All posts by medical

Neuroscience

Promoting Love and Peace Across Generations through Science and Global Partnerships – Yale School of Medicine

The environmental influence on a childs social, emotional, and cognitive development is undeniable. Unfortunately, almost half of our worlds children are at risk of not reaching their full developmental potential. The COVID-19 pandemic has been difficult for everyone, but little is known about the long-term adverse impact this may have on the worlds most vulnerable children currently living in countries with ongoing threats of violence, displacement, and conflict. Unfortunately, much of these dangers have been exacerbated by the pandemic. Peacebuilding initiatives, particularly during the early childhood years, are more important than ever as the international community prepares to navigate a post-pandemic world.

When looking for contributors to a special issue tackling the concepts of Love and Fear in the medical journal Comprehensive Psychoneuroendocrinology, Sue Carter, Distinguished University Scientist and Rudy Professor Emerita of Biology at Indiana University, and an expert in the endocrinology of love, reached out to Dr. James F. Leckman, Neison Harris Professor in the Yale Child Study Center and Professor of Pediatrics, to provide insight into the importance of early childhood peacebuilding initiatives that target young children and their families.

Dr. Leckman assembled a team of experts and practitioners in the field of early childhood development (ECD) and peacebuilding around the globe including notable colleagues from Yale University and the Early Childhood Peace Consortium (ECPC) to partner with for this special journal issue. Yale contributors consist of Dr. James F. Leckman, Catherine Panter-Brick, Ph.D., Angelica Ponguta, Ph.D., M.P.H., Rima Salah, Ph.D., Franz J. Hartl, J.D., Michael F. McCarthy, M.A., and N. Shemrah Fallon. This international collaboration resulted in the seminal paper Love and Peace Across Generations: Biobehavioral Systems and Global Partnerships.

The paper emphasizes the importance of the early childhood years on a persons lifelong development, a focus that was widely championed by Yale Professor Emeritus of Psychology, the late Edward Zigler, widely known as the founding father of Head Start who was a pioneer in the field of early childhood development, and a champion for the rights of children. The paper outlines in detail, the link between neuroscience and peacebuilding, particularly the influence that neuropeptides have in influencing social interactions, attachment, love, fear, trauma, compassion, and empathy. The paper also specifies the role of parents in providing nurturing environments. Furthermore, the authors highlight successful early childhood development initiatives that have been implemented in conflict-affected countries as well as argue that it is imperative for our next generation of youth to play an active and leading role in peacebuilding initiatives.

The authors call on the international community to address four key action points that support young children and their families:

The open access journal article is available to the public and can be downloaded along with the complete special journal issue.

Link:
Promoting Love and Peace Across Generations through Science and Global Partnerships - Yale School of Medicine

Neuroscience

IIT-Gandhinagar Opens Application Process For PG Programmes In Cognitive Science, Society And Culture – NDTV

The application process will conclude on January 20

Image credit: IIT Gandhinagar Press Release

The Indian Institute of Technology (IIT Gandhinagar) is inviting applications for the post graduate (Masters) programmes in Cognitive Science, Society and Culture. The students can apply for the programmes on the official website- iitgn.ac.in. For M.Sc (Cognitive Science) programme, students have to apply on the official website- cogs.iitgn.ac.in/cogs-msc and for MA (Society and Culture), apply at hss.iitgn.ac.in/masc.

The application process will conclude on January 20. "Due to the COVID-19 pandemic, both admission tests and interviews for the courses will be conducted online. Applications for these two courses can be obtained from the following link - admissions.iitgn.ac.in/pgadmission," the release mentioned. The entrance exam and interviews will be conducted online due to Covid-19, the dates of which will be informed later.

The M.Sc in Cognitive Science will cover industry roles such as Educators, User Experience (UX), Linguistic analysts, Data analysts, Product developers/designers, AI engineers, Cognitive rehabilitation, Robotics, consumer behaviour etc, academic roles- Teaching or Research in, Human-Computer Interface, Neuroscience, Decision Making, etc. and International Ph.D. in opportunities.

In the MA programme in Society and Culture, the students will get familiar with academic roles such as Teaching or Research in Ecological Sciences and Public Policy, among others, and industry roles- Journalism, Advertising/media, Communications, Writing, Human resources. The students will also get an opportunity to do doctorate (Ph.D.) from varsity abroad and work with non-profit organisations (NGOs). "The M.A. in Society and Culture provides for fundamental learning, debates, and methods in the disciplines of literature, sociology, anthropology, political science, and history. The two-year masters program emerges from a conviction that students need to be trained to understand the social and political context they are part of," the release mentioned.

Prof Jaison. A. Manjaly, Head, Discipline of Humanities and Social Sciences, IIT Gandhinagar, said, The interdisciplinary nature of all the courses at IIT Gandhinagar makes a student's learning experience highly enriching. The M.A. in Society and Culture offers students diverse perspectives on social and cultural factors with a nuanced and more in-depth understanding of their context. The M.Sc. in Cognitive Science, on the other hand, offers a deeper understanding of mind, brain, and cognition. These programs are also uniquely aligned to the IITGN's vision to enable lifelong learning among the students.

The candidates required financial assistance can apply for 'On-Campus Employment Opportunities Program. "The Institute also encourages the M.Sc. (Cognitive Science) and M.A. (Society and Culture) students to present their research work at national and international conferences, and provides travel scholarships of up to Rs. 60,000," the release read.

In both programs, students will have unique research experiences like conducting field-work, conducting ethnographic research in the old city of Ahmedabad, visiting historical and archeological sites in Gujarat, conducting experiments in the state of the art cognitive science lab, traveling across the country through the IIT Gandhinagar Explorer Fellowships, taking advantage of the national and international academic and industrial internship opportunities and much more. Exposure to international faculty is another highlight of these programs, it mentioned.

Cognitive Science is a fast-growing emerging field that works at the intersection of philosophy, psychology, computer science, neuroscience, and Artificial Intelligence while the Society and Culture program provides exposure to key disciplines within the Humanities and Social Sciences including, history, culture studies, literature, translation studies, sociology, political science and anthropology. For details, please visit the website- iitgn.ac.in.

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IIT-Gandhinagar Opens Application Process For PG Programmes In Cognitive Science, Society And Culture - NDTV

Immunology

Hyris Fully Embraces the Immunology Sector to Better Fight COVID-19 and Beyond, Presenting Its New, Disruptive T-Cell Test to the International…

LONDON, Dec. 15, 2021 (GLOBE NEWSWIRE) -- As the COVID-19 pandemic keeps causing concerns, with new variants spreading worldwide, it is now widely recognized that we must move beyond a "test&trace" only approach. World leaders and health institutions today aim to achieve high immunity rates among the population, facing the unprecedented challenge of a worldwide vaccination campaign against an emerging virus, for which no vaccine existed until a year ago.

"Alongside with our genetic tests to detect SARS-CoV-2 anywhere, and at any time, we knew that we had to put our knowledge at the service of vaccination campaigns even further, leveraging the versatility of our AI platform to deliver a new kind of immunology test." So says Stefano Lo Priore, Founder and CEO at Hyris, a global biotech company renowned for its innovative and inclusive approach to genetic analysis. Hyris offers a wide range of solutions to support the fight against COVID-19 worldwide. Several Medical professionals and decision-makers have already made use of the Hyris SystemTM to reliably detect the presence of all the main Variants of Concern.

As a key part of a long-term strategy to fight COVID-19, Hyris keeps supporting Immunology Research, now presenting its new test to detect the body's T Cell immune response to SARS-CoV-2 on 17 December 2021, at "A-WISH", Alicante-Winter Immunology Symposium in Health. Organized by the Spanish Society of Immunology (SEI) and the University of Alicante (UA), the "A-WISH" Symposium promotes the advancement of the study of immunology, infectious diseases and vaccinology as well as Life and Health Sciences. This first edition specifically aims to address strategies for the COVID-19 response and pandemic preparedness, the development of the vaccines against SARS-CoV-2 and the immunological response to infection and different COVID-19 vaccines.

"Until now, antibody testing has been considered the only tool to measure immunity to SARS-CoV-2," explains Isabella Della Noce, Chief Biologist at Hyris, "but individuals exposed to the virus or vaccinated do not necessarily develop or maintain antibody positivity. That is why we need to focus on T-Cells as they act together with antibodies to prevent pathogen spread and remove virus-infected cells. An individual negative to an antibody test could still be immune, thanks to responsive T-Cells. Therefore, measuring T-Cells response is a new disruptive approach to fight SARS-CoV-2."

The new Hyris T-Cells clinical Test was developed through exclusive agreements between Hyris and some illustrious healthcare scientific organizations, such as with Singapore Duke-NUS Medical School and New York Ichan School of Medicine at Mount Sinai, both well renowned worldwide for their publications and studies within the immunology and virology fields.

"This new test enables quick evaluation of T-cell immune responses in COVID-19 convalescent patients as well as vaccinated people, also indicating where patients are responsive due to vaccination, virus exposure or both,"specifies Lorenzo Colombo, Global Chief Technical Officer at Hyris. "And that's where PCR testing comes into the picture. Not only data show that PCR is fully comparable in accuracy and sensitivity with other assays traditionally used to measure the body's immune response, but it is more convenient and faster as a widely used diagnostic technology. This is indeed a new dimension for vaccine strategies."

This new test workflow has been already adopted by international research projects and committees, such as VACCELERATE, the European Program for the acceleration of phase 2 & 3 COVID-19 vaccine trials and the creation of a pan-European platform for clinical trial design and conduct, and the Spanish governmental Project Ene-Covid, the "Estudio Nacional de sero-Epidemiologa de la Infeccin por SARS-CoV-2 en Espaa".

"To support and validate vaccination campaigns worldwide, we need much greater access to accurate tests, especially in the Immunology field," concludes Lo Priore. "This disruptive approach can also be applied to other immunology areas, such as oncology or related to even more specific human pathogens. It can also focus strategically on specific patients' categories, such as, for example, immune-compromised, transplanted or cancer patients. Our immune system really is the perfect "source-code" to our knowledge, about how to take care of life."

The 2021 "A-WISH" Symposium will bring together a group of internationally recognized immunologists, microbiologists, molecular biologists, epidemiologists, virologists and professionals from a wide range of disciplines in the biomedical field to present and discuss the most recent results of top-tier immunology scientific research and innovations. Hyris will participate in the discussion, aiming to accelerate the development of new approaches to disease prevention.

Contact a Hyris expert to discover how to perform beyond your current diagnostic capability, atinfo@hyris.net.

Related Images

Image 1: Hyris presents its disruptive T-Cells test to detect the body's immune response to SARS-CoV-2.

A doctor holding a tablet showing the HYRIS bAPP

This content was issued through the press release distribution service at Newswire.com.

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Hyris Fully Embraces the Immunology Sector to Better Fight COVID-19 and Beyond, Presenting Its New, Disruptive T-Cell Test to the International...

Immunology

Characterizing telemedicine use in clinical immunology and allergy in Canada before the COVID-19 pandemic – DocWire News

This article was originally published here

Allergy Asthma Clin Immunol. 2021 Dec 13;17(1):131. doi: 10.1186/s13223-021-00635-1.

ABSTRACT

RATIONALE: There exists a geographic barrier to access CIA care for patients who live in rural communities; telemedicine may bridge this gap in care. Herein we characterized the use of telemedicine in CIA at a population-based level and single centre.

METHODS: Before the COVID-19 pandemic, telemedicine care was provided via the Ontario Telemedicine Network (OTN) in Ontario, Canada. Descriptive data were collected from the OTN administrative database and from electronic medical records at a single academic centre during 2014 to 2019. The potential distance travelled and time saved by telemedicine visits were calculated using postal codes.

RESULTS: A total of 1298 telemedicine visits was conducted over OTN, with an average of 216 visits per year. Only 11% of the allergists/immunologists used telemedicine to provide care before the COVID-19 pandemic. In the single centre that provided the majority of the telemedicine care, 66% patients were female and the overall mean age was 46. The most common diagnosis was immunodeficiency (40%), followed by asthma (13%) and urticaria (11%). Most patients required at least one follow-up via telemedicine. The average potential two-way distance travelled per visit was 718 km and the average potential time travelled in total was 6.6 h.

CONCLUSION: Telemedicine was not widely used by allergists/immunologists in Ontario, Canada before the COVID-19 pandemic. It could offer a unique opportunity to connect patients who live in remote communities and allergists/immunologists who practice in urban centres in Canada. Independent of the current pandemic, our study further highlights the need for more physicians to adopt and continue telemedicine use as well as for healthcare agencies to support its use as a strategic priority once the pandemic is over.

PMID:34903277 | DOI:10.1186/s13223-021-00635-1

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Characterizing telemedicine use in clinical immunology and allergy in Canada before the COVID-19 pandemic - DocWire News

Immunology

Pfizer Augments Inflammation and Immunology Business with $6.7 Billion Buy – BioSpace

Pierre Suu/Getty Images

The share price of Arena Pharmaceuticalsnearly doubled in premarket trading after pharma giant Pfizer announced it was acquiring the company and its diverse portfolio of developmental and clinical assets, including a late-stage ulcerative colitis treatment, in an all-cash deal valued at approximately $6.7 billion.

Pfizer will acquireoutstanding shares of the company for $100 per share. Arenas stock closed at $49.94 on Friday, and the share price has soared to $95.95 in premarket trading after the announcement was made.

Mike Gladstone, president and general manager of Pfizers Inflammation and Immunology division, said the acquisition of Arena would complement the companys inflammation and immunology business. He said the Arena assets would provide hope for a better and more effective treatment for patients with debilitating immuno-inflammatory diseases.

Specifically, Pfizer is eying Utah-based Arenas experimental Crohns treatment etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. Not only doesetrasimod showpotential in Crohnsbecause of its design to provide systemic and local effects on specific immune cell types, but the experimental drug can also potentiallytreat multiple immune-mediated inflammatory diseases, including ulcerative colitis, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.

Currently, etrasimod is in two Phase III studies in ulcerative colitis, a Crohns disease study, and is moving into a late-stage program in atopic dermatitis.

In Phase II studies in ulcerative colitis, etrasimod showed promise. After 12 weeks, many patients showedpositive clinical responses, clinical remission, or endoscopic improvement. Additionally, data showed that patients in the study experienced sustained or improved effects up to week 46 an open-label extension. Etrasimod also demonstrated a favorable benefit/risk profile. Data from the Phase III studies are expected in 2022.

Last month, Arena announced it achieved target enrollment in its Phase II/III CULTIVATE Study A, designed to assess the efficacy, safety, and tolerability of oral etrasimod as a potential therapy for adult participants who have moderate to severe Crohns disease and are refractory or intolerant to at least one of the currently available therapies. Etrasimod is also in two Phase II programs in eosinophilic esophagitis and alopecia areata.

Utilizing Pfizers leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases, Gladstone said in a statement.

In addition to etrasimod, Arenas pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase II development to treat microvascular obstruction and Raynauds phenomenon secondary to systemic sclerosis. APD418 is currently in a Phase II clinical trial for acute heart failure.

Arena President and Chief Executive Officer Amit D. Munshi expressed excitement regarding the planned acquisition. Munshi said the proposal recognizes Arenas potentially best-in-class S1P molecule and contribution to addressing unmet needs in immune-mediated inflammatory diseases. When the merger goes through, Munshi said Pfizers capabilities will accelerate the companys mission to bring those medications through the regulatory paths and to patients who need new options.

We believe this transaction represents the best next step for both patients and shareholders, Munshi said in a statement.

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Pfizer Augments Inflammation and Immunology Business with $6.7 Billion Buy - BioSpace

Immunology

Luke O’Neill says booster helped to ensure he only got ‘mild’ Covid – The Irish Times

Immunology professor Luke ONeill has encouraged people to get vaccinated, saying he is only experiencing mild symptoms of Covid-19 as a result of having beenjabbed.

Speaking to The Irish Times on Monday evening, Prof ONeill said that he was deemed a close contact of a confirmed case, and the second HSE antigen test he took on Friday was positive.

On Saturday, he got a PCR test to confirm the result, which came back positive on Sunday.

Im pretty healthy because of the vaccine... vaccines prevent severe disease, and Ive got very mild symptoms, thank God, he said.

People who are fully-vaccinated should not be too worried about Covid, according to Prof ONeill. The virus might grow in your nose... The vaccine is really working to protect your lungs, not so good at your nose, because the immune system cant get there. Thats whats happened to me, its stayed in my nose, and its like a cold.

However, he said people who are immunocompromised are most at risk at the moment, and he was glad to see the National Immunisation Advisory Committee (Niac) recommending a fourth dose to people in this category.

We worry about the immunocompromised. These are people who are on chemotherapy, or some other reason their immune system isnt working properly. They need the best possible chance at protection.

He said that now that we know the vaccines are safe, we should utilise them as much as possible. Niac have said immunocompromised people should get a forth dose three months after their third.

Prof ONeill added that children should hopefully get vaccinated soon, with the first shipment of childrens vaccines arriving into Ireland this week.

It was especially important to vaccinate children who were immunocompromised as they had no protection yet, he said.

He also thought that offering a booster dose to everyone three months after their second dose, regardless of what vaccine they received, was a wise move ahead of the increased socialisation around Christmas. Minister for Health Stephen Donnelly announced this change on Monday evening on foot of Niacs recommendation.

There was good evidence published that three months works basically, you get a good response... theres no need to wait for five months.

Omicron has changed the situation, he added, and the Government and Niac had responded to it appropriately.

He doesnt think that everyone will need a forth dose, but added that it was hard to know yet. It might be offered to older people... younger people usually have a stronger immune system.

Earlier, Prof ONeill said he would be quadruply vaccinated, having had the booster on Thursday after his two-shot vaccine, and then testing positive for Covid at the weekend.

Now is the time to boost as many as possible, he told RT Radio Ones Today with Claire Byrne show.

He said that, even if symptoms from the Omicron variant were milder, as research had indicated, there could still be a number of people who ended up in hospital and that would put pressure on the health system.

However, it was still uncertain how strong the level of infection was , he said, which was why it was important for everyone to be boosted.

This article was amended on December 14th, 2021

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Luke O'Neill says booster helped to ensure he only got 'mild' Covid - The Irish Times

Immunology

Corbett Named One of Time’s Heroes of the Year | Newsroom – UNC Health and UNC School of Medicine

Kizzmekia Corbett, PhD, a vaccine scientist at the National Institutes of Health and UNC School of Medicine Alumna, was named one of Time magazines Heroes of the Year for her work on developing a COVID-19 vaccine.

Kizzmekia Corbett, a 2014 graduate of the UNC School of Medicine Microbiology and Immunology PhD Program, has been named among Time Magazines 2021 Heroes of the Year.

Times 2021 Heroes of the Year recognition honors the scientists whose work produced COVID-19 vaccines, including Corbett; Barney Graham, MD, PhD, former deputy director of the NIH Vaccine Research Center; Katalin Kariko, PhD, biochemist and adjunct professor of neurosurgery at the University of Pennsylvania Perelman School of Medicine; and Drew Weissman, MD, PhD, Roberts Family Professor in Vaccine Research in the Perelman School of Medicine.

As a student in the UNC School of Medicine, Corbetts mentor was Aravinda de Silva, PhD, professor in the UNC Department of Microbiology and Immunology. Corbett focused on vaccine development and studied dengue virus at UNC. She won an off-campus dissertation fellowship from the UNC Graduate School and conducted research in Sri Lanka, and she was involved in extracurricular activities, including serving as a representative on the UNC Student Congress, a delegate to the UNC System Association of Student Governments, a staff member in the Honor System Attorney Generals office, and as a member of the science policy advisory group.

In 2014, Corbett was appointed to serve as the team lead for coronavirus research within the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Centers Viral Pathogenesis Laboratory. Corbetts team partnered with Moderna to create a vaccine using state of the art mRNA technology in. The FDA cleared Modernas vaccine for emergency use in December 2020.

Today, Corbett is an assistant professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

Her work has garnered several prestigious awards, including the Benjamin Franklin Next Gen Award and the Salzman Memorial Award in Virology. Additionally, the Board of Commissioners in Corbetts hometown of Hillsborough, North Carolina, declared Jan. 12, 2021, as Kizzmekia Kizzy Corbett Day.

In February 2021, Corbett was named to Time Magazines 2021 TIME100 Next List, and in May 2021, Corbett and Anthony Fauci, MD, director of the NIAID, delivered UNC-Chapel Hills Spring Commencement Address.

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Corbett Named One of Time's Heroes of the Year | Newsroom - UNC Health and UNC School of Medicine

Immunology

US FDA Approves Pfizer’s XELJANZ (tofacitinib) for the Treatment of Active Ankylosing Spondylitis | Small Molecules | News Channels -…

DetailsCategory: Small MoleculesPublished on Wednesday, 15 December 2021 10:02Hits: 300

NEW YORK, NY, USA I December 14, 2021 I Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ / XELJANZ XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

We are proud to offer XELJANZ, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease, said Mike Gladstone, Global President, Inflammation & Immunology, Pfizer. This regulatory approval affirms the clinical value and versatility of XELJANZ, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.

The approval of XELJANZ for AS is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS)20 response was significantly greater with tofacitinib (56.4%, n= 75) versus placebo (29.4%, n=40) (p<0.0001). In addition, the percentage of patients achieving an ASAS40 response was significantly greater with tofacitinib (40.6%, n=54) versus placebo (12.5%, n=17) (p<0.0001), a key secondary endpoint of the study.1 ASAS20/40 are used for defining improvement or response to treatment.2 The safety profile observed in patients with AS treated with XELJANZ was consistent with the safety profile observed in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Ankylosing spondylitis, a type of arthritis that causes inflammation in certain parts of the spine, affects more than 350,000 people in the U.S.3 This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility,4 said Steven Taylor, Executive Vice President, Mission and Strategic Initiatives of the Arthritis Foundation. With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease.

About XELJANZ (tofacitinib)

XELJANZ is the first and only oral JAK inhibitor approved in the United States in five indications. XELJANZ is indicated in patients who have had an inadequate response or intolerance to one or more TNF blockers: in adults with active AS, adults with moderately to severely active RA, active PsA, moderately to severe active ulcerative colitis (UC) and in children two and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012.5,6,7 As the developer of XELJANZ, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of this medicine through robust clinical development programs in the treatment of immuno-inflammatory conditions.

Earlier this month, the FDA updated the prescribing information for XELJANZ and included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies and thrombosis (with corresponding updates to applicable warnings and precautions). In addition, indications for the treatment of adults with moderately to severely active RA or active PsA, and patients who are two years of age and older with active pcJIA were revised to require inadequate response or intolerance to one or more TNF blockers.

About Ankylosing Spondylitis

Ankylosing Spondylitis is a chronic, inflammatory disease that affects men and women in early adulthood. The onset of symptoms usually occurs before the age of 30 and seldom occur after the age of 45. Symptoms of AS include chronic pain and stiffness in the back and hips for those living with the disease and can negatively impact health-related quality of life. Over time, some patients may experience fusion of the vertebrae in the spinal column.8 According to studies, more than 350,000 people live with AS in the United States.3

INDICATIONS

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Ulcerative Colitis

Polyarticular Course Juvenile Idiopathic Arthritis

Please see full Prescribing Information, including BOXED WARNING for XELJANZ available at: http://www.xeljanzpi.com.

About Pfizer Inflammation & Immunology

At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients with these debilitating diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.

To learn more, visit http://www.pfizer.com/science/immunology-inflammation.

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 170 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.

1 Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Apr 27;80(8):100413. doi: 10.1136/annrheumdis-2020-219601. Epub ahead of print. PMID: 33906853; PMCID: PMC8292568. 2 Landew R, van Tubergen A. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47. doi:10.1007/s11926-015-0522-3 3 Strand V, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res (Hoboken ). 2013;65:1299-1306. doi:10.1002/acr.21994 4 Johns Hopkins Arthritis Center. Ankylosing Spondylitis. Accessed December 1, 2021. https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis 5 Pfizer Data on File. XELJANZ Worldwide Registration Status. 6 ClinicalTrials.gov. Tofacitinib RA Studies. Accessed June 25, 2020. 7 Pfizer. Data on File. Tofa Counts. April 2019 8 University of Maryland Medical Center. A Patients Guide to AS. Accessed August 2021. Available at: https://www.umms.org/ummc/health-services/orthopedics/services/spine/patient-guides/ankylosing-spondylitis

SOURCE: Pfizer

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US FDA Approves Pfizer's XELJANZ (tofacitinib) for the Treatment of Active Ankylosing Spondylitis | Small Molecules | News Channels -...

Immunology

Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in AML Patients – BioSpace

AML Biomarker Identification Can Improve Clinical Trials for New Drugs and Accelerate Drug Approvals

ATLANTA--(BUSINESS WIRE)-- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from a clinical study using the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) to predict therapy response for individual Acute Myeloid Leukemia (AML) patients were featured in a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition held December 11-14, 2021 in Atlanta, Georgia. The complete results from this study are available online in the ASH Meeting Library as Abstract 1299.

In the study, the Cellworks Biosimulation Platform and CBM was used to assess cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML. The study found that Cellworks biosimulation identifies novel biomarkers that predict therapy response in AML patients, which offers the opportunity to tailor FDA-approved chemotherapy regimens to each patient to improve disease control and minimize toxicity. In addition, biosimulation is emerging as an essential tool to improve the success rate of clinical trials and speed the development of lifesaving medicines for the patients that need them.

From comprehensive genomic inputs, the Cellworks Biosimulation Platform identifies pathway based polygenic biomarkers that predict the efficacy of novel drug combinations and new drugs for AML patients, said Dr. Michael Castro, MD, Chief Medical Officer at Cellworks. Cellworks AML biomarker identification and therapy response prediction capabilities should accelerate clinical trials for new therapies and improve trial success rates by predicting if a patients genomic profile will respond to specific regimens. Biosimulation has the ability to improve outcomes for patients, avoid drugs that produce only toxicity and extend the reach of precision medicine in the clinic.

The Cellworks Biosimulation Platform simulates how a patient's personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 4,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. By reliably predicting an individual patients therapy response prior to receiving the treatment, the Cellworks Platform can guide the selection of the optimal treatment, help patients avoid ineffective therapies and improve patient outcomes.

Clinical Study: ASH Abstract 1299

Biosimulation using Cellworks Computational Omics Biology Model (CBM)-based assessment of cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML.

Background

Genomic heterogeneity in leukemic blasts characterizes AML patients and is associated with variable drug responses. In this study, 539 AML patients were selected based largely on genomic data published in TCGA and PubMed. The Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to identify novel genomic biomarkers associated with response among AML patients treated with cytarabine (ARA-C) + idarubicin or daunorubicin (anthracycline) with or without etoposide (VP16).

Results

Cellworks biosimulation of ARA-C + anthracycline with and without VP16 identified biomarkers responsible for therapy responses. Additionally, the biosimulation identified novel drug combinations for non-response to these standard combinations. Altogether, 89 of the 539 patients (16.5%) could have been managed with a potentially superior treatment approach based on the biosimulation by either adding or omitting VP16 or being treated with an alternative therapy.

Conclusion

This study highlights patients for whom triplet therapy promises potential superior benefit, others who would benefit equally from doublet therapy without VP16 and others unlikely to respond to standard or triplet therapy for whom an alternative personalized approach might offer better outcomes. In AML, Cellworks biosimulation offers the possibility to tailor the chemotherapy regimen to each patient to improve disease control and minimize toxicity.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multiomics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts personalized therapy responses for patients. The Cellworks Therapy Biosimulation Platform optimizes the uniqueness of each patients cancer by utilizing their multiomic data to create a personalized disease model using Cellworks proprietary Computational Omics Biology Model (CBM). The Cellworks Platform uses the personalized disease model to identify disease-biomarkers unique to each patient and biosimulate the patients responses to drugs and therapy regimens. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

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Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in AML Patients - BioSpace

Immunology

First cases of the omicron variant of coronavirus confirmed in Slovenia | GOV.SI – Gov.si

Marta Grgi Vitek presented the updated vaccination recommendations. She said on the subject of the vaccination of children up to 12 years of age that vaccination is recommended for children with chronic diseases and those living with people having such diseases. The recommendations will also be modified to cover the booster dose. The booster dose is recommended after six months, with a minimum interval of three months between the primary dose vaccination and the booster dose. As Grgi Vitek added, the consultation group that met yesterday also agreed with the European Commission's proposal to limit the validity of the Digital COVID Certificate. For those vaccinated with the primary dose of COVID-19 vaccine, the validity of the Digital COVID Certificate will thus be limited to 270 days. After this period the certificate will expire and a booster dose will be required to renew the certificate.

According to Dr Miroslav Petrovec, four samples of the omicron variant were detected in the last screening tests carried out at the Institute of Microbiology and Immunology. The persons infected come from the Ljubljana area and were tested in the period from 29 November to 6 December. The epidemiological data are still being investigated. One of the infected persons contracted COVID-19 last year. Dr Petrovec therefore urged everyone to get vaccinated and invited those who received two doses of the vaccine at least six months ago to get vaccinated with a third dose.

In his introduction, Minister Poklukar presented the epidemiological indicators measuring the burden of the disease in hospitals. As he pointed out, 83 % of the 235 COVID-19 patients that are in intensive care have not been vaccinated. According to the Minister, there are a total of 817 coronavirus patients in hospital, of whom 71 % have not been vaccinated.

The Minister believes that the discovery of omicron may cause another COVID-19 wave. The decline in the daily number of infections in recent days is also slowing down and the Minister renewed his call to the people to get vaccinated.

Poklukar noted that 90% of the patients admitted to the COVID-19 wards are over 45 years of age. In COVID-19 intensive care units the situation is the same. He also pointed out that approximately 190,000 people aged over 50 years have not yet been vaccinated. In this age group, the rate of hospitalisation is about 10 %, while the rate of admissions to intensive care units amounts to 3 %. In the light of the rapid transmissibility of the omicron variant, between 15,000 and 20,000 hospital admissions can be expected. The virus will continue to burden hospitals until summer, which will be difficult for the health sector to sustain.

The Minister added that from 19 to 23 December 2021 a vaccination campaign will take place across Slovenia. Vaccination centres will be open from 8 am to 8 pm at all current locations. In each statistical region there will also be a vaccination centre or a location where vaccination will take place form 8 pm to 8 am. Mobile units will also be set up, in larger numbers than in the past, concluded Minister Poklukar.

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First cases of the omicron variant of coronavirus confirmed in Slovenia | GOV.SI - Gov.si