CARLSBAD, Calif., Oct. 5, 2021 /PRNewswire/ -- Thermo Fisher Scientific today announced the launch of Gibco Cell Therapy Systems (CTS) NK-Xpander Medium, a GMP-manufactured cell culture medium that supports large-scale growth and culture of functional natural killer (NK) cells with or without the use of feeder cells. This is the first medium from Thermo Fisher specifically designed to support expansion of NK cells for cell therapy applications and is supported by raw material traceability and regulatory documentation.

"Cell therapy developers are increasingly turning to NK cells because they do not elicit the kinds of active immune responses that trigger conditions such as graft versus host disease," said Mark Powers, vice president, research and development at Thermo Fisher Scientific. "With NK-Xpander Medium, manufacturers can reach the necessary scale they need for NK cell therapies while minimizing regulatory burden and risk."

NK cells grown in NK-Xpander Medium exhibit a greater rate of expansion when compared to NK cells grown in other media and demonstrate cell killing in in vitro and in vivo models. In addition to their low immunogenicity, the ease of availability and sourcing of NK cells, coupled with efficient in vitro expansion, make them ideally suited for the development of allogeneic cell therapies. Unlike autologous therapies, which are produced using a patient's own cells, allogeneic cell therapies are derived from healthy donor tissue, and are more conducive to cost-effective scale-up of cell therapy manufacturing.

"NK cell therapies hold promising applications in treating solid tumors, which haven't been well served by therapies derived from other cell types," said Richard Eckert, professor and chairman at University of Maryland School of Medicine. "To capitalize on the promise of these therapies, our lab used human NK cells grown in Gibco CTS NK-Xpander Medium to study their impact on solid tumor-derived cancer cells. The NK cells cultured in NK-Xpander Medium displayed robust and potent cancer cell killing activity."

NK-Xpander Medium is part of Thermo Fisher's CTS product line, a comprehensive portfolio of GMP-manufactured products backed by regulatory documentation and designed to work synergistically, from cell isolation/activation to gene transfer and cell expansion, to address cell therapy developers' manufacturing workflow needs.

To learn more about Thermo Fisher's cell and gene therapy solutions, please visit http://www.thermofisher.com/CGT. To learn more about Gibco CTS NK-Xpander Medium, please visit http://www.thermofisher.com/nkcelltherapy.

* For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. This product is not intended for direct administration into humans or animals.

About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visitwww.thermofisher.com.

# # #

Media Contact Information:

Mauricio Minotta Phone: 760-805-5266 Email: [emailprotected]

Jessika Parry Phone: 419-266-4016Email: [emailprotected]

SOURCE Thermo Fisher Scientific

http://www.thermofisher.com

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New Culture Medium Supports Expansion of Natural Killer Cells for Cell and Gene Therapies - PRNewswire

Recommendation and review posted by Bethany Smith

EXTON, Pa., Sept. 29, 2021 /PRNewswire/ --Castle Creek Biosciences, Inc., a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options, today announced a research collaboration with Mayo Clinic to advance discovery and pre-clinical development of investigational gene therapy candidates for the treatment of osteogenesis imperfecta (OI) and classical Ehlers-Danlos syndrome (EDS), which are rare genetic connective tissue disorders that currently have no treatments approved by the U.S. Food & Drug Administration (FDA). The research will be led by principal investigator David R. Deyle, M.D., a board-certified medical geneticist with the department of medical genetics at Mayo Clinic and a leader in the field of connective tissue disorders.

"We are honored to be working with Dr. Deyle and his highly regarded research team at Mayo Clinic to identify and evaluate gene therapy candidates that hold promise for treating debilitating, rare connective tissue disorders with high unmet medical needs," said Matthew Gantz, president and chief executive officer of Castle Creek Biosciences. "We expect this initiative will be the first of multiple Castle Creek strategic collaborations with leading medical research institutions that have the potential to expand our innovative gene therapy discoveries for rare diseases and offer hope to underserved patient communities impacted by these devastating conditions."

Osteogenesis imperfecta, also known as brittle bone disease, is caused by genetic mutations that affect the synthesis of Type I collagen and can lead to fragile bones, scoliosis, short stature, dental disorders, and laxity of skin ligaments. OI is estimated to affect one in 6,600 people in the U.S. and may be diagnosed at any age. Classical EDS results from genetic mutations affecting synthesis of Type V collagen and is associated with skin hyperextensibility and fragility, hypotonia, joint instability, chronic pain, and fragile blood vessels. Vascular and pulmonary complications have also been reported. EDS is estimated to affect one in 20,000 people in the U.S.

"Castle Creek is leveraging its proven expertise and experience in rare diseases and late-stage clinical development of cell and gene therapies to establish strategic collaborations with world-class research organizations for studying early-stage novel treatments to address critical, unmet medical challenges of patients suffering from rare genetic conditions," said Jeff Aronin, founder and chairman of Castle Creek Biosciences, and founder, chairman and chief executive officer of Paragon Biosciences, LLC. "We commend Matthew and his leadership team for their strategic insight and guidance that have long-term potential to fuel discovery and advancement of innovative gene therapy candidates and enhance the depth of Castle Creek's pipeline."

For this research collaboration, Castle Creek will contribute its proficiency in rare diseases and gene therapy development and has licensed intellectual property related to OI and classical EDS from Mayo Clinic. Following completion of the discovery through pre-clinical development phases at Mayo Clinic, Castle Creek anticipates moving into clinical development of selected gene therapy candidates at its in-house, commercial-scale current good manufacturing practices (cGMP) manufacturing facility located in Exton, Pa.

About Castle Creek Biosciences, Inc.

Castle Creek Biosciences, Inc. is a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options. The company's proprietary autologous fibroblast platform potentially allows for the development ofpersonalized, targeted and redosable cell-based gene therapy product candidates formonogenic and chronic disorders. The company's most advanced product candidate, dabocemagene autoficel (D-Fi), is currently being evaluated in a Phase 3 clinical trial for the localized treatment of chronic wounds due to recessive dystrophic epidermolysis bullosa (RDEB). The company is also currently evaluating FCX-013 in a Phase 1/2 clinical trial for the treatment of moderate to severe localized scleroderma. In addition, Castle Creek Biosciences is pursuing discovery and potential development of early-stage novel product candidates with the goal of expanding its robust pipeline into other rare diseases and broader indications where there are significant unmet needs. The company operates an in-house, commercial-scale manufacturing facility in Exton, Pennsylvania that benefits from the validated systems and processes previously implemented at the site for manufacture of an FDA-approved cell therapy product.Castle Creek Biosciences, Inc. is a portfolio company of Paragon Biosciences, LLC. For more information, visit https://castlecreekbio.com/or follow Castle Creek on Twitter @CastleCreekBio.

About Paragon Biosciences, LLC

Paragon is a global life science leader that creates, builds and funds innovative biology-based companies in three key areas: cell and gene therapy, adaptive biology and advanced biotechnology. The company's current portfolio includesCastle Creek Biosciences,CiRC Biosciences,Emalex Biosciences,Evozyne,Harmony Biosciences,Qlarity Imaging,Skyline Biosciences, and a consistent flow of incubating companies created and supported by the Paragon Innovation Capital model. Paragon stands at the intersection of human need, life science, and company creation. For more information, please visithttps://paragonbiosci.com/.

Media Contacts

Jenna Urban Berry & Company Public Relations 212.253.8881 [emailprotected]

Karen CaseyCastle Creek Biosciences302.750.4675 [emailprotected]

SOURCE Castle Creek Biosciences, Inc.

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Castle Creek Biosciences Expands its Innovative Gene Therapy Platform for Rare Genetic Connective Tissue Disorders through Research Collaboration with...

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today celebrated the grand opening of the Genetic Therapies Center of Excellence (GTCOE), its new research facility in Columbus, Ohio.

The 85,000 square foot state-of-the-art facility expands Sarepta’s research and development capabilities and footprint, which includes sites in Cambridge, Andover and Burlington, Mass. With more than 70 employees today and plans to double the number of employees by the end of 2022, the Center is focused on discovery, pre-clinical and clinical development supporting Sarepta’s pipeline of genetic medicines which includes RNA, gene therapy and gene editing programs. The Center also supports process development and optimization work that enables the transition from clinical-scale to commercial-scale manufacturing, a critical task facing companies developing gene therapies.

Advances in the science of genetic medicine are creating incredible opportunities to develop medicines with the potential to transform the lives of people with rare diseases. Sarepta’s Genetic Therapies Center of Excellence complements and enhances our existing research and development expertise and will play a central and strategic role in our future as the leader in precision genetic medicine,” said Doug Ingram, president and chief executive officer, Sarepta.

Among the guests joining the Sarepta team today for a dedication, ribbon-cutting ceremony and facility tours: The Honorable Jon Husted, Ohio’s Lieutenant Governor; Pat Furlong, president and chief executive officer, Parent Project Muscular Dystrophy (PPMD); Jessica Evans, assistant director, The Speak Foundation; local officials; and luminaries from Columbus’ growing biotechnology sector. At the event, Sarepta also announced a $20,000 donation to the Ronald McDonald House Charities of Central Ohio, with Dee Anders, chief executive officer and executive director, Ronald McDonald House Charities of Central Ohio, present to accept.

Sarepta has operated in Columbus since 2018 and we’re proud to be at the forefront of Columbus’ emergence as a leading hub for biotechnology committed to the local community and the patients and families we serve,” said Louise Rodino-Klapac, Ph.D., Sarepta’s Columbus-based executive vice president and chief scientific officer. Our growing presence in Ohio will help us strengthen our close working relationships with long-standing local partners such as Nationwide Children’s Hospital, while we work with the greatest urgency to advance our pipeline, further the science of genetic medicine and create an environment where future generations of scientific talent will thrive.”

Sarepta Therapeutics’ decision to expand in Ohio is the latest example that Ohio is a great state to grow a business,” said Lt. Governor Jon Husted. When we created the Columbus Innovation District last year, we were focused on cultivating the right environment in central Ohio to attract new investments and jobs in gene and cell therapy. This new facility is a victory, as it builds on our strategy, creating jobs and producing some of the most advanced research and development of precision genetic medicine, further solidifying Ohio as a leader in gene therapy.”

About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit http://www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at http://www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Forward-Looking Statements This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding potential opportunities in the rare disease space; the potential transformative benefits of medicines in the rare disease space; our plans to double the number of employees in Columbus, Ohio by the end of 2022; and the potential for our growing presence in Ohio to help strengthen our close working relationships with long-standing local partners while we work with the greatest urgency to advance our pipeline, further the science of genetic medicine and create an environment where future generations of scientific talent will thrive.

These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Many of these risks and uncertainties are beyond our control. Known risk factors include, among others: we may not be able to execute on our business plans and goals, including meeting our expected or planned regulatory milestones and timelines, clinical development plans, and bringing our product candidates to market, due to a variety of reasons, many of which are outside of our control, including possible limitations on company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; the impact of the COVID-19 pandemic; and those risks identified under the heading Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2020, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings we make, which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties we face, we encourage you to review our SEC filings. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. We undertake no obligation to update forward-looking statements based on events or circumstances after the date of this press release, except as required by law.

Source: Sarepta Therapeutics, Inc.

Investor Contact: Ian Estepan, 617-274-4052 iestepan@sarepta.com

Media Contact: Tracy Sorrentino, 617-301-8566 tsorrentino@sarepta.com

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Sarepta Therapeutics Opens Genetic Therapies Center of Excellence in Columbus, Ohio - Stockhouse

Recommendation and review posted by Bethany Smith

Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market report focused on the comprehensive analysis of current and future prospects of the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing industry. It describes the optimal or favourable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period. An in-depth analysis of past trends, future trends, demographics, technological advancements, and regulatory requirements for the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market has been done in order to calculate the growth rates for each segment and sub-segments.

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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Top Key Vendors of this Market are:

BioReliance, Cobra Biologics, Oxford BioMedica, UniQure, FinVector, MolMed, MassBiologics, Richter-Helm, FUJIFILM Diosynth Biotechnologies, Lonza, Aldevron, Eurogentec, Cell and Gene Therapy Catapult, Biovian, Thermo Fisher Scientific (Brammer Bio), VGXI, PlasmidFactory, bluebird bio, Novasep, Spark Therapeutics, Vigene Biosciences.

Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Segmentation:

Product Type Segmentation:

CancersInherited DisordersViral InfectionsOthers

Industry Segmentation:

CancersInherited DisordersViral InfectionsOthers

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market. This report is a consolidation of primary and secondary research, which provides market size, share, dynamics, and forecast for various segments and sub-segments considering the macro and micro environmental factors. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market.

The influence of the latest government guidelines is also analysed in detail in the report. It studies the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing markets trajectory between forecast periods. The cost analysis of the Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market has been performed while keeping in view manufacturing expenses, labour cost, and raw materials and their market concentration rate, suppliers, and price trend.

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The report provides insights on the following pointers:

Market Penetration: Comprehensive information on the product portfolios of the top players in the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market.

Regions Covered in the Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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Table of Contents

Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Research Report 2021 2027

Chapter 1 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Forecast

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Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market to Witness Huge Growth by 2028 | BioReliance, Cobra Biologics, Oxford BioMedica...

Recommendation and review posted by Bethany Smith

Cell therapy plays an important role in vascular and hematopoietic, neural, skeletal, pancreatic, periodontal, and mucosal tissue regeneration. Platelet-derived growth factors and bone morphogenetic factors are gaining high demand for diabetic neuropathic ulcers and periodontal defects, and tissue regeneration at sites of tibia fractures. Increasing demand for transforming growth factors in regenerative medicine is expected to propel market growth substantially over the coming years.

Stem cell research continues to expand due to high adoption of stem cell treatment. Therefore, bone morphogenetic proteins (BMPs) and TGF-beta proteins are gaining demand and supporting the clinical development of cellular therapies. Cell culture has helped the most in oncology research as cancer cells are more responsive to culture in vitro, which, in turn, is drive demand in research areas.

Increasing healthcare R&D expenditure further improves the chances of breakthrough treatment options. Rapidly growing healthcare expenditure is resulting in new molecule discovery, evaluation of various molecules for possible disease treatment, and adoption of innovative approaches in these studies.

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Key manufacturers of transforming growth factor are focusing on the development of technology to cater to specific research requirements.

The COVID-19 pandemic affected health services for other diseases such as hypertension, cancer, diabetes, and cardiovascular diseases. Selective procedures such as orthopedic joint replacement were impacted. Shifted focus of healthcare professionals from these diseases to address the COVID-19 crisis negatively impacted the overall healthcare industry.

However, the transforming growth factor space did not see any long-term adverse effect on its business. A short-term impact of COVID-19 has been seen on the market due to disruptions in the supply chain and research activities during lockdowns. The market is projected to experience smooth growth over the coming years.

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Key Takeaways from Market Stud

By grade, the GMP segment is fast-growing at CAGR of 9.3%, on the back of rise is demand for supreme quality growth factors across regions.

Based on product, bone morphogenetic proteins (BMPs) is leading with over 43% market share.

Oncology research is estimated to lead the market by application. This segment accounted for approximately 22% share of the market.

Pharmaceutical and biotechnology companies lead demand for transforming growth factors with a market share of 48%.

By region, North America is set dominate the global market with a value share of around 41%. Europe is slated to be the second-largest leading region with a value share of 32%.

"Increasing drug discovery and stem cell research is expected to drive market expansion of transforming growth factors over the next ten years," says an analyst of Persistence Market Research.

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Market Competition

Agreements, collaborations, and partnerships have emerged as the key growth strategy adopted by industry players. By focusing on these strategies, key stakeholders are expanding their geographic footprints and strengthening their existing product portfolios.

In February, 2019, Roche entered into a definitive merger agreement to acquire Spark Therapeutics.

In 2021, Bio-Techne Corporation) and Catamaran Bio expanded their collaboration for the development of cell engineering and cell process technologies for use by Catamaran in the manufacturing of CAR-NK cell therapy products.

What Does the Report Cover?

Persistence Market Research offers a unique perspective and actionable insights on the transforming growth factor market in its latest study, presenting historical demand assessment of 2016 2020 and projections for 2021 2031.

The research study is based on the product (activin, bone morphogenetic proteins (BMPs), TGF-beta proteins), grade (GMP grade, NON-GMP grade), application (oncology research, haematology research, wound healing research, dermatology research, cardiovascular disease & diabetes, cell therapy and ex vivo manufacturing, others), end user (pharmaceutical and biotechnology companies, research centres & academic institutes, CMOs and CDMOs), across seven key regions of the world.

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Persistence Market Research (PMR), as a 3rd-party research organization, does operate through an exclusive amalgamation of market research and data analytics for helping businesses ride high, irrespective of the turbulence faced on the account of financial/natural crunches.

Overview:

Persistence Market Research is always way ahead of its time. In other words, it tables market solutions by stepping into the companies'/clients' shoes much before they themselves have a sneak pick into the market. The pro-active approach followed by experts at Persistence Market Research helps companies/clients lay their hands on techno-commercial insights beforehand, so that the subsequent course of action could be simplified on their part.

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Transforming Growth Factor Sales Gaining Traction & to reach US$ 709.9 Mn with Significant Development in Cell Therapy Research - PRNewswire

Recommendation and review posted by Bethany Smith

Research and development of stem cell-based therapies, where a patients own cells, or those from a donor, are used to fight injury and disease, is one of the fastest growing areas in the biotech space. Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company in the thick of clinical development, continues to advance its investigational therapeutic, Lomecel-B, for chronic, aging-related and life-threatening conditions.

The company recently announced the results of its randomized, blinded and placebo-controlled Phase 2 trial to evaluate the safety and efficacy of its proprietary Lomecel-B infusion in frail, older patients between 70 and 85 years old. The trial, which was partially funded by the National Institute on Aging, evaluated a single intravenous infusion of 4 different doses of Lomecel-B cell therapy compared to placebo on the change in the distance a person could walk in 6 minutes (a test known as the 6-minute walk test). Results showed that a single infusion of Lomecel-B resulted in an increase in walk distance of approximately 50 meters (164 feet) at 6 and 9 months after infusion, while the placebo-treated subjects showed minimal improvement at 6 months and a deterioration by 9 months.

Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors, which are culture-expanded in Longeverons current good manufacturing practice cell-processing facility. According to trial results so far, Lomecel-B, and MSCs in general, may be injected or infused into an unrelated recipient without triggering a harmful reaction (rejection) due to the biochemical properties of these specialized cells. This is in part what makes this class of biologic so intriguing for use as a regenerative therapeutic.

A growing global trend is for biotech companies to direct their services to the cell and gene therapy industry and moving to expand into a new branch of the pharmaceutical contract development and manufacturing organization world.

Story continues

The U.S. Food and Drug Administration (FDA) has approved a small number of cell and gene therapy drugs. Still, a new product pipeline is fighting for the agencys attention with approximately 1,200 experimental therapies more than half in Phase 2 clinical trials. The annual sales growth estimates for cell therapies are projected to reach 15%.

Longeveron has also initiated a Phase 2 trial evaluating the safety and efficacy of Lomecel-B injection into the heart of children born with hypoplastic left heart syndrome (HLHS), a rare and often fatal congenital heart defect.

Longeveron believes that using the same cells that promote tissue repair, organ maintenance and immune system function can develop safe and effective therapies for some of the most challenging diseases and conditions associated with aging.

We continue to make steady progress advancing our Lomecel-B clinical research programs forward, Longeveron CEO Geoff Green said. We have encouraging top-line results from our Aging Frailty program, and anticipate initiating a Phase 2 trial in Alzheimers disease later this year.

Longeveron shared their review of the Aging Frailty trial data with independent frailty experts, with the objective of planning the next steps for the program. The company presented clinical data at the 2021 International Conference on Frailty & Sarcopenia Research on Sept. 29 during a round-table presentation.

Learn more about Longeveron at http://www.longeveron.com.

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

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Longeveron Successfully Advancing its Cell-Based Therapy Studies in a Growing Industry Segment - Yahoo Finance

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Hemoglobinopathies Market Size, Share & Trends Analysis Report by Type (Thalassemia, Sickle Cell Disease, Other Hemoglobin (Hb) Variants), by Diagnosis, by Therapy, by Region, and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The global hemoglobinopathies market size is expected to reach USD 15.7 billion by 2028, expanding at a CAGR of 10.8%

Increasing awareness regarding hemoglobinopathies and government initiatives to diagnose the diseases at an early stage are expected to propel market growth over the forecast period. Moreover, increasing R&D investment, the presence of a promising drug pipeline, and technologically advanced diagnostics platforms are expected to boost the growth of the market.

The development of novel curative technologies, such as CRISPR/Cas9 and hematopoietic stem cell transplantation, coupled with a promising pipeline, is expected to propel market growth. Moreover, the presence of regulatory agencies, such as the FDA, which are working toward improving drug approval rate by granting accelerated approval for hemoglobinopathies drugs, is expected to drive the market.

Initiatives such as the Sickle Cell Awareness Initiative (SCAI) are working toward educating the people about the disease, which will increase the diagnosis and treatment rate. SCAI also raises funds for individuals affected with sickle cell diseases (SCDs) and provides research funding.

Moreover, governments of Middle Eastern and Asian countries provide funds for R&D of hemoglobinopathies treatment. For instance, various programs undertaken by governments, such as thalassemia screening in neonates and providing medicines, are impacting the market growth positively.

The high patient population in low-income countries has encouraged market players and non-profit organizations to launch several initiatives to improve the access to the therapy.

For instance, in February 2019, the Access to Excellent Care for Sickle Cell Patients Pilot Program (ACCEL) was launched by Global Blood Therapeutics, Inc. in order to provide research funding for novel SCD projects, with an aim to expand the access to optimal healthcare for sickle cell disease.

Biopharmaceutical companies are collaborating with nonprofit organizations to promote public awareness about hemoglobinopathies.

An increase in investment and funding for the development of novel therapies to treat hemoglobinopathies will further boost the market growth over the forecast period. The National Heart, Lung, and Blood Institute (NHLBI) has significantly invested in research & development in sickle cell disease.

The NHLBI supports research work through various initiatives. Furthermore, private funding such as the Bronx Blood Research Fund (BBRF) provides a platform for research and management of thalassemia and other hemoglobinopathies.

Gene therapy has emerged as a promising treatment option for managing hemoglobin disorder as it targets the underlying genetic cause of the condition through the administration of one-time gene therapy and significantly reduces the need for blood transfusions.

The current pipeline of gene therapy products includes CTX001 (CRISPR Therapeutics), BIVV003 (Sangamo Therapeutics, Inc. & Bioverativ Inc), and HGB-206 (bluebird bio, Inc).

Hemoglobinopathies Market Report Highlights

Global Hemoglobinopathies Market Variables, Trends & Scope

Penetration and Growth Prospect Mapping

Epidemiology Assessment of Hemoglobinopathies

Market Variable Analysis

Market Restraint Analysis

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/8dphl0

Link:
Global Hemoglobinopathies Markets, 2021-2028 - High Unmet Needs / Increasing R&D Investment / Initiatives to Improve Disease Awareness -...

Recommendation and review posted by Bethany Smith

Published: Oct. 4, 2021 at 6:00 AM EDT

NEW YORK, Oct. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the2021 Cell & Gene Meeting on the Mesa, being held as a hybrid conferenceOctober 12-14, and October 19-20, 2021.

Dr. Lindborg's presentation highlights the expansion of Brainstorm's technology portfolio to include autologous and allogeneic product candidates, covering multiple neurological diseases. The most progressed clinical development program, which includes a completed phase 3 trial of NurOwn in ALS patients, remains the highest priority for Brainstorm. Brainstorm is committed to pursuing the best and most expeditious path forward to enable patients to access NurOwn.

Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning October 12. Those who wish to listen to the presentation are required to registerhere. At the conclusion of the 2021 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website underEvents and Presentations.

About the 2021 Cell & Gene Meeting on the Mesa

The meeting will feature sessions and workshops covering a mix of commercialization topics related to the cell and gene therapy sector including the latest updates on market access and reimbursement schemes, international regulation harmonization, manufacturing and CMC challenges, investment opportunities for the sector, among others. There will be over 135 presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

The conference will be delivered in a hybrid format to allow for an in-person experience as well as a virtual participation option. The in-person conference will take place October 12-14 in Carlsbad, CA. Virtual registrants will have access to all content via livestream during program dates. Additionally, all content will be available on-demand within 24 hours of the live program time. Virtual partnering meetings will take place October 19-20 via Zoom.

About NurOwn

The NurOwntechnology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwntechnology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website atwww.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwnmanufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwntreatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwntreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwntreatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

ContactsInvestor Relations:Eric GoldsteinLifeSci Advisors, LLCPhone: +1 646.791.9729egoldstein@lifesciadvisors.com

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com

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BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa - WSAZ-TV

Recommendation and review posted by Bethany Smith

SAN DIEGO--(BUSINESS WIRE)--DTx Pharma, Inc. (DTx), a privately-held biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease, announced that Dr. Arthur Suckow, Co-Founder and CEO, will present at the Ophthalmology Innovation Summits Retina Innovation Showcase on October 7, 2021, during the Annual Scientific Meeting of the American Society of Retina Specialists.

Dr. Suckow will make a presentation during the Spotlight on Cell and Gene Therapy session and discuss DTx Pharmas most advanced program for retinitis pigmentosa (RP). RP is a rare disorder that affects roughly 1 in 4,000 people, both in the United States and worldwide. People with the disease tend to initially develop night blindness, followed by total blindness, as a result of the death of their photoreceptor cells. No therapeutic options exist for this condition that can be caused by more than 300 mutations of 100 different genes.

DTx Pharmas proprietary FALCON (Fatty Acid Ligand Conjugated Oligonucleotide) delivery platform is designed to improve the efficacy of RNA therapies by using fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. Using this novel technology platform, DTx Pharma can improve the cellular uptake of targeted RNA therapies and apply therapies to multiple cell types in the eye, with the goal of developing a gene agnostic therapy for RP.

There are no effective therapeutics for this debilitating disease. We look forward to presenting our preclinical data this week and to working with the experts in retinitis pigmentosa to evaluate a game-changing therapeutic in patients over the next several years, says Dr. Suckow.

About DTx Pharma

DTx Pharma, Inc. is a privately held biotechnology company based in San Diego, CA creating novel RNA-based therapeutics to treat the genetic drivers of disease. The companys proprietary delivery technology platform utilizes fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. In preclinical studies, DTx has demonstrated cellular uptake and broad activity of oligonucleotides in the retina, muscle, heart, neurons, T cells, and other specialized cell types. To advance the FALCON platform toward and into clinical development, DTx has raised more than $100M in combined investment from several of the worlds leading healthcare investors including RA Capital Management and Access Biotechnology, pharmaceutical companies such as Eli Lilly and Company, the National Institute of Health (NIH), and research foundations such as the CMT Research Foundation (CMTRF). To learn more about DTx Pharma, please visit http://www.dtxpharma.com and follow DTx on LinkedIn and Twitter @DTxPharma.

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DTx Pharma to Present at the OIS Retina Innovation Showcase - Business Wire

Recommendation and review posted by Bethany Smith

Bench-to-bedside

Armed with this knowledge, further experiments showed that giving G-CSF, which is already used clinically as an immune system booster in cancer patients to mice with non-mutant IDH1 also increased their survival. And giving it in combination with the immune-stimulating gene therapy had an even bigger impact.

The team also confirmed that patients who have gliomas with mutated IDH1 also have higher levels of G-CSF circulating in their blood a clue that the findings will be applicable beyond the mouse models.

The next step, says Lowenstein, will be to work on moving these findings into a clinical trial, building on the current, ongoing trial using the immunotherapy/gene therapy combination.

Our study shows two main things: Patients with the IDH1 mutation may benefit from immunotherapy due to the G-CSF their tumors are producing, he said. And patients without the mutation may benefit from combining treatment with G-CSF and immunotherapy.

Additional authors include Brandon L. McClellan, Ruthvik P. Avvari, Rohit Thalla, Stephen Carney, Margaret S. Hartlage, Santiago Haase, Maria Ventosa, Ayman Taher, Neha Kamran, Li Zhang, Syed Mohammed Faisal, Felipe J. Nez, Mara Beln Garcia-Fabiani, Wajd N. Al-Holou, Daniel Orringer, Jason Heth, Parag G. Patil, Karen Eddy, Sofia D. Merajver, Peter J. Ulintz, Joshua Welch, Chao Gao, Jialin Liu and Gabriel Nez all of U-M; Shawn Hervey-Jumper of University of California, San Francisco; and Dolores Hambardzumyan of the Tisch Cancer Institute, Mount Sinai School of Medicine, New York.

Funding for the work was provided by National Institutes of Health and National Institute of Neurological Disorders & Stroke (R37-NS094804, R01-NS105556, R21- NS107894, R01- NS076991, R01-NS082311, R01-NS096756; the U-M Department of Neurosurgery; the Pediatric Brain Tumor Foundation, Leahs Happy Hearts Foundation, Ians Friends Foundation, Chad Tough Foundation, Pediatric Brain Tumor Foundation, and Smiles for Sophie Forever Foundation, National Cancer Institute (T32-CA009676), American Brain Tumor Association Basic Research Fellowship and a Rogel Cancer Center Scholar Award.

Paper cited: G-CSF secreted by mutant IDH1 glioma stem cells abolishes myeloid cells immunosuppression and enhances the efficacy of immunotherapy, Science Advances. DOI: 10.1126/sciadv.abh3243

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Glioma subtype may hold the secret to the success of immunotherapies - Michigan Medicine

Recommendation and review posted by Bethany Smith

DUBLIN, September 30, 2021--(BUSINESS WIRE)--The "Viral Vectors And Plasmid DNA Manufacturing Market Size By Product Type, By Application, By End Product, By Geographic Scope And Forecast" report has been added to ResearchAndMarkets.com's offering.

The Global Viral Vectors and Plasmid DNA Manufacturing Market was valued at USD 583.71 Million in 2020 and is projected to reach USD 1,866.90 Million by 2028, growing at a CAGR of 15.40% from 2021 to 2028.

A growing number of patients opting for gene therapy is a major factor propelling the growth of the Viral Vectors and Plasmid DNA Manufacturing market. Gene therapy is a leading field in medical science, which promises new treatment development for patients suffering from various disease. Genetically modified therapies have emerged as a promising treatment approach for various diseases (primarily ones that currently have no cure), including inherited disorders and certain viral infections. Demand for plasmid DNA is rising steeply because of a boom in gene therapy development.

This report provides an all-inclusive environment of the analysis for the Viral Vectors And Plasmid DNA Manufacturing Market. The market estimates provided in the report are the result of in-depth secondary research, primary interviews and in-house expert reviews. These market estimates have been considered by studying the impact of various social, political and economic factors along with the current market dynamics affecting the Viral Vectors And Plasmid DNA Manufacturing Market growth.

Along with the market overview, which comprises of the market dynamics the chapter includes a Porter's Five Forces analysis which explains the five forces: namely buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Viral Vectors And Plasmid DNA Manufacturing Market. It explains the various participants, such as system integrators, intermediaries and end-users within the ecosystem of the market. The report also focuses on the competitive landscape of the Viral Vectors And Plasmid DNA Manufacturing Market.

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The report will provide a valuable insight with an emphasis on the global market including some of the major players such as Merck KGaA, Lonza, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., Cobra Biologics Ltd., Brammer Bio, Waisman Biomanufacturing, Genezen, YPOSKESI, Advanced BioScience, Laboratories, Inc. (ABL, Inc.), Novasep Holding S.A.S, ATVIO Biotech Ltd, and Others.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

3.1 Market Overview

3.2 Global Viral Vectors and Plasmid DNA Manufacturing Market Regional Insights

3.3 Global Viral Vectors and Plasmid DNA Manufacturing Market Geographical Analysis

3.4 Global Viral Vectors and Plasmid DNA Manufacturing Market, by Product Type

3.5 Global Viral Vectors and Plasmid DNA Manufacturing Market, by Application

3.6 Global Viral Vectors and Plasmid DNA Manufacturing Market, by End Product

3.7 Future Market Opportunities

3.8 Global Market Split

4 Market Outlook

4.1 Global Viral Vectors and Plasmid DNA Manufacturing Market Outlook

4.2 Market Drivers

4.2.1 Increasing Number of Patients Opting for Gene Therapy

4.2.2 Rising Prevalence of HIV/Aids and Growing R&D Funding from Several Organizations

4.3 Restraints

4.3.1 Manufacturing Challenges Pertaining to Large Scale Production of Vectors

4.4 Opportunities

4.4.1 Growing Healthcare Infrastructure and Government Support

4.4.2 Growing Number of Gene Therapy Candidates, Coupled With Their Rapid Progression Through Various Phases of Clinical Development

4.5 The Impact of Covid-19

4.6 Porters Five Force Model

4.7 Product Life Line

5 Market, by Product Type

5.1 Overview

5.2 Viral Vector

5.3 Plasma DNA

5.4 Non-Viral DNA Vectors

6 Market, by Application

6.1 Overview

6.2 Cancer

6.3 Inherited Disorder

6.4 Infectious Diseases

6.5 Others

7 Market, by End Product

7.1 Overview

7.2 DNA Vaccines

7.3 Gene Therapy

7.4 Immunotherapy

7.5 Others

8 Market, by Geography

8.1 Overview

8.2 North America

8.3 Europe

8.4 Asia-Pacific

8.5 Row

9 Competitive Landscape

10 Company Profiles

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

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005708/en/

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Viral Vectors and Plasmid DNA Manufacturing Market 2021; Growing Number of Gene Therapy Candidates, Coupled with their Rapid Progression through...

Recommendation and review posted by Bethany Smith

LAWRENCEVILLE, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, announces the strengthening of its management team with a new hire and a promotion in its vaccine development program, and the hiring of a veteran clinical trial project manager for its Phase II GEN-1 immunotherapy study in advanced ovarian cancer. These changes all are effective immediately and are as follows:

Carlo Iavarone, Ph.D. joins as Senior Director, Non-Clinical Research

Subeena Sood, Ph.D. promoted to Senior Manager, Biology and Preclinical Studies

Beth J. Llewellyn joins as Director of Clinical Operations

Dr. Iavarone will serve as project leader for the PLACCINE vaccine initiative. He will be based in Huntsville, Ala. and brings to Celsion more than 15 years of experience investigating and leading the development of vaccines, including molecular target identification and characterization of RNA vaccines. Most recently, from 2019 until 2021 he was a science advisor for both Guidepoint and Clora, providing input for a viral target and RNA vaccine delivery system. Dr. Iavarone joined GlaxoSmithKline in 2015 as a senior scientist studying small molecules and RNA vaccines in animal and human cell lines. From 2007 until 2015 he held positions of increasing responsibility at Novartis, including as a principal scientist for a melanoma vaccine project.

Dr. Iavarone has authored more than 15 papers on oncology and vaccine research that were published in peer-reviewed journals. He holds a Ph.D. in Molecular Pathology and Physiopathology from Federico Il University in Naples, Italy, and did his post-doctoral work at Novartis in Siena, Italy.

Dr. Sood is responsible for assay development and in vivo experiments for the PLACCINE DNA vaccine and gene therapy program, and also is based in Huntsville. She has experience with several pharmaceutical companies in experiment design, pharmacological and biochemical assays, manufacturing process design and development, and optimization and implementation of Quality by Design. Dr. Sood joined Celsion as manager of animal research in 2019, where she has designed and conducted all preclinical research. Prior to Celsion, since 2017 she was a Formulation Scientist II at Novocol Healthcare. From 2016 to 2017 Dr. Sood was a Research Associate II at Nektar Therapeutics, and from 2015 to 2016 she was a Quality Control Chemist I at Par Pharmaceuticals. She also worked in regenerative medicine as a Research Fellow at Medstar Heart Institute, Washington Hospital Center in Washington, D.C. from 2010 to 2013.

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Dr. Sood has authored more than 25 articles published in peer-reviewed journals, mainly in the area of cardiology and oxidative stress. She received her Ph.D. in Pharmacology from the All India Institute of Medical Sciences in New Delhi, and was a post-doctoral associate at the Baylor College of Medicine.

Ms. Llewellyn is responsible for the management of the ongoing Phase II OVATION 2 Study with GEN-1 in advanced ovarian cancer and will be based at our corporate office in Lawrenceville. Previously she was the President of 2L Pharma, a clinical operations consulting firm she founded in 2014. Her work included preparing protocols for Investigational New Drug submissions to the U.S. Food and Drug Administration, clinical trial site qualification and compliance and functioning as a liaison between clinical trial sites, contract research organizations and study sponsors. From 2011 to 2014 she was a Clinical Operations Management Consultant for Alba Therapeutics with oversight for all clinical activities related to a Phase IIb protocol investigating the use of a novel pharmaceutical agent for celiac disease. From 2010 to 2011 she was a Clinical Research Associate for Nabi Biopharmaceuticals, where she was responsible for providing in-house and field study monitoring, operational guidance and general assistance for multiple protocols investigating the use of a novel vaccine.

Ms. Llewellyn has been involved in over 30 clinical trials in a variety of therapeutic areas including oncology and infectious disease. She received a B.A. in psychology from Ohio University. Her graduate training in experimental psychology included studies in research design and statistical analysis.

As we continue to advance the development of our PLACCINE DNA-mediated vaccine platform and or Phase II study of GEN-1, we are delighted to deepen our bench strength with these talented and experienced professionals, said Michael H. Tardugno, Chairman, President and Chief Executive Officer of Celsion. Dr. Iavarone brings impressive clinical development experience particularly in RNA vaccines, which is so important Celsions work to develop a SARS-CoV-2 vaccine utilizing a DNA plasmid that encodes for multiple viral antigens.

Dr. Sood has been instrumental in the successful development of assays used to evaluate biological activity of our first generation of vaccines. She has proven herself to be a capable scientific leader, whose expertise will be relied upon as we complete our preclinical work to establish proof of concept using for the PLACCINE platform Covid-19 as a benchmark vaccine.

Lastly, as we advance our Phase 2 study with GEN-1 in advanced ovarian cancer, we welcome Ms. Llewellyn to Celsion. She is charged with ensuring that trial enrollment proceeds as planned, and we are confident she will capably address any protocol issues that might arise, Mr. Tardugno continued. Overall, we believe that with this strengthened team we are better able to realize the promise of Celsions technologies for the benefit of patients and our stockholders.

About Celsion Corporation

Celsion is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of innovative cancer treatments, including immunotherapies, DNA-based therapies and directed chemotherapies through clinical trials and eventual commercialization. The companys product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is under investigator-sponsored development for several cancer indications. Celsion also has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular transfection. For more information on Celsion, visit http://www.celsion.com.

Forward-looking Statements

Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the platform having the potential to provide broad protection against coronavirus disease 2019 (COVID-19), and possible future mutations of SARS-CoV-2 or other coronaviruses. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of the Companys platform to provide broad protection against COVID-19, and possible future mutations of SARS-CoV-2 or other coronaviruses, the issuance of a patent to the Company for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes COVID-19, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in the Celsion's periodic filings with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Celsion Investor ContactJeffrey W. ChurchExecutive Vice President and CFO609-482-2455jchurch@celsion.com

LHA Investor RelationsKim Sutton Golodetz212-838-3777kgolodetz@lhai.com

# # #

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Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities - Yahoo Finance

Recommendation and review posted by Bethany Smith

DALLAS--(BUSINESS WIRE)--Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced that it has been granted orphan drug designation from the European Commission for TSHA-101, an AAV9-based bicistronic gene replacement therapy in development for GM2 gangliosidosis, also called Tay-Sachs or Sandhoff disease.

GM2 gangliosidosis is a fatal neurodegenerative disease caused by deficiency in the lysosomal enzyme -hexosaminidase A, also known as Hex A. The prognosis is devastating, with infantile forms often leading to death within the first four years of life and juvenile onset patients rarely surviving beyond mid-teens, said Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. Residual Hex A activity correlates with the severity of GM2, and based on our understanding of this correlation, small increases in Hex A activity are likely to lead to significant improvements in clinical outcomes and quality of life. Based on dose-dependent improvements in survival in preclinical models, we are highly encouraged that our novel bicistronic gene therapy approach with TSHA-101 has the potential to be a life changing therapy for patients suffering from this rapidly progressive disorder with no current treatment options.

GM2 gangliosidosis is a rare and fatal monogenic lysosomal storage disorder that is part of a family of neurodegenerative genetic diseases that includes Tay-Sachs and Sandhoff diseases. The disease is caused by defects in the HEXA or HEXB genes that encode the two subunits of the -hexosaminidase A (Hex A) enzyme. These genetic defects result in progressive dysfunction of the central nervous system. Residual Hex A enzyme activity determines the severity of the disease. The infantile form of the disease has an onset of symptoms usually before six months of age with residual Hex A enzyme activity of less than 0.1%. Juvenile onset occurs between 1.5 and five years of age with residual Hex A enzyme activity of approximately 0.5%. Early adult onset of the disease has residual Hex A enzyme activity of between 2% to 4%. There are no approved therapies for the treatment of the disease, and current treatment is limited to supportive care.

TSHA-101 is an investigational gene therapy that delivers the HEXA and HEXB genes that make up the -hexosaminidase A enzyme. The two genes are driven by a single promoter within the AAV9 bicistronic vector ensuring that the 2 sub-units of Hex A are produced in a one-to-one ratio within each cell, which is important to ensure efficient production of the transgene. TSHA-101 is the first and only bicistronic vector currently in clinical development and has been granted Orphan Drug and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA). TSHA-101 is administered intrathecally and is currently being evaluated in a single arm, open-label Phase 1/2 clinical trial for the treatment of infants with GM2 gangliosidosis sponsored by Queens University. Preliminary clinical safety and biomarker data are expected by year-end 2021.

The European Commission grants orphan drug designation for medicines being developed for the diagnosis, prevention or treatment of treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union. Orphan designation in the European Union includes benefits such as protocol assistance, reduced regulatory fees and market exclusivity.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, including TSHA-101, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, TSHA-101s eligibility for accelerated approval in the United States and Europe, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, and the potential market opportunity for these product candidates. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2020, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, both of which are available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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Taysha Gene Therapies Receives Orphan Drug Designation from the European Commission for TSHA-101 for the Treatment of Infantile GM2 Gangliosidosis -...

Recommendation and review posted by Bethany Smith

An Ottawa biotech startup has raised millions of dollars to scale up its technology that aims to supercharge production of a key component in emerging gene therapies for cancer and other diseases.

Virica Biotech announced the series-A round, which was led by New York-based Dynamk Capital, on Monday. The company did not reveal the exact value of the deal, which is expected to close later this year with additional contributions from follow-on investors, but co-founder and CEO Jean-Simon Diallo said it was a multimillion-dollar investment.

Founded in 2018, Virica Biotech makes specialized compounds that help boost production of viral vectors, which deliver material into infected cells thats designed to fix defective genes responsible for diseases such as cancer and hereditary blindness.

Diallo used a cooking analogy to describe the process, likening viral vectors to kernels of popcorn that need the catalyst his firm provides to rapidly reproduce.

If you dont apply some heat, youre going to get maybe a few popped kernels, but thats it, he said. Adding our (product) basically allows you to fully pop the popcorn. Were kind of supercharging the microwave, if you will.

Diallo began working on the technology alongside pioneering Ottawa Hospital cancer researcher Dr. John Bell a decade ago as a way to help cancer-fighting viruses bypass the human immune systems defences.

When financing proved hard to come by due to the lengthy approvals process for such therapies, Diallo found another use for the compound that didnt require the same stringent testing: an additive to boost the effectiveness of traditional vaccines that contain virus particles.

Investors soon took note, and the company raised nearly a million dollars in seed funding by early 2020, just as the pandemic triggered a worldwide R&D effort to develop a new vaccine against COVID-19.

While his compound doesnt work on mRNA vaccines that have widely used in the fight against the coronavirus, Diallo says the pandemic gave his firm a proverbial shot in the arm nonetheless.

It forced us to get set up very quickly, he explained. There was certainly a lot of interest in the technology. COVID kind of got us moving. We realized that the opportunity for improving the manufacturing yield of gene therapies in particular was quite enormous.

Diallo says Virica now has contracts with more than 20 manufacturers of gene therapies that hope his products will make their treatments cheaper and more effective.

The firms revenues have more than doubled in the past 18 months, and Diallo expects Viricas headcount to grow from 16 to at least 30 by next year as demand for its technology ramps up. In addition, he says he still sees a big upside in the vaccine market, which now accounts for about 15 per cent of the firms sales.

Historically, the vaccine industry has always been very slow to move, he said. Hopefully, (the COVID) crisis will change things a little bit for the better because everybody had to kind of roll up their sleeves and innovate.

Virica was initially based out of Bayview Yards as part of Invest Ottawas pre-accelerator program. But the growing startup struggled to find suitable lab space in the region until the new Ottawa of Ottawa Health Innovation Hub helped it secure a 3,000-square-foot facility at the University of Ottawa Heart Institute that officially opened this week.

Diallo, a biochemistry professor at uOttawa and a senior scientist at the Ottawa Hospital Research Institute, said he considered moving the company to Montreal and Toronto. He called on the citys business and political leaders to beef up support for biotech ventures like his that are in the early stages of commercializing their products.

We were really glad to be able to stay in Ottawa, Diallo said. There is a biotech sector in Ottawa, it is growing and we need to work together to foster it. Otherwise, people like me are going to leave. Its that simple.

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Ottawa biotech startup Virica gets multimillion-dollar funding injection for gene therapy-boosting technology - Ottawa Business Journal

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Nucleic Acid Therapeutics CDMO Market - A Global and Regional Analysis: Focus on Product, Technology, and End User - Analysis and Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

The global nucleic acid therapeutics CDMO market was valued at $1,546.4 million in FY2020 and is estimated to reach $4,463.7 million by 2030.

The completion of human genome sequencing and the elucidation of the molecular pathways that are critical in the disease molecule interaction have offered an unprecedented opportunity and growth for the development of nucleic acid-based therapeutics. However, to keep with the manufacturing and development of such therapies, the pharmaceutical companies have established partnerships with the contract development and manufacturing company (CDMO) which are the viable alternatives to the in-house development of the drugs. Moreover, the success of the respective business model has also led these CDMOs to become an integral part of such pharmaceutical companies' value chain.

The increasing willingness to outsource drug development to the CDMOs, and the rising need for pharmaceuticals have resulted in the expansion of the global market for nucleic acid therapeutics CDMO.

In the past decade, there has been a vast increase in the amount of gene sequence information that has the potential to revolutionize the way diseases are categorized and treated. Traditional diagnoses, largely anatomical or descriptive in nature, are likely to be superseded by the molecular characterization of the disease. The fact that certain genes drive key disease processes will also enable the rational design of gene-specific therapeutics. Antisense oligonucleotides represent a technology that can play multiple roles in this process. Further, at present, there are 16 nucleic acid therapies approved by the FDA and EMA and many more in the pipeline implying the reliance and acceptance over the usage of such therapies in the market.

Market Growth Drivers

Market Challenges

Market Opportunities

Key Questions Answered in this Report:

Key Topics Covered:

1 Markets

1.1 Industry Outlook

1.2 Product Definition

1.3 Global Nucleic Acid Therapeutics CDMO Market Footprint, ($ Million), 2020-2030

1.4 Current Nucleic Acid Therapeutic CDMOs Landscape

1.5 Significant Usage of Nucleic Acid in Therapeutics

1.6 Types of Nucleic Acid Synthesized for Therapeutics

1.7 Market Dynamics

1.7.1 Market Drivers

1.7.1.1 Accelerating Shift of the Pharmaceutical Market Toward Innovative Biologic and Cell and Gene Therapy Products

1.7.1.2 Reduction in Overall Manufacturing Cost at CDMOs

1.7.1.3 Rising Approvals of Nucleic Acid Therapeutics

1.7.2 Restraints

1.7.2.1 Lack of Expertise in Nucleic Acid Manufacturing

1.7.2.2 Supply Chain and Logistical Challenges

1.7.2.3 Difficult Therapeutic Classification Due to Wide Variety of Nucleic Acids

1.7.3 Opportunities

1.7.3.1 Increasing Outsourcing Trend Among Pharmaceutical Companies

1.7.3.2 Accelerating Research and Development Along with Technology

1.7.3.3 Growth in Developing Countries

2 Competitive Landscape

3 Chemical Synthesis Method

4 Technology

5 End-User

6 Products

7 Regions

8 Markets - Competitive Benchmarking & Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/1x5210

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Nucleic Acid Therapeutics CDMO Market to Reach $4463.7 Million by 2030 - ResearchAndMarkets.com - Business Wire

Recommendation and review posted by Bethany Smith

Martinez had never organized a social media campaign and doesnt consider herself social media savvy. But after ARG won the $100,000 grant, she was running focus groups, coordinating an advisory group of cancer organizations, building a team of co-investigators and partnering with the ARG communications specialist. The young women made it very clear they did not want to be told what to do, Martinez says of the focus groups. Drink less for your breasts felt more like a helpful suggestion.

Planning for the social media campaign began just as the pandemic forced a national shutdown. As the pandemic dragged on, alcohol consumption rose, especially among women. Days of heavy drinking among women, defined as four or more drinks within a couple of hours, rose by 41 percent, according to a survey by the RAND Corporation. (The study compared a baseline survey of 1,540 adults conducted in the spring of 2019 with their responses during a follow-up in the spring of 2020.)

But pushing back against alcohol consumption isnt simple. As the US found during a disastrous prohibition period from 1920 to 1933, opposing alcohol is not popular. When Sharima Rasanayagam,chief scientist for Breast Cancer Prevention Partnersin San Francisco, gives talks about environmental causes of breast cancer, her audience is raptuntil she mentions alcohol. People like to drink and they dont like to hear that, she says. She tells them that quantity matters: At the very least, drink less.

Its a message she delivers with care, to avoid giving women a reason for self-blame if they develop breast cancer and wonder Why me? Cases of breast cancer cant be tied to alcohol alone, because many factors, including genetics and environmental exposures, contribute to the disease, she explains in a YouTube video linked to the Breast Cancer Prevention Partners website. But Rasanayagam notes that risks add upand alcohol is one that women can reduce. Fewer drinks, whether over time or in one day, mean less exposure to acetaldehyde and potentially less effect on estrogen. Its been shown that the less you drink, the lower your risk, she says. (Breast Cancer Prevention Partners is an advisor to the Drink Less for Your Breasts campaign.)

Its a nuanced message but, in its own way, a bold one, as framed in a social media campaign, says David Jernigan, an alcohol policy expert at Boston University, who has been working in the field for 35 years. What Priscilla is doing in California is groundbreaking, he says.

Jernigan asserts that the harm from alcoholwhich also includes drunk driving and an association with violencewarrants a large-scale response similar to anti-tobacco efforts. He notes that in Estonia, a campaign urging Lets drink less by half! actually lowered per capita consumption by 28 percent. (Estonias alcohol policy also included restrictions on advertising, more enforcement of driving-under-the-influence laws, higher taxes, and a focus on treatment.)

The World Health Organization is also developing a global action plan; the current draft sets a goal of reducing per capita consumption by 20 percent by 2030 (with 2010 consumption levels as the baseline). It urges nations to develop and enforce high-impact policy options, such as higher alcohol taxes, restrictions on advertising, and emphasizes awareness of health risks.

Jernigan calls that effort a good step that doesnt go far enough. He favors the development of an international treaty on alcohol, similar to the Framework Convention on Tobacco Control, the first such negotiated through the World Health Organization. It has been signed by 168 countries that committed to taking steps to restrict tobacco advertising, raise cigarette taxes, and prevent youth smoking.

Read more here:
Alcohol Is the Breast Cancer Risk No One Wants to Talk About - WIRED

Recommendation and review posted by Bethany Smith

When Linda Collins was diagnosed with endometrial cancer in her early 60s, she wanted to find the best treatment possible.

After doing her research, she felt confident she would receive the care she needed at Memorial Sloan Kettering Cancer Center.

She also knew what she needed to give her peace of mind. When I called the MSK Patient Access Service to ask about an appointment, I told them that as a Black woman, I would feel more comfortable with a female doctor who is a person of color.

She explains that years before, I had a white, male gynecologist who dismissed concerns that I had. Respectfully, it seemed like he couldnt be bothered. And I have great insurance!

Linda searched the MSK website and knew she had found the doctor she hoped for in Carol Brown, a gynecologic oncology surgeon and MSKs Chief Health Equity Officer.

Dr. Carol Brown, gynecological oncology surgeon

Dr. Brown has devoted her career to improving cancer disparities that mean some groups of people suffer far worse outcomes, particularly Black people.

In May 2021, she launched an important new initiative as the leader of the Endometrial Cancer Equity Program (ECEP).Endometrial cancer develops in the lining of the uterus (womb) and is also sometimes referred to as uterine cancer.

The programs goals are to educate Black women about endometrial cancer, help those diagnosed find appropriate care, and ultimately find treatments to improve outcomes for all women facing the disease, like Linda.

The numbers are truly shocking.

Black women are nearly twice as likely to die of endometrial cancer as white women, even though the disease is actually slightly more common in white women than in Black women.

The number of cases of endometrial cancer is also on the rise, with the greatest increase among Black women.

Dr. Brown stresses that many factors play a role in the troubling disparity in endometrial cancer, including poorer access to health care in some communities, a lack of awareness among some providers, and research efforts that often have not included enough people who are Black, Hispanic, and Asian.

Dr. Brown says research also suggests another important factor may be a cruel twist of biology.

Dr. Brown points out that the disparity in survival between Black and white women diagnosed with endometrial cancer hasnt changed in four decades. Theres no question that if the difference was only about access to health care, the disparity would have at least narrowed. Thats what weve seen happen in cervical cancer and most forms of breast cancer, when you compare Black and white women. But not endometrial cancer.

One distinction coming into clearer focus is that Black women are more often diagnosed with rare but aggressive forms of endometrial cancer.

Black women are more likely to have papillary serous carcinoma of the endometrium as well as carcinoma sarcoma, Dr. Brown says. Cancers caused by these two types of cancer cells definitely lead to worse outcomes and that in itself is a biologic difference.

Ying Liu is a medical oncologist whose specialty is the genetic component of gynecological cancers. She works alongside Dr. Brown investigating cancer disparities.

Dr. Liu explains that one aspect we are looking at is whether these biological differences in the kinds of cancer more commonly found in Black women are not as well targeted by current treatments. That may explain some of the disparity in survival rates between Black and white patients.

The ultimate goal of research at MSK is to better understand these biological differences in endometrial tumors, down to the molecular level, and then use this knowledge to identify weaknesses in the tumors that are more common in Black women. Then, its about finding therapies to treat them.

Dr. Brown explains at MSK we probably have one of the largest groups of Black female patients in the country where we can analyze the genetics of their endometrial cancer tumors as well as their personal genetics.

Lindas diagnosis was an aggressive papillary serous carcinoma, the type that more commonly affects Black women. Fortunately, the cancer was caught at an early stage.

Linda recalls that within days of our first appointment, Dr. Brown performed a laparoscopic hysterectomy, which involves a much smaller incision, and also removed my fallopian tubes, ovaries, and nearby sentinel lymph nodes. To reduce the chance the cancer could come back, Linda underwent a short course of radiation.

Linda says of her treatment, the staff was just fantastic. And I love Dr. Brown. She was so proactive and always took the time to answer all my questions.

Today, Linda is doing the things she loves. She is a pillar of her community in the Bronx, serving as president of her building association, leading clothing drives for homeless shelters, and serving as a liaison with police associations, among other efforts.

After a 32-year career, most of it in government, she says I just love to serve people.

She also wanted to be sure she was around for her family, retiring from the working world in her mid-50s. She explains as a Black woman, you have the sense that your life expectancy might not be as long as the next person.

Dr. Brown and her colleagues hope their new initiative can help.

Since May 2021, the ECEP has participated in community events that have reached more than 500 women in predominately Black neighborhoods that stretch across Long Island, Brooklyn, and Queens.

In addition, Dr. Brown and colleagues including MSK nurse practitioner Latasha Anderson-Dunkley have screened over 20 women at high risk who have been identified through the ECEP. The goal is to assess whether the women have cancer or precancerous conditions and get them appropriate care.

Dr. Brown says its particularly important that women and their providers are aware of endometrial cancer because as cases rise, the symptoms of the disease are not always clear cut.

Traditionally, providers have focused on symptoms that include bleeding in post-menopausal women, who often have other symptoms such as obesity and diabetes, she explains. But this cancer can present as just a heavier-than-usual period bleeding in your 40s. Thats true of all women and particularly Black women.

For Linda, making women aware of how they can protect their health is just what the doctor ordered. To me, outreach and education is so important, because you dont know what you dont know. Too often, this kind of outreach doesnt happen in communities of color. But if it does, it can save lives.

Key Takeaways

Read the original post:
Why Black Women Are Twice as Likely to Die of Endometrial Cancer and What MSK Is Doing to Change It - On Cancer - Memorial Sloan Kettering

Recommendation and review posted by Bethany Smith

Its possible that the timing is not propitious for the launch of a new entertainment series centred on the investigation of a young womans murder. The outrage surrounding the conviction of a serving Metropolitan police officer for the rape and killing of Sarah Everard, and the visibility it has given to the endemic violence against women, is a hurdle to overcome. Channel 4s six-part offering Murder Island also has a further point of connection with the case and the context. One of its participants is former chief superintendent Parm Sandhu, who last week gave an interview to Radio 4s World at One about her experience in the Met. She discussed female officers unwillingness to report sexist and misogynist behaviour for fear that the men will close ranks, and said that the fear that most women police officers have got is that when you are calling for help, you press that emergency button on your radio, theyre not going to turn up and youre going to get kicked in the street.

On the other hand, the vulnerability of women to rapists and murderers is not exactly new information and it hasnt curbed appetites for its exploitation as entertainment before now. So maybe this is by the by. Plus, Murder Islands USP is that it is a new genre a hybrid drama/reality show that keeps the involvement of police proper to a minimum. Instead, four pairs of amateur detectives will compete to solve a murder mystery written by Ian Rankin, about the stabbing of Charly Hendricks in a cottage on a remote Scottish island by a person or persons unknown. One team will be eliminated at each stage of the investigation the winners get a 50,000 prize.

Put like that, I am even less sure than I was that this counts for rather than against the new venture.

Context aside, how does the new format fare? The reality show element sings its customary siren song, giving us competitors spanning the full range of capability. At one end of the spectrum are Andrew and Nick, ambitious, articulate and with the lean, hungry look of leopards on the prowl. Andrews father and grandfather were detectives and he is hoping genetics will out. Although they have to be warned like the rest about making assumptions rather than gathering evidence and seeing what it tells them, they seem to have a basic grasp of procedure and, when it comes to assessing timelines and comparing testimonies, logic. If you had money and cared enough, you would bet on them to win.

At the other end there are Dot and Rox, who have to be told not to stand in the blood pool at the crime scene. They became friends when they worked in the same pub, and reckon they know how to read people. This will be very useful once we move to an all-intuition criminal justice system, but, as things stand, makes them merely extremely fun to watch. Told off by Simon Harding, one of the former detectives who is overseeing and evaluating the teams, for taking more photos of the processed crime scene than he would take on holiday, they wonder aloud how boring his holidays must be.

As we cut between the reality show scenes, full drama scenes play out with the fictional characters. As the competitors travel around the village interviewing Charlys friends, acquaintances and other people of interest played by actors, a story builds of a proposed development on the island that is cleaving the community, Charlys activism on behalf of those against the scheme and a possible love triangle between her, Jean the shopkeeper and particularly dour local Hamish. There is also a pregnancy, mysterious events in the far-flung land of Glasgow that have yet to be fully uncovered and the pubs owner Toby looks shifty to us all.

The goal of all hybrid genres is to double the value of watching. On most occasions, however, it simply halves it because neither contribution is fully developed and each undercuts the others momentum. Murder Island, judged on the first episode, falls into the latter camp. Things may improve as teams are eliminated, allowing the hour to tighten up. It will help, too, if the interactions between the detectives and the actors become less stagey and awkward as they relax into the situation and its strange demands.

How much context matters, of course, is up to us.

View post:
Murder Island review a contest to solve the killing of a young woman? Bad timing - The Guardian

Recommendation and review posted by Bethany Smith

One question to startOctober: Are you getting enough Vitamin D?The benefits from Vitamin D seem never-ending, and now a new women's health study may point to yet one more. Biology researchers in a region with an "elevated risk of breast cancer" have zeroed in on a specific link between the disease and a nutritional deficiency.

Keep reading to learn more about the possible link between breast cancer and Vitamin D. Also, readThe #1 Best Juice to Drink, Says Nutritionist.

In a new issue of the peer-reviewed journal, Nutrition and Cancer, three genetics and biochemistry researchers in Pakistan have published a new study, in which they state, "Pakistani females are at elevated risk of breast cancer."

They also note that Vitamin D deficiency is "an ignored contributing factor" to the illness, "despite a strong association."

Sign up for the Eat This, Not That! newsletter to get food & wellness news delivered daily.

The study included 154 women who had been diagnosed with breast cancer, and 248 selected at random for the control group.

The researchers note that out of these 402 women, 51.5% "were completely ignorant of their [Vitamin D] level." Between the women who weren't aware of their Vitamin D intake versus those who held some awareness, the researchers noted higher incidence of breast cancer among those who were entirely uncertain.

RELATED:These Foods May Increase Your Breast Cancer Risk, Says New Study

Upon analysis, the team discovered a couple insightful trends. They found that women ages 41 to 50 years old were most prone to a Vitamin D deficiency.

Interestingly, women in cities were 12% more likely to suffer a Vitamin D deficiency than women who lived in rural areas.

A possible explanation for this may be greater outdoor exposure to sunlight, which triggers the body to produce Vitamin D. Perhaps more importantly, the higher Vitamin D levels among rural woman might highlight the importance of having access to fresh, nutritious foods, thanks to their proximity to agriculture.

RELATED:The #1 Way to Tell If You Need More Vitamin D, Says Dietitian

The researchers state: "It was concluded that [Vitamin D] deficiency is a highly contributing factor for breast cancer so every female must be aware of the importance of [Vitamin D] and should maintain a sufficient level of this crucially important vitamin."

For more Vitamin D wisdom, readSimple Ways to Avoid Vitamin D Deficiency, Say Experts.

Also, keep reading:

View original post here:
One Major Effect Vitamin D May Have in Preventing Breast Cancer, New Study Suggests | Eat This Not That - Eat This, Not That

Recommendation and review posted by Bethany Smith

MADISON, WIS. Cutting Edge Thunder Faye was crowned the Grand Champion Female at the International Brown Swiss Show at World Dairy Expo. Faye won the Aged Cow, Six-Year-Old & Over Class before taking the Senior Champion Female title. Faye was also awarded the $1,000 Udder Comfort Grand Champion Cash Award, the Alan Hetts Memorial Trophy, the Vid Vye Memorial Trophy and the Swiss Bell. Following Faye, the Reserve Grand Champion Female was won by Cutting Edge F Faroh-ETV. Faroh won the Senior Three-Year-Old Class before winning Intermediate Champion Female. Both Faye and Faroh are owned by Ken Main and Kenny Joe Manion of Copake, New York.

Reserve Senior Champion Female honors were awarded to Iroquois Acres Jong Cali, the second-place Aged Cow Six-Year-Old & Over Class exhibited by Matthew Pacheco of Kerman, California. Reserve Intermediate Champion Female, Siegrets Damian Pinapple, was second place in the Senior Three-Year-Old Cow Class and was shown by Leslie & Linda Bruchey of Westminster, Maryland.

Pit-Crew Formula Tawny, leased by Abby Foss and owned by Pit-Crew Genetics of Cambridge, Minnesota, was the Junior Champion Female. Tawny was the winning Winter Yearling Heifer while the first-place Fall Heifer Calf, Wright-Way Famous Tik Tok-ET, exhibited by Landree & Dakota Fraley of Muncy, Pennsylvania, was named Reserve Junior Champion Female.

Elite Dairy 2 of Copake, New York was awarded Premier Breeder and was presented the Ira Inman Award. Winning both Premier Exhibitor and Premier Exhibitor of the Heifer Show, in addition to Premier Breeder of the Heifer Show, was Pit-Crew Genetics of Cambridge, Minnesota. Voelkers Td Carter was named Premier Sire and Premier Sire of the Heifer Show.

Official judge Lynn Harbaugh of Marion, Wisconsin, and associate judge Phillip Topp of Botkins, Ohio placed a total of 343 animals in the 2021 International Brown Swiss Show.

Complete class results can be found atworlddairyexpo.com.

Serving as the meeting place of the global dairy industry, World Dairy Expo brings together the latest in dairy innovation and the best cattle in North America. The dairy industry will return to Madison, Wis. for the 54thevent, September 28 October 2, 2021, when the worlds largest dairy-focused trade show, dairy and forage seminars, world-class dairy cattle show and more will be on display. Download the World Dairy Expo mobile event app, visitworlddairyexpo.comor follow WDE onFacebook,Twitter,LinkedIn,Spotify,InstagramorYouTubefor more information.

View post:
Wisconsin Dairy Expo: Faye and Faroh finish first at the International Brown Swiss Show - Wisbusiness.com

Recommendation and review posted by Bethany Smith

The editor of a leading medical journal has apologized in the wake of outrage stemming from a recent cover of the publication referring to biological women as bodies with vaginas.

In the latest issue of The Lancet, the British-based journal featured a quote on the front cover from a peer-reviewed piece on the anatomy and physiology of bodies with vagina.

Richard Horton, editor-in-chief of the journal,issued a statementthis week in response to the backlash the publication faced for the terminology.

[W]e have conveyed the impression that we have dehumanized and marginalized women, he said. [I] apologize to our readers who were offended by the cover quote and the use of those same words in the review. At the same time, I want to emphasize that transgender health is an important dimension of modern health care, but one that remains neglected.

LISTEN TO TODAYS PODCAST AND SUBSCRIBE:

Horton defended the article by stating the article in question calls for greater efforts to overcome the lack of knowledge and stigma too often associated with menstruation.

These are serious issues that demand serious actions, he explained. We encourage people to read the full review and support a growing movement against menstrual shame and period poverty.

Critics saw the terminology as demeaning and an erasure of the female experience.

David Curtis, an honorary professor of genetics, evolution, and environment at University College London,arguedits difficult to imagine why any medical researcher would want to submit their paper to The Lancet journal when they are happy to refer to women on their front cover with language which would be considered inappropriate even in a red light district.

Another critic, Claire Heuchan, an author who describes herself as a black radical feminist,condemned the characterizationas sexist and hypocritical, noting The Lancet has not referred to biological males as bodies with penises.

This framing makes it sound like a coincidence that bodies with vaginas have been neglected medicine, as if it were not the product of a discrimination and oppression specific to the female sex, she wrote. Medical misogyny exists and refusing to acknowledge women perpetuates it.

Dr. Jane Clare Jones, who classifies herself as a philosopher and a feminist, took issue with Hortons apology,writingshe is not offended, as the editor suggested.

Were angry with your colluding with the political erasure of women, she explained. Especially in a context when you are supposed to be rectifying that historic erasure.

The dustup over The Lancets description of women came the same week people on social media rebuked the left-leaning American Civil Liberties Unionfor censoring a pro-abortion quoteby the late U.S. Supreme Court Justice Ruth Bader Ginsburg.

In 1993, as part of her written responses to questions submitted during her Senate confirmation hearing, Ginsburg wrote: The decision whether or not to bear a child is central to a womans life, to her well-being and dignity. It is a decision she must make for herself. When government controls that decision for her, she is being treated as less than a fully adult human responsible for her own choices.

The ACLU, however, edited her quote to be more trans-inclusive by removing any reference to women or female pronouns.

***As the number of voices facing big-tech censorship continues to grow, please sign up forFaithwires daily newsletterand download theCBN News appto stay up-to-date with the latest news from a distinctly Christian perspective.***

View original post here:
'We're Angry': Medical Journal Apologizes for Referring to Biological Women with Trans-Inclusive Phrase - CBN News

Recommendation and review posted by Bethany Smith

Ten images and two videos created by University of WisconsinMadison students, faculty and staff have been named winners of the 2021 Cool Science Image Contest.

A panel of nine experienced artists, scientists and science communicators judged the scientific content and aesthetic and creative qualities of scores of images and videos entered in the 11th annual competition. The winning entries showcase animals and plants, the invisibly small structures all around us, and stars and nebulae millions of millions of miles away.

An exhibit featuring the winners is open to the public at the McPherson Eye Research Institutes Mandelbaum and Albert Family Vision Gallery on the ninth floor of the Wisconsin Institutes for Medical Research, 111 Highland Ave., through December. A reception open to the public for the contest entrants will be held at the gallery on Oct. 7 from 4:30 to 6:30 p.m.

Winning submissions were created with point-and-shoot digital cameras, cutting-edge microscopes, and telescopes of both the backyard and mountaintop variety.

Because sometimes, theres no substitute for the visual.

An image often can convey meaning more effectively than words, says Ahna Skop, a longtime contest judge, artist and UWMadison professor of genetics and active ambassador for science. We know from marketing and education research that adding a picture with words to a slide increases retention of knowledge by 65 percent. The visual communication of science is critical for the transference of knowledge broadly.

Story continues after gallery

1 A winterover one of the two staff members who stay through the minus-100-degree Fahrenheit nights of Antarcticas coldest months hikes underneath the stars and aurora to the South Pole home of IceCube, a UWMadison-led neutrino telescope frozen in a cubic kilometer of ice.

Yuya Makino,assistant scientist, IceCube Neutrino Observatorydigital camera

2 The large holes in this cross-section of a stalk of desert stringybark, Eucalyptus arenacea, are conduits through the plant tissue that help researchers quantify the way the plant native to dry parts of Australia adapts to a new, wetter environment.

Kennah Konrad,undergraduate student, Botany;Duncan Smith,graduate student, Botanycompound microscope

3 Fluorescent antibodies highlight the extensive nervous system of a mouse heart. By creating maps of cardiac nerves with unprecedented accuracy, researchers can explore how those nerves influence heart function.

Rebecca Salamon,graduate student, Cell and Regenerative Biologyconfocal microscope

4 Messier 42, known as the Orion Nebula, is in the sword of the constellation Orion and is one of the brightest nebulae in the sky. At just 1,400 light-years away and 24 light-years across, it is one of the closest and largest regions of dense gas and dust in which stars are formed.

Jeffrey E. Shokler,associate director, Office of Undergraduate Advisingrefractor telescope and CCD camera

5 The carnivorous sundew plant snags insect meals with armloads of tentacles that it can move to tighten its grip and bog down prey in sticky secretions. The leaves roll up around a meal to facilitate digestion by enzymes and absorption of the nutrients.

Nisha Iyer,postdoctoral fellow, Wisconsin Institute for Discoverydigital camera

6 Mazes of tiny structures less than 15 billionths of a meter across and made of some of the smallest ribbons of graphene layers of carbon just a single atom thick ever fabricated represent an important step toward graphene-based telecommunications devices.

Joel Siegel and Margaret Fortman,graduate students, Physics;Jian Sun,graduate student, Materials Science;Jonathan Dwyer,PhD alumnus, Chemical Engineeringscanning electron microscope

7 A pair of mating dragonflies pause on the surface of a Minnesota pond. Dragonfly coupling begins with the male (with blue markings) gripping the female with claspers at the very end of his abdomen. To complete the act, the female will bend her abdomen underneath her body to meet the males abdomen and create a characteristic heart shape.

Shin-Tsz (Lucy) Kuoundergraduate student, Computer Science and Economicsdigital camera

8 White matter, the connective nerve tissue of the brain, has been colored according to the predominant orientation of fibers red, right-left; green, front-back; blue, up-down in different regions of the human brain to reveal pathways traversing the regions. Understanding white matter organization may offer insights into normal brain development as well as into the study of neurological disorders.

Jose Guerrero,postdoctoral fellow, Medical Physics;Andrew Alexander,professor, Medical Physics;Peter Ferrazzanoprofessor, Pediatricsmagnetic resonance imaging scanner

9 The yellow connecting arms, called axons, of diseased human brain cells grow willy-nilly across boundaries of inhibitory chemicals (the red stripes). Healthy axons would precisely follow the dark lanes, giving researchers the opportunity to test the effects of disease-causing mutations on axon growth.

Timothy Catlettgraduate student, Cell and Molecular Biology;Timothy Gomez,professor, Neuroscienceconfocal microscope

10 By varying the exact size and shape of these micrometer-wide, star-shaped pillars etched into a silicon wafer, researchers can carefully manipulate light passing through a lens to correct for aberrations that would otherwise focus different wavelengths of light on different points in space.

Gregory Holdman,graduate student, Physicsfocused ion beam and scanning electron microscope

Recurrent neural networks are the computing engines behind state-of-the-art applications from self-driving cars to speech recognition like Amazons Alexa. The behavior of these networks is challenging to characterize, but it can be visualized for small networks. This video displays the behavior of a network with just three neurons, showing the way their output evolves by mapping their values in blue. The result, a fractal structure called a strange attractor, could help researchers better understand the behavior and characteristics of these kinds of networks.

David J. Nowak, alumnus and auditing student; Robert D. Nowak, professor, Electrical and Computer Engineering

Captured at 20,000 frames per second, this video shows the shock-wave-induced mixture of two gasses raw imagery on the left; adjusted to better reflect concentration of the lighter gas on the right. Experiments like this are run in the 9-meter-tall Wisconsin Shock Tube, depicted at left, to simulate and explore mixing at the interface of materials in extreme conditions like nuclear fusion, supernovae and hypersonic propulsion.

Josh Herzog, postdoctoral fellow, and Professor David Rothamer, both of Mechanical Engineering; Riccardo Bonazza, professsor, Engineering Physics

Continued from above gallery

There can be an ineffable sort of something that makes a particularly effective science image its the Cool in Cool Science Image Contest but the good ones have much in common.

Youll know it when you see it. Its like seeing Starry Night or the Mona Lisa for the first time, in person. They hit you deep and quickly, Skop says. They are beautiful to the eye, simple, and convey meaning. Some images just take your breath away.Looking deeper they exquisitely communicate the secrets of science beautifully.

The Cool Science Image Contest recognizes the technical and creative skills required to capture images or videos that capably reveal something about science or nature while also leaving an impression with their beauty or ability to induce wonder. The contest is sponsored by Madisons Promega Corp., with additional support from the UWMadison Division of the Arts.

Winning entries are shared widely on UWMadison websites, and all entries are showcased at campus science outreach events and in academic and lab facilities around campus throughout the year. Because there was no opportunity to show off the 2020 contest winners in-person, this years exhibit is a double-feature for both the 2020 and 2021 contests. See last years winners.

The contest judges were:

Steve Ackerman, professor of atmospheric and oceanic sciences and vice chancellor for research and graduate education

Terry Devitt, emeritus director of research communications, University Communications

Kevin Eliceiri, director, Laboratory for Optical and Computational Instrumentation

Michael King, visual communications specialist, College of Agricultural and Life Sciences

Steve Paddock, former scientist, Molecular Biology

Kara Rogers, science writer and editor, Encyclopedia Britannica

Ahna Skop, professor of genetics

Kelly Tyrrell, director of research communications, University Communications

Craig Wild, videographer, University Communications

View original post here:
The 2021 winners: Cool Science Image Contest - University of Wisconsin-Madison

Recommendation and review posted by Bethany Smith

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Meghan Walla-Murphy stooped to examine a twisted pile of dried poop, obscured by golden grass on an arid ridge in eastern Napa County. It may have belonged to one of the feral pigs that run rampant in the area. Or it may have been evidence of black bears, whose presence in Wine Country appears to be on the rise.

Walla-Murphy picked it up for a closer look.

No undigested identifiers, she said. Probably pig. She set it down and kept hiking.

Walla-Murphy, 46, is an ecological consultant and wildlife tracker who lives in western Sonoma County. Two years ago, she started the North Bay Bear Collaborative, an effort to bring together state wildlife experts, land managers, property owners, nonprofits, tribes and researchers for discussions about cultivating a bear culture in California.

On a recent survey near Atlas Peak in Napa County, Walla-Murphy and a pair of volunteers found 13 signs of bear scat and claw marks on the trunk of an oak.

Volunteer Alan Studley holds what appears to be a charred deer skull found in the slopes of Foss Valley.

The bears are here in the North Bay now, Walla-Murphy said. So, how do we figure out how to live with them?

Incidents involving black bears are escalating in the mountainous areas of Napa, Sonoma and Marin counties, and state wildlife biologists want to know why. Nuisance reports have jumped from an average of about 67 per year from 2010 to 2016 to more than 200 last year and upward of 200 so far this year, according to the California Department of Fish and Wildlife.

Sightings reported to the department have also climbed significantly in the past decade. One of the creatures was even spotted two years ago sauntering through downtown Napa highly unusual behavior.

A running theory is that the rise signals the southern expansion of a large black bear population in Mendocino and Humboldt counties, which could portend more bear-human encounters to come in the greater Bay Area.

If the bears are getting pushed toward the Bay Area, thats their southern limit. Theres real potential for human-wildlife conflicts, said Stacy Martinelli, a wildlife biologist at Fish and Wildlife. Were trying to understand whats going on, so we can make some management decisions before that happens.

Ecological consultant Meghan Walla-Murphy (left) of Sonoma County leads volunteers on a hunt for bear scat in the hills above Foss Valley in Napa County.

First, they need to know how many bears are roaming around.

In decades past, wildlife managers divined population estimates from the number of unique bear teeth provided by hunters and aerial surveys via helicopter crude, imperfect tactics at best. Estimates from Fish and Wildlife put the state black bear population at 30,000 to 40,000 in 2016, up from 10,000 to 15,000 in 1992. Activity around Lake Tahoe, the unofficial black bear capital of California where the animals live about one per square kilometer, is fairly well documented, but its a mystery most everywhere else.

We really dont know as much as we should know about whats happening with bears in different places around the state, Martinelli said.

In the past two years, Fish and Wildlife has embarked on a study that uses genotyping to identify and sex individual black bears in the North Bay by their DNA. Its a relatively new and much less disruptive method that has helped the state more accurately monitor populations of deer, elk and the Sierra Nevada red fox, which was recently listed as an endangered species.

State biologists hope to eventually track bears movements and plot their home ranges as well, which could help the North Bays rural residents better prepare to coexist with their furry new neighbors. Bears have been known to show up at vineyards this time of year to munch ripe grapes off the vine and suck down water from irrigation ponds.

This approach hinges, in part, on the expertise of Walla-Murphy and participation from the bear collaboratives volunteers: The biologists need DNA samples, and the best way to get them is by finding bear excrement. Another way to gather DNA is by setting out hair snares in bear territory designed to snag fur from the animals. But that involves the labor-intensive process of lugging bales of barbwire into remote areas.

Meghan Walla-Murphy hikes into Foss Valley in Napa County during a recent scat survey.

For the past year, Walla-Murphy has orchestrated volunteer surveys in Sonoma, Napa and Marin, and collected hundreds of scat specimens. The samples are processed at UC Davis and logged into a growing database of individuals with identifiers such as Sonoma Female 1 as well as their locations. The more samples Walla-Murphy and her revolving group of volunteers collect, the clearer the picture of bear activity becomes.

With a robust flow of these data points, we can study reproductions, survival, their space use and if theyre concentrating, say, near places where people are leaving their trash out, said Ben Sacks, a UC Davis professor of mammalian genetics who is handling the DNA analysis. There is tremendous potential for these noninvasive genetic methods and a lot of untapped applications.

A deeper dive into the scat specimens could illuminate the bears diets and show whether a given female is pregnant, Sacks said. But thats beyond the scope of the current study. For now, the goal is to get an accurate count and a snapshot of where theyre ranging.

Several factors could be pushing more black bears south toward the Bay Area: drought, food shortages, wildfires or just steady growth of a healthy population.

Usually its not one reason, its multiple reasons, Martinelli said.

Back on the scat hunt in Napa, Walla-Murphy led two volunteers across a ridgeline above Foss Valley, a narrow avenue largely given over to grape-growing, which partially burned in the Glass Fire last year. Amid the blackened landscape, new plant life was emerging: Wildflowers blossomed, and bright, leafy tufts of oak resprouted from charred root crowns.

Walla-Murphy has surveyed this area for years and noticed that the fire didnt chase away the bears for long, like one might have assumed. The animals were present before the fire and returned almost immediately afterward.

Wildlife tracker Meghan Walla-Murphy (second from right) and two volunteers look across vineyards in Napa Countys Foss Valley. The North Bays black bear population is growing.

The fires are often creating more food forage-ability for bears, Walla-Murphy said. We see deer and foxes and bobcats come back right away as well. The animals know how to live with fire.

Within that simple observation is an insight Walla-Murphy hopes will steer the direction of bear management in California: A more natural landscape supports more natural animal behavior, which makes living with wildlife easier for humans.

If we can really begin to steward and tend our landscapes better so that theres more diversity and theyre regenerative and they have more forage for wildlife, that ideally will keep the bears in their natural habitat rather than pushing them into cities for food, she said.

Gregory Thomas is The San Francisco Chronicles editor of lifestyle a outdoors. Email: gthomas@sfchronicle.com Twitter: @GregRThomas

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Bear incidents are rising in the North Bay. Biologists sent in a wildlife tracker to find out why - San Francisco Chronicle

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Samadhi, a cow, is likely to become the proud mother of 100 calves with the application of in-vitro fertilisation. At Phaltan in Satara district, farmer Dayaram Thengil, is overjoyed that eight surrogate cows from his herd, are carrying the pregnancies through IVF of Samadhi, a Gir cow.

Dr Shyam Zawar, chief scientist at J K Trust a city-based NGO working in the field of animal husbandry, which has set up a state-of-the-art in-vitro fertilisation-embryo transfer laboratory at Vadgaon Rasai told The Indian Express that a cow in its lifespan of 15-16 years will give birth to a maximum of 8-10 calves. Our lab was set up in 2016 to produce IVF embryos from elite indigenous cows such as Gir and Sahiwal, Zawar said. The cattle IVF and ET technology, which is being widely used around the world, can be customised and adapted to suit Indian climatic conditions, Zawar said.

The Trust has succeeded in establishing 74 IVF pregnancies from Samadhi in just 12 months and plans to reach 100 IVF pregnancies in the next two months.

Of these 74 IVF pregnancies, 30 IVF calves have already taken birth at various farms across the country, including Pune, Ahmednagar and Satara districts.

Of the 10 recipient cows, eight are confirmed pregnant and they are about to calve in a weeks time. The semen used for IVF was that of the famous Brazilian Gir bull namely Espanto, Zawar told The Indian Express.

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Dayaram, too, said he was amazed when eight of his cows were confirmed pregnant in such a short time. IVF is a reproductive technique where matured eggs are harvested from a female and fertilised with sperm in a laboratory. The fertilised egg is planted in the body of the female animal after 6-7 days when cell division starts. The embryo develops normally after its gestation period.

IVF is mostly used in bovine animals to plant an embryo of superior genetics into a surrogate mother. After the normal gestation period of nine months, the calves that are reared have the traits of the original mother and father. Normally, in such cases, the egg is harvested from an animal with proven milk yielding capacity and crossed with the sperm of a male whose mother has well documented genetics. Once fertilised, the zygote is planted in the womb of the surrogate mother, whose qualities the calf does not inherit.

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Pune-based J K Trust to soon attain 100 IVF pregnancies from Gir cow Samadhi - The Indian Express

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A little over a week after S., 34, received her second vaccination against COVID, at a time when she was menstruating, she was surprised to discover that she had begun menstruating again.

It was strange because my period is as regular as a Swiss watch. At first, I didnt give it any thought, but two weeks later I got my period again for seven days. Two weeks after that, bleeding that lasted four days. It turned out that for almost six months there were more days when I bled than when I didnt. After I talked to my friends, I realized the phenomenon is much more widespread, she said.

Growing evidence from Israel and abroad is showing that the phenomenon extends much beyond S.s social circle. In February, shortly after women of childbearing age began receiving the second shot, many of them posted on social media that they were experiencing changes in their menstruation shortly after the shot, such as irregularity and increased bleeding. Other women reported that they had begun bleeding years after menopause.

The medical establishment could not explain the phenomenon or associate it with the vaccination, among other things because irregular menstruation is common and influenced by many factors. It is usually not considered exceptional. However, the mounting complaints and increased concern women were showing over taking the shots due to the phenomenon, has spurred the medical community to look into the matter. Preliminary research has been published in Britain and the United States, and the U.S. government has allocated $1.67 million for research on the subject.

Prof. Roni Maimon, chairman of the Israel Society of Obstetrics and Gynecology, is moving ahead on the first Israeli study of the subject. In terms of biochemistry and endocrinology, we havent found a connection between disruption of menstruation and the vaccination. However, because we live in an age of evidence-based medicine, we decided to look into the phenomenon among a large number of women in Israel, he said. The exact number of women who will participate in the study is not yet decided.

The Health Ministry said it doesnt have exact data on the extent of the phenomenon in Israel. It has received reports, but because the condition is common and does not require hospitalization, there is no way to know how common it was in the population [before the vaccinations] and whether it is now more common. The ministry said similar reports have been received by major healthcare agencies abroad, and that the phenomena appear to be temporary and carry no risk.

The issue has become a topic of discussion on social media in terms of whether to take the third shot. For example, on the Facebook page Medicine for Women in Israel, one woman wrote: The two first shots brought on my period early, and six months later I began to experience bleeding between periods and irregular periods, and at the moment they cant figure out why Im very undecided about the booster.

The matter has also raised concerns aboutpossible damage to fertility. As H., 39, told Haaretz: After the first and second shots I had some irregularities in my period . The doctor explained that its because the immunological system is connected to the hormonal system, and its not really dangerous. However, H. added, In June, I started trying to get pregnant by artificial insemination. When they started talking about the booster, I was in the middle of hormone treatment. I asked the doctor whether to get the booster, and he said he didnt recommend it, that if I got pregnant, I should take it only after they see a heartbeat. When the insemination didnt work, I took got the booster.

Based on the data that has been collected, the theory is that the symptoms are connected to the vaccination but that they apparently do not stem directly from a specific vaccination. Experts believe this is the immune systems response to various vaccinations, including those not based on mRNA, like those of Pfizer and Moderna.

Dr. Ido Solt, head of Maternal Fetal Medicine at Rambam Health Care Campus in Haifa, said that although the phenomenon is connected to vaccination, it is apparently insignificant because it appears with Pfizer, Moderna and other vaccinations even though they use a different method of immunization. The theory is that this is not about a specific component of the vaccine, but rather another manifestation of an immunological response, he said.

Solt added that the papillomavirus vaccine is also known to cause menstrual irregularity. At present, women of childbearing age who contracted COVID reported phenomena of this type, Solt said.

In light of this, the treatment policy is that if the changes go one for more than two or three periods, or if a woman in menopause begins to menstruate, the case is treated as if she had not been vaccinated, Solt explained.

Its true that the vaccination impacts menstruation and can cause bleeding, but there is no evidence that this harms menstruation or fertility, Solt added. He said the symptoms had been compared to occurrences in the general population and in clinics and no negative effect had observed.

Conclusions so far

In Britain, health care authorities and researchers have said that data collection in a published study was based on voluntary reporting by women, which makes it difficult to reach definitive conclusions. Different research approaches need to be used to examine the differences between vaccinated and unvaccinated women with these symptoms.

The study, published about two weeks ago in the medical journal BMJ examined more than 30,000 reports of women with irregular menstrual symptoms from the beginning of the vaccination drive and until September 2. Most of the women who reported irregularities said things returned to normal by their next period, according to the researchers, who are from the Imperial College School of Medicine and Westminster Hospital. Unplanned pregnancies occurred at similar rates among vaccinated and unvaccinated women, and pregnancy rates at fertility clinics were similar in vaccinated and unvaccinated women.

The research indicated that the symptoms appeared among women vaccinated with vaccines using different means of immunization. The study concluded that if there is a connection between vaccination and menstruation, it is not due to a specific component in the vaccine.

In response to the study, Dr. Joe Mountfield, vice chancellor of the Royal College of Obstetrics and Gynecology, was quoted as saying there is no proof that the temporary changes would impact a womans future fertility. He recommended that taking the vaccination was important especially if a woman was planning to get pregnant, because of the higher risk pregnant women run of contracting COVID.

The Israeli Fertility Association will be holdings its annual conference on Monday, at which the impact of the vaccination on male and female fertility will be discussed. Dr. Talia Eldar-Geva, head of endocrinology and genetics at Shaare Zedek Medical Center and a former head of the association said, There is still no work dealing with long-term effects on fertility, but in the short term, there is no difference in response to fertility treatments, the number of eggs or the quality of the fetuses among men and women who have been vaccinated.

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Israeli group to research link between menstrual changes and COVID vaccines - Haaretz

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