Monthly Archives: June 2022

Tiziana Life Sciences to Present at the 2022 Biotechnology Innovation Organization Annual Convention to Discuss Recent Updates to Ongoing Clinical…

Posted: June 13, 2022 at 2:19 am

Tiziana Life Sciences Plc

NEW YORK, June 06, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (NASDAQ: TLSA) ("Tiziana" or the "Company"), a clinical-stage biopharmaceutical company enabling breakthrough immunotherapies via novel routes of administration today announced that its Chief Executive Officer and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will present at the Biotechnology Innovation Organization (BIO) Annual Convention taking place at the San Diego Convention Center, Monday June 13 - Thursday, June 16, 2022. His presentation will be primarily focused on the recent clinical updates on nasal administration of foralumab, a fully human anti-CD3 monoclonal antibody, for treatment of patients with secondary progressive multiple sclerosis. He will also provide an update on the initiation of Phase 1b trial with first-ever oral capsules of foralumab for treatment of patients with mild-to-moderately active Crohns Disease. Company management will also be participating in one-on-one meetings throughout the conference.

Presentation Information

Presenter: Kunwar Shailubhai, Ph.D., Chief Executive Officer and Chief Scientific Officer, Tiziana Life SciencesTitle: Enabling Breakthrough Immunotherapies via Novel Routes of Drug Delivery

Day: Tuesday, June 14thTime: 2:00- 2:15 pm PDTLocation: Theater 1

To register for the conference and schedule a one-on-one meeting with Tiziana Life Sciences management, please visit https://www.bio.org/events/bio-international-convention/registration.

Dr. Shailubhai will also attend the BioNJ 29th Annual Dinner Meeting and Innovation Celebration, gathering and honoring members of New Jerseys life science ecosystem, on Thursday, June 9, 2022 at 4:45 pm EDT. This meeting, taking place at the Hilton in East Brunswick New Jersey, was originally planned for February, and was postponed due to the surge of the Omicron variant.

About BIO and the BIO International ConventionThe Biotechnology Innovation Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. Our mission is to be the champion of biotechnology and the advocate for our member organizationsboth large and small. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. Corporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. We also represent state and regional biotech associations, service providers to the industry and academic centers. Currently there are over 3,000+ international and domestic companies registered to attend BIO 2022 across the biotech industry.

Story continues

About BioNJFounded in 1994, BioNJ, the New Jersey partner of BIO, has been hard at work in its mission to enhance the climate for life sciences in the State. As the representative of an industry that has the potential to change the course of human health, make our environment cleaner and the foods we eat safer and healthier, BioNJ is single-minded in its commitment to the growth and prosperity of this industry within the state of New Jersey.

About Tiziana Life SciencesTiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tizianas innovative intranasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tizianas two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tizianas technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For further information please contact:

Tiziana Life Sciences:Hana Malik, Business Development and Investor Relations Manager +44 (0) 207 495 2379email:info@tizianalifesciences.com

United States:

Investors:Irina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

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FG Urged to Adopt Biotechnology in Agriculture to Save Economy – Economic Confidential

Posted: June 13, 2022 at 2:19 am

Real Life Global Humanitarian Affairs Foundation has urged the federal government to utilise biotechnology for increased yields through genetic modified seeds and prevent importation of food products.

According to Daily Trust report, Engr Akinsola Akinsoji, the National Coordinator of Real Life, stated that the increased rate of insecurity had deterred farmers from accessing their farmlands, but that biotech could help to secure food security in the country.

Akinsoji added that with South Africa earning over $600m from genetic modified seeds in 20 years, it could be replicated in Nigeria and help widen the governments revenue.

Also Read: Free Trade Zones Contributes N29bn Tax In 2 Years NEZA

He said, For some reasons we are yet to adopt technology in our farms even as modernised farming is yet to kick-start in large scale, but without the adoption of technology, we will not be able to feed Nigerians. We all know what happened when the border was shut against rice.

He further said the use of the modified cowpea seed in the country was slow due to opposition by producers of pesticides, but pointed out that larger economic value would increase revenue base if farmers and government adopted biotech.

On whether farmers can afford it, he stated that the seeds were readily available to the farmers and that they didnt have to spend much money on it.

The government has already established the National Biotechnology Development Agency (NABDA) and they are working assiduously to make sure that the technology is made simple for every Nigerian. Our work is to break it down to the people. Farmers do not have the economic power and understanding, so we get training from the agencies and take it to them in their local languages.

Source: Daily Trust

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Animal Health Biotechnology Market 2022- Analysis and In-Depth Research on Market Size, Trends, Emerging Growth Factors and Forecast To 2030 – Digital…

Posted: June 13, 2022 at 2:19 am

The new report on Animal Health Biotechnology Market Report 2022 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2030 offered by Market Research, Inc. includes a comprehensive analysis of the market size, geographical landscape along with the revenue estimation of the industry. In addition, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Animal Health Biotechnology Market.

Biotechnology utilized in animal healthcare dates back to 19th century when the first vaccines were prepared for its use in animals. Considerable progress in the animal health biotechnology took place recently when biotechnology applications were utilized in both detecting and treating various infectious and parasitic diseases of animals.

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This market study covers and analyzes the potential of the global Animal Health Biotechnology industry, providing geometric information about market dynamics, growth factors, major challenges, PEST analysis and market entry strategy analysis, opportunities and forecasts. One of the major highpoints of the report is to provide companies in the industry with a strategic analysis of the impact of COVID-19 on Animal Health Biotechnology market.

Animal Health Biotechnology Market: Competition Landscape

The Animal Health Biotechnology market report includes information on the product presentations, sustainability and prospects of leading player including: Bayer AG, Merck & Co.Inc., Pfizer Inc., Sanofi, Santa Cruz Biotechnology

Animal Health Biotechnology Market: Segmentation

By Types

By Applications

Animal Health Biotechnology Market: Regional Analysis

All the regional segmentation has been studied based on recent and future trends and the market is forecasted throughout the prediction period. The countries covered in the regional analysis of the Global Animal Health Biotechnology market report are North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and Latin America.

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Major Points Covered in TOC:

Market Summary: It incorporates six sections, research scope, major producers covered, market segments by type, Animal Health Biotechnology market segments by application, study goals, and years considered.

Market Landscape: Here, the global Animal Health Biotechnology Market is dissected, by value, income, deals, and piece of the pie by organization, market rate, cutthroat circumstances landscape, and most recent patterns, consolidation, development, and segments of the overall industry of top organizations.

Profiles of Companies: Here, driving players of the worldwide Animal Health Biotechnology market are considered dependent on deals region, key items, net income, cost, and creation.

Market Status and Outlook by Region: In this segment, the report examines about net edge, deals, income and creation, portion of the overall industry, CAGR and market size by locale. Here, the worldwide Animal Health Biotechnology Market is profoundly examined based on areas and nations like North America, Europe, Asia Pacific, Latin America and the MEA.

Application: This segment of the exploration study shows how extraordinary end-client/application sections add to the worldwide Animal Health Biotechnology Market.

Market Forecast: Production Side: In this piece of the report, the creators have zeroed in on creation and creation esteem conjecture, key makers gauge and creation and creation esteem estimate by type.

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Next-Generation Sequencing Market Competitive Landscape, Revenue, Growth, Statistics, and Biotechnology Industry Analysis Report by 2028||Thermo…

Posted: June 13, 2022 at 2:19 am

Global Next Generation Sequencing Marketis valued atUSD 8156.4 Million in 2020and is expected to reachUSD 26762.5 Million by 2027with aCAGR of 18.5%over the forecast period.

Increasing number of cancer patients and growing research and developmentin this field are the significant factors that are driving the growth of the Global Next Generation Sequencing Market.

Scope of Next Generation SequencingMarket Report

Next-generation sequencing (NGS) is any of several high throughput approaches of DNA sequencing using the concept of massively parallel processing. Many NGS platforms differ on the basis of engineering configurations and sequencing chemistry.

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Next-Generation Sequencing Companies

Global next-generation sequencing market report covers prominent players are Thermo Fisher Scientific, Illumina, PerkinElmer, BGI Group, Agilent Technologies, Bio-Rad Laboratories, Eurofins GATC Biotech GmbH, DNASTAR lnc., Genomatrix GmbH, Oxford Nanopore Technologies, F. Hoffman-La Roche Ltd., QIAGEN, and others.

GlobalNext Generation Sequencing Market Segmentation:

By Type of Sequencing:

By Product Type

By Technology:

By Application:

By End-User:

News:

Ancestry Launched New Next Generation Sequencing Tool

On August 5th, 2020; Consumer genomic company Ancestry launched a new product dubbed Ancestry Health powered by NGS. This product will screen users for the genes associated with breast cancer, colon cancer, blood disorders and heart diseases. The service was developed by Quest Diagnostics and price of it is $179. This tool can examine harder-to-sequence variants of the human genome than traditional microarray tech. Now, consumers are spending less on nonessential items so, the hefty price tags of DTC genetic tests will likely drive consumers further away from these products. This tool could help patients cut back on meteoric costs associated with chronic illness by allowing for earlier intervention.

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North America

Europe

Asia-Pacific

Latin America

Middle EastandAfrica

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Synthetic Biology Market Size, Scope and Forecast | Cyrus Biotechnology Inc. (US), Intrexon Corporation (US), GenScript Biotech Corporation (China),…

Posted: June 13, 2022 at 2:19 am

New Jersey, United States The reports goal is to provide a detailed analysis of the Synthetic Biology Market. The study involves a study of complicated data in simple manner, as well as the industrys past and current state, as well as anticipated market size and trends. The report examines all areas of the industry, with a focus on significant companies such as big players, followers, and newcomers.

The research includes a PORTER, PESTEL analysis as well as the possible influence of microeconomic market elements. External and internal factors that are expected to make a positive or negative impact on the industry have been examined, providing decision-makers with a clear futuristic vision of the industry.

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Key Players Mentioned in the Synthetic Biology Market Research Report:

Cyrus Biotechnology Inc. (U.S.), Intrexon Corporation (U.S.), GenScript Biotech Corporation (China), Integrated DNA Technologies, Inc. (U.S.), New England Biolabs (U.S.), Thermo Fisher Scientific Inc. (U.S.), Merck KGaA (Germany), Synthetic Genomics, Inc. (U.S.), Codexis, Inc. (U.S.), Synthego Corporation (U.S.) among others.

By studying market segments and evaluating worldwide Synthetic Biology market size, the research also aids in understanding the Synthetic Biology market dynamics and structure. The research will be a full guide with a clear picture of competition analysis of key competitors in the worldwide Synthetic Biology market by product, price, cash flows, product line, strategic initiatives, and regional presence.

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Synthetic BiologyMarket Segmentation:

Synthetic Biology Market, By Product

Core Products Enabling Products

Synthetic Biology Market, By Technology

Gene Synthesis Genome Engineering Cloning Sequencing Site-directed Mutagenesis Measurement and Modeling Microfluidics Nanotechnology Bioinformatics

Synthetic Biology Market, By Application

Medical Application Pharmaceuticals Drug Discovery and Therapeutics Artificial Tissue and Tissue Regeneration Industrial Applications Biofuel and Renewable Energy Food & Agriculture Others

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Synthetic Biology Market Report Scope

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6. What will be the CAGR and size of the Synthetic Biology market throughout the forecast period?

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Spectrometry Market will grow at a CAGR of 6.4 % by 2028, Owing to Rising Demand from the Pharmaceutical and Biotechnology Industries; Fact. MR…

Posted: June 13, 2022 at 2:19 am

Increase in the Use of Spectrometry Devices in Various End-Use Industries and Rise in Technological Advancements in the Field Of Spectrometry Are Driving Market Growth, Reveals Fact.MR

Growing demand for new and enhanced instruments, increased focus on research and development in the healthcare industry, and rise in the number of contract research organizations (CROs) are some of the factors expected to boost spectrometry market growth over the coming years.

Fact.MR, a Market Research and Competitive Intelligence Provider - Fact.MR, a market research and competitive intelligence provider, has conducted a comprehensive analysis on the global spectrometry market, which is expected to rise at a CAGR of 6.4% over the forecast period (2021 to 2028).

Spectrometry instruments are used for a variety of applications in a wide range of end-use industries, including environmental testing, research, and the food and beverage industry. As a result, increased demand for these devices across various sectors is likely to propel the worldwide spectrometry market forward throughout the forecast period.

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Government organizations across the world have laid down strict rules for monitoring water and soil samples. This is contributing to increased sales of spectrometry devices, which is driving the global spectrometry market.

Because of their capacity to provide several benefits, such as increased imaging quality, portable and handheld spectrometry equipment are gaining enormous popularity in a wide range of end-use sectors. Furthermore, these devices are becoming more widely used since they help with on-site sample analysis. Growing demand for spectrometry instruments is supported by the strict regulatory environment governing the monitoring of soil and water samples.

What are the Reasons for the Rapid Growth of the Spectrometry Market?

Continuous Innovation in Spectrometry Technique to Augment Market Growth

Spectrometry techniques make use of cutting-edge technology. The innovation in handheld and portable instruments necessary for spectrometry processes is driving the worldwide spectrometry market. These devices have better imaging quality and can be used in sample analysis. It saves the time and effort required to carry heavy and bulky samples to laboratories for chemical examination.

Drug testing and drug discovery, food quality control, carbon dating, environmental testing, and defence industries all use these handheld and portable spectrometry equipment. The global spectrometer market is expected to increase because of the increasing use of spectrometry equipment in clinical research, protein identification, tissue analysis, proteomics, and toxicology.

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Key Takeaways from Spectrometry Market Study

Competitive Landscape

Key players in the spectrometry industry are focusing on offering improved solutions to maintain growth. Companies have a diverse and technologically advanced product portfolio as well as a wide global presence.

For instance,

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Winning Strategy

Players are putting more emphasis on R&D in order to increase the analytical efficiency of their product offerings. Companies in the worldwide spectrometry market are putting in more money into the development of technologically advanced products.

A large number of market participants also use tactics such as agreements, collaborations, and acquisitions to expand their product portfolios and geographic presence in the market.

New product releases, product approvals, and product upgrades are the core growth strategies employed by major players to increase their positions in the global spectrometry industry.

For instance,

Fact.MRs Domain Expertise in Healthcare Sector

Our healthcare consulting team guides organizations at each step of their business strategy by helping you understand how the latest influencers account for operational and strategic transformation in the healthcare sector. Our expertise in recognizing the challenges and trends impacting the global healthcare industry provides indispensable insights and support - encasing a strategic perspective that helps you identify critical issues and devise appropriate solutions.

Insulin Delivery Devices Market- The global insulin delivery devices market is expected to foray ahead at a healthy CAGR of 7% over a forecast period of 2020-2030. Analyzing through the market lens, it is expected to climb up in terms of revenue, to US$ 14 billion by the end of FY 2020.

Injection Pen Market- The sales of injection pens have considerably picked up in the last couple of years, as they have become a widely accepted treatment method to address a broad spectrum of medical considers.

Swab and Viral Transport Medium Market- Demand in the swab and viral and transport medium market has witnessed remarkable upsurge in the recent past, as the number of tests and laboratory experiments are registering an unprecedented high during the COVID-19 pandemic.

Medical Gases and Equipment Market- The global medical gasses and equipment market will continue exhibiting a steady growth. The demand is poised to surge even as COVID-19 outbreak tightens its noose around the world.

Medical Suction Devices Market- According to the US Census Bureau, the geriatric population is increasing at an accelerated rate. This is anticipated to act as a key driver for growth of the global medical suction devices market, which is projected to exhibit a CAGR of around 4% over the forecast period 2020-2030.

Contraceptives Market- Demand for contraceptives to register a robust 6.4% CAGR during the forecast period (2020-2025). The global contraceptives market shall surpass a valuation of US$ 37 Billion by the end of 2025.

Dental Restoratives Market- The dental restoratives market is projected to expand at a robust CAGR of 6.8% during the forecast period. The prevalence and severity of dental decay has waned over the past few years. Dental care needs have engendered a significant shift in the nature of dental care services- from conventional restorative care to cosmetic and preventive services.

Ornithine Transcarbamylase Deficiency Treatment Market- Ornithine transcarbamylase (OTC) deficiency is a genetic disorder arising due to inadequate levels of OTC, an enzyme that helps decompose and eliminate unwanted nitrogen from the human body. This process is also known as the urea cycle.

Medical Holography Market- The medical holography market was valued at US$ 447.8 Million in 2019 and is projected to reach a value pool US$ 3.5 Billion by 2026, registering a stellar CAGR of 34.0% throughout the forecast period. This is in response to increasing demand for medical holography imaging.

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Spectrometry Market will grow at a CAGR of 6.4 % by 2028, Owing to Rising Demand from the Pharmaceutical and Biotechnology Industries; Fact. MR...

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Digital Genome Engineering Market Size and Industry Analysis 2022 : Biotechnology Revolution to Boom the Digital Genome Business with Latest Research…

Posted: June 13, 2022 at 2:19 am

Digital Genome Engineering Market Size and Share is Estimated to Growth by US$ 60.35 at CAGR 11.1% during Forecast period 2028

This press release was orginally distributed by SBWire

Londan, United kingdom (SBWIRE) 06/06/2022 Digital Genome Engineering is a comprehensive digital set of genetic material that occurs in a cell or an organism. It allows experts to get a nearer look at genetic disorders, with instant access to sequence data and tools to resolve unending custom queries. Thus, the aforementioned parameters will augment the market growth. Digital Genome Engineering deals with genes & their functions and assists in finding causes behind chronic disorders and also to resolve them. This technology has sparked a revolt in invention-centred research & systems biology to expedite insight of the most complex genetic systems.

The global Digital Genome Engineering market research report provides an in-depth analysis of the existing and future state of the industry. The study comprises all market data and is based on extensive primary and secondary research. Statistics by type, industry, channel, and other parameters are included in the analysis, as well as market volume and value for each category. The coronavirus pandemic has an influence on the global economy. Several market conditions have shifted. The market is fast evolving, according to the study report, and its influence is being studied both now and in the future.

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The study offers exact figures for the industry's market size, share, production capacity, demand, and growth for the anticipated year. This is the most recent market effect analysis research for COVID-19. The Digital Genome Engineering market research looks at the market's top businesses, distributors, and the entire structure of the industrial chain. It also evaluates the aspects and criteria that may have an impact on market expansion.

The Major Key Company Profiles included in Digital Genome Engineering market study are:

-Abbott Laboratories-Agilent Technologies Inc-Becton, Dickinson and Company-Biomerieux SA-Bio-rad Laboratories Inc-Roche-Illumina Inc-Inscripta-Oxford Nanopore Technologies Ltd-Pacific Bioscience-Perkinelmer Inc-Qiagen NV-Regeneron Pharmaceuticals-Thermo Fisher Scientific Inc

Market Segmentation

The research looks on the industry's growth goals, cost awareness, and manufacturing procedures. Market segmentation by product type, application, end-user, and geography is discussed in the Digital Genome Engineering research report. A basic industry overview, as well as categorization, definition, and, as a result, the supply and demand chain structure, are included in the market study. Global research includes global marketing data, competitive climate surveys, growth rates, and critical development status information.

Russia-Ukraine War Impact on Digital Genome Engineering Market

The impact of the Russia-Ukraine conflict on the worldwide market is covered in the research study. While tensions between Russia and Ukraine have been increasing for years, the present military action heightens fears of a long-term conflict within Ukraine, as well as market and global economic implications. The market research report covers whether this ongoing conflict is making any of on target market or not.

The Digital Genome Engineering Market Segments and Sub-Segments are Listed Below:

Segmentation by type:

-Miss Target Assessment-Target Efficiency Prediction-Typing Efficiency Prediction-Measurement of Editing Efficiency of Target Genome-Other

Segmentation by application:

-Hospital-Research Institute-Institutions of Higher Learning

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Regional Analysis

From production and consumer ratios to market size and market share, import and export ratios, supply and demand, consumer demand ratios, technological advancements, research and development, infrastructure development, economic growth, and a strong market presence in every region, research covers everything. Geographic study will assist players in discovering profitable markets where they may capitalize on fresh opportunities. The Digital Genome Engineering market is divided into five regions: North America, Latin America, Europe, Asia Pacific, and the Rest of the World.

Competitive Outlook

The research report covers financial conditions, global positioning, product portfolios, income and gross profit margins, as well as technology and research breakthroughs. The Digital Genome Engineering market research focuses on the industry's most notable acquisitions, collaborations, and product launches. To provide deeper insights into key players, the study report incorporates modern research approaches such as SWOT and Porter's Five Forces analysis. The study provides a comprehensive assessment of the global competitive climate as well as critical insights into the major competitors and their expansion plans.

Table of Contents Major Key Points

1 Scope of the Report2 Executive Summary3 Digital Genome Engineering Market Size by Player4 Digital Genome Engineering by Regions5 Americas6 APAC7 Europe8 Middle East & Africa9 Market Drivers, Challenges and Trends10 Global Digital Genome Engineering Market Forecast11 Key Players Analysis12 Research Findings and Conclusion

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Research-based biopharmaceutical industry on the TRIPS waiver discussions at WTO Ministerial Conference (MC12) – IFPMA

Posted: June 13, 2022 at 2:19 am

Published on: 09 June 2022

The associations representing the global research-based biopharmaceutical industry reaffirm that weakening the intellectual property (IP) framework as proposed in the Quad compromise is unnecessary and harmful to innovation. An IP waiver does not address inequitable access to COVID-19 vaccines and will put global health security at risk. It will undermine innovation and industrys ability to partner, invest at risk, and respond quickly to future pandemics.

Industry has worked around the clock, taking a business NOT as usual approach to tackling the COVID-19 pandemic, focusing significant resources to push the boundaries of science, develop workable solutions and secure the capacity to scale up manufacturing once solutions were found, while at the same time ensuring patients would continue to receive existing medicines. This resulted in the fastest ever vaccine development and authorization (in just 326 days).

Despite these strides in science and manufacturing, for the past 18 months, the World Trade Organization (WTO) Member States have been discussing various ways to weaken the IP framework. To this day, there is no evidence that IP has been a barrier to COVID-19 vaccine production or access, nor acknowledgment of the critical role IP has played in the research, development, and production of novel, safe, and effective vaccines and therapeutics.

From the outset of the pandemic, industry knew that it would need to scale up quickly, seeking to build capacity before approvals were granted, partnering wherever possible, all while pledging to not compromise on quality, safety and efficacy[1]. To date, industry has entered into 381 partnerships for COVID-19 vaccines and 150 for COVID-19 therapeutics, of which over 88% and 79%, respectively, involve technology transfer. IP protections allowed for years of research and investment at risk to bear fruit and today we have 11 vaccines with WHO Emergency Use Listing and 36 therapeutics approved across the world.[2] Biopharmaceutical companies continue to research and invest. Academia and industry have 659 (192 in clinical phase) vaccine candidates and 1,706 (885 in clinical phase) therapeutic candidates in the pipeline.[3]

By May 2021, less than six months after the first vaccine authorization, monthly production output was close to a billion vaccine doses;[4] enough to vaccinate the world if countries were willing and able to share. At that time, industry called on governments to remove trade restrictions, share doses and prepare health systems to roll out vaccinations (5 steps to urgently advance COVID-19 vaccine equity), a message repeated in March 2022 when critical bottlenecks in vaccine delivery and administration, often linked to weak healthcare systems, were becoming even more evident (Three Priorities to Urgently Increase COVID-19 Vaccine Access). Today, it is universally recognized that COVID-19 vaccine supply is not the barrier to access with global vaccine production capacity vastly exceeding demand and doses needed to inoculate and provide boosters to the world.

During this pandemic, there have been many lessons learned that can improve equitable access for future pandemics.[5] We must redouble our collective efforts to achieve health equity, while ensuring health systems and delivery infrastructure are strengthened. COVID-19 vaccines and treatments were only possible because of decades-long investment in research and an enabling IP framework that encouraged swift, voluntary partnerships across the private, public, and academic sectors.

The TRIPS waiver discussion lacks evidence and the IP framework has fallen victim of political posturing. This week, as the WTO meets for the 12th Ministerial Conference, leaders must keep in mind that weakening the IP framework will jeopardize global health security. A much better approach is to focus on the real challenges to COVID-19 vaccine access including removing trade barriers, addressing distribution challenges, strengthening healthcare systems, and partnering to drive innovation and access.

Contact:

Guilherme Cintra, Director, Innovation Policy: g.cintra@ifpma.org

Komal Kalha, Associate Director, Intellectual Property & Trade Policy: k.kalha@ifpma.org

Abigail Jones, Director, Communications: a.jones@ifpma.org

###

About

The Association of the British Pharmaceutical Industry (ABPI) exists to make the UK the best place in the world to research, develop and use new medicines. We represent companies of all sizes who invest in discovering the medicines of the future.Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines.Every day, we partner with organisations in the life sciences community and beyond to transform lives across the UK.

TheBiotechnologyInnovationOrganization(BIO) is the worlds largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

The European Federation of Pharmaceutical Industries and Associations(EFPIA) represents the biopharmaceutical industry operating in Europe.Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and agrowingnumber of small and medium-sized enterprises (SMEs), EFPIAs mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

Innovative Medicines Canada is the national association representing the voice of Canadas innovative pharmaceutical industry. The association advocates for policies that enable the discovery, development, and delivery of innovative medicines and vaccines to improve the lives of all Canadians and supports the members commitment to being a valued partner in the Canadian healthcare system. The association represents 49 companies who invest nearly $1.4 billion in R&D annually, fueling Canadas knowledge-based economy, while contributing $8 billion to Canadas economy. Guided by the Code of Ethical Practices, all members work with governments, private payers, healthcare professionals, and stakeholders in a highly ethical manner.

The International Council of Biotechnology Associations (ICBA) is a coalition of nonprofit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries. The ICBA represents the global voice of the industry in international fora with the goal of promoting continued innovation in the human health, agriculture, and industrial and environmental sectors.

The International Federation of Pharmaceutical Manufacturers and Associations(IFPMA) represents research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industrys 2 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.

TheJapan Pharmaceutical Manufacturers Association (JPMA)is a voluntary association comprising 73 research-oriented pharmaceutical companies. JPMA has been contributing to advancing global healthcare through the development of innovative ethical drugs, facilitating sound development of the pharmaceutical industry through proactively establishing policies and recommendations in response to globalization and enhancing public understanding of pharmaceuticals.

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the countrys leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $1 trillion in the search for new treatments and cures, including $91.1 billion in 2020 alone.

Vaccines Europewas created in 1991 to provide a voice for the vaccine industry in Europe. The group represents vaccine companies of all sizes operating in Europe, and currently includes all the major global innovative and research-based vaccine companies, including small and medium-sized enterprises.

[1] https://www.ifpma.org/wp-content/uploads/2020/09/COVID-19_Vaccine_Maker_Pledge.pdf

[2] https://covid19.trackvaccines.org/agency/who/

[3] https://www.efpia.eu/media/637039/efpia-vaccines-infographic-may-2022-1.pdf

[4] Note: Global monthly production of COVID-19 vaccines reached 0.83 bn doses in May 2021, 1.2 bn doses in June 2021, 1.2 bn doses in July 2021. Source: IFPMA analysis based on Airfinity data, available at: https://science.airfinity.com/

[5] https://www.ifpma.org/wp-content/uploads/2022/05/IFPMA_COVID-19_Pandemic_Lessons_Learned_May_2022.pdf

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Research-based biopharmaceutical industry on the TRIPS waiver discussions at WTO Ministerial Conference (MC12) - IFPMA

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Fasting triggers stem cell regeneration of damaged, old immune system …

Posted: June 13, 2022 at 2:16 am

In the first evidence of a natural intervention triggering stem cell-based regeneration of an organ or system, a study in the June 5 issue of the Cell Stem Cell shows that cycles of prolonged fasting not only protect against immune system damage a major side effect of chemotherapy but also induce immune system regeneration, shifting stem cells from a dormant state to a state of self-renewal.

In both mice and a Phase 1 human clinical trial involving patients receiving chemotherapy, long periods of not eating significantly lowered white blood cell counts. In mice, fasting cycles then flipped a regenerative switch, changing the signaling pathways for hematopoietic stem cells, which are responsible for the generation of blood and immune systems, the research showed.

The study has major implications for healthier aging, in which immune system decline contributes to increased susceptibility to disease as people age. By outlining how prolonged fasting cycles periods of no food for two to four days at a time over the course of six months kill older and damaged immune cells and generate new ones, the research also has implications for chemotherapy tolerance and for those with a wide range of immune system deficiencies, including autoimmunity disorders.

We could not predict that prolonged fasting would have such a remarkable effect in promoting stem cell-based regeneration of the hematopoietic system, said corresponding author Valter Longo, Edna M. Jones Professor of Gerontology and the Biological Sciences at the USC Davis School of Gerontologyand director of the USC Longevity Institute. Longo has a joint appointment at the USC Dornsife College of Letters, Arts and Sciences.

When you starve, the system tries to save energy, and one of the things it can do to save energy is to recycle a lot of the immune cells that are not needed, especially those that may be damaged, Longo said. What we started noticing in both our human work and animal work is that the white blood cell count goes down with prolonged fasting. Then when you re-feed, the blood cells come back. So we started thinking, well, where does it come from?

Prolonged fasting forces the body to use stores of glucose, fat and ketones, but it also breaks down a significant portion of white blood cells. Longo likens the effect to lightening a plane of excess cargo.

During each cycle of fasting, this depletion of white blood cells induces changes that trigger stem cell-based regeneration of new immune system cells. In particular, prolonged fasting reduced the enzyme PKA, an effect previously discovered by the Longo team to extend longevity in simple organisms and which has been linked in other research to the regulation of stem cell self-renewal and pluripotency that is, the potential for one cell to develop into many different cell types. Prolonged fasting also lowered levels of IGF-1, a growth-factor hormone that Longo and others have linked to aging, tumor progression and cancer risk.

PKA is the key gene that needs to shut down in order for these stem cells to switch into regenerative mode. It gives the OK for stem cells to go ahead and begin proliferating and rebuild the entire system, explained Longo, noting the potential of clinical applications that mimic the effects of prolonged fasting to rejuvenate the immune system. And the good news is that the body got rid of the parts of the system that might be damaged or old, the inefficient parts, during the fasting. Now, if you start with a system heavily damaged by chemotherapy or aging, fasting cycles can generate, literally, a new immune system.

Prolonged fasting also protected against toxicity in a pilot clinical trial in which a small group of patients fasted for a 72-hour period prior to chemotherapy, extending Longos influential past research.

While chemotherapy saves lives, it causes significant collateral damage to the immune system. The results of this study suggest that fasting may mitigate some of the harmful effects of chemotherapy, said co-author Tanya Dorff, assistant professor of clinical medicine at the USC Norris Comprehensive Cancer Center and Hospital. More clinical studies are needed, and any such dietary intervention should be undertaken only under the guidance of a physician.

We are investigating the possibility that these effects are applicable to many different systems and organs, not just the immune system, said Longo, whose lab is in the process of conducting further research on controlled dietary interventions and stem cell regeneration in both animal and clinical studies.

The study was supported by the National Institute of Aging of the National Institutes of Health (grant numbers AG20642, AG025135, P01AG34906). The clinical trial was supported by the V Foundation and the National Cancer Institute of the National Institutes of Health (P30CA014089).

Chia Wei-Cheng of USC Davis was first author of the study. Gregor Adams, Xiaoying Zhou and Ben Lam of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC; Laura Perin and Stefano Da Sacco of the Saban Research Institute at Childrens Hospital Los Angeles; Min Wei of USC Davis; Mario Mirisola of the University of Palermo; Dorff and David Quinn of the Keck School of Medicine of USC; and John Kopchick of Ohio University were co-authors of the study.

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Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients with Newly Diagnosed FLT3-ITD Positive…

Posted: June 13, 2022 at 2:15 am

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Positive results from the global pivotal QuANTUM-First phase 3 trial of Daiichi Sankyos (TSE:5468) quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) compared to standard chemotherapy alone. The data were featured as part of the press program and presented during the Presidential Symposium (#S100) at the European Hematology Association (#EHA2022) Congress.

AML is one of the most common leukemias in adults with an estimated five-year survival rate of approximately 30.5%.1,2 Of all newly diagnosed cases of AML, 25% carry the FLT3-ITD gene mutation, which is associated with particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.3

Quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a 22.4% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.776 [95% CI: 0.615-0.979; 2-sided p=.0324]) in patients with newly diagnosed FLT3-ITD positive AML. After a median follow-up of 39.2 months, median OS was more than double at 31.9 months for patients receiving quizartinib (95% CI: 21.0-NE) compared to 15.1 months for patients receiving chemotherapy (95% CI: 13.2-26.2).

The safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable, with no new safety signals observed. Rates of grade 3 or higher treatment emergent adverse events (TEAEs) were similar for both study groups and the most common grade 3 or higher TEAEs occurring in 10% of patients were febrile neutropenia (43.4% quizartinib; 41.0% placebo), neutropenia (18% quizartinib; 8.6% placebo), hypokalemia (18.9% quizartinib; 16.4% placebo) and pneumonia (11.7% quizartinib; 12.7% placebo). Rates of TEAEs associated with fatal outcomes were 11.3% for quizartinib versus 9.7% for chemotherapy alone and were mainly due to infections.

QTcF > 500 ms occurred in 2.3% of patients receiving quizartinib and 0.8% of patients discontinued quizartinib due to QT prolongation. Ventricular arrhythmia events with quizartinib were uncommon. Two (0.8%) patients experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome) both in the setting of severe hypokalemia.

The QuANTUM-First results show that adding quizartinib to standard chemotherapy significantly improved overall survival in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia, said Harry P. Erba, MD, PhD, Instructor, Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke Cancer Institute. There is great interest in the increased use of targeted therapies to improve outcomes for patients with AML, particularly those with the FLT3-ITD subtype, which is one of the most common, aggressive and difficult-to-treat.

We are proud that another one of our medicines has demonstrated a significant survival advantage, as our goal is to leverage innovative science to change the way cancer is treated, said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. Adding targeted treatment with quizartinib, a potent and selective FLT3 inhibitor, to standard chemotherapy resulted in a doubling of median overall survival in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia compared to standard chemotherapy alone. Based on these positive QuANTUM-First results, we have initiated global regulatory filings in order to bring quizartinib to patients as quickly as possible.

The OS improvement with quizartinib was also supported by a sensitivity analysis censoring for the effect of allogenic hematopoietic stem cell transplant (HSCT) (HR = 0.752; [95% CI: 0.562-1.008]).

Additional secondary and exploratory analyses provide further understanding and some supporting evidence for improved OS in patients receiving quizartinib combined with chemotherapy in the trial.

The primary event-free survival (EFS) analysis (with induction treatment failure (ITF) defined as not achieving complete remission (CR) by day 42 of the last induction cycle), did not show a statistically significant difference between the two study arms; two pre-specified sensitivity analyses on EFS (the first one defining ITF as not achieving CR by the end of induction; the second one defining ITF as having not achieved composite complete remission (CRc) by the end of induction) showed HR = 0.818 [95% CI: 0.669, 0.999] and HR = 0.729 [95% CI: 0.592-0.897], respectively.

The CRc rate was numerically higher for patients receiving quizartinib compared to chemotherapy alone (71.6% versus 64.9%), and rates of CR were similar for the two study arms (54.9% and 55.4%). The median duration of CR was 38.6 months for quizartinib (95% CI: 21.9-NE) and 12.4 months for chemotherapy (95% CI: 8.8-22.7).

The median relapse-free survival (RFS) for patients who achieved CR was 39.3 months for quizartinib and 13.6 months for placebo, representing a 38.7% relative risk reduction of relapse or death (HR = 0.613 [95% CI: 0.444-0.845]).

Summary of QuANTUM-First Results for OS

Efficacy Measure*

Quizartinib +ChemotherapyN=268

Placebo +ChemotherapyN=271

HR(95% CI)

OS Primary Analysis

Median OS (95% CI)

31.9 months

(21.0 NE)

15.1 months

(13.2 26.2)

HR = 0.776

(0.615 0.979)

2-sided p = 0.0324

*A hierarchical testing procedure was used to test the primary endpoint OS, followed by EFS, CR and CRc. Formal statistical testing was stopped after EFS as its result was not statistically significant.Data cut-off: August 13, 2021Abbreviations: HR = Hazard ratio; NE = not estimable; OS = overall survival

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (aged 18-75) with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens. Eligible patients, including those who underwent allogeneic HSCT, continued with single agent quizartinib or placebo for up to 36 cycles.

The primary study endpoint was OS. Secondary endpoints include EFS, post-induction rates of CR and CRc, and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, also were evaluated. QuANTUM-First enrolled 539 patients at 193 study sites across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia (AML)

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.4 AML is one of the most common types of leukemia in adults, representing about one-third of all cases, and the average age of diagnosis is 68 years old.1 The five-year survival rate for AML is 30.5%, the lowest by far among the major leukemia subtypes, and is 9.4% for patients aged 65 and older.5,6,7 The conventional treatment for newly diagnosed AML is intensive induction and consolidation chemotherapy with HSCT for eligible patients.8 The introduction of new targeted therapies in recent years has added to the standard of care and improved outcomes for some patients with molecularly defined AML subtypes.9

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a tyrosine kinase receptor protein normally expressed by hematopoietic stem cells that plays an important role in cell development, promoting cell survival, growth and differentiation through various signaling pathways.3 Mutations of the FLT3 gene, which occur in approximately 30% of AML patients, can drive oncogenic signaling.3 FLT3-ITD (internal tandem duplication) is the most common type of FLT3 mutation in AML, occurring in about 25% of all newly diagnosed patients, and is associated with increased risk of relapse and shorter overall survival.3

About Quizartinib

Quizartinib is an oral, highly potent and selective type II FLT3 inhibitor currently in clinical development for the treatment of FLT3-ITD positive AML.3 In addition to QuANTUM-First, the quizartinib development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America. Several phase 1/2 combination studies with quizartinib are also underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

Quizartinib has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive, in combination with standard cytarabine and anthracycline induction and cytarabine consolidation. Orphan Drug Designation has been granted to quizartinib for the treatment of AML in Europe, Japan and the U.S.

Quizartinib is currently approved for use in Japan under the brand name VANFLYTA for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose to contribute to the enrichment of quality of life around the world. In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an Innovative Global Healthcare Company Contributing to the Sustainable Development of Society. For more information, please visit http://www.daiichisankyo.com.

References

1 American Cancer Society. Key Statistics for Acute Myeloid Leukemia. Updated January 2020.2 National Cancer Institute SEER Program. Cancer Stat Facts: Acute Myeloid Leukemia 3 Daver N et al. Leukemia. (2019) 33:299312.4 Global Cancer Observatory. Population Fact Sheet: World. Updated November 2020.5 National Cancer Institute SEER Program. Cancer Stat Facts: Acute Myeloid Leukemia: 5-Year Survival Rates 6 Leukemia and Lymphoma Society. Facts and Statistics. Leukemia: Survival 7 National Cancer Institute SEER Explorer. Acute Myeloid Leukemia: 5-Year Survival Rates by Age 8 Daver et al. Blood Cancer J (2020) 10(10):1079 Short et al. Cancer Discov. (2020);10:50625.

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Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients with Newly Diagnosed FLT3-ITD Positive...

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