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Human Behavior

FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help…

SILVER SPRING, Md., Feb. 3, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) and theFederal Trade Commission today signed a joint statementregarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.

"Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs" said FDA Commissioner Stephen M. Hahn, M.D. "Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients."

"Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation," said FTC Chairman Joseph Simons. "The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars."

Biological products are a diverse category of products which may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biosimilarsare biological products that are highly similar to and have no clinically meaningful differences from existing FDA-approved "reference" products. Reference products are FDA-approved biological products against which proposed biosimilar products are compared.

Biosimilar and interchangeable products have the potential to greatly reduce health care costs, similar to what has been seen with increased generic drug offerings. The 1984 Hatch Waxman Act, which created an abbreviated path to market for generic versions of small molecule drugs, has saved patients roughly $2 trillionover the past decade. While the U.S. market for biosimilar versions of biological products is still maturing, the FDA's research suggests that after market entry, biosimilars have the potential to offer significant savings. Biosimilars marketed in the U.S. typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products.

However, anti-competitive practices, such as making false or misleading statements comparing biological reference products and biosimilars, may be slowing progress and hampering uptake of these important therapies. The FDA and the FTC have serious concerns about such statements and their negative impact on public health, including their potential to create negative misperceptions about the safety or effectiveness of approved biosimilars. The agencies intend to take appropriate steps to address companies making false or misleading communications about biologics, including biosimilars and interchangeable products, which will help deter anti-competitive behavior in the biologics market and can help lead to the use of all available biological products.

As detailed in the joint statement, the agencies will also collaborate on future public outreach efforts, including bringing together participants from industry, academia and government agencies to discuss issues relating to competition in the biologics market. To this end, today we're also announcing that the FDA and FTC will hold a public workshop, "FDA/FTC Workshop on a Competitive Marketplace for Biosimilars" on March 9 at the FDA's White Oak Campus in Silver Spring, Md.

Theagencies will exchange information, when appropriate, about best practices to prevent activities that impede access to samples of the reference product that the prospective biosimilar applicant needs for testing. Additionally, the FTC intends to review patent settlement agreements involving biosimilars, to prevent antitrust violations.

Another key to ensuring that public information surrounding biosimilars and their reference products is communicated in a truthful and non-misleading manner is the FDA's regulation of industry's promotional materials for all prescription drugs, including biosimilar and reference products. Therefore, the FDA is publishing a draft guidanceoutlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

Availability of this new draft guidance and ongoing collaboration with the FTC is part of the FDA's continuing work to help ensure truthful and non-misleading prescription drug promotion and serves as another example of the FDA's commitment to public health by addressing anti-competitive tactics that aim to undermine confidence in the safety and effectiveness of FDA-approved biosimilar products.

Today's announcements are key deliverables in the FDA's Biosimilars Action Plan (BAP)that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products. The FDA is accepting commentsfrom the public on the draft guidance from Feb. 4 to April 6.

Media Contact:Jim McKinney, 240-328-7305Consumer Inquiries: Emailor 888-INFO-FDA

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

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Human Behavior

‘The Good Place’ Creator Reveals How the Series Changed His Life and What It Means to Be a Good Person – Showbiz Cheat Sheet

The Good Placeis coming to an end after four seasons; the final episode will air Jan. 30, 2020. The NBC show, developed by Michael Schur (also the creator ofParks and Recreation and formerly a writer onThe Office), recently sat down with the Daily Beast to discuss the series finale. Schur admitted that working onThe Good Place, which dives into big, universal questions and mysteries, changed the way he thought about what it means to be a good human.

The Last Laugh host, Matt Wilstein asked Schur on the podcast if working on The Good Place changed his feelings about what comes after death.

I dont know that I had a theory before the show, Schur said of the idea of the afterlife. Hes never believed in one version of it, anyway.

Im not a particularly religious person, he explained. My sort of pat answer for a very long time now has been like, I dont know Who could possibly claim to know?

However, Schur revealed that he has been transformed by the experience overall.

The things that have changed in my personal world view have less to do with what happens after we die and more to do with what matters while were on earth, he said.

Schur says rather than transforming his views on the afterlife, The Good Place altered how he looked at his life and his actions on earth.

The show has given me a better and more clear kind of worldview about what matters. What are the things that we do that we should do? What are the things that we shouldnt do? Why shouldnt we do them or why should we do them? That kind of stuff I think has changed for me.

Schur clarified: Not like, I used to think it was cool to rob banks, or something and now I dont. But: what are the underpinnings of why actions matter or dont matter? Schur credits all the annoying reading he and the writers did. The Good Place writers did a lot of research on philosophy to read in order to inform Chidis character, as well as the overall moral journey of the show.

If you read enough of this stuff and think about it enough, you become Chidi, he said. Schur continued, you become paralyzed by the simplest moral calculation. Still, Schur says the outcome was positive.

That is a joy, he said. That is a really enormous gift that this experience has given to me. Why? Schur explains it gives him purpose. Being a good person, especially on a small scale, often can feel meaningless in the grand scheme of thingsespecially in the trying times we live in. But Schurs philosophy homework paid off:

I feel like Im not flailing around trying to put words or an explanation to what I believe about what humans should do with their time. I now can say, well, heres why! Heres why it matters. Here are the philosophical underpinnings of human behavior and actions and morality and ethics.

Ultimately, Schur is grateful for the whole experience on The Good Place.

We were, in a very rare way, able to execute the show from beginning to end exactly the way we wanted to, he said. So any complaints are entirely my fault.

Schur acknowledged that endings are hard, emotionally. But onThe Good Placeending, he said, I feel good.

We put a lot of time into thinking aboutThe Good Placefinale, Schur shared. It took a lot of hard work. Especially, as he told Wilstein, The Good Place deals with universal truths and philosophical challenges.

The themes of this show are very intense, Schur explained, especially in contract to Parks and Rec. Its not like, I wonder whether Leslie Knope becomes the governor.The Good Placeis indeed after a bigger fish. However, Schur is proud of his writers rooms work on the series finale.

I think we got it right, The Good Place creator said on the podcast. I hope we did. Well find out!

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'The Good Place' Creator Reveals How the Series Changed His Life and What It Means to Be a Good Person - Showbiz Cheat Sheet

Human Behavior

Finding Humor, Calm, and Joy In Your Busy Life – Thrive Global

Research shows that 55% of who you are in rooted in heredity and genetics and 45% is how you take what you got and bring it out into the world (personalityinsights.com). It is the age old question of nature versus nurture. It is an almost even balance that creates us as humans.

So when I say I came out fun-loving, spacey, funny, whimsical, spastic and a little off kilter, I thank my 55%. I also thank my 45% because I was born into a family that supported these pieces and showed me how to use them to my advantage. I dont have ducks. I dont have a row. I have squirrels and they are everywhere.

Almost my whole lifehas been spent jumping out of the box where funny, spacey and off-kilter isntloved. I have tried to sober up my squirrels so I could be more duck like. Ifelt society liked ducks more because they gracefully stood in rows and hadtheir act together. I looked disorganized, unplanned, a hot mess!

I, now, embrace thisever-glittering piece of me. Check outthese 3 ways to build your own box for the squirrels in your head:

Stanford did a study that humor accounts for a 700% increase in learning among students. So, I may be spacey, but I am smart. Knowing that human behavior is a pattern, I know that my temperament lends itself to being really good with people and relationships. And since 85% of a humans success in life is due to their strong people skills, I have an amazing advantage. Celebrate the strengths. The people skill I am best at is humor. It sets the stage for my interactions, how my day runs, the relationships I make and turn away, and how I look at different situations. What is your best social skill? How can you use it to inform your 85%?

My whole life people have been trying to settle me down, chill me out, meditate me to calmness. It hasnt worked yet! With squirrels in my head, I have found that the typical ways to calm are not for me. I calm by buying junk at yard sales and thrift stores, having lunch with friends, or eating a bagel from my favorite bagel shop. I cant meditate. Well, I guess I could, but I dont want to.

I figured out just the other day that when I participate in guided meditation I use the humor and sass in my head to joke with the guiding voice. Totally the opposite of what is supposed to happen. Find your calm and be confident that yours may not look like someone elses. Be honest with yourself because sometimes the quirks find the calm for you!

I am fast! I am fast at running, thinking, talking, getting mad, eating and even sleeping. My squirrels need it all fast. But often I have to slow down with self-talk. I have to slow my impulses long enough to capture the outcomes of my decisions. My fast pace sometimes ends in sadness and hurt feelings so self-talk is my solution. I remember those hard feelings and make sure they dont happen again and again. Introduce your impulses to your emotions and create self-talk so they can get along.

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Finding Humor, Calm, and Joy In Your Busy Life - Thrive Global

Embryology

More Proof That Single Moms Are The Real MVPs (And The Kids Are Just Fine) – Yahoo Lifestyle

I was raised by a strong, badass single mom. She raised my sister and me on her own while maintaining a stressful job as a special education teacher. Things were not easy for us growing up. We struggled with money. Our house wasnt always neat. My mom was often stressed and exhaustedI remember her collapsing on the couch each afternoon when we came home from work.

But my sister and I always had what we needed. And despite a sometimes strained relationship with our dad, and a court custody battle that was traumatic for all involved, our mom was our rock. Her love was unconditional, she was steady and reliable, and she would do anything she could to provide the kind of life me and my sister needed.

My sister and I are both fully grown, have undergrad and graduate degrees, and are kicking ass at our careers. That strength my mother modeled definitely rubbed off on us.

I have many friends who are single moms. I see them for the incredible, strong AF warrior women they are. But sometimes they dont see themselves that way. They wonder if they are enough for their children. They worry that they dont have enough time and energy to spend on their kids. They worry about money and providing all the opportunities that two-parent homes seem to.

The thing is that yes, the struggle is real when you are a single mom. But the truth isand I hope all my single mama friends are listeningbeing a single mom isnt going to screw up your kids in some way. Two-parent households arent the only way to raise amazing children. And even roadblocks such as financial struggles dont matter as much as you might think they do.

Showing up, providing unconditional love, being emotionally available and stablethose are what matter most to kids, and single moms are as capable of providing those things as anyone else.

Its not just me who thinks so either: there is research to back up the notion that kids raised by single moms fare just as well as kids raised in two-parent homes. Awesome, right?

For example, a 2017 study conducted by the European Society of Human Reproduction and Embryology found no difference in terms of the parent-child relationship and child development in single-parent vs. two-parent homes.

This study looked at single-mother-by-choice households, meaning mothers who had made a conscious decision to raise their children on their own, often using sperm donors or other fertility treatments. Fifty-nine single-mothers-by-choice households were compared to 59 heterosexual two-parent homes.

Several very promising conclusions were found. There were no major differences in parental emotional involvement or stress between the two types of households. There were also no discernible differences in their childrens behavior.

Children in both family types are doing well in terms of their well-being, Mathilde Brewaeys one of the presenters of the study, told Science Daily.

Brewaeys also shot down the outdated (but still very prevalent) notion that you must have a man involved in the family unit for optimal child development.

The assumption that growing up in a family without a father is not good for the child is based mainly on research into children whose parents are divorced and who thus have experienced parental conflict, said Brewaeys. However, it seems likely that any negative influence on child development depends more on a troubled parent-child relationship and not on the absence of a father.

So, this is all pretty encouraging. But what about single moms who dont come to the whole thing by choiceand what about kids who come from divorced homes rife with parental conflict? These sorts of situations are all too common. Thankfully, though, theres research pointing to the fact that single mamas of all types are capable of raising wonderful, well-adjusted children.

A 2004 study from Cornell University looked at some longer-term effects of single motherhood. The article was specifically examining the academic performance and behavior of tweens and teens raised by single moms. These kids, aged 12 and 13, had been raised by a single mom for several years, and came from various ethnic backgrounds. The study researchers looked at families from white, black, and Hispanic homes.

Their findings were extremely positive and encouraging for single moms everywhere.

Overall, we find little or no evidence of systematic negative effects of single parenthood on children, regardless of how long they have lived with a single parent during the previous six years, said Henry Ricciuti, professor of human development at Cornell, in a press release.

The researchers did zero in on a few aspects that increased the likelihood of raising a well-adjusted and academically proficient child as a single mom.

The findings suggest that in the presence of favorable maternal characteristics, such as education and positive child expectations, along with social resources supportive of parenting, single parenthood in and of itself need not to be a risk factor for a childs performance in mathematics, reading or vocabulary or for behavior problems, Ricciuti says.

The researchers from the European Society of Human Reproduction and Embryology also emphasized the importance of social networks for single moms and stressed that single moms should not hesitate to reach out for help and assistance.

A strong social network is of crucial importance, Brewaeys remarked. So I would recommend that all women considering single motherhood by choice make sure of a strong social network brothers, sisters, parents, friends of neighbours. And to never be afraid to ask for help.

I would venture to say that single moms are not only capable of raising kids who turn out just fine, but kids who thrive and get shit done. I know that I personally was inspired by my mothers example of getting up every single day to go to work and take care of usdespite how hard it was and how completely exhausted she was.

She didnt always see her strength then, but I did. I am grateful to her everyday, and am in awe of all the invincible, hardworking, loving single moms out there. You are doing amazing and your kids are going to be just fine.

See the original article on ScaryMommy.com

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More Proof That Single Moms Are The Real MVPs (And The Kids Are Just Fine) - Yahoo Lifestyle

Embryology

What is 4-H? and other questions – Burlington Times News

Even though it has been around for over 100 years, many people are new to 4-H and do not realize what it is, what it has to offer, or how to become involved.

Randolph County 4-H reached over 21,000 youth in 2019. 4-H provides youth with a wealth of opportunities, hands on experiences and learning how to be a well-rounded citizen. With the start of a new year, now is the perfect time to get involved with 4-H!

Q: What is 4-H?

A: 4-H is the youth development program of Cooperative Extension for youth ages 5 to 18 that helps develop leadership, citizenship, and life skills. It aims to assist youth in becoming competent, contributing citizens.

Q: I dont live on a farm, how can I join 4-H?

A: All 4-H programs are open to any youth, regardless of membership in the 4-H program. Joining 4-H is as simple as enrolling in 4-H online by completing the online form. 4-H has deep roots in agriculture, as it began with corn and tomato clubs in the early 1900s. Today in addition to agriculture, 4-H involves Science/STEM, public speaking/communication, life skills, sewing, community service projects and much more.

Q: Isnt 4-H just about cows and cooking?

A: While 4-H addresses these programs, the entire program is more diverse. Nationally, 4-H has three mission mandates: citizenship (civic engagement, service, civic education, and leadership); healthy living (nutrition, fitness, and social-emotional health); and science (animal science and agriculture, consumer science, engineering, environmental science and natural resources, life science, and technology).

Q: What is the cost to join 4-H?

A: There is no fee to join 4-H. Some workshops and activities will have fees associated with them to help cover the cost of materials. 4-H is also a United Way Agency which helps allow us an opportunity to provide scholarships.

Q: When does 4-H meet?

A: 4-H is active year round. Typically, 4-H clubs have monthly meetings. In addition, there are county, district, and state level 4-H events, activities and competitions throughout the year.

Q: What is a 4-H club?

A: A 4-H club is an organized group of youth, supported by screened, adult volunteers. Randolph County 4-H has many different clubs that cover everything from livestock (chickens, beef cattle, goats, and dairy cattle), horses, sewing, community service, Cloverbuds (ages 5-7), shooting sports and more.

Q: What age can my child join 4-H?

A: Youth can join 4-H at age 5. A youths age for 4-H is determined by his or her age on Jan. 1 of the current year. You may continue to be a member of 4-H through age 18. Youth, ages 5 to 7 years old, are referred to as Cloverbuds, are non-competitive and receive participation ribbons in any activity they participate in.

Q: What does 4-H stand for?

A: Head, Heart, Hands, and Health. Originally, there were only three Hs Head, Heart, and Hands. A fourth H, Hustle, was added in 1908. Hustle was changed to Health in 1911.

Q: What are the 4-H delivery modes?

A: 4-H has four main delivery modes: Community Clubs, School Enrichment, Summer Programs and Special Interest Programs. We currently have nine active 4-H Clubs. School Enrichment programs can be done in any grade level. Our curriculum comes from university-based research that has been piloted and tested thoroughly and aligns with the NC Standard Course of Study.

Some examples of our school enrichment program offerings are embryology, farm to table, Junior Master Gardener, anti-bullying, bike safety, robotics, character education, public speaking and communication, and presentations.

Randolph County 4-H also offers a summer program called Randolph County 4-H Agriventures and More. The summer program is offered for ages 5-7 and then 8 and Up. The 5-7 year old program meets at our office while the 8 and up program includes trips to farms, local businesses and other outings.

The summer program offerings are released in May and registration is online or by stopping in our office. The last delivery mode is special interest projects which might be a Quiz Bowl or Judging team for a 4-H competition.

Q: As an adult, how can I become involved with 4-H?

A: 4-H is always looking for adult volunteers! Depending on the amount of time you would like to donate you can volunteer at a single event or teach a workshop. If you want a deeper level of involvement, you can become a 4-H club leader, which is a one year, renewable commitment.

Allison Walker is the 4-H Youth Development Extension Agent. Contact her at 336-467-2927 or allison_walker@ncsu.edu. For more information about 4-H or NC Cooperative Extension, contact the Randolph County Extension Office at 336-318-6000 or visit http://randolph.ces.ncsu.edu.

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What is 4-H? and other questions - Burlington Times News

Embryology

Simply Fertility Hornchurch IVF clinic ‘thrilled’ to be ranked in top three clinics in the UK | Health – Romford Recorder

PUBLISHED: 12:00 31 January 2020

April Roach

Simply Fertility's clinic in Westland Avenue, Hornchurch. Picture: Sarah Glew

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A Hornchurch IVF clinic has been named as the number one performing clinic across the south of England.

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The Simply Fertility clinic has a satellite branch in Westland Avenue, Hornchurch, has achieved a 40 per cent live birth success rate putting it in the top three clinics in the UK.

The UK's fertility watchdog, The Human Fertilisation and Embryology Authority (HFEA) recently published its first set of independent figures for Simply Fertility.

According to the fertility watchdog, Simply Fertility's 40pc success in live birth rate per embryo transferred for people under 30, is higher than the national average of 29pc.

Since opening its first clinic in 2017, Simply Fertility has been reporting each patient's outcome to the HFEA.

Sarah Walt, embryologist and centre manager at Simply Fertility, said: "The wait to independently confirm our success rates was tense - but the results have been worth it.

"We're thrilled to hear that our results rank us so highly.

"There is no greater joy or privilege for us than helping people to fulfil their dreams."

Simply Fertility aims to bring together an experienced team to use world-class techniques to give its patients the best possible chance of success.

All clinics must have a licence to operate and the HFEA inspectors visit the clinic to check the laboratory and equipment, the clinic's procedures and they ask patients for their views.

Following an inspection at Simply Fertility, the HFEA gave the clinic a five star rating in its report.

Inspectors stated in the report: "Fifty-two patients have provided feedback in the last 12 months, giving an average of a five star rating to the clinic.

"Several patients provided individual comments to the HFEA complimenting staff for being supportive, understanding and compassionate and praising the quality of the premises and treatment facilities at the centre."

The HFEA also regulates all fertility clinics in the UK and records all treatments and births.

It particularly looks at the number of births per embryo transferred.

This is important as part of its promotion of practices that minimise the chances of multiple births, which carry health risks for mothers and babies.

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Simply Fertility Hornchurch IVF clinic 'thrilled' to be ranked in top three clinics in the UK | Health - Romford Recorder

Immunology

Postdoctoral Research Fellow, Immunology job with EDINBURGH NAPIER UNIVERSITY | 195270 – Times Higher Education (THE)

Application closing date:10/02/2020Salary:33,797 (Grade 5)Package:Excellent benefits package

Job description

Postdoctoral Research Fellow - Immunology - Full time, 18 month FTC

We have an exciting opportunity for a Postdoctoral Research Fellow contributing to the project Cationic Host Defence Peptides (HDP) as Novel Therapeutic Antiviral Agents in Dengue Virus Infection.

The role

We are seeking a motivated Postdoctoral Research Fellow to work on a project thatis funded by the Medical Research Council (MRC) and the Indonesian Ministry of Research, Technology and Higher Education (RISTEKDIKTI) focused on HDP as novel therapeutic antiviral agents in Dengue virus infection.The project will focus on roles of HDP in Dengue infection in the context of the inflammatory response, together with assessing the therapeutic effects of these peptides, and their capacity for regulating autophagy and apoptosis in Dengue infection.

The project is led by Professor Peter Barlow at Edinburgh Napier University, and is a collaboration with the University of Indonesia and the Eijkman Institute for Molecular Biology in Jakarta. You will join a dynamic research group at Edinburgh Napier that has a broad interest in the mechanisms of pathogen-mediated inflammation. As part of the project the Fellow will also be expected to make 3-4 short visits to Jakarta performing experimental work and analysis. Additional costs for accommodation and living expenses for this portion of the project will be provided.

Your main responsibilities will be to design and perform the experimental work as outlined in the project award, utilising a variety of immunological and molecular techniques. You will be expected to contribute to the effective communication and publication of the findings in the scientific literature and at national and international scientific meetings and conferences.You will also be involved in the training of postgraduate research students.

Who we are looking for

You will have a PhD in Immunology, Microbiology, Infectious Diseases, Biomedical Sciences or other related discipline. You must also have a track record in immunological/infectious disease research, preferably viral infections, as evidenced by practical experience. Ideally, you will also have expertise in working with HDP, as well as epithelial models and murine models of infection. You must be highly motivated with excellent numerical skills together with excellent oral and written communication skills, and excellent project and time management skills.

For a detailed list of requirements, you can reach the full role profilehere

Please note that the successful candidate must have permission to work in the UK by the start of their employment. We are unable to sponsor any candidate for this role.

Benefits we offer

In return, we offer a great working environment where we support ambition, recognise achievement and offer an attractive benefits package. This includes a minimum of 46 days annual leave (includes bank holidays), a generous pension scheme, professional development opportunities, discounted access to onsite sports facilities and a wide range of other staff discounts.

Further information about our benefits can be foundhere

Salary: GBP 33,797 (Grade 5)

Additional Information

Application closing date: Monday 10 February 2020 (midnight GMT)Interviews will be held on: 19th FebruaryAnticipated start date: 1 April 2020

This role does not meet the minimum requirements set by UKVI to enable sponsorship of migrant workers. Therefore, we cannot progress applications from candidates who require sponsorship to work in the UK. For further information on this, please visit the UK Visas and Immigration website: https://www.gov.uk/browse/visas-immigration/work-visas

The University is committed to inclusion, demonstrated through our work in respect of our diversity awards and accreditations (Advance HE's Athena SWAN Charter) and hold Disability Confident, Carer Positive and Stonewall Scotland Diversity Champion status. More details can be foundhere

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Postdoctoral Research Fellow, Immunology job with EDINBURGH NAPIER UNIVERSITY | 195270 - Times Higher Education (THE)

Immunology

IMIDomics and Gossamer Bio Enter into a Strategic Collaboration to Advance the Development of Novel Treatments for Patients with Immune-Mediated…

DetailsCategory: More NewsPublished on Monday, 03 February 2020 15:21Hits: 200

BARCELONA, Spain I February 03, 2020 I IMIDomics S.L. today announced they have entered into a strategic collaboration with Gossamer Bio, Inc., to advance the discovery and development of novel treatments to address patients with Immune-Mediated Inflammatory Diseases (IMIDs). IMIDs affect large populations across the globe, are chronic and costly conditions, and affect patients in the prime of their lives. They constitute a broad class of diseases, including inflammatory bowel disease, multiple sclerosis, psoriatic arthritis, rheumatoid arthritis, psoriasis, and systemic lupus erythematosus, in which dysregulation of the immune response leads to inflammatory pathophysiology and ultimately tissue destruction.

The collaboration will give Gossamers world-class immunology research and development team the ability to benefit from IMIDomics unique clinical and molecular patient database to ultimately inform product discovery and development strategy. The agreement allows Gossamer to select and collaborate with IMIDomics on multiple projects, the first project being in the field of inflammatory bowel disease.

We are thrilled to work with Gossamer towards our shared goal of advancing care for patients suffering from IMIDs, and are confident our platform will accelerate Gossamers efforts to deliver important medicines for patients in need, said Dr. Sara Marsal Barril, Founder and Chief Medical Officer of IMIDomics. Exquisite characterization of IMID patients is critical to the determination of accurate diagnoses and employment of effective treatments, as well as the elucidation of disease mechanisms and discovery of new, effective medicines.

We are very excited to collaborate with IMIDomics, who have assembled a unique and world-class platform for clinical and molecular profiling of IMID patients, biobanking and analytics, said Luisa Salter-Cid, Ph.D., Chief Scientific Officer at Gossamer. Their platform will drive a deeper understanding of IMID patients and disease biology, which we hope will inform our strategy for drug discovery and development. Together we have the opportunity to deliver on our common mission of improving patient lives.

About IMIDomics

IMIDomics provides critical insights for treating patients with Immune-Mediated Inflammatory Diseases (IMIDs). IMIDomics comprehensive platform integrates access to a dynamic and high quality IMID patient biobank, corresponding curated clinical data, associated proprietary multiomics molecular data and world-class clinical expertise. The companys analytics platform extracts unique insights into disease biology and patient conditions through our proprietary interactive portal. IMIDomics unique capabilities result in novel insights that drive drug discovery and development, and guide precision treatment of patients. For more information, please visit http://www.imidomics.com.

SOURCE: IMIDomics

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IMIDomics and Gossamer Bio Enter into a Strategic Collaboration to Advance the Development of Novel Treatments for Patients with Immune-Mediated...

Immunology

Editorial: How frightened should you be about the coronavirus? Just enough to dial up routine health precautio – Chicago Tribune

Were in a phase where a lot is unknown, and that makes it scary, and there might be a tendency to a strong reaction until more is learned, Mark Mulligan, director of NYU Langone Healths division of infectious diseases and immunology, told The Wall Street Journal. Its not a time for panic or overreaction but to follow the playbook.

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Editorial: How frightened should you be about the coronavirus? Just enough to dial up routine health precautio - Chicago Tribune

Immunology

New Study Further Supports the Benefits of SPIRIVA RESPIMAT in the Treatment of Asthma – BioSpace

RIDGEFIELD, Conn., Feb. 3, 2020 /PRNewswire/ --Boehringer Ingelheimtoday presented results from a new retrospective analysis of real-world data that showed patients prescribed Spiriva Respimat (tiotropium bromide) Inhalation Spray 1.25 mcg experienced fewer asthma-related exacerbations when Spiriva Respimat was added to a popular class of asthma treatments (combination inhaled corticosteroid and long-acting beta2-agonist (ICS+LABA)) vs. patients receiving an increased dose of ICS+LABA. This new retrospective analysis of data from nearly 8,000 adults and adolescents with asthma was presented today at the Western Society of Allergy, Asthma and Immunology (WSAAI) 2020 Annual Scientific Session in Hawaii.

An asthma exacerbation, also known as an asthma attack, is characterized by coughing, wheezing, severe shortness of breath and chest tightness or pain. Symptoms can often be managed with prompt at-home therapy, but severe asthma exacerbations can become life-threatening and require emergency treatment.1

The study found that when adding Spiriva Respimat to ICS+LABA treatment, patients had fewer exacerbations and hospitalizations compared to those receiving an increased dose of ICS+LABA or continuing on high-dose of ICS+LABA, ultimately meeting the study's primary endpoint. Results also met the two secondary endpoints by showing:i

"Exacerbations are a common worry for those living with asthma. Their sudden onset can be alarming to patients and their caregivers, which is why we aim to prevent them with treatment," said Bradley Chipps, MD, Medical Director of Respiratory Therapy and the Cystic Fibrosis Center at the Sutter Medical Center in Sacramento, California, who served as an investigator and co-author of the study. "Instead of increasing the dose of the ICS+LABA, healthcare providers should consider Spiriva Respimat as a treatment option that may lower the risk and occurrence of asthma exacerbations."

Approximately 25 million people in the U.S. are living with asthma, and in more than 60% of adults, the condition is uncontrolled. Uncontrolled asthma can impair lung function, increase risk of exacerbations, reduce quality of life, and is associated with higher health care resource utilization (HCRU) and costs.2,3,4

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iResults from real-world studies are not intended for comparisons with clinical trials. Real-world studies were observational trials. Difference in study designs, patient populations, outcomes definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.

Important Safety Information

Do not use SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in this medicine.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with SPIRIVA RESPIMAT. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery.

SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA RESPIMAT can increase side effects.

Indication

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatchor call 1-800-FDA-1088.

About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales. Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit http://www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit http://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

Media Contact:

Chris WahlersBoehringer Ingelheim Pharmaceuticals, Inc.203-798-4375christopher.wahlers@boehringer-ingelheim.com

References

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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New Study Further Supports the Benefits of SPIRIVA RESPIMAT in the Treatment of Asthma - BioSpace