WASHINGTON, Jan. 25, 2022 (GLOBE NEWSWIRE) -- The GlobalHemophilia Market size is expected to reachUSD 14.2 Billionby 2028, exhibiting a CAGR of5.3%during the forecast period. Hemophilia is a bleeding condition, which leads to the prolonged bleeding after injury or a surgery due to a delay in the blood clotting, The Global Hemophilia Market is anticipated to grow at a substantial rate in coming years because of increasing cases of genetic abnormalities and prevalence of Hemophilia, states Vantage Market Research, in a report, titledHemophilia Market by Type (Hemophilia A, Hemophilia B, Hemophilia C, Others), by Treatment (On-demand, Prophylaxis), by Therapy (Replacement therapy, ITI therapy, Gene therapy), by Region (North America, Latin America, Europe, Asia Pacific) - Global Industry Assessment (2016 - 2021) & Forecast (2022 - 2028).The market size valued atUSD 12.1 Billionin 2021.

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Market Overview:

Increasing Establishment of Hemophilia Treatment Centers to Drive the Market

The availability of limited treatment therapy options and growing burden on regulatory bodies towards the treatment is resulted to increase R&D efforts. The public as well as private healthcare bodies are heavily investing in development of specialized clinics that are established to meet the targeted needs of patients. In this regard, there is increasing number of Hemophilia treatment centres that also aims at proving treatment to underprivileged patients.It is recommended by authorities that people who are suffering from Hemophilia should visit a treatment center for optimal care and health education to stay healthy. The establishment of healthcare centres is anticipated to fuel theHemophilia Market growth.Additionally, efforts are been undertaken by regulatory bodies for spreading awareness regarding the disease and providing information about the effective treatment.

The COVID-19 outbreak has affected various industries worldwide. TheHemophilia Marketis no exception. Governments across the world took severe actions like border seals, lockdown, and implementing strict social distancing measures, in order to stop swift spread of COVID-19. These actions led to severe impact on the global economy impairing various industries. The impact of COVID-19 on the market demand is considered while estimating the current and forecast market size and growth trends of the market for all the regions and countries based on the following data-points:

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The Report on Hemophilia Market Highlights:

Various Supportive Initiatives to Drive Market Growth in Asia Pacific

Asia Pacificis anticipated to witness fastest CAGR over the forecast period. The awareness campaigns and supportive initiatives taken by the government to commence the early screening of neonates, is about to boost the demand for diagnostic tools related to Hemophilia in the region. Some other factors such as advanced healthcare ecosystem and capacity of people to spend on such expensive medical services are defining the regional business growth. Additionally, easy medical reimbursement schemes are promoting the market growth.

List of Prominent Players in the Hemophilia Market:

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Recent Developments:

December, 2021:The European Medicines Agency (EMA) has approved an accelerated assessment request for etranacogene dezaparvovec, an experimental gene therapy for Hemophilia B. The decision means that, once an application is submitted seeking approval for marketing authorization of etranacogene dezaparvovec, it will be reviewed more quickly than normal which could allow patients in Europe to access the therapy sooner,

December, 2021:Global biotherapeutics leader CSL Behring announced that the Committee for Medicinal Products for Human Use (CHMP), the chief scientific body of the European Medicines Agency (EMA) accepted its request for an accelerated assessment of the etranacogene dezaparvovec Marketing Authorisation Application (MAA). Etranacogene dezaparvovec (also known as EtranaDez), currently being studied in the Phase 3 HOPE-B clinical trial, is an investigational gene therapy for people living with hemophilia B, a life-threatening bleeding disorder.

December, 2021:Patients with severe Hemophilia can develop inhibitors against factor VIII or IX, preventing factor replacement therapy from working, said Dr. Guy Young (University of Southern California, CA, USA). A quarter of patients develop these inhibitors, leading to a worse prognosis. Novel agents are needed to protect these patients from bleeding events and arthropathy and improve their quality of life. In addition, the current IV therapies need to be administered multiple times per week, resulting in venous access issues and poor adherence.

December, 2020:Pfizer Inc. and Sangamo Therapeutics, Inc., a genomic medicines company, announced updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe Hemophilia A.

Browse the Report Hemophilia Market by Type (Hemophilia A, Hemophilia B, Hemophilia C, Others), by Treatment (On-demand, Prophylaxis), by Therapy (Replacement therapy, ITI therapy, Gene therapy), by Region (North America, Latin America, Europe, Asia Pacific) - Global Industry Assessment (2016 - 2021) & Forecast (2022 - 2028) @ https://www.vantagemarketresearch.com/blog/hemophilia-225379

This market titled Hemophilia Market will cover exclusive information in terms of Regional Analysis, Forecast, and Quantitative Data Units, Key Market Trends, and various others as mentioned below:

Treatment: - On-demand, Prophylaxis

Therapy: - Replacement therapy, ITI therapy, Gene therapy

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Global Hemophilia Market to Reach $14.2 Billion by 2028 - - GlobeNewswire

Recommendation and review posted by Bethany Smith

Patient 1 with Sandhoff disease realized normalization of Hex A enzyme activity by Month 1, achieving 58-fold above the presumed asymptomatic level of 5% of normal identified by natural history at Month 3

Patient 2 with Tay-Sachs disease achieved Hex A enzyme activity 5-fold above the presumed asymptomatic level of 5% of normal identified by natural history at Month 1

First-ever data supporting bicistronic vector approach in humans, TSHA-101 is designed to deliver both HEXA and HEXB genes in the endogenous ratio

Conference call and live webcast today at8:00 AM Eastern Time

DALLAS--(BUSINESS WIRE)-- Taysha Gene Therapies (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 reported positive initial serum -hexosaminidase A (Hex A) enzyme activity data for TSHA-101 in patients with Sandhoff and Tay-Sachs diseases, which represent two forms of GM2 gangliosidosis. Todays data are the first ever to support the bicistronic vector approach in humans delivering both HEXA and HEXB genes in the endogenous ratio.

TSHA-101 is the first bicistronic vector in clinical development, representing an important first for the field of gene therapy, noted RA Session II, President, Founder and CEO of Taysha. TSHA-101 demonstrated expression of both HEXA and HEXB genes in the endogenous ratio, providing the ability to restore and normalize enzyme activity in GM2 gangliosidosis. We expect to provide continued updates on the program, with additional clinical data anticipated by the end of 2022.

Based on natural history data, patients with asymptomatic GM2 gangliosidosis have Hex A enzyme levels that are at least 5% of normal activity. Key patient findings for Hex A enzyme activity following treatment with TSHA-101 include:

Patient 1 (Sandhoff disease)

Patient 2 (Tay-Sachs disease)

Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development at Taysha added, GM2 gangliosidosis is a progressive and life-limiting disease with no treatment options. Normalization of patient Hex A enzyme activity levels 58-fold above the presumed asymptomatic level of 5% of normal identified by natural history supports TSHA-101s ability to potentially make a meaningful difference in the lives of patients with Sandhoff and Tay-Sachs diseases after a single intrathecal administration. We look forward to submitting a protocol amendment to expand patient enrollment in the ongoing Phase 1/2 trial and providing additional updates later this year.

Preliminary data suggest that TSHA-101 was well-tolerated with no significant drug-related events.

Patient 1 (Sandhoff) demonstrated signs of clinical improvement at Month 3 and was deemed stable to travel home. Upon returning home, Patient 1 (Sandhoff), who was unvaccinated, was exposed to a family member symptomatic for an upper respiratory infection, possibly Covid-19, and was hospitalized with pneumonia before contracting a secondary hospital-acquired methicillin-resistant staphylococcus aureus (MRSA) infection. On January 14, 2022, the patient succumbed to pneumonia and pleural effusion with a concomitant hospital-acquired MRSA infection. The principal investigator has made the initial assessment that the death was unrelated to study drug. Final determination from the independent data safety monitoring board (DSMB) is anticipated in the near term.

TSHA-101 is an investigational gene therapy that delivers both the HEXA and HEXB genes that comprise the -hexosaminidase A enzyme. The two genes are driven by a single promoter within an AAV9 capsid ensuring that the two sub-units of Hex A are produced in the endogenous ratio within each cell, which is important to ensure efficient production of the enzyme. TSHA-101 is the first and only bicistronic vector currently in clinical development for GM2 gangliosidosis and has been granted Orphan Drug and Rare Pediatric Disease designations by the FDA and Orphan Drug Designation from the European Commission. 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. Additional clinical safety and efficacy data are expected by the end of 2022.

GM2 gangliosidosis is a rare and devastating 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 this disease, and current treatment is limited to supportive care.

Conference Call and Webcast Information

Taysha management will hold a conference call and webcast today at 8:00 am ET / 7:00 am CT to provide an update on the GM2 gangliosidosis program. The dial-in number for the conference call is 877-407-0792 (U.S./Canada) or 201-689-8263 (international). The conference ID for all callers is 13726741. The live webcast and replay may be accessed by visiting Tayshas website at https://ir.tayshagtx.com/news-events/events-presentations. An archived version of the webcast will be available on the website for 30 days.

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, plans, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, such as TSHA-101 and including our preclinical product candidates, 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, 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, the potential market opportunity for these product candidates, and our corporate growth plans. 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 September 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220127005353/en/

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Taysha Gene Therapies Announces Positive Initial Biomarker Data For TSHA-101 - BioSpace

Recommendation and review posted by Bethany Smith

PHILADELPHIA--(BUSINESS WIRE)--SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, genetically defined neurological conditions, today announced that its Investigational New Drug (IND) application for its lead candidate, SBT101, for the treatment of adrenomyeloneuropathy (AMN), was cleared by the U.S. Food and Drug Administration (FDA).

SBT101 is the first AAV-based gene therapy in development specifically designed for people living with AMN, an adult-onset degenerative spinal cord disease caused by mutations in the ABCD1 gene. SwanBio plans to initiate a randomized, placebo-controlled Phase 1/2 clinical trial designed to assess the safety and explore the efficacy of SBT101 in patients with AMN in the second half of 2022.

Todays IND clearance is a formative milestone for SwanBio, enabling us to evolve from a preclinical company to a truly integrated research and development organization, underscoring the expertise of our team and potential of our technology platform, said Tom Anderson, chief executive officer and director of SwanBio Therapeutics. SBT101 has the potential to become the first disease-modifying treatment for patients with AMN, a devastating and progressive disease with no approved treatments. We look forward to initiating clinical development of SBT101 later this year, bringing us closer to our ultimate goal of delivering life-changing treatments to patients.

The clinical program for SBT101 builds on SwanBios unique understanding of AMN, including new insights being gathered in an ongoing natural history study. SwanBio is deeply committed to the AMN community and has worked closely with patients, family members, and expert physicians including SwanBio Co-Founder Dr. Florian Eichler to ensure that its clinical programs are designed to meet their needs. SwanBio is supported by long-term investment partners Syncona Ltd. and Mass General Brigham Ventures, which both have proven track records in gene therapy, particularly in AAV-focused therapies.

About SBT101SBT101 is the first AAV-based gene therapy in development designed to compensate for the disease-causing ABCD1 mutation, to increase ABCD1 expression, and reduce very long chain fatty acid (VLCFA) levels specifically for people living with adrenomyeloneuropathy (AMN). In preclinical studies, treatment with SBT101 demonstrated dose-dependent improvement of AMN disease markers in mouse models and was shown to be well-tolerated in non-human primates at six months post-treatment.

About AdrenomyeloneuropathyAdrenomyeloneuropathy (AMN) is the adult-onset degenerative spinal cord disease that affects people living with adrenoleukodystrophy (ALD), a category of rare, genetic, and metabolic conditions. AMN is characterized by progressive loss of mobility, incontinence, and debilitating pain. It affects adults with mutations in the ABCD1 gene, which encodes a protein essential to the processing and breakdown of very long chain fatty acids (VLCFA). Without a functioning version of this protein there is an accumulation of VLCFA to toxic levels that leads to progressive dysfunction of the central nervous system. Between 8,000-10,000 men in the U.S. and E.U. are living with AMN. There are no approved therapies for the treatment of the disease; current standard of care is limited to symptom control.

About SwanBio TherapeuticsSwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, genetically defined neurological conditions. SwanBio is advancing a pipeline of gene therapies, designed to be delivered intrathecally, that can address targets within both the central and peripheral nervous systems. This approach has the potential to be applied broadly across three disease classifications spastic paraplegias, monogenic neuropathies and polygenic neuropathies. SwanBios lead program is being advanced toward clinical development for the treatment of adrenomyeloneuropathy (AMN). SwanBio is supported by long-term, committed investment partners, including its primary investors Syncona, Ltd. (lead investor and majority shareholder) and Mass General Brigham Ventures. For more information, visit SwanBioTx.com.

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SwanBio Therapeutics Announces FDA Investigational New Drug Clearance for First AAV-Based Gene Therapy for the Treatment of Adrenomyeloneuropathy -...

Recommendation and review posted by Bethany Smith

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported that Leber Hereditary Optical Neuropathy (LHON) subjects treated with LUMEVOQ continued to experience significantly improved vision four years after a single injection of the gene therapy. The findings come from RESTORE (CLIN06), the long-term follow-up study to which participants in the RESCUE1 and REVERSE2 Phase III pivotal trials were invited.

When RESTORE subjects enrolled in the study, 2 years after the one-time injection, they had already experienced clinically meaningful improvements relative to the lowest point (the nadir) of their best-corrected visual acuity (BCVA): +18.8 ETDRS letters equivalent* in their LUMEVOQ-treated eyes and +17.3 letters equivalent in their sham-treated eyes. Four years after treatment, the bilateral improvement from nadir was sustained, with LUMEVOQ-treated eyes achieving a mean improvement against nadir of +22.5 letters equivalent and sham-treated eyes demonstrating a mean improvement of +20.5 letters equivalent.

The impact of such results on patients is demonstrated by increases in the self-reported quality of life (QoL) scores at Year 4 vs. baseline. Mean overall QoL increased by a clinically meaningful magnitude relative to baseline, driven by clinically meaningful increases in the sub-scores corresponding to mental health and the ability to carry out activities autonomously (e.g., role difficulties, dependency, near and far activities, general vision).

The 4-year RESTORE long-term extension study provides patients with Leber Hereditary Optic Neuropathy and their families as well as the neuro-ophthalmology community with highly informative data about both the efficacy and safety of intravitreal LUMEVOQ therapy, commented Dr. Robert Sergott, Director, Neuro-Ophthalmology Service, Wills Eye Hospital, and Founding Director and CEO, William H. Annesley EyeBrain Center, Thomas Jefferson University, Philadelphia, PA, USA. Compared to the natural history of LHON, the 4-year data extend and validate the 3-year observations by confirming that objective visual acuity improvement is sustained and is associated with improved functional visual quality of life without any long-term safety concern.

The RESTORE findings underline the therapeutic value of GenSights pioneering one-time treatment for LHON: durable and clinically significant improvement in visual function coupled with impressive safety, noted Bernard Gilly, Co-founder and Chief Executive Officer of GenSight. The body of evidence we have now accumulated is without doubt good news for patients needing an urgent solution for their brutal blinding condition, and consequently we are continuing to work vigorously with the relevant authorities to bring regulatory review process to a successful conclusion.

RESTORE is one of the largest long-term follow-up studies for a rare disease treatment, with 62 subjects accepting the invitation to enroll. All subjects, who were affected by LHON caused by a mutated ND4 mitochondrial gene, were treated with an intravitreal injection of LUMEVOQ in one eye and with sham injection in the other.

Table 1. BCVA Mean Improvement Vs. Nadir* In LUMEVOQ Long-Term Follow-Up (RESTORE)

2 Years Post-Injection

3 Years Post-Injection3

4 Years Post-Injection

LogMAR(Std Error)

LettersEquivalent**

LogMAR(Std Error)

LettersEquivalent**

LogMAR(Std Error)

LettersEquivalent**

LUMEVOQ-treated eyes

-0.375(0.306)

+18.8

-0.410(0.365)

+20.5

-0.453(0.440)

+22.5

Sham-treated eyes

-0.346(0.291)

+17.3

-0.387(0.369)

+19.4

-0.406(0.361)

+20.5

Note: The RESTORE sample consists of the RESCUE and REVERSE participants who accepted to be followed in the long-term follow-up study. Year 4 values were the LogMAR readings nearest to 1461 days post treatment recorded between 1461 +/- 273 days post- treatment. Missing values were imputed using the Last Observation Carried Forward (LOCF) method. *Nadir = worst best-corrected visual acuity recorded from baseline to Year 4. ** Assessments of best-corrected visual acuity (BCVA) were recorded in LogMAR. The change from nadir in LogMAR was converted to letters equivalent improvement by multiplying the LogMAR by -50 (ref. J.T. Holladay, J Refrac Surgery, 1997;13, 388-391).

Responder analyses at Year 4 indicate that improved BCVA was a benefit for a substantial proportion of the study participants. 71.0% of RESTORE subjects achieved Clinically Relevant Recovery (CRR)4 against nadir four years after treatment, and 80.7% of them had on-chart vision (BCVA 1.6 LogMAR) in one or both eyes.

Viewed against the trend in vision typically seen in untreated patients5, the findings represent a significant departure from the natural progression of LHON.

Safety findings at 4 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ is well-tolerated: no serious adverse events were recorded among LUMEVOQ-treated eyes, and no discontinuations occurred due to ocular events. There were no systemic serious adverse events or discontinuations related to study treatment or study procedure.

The review of the European Marketing Authorisation Application for LUMEVOQ is ongoing, with the decision from the CHMP expected in Q4 2022.

References and notes:

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics lead product candidate, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. The estimated incidence of LHON is approximately 1,200-1,500 new subjects who lose their sight every year in the United States and the European Union.

About LUMEVOQ (GS010; lenadogene nolparvovec)

LUMEVOQ (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. LUMEVOQ was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018.

About RESCUE, REVERSE, and RESTORE

RESCUE and REVERSE were two separate randomized, double-masked, sham-controlled Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

The primary endpoint measured the difference in efficacy of GS010 in treated eyes compared to sham-treated eyes based on BestCorrected Visual Acuity (BCVA), as measured with the ETDRS at 48 weeks post-injection. The patients LogMAR (Logarithm of the Minimal Angle of Resolution) scores, which are derived from the number of letters patients read on the ETDRS chart, were used for statistical purposes. Both trials were adequately powered to evaluate a clinically relevant difference of at least 15 ETDRS letters between drug-treated and sham-treated eyes, adjusted to baseline.

The secondary endpoints involved the application of the primary analysis to bestseeing eyes that received GS010 compared to those receiving sham, and to worseseeing eyes that received GS010 compared to those that received sham. Additionally, a categorical evaluation with a responder analysis was performed, including the proportion of patients who maintained vision (< ETDRS 15L loss), the proportion of patients who gained 15 ETDRS letters from baseline and the proportion of patients with Snellen acuity of >20/200. Complementary vision metrics included automated visual fields, optical coherence tomography, and color and contrast sensitivity, in addition to quality-of-life scales, biodissemination and the time course of immune response. Readouts for these endpoints were at 48, 72 and 96 weeks after injection.

The trials were conducted in parallel, in 37 subjects for REVERSE and 39 subjects for RESCUE, in 7 centers across the United States, the UK, France, Germany and Italy. Week 96 results were reported in 2019 for both trials, after which patients were invited to participate in a long-term follow-up study, RESTORE, for three additional years.

The primary objective is to assess the long-term safety of intravitreal LUMEVOQ administration up to 5 years post-treatment. The secondary objective is to assess the long-term treatment efficacy of the therapy and the quality of life (QoL) in subjects up to 5 years post-treatment. The first subject was enrolled on January 9, 2018. 61 subjects have enrolled.

ClinicalTrials.gov Identifiers:REVERSE: NCT02652780RESCUE: NCT02652767RESTORE: NCT03406104

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GenSight Biologics Reports Clinically Meaningful Vision Improvement is Maintained 4 Years After One-time Treatment with LUMEVOQ Gene Therapy -...

Recommendation and review posted by Bethany Smith

AMSTERDAM--(BUSINESS WIRE)--VectorY Therapeutics, a biotech company focusing on the development of innovative gene therapy approaches for the treatment of muscular and neurodegenerative disorders through vectorized antibodies, today announces a collaboration with Wageningen University to develop novel baculovirus-based technologies for the production of safe and affordable AAV gene therapies.

One of the most important challenges for the gene therapy industry is to develop robust and scalable manufacturing processes that yield safe therapies. VectorY, together with its partner Wageningen University, is making an important strategic investment in these therapies of the future, by developing a production platform capable of successfully manufacturing safe products at a significant lower COGS. The collaboration represents an important step to enable the medical and economical feasibility of gene therapy for diseases that affect larger patient populations.

Under the terms of the collaboration, the Bioprocess Engineering and Virology Groups at Wageningen University and VectorY Therapeutics will work together on two projects. One will utilize the molecular toolbox to generate innovative stable baculovirus genome seeds for AAV production at large scale. The second will focus on the design and evaluation of an intensified and scalable baculovirus production process in bioreactors using state of the art bioprocess technologies.

We are very pleased to be collaborating with VectorY to develop proprietary, next generation AAV expression systems and industry-leading bioprocessing capabilities, said Monique van Oers, Professor of Virology, Wageningen University.

We are honored to partner with Wageningen University, a significant pioneer in the Baculovirology and Bioprocessing field. This partnership will further strengthen VectorYs proprietary AAV production technologies for the development of Next Generation Gene Therapies, added Alexander Vos, CEO VectorY Therapeutics.

ENDS

Notes to Editors

About VectorY

VectorY combines the therapeutic potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for muscular and neurodegenerative diseases with high unmet medical need. Founded in October 2020, and based in the Amsterdam Science Park, VectorY is a fully integrated gene therapy company focused on the development of innovative therapeutics based on a novel AAV gene therapy platform andantibody- based targeted degradation technologies, and proprietary manufacturing technology. VectorY develops proprietary & partnered programs and product candidates are based on new technologies that will enable the next generation of highly scalable manufacturing processes within VectorYs own manufacturing facilities. VectorYs manufacturing capabilities will include a state-of-the-art multi-product GMP facility in the Netherlands, with the capability to deliver suspension based AAV viral vector manufacturing of up to 2000L for both clinical and commercial supply.

For more information, see http://www.vectorytx.com

Wageningen University & Research

The mission of Wageningen University and Research is To explore the potential of nature to improve the quality of life. Under the banner Wageningen University & Research, Wageningen University and the specialised research institutes of the Wageningen Research Foundation have joined forces in contributing to finding solutions to important questions in the domain of healthy food and living environment. With its roughly 30 branches, 6.800 employees and 12.900 students, Wageningen University & Research is one of the leading organisations in its domain. An integrated approach to problems and the cooperation between various disciplines are at the heart of Wageningens unique approach. As such, the Laboratory of Virology and The Bioprocess Engineering group work closely together in a number of biotechnological projects aimed at the further development of the baculovirus expression system for vaccine production and gene therapy applications. By combining our research efforts we can optimally profit from knowledge gained in fundamental virology and new technological developments in bioprocess engineering.

For more information, see https://www.wur.nl/en.htm

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VectorY and Wageningen University Sign Strategic Collaboration for the Development of Novel Baculovirus-based AAV Production Technologies - Business...

Recommendation and review posted by Bethany Smith

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, announced a research and development collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology by combining resources and expertise from both sides.

The Haihe Laboratory of Cell Ecosystem, run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is focused on conducting fundamental research, innovation, and translation in the cell ecosystem.

Under the agreement, both parties will jointly develop hematopoietic stem cell regenerative therapies, including the development of innovative genetically-modified hematopoietic stem cell therapies and the exploration of novel biomarkers to optimize quality control for stem cell production.

With top-notch resources and industry-university-research cooperation, well facilitate the development of cell-based medicine and therapies, said Professor Tao Cheng, Deputy Director of Haihe Laboratory of Cell Ecosystem and President of the Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences and Peking Union Medical College, a leading hematology researcher who has made a series of discoveries relating to the regulatory and regenerative mechanisms of hematopoietic stem cells. Hematopoietic stem cells (HSCs) have the potential for long-term self-renewal and can differentiate into various types of mature blood cells. These stem cells can be harnessed to provide treatment for a broad range of diseases such as hematological tumors, autoimmune diseases, and hereditary blood disorders. We believe that this collaboration with EdiGene will accelerate the innovation and translation in the field of HSCs, thus enabling healthier patients with new therapies."

Professor Cheng was awarded the second prize of the National Natural Science Award 2020 as the first author of work on basic and translational research that advanced the development of adult hematopoietic stem cells for therapeutic applications.

EdiGene is scaling up clinical translation and development of the first gene-editing hematopoietic stem cell therapy in China following the 2021 approval by the China National Medical Products Administration its IND for its investigational therapy ET-01. Our team has extensive experience in the development and translation of cutting-edge technologies including hematopoietic stem cell and gene editing, said Dong Wei, Ph.D., CEO of EdiGene. "This collaboration with Haihe Laboratory of Cell Ecosystem will further our exploration in the field of hematopoietic stem cells. The partnership with this leading academic institute and our translational know-how enable us to move forward in bringing more innovative treatment options to patients in China and around the world.

In 2021, EdiGene initiated a Phase I multicenter clinical trial of ET-01, its gene-editing hematopoietic stem cell therapy for transfusion-dependent -thalassemia. EdiGene has enrolled the first patient at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Currently, the clinical trial is being conducted in Tianjin and Guangdong-Hong Kong-Macao Greater Bay Area (Greater Bay Area). EdiGene also presented its latest research on new surface markers and migration of hematopoietic stem cells at the 63rd Annual Meeting of the American Society of Hematology (ASH) in 2021.

About Haihe Laboratory of Cell Ecosystem

The Haihe Laboratory of Cell Ecosystem ("the Laboratory"), run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is one of the five registered Haihe Laboratories approved by Tianjin Municipal People's Government. With the goal of promoting population health with cell ecosystem, the Laboratory adheres to developing technological frontier, enhancing peoples health, and promoting research, innovation, and development of cell ecosystem in five key areas: cellular ecosystem, cellular ecology and immunity, cellular ecological imbalance and major diseases, cellular ecological reconstruction and frontier technology of cellular ecological research.

About Institute of Hematology and Blood Diseases Hospital (IH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS/PUMC)

Founded in 1957, IH is a tertiary specialty hospital under the National Health Commission of China and is the supporting unit of the National Clinical Research Center of Hematologic Diseases and the State Key Laboratory of Experimental Hematology. It is also the main founding unit of Tianjin Base, the core base of the Chinese medical science and technology innovation system with the goal of becoming "the innovation hub of hematology in China." IH mainly engages in basic research, applied research, clinical diagnosis and treatment of hematological diseases, standard-setting, new technology research, new drug evaluation, and translation in hematology and related fields. IH is leading in the diagnosis and treatment of hematological diseases in China and a global scale and has made original achievements. Since 2010, IH has been awarded first place in the Hospital Specialty Reputation Ranking (Hematology) for 12 consecutive years. It has won first place in the Hematology Specialty Ranking for ten consecutive years since 2010 and ranked the first in hematology by the Scientific and Technological Evaluation Metrics (STEM) for Chinese hospitals for eight consecutive years since 2014.

About EdiGene, Inc

EdiGene is a global, clinical-stage biotechnology company focused on translating gene editing technologies into transformative therapies for patients with serious genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with offices in Guangzhou and Shanghai, China and Cambridge, Massachusetts, USA. More information can be found at http://www.EdiGene.com.

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EdiGene Enters Strategic R&D Collaboration with Haihe Laboratory of Cell Ecosystem to Develop Hematopoietic Stem Cell Regenerative Therapies and...

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Protein Expression Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

The global protein expression market is expected to grow from $2.01 billion in 2020 to $2.13 billion in 2021 at a compound annual growth rate (CAGR) of 6%. The market is expected to reach $3.03 billion in 2025 at a CAGR of 9.2%.

Major players in the protein expression market are Agilent Technologies, Bio-Rad Laboratories, Thermo Fisher Scientific Inc., New England Biolabs and Promega Corporation.

The protein expression market consists of sales of protein expression vectors, competent cells, reagents, equipment and related services. Protein expression is a process in which proteins are synthesized, modified, regulated and controlled in living organisms according to the host cell. Protein expression included yeast expression, insect expression, and bacterial expression, algal expression and mammalian cell expression.

The protein expression market covered in this report is segmented by protein expression into yeast expression, mammalian expression, algae expression, insect expression, bacterial expression, cell-free expression. It is also segmented by end use into pharmaceutical and biotechnological companies, academic research, contract research organizations; by product into reagents, competent cells, expression vectors, services, instruments and by application into therapeutic, industrial, research.

Government regulations related to protein therapeutics and production of biologics may hinder the protein expression market growth. Government regulations on biologics to undergo rigorous preclinical and clinical trials prior to regulatory approval, and time consuming process for approval of biologics with regards to health and the safety of any individual are restraining the market growth.

Marketing and distribution of biologics including insulin, hormones, therapeutic antibodies, and vaccines depends upon the successful completion of clinical trials, which is a long, expensive, and uncertain process. According to FDA, for an approval of new biologic, Under the regulations (21 CFR 314.81(b)(2)(vii) and 601.70, a clinical trial approval usually takes 10- 12 months where firms are required to submit a report annually on the status of clinical safety, clinical efficiency, clinical pharmacology, and nonclinical toxicology study.

Companies in the industry are increasingly adopting Microfluidics technology to enhance protein expression tests in order to reduce the time, cost, labor, and increase the accuracy and performance. The microfluidics technology effectively analyzes biological samples than the traditional (macroscale) instruments.

Microfluidics technology is used to measure the expression of proteins on cells and optimizes the output to generate results regarding protein expression. Therapeutics-on-a-chip (TOC) uses microfluidic platform and is able to synthesize proteins in a point of care setting to reduce cost associated with storage and transportation of therapeutic proteins.

For instance, companies such as MissionBio, NanoCellect Biomedical, RainDance Technologies and Sphere fluidics have implemented this technology in protein expression test.

Increase in demand for biologics to counter various genetic disorders and chronic diseases is one the major factors driving the research and sales of protein expression market. Biologics is a medicine produced from living organisms or contains components of living organisms such as protein, tissue, genes, allergens, cells, blood components, blood, and vaccines.

The increasing use of biologics (therapeutic protein and others) to cure chronic diseases such as cancer, cardiovascular conditions and genetic disorders, is increasing the demand for protein expression devices and equipment. According to the World Health Organization, chronic disease prevalence is expected to rise by 57% globally, by the year 2020.

Hence the rising demand for biologics is driving the protein expression market. For instance, according to an article published by Chemistry World, analysts expect the biologics market to hold a market share of more than a quarter of the entire pharmaceutical market by 2020. The global biologics market is expected to grow at 9.9% during 2018-2024.

The Protein Expression market in the U.S. is governed by Food and Drug Administration (FDA) that lays down a series of guidelines for the manufacturers and retailers of this industry. Within FDA, Center for Drug Evaluation and research (CDER) regulates biological products under FDA 101 which includes gene therapy products and vaccines. These regulations ensure quality, safety and efficacy of biological therapeutics products, and speed up innovations that make these products safer, and effective.

The US's FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens.

The European Medicines Agency has also introduced policies which include a provision to waive the scientific advice fee, which encourage more academic groups and small companies to propose candidates for biologics.

Key Topics Covered:

1. Executive Summary

2. Protein Expression Market Characteristics

3. Protein Expression Market Trends and Strategies

4. Impact Of COVID-19 On Protein Expression

5. Protein Expression Market Size and Growth

5.1. Global Protein Expression Historic Market, 2015-2020, $ Billion

5.1.1. Drivers Of the Market

5.1.2. Restraints On the Market

5.2. Global Protein Expression Forecast Market, 2020-2025F, 2030F, $ Billion

5.2.1. Drivers Of the Market

5.2.2. Restraints On the Market

6. Protein Expression Market Segmentation

6.1. Global Protein Expression Market, Segmentation by Protein Expression, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.2. Global Protein Expression Market, Segmentation by End Use, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.3. Global Protein Expression Market, Segmentation by Product, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.4. Global Protein Expression Market, Segmentation by Application, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7. Protein Expression Market Regional and Country Analysis

7.1. Global Protein Expression Market, Split by Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7.2. Global Protein Expression Market, Split by Country, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/iix75m

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Global Protein Expression Market Research Report 2021 Featuring Major Players - Agilent Technologies, Bio-Rad Laboratories, Thermo Fisher Scientific,...

Recommendation and review posted by Bethany Smith

The human heart, the size of a fist, located just behind and slightly left of the breastbone, tirelessly beats an average of 100,000 times a day. However, conditions that stop the heart from pumping blood efficiently can cause serious problems and ultimately require a heart transplantation.

In a study published in the journal 'Science Translational Medicine', researchers from Osaka University showed that a previously unknown mutation can lead to a condition called dilated cardiomyopathy, which is one of the main causes of heart failure.

Heart failure refers to an incurable condition where the heart is no longer able to meet the body's demands in terms of blood supply. It is one of the most common causes of death and it affects almost 40 million people worldwide, representing a huge public health problem. One of the main factors leading to heart failure is a disease called dilated cardiomyopathy (or DCM). DCM is characterized by dilation of the heart's chambers and a pumping disfunction. Previous research has shown that DCM is often inherited and has a genetic basis. However, for up to 80 per cent of the familial DCM cases, the genetic mutation causing the disease has still not been known.

ALSO READ: Can Omicron cause heart damage? Here's what experts say

The research team identified a gene called BAG5 as a novel causative gene for DCM. First, they studied patients from different families, highlighting a correlation between loss of function mutations in the BAG5 gene and DCM. The researchers found that this mutation has a complete penetrance, meaning that 100 per cent of the individuals presenting it will develop the disease. They then found in a mouse model of dilated cardiomyopathy that mice without BAG5 exhibited the same symptoms of human DCM, such as dilatation of the heart's chambers and irregular heart rhythm. This indicated that mutations that erase the function of BAG5 can cause cardiomyopathy.

"Here we showed that loss of BAG5 perturbs calcium handling in mouse cardiomyocytes," said Dr. Hideyuki Hakui, lead author of the study. BAG5 is important for calcium handling in the heart muscle cells, and calcium is essential for a regular rhythm and overall health of the cardiac muscle, explaining why a loss of BAG5 leads to cardiomyopathy.

"After demonstrating that BAG5 mutations led to loss of functional BAG5 protein," continued Dr. Yoshihiro Asano, senior author of the study, "we also showed that administration of an AAV9-BAG5 vector in a murine model could restore cardiac function. This finding suggests that gene therapy with adeno-associated viruses (AAV) should be further investigated as a possible treatment alternative to heart transplantation for patients who are BAG5 deficient." AAV gene therapy refers to an innovative form of therapy aimed at fixing mutated genes in diseases that have a genetic cause like DCM. Therefore, these findings have paved the way for a potential precision medicine treatment based on gene therapy.

More here:
Not just bones, calcium is vital for heart too: Study - Hindustan Times

Recommendation and review posted by Bethany Smith

New Jersey, United States,-The research study presented in this report offers a complete and intelligent analysis of the competition, segmentation, dynamics, and geographical advancement of the Gene Therapy Cell Culture Media Market. It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the Gene Therapy Cell Culture Media market. The authors of the report have segmented the Gene Therapy Cell Culture Media market as per product, application, and region. Segments of the Gene Therapy Cell Culture Media market are analyzed on the basis of market share, production, consumption, revenue, CAGR, market size, and more factors. The analysts have profiled leading players of the Gene Therapy Cell Culture Media market, keeping in view their recent developments, market share, sales, revenue, areas covered, product portfolios, and other aspects.

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The report includes company profiling of almost all important players of the Gene Therapy Cell Culture Media market. The company profiling section offers valuable analysis on strengths and weaknesses, business developments, recent advancements, mergers and acquisitions, expansion plans, global footprint, market presence, and product portfolios of leading market players. This information can be used by players and other market participants to maximize their profitability and streamline their business strategies. Our competitive analysis also includes key information to help new entrants to identify market entry barriers and measure the level of competitiveness in the Gene Therapy Cell Culture Media market.

Key Players Mentioned in the Gene Therapy Cell Culture Media Market Research Report:

Fujifilm Holdings Corporation, HiMedia Laboratories Pvt., Ltd, Lonza Group Ltd, Sartorius AG, Thermo Fisher Scientific Inc., Merck KGaA, Danaher Corporation, Takara Holdings Inc., Novartis International AG, Bio-Techne Corporation.

Gene Therapy Cell Culture MediaMarket Segmentation:

Gene Therapy Cell Culture Media Market, By Media Type

Serum-containing Media Serum-free Media Stem Cell Media Specialty Media Chemically Defined Media

Gene Therapy Cell Culture Media Market, By End User

Biotechnology & Pharmaceutical Industry Academic Institute Research Laboratory

The Gene Therapy Cell Culture Media market is segmented as per the type of product, application, and geography. All of the segments of the Gene Therapy Cell Culture Media market are carefully analyzed based on their market share, CAGR, value and volume growth, and other important factors. The report also provides accurate estimations about the CAGR, revenue, production, sales, and other calculations for the Gene Therapy Cell Culture Media market. Each regional market is extensively studied in the report to explain why some regions are progressing at a high rate while others at a low rate. We have also provided Porters Five Forces and PESTLE analysis for a deeper study on the Gene Therapy Cell Culture Media market

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Gene Therapy Cell Culture Media Market Report Scope

Geographic Segment Covered in the Report:

TheGene Therapy Cell Culture Mediareport provides information about the market area, which is further subdivided into sub-regions and countries/regions. In addition to the market share in each country and sub-region, this chapter of this report also contains information on profit opportunities. This chapter of the report mentions the market share and growth rate of each region, country and sub-region during the estimated period.

North America (USA and Canada) Europe (UK, Germany, France and the rest of Europe) Asia Pacific (China, Japan, India, and the rest of the Asia Pacific region) Latin America (Brazil, Mexico, and the rest of Latin America) Middle East and Africa (GCC and rest of the Middle East and Africa)

Key questions answered in the report:

1. Which are the five top players of the Gene Therapy Cell Culture Media market?

2. How will the Gene Therapy Cell Culture Media market change in the next five years?

3. Which product and application will take a lions share of the Gene Therapy Cell Culture Media market?

4. What are the drivers and restraints of the Gene Therapy Cell Culture Media market?

5. Which regional market will show the highest growth?

6. What will be the CAGR and size of the Gene Therapy Cell Culture Media market throughout the forecast period?

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Verified Market Intelligence is our BI-enabled platform for narrative storytelling of this market. VMI offers in-depth forecasted trends and accurate Insights on over 20,000+ emerging & niche markets, helping you make critical revenue-impacting decisions for a brilliant future.

VMI provides a holistic overview and global competitive landscape with respect to Region, Country, and Segment, and Key players of your market. Present your Market Report & findings with an inbuilt presentation feature saving over 70% of your time and resources for Investor, Sales & Marketing, R&D, and Product Development pitches. VMI enables data delivery In Excel and Interactive PDF formats with over 15+ Key Market Indicators for your market.

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About Us: Verified Market Research

Verified Market Research is a leading Global Research and Consulting firm that has been providing advanced analytical research solutions, custom consulting and in-depth data analysis for 10+ years to individuals and companies alike that are looking for accurate, reliable and up to date research data and technical consulting. We offer insights into strategic and growth analyses, Data necessary to achieve corporate goals and help make critical revenue decisions.

Our research studies help our clients make superior data-driven decisions, understand market forecast, capitalize on future opportunities and optimize efficiency by working as their partner to deliver accurate and valuable information. The industries we cover span over a large spectrum including Technology, Chemicals, Manufacturing, Energy, Food and Beverages, Automotive, Robotics, Packaging, Construction, Mining & Gas. Etc.

We, at Verified Market Research, assist in understanding holistic market indicating factors and most current and future market trends. Our analysts, with their high expertise in data gathering and governance, utilize industry techniques to collate and examine data at all stages. They are trained to combine modern data collection techniques, superior research methodology, subject expertise and years of collective experience to produce informative and accurate research.

Having serviced over 5000+ clients, we have provided reliable market research services to more than 100 Global Fortune 500 companies such as Amazon, Dell, IBM, Shell, Exxon Mobil, General Electric, Siemens, Microsoft, Sony and Hitachi. We have co-consulted with some of the worlds leading consulting firms like McKinsey & Company, Boston Consulting Group, Bain and Company for custom research and consulting projects for businesses worldwide.

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Gene Therapy Cell Culture Media Market Size | Global Industry Trends, Segmentation, Business Opportunities And Forecast To 2029 The Oxford Spokesman...

Recommendation and review posted by Bethany Smith

RANDY HUTCHINSON| Better Business Bureau

The FDA says that stem cell products may offer the potential to treat many medical conditions and diseases for which few alternative treatments exist, but almost all of them have yet to be proven to be effective or safe. That hasnt stopped unscrupulous medical professionals and other promoters from touting them as miracle cures.

Stem cells are sometimes called the bodys master cells because they develop into blood, brain, bones and the bodys other organs. Stem cells that come from bone marrow or blood are routinely used to treat cancer and other disorders of the blood and immune system. But other uses, including treating COVID-19, have not been properly studied under an FDA Investigational New Drug Application, which includes providing sufficient data from human clinical testing to help evaluate a products potential risks.

The FDA cites these potential safety concerns for unproven treatments:

There are safety risks even with your own stem cells and contamination can occur if cells are manipulated after removal.

The FTC and Georgia Attorney General sued the co-founders of the Stem Cell Institute of America for allegedly targeting seniors with bogus claims that its therapy could treat arthritis, joint pain and other orthopedic ailments. The agencies said the company also claimed its stem cell therapy is comparable or superior to surgery, steroid injections and painkillers. A related company trained chiropractors and other healthcare practitioners in making similar claims. They also hosted free educational seminars for consumers at which they promoted injections that cost approximately $5,000 per joint, with many patients receiving multiple injections.

This wasnt the FTCs first enforcement action against deceptive stem cell therapy claims. In 2018, a California physician and his companies settled with the FTC over claims their amniotic stem cell therapy could treat Parkinsons disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, heart attacks and a host of other serious ailments. The defendants earned at least $3.3 million offering injections that cost up to $15,000.

The only stem cell products approved by the FDA for use in the United States consist of blood-forming stem cells derived from umbilical cord blood. Theyre approved for limited use in patients with disorders that affect the production of blood.

In bringing the most recent action, the Acting Director of the FTCs Bureau of Consumer Protection said, At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results. At worst, it can be harmful to their health.

If youre considering a stem cell treatment, the FDA says to make sure its FDA-approved or being studied under an Investigational New Drug Application. The FTC and BBB offer these additional tips:

Randy Hutchinson is the president of the Better Business Bureau of the Mid-South. Reach the BBB at 800-222-8754.

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Beware of unproven stem cell therapies - The Jackson Sun

Recommendation and review posted by Bethany Smith

New Jersey, United States,-ThisStem Cell TherapyMarketreport provides a clear picture of key players growth as well as the qualitative aspects of business in each area. ThisStem Cell TherapyMarket Report provides a current report on revenue generation, recent trends, financial status, and costing, as well as business profiles and financial status. The competitive landscape and potential growth factors are presented in thisStem Cell TherapyMarket Report.This way market report buyers can get a clear picture of the significant growth and the resulting market strategy. Granular market data would help monitor potential profitability and make critical growth decisions.

Significant industry central participants are included in thisStem Cell Therapymarket report. Diverse market factors like sort, size, applications, and end-clients have been incorporated to examine organizations altogether in thisStem Cell Therapymarket report. Significant mainstays of the organizations, companies and industries that influence the high points and low points of organizations are moreover recollected for thisStem Cell Therapymarket report.The research, interviews with key market players, and questionnaire have been compiled based on the continuous changes in the market, challenges and restraints faced by organizations, and global autonomies to expand the field in the coming years.

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This unique Stem Cell Therapy market report also discusses COVID-19 impact and influence on the worldwide market. How might one work around it or come up with fresh techniques so that COVID-19 doesnt stifle market growth are also discussed this report. This fascinating Stem Cell Therapy market report has proven to be of great benefit to current market participants by providing them with a broad understanding of market dynamics. This Stem Cell Therapy market report is a reliable technique of the general industry scenario that indicates basic leadership if they will gain or lose money in this market.

Key Players Mentioned in the Stem Cell Therapy Market Research Report:

Osiris Therapeutics Medipost Co. Ltd., Anterogen Co. Ltd., Pharmicell Co. Ltd., HolostemTerapieAvanzateSrl, JCR Pharmaceuticals Co. Ltd., Nuvasive RTI Surgical Allosource

Stem Cell TherapyMarket Segmentation:

Stem Cell Therapy Market, By Cell Source

Adipose Tissue-Derived Mesenchymal Stem CellsBone Marrow-Derived Mesenchymal Stem CellsCord Blood/Embryonic Stem CellsOther Cell Sources

Stem Cell Therapy Market, By Therapeutic Application

Musculoskeletal DisordersWounds and InjuriesCardiovascular DiseasesSurgeriesGastrointestinal DiseasesOther Applications

Stem Cell Therapy Market, By Type

Allogeneic Stem Cell Therapy Market, By ApplicationAutologous Stem Cell Therapy Market, By Application

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Stem Cell Therapy Market Report Scope

Determining the pulse of the market becomes easy through this in-detail Stem Cell Therapy market analysis. Key players can find all competitive data and market size of major regions like North America, Europe, Latin America, Asia-Pacific and Middle East. As part of the competitive analysis, certain strategies are profiled which are pursued by key players such as mergers, collaborations, acquisitions and new product launches. These strategies will greatly help industry players to strengthen their market position and grow their business.

Key questions answered in the report:

1. Which are the five top players of the Stem Cell Therapy market?

2. How will the Stem Cell Therapy market change in the next five years?

3. Which product and application will take a lions share of the Stem Cell Therapy market?

4. What are the drivers and restraints of the Stem Cell Therapy market?

5. Which regional market will show the highest growth?

6. What will be the CAGR and size of the Stem Cell Therapy market throughout the forecast period?

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VMI provides a holistic overview and global competitive landscape with respect to Region, Country, and Segment, and Key players of your market. Present your Market Report & findings with an inbuilt presentation feature saving over 70% of your time and resources for Investor, Sales & Marketing, R&D, and Product Development pitches. VMI enables data delivery In Excel and Interactive PDF formats with over 15+ Key Market Indicators for your market.

Visualize Stem Cell Therapy Market using VMI @ https://www.verifiedmarketresearch.com/vmintelligence/

About Us: Verified Market Research

Verified Market Research is a leading Global Research and Consulting firm that has been providing advanced analytical research solutions, custom consulting and in-depth data analysis for 10+ years to individuals and companies alike that are looking for accurate, reliable and up to date research data and technical consulting. We offer insights into strategic and growth analyses, Data necessary to achieve corporate goals and help make critical revenue decisions.

Our research studies help our clients make superior data-driven decisions, understand market forecast, capitalize on future opportunities and optimize efficiency by working as their partner to deliver accurate and valuable information. The industries we cover span over a large spectrum including Technology, Chemicals, Manufacturing, Energy, Food and Beverages, Automotive, Robotics, Packaging, Construction, Mining & Gas. Etc.

We, at Verified Market Research, assist in understanding holistic market indicating factors and most current and future market trends. Our analysts, with their high expertise in data gathering and governance, utilize industry techniques to collate and examine data at all stages. They are trained to combine modern data collection techniques, superior research methodology, subject expertise and years of collective experience to produce informative and accurate research.

Having serviced over 5000+ clients, we have provided reliable market research services to more than 100 Global Fortune 500 companies such as Amazon, Dell, IBM, Shell, Exxon Mobil, General Electric, Siemens, Microsoft, Sony and Hitachi. We have co-consulted with some of the worlds leading consulting firms like McKinsey & Company, Boston Consulting Group, Bain and Company for custom research and consulting projects for businesses worldwide.

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Stem Cell Therapy Market Size, Business Opportunities and Forecast to 2029 The Oxford Spokesman - The Oxford Spokesman

Recommendation and review posted by Bethany Smith

DuBOIS Cayleigh Walkers hopes for a successful basketball season were almost benched when she tore her ACL playing summer league basketball at the YMCA in July 2021. However, the Clearfield High School sophomore resumed training just three weeks following her August surgery, fast tracking her return to the court with the Lady Bison varsity basketball team.

I was going up the court and felt it pop, Cayleigh recalled. I was in so much pain. I had to sit out the rest of the game while some of the parents tried to stretch it out. I was eager to have it examined because we were leaving for the beach two days later. Fortunately I was able to get an appointment to have it examined the next morning.

Cayleigh and her parents chose Penn Highlands Orthopedics and Sports Medicine for her care. At Penn Highlands, she was examined by Tyler Beers, PA-C, who tested her range of motion and felt around the injured area. He gave her a brace to wear and ordered an MRI which was scheduled the following week when the Walkers returned from their vacation.

The MRI revealed the torn ACL. The next day, Cayleigh met with Dr. Matthew A. Varacallo, medical director of Orthopedic Robotic Surgery at Penn Highlands Healthcare. The orthopedic surgeon specializes in sports medicine, total joint reconstruction, accelerated rehabilitation protocols and functional return to sports after surgeries and procedures.

Named to the Top 65 Total Knee Replacement Surgeons to Know by Beckers ACS Review, Dr. Varacallo pioneered the innovative Fertilized ACL technique along with Dr. Chad Lavender, an orthopedic surgeon at Marshall University in West Virginia. Currently, they are the only two surgeons in the US using the technique when performing ACL reconstruction surgery.

Typically, when an ACL tear occurs, one third of the athletes re-tear the same side or injure the other knee; but, the theory behind the Fertilized ACL technique is to improve and expedite bone tunnel healing rates, followed by graft revascularization and ligamentization (the process by which the tendon becomes a ligament) to improve graft function and incorporation into the knee joint, explained Dr. Varacallo.

The Fertilized ACL procedure begins when bone marrow is removed from the tibia the long bone on the inside of the lower leg which is rich in growth hormone and stem cells. A specialized perfusionist takes 60 milliliters of the bone marrow and spins it down to bone marrow aspiration concentrate (BMAC) which is used to initiate healing. The BMAC is mixed with bone graft. Small tunnels are then made in the femur and tibia to place the graft during the procedure. The bone graft mixture and stem cells/growth factors are then injected into the tunnels to help stimulate them to heal faster. Once the tunnels heal, the tendon can in theory possibly transform into a ligament faster.

This is truly a cutting edge procedure, explained Dr. Varacallo. In traditional ACL surgeries, the pressurized tunnels can be risk factors for re-injury because they can take up to six or seven months to heal. However, with the Fertilized ACL procedure, the tunnels heal faster because the graft starts to incorporate into the body faster. In fact, four weeks post surgery, you cannot even see the bone tunnels, the surgeon added.

Dr. Varacallo considers Cayleigh the poster child for successful ACL reconstruction because she is achieving milestones sooner than expected, and Samantha (Sam) Morgan, MS ATC PES, a certified athletic trainer with Penn Highlands Healthcare as well as with the Clearfield Area School District agrees.

Three days following surgery, Cayleigh began rehab, and at three and one half weeks post op she was running, and six to seven weeks following surgery she was punting a soccer ball. In contrast, with traditional ACL surgery, we would not see that type of progress until three or four months post op, Ms. Morgan detailed.

According to Dr. Varacallo, Cayleigh is several months ahead of where she should be in terms of her progress based on the functional testing ACL Report Card, The Report Card, which is used to measure how well a patient is meeting 15 different functional test milestones at two, four, six and eight months post op, was developed at the University of Kentucky where Dr. Varacallo completed his fellowship in Orthopedic Surgery and Sports Medicine.

The ACL Report Card is a great benchmark tool because it not only shows the medical team the patients progress, it gives the athlete something to shoot for in their rehab, said Dr. Varacallo.

I had four months of rehab five days a week, Cayleigh said, The first few weeks were challenging because I was in some pain, but Sam pushed me and helped me get through it.

At two months after surgery, Cayleigh was testing stronger on the surgery side than on the other non-injured side. One of the factors that contributed to her faster recovery was that prior to surgery she and the other patients who have Fertilized ACL reconstruction surgery have prehab.

We cannot operate on a stiff and weak knee, so prior to surgery, we have the patient undergo motion and strengthening exercises to improve outcomes following surgery, Dr. Varacallo explained. The stronger the knee heading into surgery, the faster the recovery.

In addition to enhancing flexibility, prehab teaches patients the exercises they will be doing during post-surgery rehab so that they are already familiar with what their physical therapy will entail.

Cayleigh had aggressive prehab, said Morgan. In addition to promoting flexibility of the knee, it is an educational tool that helps the patient understand the how and why of the injury and healing. Three days following surgery, Cayleigh started rehab, and because she had the prehab, she already knew how to perform her exercises.

The prehab, surgery and rehab are all interdependent on each other. In fact, Dr. Varacallo uses an analogy to tie the process together. I think of the reconstruction and healing process as a house the prehab is the foundation, surgery is the main living level and rehab is the attic.

According to Cayleighs mother, Tammy Walker, her daughters fast recovery is a combination of three factors, Dr. Varacallos innovative Fertilized ACL technique, the aggressive rehabilitation and equally important the determination by Cayleigh and Morgan to get her back to where she could play again.

We are very impressed with Dr. Varacallo, said Walker. He was very thorough and went through everything with us and even called to check on her progress following the surgery.

More here:
Penn Highlands Healthcare surgeon pioneers innovative ACL surgery offering faster recovery - The Courier-Express

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Exclusive:

Football ace Ashley Cain and his girlfriend Safiyya Vorajee have been supporting parents of children battling cancer. The couple's baby girl Azaylia died last April

Image: Instagram)

Footballer Ashley Cain has been offering hope and solace to parents of a little girl battling the cancer that claimed the life of his own precious daughter.

Reality star Ashley and girlfriend Safiyya Vorajee have been supporting dozens of sick childrens families since the death of their baby girl.

Beloved Azaylia died last April after a courageous fight against the blood cancer acute myeloid leukaemia.

The ex-Coventry City winger and his partner have now struck up a special friendship with the family of five-year-old Esha Nadeswaran, who has spent eight months fighting the same disease at Londons Great Ormond Street Hospital.

Her dad Rishya, 45, of Gants Hill, North East London, said: Esha is our absolute hero and she is incredible. With our journey, it is like a marathon with no finish. We dont know when it is going to end and so we cant even pace ourselves.

There have been days where Ive gone to bed, crawled up and cried alone. But no matter how bad a day you are having and how much you hurt inside, Ashley reminded me you must stay positive and happy for your child.

He told me not to think too far ahead and do whatever I needed to do to support Esha. Its horrible to be told your child has cancer.

Listening to Ashley, and how vulnerable he felt, really struck a chord. Our chat has kept me going.

Former Ex On The Beach star Ashley, 31, and Safiyya, 34, were devastated to lose Azaylia when she was just eight months old.

She had been given stem cell treatment, which involves replacing damaged cells with healthy ones from a blood-match donor.

Ashley said Azaylia had the heart of a lion and he was given precious extra months with her after 100,000 people registered to be a donor.

The couple got involved in Eshas battle after Rishya and wife Kavitha, 41, appealed to members of the South Asian community to volunteer to be stem cell donors.

Esha has been in hospital since last May. She has had gruelling chemo and, in October, an emergency stem cell transplant. With her parents at her bedside, constant care includes regular platelet and red blood cell transfusions.

Rishya recalls the day they received the diagnosis. He says: She had been having tummy issues. Doctors ran tests and we were told wed receive the results in a fortnight. Two hours after returning home, they rang and we knew something was badly wrong. We rushed back and were told she had an acute form of leukaemia. It has been utterly heartbreaking.

Eshas Sri Lankan heritage meant it was hard to find a donor match and the family launched a social media campaign. Safiyya then reached out.

Rishya says: I arranged a Zoom chat with Safiyya and Ashley and I spoke father to father about what it feels like to be told your child has cancer. It was very emotional.

Ashley and Safiyya also recorded a video message on Eshas birthday.

Rishya, who works in banking, says: Esha really liked it. She is such a caring little girl and the way she has bounced back to defy doctors is something of a miracle.

She is always the one who goes from room to room cheering up the other children.

Rishya and his family now have 10,000 Instagram followers. But what they havent shared is their sacrifices to give her the best possible chance of survival.

Forming a Covid bubble, Rishya and his wife have had to live apart from elder daughter Ria, 10, who is with her grandparents.

They see her once a week at arms length and were apart at Christmas and on both girls birthdays. Its been really tough, says Rishya. My wife and I take it in turns to stay with Esha. The Young Lives vs Cancer charity has kindly been able to offer accommodation for the other to stay nearby.

We have been locked in this bubble for months now and its exhausting.

Ashley and Safiyya have helped dozens of parents. They set up a foundation raising money for treatment that may not be available on the NHS.

Image:

He says: No matter how painful it is, our mission is to really help and battle for these kids fighting cancer.

We speak to parents privately and try to guide them through the experience. We know first hand the stress and trauma parents have to go through.

Eshas dad and I talked about appreciating every single moment, making sure your child thinks theres nothing wrong. You need to stay positive and be the best you can be.

The pain of losing Azaylia is with us every minute. We go to her resting place every day and I want to hold this pain forever to use it effectively to help other children have a better chance.

Safiyya adds: So many children are suffering and we want to help.

The couple are planning a fundraising cycling event in June in conjunction with the Tour of Cambridgeshire.

Ashley says: Wed like everyone to wear orange and create a sea of orange so that Azalyia can look down from heaven and see what an amazing effect she has had on this world.

To join the cycle event, go to cycleforazaylia.com. Get updates on Esha at instagram.com/for_esha

Esha has the illness that cost Azaylia her life acute myeloid leukaemia, cancer of the white blood cells.

It starts in the bone marrow and spreads to the bloodstream and is very rare in young children.

The risk increases with age and it is most common in people aged over 75.

Acute leukaemia means it progresses quickly and chemotherapy is the main treatment, killing off as many unhealthy cells as possible and reducing the risk of the patient suffering a relapse.

Stem cell therapy involves removing a persons unhealthy cells and replacing them with healthy ones from a donor.

The new cells travel in the blood of the patient to the bone marrow, where they attach and grow.

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Continue reading here:
Ashley Cain supports parents of girl, 5, battling same cancer which killed his baby - The Mirror

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This article was originally published here

J Oncol Pharm Pract. 2022 Jan 27:10781552221074269. doi: 10.1177/10781552221074269. Online ahead of print.

ABSTRACT

INTRODUCTION: Plasma cell leukemia (PCL) is a rare but aggressive variant of multiple myeloma (MM) with a poor prognosis. Due to the limited number of prospective clinical trials studying PCL, treatment options are often extrapolated from data available for the treatment of MM. Venetoclax has recently demonstrated antimyeloma activity in patients with relapsed/refractory MM carrying the t(11;14) translocation. However, few cases have reported the analogous efficacy of venetoclax in PCL.

CASE REPORT: A 64-year-old Caucasian male developed relapsed PCL despite treatment with hyperCD (hyperfractionated cyclophosphamide and dexamethasone) and Dara-KRd (daratumumab, carfilzomib, lenalidomide, dexamethasone). Due to the refractory nature of his disease and the presence of a t(11:14) translocation, the patient was subsequently initiated on venetoclax 400 mg daily and dexamethasone 4 mg once weekly.

MANAGEMENT AND OUTCOME: The patient achieved a complete response by International Myeloma Working Group criteria three months after initiating venetoclax-dexamethasone, including a repeat bone marrow biopsy that showed no abnormal plasma cells. He successfully underwent consolidation with melphalan-based autologous stem cell transplantation. He remains disease-free 9 months after venetoclax initiation.

DISCUSSION: Combination all-oral therapy with venetoclax and dexamethasone can induce deep hematologic responses in patients with relapsed/refractory PCL carrying the t(11;14) translocation.

PMID:35084252 | DOI:10.1177/10781552221074269

Original post:
Complete response following treatment of plasma cell leukemia with venetoclax and dexamethasone: A case report - DocWire News

Recommendation and review posted by Bethany Smith

For Dr Jogin Desai, CEO and co-founder of Eyestem, a leading Indian cell therapy company, a meeting in 2015 with ophthalmologist Dr Rajani Battu for a medical appointment changed everything. Following the appointment, she introduced him to patients diagnosed with degenerative diseases of the eye and the terrible suffering they have to endure.

It was an eye-opener for Desai, a native of Ahmedabad and an expert in the field of drug development. Desai, at the time, was CEO of Cenduit, an industry leader in the IRT (interactive response technology) market and the eClinical field.

From school students who cannot see their blackboards to families with children suffering from blindness because of genetic disorders and senior citizens who have lost all agency due to their inability to read, the conversation opened my eyes to a world that I didnt know existed. In the same week, I met Prof S. Ramaswamy at Instem (Institute for Stem Cell and Regenerative Medicine), again for something completely unrelated, and we discussed the possibilities of how the next two-three decades will evolve with the maturation of cell and gene therapy products worldwide, recalls Desai, in a conversation with The Better India.

Following the meeting, it dawned on Desai at the time that the world is on the cusp of a fundamental change in the healthcare landscape that will evolve over the next few decades.

Today, Dr Rajani Battu is the chief medical officer at Eyestem.

Diseases that were previously incurable will start becoming curable. As I dove deeper, I understood that most of these therapies developed in the West will cost upwards of $450,000 (about Rs 3.5 Crore) per injection. This, I believe, presented a once-in-a-lifetime opportunity for a platform that can help disrupt this paradigm and create an incredible impact on the lives of patients. I made the decision to establish Eyestem within two days of these meetings in late 2015, adds Desai.

Eyestems vision is to create a scalable cell therapy platform to treat incurable diseases and democratise access to these newer technologies.

Incorporated in late 2015, Eyestem started operations in early 2017.

As cell and gene therapies become available across the world, they will only be available to the top 0.01 % of the worlds population. Our purpose is simple: We aim to democratise access by creating a therapy that is available to a large part of the bottom 99.99% of the population in the world. To our knowledge, we are the only company in the world with such a mission. While it is hard to predict the price of the therapy at this stage we anticipate the therapy to cost 80-90% cheaper than such comparable therapies in the West. The only purpose to start Eyestem has been ensuring that the therapy reaches the people that need it the most, claims Desai.

Through its flagship product Eyecyte-RPE, the company replaces lost retinal pigment epithelium cells. It is designed to restore sight for patients in the early stages of Age-Related Macular Degeneration (AMD) and arrest losses for those in the later stages.

There is no cure for Dry Age-Related Macular Degeneration in the world. It is the largest cause of blindness for people over 50. It is estimated that over 170 million people (40 million of which are in India) suffer from this disease. Eyestem is looking to take Eyecyte-RPE for Dry AMD through clinical trials and is one of six companies worldwide pursuing this treatment, he says.

Underpinning this type of treatment are Induced-Pluripotent Stem Cell (iPSC)-based products. An iPSC is a cell that can be developed into any cell of the body. At present, there are no iPSC-based products approved anywhere in the world.

Over the next ten years, Desai explains that several such products will start becoming available in the market and diseases such as inherited blindness/pulmonary fibrosis/diabetes which were hitherto considered incurable will start becoming curable.

Subsequently, an explosion in iPSC based therapeutics combined with gene engineering will be the next wave of pharma innovation. A lot of diseases occur when the cells of our body die early or are malfunctioning. At its most basic detail, one can create tissue of any kind (be it brain, heart, lung, eye, liver, kidney) through iPSC and replace the lost/damaged cells of the body. For example, in Dry AMD, the RPE layer degenerates and our treatment would be to inject that layer (from a healthy donor) back into the body part to treat the disease, he explains.

Curing Incurable Blindness and Other Diseases

So, how does Eyestems flagship product, Eyecte-RPE, work as a mode of treatment?

The Retinal Pigment Epithelium (RPE) is one of ten layers of the retina and acts as a foundation on which the rest of the retina sits. In Dry AMD, the RPE layer disintegrates and the retinal layers disintegrate just as a building collapses when the foundation collapses.

We have grown the RPE layer in our lab and this is Eyecyte-RPE, our flagship product. This product has been injected into special models of blind rats. We have proven that the rats where our product is injected can retain their sight while the ones that are controlled rats go blind. This animal experiment has been done at Oregon Health and Science University which is a global centre of excellence for macular degeneration research. The DCGI (Drugs Controller General of India) has approved manufacturing only for clinical trials and we have not yet applied for commercial manufacturing, he explains.

In addition to this, Eyestem is also among one of five companies globally advancing the treatment of Retinitis Pigmentosa (RP) to the market called Eyecyte-PRP. Eyecyte-PRP replaces the photoreceptor cells that are lost as a consequence of this disease. RP is a group of rare, genetic disorders that involve loss of the light-sensing photoreceptor cells in the retina. It affects children and causes total blindness by the time they reach their 20s and 30s. It is estimated to affect 4 million children worldwide, of which 1.5 million are in India. Human trials for Eyecyte-PRP to treat retinitis pigmentosa is expected to begin in the second half of FY 2023.

Similarly, Eyestem is also looking to treat Idiopathic Pulmonary Fibrosis (IPF), a serious chronic disease that affects the tissue surrounding the alveoli (tiny air sacs in your lungs), with a pluripotent stem cell-based approach.

Our first human trials for our Aircyte-AEC treatment to treat idiopathic pulmonary fibrosis will begin in the second half of FY2024. Aircyte-AEC is a suspension of lung alveolar epithelial cells that are lost due to this disease. It is worth noting that pulmonary fibrosis occurs as an end-stage event in several other diseases like COVID-19, Tuberculosis and Chronic Obstructive Pulmonary Disease, notes Desai.

Meanwhile, for the sake of clarification, we asked Desai whether cell therapy necessarily means stem cell therapy? Yes, it means the same from a laymans perspective. The only difference is that there are clinics that advertise stem cell therapy for patients in India as well as the US. It is important to remember that none of these stem cell therapy products are approved by the DCGI in India or the FDA in the United States, he notes.

State of Cell Therapy in India, Funding and Moving Ahead

There are only a handful of companies in India that are pursuing cell therapy. According to Desai, the developed world, especially countries like Israel, Japan and the United States, are at least two decades ahead of India in that regard.

As more incurable diseases become curable (think diabetes or cancer) it is absolutely imperative for India to develop a base of such product development research or else we will find ourselves in a situation similar to the HIV epidemic (and cell therapy is not easy to reverse engineer unlike HIV medicines). Our patients will be at the mercy of predatory pricing of global pharma unless globally innovative products are manufactured and made available locally. Our nine-member team at Eyestem, a majority of whom are cell biology scientists specializing in this field, is looking to significantly address this issue in advance, says Desai.

Meanwhile, Desai claims that his venture has been very selective in raising funds so far since its purpose is not to raise rounds of money with higher valuations but to benefit end patients. They are laser-focused on creating affordable cell therapy and hence have set themselves a benchmark of not spending more than $4 million from idea to first in human trials. Most pharmaceutical companies, he claims, spend 10 times this amount to reach this stage.

Any drug development venture needs smart money. We were fortunate to have interest from a group of investors who have multi-decade experience in global drug development. Two institutional investors (Endiya Partners and Kotak Private Equity) joined in a subsequent pre-series A round. We are currently raising our series A and we are halfway there. About 30% has been committed by current shareholders and we have a soft commitment from a global venture fund for the other 20%. We anticipate closing this round in the next 8-12 weeks. Investors invest in ventures like ours due to the promise of immense market potential for these therapies. As soon as one obtains human data, startups like ourselves reach an inflexion point and become extremely valuable, claims Desai.

Please Note: The Better India does not verify for the future efficacy of any therapy or medical treatment mentioned in the article. Kindly consult your doctor for an informed medical opinion.

(Edited by Vinayak Hegde)

Read the original here:
Doctor Innovates Cell Therapy in India; Seeks to Make Vision Restoration 80% Cheaper - The Better India

Recommendation and review posted by Bethany Smith

The hemochromatosis gene, known as HFE, helps regulate the bodys absorption of iron. Some people can inherit a mutation to this gene that causes their bodies to absorb too much iron. Most cases occur due to C282Y and H63D mutations. When this happens, a person can develop hemochromatosis.

A person may develop symptoms related to too much iron in the body, such as joint pain, fatigue, and a loss of libido. Over time, they may also develop serious complications, such as liver damage.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) states that rare forms of hemochromatosis, called non-HFE hemochromatosis, occur due to mutations in the HAMP and HJV genes. Healthcare professionals may also refer to the HJV gene as the HFE2 gene.

If these mutations occur, a person will develop complications and symptoms at a younger age. They may also develop complications by the time they are teenagers.

This article reviews what the hemochromatosis gene is, symptoms associated with hemochromatosis, and more on how a person inherits the gene.

Hereditary hemochromatosis is a genetic disease that alters how the body regulates iron absorption. The condition causes a persons iron levels to increase to dangerous levels.

According to the National Human Genome Research Institute, in the case of hereditary hemochromatosis, a person is likely to develop the condition if they inherit two copies of the mutated hemochromatosis gene, or HFE gene. However, it is important to note that not everyone who inherits two copies will experience symptoms.

A person who inherits one copy of the mutated gene will either not develop signs and symptoms or experience mild symptoms.

When functioning normally, this gene helps regulate and prevent the excessive absorption of iron. When too much iron circulates in the body, it can cause damage to tissues and organs.

Some affected areas include:

Hereditary hemochromatosis affects approximately 1 million people in the United States.

When too much iron consistently enters the body, a person may start to experience symptoms related to the condition.

The NIDDK states that common symptoms of too much iron include:

People may also experience a darkening of their skin color, which initially appears on sun-exposed areas such as their face. This is often known as bronzing.

Not everyone will develop symptoms. Additionally, symptoms usually occur after a person reaches 40 years old, and females may develop symptoms 10 years later compared to males.

Without treatment, a person may develop complications that could cause additional symptoms. Some potential complications include:

Both parents can carry the hereditary hemochromatosis gene.

According to the National Human Genome Research Institute, a child that inherits two copies of the mutated gene has a high risk of developing hemochromatosis. However, having two copies does not guarantee a child will develop the condition.

When a person inherits only one copy of the gene, they may not develop any symptoms of the condition at all, or they may only develop slight symptoms. In these cases, they may become silent carriers of the condition.

In other words, if they have a child with another silent carrier, their child has a chance of inheriting two mutated genes and a higher chance of developing hemochromatosis.

Parents pass the hemochromatosis gene to their children. A child inherits two copies of the gene, one from each parent.

The affected genes may be recessive or dominant, which affects how many copies of the genes a person needs to develop the condition.

According to the Genetic and Rare Diseases Information Center (GARD), a child of two recessive gene carriers has a:

On the other hand, a child with a dominant gene change has a:

Several potential mutations can occur within the genes that can cause hereditary hemochromatosis to develop.

The location of the mutation determines the type of hereditary hemochromatosis a person may develop. Healthcare professionals classify the type of hereditary hemochromatosis based on the age of onset, which genes are affected, and how it is inherited.

A person can inherit an autosomal recessive condition if they inherit one copy of a mutated gene from each parent.

Individuals can develop an autosomal dominant condition if they inherit a single copy of the mutated gene from one parent. A person has a 50% chance of inheriting the mutated gene and developing the condition.

GARD states that the mutations can occur on the following genes:

Type 5 hereditary hemochromatosis occurs due to changes with the FTH1 gene. Only one family in Japan has reported the condition.

According to a 2015 article, healthcare professionals perform gene testing for hereditary hemochromatosis if they suspect a person has an iron overload alongside high levels of ferritin, which is a blood protein that stores iron, and transferrin, which is a protein in that transports iron the blood. High levels can indicate that a person has hemochromatosis.

Gene testing can confirm a hereditary hemochromatosis diagnosis.

A person with hemochromatosis will need regular testing as part of their treatment. Testing can help check iron levels and look for complications related to too much iron.

A doctor may recommend some common tests, such as a complete blood count to check for iron and protein levels, a liver biopsy to check for liver damage, and an MRI.

A person with hemochromatosis has a good chance of living a normal, healthy lifespan provided they seek treatment for their condition.

Without diagnosis and treatment, a person has a higher chance of developing serious health complications, such as liver damage or heart disease, that can affect a persons overall outlook and life expectancy.

The most common treatment for reducing iron in the blood is via phlebotomy, or drawing blood. In addition, a doctor may recommend dietary changes, iron chelation therapy, and treating any complications of the disease.

At first, a person will likely need regular blood draws. Once their blood iron levels reach a normal level, the number of blood draws will vary based on how well their ferritin and transferrin saturation levels stay within the normal range.

Regular treatment can help prevent complications and reduce their impact on a persons life if they have already begun. As a result, a person should seek treatment even if complications have already started.

A person who has a sibling living with hereditary hemochromatosis should speak with a doctor about undergoing genetic testing due to an increased risk of also having the mutated genes.

Additionally, a person with a parent who either has the condition or is a known carrier should speak with a doctor about genetic testing.

Finally, a person who knows they may have the mutated genes should speak with a doctor if they develop any symptoms that could indicate a problem with iron absorption.

Hereditary hemochromatosis can occur when a person inherits one or more copies of a mutated HFE gene. Hemochromatosis results in the body absorbing too much iron, which can lead to complications, such as cirrhosis.

A person should seek treatment for the condition as soon as possible to help prevent complications. Treatment typically involves blood draws to help reduce iron levels.

A person should also contact a doctor if they experience symptoms of iron absorption issues and have a known family member who either is living with the condition or may be a carrier.

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Hemochromatosis gene: Definition, signs, and is it hereditary? - Medical News Today

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This week on Market Squared we look at the trucker convoys and protests that befuddle us, and why mocking them, or ignoring them, is not an option

I submit the following to GuelphToday for this weeks column knowing that Im about to nuke my email from orbit. It had a good run.

So lets talk about whats going on in Ottawa right this moment (at noon on Saturday), and what happened here in Guelph last weekend.

Though theres a difference in scale, the intention and desire of the ones organizing these two gatherings are more or less the same, but while the so-called 'Freedom Convoy' has gotten a lot of attention, whats happened in Guelph with these anti-mandate groups has gotten practically none.

Last weekend, a couple of hundred people who dont consider themselves anti-mask or anti-vaccine walked though Old Quebec Street making noise while maskless to say theyre fed up with the pandemic and pandemic restrictions. Im glad were finally doing this, one woman said. Another man asked the stunned people looking on in Old Quebec Street to take off their masks and show off their smiles.

If I were to have stopped and asked those people what they just saw, they would probably be hard pressed to explain it to me. A lot of those people were too young to remember the 'freak outs'of the 1960s, and the one security guard I saw arrived on the scene several minutes late. It was over and done in less than eight minutes.

Consider what happened last Saturday as an experiment. It was an experiment for those participating to see how far they can push things, and it was an experiment for our city leadership: Can they ignore whats almost literally happening under their nose?

I know 90 per cent of the eligible population is fully vaccinated, but this is not just a matter of being vaccinated because Ive been told by a few of the people participating in these rallies that theyve gotten two jabs. Its also worth noting that over 80 per cent of Canadian truckers are fully vaccinated, but look at the attention wrought by the other 20.

To understand the inherent danger, you have to understand how people are indoctrinated. To use the word feels disturbing, but there is a continuum of information, or misinformation, that people go down and it starts with the simplest of ideas, an idea that youve already thought about in the course of the last 22 months: Arent you sick of this?

I talked to one man a few weeks ago who told me that he wont get vaccinated because he doesnt trust the government and he doesnt trust big pharma. Hey, fair enough. My sense is that a majority of Canadians, if asked, will enunciate some level of mistrust in most institutions, from the Government of Canada to the Loyal Order of Water Buffaloes. But this is how it begins.

The seeds of doubt, perhaps long sowed in the person, are then fertilized with a rapidly changing information landscape. With COVID-19 weve seen the scientific process happen in real time, and the best advice of March 2020 (disinfecting your groceries anyone?) has now been proven by researchers as pointless and ineffective in stopping the spread.

So now you dont know what to believe. Its possible you might have once trusted your family doctor, if you have a family doctor, but he or she is saying all the things you hear from the three levels of government and the World Health Organization. If you cant trust them, how can you trust your doctor? Are they in on it (whatever it is)?

Youre told to wear a mask, but some people you know on Facebook say that they dont work. Youre told to get a vaccine, but then youre told some vaccines have side effects, and those same online friends are now telling you that the other vaccines are bad, or that theyre gene therapy to change your DNA(theyre not).

And now you see the real plot and intentions. COVID-19, whether its real or fake, is a means to an end. That end could be Agenda 2021, or Agenda 2030, or the Great Reset, or some other international conspiracy to grind people under foot or de-populate the planet. All of this sounds crazy, but its also the best case scenario.

Whats more disturbing are the white supremacists and far-right figures who understand well how indoctrination works and have attached themselves to the anti-mandate movements, like the trucker convoy, to find new blood. The frightening thing is that the ones being recruited dont know or dont care that their perversion is happening, theyre just happy to have friends who believe as they believe.

And thats why we need to take these things seriously, the trucker rallies and the freak outs through local malls. To stand back and watch without saying anything is a kind of dereliction. To stand there and laugh, or to call those people names, is even worse.

Were rapidly approaching the second anniversary of the first lockdown because of COVID, and our public health leaders have started to pivot to the idea that COVID is something we must start learning to live with. Meanwhile, the pandemic of radicalization is just beginning, and living with it, like ignoring it, is not an option.

Read the rest here:
The pandemic of radicalization has begun, and we can't ignore it - GuelphToday

Recommendation and review posted by Bethany Smith

Vertex finished out 2021 strong, smashing analysts sales expectations for the full year. Chalk it up to the companys entrenched position in cystic fibrosis, where Vertex expects to maintain its lead for years to come, according to CEO Reshma Kewalramani, M.D.

Vertex snared $7.57 billion in product revenues for 2021, signaling a 22% increase year over year. For 2022, the company expects to pull in sales of $8.4 billion to $8.6 billion. For now, that growth is firmly tethered to Vertexs bread-and-butter CF franchises.

The companys 2022 guidance suggests penetration of additional CF patients will occur more rapidly than expected with age expansion and full-year impact of ex-U.S. reimbursements, RBC Capital Markets Brian Abrahams wrote in a note to clients Wednesday.

During its call Wednesday, Vertex repeated estimates that there are more than 25,000 patients who could benefit from CF newcomer Trikafta and arent yet on therapy. The company splits those patients into three groups: those whove yet to start on Trikafta in countries where the drug was recently reimbursed, patients in territories where the drug hasnt been reimbursed and younger patients, who Vertex aims to address with future Trikafta label expansions.

RELATED:JPM 2022: Vertex's Trikafta holds the line as company lays groundwork for gene editing launch

Meanwhile, the $8.4 billion to $8.6 billion range Vertex laid out seems notoriously conservative, Evercore ISIs Liisa Bayko wrote in a note to clients. [W]e expect VRTX to beat and raise throughout the year, she added.

Trikafta, for its part, carried the bulk of the sales weight last year, bringing in $1.69 billion for the last three months of 2021. The drug made about $1.09 billion during that same period in 2020. Trikafta reaped full-year 2022 sales of $5.69 billion, marking a blockbuster-worthy increase over the $3.86 billion it made in 2020.

Older CF med Kalydeco proved to be the companys next top sellerthough by a significantly smaller marginwith fourth quarter sales of $152 million. The drug made $684 million for the year. Orkambi made $147 million for the quarterslightly down from 2020s $215 millionand $772 for the year, while Symdeko pulled $80 million in the fourth quarter and $420 million for all of 2021.

Vertex is working to branch out from its CF base, and analysts seem to share the companys hopes for phase 1/2 Type 1 diabetes candidate, VX-880. That drug could potentially unlock a multibillion-dollar opportunity, which is comparable to CF and nearly all upside in our model, RBCs Abrahams said. CF forms the backbone of Vertexs pharma business, and investors have long pushed the company to diversify.

Vertex has also pinned its hopes on its gene editing program for sickle cell disease and beta thalassemia, CTX001, as its next commercial launch, Kewalramani said. The company sees tremendous potential for the treatment, and Vertex has already kicked off launch preparations ahead of planned global regulatory submissions toward the end of the year. The company is building out market access, patient support and its doctor-facing teams, as well as finalizing its manufacturing and supply chain network, the company said during its earnings call.

RELATED: Fierce Biotech's top 10 data readouts in 2022 | CRISPR Therapeutics and Vertex's CTX001amyotrophic lateral sclerosis

Still, when it comes to CF, Vertex is confident it can maintain its place at the head of the table, Kewalramani said.

More patients around the globe are treated with a Vertex CFTR modulator today than ever before, and the vast majority of that is with Trikafta, which boasts remarkable clinical trial data, the CEO said. If theres any medicine that will compete with Trikafta, it has to go head-to-head against Trikafta in clinical trials.

It has to have improved benefit, and you have to have the long-term data, she added.

The only company that has that right now is Vertex, and the most advanced competitor to Trikafta is the companys own triple combo of tezecaftor and the experimental VX-121 and VX-561, which is in phase 3 testing.

Kewalramani highlighted recent real-world Trikafta data, garnered from more than 16,000 U.S. patients, which showed the drug led to an 87% reduction in risks of lung transplant, 77% fewer pulmonary exacerbations and a 74% reduction in risk of death.

That said, the company is on the cusp of a critical external event that should settle the viability of VRTXs dominance in CF that is ABBVs triplet data, Evercores Bayko said. Consensus opinion is pointing toward lackluster data from AbbVie, but, It would be an unwelcomed surprise if the data were comparable to Trikafta, the analyst added.

AbbVie's combo, which isin phase 2 testing, comes from the company's purchase ofGalapagos' CF pipeline for$45 million in late 2018.

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What competition? Vertex touts Trikafta's competitive edge on back of strong 2021 - FiercePharma

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Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President

NORTH BETHESDA, Md. (PRWEB) January 27, 2022

The International Society for Pharmaceutical Engineering (ISPE) announced Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President, as a confirmed keynote for the 2022 ISPE Facilities of the Future Conference, taking place on 12 February in North Bethesda, Maryland and virtually.

The opening keynote session COVID's Impact on Pharma Facilities of the Future will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. Hepburn will discuss Lessons Learned from Operation Warp Speed for Rapid Vaccine Development at the opening plenary session and the executive forum dinner.

The mission of OSTP is to maximize the benefits of science and technology to advance health, prosperity, security, environmental quality, and justice for all Americans. At the OSTP, Hepburn works on preparing the country for future pandemics, with a spotlight on the acceleration of vaccines, therapies, and test development.

Previously, Hepburn was the Director of Vaccine Development at Countermeasures Acceleration Group, formerly known as Operation Warp Speed, which is an effort between the Defense Department and the Department of Health and Human Services. During the Obama administration, he was the Director of Medical Preparedness for the White House National Security Council. Additionally, he served as an infectious disease doctor for the U.S. Army for over two decades.

Representatives from Bristol-Myers Squibb, CRB, and Merck will round out a compelling line-up of expert speakers at the opening plenary session.

Featuring technical presentations from regulatory authorities and industry leaders already planning and building facilities of the future, the 2022 ISPE Facilities of the Future Conference will explore topics such as patient-specific cell and gene therapy facilities, new developments in the use of artificial intelligence, innovations in treatment and the transforming technologies that produce them, and moving forward from the COVID-19 era.

To ensure this experience is accessible to all, this conference will be in North Bethesda, Maryland, with virtual componentsdelivering thought-provoking learning and global networking opportunities whether attendees choose to join us in-person or virtually.

Explore the agenda and register at ISPE.org/FOF22.

About ISPEThe International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.

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US Office of Science and Technology Senior Advisor to Deliver Keynote Address at the 2022 ISPE Facilities of the Future Conference - PR Web

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Mol Biotechnol. 2022 Jan 29. doi: 10.1007/s12033-021-00431-7. Online ahead of print.

ABSTRACT

Biotechnological approaches have always sought to utilize novel and efficient methods in the prevention, diagnosis, and treatment of diseases. This science has consistently tried to revolutionize medical science by employing state-of-the-art technologies in genomic and proteomic engineering. CRISPR-Cas system is one of the emerging techniques in the field of biotechnology. To date, the CRISPR-Cas system has been extensively applied in gene editing, targeting genomic sequences for diagnosis, treatment of diseases through genomic manipulation, and in creating animal models for preclinical researches. With the emergence of the COVID-19 pandemic in 2019, there is need for the development and modification of novel tools such as the CRISPR-Cas system for use in diagnostic emergencies. This system can compete with other existing biotechnological methods in accuracy, precision, and wide performance that could guarantee its future in these conditions. In this article, we review the various platforms of the CRISPR-Cas system meant for SARS-CoV-2 diagnosis, anti-viral therapeutic procedures, producing animal models for preclinical studies, and genome-wide screening studies toward drug and vaccine development.

PMID:35091986 | DOI:10.1007/s12033-021-00431-7

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The Trend of CRISPR-Based Technologies in COVID-19 Disease: Beyond Genome Editing - DocWire News

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A gene-editing treatment known as CRISPR appears to have positive results for people suffering from a rare visual disorder.

According to new reports, researchers injected seven volunteers with CRISPR to treat a rare vision disorder. Unlike other treatments, scientists designed CRISPR to fight diseases at a genetic level. Following the experiment, some of the volunteers noted a marked improvement in their eyesight. The affected individuals were all born with vision disorders, however, thanks to CRISPR, theyre now able to see better.

This is the first time scientists injected CRISPR directly into the human body. Previously, scientists had removed affected cells from the body and then conducted tests using the gene-editing procedure in the safety of a lab. From there, the scientists infused the modified cells back into the patients. With this experiment, though, the seven volunteers were injected directly with the treatment.

Scientists at the Casey Eye Institute conducted the study. The institute itself is part of the Oregon Health & Science University. Dr. Mark Pennesi shared the results of the CRISPR trial at the International Symposium on Retinal Degeneration late last year.

Following the injections, one of the patients shared that she was now able to safely navigate the area where she works. Another patient said that he could now see colors for the first time after the treatment. Both volunteers had suffered from LCA, or Leber congenital amaurosis, a severe vision impairment.

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. Scientists engineered the treatment in 2012. It was intended to act as a biological tool for altering DNA. In the past ten years, though, scientists have found a multitude of other users for the gene-editing procedure.

Thats where the most recent study comes into play. By injecting the CRISPR directly into the body, scientists were able to see how it would more greatly affect it as a whole. Additionally, being able to inject it directly would allow them to treat disorders and diseases in areas where it isnt safe to remove cells, like the brain.

Because it focuses on editing things at a genetic level, scientists hope that CRISPR will open new doors to fighting cancer and other diseases. Once improved and thoroughly studied, it could become one of the most powerful treatments the medical community has available.

Its a really amazing technology and very powerful, Pennesi told NPR back in September.

Now that were seeing some additional pushes for the treatment, we could see some other studies appearing in the coming months. Of course, it is worth noting that not all the volunteers experienced any improvements. As such, theres no real timetable for when CRISPR could become a more widespread treatment.

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This remarkable tech can actually improve the eyesight of the visually impaired - BGR

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market report will be very beneficial to both of the sides in the market that is an established firm and a relatively new entrant. It helps the established firms to know about the moves which are being performed by their competitors whereas it helps the new entrants by educating them about the market situations and the industry trends. This market report includes market share appraisals for regional and global levels, detailed overview of parent market potential and niche segments/regions exhibiting promising growth, in-depth analysis of the global order management software market and current & future trends to elucidate imminent investment pockets.

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The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is expected to witness market growth at a rate of 26.88% in the forecast period of 2021 to 2028. Data Bridge Market Research report on clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market provides analysis and insights regarding the various factors are expected to be prevalent throughout the forecast period while providing their impacts on the markets growth. The rise in the demand in the food industry for better products with improved quality and nutrient enrichment is escalating the growth of clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

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The major players covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are Applied StemCell, ACEA BIO, Synthego, Thermo Fisher Scientific, GenScript, Addgene, Merck KGaA, Intellia Therapeutics, Inc, Cellectis, Precision Biosciences, Caribou Biosciences, Inc., Transposagen Biopharmaceuticals, Inc, OriGene Technologies, Inc., Novartis AG, New England Biolabs, Rockland Immunochemicals Inc., ToolGen, Inc., TAKARA BIO INC., Agilent Technologies, Inc., Abcam plc, and CRISPR Therapeutics AG among other domestic and global players.

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The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies focus related to clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene is referred to as a genome editing technology that permits the genetic material to be added, altered and removed in an organisms DNA.

Major factors that are expected to boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the forecast period are the rise in the incidence ofgeneticdisorders and the utilization of genome editing. Furthermore, the private and government funding is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. Moreover, the rise in thetechnologydevelopment in the CRISPR gene editing is further estimated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. On the other hand, the off target effects and delivery is further projected to impede thegrowthof the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the timeline period.

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Scope and Market Size

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Country Level Analysis

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is analysed and market size information is provided by country, therapeutic application, application, technology, services, products and end users as referenced above.

The countries covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are U.S., Canada and Mexico in North America, Peru, Brazil, Argentina and Rest of South America as part of South America, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), South Africa, Saudi Arabia, U.A.E, Kuwait, Israel, Egypt, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

North America dominates the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the considerable investments made by biotechnology and pharmaceutical companies. Furthermore, the rise in the healthcare infrastructure will further boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region during the forecast period. Asia-Pacific is projected to observe significant amount of growth in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the increasing of the per capita income. Moreover, the early accessibility of authorized therapies is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region in the coming years.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, disease epidemiology and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market 2022 Business Outlook with Pandemic Scenario Analysis and...

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AstraZeneca said the U.S. government agreed to purchase additional 500,000 doses of its Covid-19 preventive medicine Evusheld (tixagevimab/cilgavimab).

AZ had said that it would initially supply 1 million doses of Evusheld. However, if most of the doses go to the U.S., other countries will have limited access to AZs preventive therapy.

AZ welcomed the U.S. governments plan to buy 500,000 doses of Evusheld on Wednesday.

Evusheld is a combination drug mixing long-acting antibodies, tixagevimab and cilgavimab, derived from B cells donated by convalescent patients after Covid-19 infection.

The antibody treatment was discovered by Vanderbilt University Medical Center and licensed to AZ, which optimized the drug with half-life extension.

The medicine aims to prevent Covid-19 infection in immunocompromised people.

According to AZ, the half-life extension more than triples the durability of its action compared to conventional antibodies. In addition, the company said that the consecutive two doses of tixagevimab 150mg and cilgavimab 150 mg could afford up to 12 months of protection from Covid-19.

On Dec. 8, Evusheld received FDA approval for the pre-exposure prophylaxis of Covid-19 in people who experienced serious adverse reactions of Covid-19 vaccines or those with immune compromise. Earlier, the U.S. government signed a deal with AZ to purchase 700,000 doses of Evusheld.

The U.S. has confirmed the purchase of 1.2 million doses of Evusheld so far, and the additional 500,000 doses will be shipped to the U.S. within the first half of this year.

As the U.S. secured most of the initial supply of Evusheld, other countries will face a limited chance to purchase the preventive therapy.

Our headquarters basic stance is that we will apply for marketing license in countries that confirmed the pre-purchase of Evusheld, an official at AstraZeneca Korea said. As the quantity of Evusheld is insufficient, we are distributing the remaining stock of Evusheld, excluding those going to the U.S., to several developed countries in Europe.

This means that if the Korean government does not discuss a pre-purchase of Evusheld, AZ will not seek marketing approval pre-emptively.

The Ministry of Food and Drug Safety is doing a preliminary review on Covid-19 vaccines and treatments. But this happens only when a company submits related data.

The regulator is not reviewing Evusheld now.

However, the Korea Disease Control and Prevention Agency (KDCA) plans to discuss Evusheld purchase with AZ soon. The drug is expected to become an option for Korean immunocompromised people to prevent Covid-19.

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US will buy additional doses of Covid-19 preventive drug Evusheld. What about Korea? - Korea Biomedical Review

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Rory Moore (pictured) has worked at Ekati, the first diamond mine in Canadas Northwest Territories, on and off for years. He was part of the original crew that first developed the mine in the 1990s. In 2018, he rejoined what was then called Dominion Diamond. He then became its interim president in January 2020, and in November, he was appointed the full-time CEO of what is now called the Arctic Canadian Diamond Co.

Here, he talks with JCK about his view on the diamond market, how Arctic looks at Canadian cutting and Canadian-origin stones, and why Ekati might confound expectations and stay around for a while.

Can you bring us up to date on whats happening with Ekati and its current ownership structure?

With the onset of COVID, the diamond market closed. We had a partnership with Rio Tinto in the Diavik mine, which is a neighboring mine. After COVID, we [initially] elected to put Ekati on care and maintenance, because we had $200 million worth of diamonds in inventory, but we couldnt sell them. We didnt want to burn through our cash reserves quickly. However, when Diavik did continue to operate, we were obliged to pay our 40% interest in the operating costs, and that would have very quickly have chewed up our cash reserves. So, we [filed] for CCAA [insolvency protection].

That triggered its sale process and the former owners, Washington, participated in that and ultimately withdrew their bid to buy the assets, and then the debt holders stepped in, represented by the three principal organizations: DDJ Capital, Brigade Capital, and Western Asset Management. The three of them stepped in and bought the assets and [provided us] with some additional cash to reopen the mine and get going again.

We restarted the mine in January last year, which is in the dead of the Arctic winter, so that was challenging. We had lots of startup problems, but ultimately now we have got the mine running at a steady state. Fortunately, we had some nice tailwinds from a strong rough diamond market last year, so prices were very robust and that really helped us with our restart. We met our revenue targets last year despite all the challenges.

You have said you want to extend the mine life. How do you plan to do that?

The best days of Ekati are behind us in terms of quality of ore bodies. During the early years, when BHP owned the mine, the ore bodies were very rich and very close to the central infrastructure at the mine, which is the process plant. So operating costs were very low, and revenue was very high. It was a highly profitable mine.

As time has gone on, those bodies have been mined out, and we are now mining lower-value ore bodies further away from the plant. Our main open pit, Sable, is 17 kilometers north of the process plant. Its a lower-revenue ore body and theres additional transportation and logistics involved in getting the ore from the open pit to the process plant. Then, to the south, weve got our Misery underground mine, which is a high-revenue ore body that has now gone underground, so its mining at a lower production rate. And thats 25 kilometers south of the processing plant, so again, weve got to transport the ore to the plant.

What we faced going forward is, as these ore bodies come to their natural end, Stable in particular, they were not valuable enough to support conventional underground mining. And, so, what weve done is over the past four yearsand this is what Ive been working onis looking at alternative, more creative ways to mine these ore bodies so we can still mine them profitably.

Weve come up with a system, its called underwater remote mining. Essentially, we flood the pit, and after the open pit mining is completed, and we continue to mine it underwater, using specialized underwater surface mining machines that weve developed in conjunction with a company out of Holland called Royal IHC. We are very confident that its going to work, and the beauty of this method is that you only mine ore and not waste. So, with conventional mining, you have to mine a lot of waste. In fact, at Sable, theres seven times more waste [being mined] than ore. If you remove all that waste mining, suddenly your costs are dramatically lower, and youve got a profitable mining operation again. Thats the way we are going into the future.

We have designed all the equipment, and we are going to construct the first of that equipment this year. Then, were going to do a big production trial in 2024. Were building equipment this year, and then over 2023 and 2024, were gonna test that equipment and then implement it in 2024 for future mining at Sable, and then extend that to other ore bodies. The future of Ekati is underwater remote mining, which has not been done in this sort of setting at all in the past. We are spearheading some new innovative mining techniques.

Assuming that all comes to fruition, how long will that extend the mine life?

Initially, the first phase will take us to 2029. The other thing that were doing at the moment is developing a new conventional open-pit mine at the same time. That will take us to 2028. We also have the opportunity to extend mine life through underwater remote mining at Point Lake. That ore body has 50 million tons of kimberlite in it. So, if the underwater remote mining works, well get an additional 10 years of mining out of Point Lake. Then, we have another ore body that was mined by BHP called Fox, and that has 40 million tons of kimberlite left in it. Weve done studies to potentially develop it with underground conventional mining, and it doesnt make the grade. So, we would look to mine that underwater as well, which would add another 10 years of mine life. So, essentially, we have decades of mine life extension, but we have to prove the system first.

You said youre confident that will work.

Yes. Im very confident. Components of the technology have been routinely used in other applications, in conventional dredging operations throughout the world. We are putting it all together in a system that hasnt been used in this application. None of it is rocket science. Its all proven technology.

The owners have been very supportive, and they have been very open to funding our development of [the underwater remote mining] method. Weve got a stable operation now, and our immediate focus is to pay down the debt that we have, and weve already started that process this year. We had a good revenue year, and weve already paid down the debt very substantially.

There have been concerns raised about underwater mining from an environmental point of view. How do you respond to that?

In fact, this method is significantly more environmentally friendly than open-pit mining. Thats because, firstly, you dont have any big waste dumps. So, all that footprint of the waste dumps interfering with caribou migration or changing the landscape, that goes away. You have a closed water system, so all the water thats in the mine [goes to] a pond next door to the open-pit mine, where well settle out the sedimentary material. It will be a closed system. So, no water thats been disturbed or polluted in any way will get out into the secondary environment. Its very much contained and has an incredibly small footprint.

The machine has been devised so that all the hydraulic fluids in the machine are biodegradable. Id be lying to you if I said were not going to burst hydraulic hoses once in a while. We will have hydraulic oil spills, but [they will be] biodegradable hydraulic oils by design that will not contaminate the water in any meaningful way. So, the environmental impact is much lower, and thats a positive for the project as well.

What has been the reaction from the local community to Ekati restarting?

Our northern partners are very relieved that we are back in production. We have a lot of training and career opportunities for people of the north. There was big relief that we did come through the CCAA process, that weve hired a whole lot of new people, and our training programs, apprenticeship programs, leadership programs are back in place. Weve got partnerships with the local indigenous groups and communities. Theyve supported us very well, as has the government of Northwest Territories. Its all pretty positive, after a tough period of 10 months not being in production

You no longer have 40% ownership in the Diavik mine, as Rio Tinto took it over. How does that affect you?

On a practical basis, it doesnt impact us much, because we were essentially a passive partner in that. Rio Tinto operated that mine and we just participated in quarterly management committee meetings. It doesnt impact our workforce in any way, as we had nobody working at Diavik.

What it does impact is the product mix that we take to the market. We used to have a big production out of Ekati, supplemented by a fairly significant production out of Diavik, which gave us higher carats and higher volumes to sell into the rough market and gave us more options for product mix for our clients. Weve lost a bit of flexibility in accommodating our clients exact needs when it comes to the product mixes.

But the productions are fairly similar between Ekati and Diavik. So, the impact of that hasnt been too significant. Its more that weve just got a lower volume of diamonds to sell.

Your company has been renamed Arctic, which is probably a more potent name from a marketing point of view, in that it symbolizes Canada. Do you expect to get more involved in marketing your product?

We recognize that we are diamond producers, and thats what weve got to focus on. We are an active member of the Natural Diamond Council, and so we actively participate in that and contribute to that initiative through our membership fees. We think that the Natural Diamond Council is doing a great job of promoting natural diamonds. We recognize that if you wanted to do a good job of marketing a luxury product like diamonds, youve got to have a big budget for that, and thats just not where we fit in. All of us producers together are much more powerful than individuals trying to do that separately.

A lot of producers are looking into origin certification? Will you do that?

A percentage of our diamonds are sold through the Canadamark program. They tend to be the higher-quality goods. We think its an important consideration, given that the new generations of customers are much more concerned about the origin of the products that they buy and that the products have been produced a sustainable way. I think Canadian-origin diamonds are highly prized by millennials because they know that Canada has high environmental guidelines and social economic guidelines and the way we run our mines in Canada is of the highest standard. Thats not to say that a diamond produced in Africa has not been ethically produced, because the big mines in Africa are run according to the highest international standards. There may be a perception that all these African [stones] are still blood diamonds, but the reality is that the absolute majority of diamonds coming out of Africa are produced in a very ethical way. But Canada does have brand appeal.

Theres been talk of new factories in Canada. Thats been tried before, and it didnt work. Do you think Canadian cutting has a future?

I think its always going to be a challenge to manufacture diamonds in Canada, particularly in the north. You are competing against India, and India has really done an incredible job of capturing that part of the supply chain of diamonds. You cant compete on costs, and they actually have become incredibly skilled at polishing diamonds.

Its admirable to see people try, because the more we can capture business opportunities in Canada, the better. But I think its a struggle.

Do you expect rough diamond prices to continue to remain strong?

At the moment, everybody in the business expects that rough diamond prices will remain strong in the short- to medium-term. Obviously, its very difficult to predict longer term. Supply has been impacted by COVID, so supply of rough diamonds is lower than it was forecast to be. Demand is incredibly strong, fueled mostly by the U.S. and China. Theres been very strong demand for our product, and the commentary over the holiday season was that sales were very strong on the retail side. In the short-term, I think the macro factors for our industry, and for rough diamond prices, are very good.

(Photos courtesy of Arctic Canadian Diamond Co.)

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Interview With Rory Moore, CEO Of Arctic Canadian Diamond Co. - JCK

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Isoflavones Market Research Report by Product (Capsule, Liquid, and Powder), by Source (Chickpea, Red Clover, and Soybeans), by Component, by Application, by Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2026 - Cumulative Impact of COVID-19

New York, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Isoflavones Market Research Report by Product, by Source, by Component, by Application, by Region - Global Forecast to 2026 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p06202161/?utm_source=GNW

The Global Isoflavones Market size was estimated at USD 1,333.21 million in 2020 and expected to reach USD 1,412.48 million in 2021, at a CAGR 6.05% to reach USD 1,896.77 million by 2026.

Market Statistics:The report provides market sizing and forecast across five major currencies - USD, EUR GBP, JPY, and AUD. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2019 are considered historical years, 2020 as the base year, 2021 as the estimated year, and years from 2022 to 2026 are considered the forecast period.

Market Segmentation & Coverage:This research report categorizes the Isoflavones to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Product, the market was studied across Capsule, Liquid, Powder, and Tablet.

Based on Source, the market was studied across Chickpea, Red Clover, and Soybeans.

Based on Component, the market was studied across Daidzein, Formononetin, and Genistein.

Based on Application, the market was studied across Cosmetics & Personal Care, Food & Beverages, and Nutraceutical.

Based on Region, the market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand. The Europe, Middle East & Africa is further studied across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable 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.

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Isoflavones Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Competitive Scenario:The Competitive Scenario provides an outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section deliver valuable thoughts at the different stage while keeping up-to-date with the business and engage stakeholders in the economic debate. The competitive scenario represents press releases or news of the companies categorized into Merger & Acquisition, Agreement, Collaboration, & Partnership, New Product Launch & Enhancement, Investment & Funding, and Award, Recognition, & Expansion. All the news collected help vendor to understand the gaps in the marketplace and competitors strength and weakness thereby, providing insights to enhance product and service.

Company Usability Profiles:The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Isoflavones Market, including Archer Daniels Midland Company, BASF SE, Bio-Gen Extracts Pvt. Ltd., Cargill, Incorporated, Fujicco Co., Ltd., Futureceuticals Inc., GNC Holdings Inc., International Flavors & Fragrances, Inc., InVite Health, Inc., Koninklijke DSM N.V., Lactonova Nutripharm Pvt Ltd, Life Extension Foundation, Nexira Inc., NOW Foods, Nutra Green Biotechnology Co. Ltd., NutraScience Labs, Shaanxi Hongda Phytochemistry Co., Ltd., Shanghai Freemen, SK Bioland, and Xena Bio Herbals Pvt Ltd..

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:1. What is the market size and forecast of the Global Isoflavones Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Isoflavones Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Isoflavones Market?4. What is the competitive strategic window for opportunities in the Global Isoflavones Market?5. What are the technology trends and regulatory frameworks in the Global Isoflavones Market?6. What is the market share of the leading vendors in the Global Isoflavones Market?7. What modes and strategic moves are considered suitable for entering the Global Isoflavones Market?Read the full report: https://www.reportlinker.com/p06202161/?utm_source=GNW

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Isoflavones Market Research Report by Product, by Source, by Component, by Application, by Region - Global Forecast to 2026 - Cumulative Impact of...

Recommendation and review posted by Bethany Smith