Category Archives: Biotechnology

TUSTIN, Calif. and MORGAN HILL, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, and Aragen Bioscience, a leading contract research organization (CRO) focused on accelerating pre-clinical biologics product development, today announced a co-marketing agreement that will provide clients an integrated sequence-to-manufacturing service. Under terms of the non-exclusive agreement, the companies will offer customers Aragens cell line development expertise integrated with Avids upstream and downstream process development and analytical services to drive efficiencies and reduce overall timelines for delivering CGMP bulk drug substances.

With pharmaceutical and biotechnology companies focused on delivering their innovative medicines to patients as quickly as possible, this alliance aims to speed the entire CGMP manufacturing process by having a single, integrated team oversee a single, integrated project timeline with significant built-in process efficiencies, saidTimothy Compton, chief commercial officer of Avid. We view this collaboration with Aragen as a significant win for current and future clients of both companies and we are excited to contribute our deep CDMO expertise to the partnership, particularly our more than 15 years of commercial product manufacturing experience.

I am excited about this partnership that will enable us to accelerate drug development timelines and deliver new biologic therapeutics to patients faster by integrating two best-in-class offerings to our customers, said Axel Schleyer, CEO of Aragen. Our services in discovery, cell line development, which includes our innovative RapTr platform, protein production and preclinical testing are a great match with Avids clinical and commercial manufacturing capabilities. We look forward to this collaboration that advances novel ideas into breakthrough medicines.

AboutAvid Bioservices, Inc.

Avid Bioservicesis a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.www.avidbio.com

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products. http://www.aragenbio.com

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Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process...

Research report on Agricultural Biotechnology Market size | Industry Segment by Applications, by Type, Regional Outlook, Market Demand, Latest Trends, Agricultural Biotechnology Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyzes current market size and upcoming 5 years growth of this industry.

Report Covers Global Industry Analysis, Size, Share, CAGR, Trends, Forecast And Business Opportunity.

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Global Agricultural Biotechnology Market valued approximately USD XXX billion in 2016 is forecasted to grow with a healthy growth rate of more than XX% over the forecast period 2018-2025. The major factors speculated to augment the markets are growing population size, globally increasing transgenic crops demand due to increasing food requirements, rising per capita income. Agricultural biotechnology, also known as agritech, is an area of agricultural science that uses scientific tools and techniques, including genetic engineering, molecular markers, molecular diagnostics, vaccines, and tissue culture, to modify living organisms: plants, animals, and microorganisms.

The regional analysis of Global Agricultural Biotechnology Market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America region is the leading region across the world in terms of market share. Whereas, owing to countries viz. India, Indonesia, China, and Japan, the Asia Pacific region is expected to exhibit higher growth rate / CAGR over the forecast period 2018-2025.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Technology:Synthetic BiologyDeoxyribonucleic Acid (DNA) SequencingGenome Editing ToolsRibonucleic Acid (RNA) InterferenceBiochips

By Product:Crop Protection ProductsBiostimulantsBiopesticidesTransgenic SeedsCottonSoybeanFruits & vegetablesMaizeOthers

By Regions:North AmericaU.S.CanadaEuropeUKGermanyAsia PacificChinaIndiaJapanLatin AmericaBrazilMexicoRest of the World

Furthermore, years considered for the study are as follows:Historical year 2015, 2016Base year 2017Forecast period 2018 to 2025

The industry is seeming to be fairly competitive. Some of the leading market players include Bayer AG, Dowdupont Inc., Syngenta AG, BASF SE, Adama Agricultural Solutions Ltd., Certis USA LLC, Evogene Ltd., KWS SAAT SE, Monsanto Company, Vilmorin & CIE, and so on. The fierce competitiveness has made these players spend in product developments to improve the customers requirements.

Target Audience of the Agricultural Biotechnology Market Study:Key Consulting Companies & AdvisorsLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Resellers (VARs)Third-party knowledge providersInvestment bankersInvestors

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Table of Content:

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the Global Agricultural Biotechnology Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Global Agricultural Biotechnology Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the Global Agricultural Biotechnology Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Global Agricultural Biotechnology Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the Global Agricultural Biotechnology Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the Global Agricultural Biotechnology Market.

Market Forecast:Here, the report offers a complete forecast of the Global Agricultural Biotechnology Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

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Originally posted here:
COVID-19 pandemic Agricultural Biotechnology Market 2019 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected...

Shire

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Nanoparticles in Biotechnology and Pharmaceuticals market. A competition analysis is imperative in the Nanoparticles in Biotechnology and Pharmaceuticals market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Nanoparticles in Biotechnology and Pharmaceuticals across the world has been calculated through primary and secondary research. The Nanoparticles in Biotechnology and Pharmaceuticals Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Highlights of the Nanoparticles in Biotechnology and Pharmaceuticals market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Nanoparticles in Biotechnology and Pharmaceuticals market. Additionally, it includes a share of every segment of the Nanoparticles in Biotechnology and Pharmaceuticals market, giving methodical information about types and applications of the market.

Key point summary of the Nanoparticles in Biotechnology and Pharmaceuticals market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Nanoparticles in Biotechnology and Pharmaceuticals market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Nanoparticles in Biotechnology and Pharmaceuticals market

Chapter 2: Evaluating the leading manufacturers of the global Nanoparticles in Biotechnology and Pharmaceuticals market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Nanoparticles in Biotechnology and Pharmaceuticals market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Nanoparticles in Biotechnology and Pharmaceuticals market describes Nanoparticles in Biotechnology and Pharmaceuticals industry expansion game plan, the Nanoparticles in Biotechnology and Pharmaceuticals industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

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Original post:
Nanoparticles in Biotechnology and Pharmaceuticals Market Future Growth by In Depth Industry Analysis, Size, Trends and Forecast to 2026 - Cole of...

While much of the federal governments recent activity has surrounded COVID-19, some agencies are continuing their work in other areas, including agricultural biotechnology. In this blog, I invite you to take a break from the coronavirus news cycle as I summarize three developments you may have missed that have occurred in agricultural biotechnology in the United States since the start of 2020.

On March 30th, the Environmental Protection Agency (EPA) approved the herbicide Isoxaflutole for use on soybeans that were genetically engineered to be resistant to that herbicide (the soybean variety was approved by the US Department of Agriculture (USDA) years earlier). EPA concluded that under certain conditions, the herbicide could be used in an environmentally protective manner in certain parts of the country. The EPA registration classifies Isoxaflutole as a restricted-use pesticide, which means it can only be applied by applicators who receive special training, and it cannot be applied aerially or through irrigation systems. Geographically, its use on soybeans is limited to specific counties in 25 states (because those areas do not have endangered species that would have required EPA to conduct a detailed assessment to comply with the Endangered Species Act). The registration is limited to five years, which will allow EPA to review compliance with the use restrictions and monitor development of any resistant weeds. EPA also requires the registrant (Bayer CropScience) to establish a weed resistance management plan, including development and implementation of an education program encouraging farmers using the herbicide to take steps to prevent resistant weed development.

While safe and effective herbicides are necessary to produce our food, this registration raises some obvious compliance issues. First, Isoxaflutole was not approved for use in Illinois and Iowa, two of the largest growers of soybeans. Isoxaflutole is also approved for use as a pre-emergence herbicide on corn fields in 8 additional states where it is not approved for use on the herbicide-tolerant GE soybeans (and its use has been banned by state regulators in some counties in some Minnesota, Wisconsin, and Michigan to prevent groundwater contamination). How will EPA ensure that this herbicide is only used on soybeans in geographically approved regions of the country? The situation seems ripe for illegal use by some farmers.

Second, while I applaud EPAs inclusion on the label of actions to be carried out by the developer and farmers to prevent resistant weed development, those actions are not enough. The Isoxaflutole label only states that Appropriate resistance management strategies should be followed and that to delay resistance, take one or more of the following steps. Those statements suggest, but do not legally obligate, farmers to carry out activities such as pesticide rotations from season to season or adoption of integrated weed management programs. Farmers could comply just by switching to a different herbicide if resistant weeds develop or by reporting any suspected resistance to the developer (two of the actions suggested by EPA on the pesticide label under resistance management)but even those are not required. Given the history of overuse of glyphosate by farmers growing GE corn and soybeans, which has resulted in millions of acres of resistant weeds, EPA registration should have explicitly required resistant weed prevention by farmers.

On March 4th, the Food and Drug Administration (FDA) launched its Feed Your Mind website, which is the first public-facing product from the $7.5 million that Congress appropriated starting in 2017 for an Agricultural Biotechnology Education and Outreach Initiative. According to FDA, the initiatives goal is toshare science-based information that educates, informs, and broadens understanding about agricultural biotechnology for consumers. Congress (and the special interests that lobbied for the appropriation) clearly intended to use the authoritative voice of FDA to increase consumers understanding of agricultural biotechnology and correct misconceptions and misinformation.

The initiatives website includes fact sheets, infographics, and videos. It will be followed by additional materials for middle school classrooms, resources for health professionals, and consumer materials later in 2020 and in 2021.

In reviewing Feed Your Mind, one finds information that is scientifically accurate (with reliable references) and relatively easy for a non-scientist to understand. If you know nothing about GMOs and read the websites contents, you will clearly be better informed about what GMOs are, although not necessarily about why GMOs have been so controversial. The question that remains is how this website (which is not easy to find from FDAs homepage, nor does it quickly appear when entering basic questions about GMOs into an internet search engine) will educate a significant segment of American consumers. Will FDA promote the website and its materials through an ad campaign? Will they send emails or postcards to Americans telling them to visit the website?I cannot imagine that the average American consumer visits FDAs website with any great frequency. One can reasonably assume that the number of consumers who will search for the Feed Your Mind website, even if they know it exists, will be extremely small. So far, FDA has only announced the website to its list of stakeholders. Much more outreach will be needed if the information they have generated is to have the impact Congress intended

On March 19th, the Department of Interiors Fish and Wildlife Service (FWS) announced that it had completed a draft Programmatic Environmental Assessment (PEA) to assess the use of GE crops for natural resource management in the National Wildlife Refuge System. The public comment period on the PEA ended April 19th.

Lets explain how we got here. Currently, approximately 28,000 acres of refuge land in the Southeast is contracted out by FWS to farmers who grow primarily corn, soybeans and rice. In those contracts, farmers agree not to harvest 25% of their crop so it can be left as food consumed by waterfowl and other animals that the refuges support. Agricultural fields also maintain open habitat to support wildlife and control invasive species. Contract farmers utilized GE crops until 2012, when a lawsuit stopped the practice pending a PEA in compliance with the National Environmental Policy Act (NEPA). This PEA is the result of that process.

The PEA covers ten states and two territories in the Southeastern United States and recommends a policy that would allow the growing of GE crops on NWR land. The PEA compares the period before 2012 (with GE crops) and after 2012 (without them). They find that the pesticide use (pounds of active ingredient) increased 68% after farmers stopped using GE crops in 2012 and the number of active ingredients increased 76%. Other facts supporting the PEAs conclusion that the growing of GE crops should be allowed include findings that NWR staffs workload was less when farmers used GE crops and farmers had increased yields. Finally, they found using GE crops was consistent with the FWSs Integrated Pest Management Policies.

In the United States, farmers have grown GE crops for more than twenty years, reaping their benefits such as reduced insecticide use on corn and cotton crops while managing their risks (although not always well). If those same GE crops can be beneficial to farmers growing crops on NWR lands without demonstrable risk, as the PEA appears to show, then it seems like they should be permitted to plant them.

After reviewing the comments received, FWS will issue a final PEA. But the process does not end there. The PEA is necessary, but not sufficient for permitting the growing of GE crops in NWRs. Next, individual refuges in the Southeastern region can conduct their own site-specific analysis to determine whether to authorize their farmers to use a GE crop.

Now that youre caught up on the latest in agricultural biotechnology, stay tuned for additional developments we expect in the coming weeks. These include USDAs revisions to 7 C.F.R. Part 340 addressing its oversight of GE organisms that might be plant pests, and EPAs proposal on how its regulation of plant-incorporated protectants will apply to genome-edited crops. Check back with the Biotech Blog for coverage of these and more!

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Biotech Blog: Update on Government Activities on Agricultural Biotechnology in 2020 - CSPI Newsroom

The first sustainable cleaning products appeared on the professional hygiene market in the early 1990s and the increase in demand for these products has led to innovation and several new technologies. Biotechnology is one of the most important, as Steve Teasdale, vice-president of scientific affairs at Innuscience explains.

The first sustainable cleaning products appeared on the professional hygiene market in the early 1990s. At the time, these technologies generally did not perform especially well and were not unanimously accepted by a generally insensitive marketplace. Since then, and with more receptive audience the demand for these products continues to grow and to the point where their use is increasingly mandated in many places.

This increase in demand for such products has in turn led to innovation and the development of several new technologies. As you would expect, some quickly disappeared while others remained on the market and continued to evolve. Biotechnology is one of the most important of these, and as market conditions evolve, it continues gaining increasingly important market awareness and share.

The list of chemical ingredients historically used in cleaning products and which are now considered undesirable, of concern or are even banned continues to grow. Given their contribution to cleaning efficacy, their removal must be compensated using new substances and/or technologies. This situation has helped to promote and encourage the technological development for alternative solutions arising from biotechnology; among other things.

It is in this context that significant efforts have been invested in to bring us to a point where it is now possible to obtain as good, or even better levels of cleaning performance using biotechnological cleaning products.

Green cleaning products which mainly used ingredients derived from biotechnological processes bacterial cultures, enzyme extracts and other bio-ingredients appeared in the late 1990s. Since then, they have become increasingly popular; with increased recognition and steady commercial growth.

Specific knowledge

The ability to develop biotech cleaning products is not universally available and requires specific technological knowledge and skills that are relatively young and unusual in the professional hygiene market. While our industry has been dominated by chemistry for decades, the arrival of biotechnology has required a significant commitment in terms of energy and resources whether it be in terms of research tools, research, performance analysis, stability assessment or at the level of standards and regulatory compliance.

The manufacture of biotech cleaning products also requires unique expertise. Manufacturing cleaning products with bio-active and/or surface active molecules requires the development of special processes, procedures and quality standards. There have been many developments in this field and the standards and processes implemented are now recognised by the scientific community (Teasdale et al., Food and Chemical Toxicology https://www.sciencedirect.com/science/article/pii/ S0278691517306270)

The evolution of biotechnologies for professional cleaning is booming. We are seeing more and more products using bio-surfactants. These are surface active molecules which are produced by microorganisms and which have unique and remarkable environmental and performance properties.

Other technologies stemming from biotechnologies are under development and already starting to be introduced on the market. This is the case with new disinfection technologies that use viruses that kill targeted microbial pathogen (bacteriophages) in a very specific way instead of disrupting the entire existing microbial flora.

The use of biotechnological cleaning products has brought cleaning to a new dimension. While traditional chemical cleaners have the ability to solubilise and/or emulsify dirt, biotech cleaning products also have the ability to break and remove dirt through hydrolysis and biodegradation. This action has the additional benefit of residual activity beyond the short period of mechanical action applied during cleaning or post-cleaning action.

This new dimension of cleaning goes towards a significant revision of the traditional foundations of the famous Sinner Circle cleaning action continues for hours beyond the application of mechanical action.

Thanks to the characteristics of their make-up and their function, biotech ingredients make it possible to develop cleaning products that are highly concentrated and contain very low concentrations of chemical ingredients (mainly surfactants) once diluted before use. It also makes it possible to achieve very high cleaning and detergency performance without having to resort to using high pH, sequestering agents, builders, solvents and other substances which contribute to increasing the pollutant load and which is the reason why traditional chemical cleaning products are harmful for the environment and cleaning staffs health.

First patent

For example, in the year 2000 the first biotechnological neutral pH degreaser for kitchen floors was patented and then marketed. This diluted degreasing solution contained less than 0.05 per cent active ingredient and degreased a kitchen floor more efficiently than a traditional alkaline degreaser containing 25 times the amount of active ingredients.

Reduction using less is the first and most effective eco-friendly cleaning approach. This products high concentration rate makes it possible, among other things, to reduce the transport and use of plastic. Its high efficiency allows for very high dilution rates reducing the amount of cleaning ingredients used.

In addition, the use of this biotech degreaser directly impacted on reducing cleaning staffs risk of having an accident. It did not lead to any increase in slipperiness on kitchen floors as can happen with alkaline chemical degreasers. Thus, this reduced the risk of slip and fall in the kitchen whilst its ensured there was no risk of skin or eye burns due to its non-corrosive classification.

Broader concept

The concept of a green cleaning product refers to cleaning products that have a lower and less harmful environmental impact than that of traditional cleaning products. Although this dimension is noble and desirable, the concept for an eco-responsible cleaning product uses a much broader concept that integrates environmental, societal and economic parameters.

In order for a cleaning product to contribute in a sustainable way to the development of our industry, it must integrate these three main axes that define the concept of sustainable development. Thus, beyond the environmental impact cleaning staffs health and wellbeing as well as the cost of use must be considered when developing new cleaning technologies.

In the previous example concerning the biotech degreasing product for kitchen floors it is clear that this products use has a direct impact on aspects which are both environmental and societal. But what about the cost of use? A cleaning product that benefits the environment and workers health cannot offer a sustainable solution if it costs more to use. However, the use of biotechnologies makes it possible to develop cleaning products that advantageously integrate the economic aspect.

Since bacterial cultures and enzymatic extracts are highly effective even at very low concentrations and considering their residual and prolonged cleansing action, biotechnological cleaning products can be diluted at very high rates while providing outstanding cleaning performance. These high dilution rates lead to high-performance cleaning solutions that have a very low cost per litre in their applicative usage.

Additionally, biotech cleaning products have the ability to reduce odours due to their mode of action and their ability to extract a greater amount of dirt from surfaces; especially those which are porous and difficult to clean. In public toilets, some odours may be generated following the passage of a user.

However, in reality the most disturbing odours are those which are permanently present and that emanate from surfaces which have accumulated water and more particularly urine. The floors near bowls and urinals are particularly prone to generating these unpleasant odours.

Solving the problem

In view of their inability to solve these problems, a number of stakeholders resort to using methods that are more or less effective and that never really solve the problem. It is common to widely distribute air fresheners to mask these odours. As a last resort, we sometimes see cleaning staff use a rotary floor scrubber and a floor stripper in an attempt to unclog the problematic surfaces with no success.

Ultimately, we have all already visited bathrooms where, in desperation, the floor had been sealed with a floor finish in order to trap smelly dirt. These solutions, which are not really solutions, are all bad for the environment, the cleaning staff and the buildings tenants.

The use of air fresheners is particularly harmful and far from being a sustainable solution. These products are essentially volatile organic compounds (VOCs) and they contribute to deteriorating indoor air quality. They also cause multiple inconveniences, discomfort and symptoms which are grouped together and recognised as the Sick Building Syndrome. In addition, these air fresheners attract bad publicity and are considered by more and more people as a pollutant and an invasive nuisance. They are frequently the subject of complaints when used unreasonably.

Now, with the help of a biotechnological all-surface toilet cleaner, it is possible to clean all surfaces, including the floors. This makes it possible to dislodge the dirt accumulated over the years, which are the main sources of bad smells. After a few days of use, bad smells gradually disappear. This approach makes it possible to better clean the floors, but above all to eliminate those air fresheners.

Conclusion

As mentioned by a famous scientist who has left a mark in our history, We cannot solve a problem by using the same approach that we had used to create it. Thus, we had and still have a desperate need for new technologies that will provide real and sustainable solutions to the environmental and societal problems associated with professional cleaning and that we are still faced with today. Biotechnology is a good example of a technological and innovative contribution in this field.

innuscience.com

Originally posted here:
The Role Of Biotechnology In Sustainable Cleaning Products - European Cleaning Journal

Bixink will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in South Korea. Under the terms of the agreement, Puma will receive upfront and milestone payments of up to $6 million, as well as significant double-digit royalties on the sales of NERLYNX in South Korea.

Our new agreement with Bixink demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market, stated Alan H. Auerbach, Chief Executive Officer and President of Puma. We are excited about the potential to provide South Korean breast cancer patients with access to NERLYNX.

We are excited about the opportunity to provide NERLYNX to patients with HER2-positive breast cancer in South Korea and plan to file for its market authorization before the end of 2020, said Dr. Sung Chul Kim, Chief Executive Officer of Bixink Therapeutics. NERLYNX is our top priority as we aspire to be a leading South Korean company in the field of oncology therapeutics.

Neratinib is approved in the United States for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and HER2-positive metastatic breast cancer and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

The most common adverse reactions (reported in 5% of patients) were as follows:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and http://www.NERLYNX.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

About Bixink

Bixink Therapeutics Co. Ltd. is a new South Korean company dedicated towards establishing a new treatment paradigm via converging biotechnology and information technology. Currently focused on the field of anti-cancer drugs and digital therapeutics, Bixink will start commercialization of anti-cancer drug NERLYNX and aims to diligently secure follow up pipeline products, including cancer supportive care and oncologics with novel drug delivery. Bixink also actively seeks various opportunities for collaboration such as co-development and strategic investment to drive its momentum for growth. As one of the pioneers in the field of digital therapeutics in South Korea, Bixink is capable of analysis, R&D, development and validation, and plans to file an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration by the end of this year to launch its first digitalized cognitive behavioral therapy for obsessive compulsive disorder. In the long term, Bixink strives to create a new path by encompassing medicines and digital therapeutics with better clinical outcomes and cost-effectiveness for patients. Bixink strives to push the boundaries of technology to transform medicine.

To find out more about Bixink Therapeutics, please visit http://www.bixink-therapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the international expansion of NERLYNX. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Pumas business or the global economy and financial markets, generally, from the global COVID-19 pandemic, and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005669/en/

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Puma Biotechnology and Bixink Therapeutics Enter into Exclusive Licensing Agreement to Commercialize NERLYNX (neratinib) in South Korea - BioSpace

TMR estimates that the healthcare cleanroom consumables market features fragmented and highly competitive vendor landscape. The large number of companies present in the market is leading to increase level of competition in the global market. Some of the key players dominating the globalhealthcare cleanroom consumables marketare Valutek, Texwipe, Nitritex Ltd., DuPont, and Kimberly-Clark Corp. These key players collectively accounted for 52% of the overall revenue. Additionally, the key players are getting benefit from commercialization of products coupled with implication of cost-cutting measures during manufacturing. However, lack of product differentiation is creating challenge for key players. Thus, the players are increasingly trying to offer products at competitive pricing, and in turn, the intense price war is taking shape on a global level.

The analysts at TMR estimates, the global healthcare cleanroom consumables market is likely to exhibit growth at a CAGR of 4.76% during the period from 2015 to 2023. At this growth rate, the market is likely to reach a valuation of US$3 bn by 2023 from rising from a valuation of US$2 bn in 2014. This growth is attributable to rising need for new and effective drugs.

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On the basis of applications, the market is dominated by the segment of biotechnology and is estimated to remain dominant in the coming years. On the basis of geography, the market in North America is estimated to be the leading region in terms of revenue and to be dominant in coming years. The regional market stood at the US$0.7 bn in 2014 and is expected to grab a value of US$10.3 bn by the end of 2023. The Europe is expected to account for second-leading share and is estimated to grab a value of US$0.9 bn by 2023 from a value of US$0.6 bn in 2014. This growth is attributable to high demand for cleanroom consumables in the region coupled with increasing demand from the pharmaceuticals and biotechnology industry.

Booming Research Activities in Healthcare Drives Market Growth

The healthcare cleanroom consumable market has gained pace from past few years as the external factors such as chemicals, vapors, dust and other microorganisms in air is lowering the production capacity. Additionally, these external factors influence negatively on the products and facilities of drugs and medical devices. Thus, demand for the cleanroom consumables especially in the healthcare is growing substantially, which in turn is propelling growth of the healthcare cleanroom consumable market.

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Cleanroom consumables have robust applications in the healthcare and medical industry as the importance of cleanliness is higher in the sector, which is benefiting growth of the global healthcare cleanroom consumable market. The other sectors of the healthcare industry such as pharmaceuticals, devices, and hospitals are driving growth of the global healthcare cleanroom consumable market. Additionally, high demand for the cleanroom consumables from biotechnological labs is high as the devices can easily get affected due to organisms in the room or air. This is key factors driving growth of the healthcare cleanroom consumable market and is expected to be major factors influencing growth in coming years.

Need of High Investment Restrains Market Growth

However, requirement of high investment on healthcare cleanroom consumables and devices is restraining growth of the healthcare cleanroom consumable market. Additionally, availability of customized healthcare cleanroom consumables as per requirement is difficult which is hampering growth to some extent. Further, the healthcare cleanroom consumables such as gloves are not the reusable and require long time for recycling, which creates the challenge for key players. This is another key concerns and major factor slowing the growth of the healthcare cleanroom consumable market. Nonetheless, the continuous research and development coupled with robust investment and commercialization of biotechnological products for development of chronic diseases such as cancer is estimated to offer lucrative opportunities for growth in the healthcare cleanroom consumable market in coming years.

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This information is encompassed inthe report by TMR, titled, Healthcare Cleanroom Consumables Market (Product - Wipers (Dry and Wet), Cleanroom Apparels(Coverall, Frock, Boot Cover, Shoe Cover, Bouffant, Sleeves, Pants, Face Masks, and Hood), Cleaning Products (Cleanroom Mops, Buckets, Wringers, Squeegees, Validation Swabs, and Cleaning Chemicals), and Cleanroom Stationery (Paper, Notebook and Adhesive Pads, Binders and Clipboards, and Labels); Application - Pharmaceutical, Biotechnology, Medical Devices, Academia, and Hospitals) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 20152023.

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

Contact

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Healthcare Cleanroom Consumables Market: Increasing Commercialization of Biotechnology-based Products to Boost the Demand - BioSpace

B.R.A.I.N. Biotechnology Research and Information Network AG (ETR:BNN) shareholders will doubtless be very grateful to see the share price up 54% in the last month. But that doesn't help the fact that the three year return is less impressive. In fact, the share price is down 46% in the last three years, falling well short of the market return.

Check out our latest analysis for B.R.A.I.N. Biotechnology Research and Information Network

B.R.A.I.N. Biotechnology Research and Information Network isn't currently profitable, so most analysts would look to revenue growth to get an idea of how fast the underlying business is growing. Generally speaking, companies without profits are expected to grow revenue every year, and at a good clip. As you can imagine, fast revenue growth, when maintained, often leads to fast profit growth.

In the last three years, B.R.A.I.N. Biotechnology Research and Information Network saw its revenue grow by 19% per year, compound. That's a fairly respectable growth rate. Shareholders have endured a share price decline of 19% per year. This implies the market had higher expectations of B.R.A.I.N. Biotechnology Research and Information Network. However, that's in the past now, and it's the future is more important - and the future looks brighter (based on revenue, anyway).

The graphic below depicts how earnings and revenue have changed over time (unveil the exact values by clicking on the image).

XTRA:BNN Income Statement May 4th 2020

If you are thinking of buying or selling B.R.A.I.N. Biotechnology Research and Information Network stock, you should check out this FREE detailed report on its balance sheet.

B.R.A.I.N. Biotechnology Research and Information Network shareholders may not have made money over the last year, but their total loss of 6.2% isn't as bad as the market loss of around 6.2%. Furthermore, the stock lost shareholders 19% per year over three years, so the one-year return was better in a relative sense. It is of course not much comfort to know that the losses have slowed. Shareholders will be hoping for a proper turnaround, no doubt. It's always interesting to track share price performance over the longer term. But to understand B.R.A.I.N. Biotechnology Research and Information Network better, we need to consider many other factors. Take risks, for example - B.R.A.I.N. Biotechnology Research and Information Network has 1 warning sign we think you should be aware of.

Of course B.R.A.I.N. Biotechnology Research and Information Network may not be the best stock to buy. So you may wish to see this free collection of growth stocks.

Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on DE exchanges.

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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The B.R.A.I.N. Biotechnology Research and Information Network (ETR:BNN) Share Price Is Down 46% So Some Shareholders Are Getting Worried - Yahoo...

Coronavirus Real-Time Detection Kits Market 2020

This report studies the Coronavirus Real-Time Detection Kits Market with many aspects of the industry like the market size, market status, market trends and forecast, the report also provides brief information of the competitors and the specific growth opportunities with key market drivers. Find the complete Coronavirus Real-Time Detection Kits Market analysis segmented by companies, region, type and applications in the report.

The major players covered in Coronavirus Real-Time Detection Kits Market Zhijiang biology, Sansure, Shanghai Huirui Biotechnology, Geneodx, Shanghai BioGerm Medical Biotechnology, Da An Gene, Wondfo, and INNOVITA

The final report will add the analysis of the Impact of Covid-19 in this report Coronavirus Real-Time Detection Kits industry.

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Coronavirus Real-Time Detection Kits Market continues to evolve and expand in terms of the number of companies, products, and applications that illustrates the growth perspectives. The report also covers the list of Product range and Applications with SWOT analysis, CAGR value, further adding the essential business analytics. Coronavirus Real-Time Detection Kits Market research analysis identifies the latest trends and primary factors responsible for market growth enabling the Organizations to flourish with much exposure to the markets.

Market Segment by Regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

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

South America (Brazil, Argentina, Colombia etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Research objectives:

To study and analyze the global Coronavirus Real-Time Detection Kits market size by key regions/countries, product type and application, history data from 2013 to 2017, and forecast to 2026.

To understand the structure of Coronavirus Real-Time Detection Kits market by identifying its various sub segments.

Focuses on the key global Coronavirus Real-Time Detection Kits players, to define, describe and analyze the value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Coronavirus Real-Time Detection Kits with respect to individual growth trends, future prospects, and their contribution to the total market.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

To project the size of Coronavirus Real-Time Detection Kits submarkets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

The Coronavirus Real-Time Detection Kits Market research report completely covers the vital statistics of the capacity, production, value, cost/profit, supply/demand import/export, further divided by company and country, and by application/type for best possible updated data representation in the figures, tables, pie chart, and graphs. These data representations provide predictive data regarding the future estimations for convincing market growth. The detailed and comprehensive knowledge about our publishers makes us out of the box in case of market analysis.

Table of Contents: Coronavirus Real-Time Detection Kits Market

Chapter 1: Overview of Coronavirus Real-Time Detection Kits Market

Chapter 2: Global Market Status and Forecast by Regions

Chapter 3: Global Market Status and Forecast by Types

Chapter 4: Global Market Status and Forecast by Downstream Industry

Chapter 5: Market Driving Factor Analysis

Chapter 6: Market Competition Status by Major Manufacturers

Chapter 7: Major Manufacturers Introduction and Market Data

Chapter 8: Upstream and Downstream Market Analysis

Chapter 9: Cost and Gross Margin Analysis

Chapter 10: Marketing Status Analysis

Chapter 11: Market Report Conclusion

Chapter 12: Research Methodology and Reference

Key questions answered in this report

What will the market size be in 2026 and what will the growth rate be?

What are the key market trends?

What is driving this market?

What are the challenges to market growth?

Who are the key vendors in this market space?

What are the market opportunities and threats faced by the key vendors?

What are the strengths and weaknesses of the key vendors?

Inquire More about This Report https://www.reportsandmarkets.com/enquiry/global-coronavirus-real-time-detection-kits-market-research-report-2020?utm_source=coleofduty&utm_medium=36

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Reports and Markets is not just another company in this domain but is a part of a veteran group called Algoro Research Consultants Pvt. Ltd. It offers premium progressive statistical surveying, market research reports, analysis & forecast data for a wide range of sectors both for the government and private agencies all across the world. The database of the company is updated on a daily basis. Our database contains a variety of industry verticals that include: Food Beverage, Automotive, Chemicals and Energy, IT & Telecom, Consumer, Healthcare, and many more. Each and every report goes through the appropriate research methodology, Checked from the professionals and analysts.

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Coronavirus Real-Time Detection Kits Market to Witness Astonishing Growth With Zhijiang biology, Sansure, Shanghai Huirui Biotechnology, Geneodx,...

FLORHAM PARK, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Companys proprietary Versamune T-cell activating technology, today announced that the Company will release financial results for the first quarter ended March 31, 2020 on Wednesday, May 13, 2020, before the market opens. Following the release, Dr. Frank Bedu-Addo, Chief Executive Officer, will host a conference call to review the financial results and provide a business update.

The conference call is scheduled to begin at 8:00 am ET on Wednesday, May 13, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at http://www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotechs website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13703263.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Companys proprietary Versamune T-cell activating technology platform. Versamune effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit http://www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Media & Investor Relations Contact:

Deanne RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com

Tram Bui / Alexander LoboThe Ruth GroupPhone: +1 (646) 536-7035 / +1 (646) 536-7037Email: tbui@theruthgroup.com / alobo@theruthgroup.com

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PDS Biotechnology Announces Conference Call and Webcast for First Quarter 2020 Financial Results - GlobeNewswire