Category Archives: Biotechnology

Despite the signing of a Memorandum of Understanding on animal biotechnology at the end of the Trump administration between the USDA and the Department of Health and Human Services, animal biotechnology approvals remain stalled. Secretary of Agriculture Tom Vilsack says hes committed to working with the Food and Drug Administration on creating proper jurisdiction of animal biotech oversight, but concerns exist on the originally signed MOU.

Animal biotechnology refers to genetic altering of animals through a range of potential processes, including recombinant DNA techniquesand genome editing, to improve certain traits or characteristics of these animals. These practices have the potential to develop resistance and mitigate diseases including zoonotic infections like SARS-CoV-2 and avian influenza, to reduce methane emissions, improve heat tolerance, and much more.

Currently, these technologies are regulated by FDA under its animal drug authority, through a process that has proven prohibitively onerous. To date, only two animals intended for agricultural purposes have ever been approved by the FDA for domestic use, both taking decades for full approval.

The National Pork Producers Council says it supports giving USDA regulatory authority over gene editing in food animals, pointing out that the agencys Animal and Plant Health Inspection Service already has a review process in place for gene editing in plants, which can serve as a model for livestock. Under a USDA-proposed rule, the agency would have primary regulatory jurisdiction of gene-edited animals.

Ahead of a hearing in the House Agriculture Committee on livestock issues, nearly two-thirds of the committee (37 members) signed and sent a letter to Vilsack and FDA Acting Commissioner Janet Woodcock urging timely progress in the reform of regulatory frameworks and animal biotechnology products. Lawmakers cited genetic improvements as a hallmark of agriculture and called on USDA Vilsack and Woodcock to make improvements that would modernize the regulatory system for animal genetics and assure timely adoption of biotechnology innovations.

Related:HHS, USDA sign MOU on animal biotechnology

Rep. Vicki Hartzler, R-Mo., asked Vilsack during the hearing when a pig that has been found to be resistant to PRRScould be used by producers. Vilsack responded that he shares her goal of instituting an appropriate regulatory structure to use the tools and innovations available. There are ways in which we have to work collaboratively with our friends at FDA to make sure our regulatory system is able to respond quickly enough and be able to keep pace with the pace of change, the secretary told House Ag members.

In questioning from Rep. Jim Baird, R-Ind., who serves as the ranking member of the House Agriculture Committees subcommittee on biotechnology, Baird notes that concerns on the cumbersome regulatory process sends the wrong message and tends to stifle innovation.

Innovation has been the very backbone of agriculture throughout time. In the last several decades, that innovation has begun to look different as the technology has changed, but the goal remains the same to create the safestand most sustainable, abundant, and stable food supply in the world, says Baird.

The unfortunate reality though, is that our regulatory system has not kept up with this technology and has created a near-impossible challenge to get these products to market, Baird says. USDA needs to take the lead in developing new, risk and science-basedregulatory pathways that encourage agricultural innovation, provide access to valuable new technologies to American livestock producers, and ensurefood safety and security for consumers.

During the hearing, Vilsack said as a department, USDA attempted to reach an agreement with HHS and FDA during the Trump administration with an original MOU signed, however, the then FDA administrator was not supportive of transferring oversight of animal products to USDA.

Related: Animal gene editing turf war battle continues

Vilsack says hes not sure HHS published the memorandum as there were some concerns on whether HHS had adequate authority to sign the memorandum. Vilsack says theyre now in the process to take a look at the MOU and determining whether or not there are steps that need to be taken to make sure we have bright lines between what we do and what FDA does.

Kevin Scott, a soy grower from Valley Springs, South Dakotaand American Soybean Association president, welcomed the bipartisan letter.

With devastating animal diseases at our nations doorstep, the need for genetic innovations to protect our flocks and herds has never been greater. Representatives Plaskett and Baird should be commended for leading the House Agriculture Committee in this impressive bipartisan appeal for much-needed biotechnology regulatory modernization to protect our nations livestock. We urge our countrys regulators to heed their call, says Scott.

ASA agrees that the existing regulatory process for review of animals using biotechnology innovations needs to be streamlined for more timely adoption and applauds the legislators letter.

Originally posted here:
Vilsack working with FDA on animal biotechnology - National Hog Farmer

SAN CARLOS, Calif., October 11, 2021--(BUSINESS WIRE)--AcureX Therapeutics Corporation, a privately-held preclinical-stage biotechnology company focused on developing disease altering therapeutics for neurodegenerative diseases, today announced that it was selected to present at the Oppenheimer Biotechnology Emerging Science Summit on October 15th, 2021.

Presentation details:

Halting Neurodegeneration with Miro1 Directed TherapiesPresented by: William Shrader, Ph.D., Co-founder and CEO AcureX TherapeuticsDate and time: October 15th, 2021 at 1:30p.m. ET / 10:30a.m. PT

The Oppenheimer Biotechnology Emerging Science Summit will be held virtually and will feature Stanford Universitys SPARK program. Presentations will be given by experts in the fields of oncology, immunology, neurology, and gene therapy, as well as management from several publicly traded companies.

William Shrader, Ph.D. said, "We at AcureX are pleased to be recognized as a leader in an emerging field and we are delighted to share our novel drug discovery approach at this prestigious forum."

About AcureX Therapeutics

The mission of AcureX Therapeutics is to halt neurodegenerative diseases driven by impaired mitophagy, starting with Parkinsons Disease. AcureX expects to have one or more late-preclinical therapeutic candidates for Parkinsons in human trials within two years, followed by candidates for other neurodegenerative diseases. AcureXs novel approach and founding intellectual property are based on recent discoveries made by the companys inventor and co-founder, Xinnan Wang MD, Ph.D. AcureX has built a unique target and drug discovery platform to accelerate drug development and de-risk clinical trials with an exclusive license to the founding intellectual property. The AcureX team is led by veteran scientists with a proven track record in CNS drug development and serial life sciences entrepreneurs. For more information, please visit https://www.acurex.com.

Story continues

Oppenheimer Biotechnology Emerging Science Summit Registration

To express interest, please contact your Oppenheimer Institutional Salesperson or email Deena Sullivan at Deena.Sullivan@opco.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20211011005102/en/

Contacts

Ashley Gonzalez, Ph.D.Info@acurex.com

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AcureX Therapeutics to Present at Oppenheimer Biotechnology Emerging Science Summit - Yahoo Finance

DUBLIN--(BUSINESS WIRE)--The "Analytical instrument Market in US 2021-2025" report has been added to ResearchAndMarkets.com's offering.

The analytical instrument market in the US is poised to grow by $ 5.57 bn during 2021-2025, progressing at a CAGR of almost 3%.

The market is driven by the rise in demand for generic drugs and stringent government regulations. This study also identifies the decline in the price of PV systems as one of the prime reasons driving the analytical instrument market in the US growth during the next few years.

The report on analytical instrument market in the US provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers an up-to-date analysis regarding the current us market scenario, latest trends and drivers, and the overall market environment.

The robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading analytical instrument market in US vendors that include ABB Ltd., Agilent Technologies Inc., AMETEK Inc., Bio-Rad Laboratories, Inc, Bruker Corp., Danaher Corp., General Electric Co., Honeywell International Inc., Mitsubishi Electric Corp., and Siemens AG.

Also, the analytical instrument market in US analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

Key Topics Covered:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Product

Market Segmentation by End-user

Customer landscape

Vendor Landscape

Vendor Analysis

Appendix

For more information about this report visit https://www.researchandmarkets.com/r/ue0qgq

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US Analytical instrument Market Report 2021-2025: Focus on Pharmaceutical and Biotechnology, Food and Beverage, & Environmental Testing -...

Renowned industrialist and founder chairman of Praj Industries, Dr Pramod Chaudhari, who is popularly known as the Ethanol man, recently said that agricultural inputs form the base of biotechnology and these can be used to uplift the socio-economic status of farmers. Dr Chaudhari was speaking at an event held in his honour and hosted by United Western Business Forum at Hotel Sayaji in Wakad.

Dr Chaudhari was felicitated by Dr Anand Deshpande, the CMD of Persistent Systems, for being the first Indian recipient of the prestigious George Washington Carver Award, 2020.

Pune Mayor Murlidhar Mohol and PMRDA (Pune Metropolitan Region Development Authority) Commissioner Dr Suhas Diwase also attended the programme.

Dr Chaudhari said that biofuels are redefining transportation fuel mix and they also help combat climate change as they have low carbon content. The use of agricultural feedstock for production of biofuels provided an additional source of income to farmers, he added. Dr Chaudhari said that bio-based renewable chemicals and materials are the new frontier of bioeconomy.

Mohol said Dr Chaudharis achievement is a matter of pride for Puneites and added that People like Dr Chaudhari will inspire the youth of the city.

Dr Deshpande said an entrepreneur should always think about achieving the next level for his business, because any business can stagnate after reaching a certain level of success. He also suggested that a wide base of mentors was required to guide the entrepreneurs through difficult times.

The dean of alumni and corporate relations at IIT Bombay, Dr Suhas Joshi, said that the institute was in advanced stages of discussions with Dr Chaudhari for setting up a lifelong learning centre for IIT-B alumni. The institute has a strong base of over 65,000 alumni working across various segments and they have an urge to learn new skills from their alma mater, Joshi added.

Dr Diwase pointed out that biotechnology had the potential to make agriculture sustainable and economically viable. This will also help reduce urban influx and ease pressure on cities, he said. The current Covid-19 pandemic has shown the youth the importance of moving back to the fields rather than seeking opportunities in big cities, he said.

Go here to read the rest:
Biotechnology can be used to improve condition of farmers, says Ethanol man - The Indian Express

It's nice to see the Clal Biotechnology Industries Ltd. (TLV:CBI) share price up 16% in a week. Meanwhile over the last three years the stock has dropped hard. Tragically, the share price declined 56% in that time. So the improvement may be a real relief to some. After all, could be that the fall was overdone.

While the stock has risen 16% in the past week but long term shareholders are still in the red, let's see what the fundamentals can tell us.

See our latest analysis for Clal Biotechnology Industries

To paraphrase Benjamin Graham: Over the short term the market is a voting machine, but over the long term it's a weighing machine. One imperfect but simple way to consider how the market perception of a company has shifted is to compare the change in the earnings per share (EPS) with the share price movement.

Clal Biotechnology Industries became profitable within the last five years. That would generally be considered a positive, so we are surprised to see the share price is down. So given the share price is down it's worth checking some other metrics too.

We note that the dividend seems healthy enough, so that probably doesn't explain the share price drop. We like that Clal Biotechnology Industries has actually grown its revenue over the last three years. But it's not clear to us why the share price is down. It might be worth diving deeper into the fundamentals, lest an opportunity goes begging.

You can see below how earnings and revenue have changed over time (discover the exact values by clicking on the image).

Balance sheet strength is crucial. It might be well worthwhile taking a look at our free report on how its financial position has changed over time.

When looking at investment returns, it is important to consider the difference between total shareholder return (TSR) and share price return. Whereas the share price return only reflects the change in the share price, the TSR includes the value of dividends (assuming they were reinvested) and the benefit of any discounted capital raising or spin-off. It's fair to say that the TSR gives a more complete picture for stocks that pay a dividend. We note that for Clal Biotechnology Industries the TSR over the last 3 years was -50%, which is better than the share price return mentioned above. This is largely a result of its dividend payments!

Clal Biotechnology Industries shareholders are down 5.6% for the year (even including dividends), but the market itself is up 48%. However, keep in mind that even the best stocks will sometimes underperform the market over a twelve month period. However, the loss over the last year isn't as bad as the 7% per annum loss investors have suffered over the last half decade. We would want clear information suggesting the company will grow, before taking the view that the share price will stabilize. While it is well worth considering the different impacts that market conditions can have on the share price, there are other factors that are even more important. Take risks, for example - Clal Biotechnology Industries has 4 warning signs (and 1 which is significant) we think you should know about.

For those who like to find winning investments this free list of growing companies with recent insider purchasing, could be just the ticket.

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

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.

See the article here:
Investors in Clal Biotechnology Industries (TLV:CBI) from three years ago are still down 50%, even after 16% gain this past week - Simply Wall St

Accelerate development of GMP-grade production enzymes essential for manufacturing mRNA-based biopharmaceuticals

SEOUL, Korea and LANGENFELD, Germany, October 13, 2021 / B3C newswire / -- Today, Cellumed Co. Ltd., listed stock market company and Germany based ARTES Biotechnology GmbH announce the execution of a Development and License Agreement aiming at the generation of microbial production cell lines, processes and documentation for the cGMP manufacturing of two enzymes required in the manufacturing process of mRNA vaccines.

Under this agreement, ARTES shall be responsible for the development of high yield microbial cell lines expressing two recombinant enzymes. Further steps at ARTES will include the development of up- and downstream processes as well as of the analytical assays to characterize the two products. Results will be transferred by ARTES to its German CMO partner Richter-Helm BioLogics GmbH & Co. KG for subsequent cGMP production. The project management will be supported by ARTES Korean representative Quality by Design, Inc.

Cellumed predicts that the mRNA platform will gradually expand product development in the future as a base technology with high potential for developing other vaccines and therapeutics even after COVID-19 subsides. Therefore, Cellumed will realize technological independence of materials through the localization of production enzymes, which are key raw materials for mRNA vaccines. In addition, it is planning to supply production enzymes in Korea first, and is also planning to gradually advance into the global market.

Statement of Dr. Michael Piontek, Managing Director of ARTES Biotechnology: We are very proud being chosen by Cellumed for this important task of supporting the establishment of most up-to-date mRNA technology in South-Korea. We will contribute our long term experience in recombinant biotechnology and will give all our outstanding expertise and know-how in this collaboration. We are looking forward to building a strong and long lasting relation with Cellumed.

About CellumedCellumed is leading the field of tissue graft materials based on human-derived biomaterials, leading the localization of artificial joints and succeeding in establishing a recombinant protein production system that cultivates a large amount of growth factors for treatment. In addition, it is the best musculoskeletal medical device specialist in Korea, developing various products by combining excellent biotechnology and biomaterials and leading to high value-added of existing products.Cellumed was established in 1997 under the corporate philosophy of respect for human beings and received approval for establishment of a human tissue bank from the Ministry of Food and Drug Safety (MFDS) in 2005. Cellumed's human tissue bank is processed and distributed into safe and excellent tissue graft materials by specialized researchers. Products are continuously researched and developed.Cellumed succeeded in developing and mass-producing rhBMP2, a recombinant protein derived from animal cells (CHO Cell), for the first time in Asia and for the second time in the world. In addition to rhBMP2, we have also succeeded in developing various recombinant protein growth factors such as BMP4, BMP7, GDF5, TGF-1, and FGF7 so that more people can lead a healthy life. We will become the most competitive global bio company in the world through innovative bio product portfolios.

About ARTESARTES Biotechnology GmbH is a Germany-based company specialized in recombinant protein production, process and vaccine (VLP-based) development from microbial expression systems. ARTES offers generation of optimized production cell lines in proprietary yeast expression systems based on Hansenula polymorpha and in bacteria. In addition to genetic engineering, the company provides fermentation and downstream process development, analytical assay development and production cell line characterization. ARTES operates worldwide from its 850 sqm S1 facilities in Langenfeld.

Contact

ARTES Biotechnology GmbHDr. Melanie Piontek+49 2173 27587 12This email address is being protected from spambots. You need JavaScript enabled to view it.

Keywords: Cell Line; Technology; Cell Culture Techniques; Culture Media; Cell Proliferation; Cell Line Development; Cells, Cultured; Recombinant Proteins; Productivity; Biological Products; RNA, Messenger; Commerce; Republic of Korea; Germany

Published by B3C newswire

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Cellumed and ARTES Sign Development and License Agreement - b3c newswire