Murfreesboro Medical Clinic & SurgiCenter is committed to meeting the needs of Rutherford County's growing community. In addition to adding two new locations in 2019, MMC will be adding five new doctors to its team of physicians.The physicians joining MMC this fall are: Christopher Albergo, M.D. (Endocrinology), Lauren Blackwell, D.O. (Pediatrics), C. Brad Bledsoe, M.D. (Dermatology), Britni Caplin, M.D. (ENT), and Brittany Cook, M.D. (Ophthalmology)."With a national shortage of physicians, it is becoming more and more challenging to find quality physicians to meet the growing healthcare needs of our community," noted Joey Peay, MMC's Chief Executive Officer. "For MMC to find five quality physicians to join us in 2019 in addition to the nine that began practicing at MMC in 2018 is truly remarkable! Each of them will be a valuable member of our medical team and a wonderful member of the Murfreesboro community."Christopher Albergo, M.D. is a board-certified Endocrinologist skilled in general endocrinology, including Hypothyroid, Parathyroid, Thyroid Cancer, Graves' Disease, Pituitary disorders, Adrenal disorders, Hypogonadism , PCOS, Obesity, Diabetes and Osteoporosis. Lauren Blackwell, D.O. is a board-certified Pediatrician skilled in general pediatrics, acute and chronic conditions, as well as routine check-ups and sports physicals for children birth through 18 years of age. Her special interests include ADHD and newborn care. She is also an advocate for breast feeding and enjoys working with moms and newborns to promote successful breast feeding.C. Brad Bledsoe, M.D. is a board-certified Dermatologist skilled in general and surgical dermatology, skin cancer detection, treatment and prevention, precancerous skin lesions (actinic keratoses) and sun damaged skin, acne, rosacea, psoriasis, eczema, dry skin, and other rashes, warts and other viral, bacterial and fungal skin infections, cysts, lipomas, and other nodules, laser procedures, teledermatology and medical technology. Britni Caplin, M.D. is a board-certified Otolaryngologist skilled in adult and pediatric Otolaryngology, Thyroid and Parathyroid Surgery, Otology, Nasal and Sinus Surgery including Balloon Sinuplasty and other In-Office Procedures, and Head and Neck Surgery.

Brittany N. Cook, M.D. is a board-certified Ophthalmologist skilled in Cataract surgery including Refractive Cataract surgery, Toric and Multifocal lens implants, Dry eyes, Blepharitis and Ocular Surface Disease, Refractive surgery including LASIK and PRK, Ocular surface growths including Pterygia, Macular degeneration, Diabetic retinopathy, and Glaucoma.

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Murfreesboro Medical Clinic & SurgiCenter is proud to announce the addition of five new physicians to its practice in 2019 - Wgnsradio

Recommendation and review posted by Bethany Smith

Male hypogonadism is a condition in males wherein the testes depict a significantly reduced functioning level than normal. Reduction in rate of biosynthesis of the male sex hormones consequently results into male hypogonadism, which can vary in terms of severity among individuals. Partial or complete infertility are among major end-results entailing male hypogonadism, which in turn have created the need for effective treatment. XploreMR has published a new comprehensive research report titled, Male Hypogonadism Market: Global Industry Analysis (2012-2016) and Forecast (2017-2026). The report covers present market scenario as well as imparts future growth prospects of the male hypogonadism market for the period between 2017 and 2026. The report also engulfs key drivers, hindrances, opportunities and trends that are affecting expansion of the global male hypogonadism market. The report offers an overall picture of the global male hypogonadism market, in order to help businesses seeking opportunities for making investments in the market.

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The report provides an exhaustive synopsis of the global male hypogonadism market, engulfing an executive summary that elucidates the core trends influencing the market expansion. This chapter also sheds light on impacts that the dynamics are likely to pose on growth of the market in the long run. The report also imparts figures appertaining to CAGRs from a historical and forecast point of view. An overview of the global male hypogonadism market follows the executive summary, and issues a clear picture of the markets scope to the report readers. The overview includes a concise market introduction succeeded by a formal definition of male hypogonadism. Chapters subsequent to the overview elaborates several dynamics including driving factors, limitations and prospects being observed in the market through the forecast period. Meanwhile these chapter also inundate detailed insights related to the bottom line of enterprises, global economy and fiscal stimulus.

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Competition Landscape

This analytical research report on the global male hypogonadism market is a complete package, which includes intelligence on key participants underpinning the market expansion. In the last chapter of the report, which elucidates the competitive scenario of the market, strategies implemented by the market players, along with their product overview, company overview, key financials, key developments and SWOT analysis has been rendered exhaustively. In addition, region-wide spread of these market players, their future expansion plans, market shares, revenues, and mergers & acquisition activities between them have been described in detail in this concluding chapter of the report. An intensity map has been employed in the report to profile the market players situated across geographies.

Research Methodology

Credibility of the researched statistics and data is backed by the unique research methodology employed by the analysts at XMR, which ensures higher accuracy. XMRs research report on the global male hypogonadism market can assist its readers in gaining detailed insights on many different aspects governing the market around key regional segments included in the report. The report readers can further slate key strategies for tapping into vital revenue pockets and gaining benefits over the intensifying competition in the market. Information presented in the report has been scrutinized and monitored thoroughly by XMRs industry experts. Figures and numbers offered in the report have also been validated by the analysts in order to facilitate strategic decision making for the report readers.

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Male Hypogonadism Market To Increase at Steady Growth Rate - Herald Space

Recommendation and review posted by Bethany Smith

The global market for testosterone replacement therapy is characterized by the presence of a large number of small and large scale manufacturers. All of the manufacturers have been steadfast in filling the meagre market gap in order to enhance their prospects of growth. Furthermore, research and development has been the central characteristic of al the market players operating in the global market. In 2015, it was found that 80% of the total market share was held by the top five market vendors with AbbVie Inc. taking the lead.

The large scale vendors are focusing on establishing an iconic brand for their product by resorting to rigorous marketing and advertising tactics. The smaller companies are expected to concentrate on capturing the local and regional markets to sustain themselves in the current scenario of stiff competition. A negative implication for the leading market players in recent times has been the loss of patents for their products. This has not only plundered them of revenues but has also affected the workflow of these companies.

The market players are expected to launch awareness campaigns about testosterone replacement therapies in order to educate and inform the consumers. Hence, the market for testosterone replacement therapies is expected to witness the emergence of several new trends and opportunities over the forthcoming years. Some of the key players in the global testosterone replacement therapy market include Bayer AG, Endo Pharmaceuticals, Inc., Novartis AG, and Allergen plc.

The CAGR for theglobal testosterone replacement therapy marketis estimated to be -4.20% over the period between 2016 and 2024. The negative growth rate of the global market is expected to take the market value from US2.0 bn in 2015 to a decreased value of US$1.3 bn by 2024-end.

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High Incidence of Hypogonadism to Drive Market Demand

Research studies suggest that around 30% of all men suffer from testosterone deficiency, which has driven demand within the global market for testosterone replacement therapy. Furthermore, the population demographic of men in the age range of 40-79 years is more likely to suffer from testosterone deficiency. The need for mutation or having an offspring amongst men in the aforementioned age range has driven demand within the global market.

Moreover, the geriatric population has been on a rise, which underhandedly contributes to market growth. Several campaigns aimed at educating people about the benefits of testosterone replacement therapy have been an important propeller of demand within the global market. It is anticipated that more people suffering from testosterone deficiency would resort to these therapies over the coming years.

Side Effects of Testosterone Replacement Therapy Could Obstruct Market Growth

Despite the rising awareness amongst the masses about the advantages of testosterone replacement therapies, the market growth is hindered by the apprehension of the people. The chances of developing metabolic disorders are higher in men who undergo testosterone replacement therapies. Furthermore, the risk of developing cardiovascular diseases also discourages people from resorting to testosterone replacement therapies. The FDA has also cautioned people about the use of such therapies by issuing strict warnings, which has further obstructed the growth of the global market.

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Testosterone Replacement Therapy Market : Analysis and Opportunity Assessment 2016-2024 - OnYourDesks

Recommendation and review posted by Bethany Smith

Russia Cryonics TechnologyMarket report explains the basic aspects of the industry and market statistics. The recent advances in technology, business plans, policies, possibilities for development and risks to the sector are being developed. The reports two major sections are defined, namely market revenue in (USD Million) and market size. The report examines the Russia Cryonics Technology market considering the export and import numbers along with the current industry chain. The Russia Cryonics Technology market report delivers an unbiased and extensive analysis of the on-going trends, opportunities/ high growth areas, drivers, which would help stakeholders to device and align Business strategies according to the current and future market dynamics. The Russia Cryonics Technology Market Report offers energetic visions to conclude and study the market size, market hopes, an competitive backgrounds. As per the world economic growth rate of the past four years, market size is estimated from xxx million $ in 2015 to xxx million $ in 2018. The Russia Cryonics Technology Market is expected to exceed more than US$ xxx million by 2023 at a CAGR of xx% in the given forecast period.

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The Russia Cryonics Technology Market report contains exhaustive data on the most important factors the growth of the company. The report contains a study on the change in the dynamics of competition. It also delivers specific awareness that helps you choose the right business executions and steps. The Russia Cryonics Technology Market report systematically presents information in the form of organizational charts, facts, diagrams, statistical charts, and figures that represent the state of the relevant trading on the Global and regional platform. Additionally, the report comprises the overall business chain, through which growth rate and decline rate of the specific industry in the market can be analyzed. The total cost spent on manufacturing the product and analysis of its assembling procedure is also described in the report.

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This study presents the Russia Cryonics Technology production, revenue, and market share and growth rate for each key company, and also covers the breakdown data (production, consumption, revenue and market share) by regions, type and applications. History breakdown data from 2014 to 2019, and forecast to 2025. For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2019.

Competitive Analysis:The key players are highly focusing innovation in production technologies to improve efficiency and shelf life. The best long-term growth opportunities for this sector can be captured by ensuring ongoing process improvements and financial flexibility to invest in the optimal strategies. Company profile section of players such asAlcor Life Extension Foundation, Biocision, Cellulis, Cesca Therapeutics, Cryologics, Cryonics Asia Ltd., Cryonics Institute, Cryotherm, GE Healthcare, Humai, Kriorus, Oregon Cryonics, Osiris, Panasonic Biomedical, Praxair Technology, Sigma-Aldrich, Southern Cryonics, Thermo Fisher Scientific, VWRincludes its basic information like legal name, website, headquarters, its market position, historical background and top competitors by Market capitalization / revenue along with contact information. Each player/ manufacturer revenue figures, growth rate and gross profit margin is provided in easy to understand tabular format for past 5 years and a separate section on recent development like mergers, acquisition or any new product/service launch etc.

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Reason to purchase: 1) Global Russia Cryonics Technology Market Outline, Market Size Estimates, Industry Scope, and Division.2) Competitive analysis is specified for eminent Russia Cryonics Technology players, price structures and value of production.3) Focuses on the key Russia Cryonics Technology manufacturers, to study the capacity, production, value, market share and development plans in future.4) Global Russia Cryonics Technology Market Drivers, Opportunities, Emerging Sectors, and Recent Plans and Policies are shown.5) The current status of the global Russia Cryonics Technology Market, current market & the two regional and region level.6) To analyze the opportunities in the market for stakeholders by identifying the high growth segments.

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Russia Cryonics Technology Market Insights Report 2019 2025 : Alcor Life Extension Foundation, Biocision, Cellulis - ScoopJunction

Recommendation and review posted by Bethany Smith

BERKELEY, Calif., Sept. 24, 2019 /PRNewswire/ -- Today, the U.S. Patent and Trademark Office (USPTO) granted a new CRISPR-Cas9 patent to the University of California (UC), University of Vienna, and Dr. Emmanuelle Charpentier, bringing new compositions and methods to the continuously expanding patent portfolio. U.S. Patent 10,421,980 covers compositions of certain DNA-targeting RNAs that contain RNA duplexes of defined lengths that hybridize with Cas9 and target a desired DNA sequence.

The patent also covers methods of targeting and binding a target DNA, modifying a target DNA, or modulating transcription from a target DNA wherein the method comprises contacting a target DNA with a complex that includes a Cas9 protein and a DNA-targeting RNA.

In September, several patents have been issued to UC, increasing its U.S. CRISPR-Cas9 portfolio to 15 patents. In the coming months, based on applications allowed by the USPTO, UC's portfolio will total 18 patents, covering compositions and methods for the CRISPR-Cas9 gene-editing technology, including targeting and editing genes and modulating transcription in any setting, such as within plant, animal, and human cells.

"With every patent that issues, UC strengthens its position as the leader in CRISPR-Cas9 intellectual property in the United States," said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR-Cas9 matters for UC and a Director at Sterne, Kessler, Goldstein & Fox. "We are steadfast in our commitment to developing a comprehensive patent portfolio that protects the groundbreaking work of the Doudna-Charpentier team on CRISPR-Cas9."

The Doudna-Charpentier team that invented the CRISPR-Cas9 DNA-targeting technology included Jennifer Doudna and Martin Jinek at the University of California, Berkeley; Emmanuelle Charpentier (then of Umea University); and Krzysztof Chylinski at the University of Vienna. The compositions and methods covered by today's patent, as well as the other compositions and methods claimed in UC's previously issued patents and those set to issue, were included among the CRISPR-Cas9 gene editing technology work disclosed first by the Doudna-Charpentier team in its May 25, 2012 priority patent application.

Additional CRISPR-Cas9 patents in this team's portfolio include 10,000,772; 10,113,167; 10,227,611; 10,266,850; 10,301,651; 10,308,961; 10,337,029; 10,351,878; 10,358,658; 10,358,659; 10,385,360; 10,400,253; 10,407,697; and 10,415,061. These patents are not a part of the PTAB's recently declared interference between 14 UC patent applications and multiple previously issued Broad Institute patents and one application, which jeopardizes essentially all of the Broad's CRISPR patents involving eukaryotic cells.

International patent offices have also recognized the pioneering innovations of the Doudna-Charpentier team, in addition to the 15 patents granted in the U.S. so far. The European Patent Office (representing more than 30 countries), as well as patent offices in the United Kingdom, China, Japan, Australia, New Zealand, Mexico, and other countries, have issued patents for the use of CRISPR-Cas9 gene editing in all types of cells.

University of California has a long-standing commitment to develop and apply its patented technologies, including CRISPR-Cas9, for the betterment of humankind. Consistent with its open-licensing policies, UC allows nonprofit institutions, including academic institutions, to use the technology for non-commercial educational and research purposes.

In the case of CRISPR-Cas9, UC has also encouraged widespread commercialization of the technology through its exclusive license with Caribou Biosciences, Inc. of Berkeley, California. Caribou has sublicensed this patent family to numerous companies worldwide, including Intellia Therapeutics, Inc. for certain human therapeutic applications. Additionally, Dr. Charpentier has licensed the technology to CRISPR Therapeutics AG and ERS Genomics Limited.

View original content:http://www.prnewswire.com/news-releases/uspto-awards-15th-us-crispr-cas9-patent-to-university-of-california-300923678.html

SOURCE University of California Office of the President

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USPTO awards 15th U.S. CRISPR-Cas9 patent to University of California - P&T Community

Recommendation and review posted by Bethany Smith

Integration of CRISPR-case9 technology to accelerate the discovery of innovative antibiotics

DEINOVE (Euronext Growth Paris: ALDEI), a French biotechnology company that relies on a radical innovation approach to develop innovative antibiotics and bio-sourced active ingredients for cosmetics and nutrition, announces that it has expanded its technological platform with an advanced genetic tool, the CRISPR-cas9 system, to enhance its ability to optimize various microorganisms.

In the last few years, DEINOVE has set up a high throughput genetic engineering platform specifically dedicated to rare microorganisms and thus demonstrated its ability to adapt genetic tools to poorly described organisms. Thus, the exploitation of Deinococci as microbial plants has allowed the large-scale production of pure high value-added compounds such as carotenoids. It should be recalled that Deinococci are extremophilic microorganisms whose biological and molecular specificities have so far been little studied and therefore unexploited.

After developing a platform dedicated to the identification of novel antibiotic structures produced by rare bacteria (AGIR Program), DEINOVE strengthens its expertise in genetic engineering with the integration of a cutting-edge tool, the CRISPR-cas9 technology, known as molecular scissors, which has revolutionized genetic engineering in recent years.

The objective for DEINOVE is to be able to directly manipulate the strains producing antimicrobial activities or to transfer these activities into phylogenetically close frames. This has been successfully achieved by the Company which has made the Streptomyces chassis an effective producer of a pharmaceutical intermediate initially produced by Microbacterium arobescens (proof of concept DNB101/102).

Genome editing occurs at two levels. First, highlights the cluster of genes at the origin of the antibiotic activity of interest. To optimize the spectrum of activity and eliminate any potential cytotoxicity, the structure of a natural molecule can then be modified by directly, finely and precisely editing the genes responsible for this activity.

This technology opens up many opportunities in the identification and optimized production of new antibiotic structures.

"Our expertise in the genetic engineering of a variety of microorganisms, unusual for some, is unique, and the integration of CRISPR-cas9 extends the possibilities of our platform," says Georges GAUDRIAULT, Scientific Director of DEINOVE. "We continue to structure the various technological bricks of the AGIR platform to be able to drastically accelerate the identification and optimization of new antibiotic structures. This technology is an additional asset in our race against the clock in the face of rising antimicrobial resistance."

ABOUT DEINOVE

DEINOVE is a French biotechnology company, a leader in disruptive innovation, which aims to help meet the challenges of antibiotic resistance and the transition to a sustainable production model for the cosmetics and nutrition industries.

DEINOVE has developed a unique and comprehensive expertise in the field of rare bacteria that it can decipher, culture, and optimize to disclose unsuspected possibilities and induce them to produce biobased molecules with activities of interest on an industrial scale. To do so, DEINOVE has been building and documenting since its creation an unparalleled biodiversity bank that it exploits thanks to a unique technological platform in Europe.

DEINOVE is organized around two areas of expertise:

Within the Euromedecine science park located in Montpellier, DEINOVE employs 60 employees, mainly researchers, engineers, and technicians, and has filed more than 350 patent applications internationally. The Company has been listed on EURONEXT GROWTH since April 2010.

CONTACTS

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Integration of CRISPR-case9 technology to accelerate the discovery of innovative antibiotics - Yahoo Finance

Recommendation and review posted by Bethany Smith

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

DEINOVE (Paris:ALDEI) (Euronext Growth Paris: ALDEI), a French biotechnology company that relies on a radical innovation approach to develop innovative antibiotics and bio-sourced active ingredients for cosmetics and nutrition, announces that it has expanded its technological platform with an advanced genetic tool, the CRISPR-cas9 system, to enhance its ability to optimize various microorganisms.

In the last few years, DEINOVE has set up a high throughput genetic engineering platform specifically dedicated to rare microorganisms and thus demonstrated its ability to adapt genetic tools to poorly described organisms. Thus, the exploitation of Deinococci as microbial plants has allowed the large-scale production of pure high value-added compounds such as carotenoids. It should be recalled that Deinococci are extremophilic microorganisms whose biological and molecular specificities have so far been little studied and therefore unexploited.

After developing a platform dedicated to the identification of novel antibiotic structures produced by rare bacteria (AGIR Program), DEINOVE strengthens its expertise in genetic engineering with the integration of a cutting-edge tool, the CRISPR-cas9 technology, known as molecular scissors, which has revolutionized genetic engineering in recent years.

The objective for DEINOVE is to be able to directly manipulate the strains producing antimicrobial activities or to transfer these activities into phylogenetically close frames. This has been successfully achieved by the Company which has made the Streptomyces chassis an effective producer of a pharmaceutical intermediate initially produced by Microbacterium arobescens (proof of concept DNB101/102).

Genome editing occurs at two levels. First, highlights the cluster of genes at the origin of the antibiotic activity of interest. To optimize the spectrum of activity and eliminate any potential cytotoxicity, the structure of a natural molecule can then be modified by directly, finely and precisely editing the genes responsible for this activity.

This technology opens up many opportunities in the identification and optimized production of new antibiotic structures.

"Our expertise in the genetic engineering of a variety of microorganisms, unusual for some, is unique, and the integration of CRISPR-cas9 extends the possibilities of our platform," says Georges GAUDRIAULT, Scientific Director of DEINOVE. "We continue to structure the various technological bricks of the AGIR platform to be able to drastically accelerate the identification and optimization of new antibiotic structures. This technology is an additional asset in our race against the clock in the face of rising antimicrobial resistance."

ABOUT DEINOVE

DEINOVE is a French biotechnology company, a leader in disruptive innovation, which aims to help meet the challenges of antibiotic resistance and the transition to a sustainable production model for the cosmetics and nutrition industries.

DEINOVE has developed a unique and comprehensive expertise in the field of rare bacteria that it can decipher, culture, and optimize to disclose unsuspected possibilities and induce them to produce biobased molecules with activities of interest on an industrial scale. To do so, DEINOVE has been building and documenting since its creation an unparalleled biodiversity bank that it exploits thanks to a unique technological platform in Europe.

DEINOVE is organized around two areas of expertise:

Within the Euromedecine science park located in Montpellier, DEINOVE employs 60 employees, mainly researchers, engineers, and technicians, and has filed more than 350 patent applications internationally. The Company has been listed on EURONEXT GROWTH since April 2010.

Visit http://www.deinove.com

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DEINOVE: Integration of CRISPR-case9 Technology to Accelerate the Discovery of Innovative Antibiotics - Business Wire

Recommendation and review posted by Bethany Smith

A study has shown that CRISPR can be used as a regenerative technique to treat Duchenne muscular dystrophy, which could be developed as a therapeutic option for humans.

Researchers have successfully demonstrated in a mouse model that CRISPR can regenerate muscle suffering from Duchenne muscular dystrophy (DMD). They believe that with more study, their method may be used to treat children with the condition.

The study was led by the University of Missouri School of Medicine, US in collaboration with other researchers. Previous research has shown that children with DMD have a gene mutation that interrupts the production of a protein known as dystrophin.

If we can correct the mutation in muscle stem cells, then cells regenerated from edited stem cells will no longer carry the mutation. A one-time treatment of the muscle stem cells with CRISPR could result in continuous dystrophin expression in regenerated muscle cells, said Dr Dongsheng Duan, Margaret Proctor Mulligan Professor in Medical Research in the Department of Molecular Microbiology and Immunology at the MU School of Medicine and the senior author of the study.

The researchers first delivered the gene editing tools to immune-deficient mouse muscle through a viral vector known as AAV9. They observed that the transplanted muscle died first, then regenerated from its stem cells, which carried the edited gene.

Previous research has shown that children with DMD have a gene mutation that interrupts the production of a protein known as dystrophin

Next, they tested their method in a mouse model of DMD. The stem cells in the diseased muscle were edited and produced dystrophin.

This finding suggests that CRISPR gene editing may provide a method for lifelong correction of the genetic mutation in DMD and potentially other muscle diseases, Duan said. Our research shows that CRISPR can be used to effectively edit the stem cells responsible for muscle regeneration. The ability to treat the stem cells that are responsible for maintaining muscle growth may pave the way for a one-time treatment that can provide a source of gene-edited cells throughout a patients life.

The results were published in Molecular Therapy.

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CRISPR used to treat Duchenne muscular dystrophy in mice - Drug Target Review

Recommendation and review posted by Bethany Smith

The hubris of some scientists knows no bounds. Less than a year after He Jiankui, a Chinese biophysicist, drew scorn and censure for creating gene-edited twins, Denis Rebrikov, a Russian molecular biologist, boldly announced his plan to follow in Hes genome editing footsteps. Rebrikovs initial stated goal for his proposed research was to prevent the transmission of HIV from infected women to their offspring, though he later suggested other targets, including dwarfism, deafness, and blindness.

In 1998, Nobel laureate Mario Capecchi suggested that resistance to HIV infection was a genetic enhancement that might appeal to potential parents. Twenty years later, in November 2018, He revealed his use of CRISPR-Cas9 genome editing technology to disable a gene called CCR5 in an attempt to create children with resistance to HIV.

Hes research activities were known to a number of senior American scientists, all of whom elected to remain silent about his work. It was only after the twins birth that the world learned of this secret science. Matthew Porteus, one of the scientists who was complicit in the silence, summarized his promise of confidentiality to He this way:

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Youre a scientist talking to a scientist. Our culture is that you respect confidentiality and that when people reveal things in confidence to you, you respect that confidence. And I said, well, Im not going to publicly discuss what you just told me because that is for you to publicly discuss.

A groundswell of condemnation followed Hes public announcement of the twins birth. There was pointed criticism from Feng Zhang, one of the co-discoverers of the CRISPR-Cas9 genome editing technology, and from David Baltimore, who co-chaired international summits of human genome editing in 2015 and 2018. Quoting from the first International Summit Statement, Zhang and Baltimore independently affirmed that the experiment was irresponsible given the lack of data confirming the safety and effectiveness of using CRISPR in humans, as well as the absence of broad societal consensus.

Members of the organizing committee for the 2018 International Summit on Human Genome Editing where He first presented some of the details of his research described the experiment as irresponsible and said it failed to meet international norms. The committee did not, however, reaffirm the position outlined in the 2015 Summit Statement that [i]t would be irresponsible to proceed with any clinical use of germline editing unless and until: (i) the relevant safety and efficacy issues have been resolved, based on an appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application. Instead, the committee concluded that heritable genome editing could be acceptable in the future and suggested that it was time to define a rigorous responsible translational pathway toward such trials.

This shift in orientation is particularly noteworthy when considering the following. In 2015, a researcher performed genome editing on non-viable human embryos that did not involve the transfer of edited embryos to a woman for reproduction. The first summit organizing committee determined that heritable genome editing research was irresponsible unless and until In 2018, He performed genome editing on viable human embryos and transferred these edited embryos to a woman who gave birth to gene-edited children, yet the second summit organizing committee asserted the need for a responsible pathway forward.

Several authors of the 2015 Summit Statement, myself included, disagreed with the position taken by the authors of the 2018 Summit Statement. Along with others, including two of the three CRISPR pioneers Emmanuelle Charpentier and Feng Zhang we issued a call in March 2019 to adopt a moratorium on heritable genome editing. Jennifer Doudna, the other CRISPR pioneer, expressly declined to participate in this initiative.

We reiterated the importance of dialogue within and across nations, and the need for broad societal consensus on the appropriateness of altering the human genome for a particular purpose before any such research could proceed. The purpose of the proposed global moratorium was to provide time for careful study of the relevant technical and ethical issues to determine whether to pursue heritable human genome editing and, if that question were answered in the affirmative, to then determine how to proceed with making modifications to the human genome.

The whether of heritable human genome editing has not been resolved, and yet some scientists continue to race ahead with the how of it, essentially ignoring the myriad calls for public consultation. To be sure, other scientists are willing to heed the call, but would prefer to limit public consultation to public education.

I dont agree with this position. As I write in a new book, Altered Inheritance, we need to move the dial from public education (which typically is limited to talking at the public), to public engagement (which necessarily involves listening to the public), and then on to public empowerment (which is about shared decision-making).

To this end, we need slow science. Science needs time to think and to digest. Time is also needed to promote ethics literacy and to facilitate broad societal consensus where the goal is unity, not unanimity. Decision-making by consensus is about engaged, respectful dialogue and deliberation, where all participants recognize at the outset that knowledge is value laden; that we can and should learn from each other; and that no one should impose his or her will on others.

Metaphorically speaking, the human genome belongs to all of us. So we should all have a say in whether to proceed with making heritable changes to our shared genome. Decision-making by consensus, which begins with outreach and openness, is a means to this end. The goal is to create an environment in which all positions (not all persons) can be heard and understood, and in which there are reasonable opportunities for integrity-preserving compromises in pursuit of the common good. The underlying values are inclusivity, responsibility, self-discipline, respect, co-operation, struggle, and benevolence.

Scientists can meaningfully contribute to consensus building around genome editing. As individuals and as committee members, for example, they can effectively serve the common good by helping policymakers, legislators, and members of the public better align scientific information and opportunities with discrete values and interests.

I wrote Altered Inheritance as a call to action. It is a call for scientists to slow down, to reflect deeply on their science and their priorities, and to find meaningful ways to contribute to science policy in pursuit of the common good. It is also a call for all of us to take collective responsibility for the biological and social future of humankind as we think carefully about what kind of world we want to live in, and how genome editing technology might help us build that world.

Franoise Baylis is University Research Professor at Dalhousie University in Halifax, Nova Scotia, and author of Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (Harvard University Press, September 2019).

Link:
Genome editing needs a dose of slow science - STAT

Recommendation and review posted by Bethany Smith

As a growing population and climate change threaten food security, researchers around the world are working to overcome the challenges that threaten the dietary needs of humans and livestock. A pair of scientists is now making the case that the knowledge and tools exist to facilitate the next agricultural revolution we so desperately need.

Cold Spring Harbor Laboratory (CSHL) Professor Zach Lippman, a Howard Hughes Medical Institute investigator, recently teamed up with Yuval Eshed, an expert in plant development at the Weizmann Institute of Science in Israel, to sum up the current and future states of plant science and agriculture.

Their review, published in Science, cities examples from the last 50 years of biological research and highlights the major genetic mutations and modifications that have fueled past agricultural revolutions. Those include tuning a plants flowering signals to adjust yield, creating plants that can tolerate more fertilizer or different climates, and introducing hybrid seeds to enhance growth and resist disease.

Beneficial changes like these were first discovered by chance, but modern genomics has revealed that most of them are rooted in two core hormonal systems: Florigen, which controls flowering; and Gibberrellin, which influences stem height.

Lippman and Eshed suggest that in an age of fast and accurate gene editing, the next revolutions do not need to wait for chance discoveries. Instead, by introducing a wide variety of crops to changes in these core systems, the stage can be set to overcome any number of modern-day challenges.

Dwarfing and flower power revolutions

To explain their point, the scientists reviewed research that focused on key moments in agricultural history, such as the Green Revolution.

Before the 1960s, fertilizing for a large wheat yield would result in the plants growing too tall. Weighed down with their grainy bounty, the wheat stems would fold and rot away, resulting in yield losses. It was only after Nobel laureate Norman Borlaug began working with mutations that affect the Gibberellin system that wheat became the shorter and reliable crop we know today. Borlaugs dwarfing was also applied to rice, helping many fields weather storms that would have been catastrophic only years before. This reapplication of the same technique to a different plant hinted that a core system was in play.

More recent examples Lippman and Eshed mention include the changes undergone by cotton crops in China. There, growers turned the normally sprawling, southern plantation plant into a more compact, faster flowering bush better suited for Chinas northern climate. To do so, they took advantage of a mutation that affects Florigen, which promotes flowering, and its opposite, Antiflorigen.

This kind of change is related to Lippmans works. He often works with tomatoes and explained that an Antiflorigen mutation in tomato was also the catalyst that transformed the Mediterranean vine crop into the stout bushes grown in large-scale agricultural systems throughout the world today. Whats striking, Lippman said, is that cotton is quite unlike any tomato.

Theyre evolutionary very different in terms of the phylogeny of plants. And despite that, what makes a plant go from making leaves to making flowers is the same, he said. That core program is deeply conserved.

Fine-tuning a revolution

As the review details, this has defined what makes an agricultural revolution. A core system either Gibberellin, Florigen, or both is affected by a mutation, resulting in some helpful trait. In a moment of pure serendipity, the plants boasting this trait are then discovered by the right person.

It then takes many more years of painstaking breeding to tweak the intensity of that mutation until it affects the system just right for sustainable agriculture. Its like tuning an instrument to produce the perfect sound.

Lippman and Eshed note that CRISPR gene editing is speeding up that tuning process. However, they show that the best application of gene editing may not be to just tune preexisting revolutionary mutations, but instead, to identify or introduce new ones.

If past tuning has been creating genetic variation around those two core systems, maybe we can make more variety within those systems, he said. It would certainly mitigate the amount of effort required for doing that tuning, and has the potential for some surprises that could further boost crop productivity, or adapt crops faster to new conditions.

A future in chickpeas?

More of that genetic variety could also set the stage for new agricultural revolutions. By introducing genetic variation to those two core systems that define most revolutions, farmers might get to skip the serendipitous waiting game. Chickpea is one example.

Theres a lot more room for us to be able to create more genetic diversity that might increase productivity and improve adaptation survival in marginal grounds, like in drought conditions, Lippman said.

Drought resistance is just one benefit of under-utilized crops. Past revolutions have allowed crops to be more fruitful or to grow in entirely new hemispheres. Having a means to continue these revolutions with more crops and at a greater frequency would be a boon in a crowded, hungry, and urbanizing world.

Given that rare mutations of Florigen/Antiflorigen and Gibberellin/DELLA mutations spawned multiple revolutions in the past, it is highly likely that creating novel diversity in these two hormone systems will further unleash agricultural benefits, the scientists wrote.

Original article: The next agricultural revolution is here

More:
CRISPR gene editing poised to streamline next 'agricultural revolution,' plant scientists say - Genetic Literacy Project

Recommendation and review posted by Bethany Smith

Organic grower groups on Sept. 17 wrote they are strongly opposed to opening a formal dialogue about allowing gene-editing in organic agriculture.

A letter from the Organic Farmers Association (OFA), was signed by 79 organic farm organizations and sent to Secretary Sonny Perdue and other top officials and lawmakers.

Introducing any dialogue about any form of genetic engineering into organics would be a major distraction for the USDA NOP and the National Organic Standards Board, Kate Mendenhall, director of OFA, said in a press release. We have crucial issues in organic agriculture that need the Departments full attention, such as stopping organic import fraud, closing certification loopholes, enforcing our current organic standards equitably and uniformly, and updating obsolete database technology.

Gene editing and all other forms of genetic engineering are currently prohibited under the guidelines of organic certification. The letter came in response to an earlier statement by Department Undersecretary Greg Ibach concerning opening a dialogue about gene-editing in organic agriculture.

Read full, original article: Organic growers: Gene-editing dialogue a bad idea

The rest is here:
Organic Farmers Association rejects USDA offer to discuss benefits of CRISPR gene editing - Genetic Literacy Project

Recommendation and review posted by Bethany Smith

Geneticengineering. I realize that this topic has been beaten to death in popularculture, but I dont think the focus has been on the actual technologyreallyonly the flashy outcomes for lay people. I can understand the need to simplifyand sensationalize for entertainment, but decoupling the effects from the causeis, at best, ignorant and, at worst, misleading.

The reason that genetic engineering is populartoday is largely because of the discovery of CRISPR. But its important to notethat the field itself is not new; nearly all commercial forms of insulin arefrom genetically engineered bacteria.

Prior to Clustered Regularly InterspacedShort Palindromic Repeats (CRISPR), technologies like Zinc Finger Nucleases(ZFNs) were somewhat random. While it was likely that the gene you wanted tomanipulate would be inserted into a specific location, it was unclear where inthe hosts DNA it would end up. Far more often than not, the gene would end upeither in the middle of another host gene (likely lethal) or end up in thejunkyard of the host genome, which is effectively useless. Both problemseffectively made genetic engineering on humans far too risky.

The introduction of CRISPR, however, hascompletely changed the field.

CRISPR works similarly to ZFNs, exceptthat it has a very specific targeting domain so that the genes almost alwaysend up in the location that you want them to. While there are still minor kinksto correct, the technique will likely be perfected within this decade. Whilethis technique is no doubt one of the finest inventions in the field ofbiology, even the person that discovered it, Dr. Jennifer Doudna, is callingfor the halting of research in the field until bioethics has a chance to catchup.

The terms designer babies and genedrive are very common buzzwords; however, they genuinely do present ethicalchallenges for us a species. For example, most people wouldnt have a problemusing CRISPR to eradicate debilitating genetic conditions or destroying theability of insect-carried diseases to infect people.

The problem arises when we begin toconsider what counts as pathology, there is an argument that variation fromsocietal, social or biological normality makes people unique. Surely somethinglike schizophrenia or leukemia is morally permissible to eradicate, but whatabout autism, homosexuality or intersexuality?Its a relatively short slippery slope before you end up at eugenics.

Another cause for concern is theecological impact of transgenics. Using the CRISPR based Gene Drive construct,you can force all offspring of a transgenic organism to carry your gene andtheir offspring, and then their offspring. This is ideal in a lab; however, ifa single individual is accidentally released into the environment, it could easilydamage genetic diversity, and permanently disturb the careful equilibrium of anecosystem.

There are instances in which not usingcheap, readily available technology like CRISPR to cure or prevent diseases maybe unethical. For example, the technology to destroy the means by which malariaspreads already exists. Is it really ethical to allow a disease that affectsover 200 million people a year (90% of whom are children) to exist? Are therelimits that we shouldnt cross? Until we have those discussions and draw thelines, research in genetic engineering is effectively playing with fire,analogous to research in nuclear fission during the Cold War.

Like a thermonuclear bomb, releasingCRISPR technology into the world, whether using it for humans or other animals,is not an action that we can reverse, and its results could be equallycatastrophic to life on earth.

These discussions arent entirelyhypothetical by the way; the first genetically modified human babies were bornin China last year.

To clarify, I am not against progress inCRISPR research. I am a huge fan of the technology and I believe it can be aninvaluable resource to improve the world. However, as a student in this field,I am concerned with the ramifications of this techology, enough that it givesme pause. The public discussion surrounding genetic engineering and legislationdesperately needs to catch up to the science.

See the rest here:
Genetic engineering and the end of the world - The Medium

Recommendation and review posted by Bethany Smith

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Global Gene Editing Tools Market 2019 Growth Analysis Thermofisher Scientific, CRISPR Therapeutics, Editas Medicine, NHGRI, Intellia Therapeutics -...

Recommendation and review posted by Bethany Smith

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Caribou Biosciences, Integrated DNA Technologies (IDT), CRISPR Therapeutics, Merck, Mirus Bio, Editas Medicine, Takara Bio, Thermo Fisher Scientific, Horizon Discovery Group, Intellia Therapeutics, Agilent Technologies, Cellecta, GenScript, GeneCopoeia, Synthego

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Genome Editing, Genetic engineering, gRNA Database/Gene Librar, CRISPR Plasmid, Human Stem Cells, Genetically Modified Organisms/Crops, Cell Line Engineering

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CRISPR Cas9 Market Outlook -Industry Growth Factors, Market Revenue and More - Stock Market Pioneer

Recommendation and review posted by Bethany Smith

The hubris of some scientists knows no bounds. Less than a year after He Jiankui, a Chinese biophysicist, drew scorn and censure for creating gene-edited twins, Denis Rebrikov, a Russian molecular biologist, boldly announced his plan to follow in Hes genome editing footsteps. Rebrikovs initial stated goal for his proposed research was to prevent the transmission of HIV from infected women to their offspring, though he later suggested other targets, including dwarfism, deafness, and blindness.

In 1998, Nobel laureate Mario Capecchi suggested that resistance to HIV infection was a genetic enhancement that might appeal to potential parents. Twenty years later, in November 2018, He revealed his use of CRISPR-Cas9 genome editing technology to disable a gene called CCR5 in an attempt to create children with resistance to HIV.

Hes research activities were known to a number of senior American scientists, all of whom elected to remain silent about his work. It was only after the twins birth that the world learned of this secret science. Matthew Porteus, one of the scientists who was complicit in the silence, summarized his promise of confidentiality to He this way:

Youre a scientist talking to a scientist. Our culture is that you respect confidentiality and that when people reveal things in confidence to you, you respect that confidence. And I said, well, Im not going to publicly discuss what you just told me because that is for you to publicly discuss.

Read more: He Jiankui tried to protect CRISPR babies against HIV. But his attempted fix shortens lives, study shows

A groundswell of condemnation followed Hes public announcement of the twins birth. There was pointed criticism from Feng Zhang, one of the co-discoverers of the CRISPR-Cas9 genome editing technology, and from David Baltimore, who co-chaired international summits of human genome editing in 2015 and 2018. Quoting from the first International Summit Statement, Zhang and Baltimore independently affirmed that the experiment was irresponsible given the lack of data confirming the safety and effectiveness of using CRISPR in humans, as well as the absence of broad societal consensus.

Members of the organizing committee for the 2018 International Summit on Human Genome Editing where He first presented some of the details of his research described the experiment as irresponsible and said it failed to meet international norms. The committee did not, however, reaffirm the position outlined in the 2015 Summit Statement that [i]t would be irresponsible to proceed with any clinical use of germline editing unless and until: (i) the relevant safety and efficacy issues have been resolved, based on an appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application. Instead, the committee concluded that heritable genome editing could be acceptable in the future and suggested that it was time to define a rigorous responsible translational pathway toward such trials.

Story continues

This shift in orientation is particularly noteworthy when considering the following. In 2015, a researcher performed genome editing on non-viable human embryos that did not involve the transfer of edited embryos to a woman for reproduction. The first summit organizing committee determined that heritable genome editing research was irresponsible unless and until In 2018, He performed genome editing on viable human embryos and transferred these edited embryos to a woman who gave birth to gene-edited children, yet the second summit organizing committee asserted the need for a responsible pathway forward.

Several authors of the 2015 Summit Statement, myself included, disagreed with the position taken by the authors of the 2018 Summit Statement. Along with others, including two of the three CRISPR pioneers Emmanuelle Charpentier and Feng Zhang we issued a call in March 2019 to adopt a moratorium on heritable genome editing. Jennifer Doudna, the other CRISPR pioneer, expressly declined to participate in this initiative.

Read more: The CRISPR shocker: How genome-editing scientist He Jiankui rose from obscurity to stun the world

We reiterated the importance of dialogue within and across nations, and the need for broad societal consensus on the appropriateness of altering the human genome for a particular purpose before any such research could proceed. The purpose of the proposed global moratorium was to provide time for careful study of the relevant technical and ethical issues to determine whether to pursue heritable human genome editing and, if that question were answered in the affirmative, to then determine how to proceed with making modifications to the human genome.

The whether of heritable human genome editing has not been resolved, and yet some scientists continue to race ahead with the how of it, essentially ignoring the myriad calls for public consultation. To be sure, other scientists are willing to heed the call, but would prefer to limit public consultation to public education.

I dont agree with this position. As I write in a new book, Altered Inheritance, we need to move the dial from public education (which typically is limited to talking at the public), to public engagement (which necessarily involves listening to the public), and then on to public empowerment (which is about shared decision-making).

To this end, we need slow science. Science needs time to think and to digest. Time is also needed to promote ethics literacy and to facilitate broad societal consensus where the goal is unity, not unanimity. Decision-making by consensus is about engaged, respectful dialogue and deliberation, where all participants recognize at the outset that knowledge is value laden; that we can and should learn from each other; and that no one should impose his or her will on others.

Read more: Could editing the DNA of embryos with CRISPR help save people who are already alive?

Metaphorically speaking, the human genome belongs to all of us. So we should all have a say in whether to proceed with making heritable changes to our shared genome. Decision-making by consensus, which begins with outreach and openness, is a means to this end. The goal is to create an environment in which all positions (not all persons) can be heard and understood, and in which there are reasonable opportunities for integrity-preserving compromises in pursuit of the common good. The underlying values are inclusivity, responsibility, self-discipline, respect, co-operation, struggle, and benevolence.

Scientists can meaningfully contribute to consensus building around genome editing. As individuals and as committee members, for example, they can effectively serve the common good by helping policymakers, legislators, and members of the public better align scientific information and opportunities with discrete values and interests.

I wrote Altered Inheritance as a call to action. It is a call for scientists to slow down, to reflect deeply on their science and their priorities, and to find meaningful ways to contribute to science policy in pursuit of the common good. It is also a call for all of us to take collective responsibility for the biological and social future of humankind as we think carefully about what kind of world we want to live in, and how genome editing technology might help us build that world.

Franoise Baylis is University Research Professor at Dalhousie University in Halifax, Nova Scotia, and author of Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (Harvard University Press, September 2019).

Read more:
Opinion: Before heritable genome editing, we need slow science and dialogue within and across nations - Yahoo News

Recommendation and review posted by Bethany Smith

The Global CRISPR and Cas Genes Market Research Report Forecast 2019-2028: The research study has been prepared with the use of in-depth qualitative and quantitative analyses of the global CRISPR and Cas Genes Market. The report offers a complete and intelligent analysis of the competition, segmentation, dynamics, and geographical advancement of the Global CRISPR and Cas Genes Market. It takes into account the CAGR, value, volume, revenue, production, consumption, sales, Manufacturing cost, prices, and other key factors related to the global CRISPR and Cas Genes Market.

The report helps the companies to better understand the CRISPR and Cas Genesmarket trends and to grasp opportunities and articulate critical business strategies. Also includes company profiles of market top companies like (contact information, product details, gross capacity, price, cost and more) are covered. this study of top companies in the market have been identified through secondary research, and their shares have been determined through primary and secondary research. and All percentage shares split, and breakdowns have been determined using secondary sources and verified primary sources.

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Key Players of the Global CRISPR and Cas Genes Market:

Addgene Inc, AstraZeneca Plc., Bio-Rad Laboratories Inc, Caribou Biosciences Inc, Cellectis S.A., Cibus Global Ltd, CRISPR Therapeutics AG, Editas Medicine Inc, eGenesis Bio, GE Healthcare, GenScript Corporation

Market Segmentation:

Segmentation on the basis of product:

Vector-based CasDNA-free CasSegmentation on the basis of application:

Genome EngineeringDisease ModelsFunctional GenomicsKnockdown/ActivationSegmentation on the basis of end user:

Biotechnology & Pharmaceutical CompaniesAcademic & Government Research InstitutesContract Research Organizations

Market Segment by Regions, regional analysis covers 2019-2028:

United States, Canada, and Mexico: North America

Germany, France, UK, Russia, and Italy: Europe

China, Japan, Korea, India, and Southeast Asia: Asia-Pacific

Brazil, Argentina, Colombia, etc.: South America

Saudi Arabia, UAE, Egypt, Nigeria, and South Africa: Middle East and Africa

Have Any Query Or Specific Requirement? Ask Our Industry Expertshttps://marketresearch.biz/report/crispr-and-cas-genes-market/#inquiry

Table of Content:

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

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

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

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

Application or End User: This section of the research study shows how different end-user/application segments contribute to the global CRISPR and Cas Genes Market.

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

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

Appendix: Here, we have provided a disclaimer, our data sources, data triangulation, research programs, market breakdown and design, and our research approach.

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Global CRISPR and Cas Genes Market 2019 | Detailed Overview of the Market with Current and Future Industry Challenges and Opportunities - Stock Market...

Recommendation and review posted by Bethany Smith

DARPA Safe Genes concept

WASHINGTON: If you talk with senior defense officials there is one threat they will acknowledge is at the top of their list but they rarely discuss in public biological weapons. NowDARPA wants to develop defenses against biologically engineered threats before they are ever unleashed, the agencys director made clear this morning. That includes proactively editing troops DNA to produce a wide array of antibodies and biochemically blocking hostile attempts to edit DNA.

Our focus is about the protection aspect and the restoration, versus enhancement, Steven Walker said when I asked him about human augmentation during a CSIS conference. All these technologies, theyre dual use. You can use them for good; you can use them for evil and DARPA is about using them for good, to protect our warfighters.

Steven Walker

Super Immunity

That doesnt mean the US military has forsworn the genetic editing of human beings. To the contrary, Walker is very interested in ways to enhance the immune system, effectively turning the body into its own pharmaceutical factory.

Can you actually protect a soldier on the battlefield from chemical weapons and biological weapons by controlling their genome, [by] having the genome produce proteins that would protect the soldier from the inside out? he asked.

Well, why not just brew the necessary vaccines, anti-viral treatments, and anti-toxins in a normal factory and issue them as needed to the troops? Thats how weve dealt with naturally occurring diseases. And DARPA is working on that too, Walker said, with a program to build a vaccine in 60 days or less for 20,000 people for a virus youve never seen before.

The problem is that developing, producing, stockpiling, and dispensing one treatment at a time even in just 60 days may not work fast enough against future bioweapons. As soon as you develop a defense against one form of artificial plague, the enemy can use gene-editing tools to create a different version, one whose biochemical structure is just different enough that the old antibodies dont recognize it anymore.

Many diseases naturally mutate this way all the time. Thats why you can get a series of shots in childhood that protect you against measles or chicken pox for the rest of your life, but you need a new flu shot every year to stop the latest strain and no ones figured out how to stop the common cold. The so-called Spanish Flu of 1918-19 killed more people than World War I; imagine that as a weapon.

To have a shot available for every case that might be out there is becoming more and more intractable, because [of] synthetic biology and the ability of folks anywhere in the world to make something thats slightly different, Walker said. You cant stockpile enough of the vaccine or the antivirus capability to protect the population against that in the future.

Schematic of how CASPR Cas9 gene editing works

Undoing the Edit

DARPA is also looking at neutralizing or even reversing the effects of CRISPR Cas9 itself, the enzyme that made todays breakthroughs in gene-editing possible in the first place. (Its worth noting that China is now a leading country in gene editing science and its technology.)

How do we reverse it [genetic editing] if it gets out into the wild and gets out of control? Thats what the Safe Genes program is all about, Walker said. Weve actually made a lot of progress there in being able to control gene edits.

Walker didnt go into specifics, but theres plenty of non-military work in this area as well. Its even led by some of the pioneers of gene editing themselves, who understandably would like a way to undo the effects if one of their experiments goes wrong.

The irony of gene editing is that the crucial tool wasnt invented from scratch in the lab: It was found in nature. Many bacteria use CRISPR a whole complex of DNA sequences as a natural defense against invading viruses, allowing them to recognize the viral DNA as a foreign body and then use the Cas9 protein to cut it apart, killing the virus. (Though technically viruses arent living things in the first place). Scientists repurposed CRISPR Cas9 to snip apart and reorganize genes.

It turns out that, over millions of years of evolution, some viruses have developed an immunity to CRISP Cas9. They use so-called Anti-CRSPR proteins that shut down the enzyme so it cant start slicing DNA which would stop gene editing dead.

Lisa Porter

Benign Biotech

There are many more benign applications for biotechnology, said Walkers boss, Lisa Porter, the deputy under secretary of defense for research & engineering.

When we think biotech in DoD, we think chem/bio defense, and thats an element of the problem but theres also a lot of opportunity space that people dont necessarily realize unless they talk to the biologists, Porter told the CSIS conference. [So] we will be focusing, not just on the traditional tenets of biotech that we always do, but well be expanding into, what are the opportunities for new materials, new applications?

One biotech project she offered as an example is developing new materials to rapidly lay down new runways. Thats a matter of intense interest to the Air Force, which is increasingly worried its big central bases are easy targets for long-range missiles and wants new ways to either repair them or create alternative sites in a hurry.

What about human augmentation (boosted humans)? That gets a lot of concern and media attention, Porter said and quite rightly: You read about what China is doing and we should be concerned, because they dont have the same set of moral and ethical norms that we have in our country. (DARPA is careful to note in many of the web pages outlining genetic and related work that they work closely with recognized ethicists to ensure they are not crossing lines that should not be crossed.)

Porter, like Walker, did not mention any American plans to biologically enhance our own troops. But there are DARPA efforts that could, in the fast-changing world of biotech, lead to smarter, faster healing and stronger humans. Or try to stop what other countries have done to their troops.

Originally posted here:
DoD On Biotech: Build Sound Defenses First Breaking Defense - Defense industry news, analysis and commentary - Breaking Defense

Recommendation and review posted by Bethany Smith

Dear Doctor,

My period usually lasts longer than a week, however, this month, it has gone beyond that. I have had it for over two weeks now and the bleeding is heavier than usual. This is accompanied by dizziness and nausea. Is this something I should worry about?

Lyna

Dear Lyna,

What is your age currently? A woman having normal regular menstrual cycles previously can have irregular cycles around menopause. This happens because the balance of hormones governing the menstrual cycles changes at this age. Actual cessation of menses occurs some time later around 50 years of age, some years sooner or later. But the changes start from around 40 years or so. This is manifested in the form of irregular periods with scanty or prolonged and heavy bleeding.

Though this change in menstrual cycles is normal, if recurrent or persistent, it is a cause for concern.

Excess bleeding due to menopause is diagnosed clinically and by investigations to exclude other causes of prolonged bleeding. Treatment is by hormonal therapy. But at this age, it is necessary to weigh the advantage of hormonal therapy, versus the potential harm caused due to its side effects like clotting, hypertension, heart problems, and et cetera. Iron supplements are given if anaemia occurs. In severe cases, the uterus is removed surgically.

Heavy and or prolonged bleeding can be due to uterine fibroids. Fibroid is benign tumour that develops in the inner lining of uterus and can be small or big in size, single or multiple in number. Apart from heavy and or prolonged menstrual bleeding, they can cause lower abdominal pain, discomfort and backache. Fibroids are easily diagnosed by ultrasound. Treatment is by hormones or surgery.

Excess and or prolonged bleeding during menses can be due to other hormonal disorders. Hyperthyroidism, i.e. excess amount of hormones released by thyroid gland is one of them. This can occur at any age. Other manifestations of hyperthyroidism like excess sweating, tremulousness of hands, increased appetite, altered bowel movements, to mention a few, may be present or absent, along with excess menstrual bleeding. Hyperthyroidism is easily diagnosed by a simple blood test and is treatable. Hypopituitarism, adrenal gland disorders are other endocrine ailments, which can cause prolonged menstrual bleeding. These disorders are also easily diagnosed and are treatable.

Excess menstrual bleeding can be a side effect of anti-clotting drugs like aspirin and clopidrogel. Some women may develop it as a manifestation of inherent bleeding disorders.

Heavy and or prolonged bleeding mostly results in chronic anaemia, i.e., deficiency of necessary amount of haemoglobin (component of blood that carries oxygen to the body cells). This manifests as early fatigue, joint pain, palpitations and breathlessness on exertion. Over time, chronic anaemia puts strain over the heart resulting in heart failure. This is prevented by treating heavy bleeding during periods. Treatment depends on the cause.

Dr. Rachna Pande is a specialist in internal medicine.

More here:
What causes prolonged menstrual bleeding? - The New Times

Recommendation and review posted by Bethany Smith

ROCKLAND, MA and NEW YORK, US, September 20, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The opinion was based on positive findings from the Phase III JAVELIN Renal 101 study, which demonstrated a significant extension in median progression-free survival (PFS) and a clinically meaningful improvement in objective response rate (ORR) for the combination across all prognostic risk groups compared with sunitinib.1 The CHMP positive opinion will be reviewed by the European Commission (EC), with a decision anticipated in the fourth quarter of this year. EMD Serono and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.

"Today's positive CHMP opinion is a significant step toward potentially transforming the treatment landscape and bringing much needed options to people living with advanced renal cell carcinoma in Europe. We believe that the combination of BAVENCIO plus axitinib has the potential to help address a significant need for patients with advanced renal cell carcinoma for first-line treatments with a benefit across all prognostic risk groups, and we look forward to a decision from the European Commission," said Luciano Rossetti, Head of Global R&D for EMD Serono.

In 2018, an estimated 136,500 new cases of kidney cancer were diagnosed in Europe, and approximately 54,700 people died from the disease.2 RCC is the most common form of kidney cancer, accounting for about 3% of all cancers in adults.2 Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.3,4 About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy,5,6for reasons that may include poor performance status oradverse events from their initial treatment.5,7,8The five-year survival rate for patients with metastatic RCC is approximately 12%.9

"Kidney cancer represents a significant burden in Europe, where incidence rates are among the highest in the world," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Pfizer has been a leader in the development of kidney cancer treatments for more than a decade, and it is a privilege to continue our efforts to bring a new treatment option to this community."

The U.S. Food and Drug Administration (FDA) approved BAVENCIO in combination with axitinib for the first-line treatment of patients with advanced RCC in May 2019.10 Asupplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted inJapanin January 2019.

About the JAVELIN Renal 101 Study

The Phase III JAVELIN Renal 101 study is a randomized, multicenter, open-label study of BAVENCIO in combination with axitinib in 886 patients with untreated advanced or metastatic RCC. The major efficacy outcome measures were PFSas assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumors (PDL1 expression level 1%). If PFS was statistically significant in patients with PD-L1-positive tumors, it was then tested in all patients irrespective of PD-L1 expression. PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PDL1 expression, objective response, time to response (TTR), duration of response (DOR) and safety are included as secondary endpoints. The study is continuing for OS.

About the JAVELIN Clinical Development Program

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 10,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include gastric/gastro-esophageal junction cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer and urothelial carcinoma.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.11-13 BAVENCIO has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.13-15 In November 2014, EMD Serono and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indication in the US

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

Axitinib Important Safety Information from the US FDA-Approved Label

Hypertension including hypertensive crisis has been observed with axitinib. Blood pressure should be well controlled prior to initiating axitinib. Monitor for hypertension and treat as needed. For persistent hypertension, despite use of antihypertensive medications, reduce the dose. Discontinue axitinib if hypertension is severe and persistent despite use of antihypertensive therapy and dose reduction of axitinib, and discontinuation should be considered if there is evidence of hypertensive crisis.

Arterial and venous thrombotic events have been observed with axitinib and can be fatal. Use with caution in patients who are at increased risk or who have a history of these events.

Hemorrhagic events, including fatal events, have been reported with axitinib. Axitinib has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.

Cardiac failure has been observed with axitinib and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with axitinib. Management of cardiac failure may require permanent discontinuation of axitinib.

Gastrointestinal perforation and fistula, including death, have occurred with axitinib. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.

Hypothyroidism requiring thyroid hormone replacement has been reported with axitinib. Monitor thyroid function before initiation of, and periodically throughout, treatment.

No formal studies of the effect of axitinib on wound healing have been conducted. Stop axitinib at least 24 hours prior to scheduled surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed with axitinib. If signs or symptoms occur, permanently discontinue treatment.

Proteinuria has been observed with axitinib. Monitor for proteinuria before initiation of, and periodically throughout, treatment with axitinib. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment.

Liver enzyme elevation has been observed during treatment with axitinib. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment.

For patients with moderate hepatic impairment, the starting dose should be decreased. Axitinib has not been studied in patients with severe hepatic impairment.

Axitinib can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception during treatment.

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided.

Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.

Please see full Prescribing Information for axitinib.

ADVERSE REACTIONS (BAVENCIO + AXITINIB)

Fatal adverse reactionsoccurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions(all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib(vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities(all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib(vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

The most common adverse reactions (all grades, 20%)in patients with advanced RCC receiving BAVENCIO in combination with axitinib(vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades,20%)worsening from baselinein patients with advanced RCC receiving BAVENCIO in combination with axitinib(vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

About Merck KGaA, Darmstadt, Germany-Pfizer Alliance

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germanyand Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germanyand Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany, in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2018, Merck KGaA, Darmstadt, Germany, generated sales of 14.8 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com.In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of September 20, 2019. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including a potential new indication in the European Union for BAVENCIO in combination with axitinib for the treatment of patients with advanced renal cell carcinoma, the alliance between MerckKGaA, Darmstadt, Germany, and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO and axitinib; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data and uncertainties regarding whether the other primary endpoint of JAVELIN Renal 101 will be met; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and whenany drug applications may be filed for BAVENCIO in combination with axitinib in any other jurisdictions or in any jurisdictions for any other potential indications for BAVENCIO or combination therapies; whether and when the pending applications in the European Union and Japan for BAVENCIO in combination with axitinib may be approved and whether and when regulatory authorities in any jurisdictions where any other applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO in combination with axitinib may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO or combination therapies, including BAVENCIO in combination with axitinib; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

References

Your Contacts EMD Serono Inc. Media Gangolf Schrimpf +49 6151 72 9591 Investor Relations +49 6151 72 3321

Pfizer Inc., New York, USA Media Jessica Smith +1 212 733 6213 Investor Relations Ryan Crowe +1 212 733 8160

SOURCE EMD Serono

Excerpt from:
CHMP Adopts Positive Opinion for BAVENCIO (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma -...

Recommendation and review posted by Bethany Smith

Presentations of interest include a late-breaking abstract on expanded Phase 3 data in BRAF-mutant metastatic colorectal cancer

Pfizer Inc. (NYSE:PFE) is presenting data across its industry-leading oncology portfolio, including company-sponsored and collaborative research studies, spanning 11 therapies in 22 types of cancer, at the European Society for Medical Oncology (ESMO) Congress to be held in Barcelona, Spain, September 27 - October 1, 2019. Data from nearly 50 abstracts involving Pfizer cancer medicines will illustrate the diversity of the portfolio and the companys cutting-edge scientific approach. For the first time, this will include data presentations on compounds from the acquisition of Array Biopharma Inc.

At this years ESMO Congress, were looking forward to showcasing how were embodying ESMOs theme of translating science into better patient care, said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. Whether its studying patient populations such as those affected by BRAF-mutant metastatic colorectal cancer who are in need of new treatment options, utilizing new techniques like real-world evidence to understand further the impact of our medicines in the non-clinical trial setting, or studying a different way to administer a treatment that may be more convenient for patients, Pfizer is leading the way in taking innovative approaches to meeting the needs of people living with cancer.

Clinical data can be complex and often difficult to understand if a person is not a scientist. To help interested non-scientists better understand the latest research, Pfizer developed summaries in non-technical language for research results being presented at this years ESMO Congress. These informational materials, called abstract plain language summaries (APLS), will be made available for non-scientists to learn more about Pfizers latest scientific developments.

Key Pfizer-sponsored abstracts leveraging the depth of Pfizers scientific advances include:

Details for key Pfizer-sponsored oral presentations, poster discussions and poster presentations are below:

In Europe, BAVENCIO (avelumab)is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

BAVENCIO Important Safety Information from the U.S. FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

Please see full U.S. Prescribing Information and Medication Guide for BAVENCIO available at http://www.Bavencio.com.

About INLYTA (axitinib)

In Europe, INLYTA (axitinib) is indicated for the treatment of adult patients with advanced renal-cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

In the U.S., INLYTA is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

INLYTA Important Safety Information from the U.S. FDA-Approved Label

Hypertension including hypertensive crisis has been observed with axitinib. Blood pressure should be well controlled prior to initiating axitinib. Monitor for hypertension and treat as needed. For persistent hypertension, despite use of antihypertensive medications, reduce the dose. Discontinue axitinib if hypertension is severe and persistent despite use of antihypertensive therapy and dose reduction of axitinib, and discontinuation should be considered if there is evidence of hypertensive crisis.

Arterial and venous thrombotic events have been observed with axitinib and can be fatal. Use with caution in patients who are at increased risk or who have a history of these events.

Hemorrhagic events, including fatal events, have been reported with axitinib. Axitinib has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.

Cardiac failure has been observed with axitinib and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with axitinib. Management of cardiac failure may require permanent discontinuation of axitinib.

Gastrointestinal perforation and fistula, including death, have occurred with axitinib. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.

Hypothyroidism requiring thyroid hormone replacement has been reported with axitinib. Monitor thyroid function before initiation of, and periodically throughout, treatment.

No formal studies of the effect of axitinib on wound healing have been conducted. Stop axitinib at least 24 hours prior to scheduled surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed with axitinib. If signs or symptoms occur, permanently discontinue treatment.

Proteinuria has been observed with axitinib. Monitor for proteinuria before initiation of, and periodically throughout, treatment with axitinib. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment.

Liver enzyme elevation has been observed during treatment with axitinib. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment.

For patients with moderate hepatic impairment, the starting dose should be decreased. axitinib has not been studied in patients with severe hepatic impairment.

Axitinib can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception during treatment.

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided.

Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.

Please see full U.S. Prescribing Information for INLYTA at http://www.Inlyta.com.

About IBRANCE (palbociclib)

In Europe, IBRANCE (palbociclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone agonist.

In the U.S., IBRANCE (palbociclib) 125 mg capsules is indicated for the treatment of adult patients with HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or fulvestrant in patients with disease progression following endocrine therapy.

IBRANCE Important Safety Information from the U.S. FDA-Approved Label

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade 3 adverse reactions (5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade 3 adverse reactions (5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis.

Please see full U.S. Prescribing Information for IBRANCE at http://www.Ibrance.com.

About XTANDI (enzalutamide)

In Europe, XTANDI (enzalutamide) is indicated for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC); the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

In the U.S., XTANDI is indicated for the treatment of patients with CRPC.

XTANDI Important Safety Information from the U.S. FDA-Approved Label

Warnings and Precautions

Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Patients in the study had one or more of the following pre-disposing factors: use of medications that may lower the seizure threshold; history of traumatic brain or head injury, cerebrovascular accident or transient ischemic attack, Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post-approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.7% vs 1.2%). Grade 3-4 ischemic events occurred in 1.2% of patients on XTANDI versus 0.5% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures In the placebo-controlled clinical studies, falls occurred in 10% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 8% of patients treated with XTANDI and in 3% of patients treated with placebo. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Embryo-Fetal Toxicity Safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. XTANDI should not be handled by females who are or may become pregnant.

Adverse Reactions

The most common adverse reactions ( 10%) that occurred more frequently ( 2% over placebo) in the XTANDI patients from the randomized placebo-controlled trials were asthenia/fatigue, decreased appetite, hot flush, arthralgia, dizziness/vertigo, hypertension, headache and weight decreased. In the bicalutamide-controlled study, the most common adverse reactions ( 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In the placebo-controlled study of metastatic CRPC (mCRPC) patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-nave mCRPC patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher adverse reactions were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an adverse event as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. In the bicalutamide-controlled study of chemotherapy-nave mCRPC patients, Grade 3-4 adverse reactions were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials in patients with mCRPC, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). In the placebo-controlled trial in patients with nmCRPC, Grade 1-4 neutropenia occurred in 8% of patients receiving XTANDI (0.5% Grade 3-4) and in 5% of patients receiving placebo (0.2% Grade 3-4).

Hypertension: In the two placebo-controlled trials in patients with mCRPC, hypertension was reported in 11% of XTANDI patients and 4% of placebo patients. Hypertension led to study discontinuation in <1% of patients in each arm. In the placebo-controlled trial in patients with nmCRPC, hypertension was reported in 12% of patients receiving XTANDI and 5% of patients receiving placebo.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see full U.S. Prescribing Information for XTANDI at http://www.Xtandi.com.

About LORBRENA (lorlatinib)

In Europe, LORBRENA (lorlatinib) is marketed as LORVIQUA and is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.

In the U.S., LORBRENA is indicated for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

LORBRENA Important Safety Information from the U.S. FDA-Approved Label

Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. Avoid concomitant use of LORBRENA with moderate CYP3A inducers. If concomitant use of moderate CYP3A inducers cannot be avoided, monitor AST, ALT, and bilirubin 48 hours after initiating LORBRENA and at least 3 times during the first week after initiating LORBRENA. Depending upon the relative importance of each drug, discontinue LORBRENA or the CYP3A inducer for persistent Grade 2 or higher hepatotoxicity.

Central Nervous System (CNS) Effects: A broad spectrum of CNS effects can occur. These include seizures, hallucinations, and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume at the same or reduced dose or permanently discontinue based on severity.

Hyperlipidemia: Increases in serum cholesterol and triglycerides can occur. Grade 3 or 4 elevations in total cholesterol occurred in 17% and Grade 3 or 4 elevations in triglycerides occurred in 17% of the 332 patients who received LORBRENA. Eighty percent of patients required initiation of lipid-lowering medications, with a median time to onset of start of such medications of 21 days. Initiate or increase the dose of lipid-lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at same dose for the first occurrence; resume at same or reduced dose of LORBRENA for recurrence based on severity.

Atrioventricular (AV) Block: PR interval prolongation and AV block can occur. In 295 patients who received LORBRENA at a dose of 100 mg orally once daily and who had a baseline electrocardiography (ECG), 1% experienced AV block and 0.3% experienced Grade 3 AV block and underwent pacemaker placement. Monitor ECG prior to initiating LORBRENA and periodically thereafter. Withhold and resume at reduced or same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.5% of patients, including Grade 3 or 4 ILD/pneumonitis in 1.2% of patients. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis. Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.

Embryo-fetal Toxicity: LORBRENA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception, since LORBRENA can render hormonal contraceptives ineffective, during treatment with LORBRENA and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for 3 months after the final dose.

Adverse Reactions: Serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7% of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%). The most common (20%) adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea; the most common (20%) laboratory abnormalities were hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase.

Drug Interactions: LORBRENA is contraindicated in patients taking strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers and strong CYP3A inhibitors. If concomitant use of moderate CYP3A inducers cannot be avoided, monitor ALT, AST, and bilirubin as recommended. If concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the LORBRENA dose as recommended. Concomitant use of LORBRENA decreases the concentration of CYP3A substrates.

Lactation: Because of the potential for serious adverse reactions in breastfed infants, instruct women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. The recommended dose of LORBRENA has not been established for patients with moderate or severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment. The recommended dose of LORBRENA has not been established for patients with severe renal impairment.

Please see full U.S. Prescribing Information for LORBRENA at http://www.Lorbrena.com.

About BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)

In Europe, BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.

In the U.S., BRAFTOVI and MEKTOVI are indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Read more from the original source:
Pfizer Presents Scientific Advancements in Cancer Care at the ESMO Congress 2019 Highlighting Expanded Portfolio - Yahoo Finance

Recommendation and review posted by Bethany Smith

Events

n Crosskeys Human Resources Inc. is offering flu shots 10:30-11:30 a.m. Sept. 23 at the Brownsville seniors center, 302 Shaffner Ave., and 11 a.m. to noon Oct. 2 at the Republic facility, 36 Fairgarden St., Republic. A professional from Rite Aid in Grindstone will administer the shots. Participants must bring Medicare/other insurance cards for payment.

n Monongahela Valley Hospital will host a prostate cancer screening and education program at 5 p.m. Sept. 25 in the education conference center. The event is free. At the screening, men will be offered a digital rectal exam (DRE), the standard test for prostate cancer; a hemocult test and a Prostate Specific Antigen (PSA) blood test. The screening and education program will be conducted by MVH staff. Registration: 724-258-1333.

n Monongahela Valley Hospital will host a multiphasic blood analysis 7-10 a.m. Sept. 28 in the education conference center. This 36-function screening costs only $30 and is open to the public. Additional tests available include: Immunochemical Fecal Occult Blood, 3-D mammogram, Hemoglobin A1C, Thyroid Stimulating Hormone, Prostatic Specific Antigen, and Vitamin D. Participants are asked to provide the full name and complete address of the physician to whom their test results will be sent afterwards. Testing is by appointment only. The deadline to register is Sept. 25, and registrations must be made Monday through Friday from 8:30 a.m. to 2:30 p.m. by calling 724-258-1282.

n Medicares annual open enrollment period runs Oct. 15 through Dec. 7. For a list of enrollment centers and their dates and times open for enrollment, call Southwestern Pennsylvania Human Services, Inc. at 724-489-8080.

Courses

n Exercise classes, Tuesdays and Thursdays, Center in the Woods, 130 Woodland Court, Brownsville. Classes include chair dancing at 9:30 a.m. followed by healthy steps at 11 a.m. Information: 724-938-3554.

n Monongahela Valley Hospital will host a free talk about Gastrointestinal Reflux Disease (GERD) on Thursday, Oct. 3, at 6 p.m. in the Anthony M. Lombardi Education Conference Center at Monongahela Valley Hospital. Dr. Arshad Bachelani will discuss GERD, a digestive disorder in which the contents of the stomach flow back into the esophagus, leading to heartburn, difficulty swallowing, regurgitation of food and cough, to name a few. Long term GERD can lead to complications in the esophagus that can make swallowing difficult, cause an ulcer or the cause development of precancerous cells. Dr. Bachelani will talk about treatment options available that include medications as well as surgery. Registration: monvalleyhospital.com or 724-258-1333.

n Monongahela Valley Hospital will host a free talk about Cervical Disc Replacement at 6 p.m. Oct. 15, in the Anthony M. Lombardi Education Conference Center. Dr. Eric Nabors will discuss diseases that affect cervical discs, causing chronic neck and/or arm pain and treatment options. He will thoroughly cover surgical treatment option of cervical disc replacement by describing the procedure, when it is a viable option and who is a good candidate for the surgery. Registration: monvalleyhospital.com or call 724-258-1333.

n The four-week Smoke Free For Life program, sponsored by BREATHE Pennsylvania will be hosted by the Monongahela Valley Hospital 9-11 a.m. every Monday in September. Program participants will learn how to overcome barriers that keep them from quitting, develop a customized quit-plan that will lead to success, learn the art of positive self-talk, practice sound techniques to manage stress, develop strategies that will prevent relapse and receive support in a positive and comfortable environment. The session is broken down into four, two-hour courses. Space is limited and pre-registration is required. Registration: 724-258-1462.

n Monongahela Valley Hospital will host a Weight Control and Wellness Support Group at 6 p.m. Sept. 23 in the education conference center. The bariatric support group activities are designed to reinforce key principles of success and help participants learn concepts that are sometimes difficult to grasp after bariatric surgery. Professionals such as dietitians, psychologists and fitness instructors may be invited to speak. Other presenters may discuss topics such as grooming, dating and cooking. The ultimate purpose of the support group is to help participants achieve and maintain their goal weights in a way that is as physically and mentally healthy as possible. Registration: 724-258-1333.

n Monongahela Valley Hospital will host the course Advanced Carbohydrate Counting from 9 to 11 a.m. Sept. 26 in the education conference center. This program is a diabetes self-management class designed to educate you on how to count carbohydrate content in food to improve blood sugar control. Topics include how to track effects of carbohydrates and blood sugar, glycemic index and how to read food nutrition labels. Registration is required at least one week prior to the start of class by calling 724-258-1483.

n Monongahela Valley Hospital through the Community Care Network is offering a Smoke Free for Life program from 11 a.m. to 1 p.m. Sept. 23 and 30 in the education conference center. The four-week program is broken down into four, two-hour courses and is designed to help participants develop strategies to quit smoking, prevent relapse as well as receive support in a positive and comfortable environment. Registration: 724-258-1462.

Support groups

n Breaking Addiction, HEAL Group for Men. This small group meeting for men is designed to help those who have a desire to overcome addictions and find a new direction in life. All sessions give instruction for practical life skills through Biblical Principles found in Gods Word. Discussion and interaction are encouraged at each group meeting. They are scheduled at 7 p.m. the first, second and fourth Thursdays of the month at Eagle Ranch Ministries Inc., 1579 Pleasant Valley Road, Mount Pleasant. Registration: 724-542-7243.

n Breaking Addiction, HEAL Group for Women. This small group meeting for women is designed to help those who have a desire to overcome addictions and find a new direction in life. All sessions give instruction for practical life skills through Biblical Principles found in Gods Word. Discussion and interaction are encouraged at each group meeting. The meetings are scheduled for 7 p.m. every Tuesday at Eagle Ranch Ministries Inc., 1579 Pleasant Valley Road, Mount Pleasant. Registration: 724-244-5261 or 412-969-8520.

n Caregiver support group, 6:30-8:30 p.m., the fourth Wednesday of the month at Lafayette Manor. Classes meet in the new physical therapy department. Light refreshments are provided. Open for family and friends who have lost a loved one to cancer. Registration: http://www.excelahealth.org or 877-771-1234.

n Mon Valley Hospital will host a Suicide Bereavement Support Group 12:30 p.m. Sept. 23 in the education conference center. This support group is a four-month program that meets the second and fourth Mondays of each month. This program is led by a licensed psychologist and is free and open to all those touched by suicide. Required registration: 724-678-3601.

n Grief support group, 6-8 p.m. first Tuesday of every month, at the St. John the Evangelist Church on West Crawford Avenue in Connellsville. The group is a collaborative effort for those facing grief due to the loss of a loved one from addiction. Information: 724-628-6840.

n Al-Anon Family Groups, 8 p.m. Wednesdays, Trinity Church parlor, Fayette and Morgantown streets, Uniontown. Please enter at the handicapped ramp entrance. A second is scheduled for 7:30 p.m. Fridays, Christian Church, Pittsburgh Street, Connellsville. These meetings are for anyone who has been affected by or is having problems from someone elses drinking. Information: al-anon.alateen.org or pa-al-anon.org.

n Survivors of Incest Anonymous group, 6:30-8 p.m. the first and third Mondays of the month, excluding holidays. This 12-step recovery program is meant for men and women aged 18 or older who were sexually abused by a trusted person as a child. The group meets at the Mount Macrina Retreat Center. A similar group, Healing Friends, is from 6:30-7:30 p.m., East Liberty Presbyterian Church in Pittsburgh, on the second and fourth Tuesdays of the month. Information: peopleofcourage@gmail.com siawso.org, or healingfriends8@gmail.com.

n Missing Piece of My Heart support group, 6-8 p.m. the last Thursday of each month at the Crime Victims Center conference room in the Oliver Square Plaza. The group is for families who have lost a child to a violent crime. Information: 724-438-1470.

n Silver Generation Support Program, 10 a.m. to noon Wednesdays, East End United Community Center, Uniontown. The program is for ages 55 and older. Information: 724-437-1660.

More here:
Health briefs 09-23-19 | Healthy Living - Uniontown Herald Standard

Recommendation and review posted by Bethany Smith

Sleep problems are one of the most common ME/CFS symptoms. Sleep dysfunction is a critical piece of the complex puzzle that is chronic fatigue syndrome, and ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome) patients are eager for treatments that will help to improve and normalize their sleep. When I was diagnosed with ME/CFS by my primary care physician, she said, The first thing to do is to correct your sleep problems. That will make all of your other chronic fatigue syndrome symptoms improve. She was right! Here are ways to help you fall asleep faster, sleep better, and wake up feeling refreshed.

In order to treat ME/CFS sleep dysfunction, it helps to understand what healthy sleep looks like. A night of refreshing sleep consists of sleep cycles, moving through various stages in a predictable pattern:

Those deep Stages 3 and 4 are especially important for immune health, endocrine (hormone) function, and energy; its when our bodies recover and rebuild.

A healthy endocrine system, which produces hormones at the right times and in the right amounts, helps regulate sleep (and everything else).

Why do ME/CFS patients feel like we are half-awake all night and still exhausted in the morning? Traditional sleep studies comparing ME/CFS patients to healthy controls often find no measurable differences in our sleep cycles, though some show reduced total sleep time and sleep efficiency. Newer studies, using entirely different ways of measuring sleep, though, are finding that ME/CFS patients have more disruptions in REM sleep and deep stage (3 & 4) sleep. Our brains will sometimes jump right from REM or even deep stage sleep into being awake or in light Stage 1 sleep, instead of cycling through each stage as is normal. These REM disruptions in the studies correlated with worse symptoms the next day.

The hormone side is also not entirely clear. The few studies of serotonin levels in ME/CFS patients have shown contradictory results, though some do show abnormal serotonin function, indicating our bodies arent controlling serotonin the way a healthy body should. This matters because sleep deprivation causes a multitude of serious health problems, worsening every aspect of ME/CFS.

When an ME/CFS patient mentions sleep problems, doctors usually send him/her for a sleep study. The problem is, as noted above, that even carefully controlled scientific studies often fail to show abnormalities in our sleep using standard measures. Sleep studies do have an important function, though. They are designed to diagnose primary sleep disorders, like sleep apnea, restless legs syndrome, and narcolepsy. Plenty of ME/CFS patients also have a sleep disorder (some studies indicate we have a greater risk of primary sleep disorders), and its important to diagnose and treat those. Consider a sleep study to diagnose or rule out a primary sleep disorder, but dont expect it to find much with respect to your ME/CFS sleep dysfunction.

The key to correcting our sleep problem at its source is to target those hormones that are responsible for good quality sleep. This is different than taking sedatives to knock you out; it means actually correcting the problem so that your sleep feels normal and natural, and you wake up feeling refreshed. There are different ME/CFS treatment approaches to try, and it often takes some trial and error, sometimes combining treatments, to find what works best for you. Work with a doctor to find the right combination and to prevent increasing serotonin too much.

My son and I both have ME/CFS, plus tick infections, but I listened to my doctor all those years ago and treated sleep dysfunction first. Once my son got sick, we did the same for him, and we have both been sleeping a solid 9-11 hours of good quality, normal-feeling sleep every night for over twelve yearsand waking up feeling refreshed most mornings.

I first tried amitriptyline at its lowest dose, but it left me groggy in the morning. Next, I tried nortriptyline liquid in tiny doses (we started with that for my son) and gradually increased the dose as needed, until we each leveled out at an effective dose; then we switched to more convenient capsules. After a year or two, the nortriptyline wasnt working quite as well, so we added trazodone, again starting low, at just 25 mg. We both ended up (hes an adult now) at a combination of 50 mg nortriptyline and 100 mg trazodone (low doses compared to what is used for depression). We both also take melatonin supplements (5 mg for me and 8 mg for him), and I have a prescription for low-dose Ambien that I only use rarely, when I travel. We both also take plenty of magnesium, B6, and the other nutrients listed above.

Although the sleep dysfunction of ME/CFS cant be corrected just with standard guidelines for sleep hygiene, you do need to promote better sleep, in addition to whatever treatments you try. As one sleep expert explains, getting a good nights sleep requires an intricate coordination of many different elements, including some of the basics:

Myalgic encephalomyelitis and chronic fatigue syndrome are a complex web of intricate causes and effects, involving every system in the body. When sleep is disrupted, problems in the endocrine, immune, and nervous systems occur, worsening all ME/CFS symptoms. Similarly, when you treat sleep problems in ME/CFS, there will be improvements in all of these systems, leading to improved symptoms. Best of all, improving those systems will lead to even better quality sleep, in a positive domino effect. The best treatment approaches not only help you fall asleep and stay asleep but improve the quality of your sleep so that you wake up feeling refreshed and ready for a new day.

Suzan Jackson, a frequent ProHealth contributor, is a freelance writer who has had ME/CFS since 2002 and also has Lyme disease. Both of her sons also got ME/CFS, in 2004, but one is now fully recovered after 10 years of mild illness and the other just graduated from college, with ME/CFS plus three tick-borne infections. She writes two blogs, Living with ME/CFS at http://livewithcfs.blogspot.com and Book By Book at http://bookbybook.blogspot.com, and wrote an upcoming book being released in fall 2019, Finding a New Normal: Living with Chronic Illness. You can follow her on Twitter at @livewithmecfs.

Resources:

Trazodone (Desyrel) Is. Phoenix Rising website.

Alban, D, Alban P. Use Tryptophan to Boost Serotonin for Better Mental Health. Be Brain Fit website (April 3, 2019).

Bell, D. Sleep in CFS. Lyndonville News (January 2005) 2(1).

Castro-Marrero, J, SezFrancs, N, et al. Treatment and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: All Roads Lead to Rome. British Journal of Pharmacology (March 2017) 174(5), pp. 345-369.

Cleare, A. The Neuroendocrinology of Chronic Fatigue Syndrome. Endocrine Reviews (April 1, 2003) 24(2), pp. 236-252.

Field, T, Hernandez-Reif, M. et al. Cortisol Decreases and Serotonin and Dopamine Increase Following Massage Therapy. International Journal of Neuroscience (July 7, 2009), pp. 1397-1413.

Jackson, ML, Bruck, D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine (December 15, 2012) 8(6), pp. 719-28.

Kishi, A. Presentation: Sleep Disturbances in ME/CFS. The National Academies of Science, Engineering & Medicine Health and Medicine Division. May 5, 2014.

Kishi, A., Natelson, BH., et al. Sleep-stage Dynamics in Patients with Chronic Fatigue Syndrome with or without Fibromyalgia. Sleep (November 1, 2011) 34(11), pp. 1551-60.

Lapp, C. Using Antidepressants to Treat Chronic Fatigue Syndrome. CFIDS Chronicle (Summer 2001).

Morillas-Arques, P,Rodriguez-Lopez, CM,et al. Trazodonefor the treatment offibromyalgia: an open-label, 12-week study. BMC Musculoskeletal Disorders(Sep 10, 2010) 11, p. 204.

Rowe, PC, Underhill, RA, et al. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Diagnosis and Management in Young People: a Primer. Frontiers in Pediatrics (June 19, 2017).

Yamamoto, S, Ouchi, Y, et al. Reduction of Serotonin Transporters of Patients with Chronic Fatigue Syndrome. NeuroReport (December 3, 2004) 15(17), pp. 2571-4.

Go here to read the rest:
Treating Sleep Problems in Chronic Fatigue Syndrome - ProHealth

Recommendation and review posted by Bethany Smith

Bathrooms are one of the only places where we can expect to have complete privacy. In todays world, we bring technology with us everywhere we go. The bathroom is the last sacred place where some of us leave technology behind and completely disconnect. Not for long...

For a while, determined Japanese companies have been bringing innovation to a niche market; the smart toilet market. They have been up to selling high-tech toilets at exorbitant prices since the 1980s. Meanwhile, on the other end of the globe, the Western world has been ignoring a much-needed toilet upgrade. Some of the earliest innovations in the Japanese toilet industry include heated seats to make you as comfortable as possible, remote controls that let you flush the toilet and close the lid with the press of a button and the use of ultraviolet rays to clean the toilet bowl and get rid of bacteria.

How could AI possibly contribute to improving your toilet? Toilets will now be equipped with Amazons Alexa so you can finally order you it to play music, close the lid, flush etc with voice commands, completely hands-free. These toilets are sold, randing from 1000 up to TOTOs 10000 toilet. TOTO was the first company to create smart toilets and they have mastered this market space. An American based company called Kohler has started making their own range of smart toilets which are becoming increasingly popular in the western world, shifting more people away from using traditional toilets.

See more here:
AI in smart toilets- could identify signs of diseases - AI Daily

Recommendation and review posted by Bethany Smith

If youre preparing for the United States Medical Licensing Examination (USMLE) Step 1 exam, you might want to know which questions are most often missed by test-prep takers. Check out this example from Kaplan Medical, and read an expert explanation of the answer. Also check outall posts in this series.

A 32-year-old woman comes to the physician because of amenorrhea for the past 15 months after delivering a baby. She says that she has also had fatigue, facial swelling, cold intolerance and has gained an additional 4.5 kg (10 lb) since her baby was born. A review of her records shows that the delivery was complicated by severe hemorrhage. Laboratory studies of serum show:

LH <1 IU/L

Estradiol 5 pg/mL (normal 20100 pg/mL)

TSH 0.1 U/mL

Injection of 500 g of TRH fails to produce an increase in either serum TSH or prolactin. Assay of other hormones is most likely to show normal levels of which of the following hormones?

A. Aldosterone

B. Cortisol

C. Follicle-stimulating hormone (FSH)

D. Gonadotropin-releasing hormone (GnRH)

E. Growth hormone

The correct answer is A.

Sheehan syndrome is hypopituitarism caused by ischemic damage to the pituitary resulting from excessive hemorrhage during parturition. The pituitary is enlarged during pregnancy; it is more metabolically active and more susceptible to hypoxemia. The blood vessels in the pituitary may be more susceptible to vasospasm because of high estrogen levels. In about 30 percent of women who have excessive hemorrhage during parturition, some degree of hypopituitarism eventually manifests.

The symptoms depend on how much of the pituitary is damaged and what cell types are destroyed. Although some pituitary hormones may be unaffected, even in severe hypopituitarism, pituitary hormones and the hormones controlled by them are more likely to be reduced than hormones that are not primarily controlled by anterior pituitary function. Our patient has amenorrhea (decreased LH) and symptoms of hypothryoidism (decreased TSH). Aldosterone secretion is relatively independent of adrenocorticotropic hormone; it is controlled mainly by angiotensin II and plasma potassium concentration. Aldosterone is least likely to be reduced by hypopituitarism. Treatment is replacement of thyroid hormone and cortisol.

Read these explanations to understand the important rationale for each answer to help you prepare with future studying.

Choice B: Cortisol is controlled by pituitary production of ACTH; because ACTH is often impaired in Sheehan syndrome, reduced secretion of cortisol is likely.

Choice C: The pituitary necrosis that is the root cause of Sheehan syndrome is highly likely to reduce secretion of follicle-stimulating hormone (FSH). The observation of reduced estradiol in this patient strongly suggests that FSH is low because estradiol increases as follicular development occurs.

Choice D: The presence of the depressed levels of estradiol and leuteinizing hormone (LH) in this patient releases hypothalamic secretion of GnRH from its normal feedback control. GnRH levels are likely to increase above normal.

Choice E: Growth hormone is very likely to be reduced by the pituitary necrosis.

For more prep questions on USMLE Steps 1, 2 and 3, viewother posts in this series.

The AMA selected Kaplan as a preferred provider to support you in reaching your goal of passing the USMLE or COMLEX-USA.AMA members can save 30% on access to additional study resources, such as Kaplans Qbank and High-yield courses. Learn more.

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Kaplan USMLE Step 1 prep: Woman has amenorrhea after birth of baby - American Medical Association

Recommendation and review posted by Bethany Smith

Monday, September 23 marks the next equinox and the start of Autumn season in the Northern Hemisphere, where days will begin to get shorter, nights get dark earlier, and the temperatures will drop.

Monday marks Autumnal Equinox, one of two days when the sun is located exactly above the Earths equator and day and night are roughly equal.

Fall is an easy season to love. One thing you might not realize, though, is that the change in temperature has some effects on your health.

Here are 19 surprising ways fall weather affects your wellbeing, according to msn.

1. Your risk of heart attack increases

Your heart definitely isnt a fan of that chill in the air. "In colder weather, we typically see rates of heart attacks go up," says New York City-based internist and cardiologist Edo Paz, MD, a doctor with K Health. "There are various reasons for this, including increased blood pressure and increased risk of blood clots. The best way to mitigate this risk is to dress warm."

2. Your eyes get dry

The cold, dry air of the fall has a tendency to dry your eyes out and leave a burning sensation in its wake. "Seasonal changes like dryer air make dry eye worse," according to the experts at Piedmont Eye Care in Charlotte, North Carolina. Thats because they either "cannot produce enough tears or they produce low-quality tears."

When your eyes are begging for moisture, you can get some relief by using artificial tears or getting some eye drops from your doctor. The optometrists at Piedmont also suggest getting a humidifier, protecting your eyes outside with either a hat or sunglasses, staying hydrated, taking breaks from screen time, and trading in your contacts for glasses.

3. Your skin becomes cracked and dry

Cold weather doesnt just bring on eye dryness. It also dries out your skin, says Paz. To combat the problemand make sure youre not itchy and cracked all season longuse plenty of lotion, load up on sunscreen, and skip the long, hot showers and baths, which only dry your skin out even more.

4. You experience more aches and pains

Always feel more achy in the colder months? Youre not alone. Research has shown there may be an association between colder temperatures and an increase in aches and pains, particularly in the back and neck areas.

There are multiple theories behind this, but one prominent one, according to University of Chicago Medicine rheumatologist Anisha Dua, MD, MPH, is because of the "drops in barometric pressure, which causes tendons, muscles, and the surrounding tissues to expand." According to Dua, "because of the confined space within the body, this can cause pain, especially in joints affected by arthritis."

5. Your vitamin D levels plummet

In the summertime, all that sunshine you absorb gives you more than enough vitamin D. However, once the season shifts, thats not quite the case anymore.

"In the fall, our vitamin D levels fall rapidly," says Kristine Blanche, PhD, RPA-C, owner of the New York-based Integrative Healing Center. According to Blanche, as your vitamin D levels fall, youre not only more susceptible to colds and the flu, but this can also affect your hormone levels.

6. You feel depressed

Fall should bring on joy in the form of fun family-centric holidays and cozy movie nights by the fire. However, its also known to bring on the seasonal affective disorder (SAD), which "can cause depression symptoms typically due to less exposure to sunlight, says Paz. His advice? "Stick to a regular workout routine" to keep your endorphin levels up.

7. And you lack energy, too!

SAD doesnt just affect your mood. It also affects your energy levels. Along with making you depressed, the seasonal disorder can also cause you to feel sluggish and agitated come fall, according to the Mayo Clinic. If this is the case for you, chat with your doctor about treatment options so the changing seasons dont dampen your spirits.

8. You have trouble breathing

Once the air gets cold, you might have a harder time breathing. According to the American Lung Association, cold, dry air can irritate the airways of those who are already dealing with breathing issues from asthma or chronic obstructive pulmonary disease (COPD). If you know you have airway issues, always make sure youre bundling up and avoid exercising outdoors when the air is especially dry.

9. Youre at a higher risk of getting sick

When the temperature drops and youre spending more time indoors, youre at a higher risk of coming down with a cold or the flu. According to Berkeley Wellness at the University of California, people pick up viruses in the fall not from the weather itself, but from the subsequent time spent indoors in close proximity to others. Of course, sitting within close range of someone whos sick increases your chances of picking up their germs.

10. Your allergies take a turn

Your allergies are inevitably going to be impacted by the fall weather. However, whether thats for the better or for the worse depends on what exactly youre allergic to.

"The arrival of fall weather will bring relief for some, and a worsening of symptoms for others," says California-based physician Alexandra Stockwell, MD. "Anyone who suffers from an allergy to pollen will start to feel some relief when temperatures drop, humidity improves, and pollen is no longer in the air. And for anyone allergic to mold, the fall weather can exacerbate symptoms. Mold thrives in leaf piles, compost piles, and anywhere organic matter is decomposing. Because its airborne, you can be negatively impacted by mold from surrounding areas."

11. You get more headaches

Its not uncommon for cold weather to cause headaches. Thats because, according to the Mayo Clinic, the fall season is full of migraine triggers, ranging from dry air to barometric pressure changes.

12. You sleep better

When you get enough sleep every night, your mood improves, your energy levels increase, and you have fewer junk food cravings. And the transition from summer to fall could be the key to finally helping you get on a solid sleep schedule.

"Going to bed earlier as it gets dark earlier results in better quality sleep, better insulin control, and feeling rested enough to work out the next day," says Monica Auslander Moreno, MS, RD, LD/N, nutrition consultant for RSP Nutrition in Miami Gardens, Florida. Its a win in the bedroom that translates to more success in the kitchen, at the gym, and pretty much everywhere else.

13. You experience hair loss

According to The Choe Center For Hair Restoration in Virginia Beach, Virginia, people typically lose between 50 and 100 strands of hair a day. However, in the fall monthstypically in October and Novemberthis number tends to be closer to 100. If you notice some extra shedding in the shower or when youre brushing your hair in the fall, its likely nothing to worry about.

14. Your diet could get better

During the summer months, its fun to get out and enjoy the warm weather at outdoor bars and restaurants. In the fall, however, youre much more inclined to make the most of your kitchen, which is great news for both your wellbeing and your waistline.

"The cooler temperatures make fall a great time to hit up the farmers markets and add some local and seasonal foods into your diet," says Sheli Msall, RDN, the dietitian behind Nutritionist Abroad. "Its also a fun season to cook and bake in, as you dont mind warming up the kitchen now that its getting cooler outside."

15. Or you might pack on the pounds

While fall can bring on healthy eating habits, the change in season can also have the opposite effect. "When the weather turns colder, we generally adjust our eating styles to warm comfort foods associated with family events and holidays," says Brenda Rea, MD, DrPH, PT, RD, family and preventive medicine physician at Loma Linda University Health in Loma Linda, California. "This often can result in more hot and sugary drinks, hot soups laden with saturated fat and salt, and, of course fruit pies with sugar, saturated fat, and refined flour."

Luckily, Rea says that these comfort foods can easily be replaced with similarand much healthier!alternatives that are just as satisfying. "Hot sugary drinks can be replaced with hot green tea or lemon water; soups can have less salt and no added fats while still maintaining a fabulous taste, and fruit can be consumed fresh and made into a fruit compote with dates for sweetening," she suggests.

16. You could inadvertently be warding off inflammation

Chronic inflammation can lead to a long list of health problems, from heart disease to autoimmune disorders. The good news? Having the urge to sip on some tea during the chilly fall months could help fight it off. "Fall teas and spices are anti-inflammatory," says Moreno. Sip on green tea, turmeric tea, and ginger tea for the best results.

17. You might become more active

During the summer, the sun is strongoften too strong to allow for a run or any other type of outdoor workout. Once fall hits, though, the weather cools down a little, making it a great time to up your activity levels before winter hibernation hits.

"As the weather cools, its a perfect opportunity to bike, walk, or run outside in the crisp fall weatherespecially in the mornings before work and on weekends," says Moreno. "Who doesnt like to ogle the beautiful foliage?"

18. But you could also become more sedentary

Though for some people the tepid temperatures of fall are ideal for outdoor activities, for others, its quite the opposite. The cooler weather could send you straight into hibernation-mode, causing you to abandon your exercising habits in favor of lounging on the couch.

If youre avoiding the outdoors, make sure youre at least incorporating some at-home exercises into your routine. There are plenty of different apps, online workout programs, and free videos on YouTube to take advantage of.

See the original post:
It's officially autumn..see how autumn weather may affect your health! - Roya News English

Recommendation and review posted by Bethany Smith