PITTSBURGH, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (Nasdaq:KRYS), a fully integrated gene therapy company driven by its proprietary, engineered herpes simplex virus type 1 vector (HSV-1) platform, today announced that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to KB407, currently in preclinical development for the treatment of cystic fibrosis (CF).

We are pleased to receive Orphan Drug Designation for KB407 to treat cystic fibrosis as this is an important step forward in our efforts to address the continued unmet need in this devastating disease, said Suma M. Krishnan, founder and chief operating officer of Krystal Biotech. We are excited by the results of the in vitro data thus far, as presented at ASGCT earlier this year, and we look forward to sharing in vivo animal data later this year.

The FDAs Office of Orphan Drug Products grants Orphan Drug Designation to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan Drug Designation may allow Krystal Biotech to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of KB407, tax credits for certain clinical research costs and a waiver of the Prescription Drug User Fee Act (PDUFA) filing fees, subject to certain conditions.About KB407 for Cystic FibrosisKB407 is an inhaled, repeat-dose gene therapy product currently in the preclinical phase with plans to file an IND in 2021. In pre-clinical studies to date, KB407 has been able to successfully transduce human CF patient-derived epithelial cells and deliver functional cystic fibrosis transmembrane conductance regulator (CFTR) in vitro in 2D and 3D organotypic systems. Additional data has shown that the therapy is amendable to non-invasive inhaled administration in vivo, as indicated by successful delivery to the lungs through the use of a clinically relevant nebulizer in rodent healthy and diseased small animal models.

AboutKrystal BiotechKrystal Biotech, Inc. (NASDAQ:KRYS) is a gene therapy company dedicated to developing transformative medicines to treat diseases caused by protein or gene dysfunction. For more information, please visit http://www.krystalbio.com.

Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including but not limited to statements about the development of Krystals product candidates, such as plans for the design, conduct and timelines of ongoing clinical trials of beremagene geperpavec (B-VEC), KB105, KB104, KB301 and KB407; the clinical utility of B-VEC, KB105, KB104, KB301 and KB407, and Krystals plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301 and KB407 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301 and KB407; plans to pursue research and development of other product candidates; the sufficiency of Krystals existing cash resources; the unanticipated impact of COVID-19 on Krystals business operations, pre-clinical activities and clinical trials; and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301 and KB407, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption Risk Factors in Krystals annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystals views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystals views as of any date subsequent to the date of this release.

CONTACTS:

Investors:Ashley R. RobinsonLifeSci Advisorsarr@lifesciadvisors.com

Media:Darren Opland, PhDLifeSci Communicationsdarren@lifescicomms.com

Source: Krystal Biotech, Inc.

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Krystal Biotech's KB407 Granted Orphan Drug Designation by the FDA to Treat Patients With Cystic FibrosisThe company is on track to file an IND for...

Recommendation and review posted by Bethany Smith

Journalists received not one but three announcements this week from American Gene Technologies (AGT) touting the most promising potential cure for HIV in the world. But such claims amount to unjustified hype, advocates say. The experimental therapy has not yet been tested in humans andif it worksit could be years before its ready for clinical use.

AGT just received clearance from the Food and Drug Administration (FDA) to start the first Phase I human clinical trial of its genetically modified T-cell product, dubbed AGT103-T, which the company is developing in collaboration with researchers at the National Institute of Allergy and Infectious Disease.

From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans, the company announced in a press release. Added AGT founder and CEOJeff Galvin, I am confidentAGT103-Twill be an important step toward an eventual cure for HIV.

But advocates say such claims are not only premature, but also harmful because they give people with HIV the false impression that a cure is around the corner.

AGTs public relations strategy preys on the emotions of people living with HIV and has a deleterious effect on the understanding of the cure field overall, Seattle advocate Michael Louella told POZ. They make their outrageous comments, and these are then picked up and believed to be certain truth. Any attempt to promote a more nuanced and better-grounded understanding of gene therapy or the clinical process becomes impossible.

Although HIV can be suppressed indefinitely with combination antiretroviral therapy, it has proved exceedingly difficult to cure because a so-called reservoir of latent virus can remain hidden from the drugs in resting immune cells. Only two people appear to have been cured after bone marrow transplants from donors with HIV-resistant stem cellsa procedure far too dangerous for people who dont have life-threatening blood cancer.

Nonetheless, researchers are exploring numerous cure strategies, ranging from flushing HIV out of resting cells to genetically engineering immune cells to make them resistant to the virus. Most experts expect that a combination approach will likely be needed to maintain durable control of HIV after stopping antiretroviral therapythe definition of a functional cure.

AGTs process involves collecting immune cells from a patient and selecting those cells that target HIV antigens. A harmless lentivirus vector is then used to insert genes into the HIV-specific CD4 T cells that disable CCR5 receptorswhich most strains of HIV use to enter cellsas well as genes involved in HIV replication. The genetically modified CD4 cells are then reinfused back into the same patient in a single dose. The entire process takes 11 days.

The company said it expects the approach will provide durable control of genetically diverse strains of HIV, including those that use a different receptor (known as CXCR4) to enter cells. The experimental therapy should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment, AGT claims.

Another company, Sangamo BioSciences, previously reported promising results from early studies using a different gene therapy technique (a zinc finger nuclease) to edit out CCR5 receptors from T cells. Although it did not cure HIV, some study participants saw a reduction in the size of their viral reservoir and a long-term increase in CD4 counts. More recently, Chinese researcher He Jiankui used yet another technique (CRISPR-Cas9) to disable the CCR5 gene in human embryos in an effort to protect them from HIV.

AGTs approach not only uses a different gene-editing method to disable CCR5, but it also selects CD4 T cells that target HIV and protects them from destruction by the virus, thereby helping the selected cells survive and avoiding the wasted effort of modifying cells that wont attack HIV.

A recent medical journal report described preclinical studies of the approach, which showed that it is feasible to manufacture the modified HIV-specific CD4 T cells. AGT claims that in laboratory studies, the product demonstrates the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells. The company has not yet reported results from studies of the experimental therapy in animals.

These findings were used to support AGTs investigational new drug application to the FDA to allow the company to proceed with a Phase I study in human volunteers, which will be conducted in Baltimore and Washington, DC. Eligible participants must have been on antiretroviral therapy for one to three years, have an undetectable viral load, have a stable CD4 count above 500 and may not have any AIDS-defining conditions.

AGT expects to enroll the first participant in September, with the first infusion of genetically modified T cells to be administered in December. The company said it expects initial data by the end of the year.

But this will be far too soon to determine whether the altered T cells persist in the body or whether they can maintain long-term viral suppression after antiretroviral therapy is discontinued.

Saying AGT believes there is a high likelihood that participants in the upcoming trial will be cured is beyond outrageous and completely undermines informed consent because its an unethical inducement to participate [in trials], Richard Jefferys of the Treatment Action Group told POZ.

And its not based on a shred of evidence. To my knowledge, theres no humanized mouse data, no macaque dataits all theory, he continued. "I would hope that they pause to reconsider their PR strategy and broaden their consultation with stakeholders, including community-based advocates.

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Gene Therapy Cure Claims Are Premature, Advocates Say - POZ

Recommendation and review posted by Bethany Smith

Aug. 17, 2020 10:00 UTC

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it has filed a nonprovisional patent application with the United States Patent and Trademark Office (USPTO) entitled Methods and Systems of PCR-Based Recombinant Adeno-Associated Virus (AAV) Manufacture (the Patent). The Patent claims priority to a previously filed provisional patent application filed with the USPTO in August of 2019.

AAV is utilized to deliver a therapeutic gene of interest to a patient or a patients cells to cause the expression of the necessary protein to address a targeted disease. Reflective of its potential as one of the most promising delivery vehicles for genetic medicines, there are approximately 80 active or enrolling clinical trials that utilize AAV1. With its new patent application, Applied DNA seeks to leverage its LinearDNA platform to give gene and redirected cell therapy developers the ability to greatly improve the manufacture and quality of their AAV-vectored medicines that have the potential to address many diseases, including COVID-19.

AAV is generally accepted as the preferred vector for gene therapy, and so, has an enormous breadth as a therapeutic gene delivery system. AAV vectors are manufactured utilizing multiple plasmid DNAs as starting materials, and as the number of gene therapy programs increase, and with improving levels of clinical success and progression of therapies into late-phase clinical studies, the field is being challenged by the need for larger manufacturing scales, said Dr. James A. Hayward, president and CEO of Applied DNA Sciences. At Applied DNA, we believe we have solved the linear DNA production challenge and can make the DNA sequences at scale for gene therapies. Utilizing our LinearDNA platform to manufacture amplicons, we can deliver gene therapy constructs that potentially lower the risks that come with the use of plasmid-based AAV manufacture. As one of the only companies in the marketplace commercializing a scaled linear DNA manufacturing platform, we believe we are uniquely positioned to deliver linear DNA as an alternative to plasmids, and with this patent filing, we expand our addressable market to including AAVs.

AAV is manufactured by the triple transfection of three plasmid DNA constructs into packaging cell lines to produce recombinant adeno-associated virus. This triple transfection requires large amounts of DNAs that are currently manufactured via plasmids circular DNA constructs which are propagated in bacteria. The three DNA constructs necessary for successful AAV production are: (i) AAV Rep and Cap; (ii) AAV Helper; and (iii) the therapeutic cargo (transgene) flanked on either side by inverted terminal repeat sequences (ITR). The manufacture of plasmid DNA for the production of AAV, however, presents a number of significant challenges, including scalability, fidelity, mis-incorporation of plasmid-derived DNA sequences, high costs, and long lead times for cGMP production.

Concluded Dr. Hayward, The ITRs serve as the viral origins of replication and for packaging signals to assemble AAV in the host cell. But the triple transfection of the required plasmids, and in the strict stoichiometries required for AAV assembly, we believe adds enormously to the cost of traditional AAV manufacturing, limiting the availability of many gene therapies. Our success in simplifying the production of the critical plasmid genes for AAV production we believe enable AAV production with minimal or absent plasmids, potentially greatly enhancing production and lowering costs. The use of LinearDNA potentially lowers the risks that come with plasmids, including off-target DNA, contamination by the genes for antimicrobial resistance or other bacterial DNA, endotoxin contamination and the use of antibiotics.

The Patent claims methods for the use of specialized LinearDNATM amplicons, instead of plasmids, to manufacture AAV. The patent also claims methods and systems for the PCR-based manufacturing of AAV transgene constructs flanked on either side by the necessary ITR sequences via the Companys LinearDNA platform. Due to their complex secondary structures, the ITR sequences necessary for AAV production have historically been very challenging to amplify via PCR. Leveraging the Companys PCR expertise, the methods and systems claimed in the Patent utilize specialized PCR techniques and primer designs to mitigate the challenges caused by the ITR secondary structures, allowing for the high yield and high-fidelity manufacture of transgene ITR amplicons.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Companys common stock is listed on NASDAQ under ticker symbol APDN, and its publicly-traded warrants are listed on OTC under ticker symbol APPDW.

Applied DNA is a member of the Russell Microcap Index.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be forward-looking in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNAs future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNAs assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNAs or its partners diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the fact that there has never been a commercial drug or viral vector product utilizing PCR-produced DNA technology approved for therapeutic use, disruptions in the supply of raw materials and supplies, the unknown outcome of the patent application, and various other factors detailed from time to time in Applied DNAs SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports we file with the SEC, which are available at http://www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

1 https://clinicaltrials.gov/ct2/results?term=adeno-associated+virus&recrs=b&recrs=a&recrs=f&recrs=d&age_v=&gndr=&type=&rslt=&Search=Applyhttps://clinicaltrials.gov/ct2/results?cond=&term=%22AAV+gene+therapy%22&cntry=&state=&city=&dist=

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Originally posted here:
Applied DNA Positions LinearDNA Platform as the Next Generation Manufacturing Platform for Adeno-Associated Virus-based Gene Therapies Through New...

Recommendation and review posted by Bethany Smith

Most of Novo Nordisks kidney work has come from diabetes, but eyeing an R&D expansion, the Danish giant is putting money down on a pact to target chronic kidney disease directly.

The new deal comes with an old partner: the German drug discovery company Evotec. Under the agreement, Evotec and Novo will collaborate on discovering and developing pre-clinical candidates across different modalities for CKD. Novo will then be in charge of clinical and commercial development for any promising approaches.

The companies were loose on specifics, but between upfront payments, research funding and milestones, Evotec can earn up to 150 million ($179 million) per project.

Building on adjacencies within cardio-renal and metabolism, this collaboration will allow us to strengthen our efforts within kidney disease, Novos cardio-renal and diabetes chief Karin Conde-Knape said in a statement, adding the work will be on the basis of human relevant biology.

Although the overwhelming majority of Novos roughly $20 billion in annual sales come from insulin and other diabetes and obesity drugs, the company has talked openly about its plans to expand into other areas over the next five years, including NASH, cardiovascular disease and CKD.

In 2018, Novo also licensed a CKD drug from San Diegos Epigen for up to $200 million, although they signaled they would also develop the drug in diabetes-related conditions.

Novo and Evotec have collaborated since 2017, when Novo took a 90.3 million stake in the biotech. Its proven to be a prudent investment, in euros and cents alone. Buoyed by a string of big-name partnerships and a few milestone payments, Evotecs revenues have nearly tripled over that time period, from around 150 million in 2017 to 446 million last year. And their stock has risen from 6.87 to 22.09 today.

In 2018, Novo turned to Evotec to boost their early-stage research in the Big Pharmas bread-and-butter areas: diabetes and obesity. That deal was built solely around small molecules, but the company has since invested heavily in both biologics and gene therapy, and the new collaboration is modality agnostic.

With its partners, Evotec has worked on a long list of disease areas including anti-infective research with Bayer and the Bill & Melinda Gates Foundation, neuroscience work with Bristol Myers Squibb, and immunology work with Galapagos and Pfizer and kidney disease has been no exception.

The company has worked with Bayer on drugs for diabetics with kidney disease since 2016, as part of an up to $300 million deal. In 2017, Evotec started working with Cambridge University, the University of Bristol, and the Mario Negri Institute in Italy on what they called the NEPLEX project. It involves using micro-fluidics and iPSC stem to create a nephron-on-a-chip that can be used to test preclinical drugs.

Perhaps, most notably, the company last year teamed with Vifor Biopharma to launch NephThera, a joint venture that uses data from the massive UK kidney biobank studyand Evotecs bioinformatics platform to find new drugs.

Continue reading here:
Looking to expand beyond diabetes, Novo Nordisk enlists Evotec in CKD pact worth up to $179M per program - Endpoints News

Recommendation and review posted by Bethany Smith

The study on the Global Gene Therapy for Age-related Macular Degeneration Market strives to offer prominent and profound insights into the present market scenario and the emerging growth dynamics. The report on Gene Therapy for Age-related Macular Degeneration market also provides the market players as well as the new contenders a complete view of the market landscape. The detailed research will empower the well-established as well as the emerging players to organizetheir business planning and achieve their short-term and long-term goals.

Global financial markets are in crisis as the covid-19 coronavirus spreads worldwide. The coronavirus epidemic is relevant and has far-reaching implications for the market. Many industries are facing a rising number of critical concerns such as supply chain disruption, rising risk of recession, and a possible reduction in consumer spending. These scenarios will run in different regions and sectors, so that correct and timely market research is more important than ever. By studying all aspects, the report provides up to date market intelligence on Gene Therapy for Age-related Macular Degeneration market.

Note: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

The global Gene Therapy for Age-related Macular Degeneration market report offers detailed company profiles to bring out a clear view of the competitive landscape of the Gene Therapy for Age-related Macular Degeneration market Outlook. It also comprehends market new product analysis, financial overview, strategies and marketing trends. The following manufacturers are assessed in this report in terms of sales, revenue, and market share for each company.

The Major players profiled in this report include:

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This report offers insights into a dynamic competitive environment. It also offers a progressive viewpoint on various factors driving or restricting the market growth. The report gives an overall view of the global Gene Therapy for Age-related Macular Degeneration market by categorizing it in terms of type, application and region. These segments are analyzed by current and future trends. Regional segmentation includes current and future demand for them in North America, Asia Pacific, Europe, and the Middle East. The report collectively covers specific application segments of the market in each region.

Global Gene Therapy for Age-related Macular Degeneration Market Split by Product Type and Applications:

Types of Global Gene Therapy for Age-related Macular Degeneration Market:

Applications of Global Gene Therapy for Age-related Macular Degeneration Market:

Geographically, the detailed analysis of consumption, revenue, Gene Therapy for Age-related Macular Degeneration market share and growth rate, historic and forecast (2015-2026) of the following regions are covered-

The Report Delivers Following Points:

Comprehensive analysis of the global as well as regional markets of the global Gene Therapy for Age-related Macular Degeneration market. The growth matrix exhibits an analysis of the product segments and geographies that market players should focus to invest, combine, expand and/or diversify. Complete coverage of all the segments in the global Gene Therapy for Age-related Macular Degeneration market to analyze the trends, developments in the global market and prediction of market size up to 2027. Detailed analysis of the companies operating in the global Gene Therapy for Age-related Macular Degeneration market. The company profile includes analysis of product portfolio, revenue, SWOT analysis, porter analysis and the latest developments of the company.

Do enquire to get a strategic overview of the market, Access Research Methodology Prepared By Experts at: https://www.innovateinsights.com/report/global-gene-therapy-for-age-related-macular-degeneration/61133/#buyinginquiry

The growth of this market globally is subjected to different reasons, including consumer ace Gene Therapy for Age-related Macular Degeneration of a lot of Gene Therapy for Age-related Macular Degeneration products, inorganic company growth models, price volatility of raw materials, product innovation along with economic prospects in both producer and consumer countries.

The Report Highlights the Following Key Factors: Detailed information of the companys operations and business segments. List of key products, services, and brands of the company. List of major competitors to the company. Contact details of key locations and subsidiaries of the company. Progression of key events associated with the company. Analysts summarization of the companys business strategy. An extensive analysis of the companys strengths, weakness, opportunities, and threats.

Read more:
Global Gene Therapy for Age-related Macular Degeneration Market 2020 to Witness Huge Growth by 2026 | RetroSense Therapeutics, REGENXBIO, AGTC - Owned

Recommendation and review posted by Bethany Smith

Transfection is a process that involves production of genetically modified cells with utilization of foreign nucleic acid (DNA and RNA). This technology helps the cells in mutation of cancer cells, protein metabolism by affecting the nuclear genes and regulation of gene therapy. Transfection is an integral equipment used in investigation studies for gene function and the modulation of gene expression. Thus, it contributes in the advancement of basic cellular research, drug discovery, and target validation. The transfection reagent and equipment market is driven by rising prevalence of infectious disease, utilization of biopharmaceuticals in the production of proteins, growing obese population, and increasing prevalence of cancer. Various government initiative accentuated the growth of transfection reagent and equipment market. However, high cost of transfection reagents and equipment, risk factors during insertion of the reagents and cytotoxic effect associated with transfection technology are the major factors restraining the transfection reagents and equipment market.

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The transfection reagent and equipment market can be segmented on the basis of various methods such as physical methods and biochemical methods. The biochemical method accounts for the largest share in the overall transfection market. The biochemical based method is further segmented as calcium phosphate, DEAE-dextran, lipid mediated transfection (Lipofection), catonic polymers, activated dendrimers and magnetic beads. The physical based method includes electroporation, biolistic technology, microinjection, laserfection and others (gene gun, sonoporation). Electroporation technique is likely to account for the largest share in the equipment based transfection. The transfection reagent market, by application is segmented into biomedical research, protein product, and therapeutic delivery. The biomedical research segment was observed as one of the largest segment of the transfection reagent market.

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Geographically, North America is the largest transfection reagents and equipment market in the world due to rising prevalence of various cancers (such as cervical cancer, breast cancer, colon cancer, and prostate cancer). Moreover, rising demand for proteomics and genomics technology and upfront initiatives taken by government related to preventive healthcare have supported the growth of transfection reagents and equipment market in this region. Europe was the second largest market due to rising trend of utilization of targeted drug delivery, nanomedicine in diagnostics, clinical trials and drug development studies drive the demand of transfection reagents and equipment market. Asia-Pacific is observed to be an emerging market in transfection reagents and equipment market and is still in the initial stage. One of the important factors driving the growth of transfection reagent and equipment in the Asia-Pacific market is outsourcing of clinical trials to Asian countries by majority of the drug development companies. Moreover, development of in transfection technology, rise in demand of protein therapeutics, developing healthcare infrastructure in emerging markets such as India and China, and increasing demand from applied markets. Latin American countries such as Brazil and Mexico are the regions that have significant potential for growth due to emerging medical infrastructure, high disposable income and rising prevalence of infectious diseases. Transfection equipment and reagents market is in introductory stage especially in Latin American and African countries.

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Some of the major players in the global transfection reagent and equipment market include

Here is the original post:
Transfection Reagents And Equipment Market Share to Witness Steady Rise in the Coming Decade - Scientect

Recommendation and review posted by Bethany Smith

Dublin, Aug. 17, 2020 (GLOBE NEWSWIRE) -- The "Global Viral Vectors & Plasmid DNA Market 2020-2030: COVID-19 Implications and Growth" report has been added to ResearchAndMarkets.com's offering.

The global viral vectors & plasmid DNA market is expected to grow from $0.46 billion in 2019 to $0.60 billion in 2020, at a compound annual growth rate (CAGR) of 31.3%.

The growth is mainly due to the outbreak of COVID-19 and requires targeted delivery of the drug to treat affected patients. The number of cases has been increasing resulting in a surge in demand for viral vectors & plasmid DNA. The market is expected to reach $1.05 billion in 2023 at a CAGR of 20.4%.

The rise in the global incidence of cancer is driving the viral vector & plasmid DNA market. According to Cancer Research UK, in 2018, around 17 million new cases of cancer were recorded with deaths of around 9.6 million, and the estimated cancer incidence rate is 62% between 2018-2040 worldwide. The rise in the global incidence of cancer has boosted the demand for the viral vectors and plasmid DNA market.

The unaffordable cost of gene therapies is a major challenge in the viral vectors & plasmid DNA market. The prices of gene therapies range between $0.2 million to $2.1 million. For instance, Gilead company's Yescarta is a gene therapy that costs around $0.3 million and Bluebird Bio's Letiglobin is another gene therapy costing around $2.1 million. The high price is due to various factors like government regulations, production costs, and so on. Therefore, the unaffordable cost of gene therapies is limiting the viral vector & plasmid DNA market growth.

In January 2020, Cognate Bioservices Inc, a US-based company skilled in cell and cell-mediated gene therapy products, acquired Cobra Biologics, specialized in providing manufacturing services for plasmid DNA and viral vector, for an undisclosed amount. The acquisition is expected to create a platform for the life cycle management of cell and gene therapy products. Cobra biologics is well established in the development and manufacture of a variety of viral vectors and DNA. The combined Cognate and Cobra expertise is expected to push both the businesses to a better position to respond to current and future market demand.

North America was the largest region in the viral vectors and plasmid DNA market in 2019. Asia-Pacific is expected to be the fastest-growing region in the forecast period.

Major players in the viral vectors & plasmid DNA market are FUJIFILM Diosynth Biotechnologies, FinVector Vision Therapies, Lonza, Cobra Biologics and Pharmaceutical Services, Brammer Bio, Cell and Gene Therapy Catapult, VGXI, and MassBiologics.

Report Scope

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography. It places the market within the context of the wider viral vectors & plasmid dna market, and compares it with other markets.

Key Topics Covered

1. Executive Summary

2. Viral Vectors & Plasmid DNA Market Characteristics

3. Viral Vectors & Plasmid DNA Market Size and Growth 3.1. Global Viral Vectors & Plasmid DNA Historic Market, 2015-2019, $ Billion 3.1.1. Drivers of the Market 3.1.2. Restraints on the Market 3.2. Global Viral Vectors & Plasmid DNA Forecast Market, 2019-2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers of the Market 3.2.2. Restraints on the Market

4. Viral Vectors & Plasmid DNA Market Segmentation 4.1. Global Viral Vectors & Plasmid DNA Market, Segmentation by Product, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global Viral Vectors & Plasmid DNA Market, Segmentation by Applications, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Viral Vectors & Plasmid DNA Market Regional and Country Analysis 5.1. Global Viral Vectors & Plasmid DNA Market, Split by Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global Viral Vectors & Plasmid DNA Market, Split by Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/25hnfw

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Originally posted here:
Viral Vectors and Plasmid DNA Marketplace 2020-2030: Breakdown of Shares for Gene & Cancer Therapies, Viral Infections, Immunotherapy, Formulation...

Recommendation and review posted by Bethany Smith

Pune, Aug. 17, 2020 (GLOBE NEWSWIRE) -- The global next-generation sequencing market is forecast to exhibit a remarkable CAGR as the next-generation sequencing platform allows effective sequencing of millions of DNA molecules. Fortune Business Insights in a new report, titled Next-Generation Sequencing: Global Market Analysis, Insights and Forecast, 2019-2026 offers a detailed analysis of the competitive landscape and market dynamics.

The demand for cost-effective, accurate, and fast DNA sequencing technologies is increasing and this is further giving rise to the dominance of next-generation sequencing platforms. This will further give rise to advanced sequencing technologies for clinical purposes, which is anticipated to drive the market. Increasing advancements in bioinformatics are likely to increase the adoption of next-generation sequencing platforms to facilitate the diagnosis of rare diseases.

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As per the report, the global market is expected to rise at a ferocious CAGR of 22.2% between 2018 and 2026. In 2018, the market was worth US$ 6,335.2 Mn and the market will be a howling success as it is projected to reach US$ 31,411.3 Mn by 2026. The demand for next-generation sequencing methodologies is increasing rapidly across several applications such as diagnostics, clinical research among others.

The global economy is in absolute turmoil because of the COVID-19 pandemic outbreak. Some industries remain largely unaffected by the outbreak, some are thriving, but most are in doldrums. Although the healthcare industry is flourishing, certain markets within the industry are experiencing staggered growth. Wading through these troubled times is a difficult task and Fortune Business Insights aims at equipping your business with the most comprehensive market insights, collated and analyzed by our expert and experienced research team.

Click here to get the short-term and long-term impact of COVID-19 on this market.

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Demand for Next-Generation Sequencing Services to Rise at a High Pace

Next-generation sequencing products encompass instruments, consumables, and software. According to the findings from the report, the next-generation sequencing product segment is anticipated to lead the market over the forecast period. This is ascribable to some primary factors such as new product launches, high usage of consumables, and easy availability.

Apart from next-generation sequencing products, next-generation sequencing services are expected to grow at a higher CAGR during the forecast period. The need for novel platforms regarding advancements in bioinformatics and fast DNA data interpretation are paving way for start-ups, especially for next-generation sequencing services. With the introduction of next-generation sequencing, the cost of sequencing has reduced over the years.

This is positively impacting the growth of this segment. Furthermore, the adoption of next-generation sequencing-based testing is increasing across the world. This, coupled with attractive healthcare reimbursement policies, is expected to drive the segments growth in the projected period.

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North America Leads the Way Owing to Active Government Support

Among regions, North America is anticipated to lead the global next-generation sequencing market through the forecast duration. Rapid developments in precision medicine, next-generation DNA sequencing, and diagnostics are creating growth opportunities for the market. The market is likely to expand as companies in the biotechnology sector are continuously involving in research and development (R&D) activities, which fuels the market demand. Adapative Technologies developed a next-generation sequencing diagnostic test called ClonoSEQ for patients suffering from acute lymphoblastic leukemia or ALL and minimal residual disease or MRD. The test received FDA approval in September 2018, which in turn, contributes to the growth of the market in North America.

Increasing investments in precision medicine and a growing number of strategic collaborations are driving the market in Europe. Driven by these factors, the market in this region is expected to expand in the forecast period. Apart from these two regions, Asia Pacific is expected to expand at a remarkable growth on account of rising geriatric population and growing awareness about reproductive health.

Saphetor SA and Swift Biosciences Inc.s Partnership Aims to Target Next-Generation Sequencing Panels

Strategic partnerships and new product launches are increasingly adopted by companies as these help them to maintain their position in the market. Some of the industry developments are mentioned below:

Companies such as Illumina, Inc., Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd are likely to lead in the global next-generation sequencing market. This is mainly on account of their strong geographical presence and diversified product portfolio. Moreover, Illumina was leading in the global market owing to its rising product sales. New product launches also helped the company to strengthen its market position.

Some of the other players functioning in the global market are Agilent Technologies, Inc., BGI, PerkinElmer Inc., QIAGEN, Eurofins Scientific, PierianDx, Macrogen, Inc. among others.

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Next-Generation Sequencing Market Segmentation:

By Type

Products

Instruments & Software

Consumables

Services

By Application

Diagnostics

Research

Others

By End User

Research Institutes

Healthcare Facilities & Diagnostic Centers

Pharmaceutical & Biotechnological Companies

Contract Research Organization (CROs)

By Geography

North America (the USA and Canada)

Europe (UK, Germany, France, Italy, Spain, and Rest of Europe)

Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

Middle East & Africa (South Africa, GCC, and Rest of the Middle East & Africa)

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Have a Look at Related Reports:

Genomics Market Share and Global Trend By Type (Products, Services), Technology (Polymerase Chain Reaction, Next-generation Sequencing, Microarray, Sanger Sequencing), Application (Diagnostics, Research), End-User (Research Institutes, Healthcare Facilities & Diagnostic Centers, Pharmaceutical & Biotechnological Companies, Contract Research Organization (CROs)) & Geography Forecast till 2026

Regenerative Medicine Market Share and Global Trend By By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Geography Forecast till 2026

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Transcriptomics Market Share and Global Trend By Technology (Polymerase Chain Reaction (PCR), Microarray, Next-Generation Sequencing (NGS)), By Application (Drug Discovery, Clinical Diagnostics, Toxicogenomics), By End-User (Academic and Research Institutes, Pharmaceutical Companies, Biotechnology Companies) and Geography Forecast till 2026

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The rest is here:
Next-Generation Sequencing Market Size to Reach US$ 31,411.3 Mn, Introduction of Rapid Sequencing Technologies Drives the Market: Fortune Business...

Recommendation and review posted by Bethany Smith

For Immediate Release: August 12, 2020

Today, the U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation. Approximately 8% of patients with DMD have a mutation that is amenable to exon 53 skipping.

The FDA is committed to fostering drug development for serious neurological disorders like Duchenne muscular dystrophy, said Billy Dunn, M.D., director of the Office of Neuroscience in the FDAs Center for Drug Evaluation and Research. Todays approval of Viltepso provides an important treatment option for Duchenne muscular dystrophy patients with this confirmed mutation.

DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. It is the most common type of muscular dystrophy. DMD is caused by mutations in the DMD gene that results in an absence of dystrophin, a protein that helps keep muscle cells intact. The first symptoms are usually seen between three and five years of age and worsen over time. DMD occurs in approximately one out of every 3,600 male infants worldwide; in rare cases, it can affect females.

Viltepso was evaluated in two clinical studies with a total of 32 patients, all of whom were male and had genetically confirmed DMD. The increase in dystrophin production was established in one of those two studies, a study that included 16 DMD patients, with 8 patients receiving Viltepso at the recommended dose. In the study, dystrophin levels increased, on average, from 0.6% of normal at baseline to 5.9% of normal at week 25.

The FDA concluded that the applicants data demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit in patients with DMD who have a confirmed mutation of the dystrophin gene amenable to exon 53 skipping. A clinical benefit of the drug has not been established. In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease, and the lack of available therapies.

As part of the accelerated approval process, the FDA is requiring the company to conduct a clinical trial to confirm the drugs clinical benefit. The ongoing study is designed to assess whether Viltepso improves the time to stand for DMD patients with this confirmed mutation. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

The most common side effects observed in DMD patients (pooled from the two studies) treated with 80 mg/kg once a week were: Upper respiratory tract infection, injection site reaction, cough and fever.

Although kidney toxicity was not observed in the Viltepso clinical studies, the clinical experience with Viltepso is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking Viltepso.

Viltepso was approved under the FDAs accelerated approval pathway, which provides for the approval of drugs that treat serious or life-threatening diseases and generally offer a meaningful advantage over existing treatments. Approval under this pathway can be based on adequate and well-controlled studies showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit to patients (i.e., how patients feel or function or whether they survive). This pathway provides earlier patient access to promising new drugs while the company conducts clinical trials to verify the predicted clinical benefit.

The FDA granted this application Priority Review designation.

The FDA is granting the approval to NS Pharma, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Link:
FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation - FDA.gov

Recommendation and review posted by Bethany Smith

New York, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Hydrogels Industry" - https://www.reportlinker.com/p05896103/?utm_source=GNW Strong R&D interest is already underway for hydrogel biomaterials. New developments in hydrogel design and hydrogel synthesis are resulting in the development of hydrogels with mechanical properties. Superporous comb-type grafted hydrogels with fast response times; hybrid graft copolymers based self-assembling hydrogels; protein based hydrogels and hybrid hydrogels are the emerging new future of smart hydrogel based biomaterials. Stimuli-sensitive hydrogels, especially polypeptide based responsive hydrogels hold promising potential. Protein hydrogel are more biocompatible than synthetic hydrogel as they do not require the use of oxic chemical crosslinkers. This represents a key growth opportunity in the market given that traditional hydrogels have been largely limited by their poor mechanical properties and slow response times to stimuli. Temperature-sensitive hydrogels especially will find attractive opportunities in biomedicine.

Wound dressings currently remain a popular application area with hydrogel being effective for treating dry necrotic wounds and rapid healing of burn wounds. Hydrogel enables painless debridement of infected tissue and provides a moist wound environment for faster healing. Chitosan-based hydrogels, in this regard, are growing in popularity for their biocompatible, antimicrobial, and hemostatic effects. Acellular Hydrogel is especially valuable in accelerated healing of third-degree burn wounds and is a welcome substitute for complicated and infection prone skin grafts. Encouraging progress is being made in the use of hydrogels for targeted & controlled drug delivery. Hydrogels can prolong drug release kinetics. Their porosity and aqueous features make them perfect biocompatible drug delivery vehicles. Chitosan-based hydrogels can be loaded with active drug compounds like growth factors or stem cells that are important in providing scaffold for cell growth. The growing focus on controlled and targeted drug delivery systems in the field of cardiology, oncology, immunology, and pain management bodes well for future growth in the market. Some of the physical properties of hydrogel that can be manipulated and tuned to suit drug delivery needs include porosity, swelling and elasticity in response to stimuli such as temperature, solvent quality, pH, electric field; resistance to dissolution; free diffusion of solute molecules in water; among others. These properties help in controlled drug release and protect from drug degradation, thereby making them highly effective vehicles for drug delivery systems. Some of the types of hydrogels development for drug delivery include DNA-hydrogels; supramolecular hydrogels; bio-inspired hydrogels; and multi-functional and stimuli-responsive hydrogels. New emerging uses in contact lenses and tissue engineering will also benefit growth in the market in the coming years. The United States and Europe represent large markets worldwide with a combined share of 52.4% of the market. China ranks as the fastest growing market with a CAGR of 7.3% over the analysis period supported by the governments focus on revolutionizing biomedical engineering in the country. The country today ranks as the top country for biomedical research encouraged by a permissive regulatory climate.

Read the full report: https://www.reportlinker.com/p05896103/?utm_source=GNW

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW Expanding Applications and Product Innovations Spur Growth in the Global Hydrogel Market Emerging Economies to Post Strong Growth Industry Witnesses Rise in Demand for Synthetic Hydrogels Synthetic Hydrogels by Polymer Type: A Snapshot Global Competitor Market Shares Hydrogel Competitor Market Share Scenario Worldwide (in %): 2019 Hydrogel Competitor Market Share Scenario Worldwide (in %): 2019

2. FOCUS ON SELECT PLAYERS 3M Company (USA) ACELITY L.P, Inc. (USA) Ashland, Inc. (USA) Braun Melsungen AG (Germany) Cardinal Health, Inc. (USA) Coloplast A/S (Denmark) ConvaTec, Inc. (USA) Integra LifeSciences Holdings Corporation (USA) Evonik Industries AG (Germany) Gentell, Inc. (USA) Hollister, Inc. (USA) Mlnlycke Health Care AB (Sweden) Ocular Therapeutix, Inc. (USA) Sekisui Plastics Co. Ltd. (Japan) Smith & Nephew, Plc (UK)

3. MARKET TRENDS & DRIVERS Innovations Expand Addressable Market for Hydrogels Rise in Incidence of Chronic Diseases and High Treatment Costs Drive Demand for Hydrogel Dressings for Wound Healing Global Prevalence of Wounds Global Wound Care Market: Percentage Breakdown of Spending by Wound Type Personal Care Product: An Evolving Niche Market Global Skin Care Market Size in US$ Billion for the Years 2019, 2021, 2023 and 2025 Consumer Adoption of Hydrogel Contact Lenses Augurs Well for Market Growth Global Contact Lens Fits by Category (In %): 2019 Hydrogels Evolve as Emerging Alternative for Food Packaging Agriculture Sector Depicts Strong Growth Potential Global Water Utilization: Percentage Share Breakdown for Agricultural Practices, Industrial Processes, and Domestic Usage Rising Concerns over Polluting Water Resources: An Opportunity for Hydrogels Market Need for Wastewater Treatment Presents Opportunity for Hydrogels: Percentage of Wastewater Treated in Europe, Asia, Latin America, and Africa Growing Emphasis on Sustainability and Positive Impact on Hydrogels Growth in Biomedical Applications of Hydrogels Hydrogels for Cartilage Regeneration Growing Need for Targeted Controlled Drug Delivery (TCDD) Drives Importance of Hydrogels Hydrogel Nanoparticles: The New Hydrogels for Drug Delivery Evaporative Cooling Hydrogel Packaging: Increasing Storage Stability of Pharmaceuticals Growing Focus on Baby Hygiene Products Spells Steady Growth Opportunities for Hydrogels Annual Usage of Baby Disposable Diapers Per Infant by Region: ( Age upto 2.5 years) Global New Births (in Millions) per Annum by Geographic Region World Fertility Rate in % by Region (2013 & 2050F) Increased Demand for Feminine Hygiene Products Global Female Population by Geographic Region: Percentage Breakdown by Region for 2018 Number of Menstruating Women Worldwide by Country: 15-49 Years Female Population (in Millions) for 2013 & 2025P Aging Population and the Associated Complications Drive the Demand for Hydrogel Global Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050 Rise in Demand for Novel Hydrogel Dressings for Wound Healing Propels Innovations PRODUCT OVERVIEW Hydrogel Types of Hydrogel Natural Hydrogels Select Natural Hydrogels: Advantages and Disadvantages Synthetic Hydrogels Select Synthetic Hydrogels: Advantages and Disadvantages Hybrid Hydrogels

4. GLOBAL MARKET PERSPECTIVE Table 1: Hydrogels Global Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 2: Hydrogels Global Retrospective Market Scenario in US$ Thousand by Region/Country: 2012-2019

Table 3: Hydrogels Market Share Shift across Key Geographies Worldwide: 2012 VS 2020 VS 2027

Table 4: Natural (Raw Material) World Market by Region/Country in US$ Thousand: 2020 to 2027

Table 5: Natural (Raw Material) Historic Market Analysis by Region/Country in US$ Thousand: 2012 to 2019

Table 6: Natural (Raw Material) Market Share Breakdown of Worldwide Sales by Region/Country: 2012 VS 2020 VS 2027

Table 7: Synthetic (Raw Material) Potential Growth Markets Worldwide in US$ Thousand: 2020 to 2027

Table 8: Synthetic (Raw Material) Historic Market Perspective by Region/Country in US$ Thousand: 2012 to 2019

Table 9: Synthetic (Raw Material) Market Sales Breakdown by Region/Country in Percentage: 2012 VS 2020 VS 2027

Table 10: Hybrid (Raw Material) Geographic Market Spread Worldwide in US$ Thousand: 2020 to 2027

Table 11: Hybrid (Raw Material) Region Wise Breakdown of Global Historic Demand in US$ Thousand: 2012 to 2019

Table 12: Hybrid (Raw Material) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 13: Polyacrylate (Composition) World Market Estimates and Forecasts by Region/Country in US$ Thousand: 2020 to 2027

Table 14: Polyacrylate (Composition) Market Historic Review by Region/Country in US$ Thousand: 2012 to 2019

Table 15: Polyacrylate (Composition) Market Share Breakdown by Region/Country: 2012 VS 2020 VS 2027

Table 16: Polyacrylamide (Composition) World Market by Region/Country in US$ Thousand: 2020 to 2027

Table 17: Polyacrylamide (Composition) Historic Market Analysis by Region/Country in US$ Thousand: 2012 to 2019

Table 18: Polyacrylamide (Composition) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 19: Silicon (Composition) World Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020 to 2027

Table 20: Silicon (Composition) Market Worldwide Historic Review by Region/Country in US$ Thousand: 2012 to 2019

Table 21: Silicon (Composition) Market Percentage Share Distribution by Region/Country: 2012 VS 2020 VS 2027

Table 22: Other Compositions (Composition) Market Opportunity Analysis Worldwide in US$ Thousand by Region/Country: 2020 to 2027

Table 23: Other Compositions (Composition) Global Historic Demand in US$ Thousand by Region/Country: 2012 to 2019

Table 24: Other Compositions (Composition) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 25: Agriculture (Application) Worldwide Sales in US$ Thousand by Region/Country: 2020-2027

Table 26: Agriculture (Application) Historic Demand Patterns in US$ Thousand by Region/Country: 2012-2019

Table 27: Agriculture (Application) Market Share Shift across Key Geographies: 2012 VS 2020 VS 2027

Table 28: Healthcare & Hygiene (Application) Global Market Estimates & Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 29: Healthcare & Hygiene (Application) Retrospective Demand Analysis in US$ Thousand by Region/Country: 2012-2019

Table 30: Healthcare & Hygiene (Application) Market Share Breakdown by Region/Country: 2012 VS 2020 VS 2027

Table 31: Contact Lenses (Application) Demand Potential Worldwide in US$ Thousand by Region/Country: 2020-2027

Table 32: Contact Lenses (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019

Table 33: Contact Lenses (Application) Share Breakdown Review by Region/Country: 2012 VS 2020 VS 2027

Table 34: Drug Delivery (Application) Worldwide Latent Demand Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 35: Drug Delivery (Application) Global Historic Analysis in US$ Thousand by Region/Country: 2012-2019

Table 36: Drug Delivery (Application) Distribution of Global Sales by Region/Country: 2012 VS 2020 VS 2027

Table 37: Tissue Engineering (Application) Sales Estimates and Forecasts in US$ Thousand by Region/Country for the Years 2020 through 2027

Table 38: Tissue Engineering (Application) Analysis of Historic Sales in US$ Thousand by Region/Country for the Years 2012 to 2019

Table 39: Tissue Engineering (Application) Global Market Share Distribution by Region/Country for 2012, 2020, and 2027

Table 40: Other Applications (Application) Global Opportunity Assessment in US$ Thousand by Region/Country: 2020-2027

Table 41: Other Applications (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019

Table 42: Other Applications (Application) Percentage Share Breakdown of Global Sales by Region/Country: 2012 VS 2020 VS 2027

III. MARKET ANALYSIS

GEOGRAPHIC MARKET ANALYSIS

UNITED STATES Table 43: United States Hydrogels Market Estimates and Projections in US$ Thousand by Raw Material: 2020 to 2027

Table 44: Hydrogels Market in the United States by Raw Material: A Historic Review in US$ Thousand for 2012-2019

Table 45: United States Hydrogels Market Share Breakdown by Raw Material: 2012 VS 2020 VS 2027

Material: 2012 VS 2020 VS 202

Table 47: Hydrogels Market in the United States by Composition: A Historic Review in US$ Thousand for 2012-2019

Table 48: United States Hydrogels Market Share Breakdown by Composition: 2012 VS 2020 VS 2027

Table 49: United States Hydrogels Latent Demand Forecasts in US$ Thousand by Application: 2020 to 2027

Table 50: Hydrogels Historic Demand Patterns in the United States by Application in US$ Thousand for 2012-2019

Table 51: Hydrogels Market Share Breakdown in the United States by Application: 2012 VS 2020 VS 2027

CANADA Table 52: Canadian Hydrogels Market Estimates and Forecasts in US$ Thousand by Raw Material: 2020 to 2027

Table 53: Canadian Hydrogels Historic Market Review by Raw Material in US$ Thousand: 2012-2019

Table 54: Hydrogels Market in Canada: Percentage Share Breakdown of Sales by Raw Material for 2012, 2020, and 2027

Table 55: Canadian Hydrogels Market Estimates and Forecasts in US$ Thousand by Composition: 2020 to 2027

Table 56: Canadian Hydrogels Historic Market Review by Composition in US$ Thousand: 2012-2019

Table 57: Hydrogels Market in Canada: Percentage Share Breakdown of Sales by Composition for 2012, 2020, and 2027

Table 58: Canadian Hydrogels Market Quantitative Demand Analysis in US$ Thousand by Application: 2020 to 2027

Table 59: Hydrogels Market in Canada: Summarization of Historic Demand Patterns in US$ Thousand by Application for 2012-2019

Table 60: Canadian Hydrogels Market Share Analysis by Application: 2012 VS 2020 VS 2027

JAPAN Table 61: Japanese Market for Hydrogels: Annual Sales Estimates and Projections in US$ Thousand by Raw Material for the Period 2020-2027

Table 62: Hydrogels Market in Japan: Historic Sales Analysis in US$ Thousand by Raw Material for the Period 2012-2019

Table 63: Japanese Hydrogels Market Share Analysis by Raw Material: 2012 VS 2020 VS 2027

Table 64: Japanese Market for Hydrogels: Annual Sales Estimates and Projections in US$ Thousand by Composition for the Period 2020-2027

Table 65: Hydrogels Market in Japan: Historic Sales Analysis in US$ Thousand by Composition for the Period 2012-2019

Table 66: Japanese Hydrogels Market Share Analysis by Composition: 2012 VS 2020 VS 2027

Table 67: Japanese Demand Estimates and Forecasts for Hydrogels in US$ Thousand by Application: 2020 to 2027

Table 68: Japanese Hydrogels Market in US$ Thousand by Application: 2012-2019

Table 69: Hydrogels Market Share Shift in Japan by Application: 2012 VS 2020 VS 2027

CHINA Table 70: Chinese Hydrogels Market Growth Prospects in US$ Thousand by Raw Material for the Period 2020-2027

Table 71: Hydrogels Historic Market Analysis in China in US$ Thousand by Raw Material: 2012-2019

Table 72: Chinese Hydrogels Market by Raw Material: Percentage Breakdown of Sales for 2012, 2020, and 2027

Table 73: Chinese Hydrogels Market Growth Prospects in US$ Thousand by Composition for the Period 2020-2027

Table 74: Hydrogels Historic Market Analysis in China in US$ Thousand by Composition: 2012-2019

Table 75: Chinese Hydrogels Market by Composition: Percentage Breakdown of Sales for 2012, 2020, and 2027

Table 76: Chinese Demand for Hydrogels in US$ Thousand by Application: 2020 to 2027

Table 77: Hydrogels Market Review in China in US$ Thousand by Application: 2012-2019

Table 78: Chinese Hydrogels Market Share Breakdown by Application: 2012 VS 2020 VS 2027

EUROPE Table 79: European Hydrogels Market Demand Scenario in US$ Thousand by Region/Country: 2020-2027

Table 80: Hydrogels Market in Europe: A Historic Market Perspective in US$ Thousand by Region/Country for the Period 2012-2019

Table 81: European Hydrogels Market Share Shift by Region/Country: 2012 VS 2020 VS 2027

Table 82: European Hydrogels Market Estimates and Forecasts in US$ Thousand by Raw Material: 2020-2027

Table 83: Hydrogels Market in Europe in US$ Thousand by Raw Material: A Historic Review for the Period 2012-2019

Table 84: European Hydrogels Market Share Breakdown by Raw Material: 2012 VS 2020 VS 2027

Table 85: European Hydrogels Market Estimates and Forecasts in US$ Thousand by Composition: 2020-2027

Table 86: Hydrogels Market in Europe in US$ Thousand by Composition: A Historic Review for the Period 2012-2019

Table 87: European Hydrogels Market Share Breakdown by Composition: 2012 VS 2020 VS 2027

Table 88: European Hydrogels Addressable Market Opportunity in US$ Thousand by Application: 2020-2027

Table 89: Hydrogels Market in Europe: Summarization of Historic Demand in US$ Thousand by Application for the Period 2012-2019

Table 90: European Hydrogels Market Share Analysis by Application: 2012 VS 2020 VS 2027

Link:
The global market for Hydrogel is projected to reach US$15.3 billion by 2025 - GlobeNewswire

Recommendation and review posted by Bethany Smith

An exclusive market study published by Fact.MR on the Autologous Fat Grafting market offers insights related to how the market is projected to grow over the forecast period (2019-2029). The objective of the report is to enable our readers to understand the various aspects of the Autologous Fat Grafting market and assist them to formulate impactful business strategies. Furthermore, the different factors that are expected to influence the current and future dynamics of the Autologous Fat Grafting market are discussed in the presented study.

According to the report, the Autologous Fat Grafting market is set to reach a market value of ~US$ XX by the end of 2029 and register a CAGR growth of ~XX% during the assessment period. The report offers an in-depth understanding of the Autologous Fat Grafting supply chain, value, and volume chain across the various regional markets.

Request Sample Report @ https://www.factmr.co/connectus/sample?flag=S&rep_id=2701

Important Insights Enclosed in the Report:

The published report provides a deep understanding of the Autologous Fat Grafting market by segregating the market into different segments such as region, application, and end-use industry.

Request Methodology On This Report @ https://www.factmr.co/connectus/sample?flag=RM&rep_id=2701

Autologous Fat Grafting Market Segmentation

By Region

The regional analysis of the Autologous Fat Grafting market dives deep to understand the market scenario in different regions. The market size, share, and value of each regional market is analyzed and presented in the report along with informative tables and figures.

By Application

The report offers a clear picture of how the Autologous Fat Grafting is utilized in various applications. The different applications covered in the report include:

By End-Use Industry

The end-use industry assessment throws light on the consumption of the Autologous Fat Grafting across various end-use industries including:

Competition Landscape

The four leading companies that account for the consolidation of the competition landscape of autologous fat grafting market, continue to represent a whopping 80% share in the revenues. Allergan, MicroAire, Alma Lasers, and Human Med are expected to primarily maintain their strategic focus on partnerships and acquisitions with smaller yet active players. The latter are typically specialized in the development of meniscus repair systems for treating meniscal scars. With this, leading companies operating in autologous fat grafting industry, are eyeing feasibility of entry in the meniscal scars treatment landscape. Increasing strategic tie-ups among manufacturers of systems & accessories, and recognized research institutions, aim to ensure sufficient device supply and superior post-sales service.

Manufacturers in the autologous fat grafting market are also investing efforts in introducing innovative products, to enhance their market shares. For instance, in 2019, Alma Lasers (Sisram Medical) announced the availability of BeautiFill as the novel laser-based technique for fat harvesting, while leveraging autologous fat to restore the volume to body or face. As cellular therapies are increasingly being perceived as mainstream therapeutic option, there has been a surge in demand for adipose derived stem cells (ADSC), which is potentially applicable in tissue engineering and regeneration. Additionally, a growing focus of leading players on introducing advanced systems & accessories is likely to extend applicability of their offerings, leveraging untapped opportunities in the autologous fat grafting market.

For more incisive insights into the autologous fat grafting market, request for the report sample

Key Factors Shaping Autologous Fat Grafting Market

For more intelligence on the autologous fat grafting market, request for the report sample

Key Challenges Facing Autologous Fat Grafting Market

Additional Insight

Biomaterial Research to Open Doors to Multiple Opportunities

Autologous fat grafting technique continues to witness frequent technical modifications. The adoption of autologous fat grafting as a technique to augment and regenerate deficient, irradiated, and aged subcutaneous soft tissue and skin, with minimal complication rate and donor-site morbidity, has grown spectacularly over the recent past. An approach garnering research interests for its potential role in enhancing volumetric retention of fat grafts, involves insertion of autologous platelet-rich fibrin (PRF) into graft tissues. A relevant study indicates PRF as a concentrate that may enhance the outcome of fat grafting for plastic surgery procedures. This newer biomaterial with several potential advantages, such as simpler preparation with no external additive, is likely to trigger new product developments in the autologous fat grafting market.

Autologous Fat Grafting Market Research Methodology

A patented research methodology and a holistic approach form the base of the insightful information provided in the autologous fat grafting market report. This study provides detailed information about the key factors associated with the growth of autologous fat grafting market and presents a systematic breakdown of the factors shaping the progress of market. Detailed primary and secondary research has been done to offer information about the historic and prospective analysis of fat grafting industry, with emphasis on the autologous fat grafting procedure. The report on autologous fat grafting market has also gone through several validation tunnels to guarantee the uniqueness of the insights and key growth influencers, covered in the report.

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Important queries addressed in the Autologous Fat Grafting market report:

Reasons to Choose Fact.MR

Read more:
Autologous Fat Grafting Expected to Expand at a Steady CAGR through 2019 to 2029 - Scientect

Recommendation and review posted by Bethany Smith

Once known as a paradigm changing class of precision oncology, or targeted, drugs,1 Bruton tyrosine kinase (BTK) inhibitors are now well established as treatment for several hematological malignancies. They are named for Lt Col Ogden C. Bruton, MD, chief of pediatrics at Walter Reed Army Medical Center in the 1950s, who in 1951 discovered the first host immunodeficiency in humans, X-linked agammaglobulinemia.2,3

The BTK protein is essential to helping B cells develop and mature into functional and specialized white blood cells; these are part of the adaptive immune response in producing antibodies, or immunoglobulins.4 But mutations in the BTK gene, more than 600 of which have been identified, can lead to a sizeable reduction in the number of circulating B cells, along with reduced ability to fight infection, absence of the BTK protein, production of abnormal BTK protein, or cancer cell growth.5,6

Mutated immunoglobulins essentially malfunction in their roles as antigen receptors on the surfaces of B cells, especially in the cancer space, by not recognizing antigens as damaging or by not sending the correct signals to destroy the malignant cells.

This is where BTK inhibitors come in: They help to trigger cell death by blocking the B-cell receptor signaling that leukemias and lymphomas use to grow and survive.7 The first-generation BTK inhibitor ibrutinib (Imbruvica) came to market in 2013, when it was approved by the FDA to treat adult patients with mantle cell lymphoma. A targeted treatment, it stops cancer cells from surviving and multiplying by blocking abnormal protein signaling.8 Other indications, as monotherapy or in combination, have been approved for chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, small lymphocytic lymphoma, relapsed/refractory marginal zone lymphoma, and chronic graft-versus-host disease.9 Ibrutinib is a once-daily oral agent and can be used in the frontline and relapsed settings.10

Despite its many benefits and indications, however, ibrutinib as BTK inhibition is also associated with numerous adverse effects (AEs) on nonmalignant cells, which range from common to uncommon and from mild to severe, making ibrutinibs toxicity profile notorious.7

Among the most severe AEs are hemorrhage; high blood pressure; heart rhythm irregularities, including ventricular arrhythmias, atrial fibrillation, and atrial flutter; second primary cancers (eg, skin, other organs); and tumor lysis syndrome.11 Some of the most common AEs, occurring in more than 30% of patients, are hematological (eg, decreased platelets, neutrophils, and hemoglobin), musculoskeletal, and respiratory in nature.

Additional possible AEs include diarrhea, constipation, vomiting, skin infections, dizziness, dehydration, petechiae, arthralgia, stomatitis, rash, and fatigue.12 Ibrutinib carries warnings for use among those with bleeding problems, liver problems, and for those who are planning surgery or recently had surgery; women who are pregnant or thinking of becoming pregnant; women who breastfeed or plan to do so; and men with female partners capable of pregnancy.

Second-generation BTK inhibitors seek to improve upon first-generation agents like ibrutinib by having less cardiotoxicity, fewer AEs that result in stopping treatment, and fewer off-target effects. For example, ibrutinib inhibits the activity of 3 major off-targets: epidermal growth factor, which can result in severe skin toxicities13; interleukin-2 inducible kinase, which impairs natural killer cells cytotoxic abilities14; and the Tec family of kinases, decreasing their ability to aid in phosphorylation.15

In updated results of the ASPEN trial presented at this years virtual American Society of Clinical Oncology (ASCO) 2020 Annual Meeting, zanubrutinib (Brukinsa), the most recent second-generation BTK inhibitor to hit the US market, was shown to have a survival advantage over ibrutinib in patients with Waldenstrm macroglobulinemia who lacked the MYD88 mutation typically associated with successful treatment.16

ASPEN first compared zanubrutinib with ibrutinib in patients with Waldenstrm macroglobulinemia who have the MYD88 mutation, and zanubrutinib was shown in December 2019 to increase the incidence of complete response (CR) or very good partial response (VGPR) by close to 46% compared with ibrutinib28.9% vs 19.8%, respectivelyin patients with relapsed or refractory disease.17

The updated results, from 5 additional months of data, widened this gap, showing a 30.4% CR plus VGPR rate for zanubrutinib compared with 18.2% for ibrutinib, as well as less occurrence of atrial fibrillation/flutter of any grade, bleeding of any grade, major hemorrhage, diarrhea, and hypertension. In addition, patients without the MYD88 mutation had an overall response rate of 80.8%, which included a 50.0% major response ratewhich itself included a VGPR rate of 26.9%and 12-month progression-free survival of 72.4%.18

Lead investigator, Constantine Tam, MBBS, MD, a clinical hematologist and professor at the Peter MacCallum Cancer Centre in Victoria, Australia, noted of zanubrutinib, Those patients who potentially have a history of hypertension or have a history of atrial fibrillationor have an abnormal ECG or abnormal echocardiogrammaybe theyre the ones who would be better off on [zanubrutinib] compared with ibrutinib. We think its how clean the targeting is.19

Zanubrutinib is associated with less incidence of muscle spasm, peripheral edema, pneumonitis, and pneumonia. In essence, fewer overall AEs with second-generation BTK inhibitors means less of a need to reduce dosing and a greater likelihood of being able to stay on treatment longer. Tam noted that most AEs happen with zanubrutinib during the first year on treatment, before their incidence plateaus, whereas prolonged treatment with ibrutinib has a greater chance of inflicting cumulative damage to the vascular system.20 Compared with first-generation BTK inhibitors, the second-generation drugs are associated with fewer concerns about primary and acquired drug resistance. For example, ibrutinib use among patients with relapsed/refractory mantle cell lymphoma has been shown to both have no effect on the disease and have a negative impact on additional therapies.21

These resistance mechanisms of action are 2-fold. They are molecular, in that they involve sustained distal B-cell receptor signaling through PIK3-AKT (protein kinase B) pathway activation, NFkB pathway activation, and cell cycle progression. They also are therapeutic, in that lines of therapy administered after BTK inhibitors do not produce prolonged responses or exceptional overall survival.21

Less Cardiotoxicity in Second Generation

Some of the strongest gains in this newer generation of BTK inhibitors, however, can be seen in the cardiovascular space, when compared with the toxicities of the first-generation inhibitors

that often lead to treatment discontinuation, especially among older, sicker patients who have a history of cardiac disease. In fact, most BTK inhibitors are prescribed for older patients, because the class of drugs is used primarily to treat chronic lymphocytic leukemia, for which the average age of onset is older than 60 years.22

I think its that a lot of the toxicities are related to off-target effects, meaning the binding of the BTK inhibitor drug to receptors or molecules that are not the ones that that theyre supposed to be treating the cancer for, said Michael Kolodziej, MD, FACP, vice president and chief innovation officer, ADVI Health, in an interview with Evidence-Based Oncology.

The big ones that were identified with the first-generation inhibitors were cardiovascular, or hypertension and atrial arrhythmias, atrial fibrillation. And they were not rare side effects.

Kolodziej explained that the second-generation drugs have fewer off-target effectsless cardiovascular toxicity, atrial arrhythmias, and hypertensionbecause of their improved toxicity profile, largely because the drugs are just better at being BTK inhibitors. Its not any more complicated than that.

The chief challenge of the first-generation BTK inhibitors is that the AEs cause clinicians and patients to stop treatment with them, Kolodziej noted. The cancer does not become resistant, but the toxicities become unbearable and the patients become intolerant, he emphasized.

The thinking is that the reduced cardiovascular side effects, the reduced bleeding, are going to allow a better persistence on the second-generation drugs, he explained.

Tolerability and Payers

Indeed, in a pooled analysis of clinical trials of the second-generation BTK inhibitor acalabrutinib (Calquence), also presented in May at ASCO, lead author Richard R. Furman, MD, of Weill Cornell Medicine in New York, found that at a median follow-up of 26.4 months, 65% of patients were still on treatment. Of the 34% of patients who stopped acalabrutinib, half (17%) did so because their disease progressed; only 9% stopped due to treatment-related AEs.23

Tolerability, especially as patients define it, is increasingly important to payers, starting with Medicare. The Center for Medicare and Medicaid Innovation has announced that it will incorporate patient-reported outcomes (PROs) into the Oncology Care First model, the proposed successor to the Oncology Care Model.24 Advocates for including PROs in payment models are encouraging drug developers to broaden definitions of tolerability, to include quality-of-life data in trial designs.25

Its a straightforward idea: When patients can tolerate treatment, it improves their chances of survival. This is important, Tam said during ASCO. The longer you take the drug, the better your responses become.19

Author Information

Maggie L. Shaw is associate editor, The American Journal of Managed Care.

References

1. Erba HP. BTK inhibition in B-cell lymphomas: an overview of Bruton tyrosine kinase inhibition. Targeted Oncology. June 21, 2019. Accessed July 18, 2020. https://www.targetedonc.com/view/btk-lymphoma

2. Wyckoff AS. Dr. Brutons discovery set the stage for modern clinical immunology. American Academy of Pediatrics News. May 31, 2018. Accessed July 18, 2020. https://www.aappublications.org/news/2018/05/31/dyk053118

3. Buckley RH. [Commentary:] agammaglobulinemia, by Col. Ogden C. Bruton, MC, USA, Pediatrics, 1952;9:722-728. Pediatrics. 1998;102(suppl 1):213-215. https://pediatrics.aappublications.org/content/102/Supplement_1/213

4. Deane P. B cells: the antibody factories of the immune system. Life Extension Advocacy Foundation. August 22, 2017. Accessed July 18, 2020. https://www.lifespan.io/news/b-cells/

5. BTK gene: Bruton tyrosine kinase. US National Library of Medicine/Genetics Home Reference. Updated July 7, 2020. Accessed July 18, 2020. https://ghr.nlm.nih.gov/gene/BTK#

6. Bruton tyrosine kinase inhibitor. Science Direct. Accessed July 18, 2020. https://www.sciencedirect.com/topics/medicine-and-dentistry/bruton-tyrosine-kinase-inhibitor

7. BTK inhibitors. Drugs.com. Updated January 7, 2020. Accessed July 18, 2020. https://www.drugs.com/drug-class/btk-inhibitors.html

8. Ibrutinib. MedlinePlus. Updated May 15, 2019. Accessed July 19, 2020. https://medlineplus.gov/druginfo/meds/a614007.html

9. Imbruvica approval history. Drugs.com. Updated 2020. Accessed July 19, 2020. https://www.drugs.com/history/imbruvica.html

10. Berger JA. The evolving role of BTK inhibitors in treating chronic lymphocytic leukemia BTK inhibition: disease state effectiveness. Targeted Oncology. April 16, 2020. Accessed July 19, 2020. https://www.targetedonc.com/view/evolving-btk-cll?seriesVid=2

11. How does Imbruvica work? Imbruvica (ibrutinib). April 20, 2020. Accessed July 19, 2020. https://imbruvica.com/cll/how-does-imbruvica-work

12. Imbruvica. Chemocare. Accessed July 19, 2020. chemocare.com/chemotherapy/drug-info/imbruvica.aspx

13. Ghasoub R, Albattah A, Elazzazy S, et al. Ibrutinib-associated sever[e] skin toxicity: a case of multiple inflamed skin lesions and cellulitis in a 68-year-old male patient with relapsed chronic lymphocytic leukemia case report and literature review. J Oncol Pharm Pract. 2020;26(2):487-491. doi:10.1177/1078155219856422

14. Bennett C. Ibrutinib may impair natural killer cell cytotoxic activity, study suggests. Cancer Therapy Advisor. June 19, 2019. Accessed July 19, 2020. https://www.cancertherapyadvisor.com/home/cancer-topics/lymphoma/ibrutinib-for-mantle-lymphoma-mcl-may-impair-naturalcyto-toxic-activity/

15. Patel V, Balakrishnan K, Bibikova E, et al. Comparison of acalabrutinib, a selective Bruton tyrosine kinase inhibitor, with ibrutinib in chronic lymphocytic leukemia cells. Clin Cancer Res. 2017;23(14):3734-3743. doi:10.1158/1078-0432.CCR-16-1446

16. Garcia-Sanz R, Dimopoulos MA, Lee H-P, et al. Updated results of the ASPEN trial from a cohort of patients with MYD88 wild-type (MYD88WT) Waldenstrm macroglobulinemia (WM). J Clin Oncol. 2020;38(15 suppl; abstr e20056). doi:10.1200/JCO.2020.38.15_suppl.e20056

17. Tam CSL, Opat S, DSa S, et al. ASPEN: results of a phase III randomized trial of zanubrutinib versus ibrutinib for patients with Waldenstrm macroglobulinemia (WM). J Clin Oncol. 2020;38(15 suppl; abstr 8007). doi:10.1200/JCO.2020.38.15_suppl.8007

18. BeiGene presents updated head to head results from phase 3 trial of zanubrutinib vs. ibrutinib in patients with Waldenstrms macroglobulinemia at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. News release. BeiGene; May 29, 2020. Accessed August 3, 2020. https://www.globenewswire.com/news-release/2020/05/29/2040883/0/en/BeiGene-Presents-Updated-Head-to-Head-Results-from-Phase-3-Trial-of-Zanubrutinibvs-Ibrutinib-in-Patients-with-Waldenstrm-s-acroglobulinemiaat-the-2020-American-Society-of-Clini.html

19. Caffrey M. Zanubrutinib pulls away from ibrutinib in update, shows durable responses in Waldenstrom patients lacking key mutation. The American Journal of Managed Care. May 30, 2020. Accessed July 21, 2020. https://www.ajmc.com/conferences/asco-2020/zanubrutinib-pulls-away-from-ibrutinib-in-update-shows-durable-responses-in-waldenstrom-patients-lacking-key-mutation

20. Dr Constantine Tam discusses the benefits of zanubrutinib on cardiac effects. The American Journal of Managed Care. May 31, 2020. Accessed July 22, 2020. https://www.ajmc.com/conferences/asco-2020/dr-constantine-tam-discusses-the-benefits-of-zanubrutinib-on-cardiac-effects

21. Hershkovitz-Rokah O, Pulver D, Lenz G, Shpilberg O. Ibrutinib resistance in mantle cell lymphoma: clinical, molecular and treatment aspects. Br J Haematol. 2018;181(3):306-319. doi:10.1111/bjh.15108

22. Chronic lymphocytic leukemia. CancerWall. Accessed July 24, 2020. https://cancerwall.com/chronic-lymphocytic-leukemia-lifeexpectancy-symptoms/

23. Furman RR, Byrd JC, Own RG, et al. Safety of acalabrutinib (acala) monotherapy in hematologic malignancies: pooled analysis from clinical trials. J Clin Oncol. 2020;38(suppl 15; abstr 8064). doi:10.1200/JCO.2020.38.15_suppl.8064

24. Bekele B, Macher D, Ferguson S, et al. Emerging trends in oncology management. Avalere Health. June 2, 2020. Accessed July 31, 2020. https://avalere.com/insights/emerging-trends-in-oncology-management

25. Basch E, Campbell A, Hudgens S, et al. A Friends of Cancer research white paper: broadening the definition of tolerability in cancer clinical trials to better measure the patient experience. Friends of Cancer Research. October 24, 2018. Accessed July 31, 2020. https://www.focr.org/sites/default/files/Comparative%20Tolerability%20Whitepaper_FINAL.pdf

Read more here:
Second-Generation BTK Inhibitors Hit the Treatment Bullseye With Fewer Off-Target Effects - AJMC.com Managed Markets Network

Recommendation and review posted by Bethany Smith

By the time this column is published, the one-year anniversary of my lifesaving stem cell transplant will have come and gone. But as I sit here sweating away in the thick humidity of a rare August heat wave, and as the sun sets upon my little garden in the boroughs of North London, I cant help but bask in this moment of reflection and humble appreciation.

An entire year has come and gone, just like that. Time is such a strange, bizarre phenomenon. It feels as if it has passed by in a blur a simple snap of my fingers and yet so much has transpired. So much has unfurled and unfolded, fallen apart and come together, all in just 12 tiny months.

One year ago today, I was lying in a sterile hospital bed with a drip attached to my veins. I was puffy, exhausted, and frail from the chemicals seeping into my blood. I had no immune system and was days away from having my sisters stem cells infused into my bloodstream, where they would collectively begin to regenerate an entirely new immune system.

A year ago, I could barely walk because I was so weak. I had no connection to my body other than distrust. I was small, sad, tired, and full of grief and heartache. A year ago, the world was painfully heavy and dark. Now, as I sit here staring at the trees in my backyard and watching the sun pour through the gaps in the branches, painting the leaves a brilliant verdant green, I see so much light in the world its almost blinding.

I just returned from a weekend in the English countryside with some of my best friends. We stayed in a house beside the sea on the coast of Cornwall. The sun was warm, and the world felt like it was washed in a soft, tangerine glow. I cant remember the last time I have laughed so much. I felt wonderfully alive, radiating with joy at the sheer beauty of all the small, simple things. The tiny white and yellow daisies we picked from the bushes on the side of the road, the perfect flapping of a butterflys delicate wings, the sound of my friends laughter, the lightness of being, the magnificence of loving, and being loved in return.

This anniversary is deeply significant to me because it symbolizes just how far I have come. If only a year ago, lying in that hospital bed, Id had a crystal ball and could have seen into the future and understood that everything really would be OK. If only I could have seen my strong, able body, my mop of unruly blond curls, my happy, overflowing heart. Back then, it felt like my life was falling apart. Now, despite all the unexpected twists and turns and challenges of this tumultuous year, the disparity between where I was then and where I am now is not lost on me.

I think thats the greatest gift Ive gained from the long periods of sickness and convalescence Ive endured understanding the true value of being healthy.

Nothing can take that lesson from me now, and for that, Im deeply grateful. Ill always be able to look back and recall exactly what it felt like to lie in that ward, watching the clock, wishing time would pass, desperately longing to feel better, to just feel like myself again.

Health and time are the two things we take for granted the most, yet they are the greatest gifts we will ever have.

Despite how quickly this year has passed, it also has been filled with nothing but time. Time to sit and reflect. Time inside. Time alone. Time apart from loved ones. Its been tough, painful, and full of missing. But its also been deeply healing. I have watched as my body has transformed from a weak, thin, pale, depleted shell of skin and bones to a strong, tanned, healthy, muscular machine. I have watched the pigment return to my skin, the smile return to my cheeks, the sparkle return to my eyes. I never could have imagined the progress I would make in a year, and Im so deeply proud of myself for persevering through those dark, drawn-out days.

For anyone facing the eye of the storm now, or fresh off the boat of treatment, I want you to know that it does get better. If only I could whisper in the ear of that scared and sick girl and tell her that everything will be OK. That things wont stay dark forever. To hold on, theres so much more to come.

What a year, what a life.

***

Note: Lymphoma News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Lymphoma News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to lymphoma.

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Reflections on My 'Re-birthday' and the Past Year of Recovery - Lymphoma News Today

Recommendation and review posted by Bethany Smith

As the on-going COVID-19 pandemic continues we are facing a huge healthcare crisis. Globally the pandemic has accelerated or rather decelerated the entire human population into the confines. Work from home, social shielding and discreet outdoor ventures has not only disrupted our emotional well-being but has also drastically affected our physical health. As people are confined to their homes with reduced physical activity there is rapid bone resorption (loss) as muscles and bones are not getting adequate stimulation. Also lack of exposure to sun during the pandemic has critically affected vitamin D levels in our body. People are frequently feeling tired with lack of energy and strength. Everyone needs to be cautious about the health of their bones as much as their other needs. Bones support us and allow us to be mobile. Bone health is always a priority and we always tend to overlook it. Bone density problem is a silent manifestation and could lead to a major medical issue over a period of time. While osteoporosis onsets with age among men & women, women face the brunt a little earlier, like from their 30s. Well-versed with the situation and to avoid unnecessary bones issues, let us now take a look at some measures that can take care of your bones during the pandemic.Eat a well-balanced diet rich in calcium and vitamin DGood sources of calcium include low-fat dairy products, green leafy veggies and dry fruits. Good sources of vitamin D include fortified cereals, egg yolks, saltwater fish, liver and milk. Calcium and vitamin D work together to protect your bones - calcium helps to build and maintain bones; while vitamin D helps your body to effectively absorb calcium.

Get exposure to sunlight to make enough vitamin DRegular sun exposure is the most natural way to get enough vitamin D. The sun's ultraviolet B (UVB) rays hit cholesterol in the skin cells, providing the energy for vitamin D synthesis. Vitamin D has a significant role in calcium homeostasis and metabolism.

As per pan-India study the best time to get exposed to the sun is between 11 am and 1 pm since the wavelength of ultraviolet B (UVB) rays is 290-320nm during this period which is essential for skin to make vitamin D.

Get plenty of physical activityLike muscles, bones become stronger with exercise. The best exercises for healthy bones are strength-building and weight-bearing exercise like walking, climbing stairs, lifting weights and dancing. Try to get 30 minutes of exercise each day.

Strength-building and weight-bearing exercise provides stimulation to bone cells and helps to increased bone mineral density and bone size thus reduced the risk of osteoporosis.

Live a healthy lifestyle

See original here:
What do we need to know about our bone health during this pandemic - Times of India

Recommendation and review posted by Bethany Smith

Stem Cell Assay Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

The global Stem Cell Assay Market size is expected to Expand at Significant CAGR of +20% during forecast period (2020-2026).

Stem cell is an undifferentiated mass of cell that has the ability to divide indefinite times. It can be further differentiated into specialized cells such as blood cells, skin cells, neurons, heart cells, chondrocytes, and osteocytes under specific conditions. Unspecialized nature, self-renewal capability, and dedifferentiation are the unique features of stem cells.

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Top Key Vendors of this Market are:

Thermo Fisher Scientific, Merck, Ge Healthcare, Bio-Rad Laboratories, Promega Corporation, Agilent Technologies, Perkinelmer, Miltenyi Biotec, Cell Biolabs, Hemogenix, Stemcell Technologies, Bio-Techne Corporation, Cellular Dynamics International (Cdi)

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Stem Cell Assay market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Stem Cell Assay markets trajectory between forecast periods.

The report provides insights on the following pointers:

Market Penetration:Comprehensive information on the product portfolios of the top players in the Stem Cell Assay market.

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

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

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

Market Diversification:Exhaustive information about new products, untapped geographies, recent developments, and investments in the Stem Cell Assay market.

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The report summarized the high revenue that has been generated across locations like, North America, Japan, Europe, Asia, and India along with the facts and figures of Stem Cell Assay market. It focuses on the major points, which are necessary to make positive impacts on the market policies, international transactions, speculation, and supply demand in the global market.

Global Stem Cell Assay Market Segmentation:

Market Segmentation by Type:

(Viability/Cytotoxicty Assays, Isolation & Purification Assays, Cell Identification Assays, Proliferation Assays, Differentiation Assays)

Market Segmentation by Application:

(Regenerative Medicine & Therapy Development, Drug Discovery & Development, Clinical Research)

Table of Contents

Global Stem Cell Assay Market Research Report 2020 2026

Chapter 1 Stem Cell Assay Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

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

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

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Stem Cell Assay Market Forecast

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Stem Cell Assay Market to Witness Robust Expansion by 2026 with Top Key players like Thermo Fisher Scientific, Merck, Ge Healthcare, Bio-Rad...

Recommendation and review posted by Bethany Smith

*This post originally appeared as an article in the August 2020 edition ofHappi Magazine.

Beauty companies face an uptick in alleged false-labeling class actions. Whether the actions are justified or vexatious, one thing is certain: they are expensive to defend. By keeping the following labeling-related litigation trends in mind when considering and reviewing product labels and marketing, beauty companies can, hopefully, avoid becoming a litigation target.

All-Natural Claims

This most common type of false-labeling related lawsuit targets products that are labeled as containing a natural ingredient or as being all-natural. Targeted companies and claims have included:

The attorneys who seem to most often bring these actions also have filed lawsuits against food and beverage companies based on the same or similar label claims. The firms are leveraging their experience litigating against food and beverage to pursue the beauty industry.

Beauty companies should bear in mind that on Nov. 8, 2019, HR 5017 was introduced in the House of Representatives. This bill would amend the Federal Food, Drug and Cosmetic Act to define natural with a certain set of standards. As currently drafted, the bills definition of natural identifies a variety of characteristics that the product must have, for instance, it would have to contain at least 70% natural substances and cannot be made using any of seven processes, such as ionizing radiation. There is no present timeline for a vote on the bill, but companies should assume that its adoption will stoke litigation in this category.

Claims v. Labels

For a few thousand dollars or less, anyone can have a product lab-tested to learn whether it contains the ingredients or attributes claimed on the product label. The cases teach a variety of lessons for both labeling and playing class action defense.

In Forouzesh v. CVS Pharm., Inc., Case No. 2:18-CV-04090 (C.D. Cal), the plaintiff purchased a bottle of CVS Sport SPF 100+ Sunscreen Spray, but testing showed that the sunscreen only had an SPF of 29. CVS argued that the plaintiffs claims were preempted (in other words, that the plaintiff sought to impose on CVS a requirement that is different from or in addition to, or that is otherwise not identical with a requirement contained in the FDCA).

Ultimately, the court dismissed the lawsuit, finding the consumer did not adequately show that the product he purchased was in fact the one that his counsel tested, and, the testing methodology did not appear to comply with FDA regulations. The court gave the consumer an opportunity to amend to show such compliance, but the consumer did not timely file an amended complaint.

Sunscreens claiming to be mineral-based are also a target. For instance, in Prescott v. Bayer Healthcare et al., Case No. 5:20-cv-00102 (N.D. Cal.), plaintiffs claim that, Defendants are exposing babies and children to harmful chemical-based ingredients hidden in their sunscreens by fraudulently passing them off as safe mineral-based ingredients.

Aloe vera has also been targeted. In Kalajian v. Rite Aid Corp., Case No. 2:17-cv-06777 (C.D. Cal.), the consumer alleged that according to independent lab tests, the aloe vera products had no actual aloe vera at all. In a parallel case filed in the Northern District of Illinois, consumers argued that there was not enough of aloes active ingredient (acemannan). In this latter case, following several years of litigation, the court found, there is no evidence that a certain amount of acemannan must be present in the finished product for it to be aloe.

Companies intending to infuse their products with CBD should be aware that CBD-related class action litigation has been red hot. Actions have been filed in multiple states with consumers claiming that the CBD content listed on product labels and packaging does not match the actual CBD content. Other CBD-related class actions attack label claims stating that CBD will cure, mitigate, treat or prevent disease, or is intended to affect the structure or function of the body, in violation of FDA regulations. One topical cream has already been targeted. Dasilva v. Infinite Product Co. LLC, Case No. 2:19-cv-10148 (C.D. Cal.) (freezing point cream alleged to freeze away all aches and pains, and an afterglow healing oil alleged to be great for new tattoos, eczema, acne, scarring or open wounds.).

These cases serve as a reminder that, for companies using a marketing amount of an ingredient which requires a higher therapeutic amount to be efficacious, some thought should be given about positioning that ingredient in labeling statements and marketing materials.

Buyers Remorse

The idea of caveat emptor doesnt hold up in a courtroom when it comes to personal care product performance. Consumers have asserted that a wide range of products have not performed as expected (and therefore are falsely labeled), including:

Cases in this category are unique to their facts, making it hard to state a uniform defense to them. Legal departments should coordinate with their product managers and marketers to understand why certain label claims are made to ensure they are defensible.

Undisclosed Side Effects

This trend encompasses products that have caused actual alleged harm and those which are alleged to be dangerous but which may not have caused identifiable physical harm.

In the former category is a case against Rodan & Fields for its Lash Boost product. Lewis v. Rodan & Fields, Case No. 18-cv-02248 (N.D. Cal.). Consumers alleged that the Lash Boost eye serum had harmful side effects linked to the ingredient isopropyl closprostenate (ICP). ICP is a type of synthetic prostaglandin analog, a class of drugs used to manage glaucoma. The consumers alleged a variety of harms which were known side effects of this class of drugs, including changes in eye color, lashes falling out and not growing back, and one plaintiff had her vision damaged. While printed warnings appeared on the outside of the product container and inside on an insert, none referred to the side effects associated with ICP. The complaint referred the court to a warning letter that FDA sent to another maker of cosmetic lash enhancement products that used ICP without including warnings about the possible adverse effects associated with ICP. Based on these allegations, the court found the consumers plausibly alleged violations of five states false advertising laws.

Other cases are based on bare allegations that product ingredients are harmful without parallel allegations of personal injury (only economic damages are asserted). For instance, in Clark v. Kendo Holdings Inc., Case No. CGC-17-562492 (S.F. Super. Ct.), the consumer alleged that certain Ole Henriksen cosmetic products that contained alpha hydroxy acid (AHA) were falsely labeled. AHA in cosmetic products is said to remove the outermost layer of dead skin cells, which produces a short-term cosmetic benefit, but can also increase the damage sun-exposed skin suffers from ultraviolet radiation. The consumer alleged that this causes permanent damage and increases the risk of cancer. He also alleged that the FDA recommends that manufacturers using AHA label their products with a specific sunburn alert, and the products in question did not contain the recommended warning. The parties reached a settlement prior to class certification.

These cases are similar in that the plaintiffs attorneys expressly pointed the courts to FDA enforcement actions or advice (not taken) to bolster the complaints. As described in this article, the same has been done with FTC warnings. The attorneys are plainly using FDA and FTC guidance to guide their litigation strategy. Beauty companies legal departments should stay abreast of FDA and FTC enforcement actions and advice, as these could be harbingers of litigation trends.

Inaccessible Product

If youve ever used a cosmetic product down to the last drop, then youve experienced the tipping and tapping involved in trying to get that last bit of product out of the container. This common consumer experience has proven useful in defeating this final false-labeling class action trend.

In Ebner v. Fresh, Inc., 838 F.3d 958, 965-66 (9th Cir. 2016), the plaintiff complained that only a portion of Freshs Sugar lip product was accessible. Allegedly, the tubes screw mechanism permits only 75% of the total lip product to advance past the top of the tube. A plastic stop device prevents the remaining 25% of the product from advancing, preventing direct application from the tube to the lips. The Ninth Circuit affirmed dismissal of this lawsuit, finding that, [d]ispenser tubes that use a screw mechanism to push up a solid bullet of lip product are commonplace in the market. The reasonable consumer understands the general mechanics of these dispenser tubes and further understands that some product may be left in the tube to anchor the bullet in place. Critically, the label disclosed the correct weight of included lip product.

Despite the favorable defense outcome, plaintiffs have not abandoned this litigation theory. Subsequent lawsuits have targeted a medicated lip balm dispensed through a flexible tube, and a purveyor of cosmetics whose products are sold in sealed bottles, often made of glass, dispensed with a pump.

These cases teach two important defense lessons:

Slack fill lawsuits are a related litigation concept. Slack fill is the difference between the actual capacity of a container and the volume of product contained therein. Some slack fill has a legitimate purpose in product packaging, but nonfunctional slack fill is impermissible. If a cosmetics (opaque) packaging suggests that there is more product inside than there actually is, a beauty company may find itself facing a slack fill class action.

To conclude, by watching trends in related spaces such as food and beverage, noting FTC and FDA enforcement actions against industry peers, and revisiting product labeling with product managers and the marketing team, beauty companies can help to set themselves up to minimize the risk of litigation.

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No Reason to Blush - Lexology

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Vulvar melanosis is a common pigmentary change that accounts for most pigmented vulvar lesions. It presents as single or multiple asymptomatic macules or patches of varying size and color that may be asymmetric with poorly defined borders. The differential diagnosis of melanocytic lesions includes melanoma, which creates anxiety for patients and the physicians who diagnose the condition and treat the patients.To evaluate the clinical and dermoscopic features of vulvar melanosis and their changes over time.In this cohort study, patients with vulvar melanosis were recruited and followed up in the Department of Dermatology, University of Florence, Florence, Italy, between January 1, 1998, and June 30, 2019. Data on patient characteristics and on both the clinical and dermoscopic features of the vulvar lesions were collected. Each lesion was photographed clinically and dermoscopically at initial evaluation and at annual follow-up visits.The clinical, dermoscopic, and histopathologic features of vulvar melanosis and their changes over time.This cohort study included 129 women (mean age at diagnosis, 46 years [range, 19-83 years]) with vulvar melanosis. A total of 87 patients (67%) with vulvar melanotic lesions were premenopausal, and 84 patients (65%) had received some type of hormone therapy. The most frequent location for vulvar melanosis was the labia minora (55 [43%]), followed by the labia majora (33 [26%]). In 39 of 129 cases (30%), the lesions increased in size and changed color after initial evaluation but ultimately stabilized. No malignant evolution was documented in any patient during a median follow-up of 13 years (range, 5-20 years).This study suggests that vulvar melanosis was a benign entity, and changes in lesions over time did not signify malignant transformation. An association between hormonal status and vulvar melanosis may be hypothesized.

PubMed

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Clinical and Dermoscopic Features of Vulvar Melanosis Over the Last 20 Years. - Physician's Weekly

Recommendation and review posted by Bethany Smith

Valerian "does work on the (gamma-aminobutyric acid) receptor" that controls excited neural activity, Dasgupta said.

Warm milk and golden milk tea

Thanks to the tryptophan, calcium and magnesium in dairy, drinking warm milk before bed may help you sleep better. The warmth makes the beverage more soothing and easier to digest, Dasgupta said.

"Tryptophan's the amino acid that goes on to produce things like melatonin," he said.

"We know that melatonin is a natural hormone in your body produced by the pineal gland. And it's secreted at night and it really is part of helping you try to get that good night's sleep."

Golden milk is a traditional Indian drink with milk, cinnamon, ginger and turmeric and turmeric is rich in the component curcumin. Curcumin has anti-inflammatory effects and the potential to treat symptoms of anxiety and depression, which can interfere with sleep.

"Turmeric has also been associated with good sleep," but how inflammation affects sleep hasn't yet been fully defined, Dasgupta said. "But anything that helps with pain, with anxiety or induces some form of muscle relaxation can always be helpful with getting good sleep."

Lemon balm tea

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Tea, milk and other drinks to help you sleep (and some that will hurt) - Martinsville Bulletin

Recommendation and review posted by Bethany Smith

Dignity Health (Wikimedia photo via dailycal.org)

The California congressional delegation is deeply alarmed by proposed new healthcare rules governing the affiliation between the University of California and Catholic hospital systems that operate under religious restrictions.

Hospitals such as Dignity Health and St. Joseph Health adhere to the Ethical and Religious Directives (ERDs) set by the U.S. Conference of Catholic Bishops, not by medical professionals, New Ways Ministry reported last June. Dignity Health operates by the ERDs at 17 out of 31 of their hospitals.

According to the ACLU, NCLR, and National Health Law, Contract language explicitly states that students and providers are restricted by Catholic Directives.

The ERDs do not allow the prescription of any FDA-approved methods for preventing pregnancy including sterilization, elective abortion; assistive reproductive technology such as in-vitro fertilization (IVF) or the use of a surrogate for pregnancy; gender-affirming care such as hormone replacement therapy or surgery or physician-assisted aid in dying, The California Aggie reported June 5. Some argue that partnering with Dignity restrict care to LGBTQ+ people, women, others argue more are harmed by not partnering.

A previous attempt to expand Dignity Healths affiliation with UC San Francisco (UCSF) was called off last year after 1,500 UCSF doctors and hospital staff signed apetitionopposing the proposed expansion. The UC Working Group on Comprehensive Access (WGCA) was formed to find a way forward but failed to reach a consensus.

In August 2019, the WGCA presented two options: UC Health-backed Option 1 would allow existing affiliations to continue, understanding that some people might be denied care because of the hospitals adherence to religious doctrine. Option 2 would discourage the continued affiliation.

Evan Minton (Photo courtesy ACLU)

Evan Minton, a longtime California politico chair of the California Democratic Party LGBT caucus, was among the LGBTQ advocates who argued against the expanded relationship between UCSF and Dignity. He sued Dignity Health after his hysterectomy was cancelled because they learned he is a transgender man, about which he testified before Congress. The ACLU, which is representing him,argues that hospitals should not be able to pick and choose the care they provide to individual patients.

According to the student-run The Daily Californian,Dignity Health spokesperson Dan Loeterman said Dignity Health provides specialized services such as pediatric trauma programs, cancer treatment programs and behavioral health units that would not otherwise be available without the partnerships between UC Health and Dignity Health. We are deeply committed to providing care to everyone, regardless of who they are, said Loeterman.

UCSF noted in a statement that about half of the states doctors are trained through the UC system and without training at outside entities such as Dignity Health, UC would have to reduce its health-training enrollment, DailyCal.org reported.

Meanwhile, there is some concern the coronavirus pandemic may impact the Regents decision. After all, Catholic health systems control one in six hospital beds and are often the only location for treatment in some rural areas, New Ways Ministry reported last June 17.

The California congressional delegation wanted to register their disapproval.

In their Aug. 5 letter to UC President Dr. Michael Drake and the UC Regents, 39 out of 45 members of the Democratic delegation expressed serious concerns over UCs affiliations with hospitals and providers that impose religious restrictions limiting medically necessary care. The consequences of denying this care are serious and can even be life-threatening, they wrote. (See the letter below)

Led by U.S. Reps. Barbara Lee (D-Oakland), Julia Brownley (D-Westlake Village), and Mark Takano (D-Riverside), the letter, issued with the backing of a coalition that includes NARAL Pro-Choice California, Equality California, and the ACLU of California, noted that many of the signers strongly oppose the Trump administrations Refusal of Care Rule, which they describe as a dangerous, discriminatory regulationdesigned to allow health care institutions and providers to deny patients information and treatment based on personal religious or moral beliefs.

Given the Trump administrations repeated attacks on access to evidence-based health care, the members wrote, it is deeply alarming that the University of California, which has long been a national leader in comprehensive reproductive and LGBTQ-inclusive care, would be willing to involve its providers and patients in arrangements that subject them to religious rules that hold that basic reproductive health care is impermissible, and that directly exclude LGBTQ patients. Reproductive and LGBTQ-inclusive care is fundamental, basic health care, and we in California should stand strong in protecting it.

They strongly urge the Board to vote against Option 1. Option 1 does not require that contracts with outside health systems affirmatively state that religious directives will not apply to UC providers and students. It also does not state that hospital policies prohibiting gender-affirming services for transgender people or reproductive health services violate UCs non-discrimination policy, they wrote.

The delegation also rejected the proposition that the affiliation is necessary to expand health care access to underserved communities. In fact, hospitals with Catholic religious directives often prohibit many types of medical services that communities of color critically rely upon, particularly in the areas of reproductive and LGBTQ-inclusive health, where some of the deepest racial health inequities exist. Indeed, patients of color, low-income patients, people living with HIV and AIDS, and others who experience health disparities and systemic barriers to health care access are most in need of science-based, comprehensive care that is not limited by religious restrictions.

Moving forward with Option 1, will send a message to the nation that it is permissible to impose such limits on care, just as the Trump administration has sought to do with the Refusal of Care Rule, the delegation wrote, urging the Regents to vote to reject Option 1 and contracts that impose religious restrictions on UC providers and patients.

Rep. Mark Takano (screen grab of Takano online statement on Trump impeachment)

We, as members of the California delegation, are fighting against members of the Trump administration but were really aghast at the idea that within California, which should be using all of its muscle to ensure that discrimination does not occur in healthcare, Takano told the Los Angeles Blade. The way they push back on this is theyre saying they need to reach more people of color and low-income people.

Takano also noted that the LGBTQ community in Riverside County and all over low income areas Latinos and African Americans, in particular dont have access to HIV counseling and healthcare services.

This is still one of the most significant healthcare challenges the continued spread of HIV among low income people and people of color who may not have access to or may not have even heard about PrEP, Takano said. And this cannot be solved by entering into discriminatory contracts that will inhibit the ability to reach out to these populations. So, I reject the notion that theyre going to reach more low-income people and people of color who need healthcare.

Takano challenged UC Health to come up with alternatives. We should not be stuck with providers who insist on discrimination, he said.

This really got brought to the Regents attention because UC San Francisco was trying to get into a four- hospital agreement with Dignity Healthcare. But we blocked them, UC Board of Regents Chair John A. Perez told the Los Angeles Blade. It was clearly the pattern of discrimination against LGBT folks, in particular transgender folks, but also the limitations on reproductive healthcare.

UC Board of Regents Chair John A. Perez, California Assembly Speaker Emeritus (Photo via Regents)

The issue is personal for Perez. I have a friend who went into emergency labor and was refused a medically necessary tubal ligation, which put her in very dangerous circumstances, said Perez, an issue he addressed in open session. If you got an emergency room open to obstetrics and somebody comes in, in emergency labor, for you to put these constraints that are not based on science or medical best practice is fundamentally at odds with our obligation and our standards and our values as a public university hospital system.

Perez, who notes that he is one of three out LGBTQ Regents, is adamantly opposed to Option 1.

I will do everything in my power to make sure Option 1 is never adopted, Perez said. I believe that running a hospital or a health system and making decisions based on anything other than science the medical best interest of the patient is tantamount to the corporate practice of medicine, which California expressly prohibited by law.

Perez notes that the thorny issue raised by Option 1 has not yet been put forward. Meanwhile UC Health is focused on fighting the COVID-19 crisis. He disputes the notion of temporarily disregarding state and UC non-discrimination laws and core values to expand healthcare to low income people of color.

Were serving not only our patients, but were providing broader assistance to folks in other communities that arent part of our hospitals, Perez said. So, for example, Imperial County is about the most significantly impacted County in the state and were taking patients from Imperial County not only in San Diego and Irvine, but as far away as Davis. Were right now focused on direct patient care and direct research and helping turn the corner on COVID. And I think that really does speak to why nobody within the health operations has put this forward at this point.

More comments and the congressional letter:

University of California clinicians should not have their hands tied from providing reproductive and LGBTQ inclusive care because of religious directives, saidRep. Lee.While it is critically important to expand care to underserved communities, it should be comprehensive, not restricted care that is provided.

It is imperative that all Californians have access to quality and affordable healthcare, regardless of their gender or sexual orientation, saidRep. Brownley.The personal belief of healthcare providers should not be used to provide substandard care to classes of individuals. The University of California needs to make sure its actions do not narrow or restrict necessary healthcare, particularly for women and LGBTQ+ individuals, who have long faced roadblocks to getting the full healthcare they need and have a right to.

The University of California should not be limiting access to healthcare for LGBTQ+ people, women or other marginalized people who already face tremendous barriers to treatment but proposing to do so during a public health crisis is particularly offensive, saidEquality California Executive Director Rick Chavez Zbur.The UC is toeing a dangerous line by entertaining affiliations with hospitals that have long records of refusing LGBTQ+ inclusive and reproductive care. As Californians, we must as we always have set the example that everyone deserves care, regardless of religious belief, sexual orientation, the color of your skin or your gender identity.

California is a national leader when it comes to safeguarding and expanding reproductive freedom and LGBTQ-inclusive care which makes affiliations between the University of California and hospitals like Dignity Health, that categorically refuse to provide basic reproductive and gender-affirming care, all the more troubling, saidShannon Hovis, Director of NARAL Pro-Choice California.Discriminatory restrictions imposed by Catholic health systems are an affront to California values, plain and simple. As the fourth-largest healthcare provider in the state, the UC has a public and moral responsibility to provide high-quality, evidence-based care, free from discrimination. With so much at stake for reproductive freedom and equality in 2020, we demand that the UC Regents take action to ensure that every body is able to access the care they need.

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Takano 'aghast' at proposed UC affiliation with restrictive Catholic hospitals - Los Angeles Blade

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Julie Rowland, APRN, is now accepting new patients at Baptist Health Family and Occupational Clinic-South located at 8600 South 36th Terrace.

Rowland joined Baptist Health in the Spring, but has been a nurse practitioner in the community for four years.

Rowland earned an advanced practice nursing degree from Simmons College in Boston in 2015 and a Bachelor of Science in Nursing from the University of Central Arkansas in Conway in 2011. She has more than 13 years of nursing experience, including working in intensive care and cardiology units across the state. Rowland says her experience in hospitals inspired her to go back to school to become a nurse practitioner.

"When you treat a patient in the hospital, you usually see them at their worst, but in the clinic, you have the opportunity to educate patients at all stages of life and help them achieve their health goals," Rowland said.

Rowland provides wellness exams, preventive care and treatment for acute illness for patients who are school-age and older. Her clinical interests include diabetes, depression and preventive medicine. As the wife of a type 1 diabetic, Rowland knows firsthand how to help patients manage blood sugar levels with insulin, diet and lifestyle to prevent complications. She takes a holistic approach to patient care and values the time she spends discussing a patients individual needs.

"I like to try to do things as naturally as possible such as addressing a patients hormone and vitamin deficiencies, and overall lifestyle before adding any medications or making any changes," Rowland said.

Rowland was born and raised in Charleston. She is married with three daughters. To make an appointment with Rowland or to learn more about services provided, please call 1-888-BAPTIST.

Dr. Megan Minniear-Corrons, M.D., recently joined Mercy as a family medicine physician at Mercy Clinic Primary Care, a new Mercy location in Clarksville.

The new clinic opened Aug. 3 at No. 2 Medicine Drive in Clarksville.

Corrons is a graduate of the University of Arkansas for Medical Sciences in Little Rock and graduated summa cum laude with a bachelors degree in biology from the University of the Ozarks in Clarksville.

Corrons said because Mercys mission is to "bring to life the healing ministry of Jesus," she hopes to show the love of Christ to each patient every day.

"I chose family medicine as a way to give back to my community, because I want to have personal relationships with my patients," Corrons said. "I want the decisions that are made regarding their health care to be a collaborative effort. I want them to feel that their concerns have been heard and together we have decided on a plan for them."

Corrons is a member of the American Medical Womens Association and American Academy of Family Physicians. She has served as a representative on the Family Medicine Interest Group M4 and on the Hospital Auxiliary at Johnson Regional Medical Center in Clarksville. In addition, she has served on the fundraising and activities committees and as Sunday school and vacation Bible school director at First United Pentecostal Church of Clarksville.

She and her husband, Nathanial Corrons, live in Clarksville and attend GracePoint Church in Clarksville.

Mercy Clinic Primary Care in Clarksville is open from 8 a.m. to 5 p.m. Monday-Friday. Phone: (479) 705-2124.

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People In Business - Times Record

Recommendation and review posted by Bethany Smith

Alzheimer's is a scary disease because it means not remembering loved ones or how to do basic things like getting dressed. Until recently, doctors didn't know what caused it and couldn't offer much help. However, now that's changed.

Just like a roof with dozens of holes can only work if all of them are repaired, Alzheimer's has dozens of causes that must all be addressed, according to Dr. Dale Bredesen who has researched the causes and treatments of Alzheimer's Disease for more than thirty years.

"Let's make dementia a rare problem. Let's make Alzheimer's a rare disease, just as it should be," Dr. Bredesen told CBN News

His book,The End of Alzheimer's Disease:The First Protocol to Enhance Cognition and Reverse Decline at Any Age lists the many different causes of Alzheimer's and describes how his Bredesen Protocol can prevent the disease and has been shown to reverse symptoms in people with mild to severe cognitive decline.

Click HERE to see Lorie Johnson's full interview with Dr.Dale Bredesen about The End of Alzheimer's Program.

Sally Weinrich reversed her symptoms when she started the Bredesen Protocol after being diagnosed with the early stages of Alzheimer's Disease.

"You can get your cognition back, and that's what counts," she told CBN News.

She has been on The Bredesen Protocol for four years and has remained mentally sharp the entire time.

"I thank God for everything," she said, "From helping me hear about Dr. Bredesen, from the chance to talk to you and share it with others, because that's God's wish, for others to have health, and to help me appreciate and treasure my loved ones even more, who've been very instrumental and critical in my reversing Alzheimer's."

She says her husband Martin discovered The Bredesen Protocol through an internet search and helped his wife get started on it.

The First Step

The first step of the Bredesen Protocol involves getting what's called a "cognoscopy."

"We recommend that everyone 45 years of age or older, consider getting a cognoscospy," Dr. Bredesen said, "Especially for anyone who has any Alzheimer's or dementia in their family. Get checked out early and get on prevention."

A cognoscopy tests for each of the dozens of Alzheimer's risk factors. It's a simple procedure that involves giving blood and taking a quick, online quiz that measures a person's mental capacity compared with other people who are the same age. Since each person is different, the results will vary.

The online test measures things like memory and reaction time. The blood tests measure levels for good things like Vitamin D, Magnesium and Zinc as well as bad, such as toxins and inflammation.

DNA is Not Your Destiny

The cognoscopy also tests your genetic risk. Approximately 75 million Americans, roughly one in four people, carry one copy of the ApoE4 gene, which equates to a thirty percent increase in the risk of Alzheimer's. Approximately sevenmillion Americans carry both copies of the gene, which means they have more than a fifty percent risk of developing Alzheimer's Disease. Two-thirds of Americans with Alzheimer's Disease carry one or both copies of the ApoE4 gene.

Three-quarters of Americans carry two copies of the ApoE3 gene, which means they have a nine percent chance of developing Alzheimer's during their lifetime.

Dr. Rebecca Ryder is one of the more than 1,500 physicians who has trained under Dr. Bredesen and prescribes his protocol to her patients.

"It is a complicated disease," she said."There is no one magic bullet."

Until now, too many people didn't want to know whether they carried one or both copies of the ApoE4 gene because they felt there was nothing they could do about it. However now the opposite is true. People should know early whether they carry the gene because with early intervention science now tells us it's possible to silence it, or "turn it off."

"There are some things we can not control. Our genes. The genes we were dealt with," Dr. Ryder said, "But there's a whole field called epigenetics which says how our genes are translated. So those lifestyle factors, your diet, your exercise, all that affects what genes are promoted or not promoted for your health."

Your Personal Program

Patients can learn the nearest location of a health care professional who has trained in the Bredesen Protocol on the website. Patients can also work with their primary care physician to prescribe the blood work needed for a cognoscopy. Patients can also get a cognoscopy by working directly with practitioners at Apollo Health, the brain health community founded by Dr. Bredesen.

Dr. Ryder says she reviews the results of a patient's cognoscopy with them.

"Most patients will have a combination of things," she explained," Like they'll have a little bit of hormone, a little bit of blood sugar problems, maybe a little bit of toxin exposure."

Based on the results of the cognoscopy, the patient is prescribed a tailor-made program using diet, exercise, sleep, stress reduction, supplements, and more.

"We've seen some good reversals of cognitive decline here," Dr. Ryder said, "I mean, I have seen the patients get better here. Not all of them. As with anything, the earlier you catch it, the better."

Success Stories

So far more than 5,000 people have started the protocol. Dr. Bredesen and his team have documented cases of patients who initially scored low on the Montreal Cognitive Assessment, or MoCA, a screening that measures brain function, who improved after adopting the protocol.

Likewise, patients who had poor EEGs, which measure brain-wave speed showed improvement and those with brain shrinkage detected on MRI scans later showed increased volume after being on the protocol.

"Those 5,000 some of them MoCA scores of zero and late stage," he explained, "Now, no surprise, the earlier you get started the easier it is to get positive outcomes. However, we have seen some people even in [the] late stages with improvement."

Dr. Bredesen published research studies documenting cases with before and after evidence of improved cognition, including Sally Weinrich's.

"Life's good," Sally said, "So no matter what stage you're at, or if you have what society calls 'aging problems,' I'd encourage all your viewers to just do it. It's worth it."

Meanwhile, Dr. Bredesen's research continues.

"We're in the midst of the first trial in history in which, instead of predetermining a treatment, saying, 'OK, we're going to treat with this drug or that drug, we're instead looking at all of the different contributors to the cognitive decline for each person, and then addressing those," he continued, "And this is the way of the future. This is the way people will be treating cognitive decline for years to come."

So instead of using a single drug to treat Alzheimer's Disease, it appears a customized, multi-pronged approach to treatment and prevention could be the best strategy to fight this scourge.

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Alzheimer's Doctor: Here's How to Avoid Getting It or Reverse Symptoms if You Already Have It - CBN News

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The information provided on the show is for general information purposes only. If you have a health problem, medical emergency, or a general health question, you should contact a physician or other qualified health care provider for consultation, diagnosis and/or treatment. Under no circumstances should you attempt self-diagnosis or treatment based on anything you have seen on the show.

A good beauty regime doesnt just involve what we put ON our bodies we also need to be mindful of what we put in them! With some diet suggestions, lifestyle changes and supplements from Jamiesonto help is registered dietitian and nutritionist Nishta Saxena.

Find Nishtas recommendations below, and watch the video above for more.

Keeping out hair, skin and nails healthy is key to achieving that glow from the inside out. Jamieson Advance Hair, Skin + Nails is an advanced, once-a-day, multivitamin formula that helps promote thicker hair, stronger nails and healthier skin thanks to a high-potency dose of Biotin, and 21 other key ingredients. Biotin is a B vitamin thats known for its beauty enhancing properties, and like most B vitamins, its also beneficial for our entire body because it helps convert food into energy. Remember to check with your doctor before taking any new supplements or medication to make sure theyre right for you.

You can also get biotin in Vitamin B rich foods like eggs, fish, beef, pork, sweet potatoes, dairy products and oatmeal. Try a spinach and strawberry salad with toasted almonds and sunflower seeds for an extra boost! Not only are you getting biotin through the spinach and sunflower seeds, this salad also delivers lots of minerals and fibre.

Another great option is a broccoli and cheddar cheese fritatta, which is going to give you tons of B vitamins, thanks to the eggs and broccoli. Its also high in protein, and its great for breakfast, lunch or dinner.

Acne can be genetic, so some people are more prone to it than others. But there are still things you can do to promote healthy skin!

Staying well hydrated is key, so make sure to drink lots of water.Also, sun can really dry out the skin barrier, so during the summer months its crucial to use a good high UVA and UVB sunscreen, because not protecting your skin can really irritate it and make your acne worse.

In terms of food you want to avoid refined sugar and processed foods that cause a lot of insulin to be released in the body. And lastly, you want to focus on exercise and stress management. Stress can really impact the hormones that make acne worse, but exercise can help. It reduces stress, and brings blood flow to the skin, which helps the nourish the skin and take away some of the toxins you dont want.

Jamieson Clear Skin is designed to help improve skin tone and reduce acne inflammation. Its formulated with a unique and powerful blend of natural ingredients including Sea Buckhorn and Chaste tree, the latter of which is used in Herbal Medicine as a hormone normalizer which means it can also help relieve PMS symptoms or relieve symptoms associated with menopause. Plus, it also contains a high-potency GLA gama linoleic acid from Borage Oil, which is a fatty acid that helps reduce the inflammation commonly associated with acne.

If youre worried about wrinkles, have no fear! Some collagen in your diet can help prevent them. Collagen is a protein in the body that helps form the matrix of your skin the netting that holds it together and as we age, and women go through menopause we definitely see a reduction of collagen in our body. This leads to sagging, and a loss of elasticity in the skin

Collagen is made up of amino acids, so any foods that are high in protein are going to help make collagen foods like pork, chicken, eggs, organ meat and dairy products. Try some pork tenderloin kebabs with grilled peppers, mushrooms and vidalia onion to up your collagen intake the pork and mushrooms have all the amino acid building blocks required to make collagen, and the grilled peppers have accessory nutrients like Vitamin C which are also important for keeping your skin healthy.

In terms of a supplement, Jamieson Collagen Anti-Wrinkle is clinically proven to reduce the number of fine lines and wrinkles in 28 days. Its formulated with hydrolyzed bovine collagen which helps increase skin density and the appearance of smooth skin and its available in caplet form or strawberry flavoured liquid.

Lack of sleep can effect our mental health and our heart function and our stress hormones will go up, which may cause our body to hold on to extra fat. So what can you do? First things first, you need to prioritize sleep. Dont binge watch extra episodes of TV if its getting late go to bed! Shut all screens and blue light exposure off an hour before bed. Avoid caffeine 12 hours before sleep, because if youre a slow metabolizer of caffeine it can interrupt sleep.

You may have heard that melatonin has an important role in helping us get a good nights sleep. But what is it? Melatonin is a hormone in the body that helps regulate the sleep-wake cycle. However, some people need extra help. Thats where a product like Jamiesons Beauty Sleep could be useful! Its a safe and non-habit forming sleep aid that contains melatonin to help improve sleep quality. Plus its got two key beauty ingredients biotin and hydrolyzed collagen to help promote healthier hair, skin and nails so it really takes the idea of getting your beauty sleep to the next level!

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How to achieve beauty from the inside out with diet, lifestyle and supplements - The Loop

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Dr. Suzanne Slonim

Dallas Business Journalhonors Dr. Suzanne Slonim for her unique minimally-invasive fibroid practice

DAVID TAFFET | Senior Staff Writertaffet@dallasvoice.com

Dallas Business Journal has named Dr. Suzanne Slonim as one of its business women of the year. For 15 years, Slonim served as medical director of interventional radiology at Methodist Dallas Hospital before she founded the Fibroid Institute Dallas exclusively to treat uterine fibroids with a minimally-invasive procedure.

Slonim and her wife, Pam Gerber, searched locations around the country extensively before deciding on moving to Dallas. We were looking for a place to be safe, happy and welcomed, Gerber explained.

They had been living in Palo Alto, Calif. but couldnt afford to continue living there comfortably. So they looked in Miami, Washington, D.C., San Diego, Tampa and a few other cities but found the LGBTQ community in Dallas to be the most organized and most welcoming.

Gerber said she was apprehensive about the move. She had preconceived notions about Dallas, but both Gerber and Slonim quickly found Dallas to be an easy place to live. And, Slonim said, its a great place to practice medicine. Among the things she likes about Texas, Slonim added, is that the state has prohibitions against corporations practicing medicine. So Slonim joined an existing practice as an interventional radiologist.

The couple planned to stay in Dallas five years. That was 20 years ago.

While at her practice, Slonim created a niche market in uterine fibroid embolization or UFE. Fibroids are abnormal, usually noncancerous, growths in the uterus that cause severe abdominal pain and heavy periods. Instead of treating fibroids with a hysterectomy, UFE uses radiology to cut off the blood supply to the fibroid so it will shrink.

The plan to stay in Dallas just five years got derailed during year four when Slonim was named president of the medical staff at Methodist Dallas Hospital the first woman named to that position. That meant an additional six years in Dallas two as incoming president, two serving as president and two as immediate past president.

During that time, her UFE specialty grew. She said she became an amplifier for the relatively unknown, minimally-invasive procedure.

Gynecologists generally steer away from the UFE procedure because patients complain of pain afterwards. But Slonim said that is because those doctors havent managed their patients pain. She prepares patients ahead of time with medication especially for that first week as the fibroids begin to shrink.

In her first year in her own practice, about 10 percent of Slonims clients came through referrals from other doctors. Now, as her work has been recognized by area gynecologists, about 80 percent are referrals.

Slonim said removal of just the uterus can be a very bloody operation requiring transfusions. In some cases, even when a woman will eventually need the uterus removed, doctors now refer patients to her to shrink fibroids first, making the removal a much safer operation.

Today, Slonims office is the only one that specializes in only doing UFE. I feel passionate about it and love doing this procedure, she said. And shes passionate about making sure anyone with fibroids is given the option of UFE.

Although her companys nondiscrimination policy includes sexual orientation and gender identity, Slonim said shes never treated a trans man. Thats probably because fibroids are fed by estrogen, and hormone treatments block the growth of fibroids. But, she said, if a trans man with a uterus was seeking treatment for fibroids, shed assure him the finest medical care, something she said trans men and women dont always receive.

Gerber said that commitment to providing the finest care possible is one of the things she admires most about her wife, describing Slonim as a cross between an old-school family doctor and a modern physician using the latest technology.Slonims technique involves inserting a wire into a blood vessel in the patients wrist and steering it up the arm and down the torso into the uterus while monitoring the progress on a screen. That takes about a minute. Thats the latest technology part.

The old-school family doctor part and her bedside manner she may have learned from her parents, both of whom were doctors. Her father was from New Jersey and her mother came to the U.S. for college from Iraq then stayed for medical school. Slonim said her father retired when he was done paying for her medical school, but her mother, at 89, just stopped seeing patients earlier this year.

Slonim said her patients have her cell phone number and call her directly when they need her help. Gerber recalled one patient who was in pain because of a problem with a port who contacted Slonim in the middle of the night. The doctor had that patient come to their house where she fixed the problem.

During the COVID-19 lockdown, Slonims office was closed because the procedure she does, while stopping severe pain, is considered elective. So, like other doctors, Slonim quickly adopted the use of telemedicine, and she has been able to prepare some patients for upcoming procedures online.

She has reopened the office, but before doing so, Slonim said, she added machines that clean the air of mold and other pathogens to help keep her patients and staff safe. Hand washing stations are placed throughout the office.

Texas Medical Association has been great in getting us all the PPE we need, she said. And she reopened feeling her office was as safe and protected as possible.

Slonim and Gerber have been together 30 years. They met in an L.A. Bar: I want to be explicitly clear on this one, Gerber said. She asked me to dance.

They live in a townhouse in the SoHiP section of Oak Lawn with a couple of chickens out in the chicken coop Slonim had built for Gerbers 50th birthday. Slonim said she wanted fresh eggs, and they started with seven chickens. Theyre down to two including one who was injured, has recovered and is now pigeon-toed.

As for her business, Slonim who has spoken on the subject around the world and has written a number of books on the subject including her latest, Pain Free Periods, available at FibroidFree.com hopes to replicate her model in other cities with other doctors who are as passionate as she is about treating fibroids with UFE rather than major surgery.

See more here:
Business woman of the year - Dallas Voice

Recommendation and review posted by Bethany Smith

Novel antibody-drug conjugates (ADCs) introduce promising options for the management of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer; however, management of drug-related toxicities and optimal sequencing of HER2-targeted therapies remains an ongoing challenge, according to stakeholders who participated in a recent OncLive Scientific Interchange and Workshop.

As of 2016, approximately 3.5 million women were living with a breast cancer diagnosis in the United States, and the number of new cases of breast cancer in 2019 represented approximately 15.2% of all new cancer diagnoses. Based on data from 2014 to 2016, approximately 1 in 8 women will be diagnosed with breast cancer in their lifetime, with the largest proportion of diagnoses occurring in women between the ages of 55 and 64 years.1

HER2-positive breast cancer accounts for approximately 15% of all breast cancers.2 HER2 is a member of the ERBB family, which comprises 4 plasma membrane-bound receptor tyrosine kinases (HER1, HER2, HER3, and HER4).3 Overexpression of HER2 is identified by evaluating samples of either the primary tumor or metastatic tissue with immunohistochemistry (IHC) or fluorescent in situ hybridization (ISH). Testing guideline updates released in 2018 by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) define HER2-positive as an IHC score of 3+, which involves strong staining of the entire membrane circumference of more than 10% of tumor cells.4 Tumor specimens with an IHC score of 2+ with weak to moderate complete membrane staining in more than 10% of tumor cells are considered HER2-equivocal and require reflex testing with fluorescent ISH to clarify HER2 status. Specimens with very slight, incomplete membrane staining in more than 10% of tumor cells (IHC score 1+) or those with no observable staining (IHC score 0) are considered HER2-negative.4 Another term, HER2-low, recently emerged to describe breast cancer with an IHC score of 1+ or 2+ with a negative fluorescent or chromogenic ISH assay. More than 50% of breast cancers may be HER2-low; those with low HER2 expression and no ERBB2 amplification may experience benefit from HER2-targeted therapies.5

Recurrence and Overall Survival Rates

HER2 positivity was historically associated with high rates of recurrence and poor survival, but the availability of trastuzumab and other HER2-targeted therapies has substantially improved outcomes.2 According to a recent analysis, the estimated 5-year survival rates are 83% for hormone receptor-negative, HER2-positive breast cancer and 89% for hormone receptor-positive, HER2-positive breast cancer. Before we had targeted agents against HER2, particularly in the curative setting, it used to be among our most virulent and rapidly fatal of breast cancers, said session moderator Joyce A. OShaughnessy, MD, of Baylor University Medical Center in Dallas, Texas. [HER2 amplification] is a very, very powerful growth and survival signal. It leads to a lot of therapy resistance right across the board.

Although OShaughnessy noted that recurrence rates for HER2-positive disease are decreasing, she estimated more than half of patients who need first-line treatment for metastatic HER2-positive breast cancer have de novo metastatic disease, which emphasizes the continued need for further metastatic therapies. In addition, central nervous system (CNS) metastases are relatively common in HER2-positive breast cancer and were identified by the stakeholders as 1 of the challenges in management of their patients. Up to 50% of patients with HER2-positive advanced breast cancer develop CNS metastases in their lifetime.6 Erika P. Hamilton, MD, of Sarah Cannon Research Institute in Nashville, Tennessee, noted that it is important to identify patients in the neoadjuvant or adjuvant setting who are at higher risk for CNS relapse and most likely to benefit from early escalation of therapy.

Standard Therapy

Several targeted therapies are approved for HER2-positive breast cancer in the adjuvant and metastatic setting, including trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine (T-DM1), and neratinib.7 An additional treatment option, the kinase inhibitor tucatinib, was approved in April 2020 and is indicated in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, after receiving 1 or more HER2-targeted regimens in the metastatic setting.8 This approval was based on data from the phase 3, randomized, controlled HER2CLIMB trial, which had results that showed that the progression-free survival at 1 year among adult patients with HER2-positive breast cancer (N = 612) was significantly better with tucatinib, trastuzumab, and capecitabine than with placebo, trastuzumab, and capecitabine (33.1%; vs 12.3%; HR, 0.54; 95% CI, 0.420.71; P <.001) and risk for disease progression or death was 52% lower in those with CNS metastases who received the tucatinib combination (HR, 0.48; 95% CI, 0.340.69; P <.001).9 Although the arrival of tucatinib has helped with managing CNS metastasis in HER2-positive breast cancer, Antoinette R. Tan, MD, of Levine Cancer Institute, Atrium Health in Charlotte, North Carolina, predicted that managing these patients will remain an ongoing challenge because they are living longer.

ADCs offer a targeted approach to HER2-positive breast cancer treatment, and have also shown promise for patients with heavily pretreated disease, CNS metastases, or HER2-low expressing breast cancer.10-12 ADCs consist of a recombinant monoclonal antibody molecularly bound to a cytotoxic drug (known as the drug payload) with a synthetic linker, and they combine the antibodys high specificity for a target with the chemotherapy drugs cytotoxicity.13 HER2-targeted ADCs bind to HER2 on the cancer cell surface and are internalized by the cell, after which the cytotoxic drug component is released intracellularly and exerts its antitumor effect. ADCs may also be designed to stimulate the release of drug from the target cell into the extracellular space, which kills surrounding and bystander cells that may or may not express the target antigen (ie, a bystander effect). This may also occur if the cytotoxic drug is released after binding to the antigen and before internalization.

Trastuzumab Emtansine

The ADC trastuzumab emtansine (T-DM1) was approved in 2013 and is indicated for treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.14 T-DM1 is composed of trastuzumab linked with the chemotherapy agent DM1. This agent derives from maytansine, a plant isolate that binds tubulin and blocks microtubule assembly by hindering polymerization and enhancing depolymerization. Although the activity of maytansine is extremely potent, dose-limiting toxicities halted clinical development in early trials.15 T-DM1 resolves these toxicity limitations through a nonreducible thioether linker that prevents chemotherapy release into circulation once the linker breaks down in the tumor cell. These linkers may have minimal cytotoxicity on bystander cells. T-DM1 must be internalized by the target cell for degradation of the antibody and subsequent release of the drug to occur, and the cleaved drug product is unable to enter surrounding cells because its positively charged lysine moiety is unable to penetrate the cell membrane.16 Results from a preclinical study demonstrated that thioether linkers have lower toxicity and better potency than disulfide linkers and induce dose-dependent cell death in HER2-overexpressing breast cancer cells (SK-BR-3 and BT-474) through apoptotic and cell lysis mechanisms.17

The high efficacy and relatively good tolerability of T-DM1 have helped to establish it as a common second-line therapy for HER2-positive metastatic breast cancer.18 The phase 3 EMILIA trial randomized patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane to receive T-DM1 (n = 495) or lapatinib plus capecitabine (n = 496); primary endpoints were progression-free survival (assessed by independent review), overall survival, and safety. T-DM1 was associated with significantly longer median progression-free survival (9.6 months vs 6.4 months; HR for death from any cause, 0.65; 95% CI, 0.550.77; P <.001) and overall survival at the second interim analysis (30.9 months vs 25.1 months; HR for death from any cause, 0.68; CI, 0.550.85; P <.001).19 The T-DM1 group also had a significantly higher objective response rate than the lapatinib plus capecitabine group (43.6% vs 30.8%; P <.001) and lower rate of grade 3 or higher adverse events (AEs) (40.8% vs 57.0%).

The most commonly reported grade 3 or 4 AEs in the T-DM1 group were thrombocytopenia (12.9%) and elevations in serum aspartate aminotransferase and alanine aminotransferase (4.3% and 2.9%, respectively). For the majority of patients, onset of grade 3 or 4 thrombocytopenia occurred during the first 2 cycles of T-DM1, and most were able to continue treatment with dose modifications. Serious AEs were reported for 88 patients (18.0%) in the lapatinib-capecitabine group and 76 patients (15.5%) in the T-DM1 group.19

Regarding treatment in the adjuvant setting for patients with HER2-positive early breast cancer, T-DM1 showed positive results in the phase 3 KATHERINE trial, which randomized patients to receive adjuvant T-DM1 (n = 743) or trastuzumab (n = 743) with the primary endpoint of invasive disease-free survival. Invasive disease-free survival at 3 years was significantly better in the T-DM1 group than in the trastuzumab group (88.3% vs 77.0%; HR 0.05; 95% CI 0.390.64; P <.001). T-DM1 was generally well-tolerated in this trial, with decreased platelet counts (5.7%) and hypertension (2.0%) as the most common grade 3 or higher events. Serious AEs were reported in 94 patients (12.7%) in the T-DM1 group and 58 patients (8.1%) in the trastuzumab group.20

Although survival data have not been published yet, OShaughnessy said that the data from the KATHERINE trial highlighted T-DM1 as an effective, safe option in the adjuvant setting. This is a well-tolerated, feasible regimen that were all very, very familiar with, and its an important standard of care, particularly in the curative setting, she said.

The efficacy of T-DM1 is thought to be greater in breast cancers with high and homogeneous expression of HER2, as suggested by results of a randomized phase 2 trial that compared first-line T-DM1 to trastuzumab plus docetaxel in patients with locally advanced or metastatic HER2-positive breast cancer (N = 137). In the trial, the improvements in risk for disease progression with T-DM1 were greater in patients with HER2 messenger RNA (mRNA) expression equal to or more than the median (HR, 0.3; 95% CI, 0.180.85) than in those with HER2 mRNA expression below the median (HR, 0.85; 95% CI, 0.44-1.67). Within the T-DM1 treatment arm, patients with HER2 mRNA expression equal to or greater than the median had numerically longer progression-free survival than those with HER2 mRNA expression less than the median (not reached versus 10.6 months).21

Trastuzumab Deruxtecan

Trastuzumab deruxtecan (DS-8201a) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior antiHER2-based regimens in the metastatic setting.22 The ADC is composed of a humanized anti-HER2 antibody (trastuzumab), enzymatically cleavable tetrapeptide linker, and novel topoisomerase I inhibitor payload (DXd), which is a derivative of exatecan (DX-8951). The tetrapeptide linker, glycynglycyn-phenylalanyn-glycyn (GGFG), is decomposed by cathepsins B and L and other lysosomal enzymes that are strongly expressed inside the tumor cells.23,24 Trastuzumab deruxtecan has a higher drug-to-antibody ratio (DAR) than other ADCs, with approximately 8 molecules of DXd homogeneously conjugated to 1 trastuzumab molecule versus 2 to 4 drug molecules conjugated to the antibody molecule in other ADCs (3.5 drug molecules in T-DM1). Although a higher DAR (6 to 8) has been known to contribute to ADC instability and higher clearance, which leads to reduced efficacy and greater toxicity, the drug linker system of trastuzumab deruxtecan offers high stability in plasma and strong antitumor activity that relies on its high DAR. Unlike ADCs with a lower DAR (3.4), trastuzumab demonstrated antitumor activity in HER2-low models.23 In addition to having a higher DAR, trastuzumab deruxtecan has a DXd payload with a higher cell membrane permeability than that of T-DM1; this was shown to contribute to a bystander effect in an in vitro coculture of HER2-positive and -negative cells and an in vivo mouse model with tumors heterogeneous for HER2 expression.24

An open-label, dose-escalation, and dose expansion phase I trial evaluated safety and preliminary activity of trastuzumab deruxtecan in patients with HER2-positive, advanced- stage breast cancer previously treated with T-DM1. Analysis of the 115 patients treated with at least 1 dose of trastuzumab deruxtecan at the recommended doses for expansion showed an objective response rate of 59.5%. The most common grade 3 or higher treatment-emergent AEs were anemia (17%) and decreased neutrophil (14%), white blood cell (9%), and platelet (8%) counts, and 9 cases of interstitial lung disease or pneumonitis required discontinuation of treatment.25

The 2-part, open-label, phase 2 DESTINY-Breast01 trial enrolled patients with HER2-positive metastatic breast cancer who had been treated previously with T-DM1 (N = 184). Part 1 of the trial consisted of pharmacokinetics and dose-finding stages, and part 2 evaluated the efficacy and safety in patients treated with the recommended dose. Part 2 included a cohort of patients who had experienced tumor progression with T-DM1 and a cohort of patients who had discontinued T-DM1 due to toxicity and additional reasons other than progressive disease. The confirmed response rate (by independent central review) was 60.9% among patients who received the recommended dose of 5.4 mg/kg (95% CI, 53.468.0), and the median duration of response was 14.8 months (95% CI, 12.7not reached). The onset of response was relatively quick (median 1.6 months). Patients received a median of 6 prior cancer therapies and the confirmed response rate was 61.1% among the cohort who had tumor progression during or after receipt of T-DM1. This suggests the agent has strong activity even when HER2 is downregulated by prior targeted therapies, according to OShaughnessy. It really speaks to the noncross-resistant nature of the deruxtecan and the ability of this agent to really bind and kill cells, even with the low level of HER2 expression, she said. Some clinicians may also use trastuzumab deruxtecan in patients with a large disease burden or severe diseaserelated symptoms, according to OShaughnessy.

Trastuzumab deruxtecan may also have efficacy in patients with a history of CNS metastases, according to a subgroup analysis of 24 patients with baseline CNS metastases from the DESTINY-Breast01 trial. The overall response rate was 58.3% (95% CI, 36.677.9), including 1 patient who had a 55% regression of a metastatic brain lesion, and the median progression-free survival was 18.1 months (95% CI, 6.7-18.1). At a median follow-up of 11.1 months, 33% of patients with CNS metastases (8/24) and 26% of the overall population (48/184) experienced disease progression before the cutoff date. However, only 4 of the 48 patients with progressive disease (including 2 of 8 patients with CNS metastases at baseline) had a CNS progression.12

In the DESTINY-Breast01 trial, 57.1% of the patients who received the recommended dose had a grade 3 or higher AE. Decreased neutrophil count (20.7%) was the most common; however, the risk for drug-induced lung complications was of particular concern to the stakeholders, with 11 patients discontinuing trastuzumab deruxtecan due to pneumonitis and 5 discontinuing due to interstitial lung disease. Of the 25 reported deaths, 18 occurred during the survival follow-up period (the 47 days after end of treatment), and 2 of these were caused by situations related to interstitial lung disease, which had started during treatment.26

An analysis of 7 ongoing studies across multiple tumor types of 665 patients who received at least 1 dose of trastuzumab deruxtecan showed that 66 cases of interstitial lung disease were reported, and 13 of these were grade 3 or higher. Five patients with interstitial lung disease had a fatal outcome, and 4 of these deaths were identified as related to trastuzumab deruxtecan. Of the 665 patients, 289 were from the DS9201-A-J101 study, whose results showed that higher doses and Japanese origin may increase the probability of developing interstitial lung disease after adjustment for baseline factors, such as age, previous radiotherapy to the chest, number of previous anticancer therapies, lung metastases, and HER2 status. The study authors concluded that patients with suspected interstitial lung disease should be diagnosed early with imaging, laboratory testing, and meeting with a pulmonologist. These patients should also discontinue trastuzumab deruxtecan and, in moderate to severe cases, receive steroids.27

The interchange faculty agreed that increased awareness among clinicians and early identification of drug-related lung issues is critical. I am pretty convinced that if we catch this pneumonitis in a grade 1 or a grade 2, we can reverse it, but a lot of times its just not caught that early, said Hamilton. I think if you do get somebody with a grade 3 pneumonitis, its just beyond the point of return.

Neelima Denduluri, MD, of Virginia Cancer Specialists in Arlington, Virginia, also said that differentiating drugmediated pneumonitis from pulmonary disease related to the breast cancer itself has been challenging in her experience. She added that having a low threshold to give patients a break from the drug and/or start steroids is important for proactive management.

SYD985 ([vic-]trastuzumab duocarmazine)

Currently in development, SYD985 is an ADC composed of trastuzumab linked to the duocarmycin prodrug seco-duocarmycin-hydroxybenzamide-azaindole orseco-DUBA via a cleavable linker. The trastuzumab moiety binds to HER2 on the cell surface of the tumor, which activates endocytosis and subsequent cleaving of the linker inside the tumor cell by proteases at the valine-citrulline dipeptide and release of duocarmycin (the active moiety). Binding of duocarmycin to the minor groove of DNA followed by alkylation of adenine at the N3 position induces tumor cell death, and the trastuzumab moiety also causes antibody-dependent cell-mediated cytotoxicity in tumor cells with overexpression of HER2.28

An in vitro analysis showed that HER2 3+ and 2+ human cancer cell lines (SK-BR-2 and AK-OV-3, respectively) were sensitive to seco-DUBA, the cytotoxic component of SYD985.29 Additionally, a bystander effect has been reported for SYD985, with killing effects observed in HER2-low and negligible cells, and the cytotoxicity of SYD985 was 7 and 54 times more effective than T-DM1 for HER2/neu 3+ and HER2/neu 1+ cells, respectively (P <.0001).30

Results from a phase 1 expansion cohorts study (NCT02277717) (N = 99) on SYD985 showed an overall response rate of 33% and a median progression-free survival of 9.4 months in patients with HER2-positive breast cancer (n = 50), most of whom had received 3 or more prior HER2-targeting regimens (including T-DM1) for locally advanced or metastatic disease. SYD985 was considered to have a favorable tolerability profile, with fatigue, dry eyes, conjunctivitis, and increased lacrimation as the most common AEs. The most common grade 3 or higher AEs included neutropenia (6%) and conjunctivitis (4%).10

The efficacy and safety profile of SYD985 is also currently being reviewed in the phase 3, randomized, active-controlled TULIP trial (NCT03262935)(estimated enrollment = 345). The study launched in 2017 and is randomly assigning SYD985 or physicians choice of treatment (2:1) to patients with HER2-positive advanced or metastatic breast cancer who had disease progression during or after 2 or more HER2-targeting treatment regimens in the locally advanced or metastatic disease setting. The estimated date of study completion is May 2021.31

ADCs for HER2-Low Breast Cancer

The antitumor activity of trastuzumab deruxtecan and SYD985 in HER2-low expressing breast cancer may confer an advantage over T-DM1 in this subgroup of patients. An analysis of 54 patients with HER2-low expressing advanced breast cancer from the DESTINY-Breast01 trial showed an objective response rate, confirmed by independent central review, of 37.0%, with a median duration of response of 10.4 months, median progression-free survival of 11.1 months, and median overall survival of 29.4 months (95% CI, 12.929.4). These findings prompted the initiation of a phase 3 randomized trial (DESTINY-Breast04; NCT03734029), which will compare the efficacy and safety of trastuzumab deruxtecan with physicians choice of treatment (capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel) in patients with HER2-low expressing, unresectable, and/or metastatic breast cancer.11

In the phase 1 expansion cohorts study (NCT02277717) previously mentioned, SYD985 also showed efficacy in patients with heavily pretreated HER2-low metastatic breast cancer. The overall response rates were 27% among patients with hormone receptor-positive disease and 40% among those with triple-negative breast cancer.10

According to the stakeholders, these ADCs could fill an important niche role in the treatment of HER2-low breast cancer if these findings are confirmed in ongoing and future phase 3 randomized trials. It will be a compelling initiative to have an ADC available for this population and to figure out where to sequence it relative to how we currently treat these patients, said Tan. I would imagine [these therapies would be administered after] theyve progressed on endocrine therapy [when] trying to figure out which potential cytotoxic therapy to use.

Carl Henningson, MD, of Reginal Cancer Care Associates in Englishtown, New Jersey, added that using 1 of the new HER2-directed ADCs after hormone therapy may help address the upregulation of HER2 expression that can occur as a resistance mechanism to hormone therapy. However, Stephen Schleicher, MD, of Tennessee Oncology in Nashville, Tennessee, emphasized improving identification of patients with HER-low expressing breast cancer will also be necessary for determining whether a patient with low expression of HER2 could benefit from HER2-directed therapies. I would imagine so many of our notes say ER/PR positive, HER2-negative, and they dont specify HER2 2+, FISH-negative or HER2 1+, he said. Identifying these patients is an extra roadblock that is different than anything else in breast cancer because clinicians are familiar with HER2-positive so typically think within that framework.

XMT-1522 and ARX788 are 2 of the newest HER2-targeting ADCs currently in early-phase clinical trials for HER2-positive breast and other cancers. XMT-1522 is composed of a novel human IgG1 anti-HER2 monoclonal antibody with Auristatin F-hydroxypropylamide (AF-HPA) as the cytotoxic payload, and a biodegradable polymer conjugation platform is used to achieve an average DAR of 12 AF-HPA molecules to 1 HER2 antibody.32 Initial results from an ongoing phase 1 doseescalation trial (NCT02952729) that included patients with HER2-positive breast, lung, or gastric cancer (N = 19) showed that intravenous administration of XMT-1522 every 3 weeks is generally well-tolerated, with no dose-limiting toxicities or serious AEs attributed to the drug. Disease control (1 partial response and 4 stable disease) was achieved in 5 of 6 patients who received doses of 16 mg/m2 or 21.3 mg/m2, including those who had previously progressed on T-DM1.33

ARX788 is composed of a HER2-targeted antibody site-specifically conjugated to Amberstatin269, a cytotoxic tubulin inhibitor.34 An ongoing 2-part, phase 1 study (NCT03255070) is evaluating ARX788 infused every 3 weeks or every 4 weeks in 6 sequential dose escalation cohorts to determine the recommended phase 2 dose in patients with advanced HER2-positive breast or gastric cancer (estimated enrollment = 60).35

According to the 2020 NCCN guidelines, the preferred regimen for systemic treatment for recurrent or metastatic HER2-positive breast cancer is pertuzumab, trastuzumab, and docetaxel or paclitaxel; other multiple other recommended combinations include HER2-targeted therapy with or without cytotoxic agents.18

The stakeholders discussed how patient factors affect their decision-making in the selection and sequencing of therapies for HER2-positive breast cancer. Clinicians generally use the CLEOPATRA regimen (pertuzumab combined with trastuzumab and docetaxel) in the first-line setting. Hamilton said that for most patients without CNS metastasis, she uses T-DM1 in the second-line setting. For those with CNS metastasis, she usually uses tucatinib plus capecitabine followed by trastuzumab deruxtecan if the patients have normal liver function tests and low to moderate disease burden, and uses trastuzumab deruxtecan if the patients have a large disease burden, including pulmonary symptoms. She noted the difficulty of choosing between the tucatinib regimen and trastuzumab deruxtecan for those with CNS metastasis. I definitely am very impressed with the duration of response and the response rate with trastuzumab deruxtecan, but I also temper that with knowing that they had a median of 6 prior lines, so they were really a more heavily pretreated patient population than the tucatinib patients, she said.

Tan said that she generally prefers to give T-DM1 in the second-line setting and has just begun to incorporate trastuzumab deruxtecan as a third-line treatment in her practice. For patients with brain metastases, she previously used a tyrosine kinase inhibitor such as lapatinib; however, with the compelling tucatinib data, she now prefers a trastuzumabcapecitabine-tucatinib regimen for this patient population. She added that the recent approval of tucatinib introduces the question of whether to obtain an MRI of the brain in patients who are asymptomatic. With the availability of [tucatinib], I am now thinking that if I can get it approved, it might be worthwhile to screen and get that MRI of the brain at the point theyre progressingto then help me decide [whether] to use the tucatinib in that setting, said Tan. Schleicher added that clinicians need to communicate to payors about the importance of brain MRI in asymptomatic patients as it relates to selection of systemic therapy. Imaging is really part of the utilization management strategy, and brain MRI in the asymptomatic breast cancer patient is one of the targets, said Schleicher. We might have trouble doing that routinely depending on how much of our practice is in that space.

Denduluri said that she generally prefers T-DM1 in the second-line setting and may also consider this therapy for patients with an isolated brain metastasis, although she would discuss treatment options with the patient and consider the trastuzumab, capecitabine, and tucatinib regimen as well. For patients with several brain metastases, she would consider the trastuzumab, capecitabine, and tucatinib regimen instead of subjecting them to whole-brain radiation. Although she said that use of trastuzumab deruxtecan in the third-line setting is compelling, the transition from T-DM1 in terms of tolerability can come as a shock to many patients in her experience. I would probably use the tucatinib, cape[citabine] and tucatinib independent of brain mets if they progress on T-DM1 before I would DS-8201, knowing that DS-8201 is so active in a heavily pretreated population, she said.

At the end of the interchange, the stakeholders concluded that new ADCs, particularly trastuzumab deruxtecan and SYD985, could address unmet needs in HER2-positive breast cancer, such as HER2-low expressing disease and CNS metastases. They identified improvement in education about the drug-associated toxicities and further studies about potential roles for ADCs in other settings, such as the adjuvant setting, will be key steps moving forward.

1. SEER cancer stat facts: female breast cancer. National Cancer Institute. Bethesda, MD. March 17, 2020. Accessed July 10, 2020. https://seer.cancer.gov/statfacts/html/breast.html

2. Breast cancer facts & figures 2019-2020. American Cancer Society. Accessed July 10, 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancerfacts-and-figures-2019-2020.pdf

3. Schramm A, De Gregorio N, Widschwendter P, Fink V, Huober J. Targeted therapies in HER2-positive breast cancer - a systematic review. Breast Care (Basel). 2015;10(3):173178. doi:10.1159/000431029

4. Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline focused update. J Clin Oncol. 2018;36(20):2105-2122. doi:10.1200/JCO.2018.77.8738

5. Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol. 2020;38(17):1951-1962. doi:10.1200/JCO.19.02488

6. Pestalozzi BC, Holmes E, de Azambuja E, et al. CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). Lancet Oncol. 2013;14(3):244-248. doi:10.1016/S1470-2045(13)70017-2

7. Meric-Bernstam F, Johnson AM, Dumbrava EEI, et al. Advances in HER2-targeted therapy: novel agents and opportunities beyond breast and gastric cancer. Clin Cancer Res. 2019;25(7):2033-2041. doi:10.1158/1078-0432.CCR-18-2275

8. Tukysa. Prescribing information. Seattle Genetics; 2020. Accessed July 16, 2020. https://seagendocs.com/TUKYSA_Full_Ltr_Master.pdf

9. Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med. 2020;382(7):597609. doi:10.1056/NEJMoa1914609. Published correction appears in N Engl J Med. 2020;382(6):586.

10. Saura C, Thistlethwaite F, Banerji U, et al. A phase I expansion cohorts study of SYD985 in heavily pretreated patients with HER2-positive or HER2-low metastatic breast cancer. J Clin Oncol. 2018;36(supp 15):1014-1014. doi:10.1200/JCO.2018.36.15_suppl.1014

11. Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ib study. J Clin Oncol. 2020;38(17):1887-1896. doi:10.1200/JCO.19.02318

12. Jerusalem G, Park YH, Yamashita T, et al. CNS metastases in HER2-positive metastatic breast cancer treated with trastuzumab deruxtecan: DESTINY-Breast01 subgroup analyses. Presented at: 2020 ESMO breast cancer virtual meeting; May 2324, 2020. Abstract 138O.

13. Rinnerthaler G, Gampenrieder SP, Greil R. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer. Int J Mol Sci. 2019;20(5):1115. Published March 5, 2019. doi:10.3390/ijms20051115 Kadclya. Prescribing information. Genetech; 2019. Accessed July 16, 2020. https://www.gene.com/download/pdf/kadcyla_prescribing.pdf

15. Kovtun YV, Audette CA, Ye Y, et al. Antibody-drug conjugates designed to eradicate tumors with homogeneous and heterogeneous expression of the target antigen. Cancer Res. 2006;66(6):3214-3221. doi:10.1158/0008-5472.CAN-05-3973

16. Erickson HK, Park PU, Widdison WC, et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res. 2006;66(8):44264433. doi:10.1158/0008-5472.CAN-05-448

17. Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280-9290. doi:10.1158/0008-5472.CAN-08-1776

18. NCCN. Breast cancer. Version 5.2020. Published July 15, 2020. Accessed July 20, 2020. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

19. Verma S, Miles D, Gianni L. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Eng J Med. 2012;367:1783-1791. doi:10.1056/NEJMoa1209124

20. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617. doi:10.1056/NEJMoa1814017

21. Perez EA, Hurvitz SA, Amler LC, et al. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Breast Cancer Res. 2014;16(3):R50. doi:10.1186/bcr3661

22. Enhertu. Prescribing information. Daiichi Sankyo; 2019. Accessed July 18, 2020. https://dsi.com/prescribing-information-portlet/getPIContent?productName= Enhertu&inline=true

23. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A novel HER2-Targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res. 2016;22(20):50975108. doi:10.1158/1078-0432.CCR-15-2822

24. Ogitani Y, Hagihara K, Oitate M, Naito H, Agatsuma T. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107(7):10391046. doi:10.1111/cas.12966

25. Tamura K, Tsurutani J, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):816-826. doi:10.1016/S1470-2045(19)30097-X. Published correction appears in Lancet Oncol. 2019;(6):e293. doi:10.1016/S1470-2045(19)30292-X

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27. Powell CA, Camidge DR, Gemma A, et al. Characterization, monitoring, and management of interstitial lung disease in patients with metastatic breast cancer: Analysis of data available from multiple studies of DS-8201a, a HER2-targeted antibody drug conjugate with a topoisomerase I inhibitor payload. Poster presented at San Antonio Breast Cancer Symposium; December 48, 2018; Poster #P6-17-06.

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30. Menderes G, Bonazzoli E, Bellone S, et al. SYD985, a novel duocarmycin-based HER2-targeting antibody-drug conjugate, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2/Neu expression. Clin Cancer Res. 2017;23(19):5836-5845. doi:10.1158/1078-0432.CCR-16-2862

31. SYD985 vs. physicians choice in participants with HER2-positive locally advanced or metastatic breast cancer (TULIP). Clinicaltrials.gov. Updated April 2, 2020. Accessed July 20, 2020. https://clinicaltrials.gov/ct2/show/NCT03262935

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Antibody-Drug Conjugates in HER2-Positive Breast Cancer - OncLive

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Not all pregnancy tests are made equally. Here are the ones to avoid.

Waiting for the result of a pregnancy test can be the longest few minutes ever. It may be only two or three minutes - but theyll feel eternal. So when youre waiting for those colorful lines to appear or for the screen to show a smiley face, it helps a lot to know that the test is reliable. False positives and negatives are just too nerve-wracking.

It doesnt matter if the test youre using is digital, manual, a strip test or a plastic one, biodegradable or a blood test - all pregnancy tests rely on a single hormone to detect whether or not a woman is pregnant. Theyre all looking for human chorionic gonadotropin (hCG), only found in the body during pregnancy. The sole job of this hormone is to instruct your body not to shed the uterine lining as it would normally do during menstruation - you'll be needing it.

RELATED:This OB-GYN Practice Is Giving Away Free Pregnancy Tests Amid Pandemic

Even though many home testing brands claim to detect hCG as early as a week after conception, its best to wait a bit longer. According to the Mayo Clinic in the early days of pregnancy, the hCG concentration increases rapidly doubling every two to three days. The earlier you take the home pregnancy test, the harder it might be for the test to detect hCG. Waiting is one way to avoid a false positive or false-negative. In other words, its a good way to be sure the test is in fact accurate.

There are dozens of types of home pregnancytests, and it can be very confusing to choose one. There are digital wands that show the words pregnant or not pregnant or a friendly smiley face, but these are more expensive. Or there are simple paper strips - they dont look fancy, but you can buy them in bulk. Some claim to be biodegradable, some claim to tell you in seconds if youre having a baby.

There are a few things to be aware of when administering the test. First, it turns out that there is a wrong way to pee on a stick even though it sounds straightforward. Doing it wrong can raise the chances of a false result, so make sure not to drink too many fluids right before taking the test and to hold it the right way up. That way you can make sure that your urine isnt too diluted and that the sensitive strip will be exposed to enough hCG to detect its presence.

Next, while digital tests are tempting to buy because they lack ambivalence, they arent necessarily more precise and actually take longer to show results. Its true that theres no hemming and hawing about whether something is or isnt a line, but a recent review from The New York Times showed that digital tests can take up to three minutes while strip tests sometimes show the same results in 30 seconds. So for those who want to minimize holding their breath, they might not be the way to go. Digital tests are really just manual tests with a battery and a sensor that reads the lines for you. writes Leigh Krietsch Boerner in her review for the Times.

The Times reviewed ten types of tests and chose the First Response Early Result and Clearblue Rapid Detection as their favorites for their speed, accuracy and comfortable design.

Not very, but enough that you should always confirm a pregnancy with a physician. Its also a good idea to retake a home test a week after to confirm the results.

Ann Gronowski, PhD, is a Professor of Pathology & Immunology and Obstetrics & Gynecology at Washington University in St. Louis who made waves over the past decade for her research into home pregnancy tests. Her research began after a patient who claimed to be pregnant came into an ER with spotting and cramps but tested negative with the regular urine stick that the doctors used. She was certain she was pregnant, so we performed a blood test and an ultrasound, both of which confirmed she was pregnant, Dr. Gronowski told Futurity.

Two papers published by Dr. Gronowski and her collaborators showed that, of the eleven tests they looked at, seven were somewhat susceptible, two were highly susceptible, with two not being susceptible at all to false results. The worst one gave false negatives in 5 percent of the urine samples of pregnant women tested. That was, unfortunately, the test we were using when that initial patient came in, she said.

The scientists working on this could not divulge the names of the specific brands tested, for reasons of liability. However, since the first paper on this topic was published in 2009, the FDA has addressed the issues that the scientists had raised. However, they didnt change the ruling on previously approved, less precise tests, so its still a concern.

NEXT:Condom & Pregnancy Test Sales Have Risen In Canada During Coronavirus Pandemic

Sources:FDA,Futurity,The New York Times,Mayo Clinic

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Knowing If A Pregnancy Test Brand Is Unreliable | BabyGaga - BabyGaga

Recommendation and review posted by Bethany Smith