore and the John Z. and Akiko K. Bowers Distinguished Professor and Dean of the University of Maryland School of Medicine.
About IBBRIBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore, and the National Institute of Standards and Technology (NIST). IBBR brings together critical elements necessary to inspire transformative discoveries in the field of bioscience and biotechnology and provides innovative solutions to major scientific and engineering challenges important to society.IBBR researchers seek to advance the fields of biomedical research, therapeutic development, biomedical manufacturing, and state-of-the-art measurement technologies, to support accelerated delivery of safe and effective medicines to the public.IBBR is financially supported in part by the University of Maryland Strategic Partnership: MPowering the State, an initiative designed to achieve innovation and impact through collaboration.
For more information, contact:Nicole TenlyInstitute for Bioscience and Biotechnology ResearchUniversity of Maryland9600 Gudelsky Drive | Rockville, MD | 20850[emailprotected] | 240.314.6209
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Risk of heart disease raised in patients with diabetes, says research by Rajiv Gandhi Centre for Biotechnology – The Hindu
Posted: January 20, 2022 at 2:13 am
Researchers at the Rajiv Gandhi Centre for Biotechnology (RGCB) here have published findings that could help reduce the risk of heart disease in patients with diabetes.
The researchers have pinpointed Cyclophilin A, a protein that plays a role in several diseases in humans, as a potential drug target for reducing heart disease risk in such patients.
Heart attacks result from the rupture of cholesterol plaque deposited on artery walls. A tear or rupture activates a repairing mechanism resulting in a blood clot. Such clots can block blood flow to the heart muscle, causing a heart attack.
"Patients with diabetes mellitus have increased risk of vascular disease and are prone to such ruptures. Our research has shown that Cyclophilin A plays a major role in increasing the risk," Dr. Surya Ramachandran, a programme scientist with the Cardiovascular Diseases and Diabetes Biology lab, RGCB, was quoted as saying in a statement issued by the RGCB.
Inhibitors of Cyclophilin A would have potential use in reducing a persons vulnerability to heart attacks induced by plaque rupture, she said.
RGCB director Prof. Chandrabhas Narayana said the research findings with regard to the role played by Cyclophilin A will provide a better understanding of the molecular mechanisms underlying cardiovascular diseases. It will help in risk detection and development of novel pharmacological therapies, he said.
The findings have been published in Cells, an international journal on cell biology.
Cyclophilin A impairs the process of prompt and efficient clearance of cells that have been programmed to die, resulting in rapid plaque formation in patients with Type 2 diabetes mellitus, said Dr. Ramachandran. Clearing the dead cells is critical for inflammation resolution in patients with cardiovascular risks.
The dying cells express eat-me signals on their surface to attract macrophages, a type of white blood cell that removes dead cells. Cyclophilin A can induce programmed cell death of macrophages, which interferes with the natural process of burying of the dead cells.
Dr. Ramachandran said the research findings can lead to a reduction in the risk of heart disease in patients with diabetes.
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Global Biotechnology Media, Sera and Reagents Market to Eyewitness Massive Growth with type, applications, by 2022-2027 Discovery Sports Media -…
Posted: January 20, 2022 at 2:13 am
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Global Biotechnology Media, Sera and Reagents Market to Eyewitness Massive Growth with type, applications, by 2022-2027 Discovery Sports Media -...
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Anebulo Pharmaceuticals Names Biotechnology Industry Executive Simon Allen as CEO and Director – BioSpace
Posted: January 5, 2022 at 2:50 am
Jan. 4, 2022 12:00 UTC
AUSTIN, Texas--(BUSINESS WIRE)-- Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, has named Simon Allen as Chief Executive Officer and a member of the companys Board of Directors, effective February 1st, 2022. Mr. Allen succeeds Daniel Schneeberger, MD, who has resigned as CEO and as a Director as of that same date.
Since March 2019, Mr. Allen has served as Chief Business Officer of Ambrx Biopharma Inc. (NYSE: AMAM), a position he previously held from 2010 through 2015. Ambrx is an engineered precision biologics company developing antibody-drug conjugate and immune-oncology conjugate candidates for breast cancer, gastric cancer and other solid tumors.
I am so very proud of all Anebulo has achieved over the past 18 months, including building out a highly effective team, securing new intellectual property protection, preparing and starting a proof-of-concept clinical trial, advancing regulatory discussions with the U.S. FDA and securing financing through a successful IPO, said Dr. Schneeberger. Simon is a tremendous leader with significant commercial and business development experience, which are the most relevant skills for Anebulo at this stage. Having taken Anebulo through its start-up phase, I now plan to focus full time on my investment fund. I thank the Anebulo Board and all its employees for their collaboration and friendship.
Anebulo is ideally positioned to address the significant harm and burden of substance abuse. Our lead product, ANEB-001, has the potential to rapidly reverse the effects of acute cannabinoid intoxication, a relatively unknown yet serious affliction that sends more than 5,000 Americans to the hospital emergency department every day. Unfortunately, this number is expected to increase rapidly with legalized marijuana and access to substances that have five times the THC concentration of regular marijuana, said Mr. Allen. We are currently focused on developing the first FDA-approved therapy for emergency department physicians to treat the serious and sometimes fatal effects of cannabinoid intoxication. I am very impressed with the clear mechanism of action of ANEB-001 and the companys successful efforts to navigate the clinical, regulatory, CMC and intellectual property aspects of this opportunity. I also believe 2022 will be another transformative year for Anebulo given our plans to report topline results from our ongoing Phase 2 trial in the first half of the year. I am honored and grateful for the opportunity to lead such a talented team and look forward to taking Anebulo to the next level.
Joseph Lawler, MD, PhD, Chairman of the Anebulo Board of Directors, added, Simon is a tremendously accomplished business executive who brings to Anebulo the skills, experience and relationships necessary to advance our business plan rapidly and efficiently. I welcome him to our company and to our Board of Directors. Also, I would like to thank Daniel for leading Anebulo through a time of great progress. All of us at Anebulo wish him well in his future professional endeavors.
At Ambrx, Mr. Allen established multiple partnerships with companies including Bristol Myers Squibb, Pfizer, Merck, Eli Lilly, Astellas, BeiGene and Sino Biopharma that have generated more than $270 million in revenue with a potential $1 billion in future milestones and royalties. From 2016 to 2018 he was Chief Executive Officer of CohBar, where he transitioned the company from the preclinical to the clinical stage and managed the listing of its shares on Nasdaq, with subsequent inclusion in the Russell 2000 Index. Earlier Mr. Allen held various management, commercial and business development positions at Nuvelo, Skyepharma, CovX and Kalypsys.
Mr. Allen started his career as a research biologist in the antiviral group at Gilead Sciences before working in healthcare equity research and investment banking in the U.S. and Australia. He holds a BSc in biochemistry and genetics from the University of Sydney and an MBA from the Australian Graduate School of Management.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. For further information about Anebulo, please visit http://www.anebulo.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, along with terms such as anticipate, expect, intend, may, will, should and other comparable terms, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of Anebulo Pharmaceuticals and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including risks attendant to developing, testing and commercializing the companys product candidates, and those described in Anebulo Pharmaceuticals most recent annual report on Form 10-K and in other periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, Anebulo Pharmaceuticals undertakes no obligation to update or revise forward-looking statements to reflect changed conditions.
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