Its that time of year again an avalanche of ads urging us to drool into tubes so companies can spit back verdicts on our pasts, presents, and futures. Judging from my emails, those unceasing ads have inspired many questions about genetics in general.

Among the emails that pinged in recently:

So I started a list of my e-mails, with apologies to Hillary, and extracted three recurring themes: transgender identity, when a human life begins, and by far the largest group: interpreting DNA test results, either consumer or clinical.

What do you think about a new studythat found 20 genetic markers of transgender identity? asked a reporter from The Times of London In March 2018. Id suggested just such a study a year earlier, which hed found here.

Impressed with the study, I agreed to comment. But the reporter forgot to distinguish me from the researcher, and so throughout Europe, I was suddenly an expert on transgender genes. And that inspired some telling emails.

The first, from a trans woman born in 1948, shared her 70-page story:

As far back as I can remember I thought nothing of going into my mothers closet, pulling down her nightgowns, and putting them on. They were soft, they smelled of her, and they felt so perfect. This was me. Everything feminine fascinated me. Anything male repelled me. I wanted to emerge myself in the female world. But no matter what I did, I just couldnt look like Mommy.

Another transgender woman wrote:

I would love to have that degree of certainty that a genetic study would show. Parents would be able to perhaps work with their children instead of ignoring it either intentionally or out of ignorance.

A recent email from 58-year-old Edith brought up nature v nurture:

Two of my nine nieces and nephews are transitioning. My family has an overall fluid concept of gender identity, which we discussed with each other before either child made it known they were trans. I find myself wondering if this is true in other families.

Me too.

I repost 17 timepoints whenever womens reproductive rights are threatened, or I read or hear a comment that indicates ignorance of biology. The idea of the list came to me when considering that an embryos genome turns on at day 5, but it cant possibly exist at that point outside of a womans body.

One woman asked about fetal rights. Her ex had given her an herbal abortion tea without her knowledge when she was pregnant. Her baby so far is healthy, but she wants a court to recognize the tea-poisoning as child abuse. At what point in utero does a fetus have rights? It seems to vary state to state, she wrote.

Celia Collias, a statistics major at the University of North Carolina, offered a compelling perspective: distinguishing two types of viability. Natural ability to be physiologically independent for a human fetus is around 24 weeks. Technologically assisted viability for a human fetus is 21 weeks.

If we dont use natural viability as the cut off for reproductive rights, Ms. Collias argues, then those rights will erode as technology sets back the age of assisted viability:

Technologically assisted viability is not free. If we allow that to be the benchmark, its going to cost society a lot to care for all those fetuses where would that money come from?

Good question.

Is he really my brother? asked the woman who sent me scanned columns of genetic markers. I circled 16 of 38 that they share and sent it back: Yes.

I dont have mutations in BRCA1 or 2, so Im ok, right? I do have a mutation in ATM (or p53 or CHEK2 or PTEN or RAD51 or a few dozenothers). Inherited mutations for cancer risk go beyond the most common ones in the BRCA pair, and altogether they account for only 5 percent of cases. Yes, shes at high risk.

BRCA brings up the limited variant problem. Consumer DNA tests, for cancer or single-gene diseases, are likely to check for only the most common variants, such as a handful of mutations in the CFTR gene behind cystic fibrosis, which has more than 1,700. These health reports may provide a false sense of reassurance and should not be used for making any health decisions without confirmation testing, said Edward Esplin, MD, of Invitae, a clinical testing company, at the American Society of Human Genetics conference in October, catalyzing a flood of headlines.

I had a prenatal screen for 125 genes and one is a variant of uncertain significance. What the heck is a VUS? Do I have a mutation or not?

A VUS is a gene variant that isnt common, but hasnt shown up in someone with a disease and reported in the medical literature. Yet. I explain here.

My ethnicity estimate changed overnight. Huh? When an ancestry company adds a new group to its database of reference populations, the sections of those pie charts can shift, or a new one appear.

Im 20 weeks pregnant. The fetus has a microduplication of chromosome 18. Is that a problem? The healthy dad-to-be also had the tiny extra bit of DNA. So, no.

I just found out that I have an extra Y chromosome. Ive had severe acne since my early teens, and today Im 62 and weigh 295 pounds. Im a biker, football player, and served time for selling pot. Did my extra chromosome get me arrested?

Probably not. Being in the wrong place at the wrong time, before decriminalization, was more likely at fault.

Because most of my email brings up medical matters, heres a short guide to getting help in making sense of DNA test results related to health. (For interpreting ancestry findings, the International Society of Genetic Genealogy is an excellent resource.)

Its important to distinguish consumer DNA tests, which anyone can take by purchasing a kit and spitting or swizzling a cheekbrush, from clinical DNA tests, which a health care provider orders and the FDAs Clinical Laboratory Improvement Amendments (CLIA) regulate.

Like mushrooms materializing after a warm rain, articles, websites, books and companies are springing up to help consumers navigate test-taking and interpretation.

Finding an expert specifically trained at the graduate level in genetics a genetic counselor, PhD geneticist, or MD with genetics/genomics training is challenging because their priorities are in clinical testing, not the entertainment/education space that the consumer companies so ceaselessly promote. Other scientists may be helpful molecular biologists, biochemists but genetics as a discipline transcends DNA, including developmental, transmission, and population and evolutionary genetics too. Ancestry testing in particular melds these levels of genetics.

Assuming a sit-down with an expert to intrepret consumer DNA data isnt happening easily, here are some places to turn.

A longstanding helpful website is Genetics Home Reference, from the NIH.

A newer resource is this report from ConsumersAdvocate.org. Their researchers recently sent DNA anonymously to 9 leading consumer DNA testing companies, interpreted the data, and then wrote a detailed, clear analysis that compares the services, privacy/security measures, online resources, and cost of tests.

Consumer DNA testing is a fast-growing industry with over 26 million users worldwide. That number is expected to grow to 100 million by 2021, Sam Klau, Community Outreach at the organization, told me.

An excellent new book is DNA Nation: How the Internet of Genes is Changing Your Life, by PhD molecular biologist Sergio Pistoi. And my human genetics textbook will be out in a new edition in September. Ive added a chapter called The Genetics of Identity, inspired by having my past rewritten recently thanks to ancestry testing.

The testing company websites, like that of 23andme, provide clear and well-written info on interpreting test results. But without any prior knowledge of genetics, misinterpretation and misplaced angst can arise.

Does the average person know the difference in significance between revealing a pattern of genome-wide single-base variations (SNPs) associated with elevated risk of a trait or illness, and detecting a well-studied mutation in a single gene?

The raw data dump from consumer DNA testing can be overwhelming, and to paraphrase Elizabeth Warren: Theres a company for that. A consumer can pay to avoid bushwhacking through dense SNP forests.

Strategene, for example, is a genetic reporting tool that uses 23andMe data to identify SNPs in a few dozen well-studied, health-related genes, and not every SNP under the sun. The $45 is a sound investment; it would take hours to sort through Google Scholar to DIY. But the client needs to know about the limited variant issue of checking only for common SNPs.

(I was briefly fooled into confusing the company with 1980s biotech giant Stratagene, but its off by one letter and one capitalization. The only person named on the company website is a naturopath referred to many times as Dr., which wouldnt necessarily denote a genetics expert.)

Im curious to see how soon the medical profession catches up. Right now, genetic counselors in the US number only about 5,000. But professional organizations are stepping in. The American College of Medical Genetics and Genomics, for example, offers online continuing medical education, ACMG Genetics 101 for Healthcare Providers.

But doctors Ive encountered recently still go deer-in-the-headlights when I ask a genetics question, just to be obnoxious. And so a company like ActXmakes sense in helping medical professionals keep pace with the growing tide of patients coming in waving consumer DNA test results. The company helps physicians and patients apply 23andMe raw data to select drugs, order clinical tests to help diagnose specific conditions, and to confirm carrier status for single-gene diseases.

When I started my career as a Drosophila geneticist, mutating flies to grow legs out of their heads, I never imagined at-home DNA testing. When I started my career as a science writer and textbook author, I still couldnt have predicted at-home DNA testing. Now that its here, Im thrilled that DNA science has become so much more tangible and practical. Yet we must use the information in our strings of A, C, T, and G wisely.

Ricki Lewis is the GLPs senior contributing writer focusing on gene therapy and gene editing. She has a PhD in genetics and is a genetic counselor, science writer and author of The Forever Fix: Gene Therapy and the Boy Who Saved It, the only popular book about gene therapy. BIO. Follow her at her website or Twitter @rickilewis

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Does the 'genetics revolution' unsettle you? Here is a guide, and reasons to be hopeful - Genetic Literacy Project

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GLEN MILLS, Pa., Dec. 10, 2019 /PRNewswire/ --SmartSolutions RX, Inc. announces the launch of a new scientifically based, drug-free hair support system LOCKrx, which includes both ingestible and topical Healthy Hair Programs that create the ideal environment to maintain hair follicle cycle and growth.

Hair thinning and hair loss are a pervasive problem, affecting an estimated 80 million men and women in the U.S. Smoking, diet, stress, environment and genetics all contribute to hair loss, as well as the hormone DHT which shrinks the hair follicle and is the primary cause of loss in male and female pattern baldness. The current treatments often come with unwanted side effects and take months to generate results.

LOCKrx is a drug-free hair treatment system that addresses scalp health, both internally and externally, that directly impacts hair growth and quality.

"When formulating LOCKrx, we meticulously designed and tested both ingestible and topical ingredients that are scientifically proven to reduce the inflammation associated with damaged hair follicles and thereby improve quality of the hair," said Cynthia Rager, President and COO of Vision Medical, Inc. "Our topical LOCKrx solutions include specific growth factors clinically shown to play a key role in the hair follicle growth pathway as well as to enhance wound repair and skin regeneration, all of which improve scalp skin health, while also playing a vital role in the proliferation of skin and hair cells."

LOCKrx is available as both internal and external treatment plans, designed to work synergistically to promote healthy scalp skin and hair growth.

"Growthfactors possess the ability to stimulate hair growth through variousmechanistic pathways," said Richard Jin, M.D., Ph.D., Hair Regeneration Specialist, RJClinical Institute. "We have experienced very positive results when combiningthese with platelet rich plasma therapy to promote new and existing hairgrowthas well as using it as an alternative to PRP. This has helped us treat the mostcommon form of hair loss known as androgenetic alopecia, as well as increasethickness and density of hair in post-transplant patients."

LOCKrx Inside Healthy Hair Programis a 3-step, 6-week ingestible plan that uses unique marine and botanical ingredients, amino acids, and vitamins to address total body inflammation.

1. DEFENSE Gut Health - Prebiotic supplement that includes mineral-rich blue green algae and proven anti-inflammatory botanicals curcumin, aloe, licorice and beta-glucan to address gut health in powdered form.

2. BLOCK Hair Loss- Follicle-enrichment supplement formulated with the LOCKrx proprietary blend of botanicals, adaptogens, marine collagen, and saw palmetto to help support hair growth and block conversion of testosterone to DHT, one of the major causes of hair loss in male and female pattern baldness.

3. GUARD Healthy Hair Tabs- Premier blend of complexed Vitamin B plus biotin in the most bio-available form.

LOCKrx Outside Healthy Hair Programis a combination of clinical and at-home applications of growth factor solutions that support and balance the scalp microbiome, while enhancing the environment for healthy hair growth:

VisionMedical, Inc. has exclusive physician distribution rights for LOCKrx.

Smart Solutions RX, Inc.

Smart Solutions RX, Inc. formulates, develops, manufactures and distributes products for medical aesthetic applications to hair and skin. A blend of scientific research and innovative formulation and delivery systems are the hallmark, as evidenced in the LOCKrx brand for healthy hair support. Medical aesthetic protocols and workshops are integrated into the superior customer support program. http://www.smartsolutionsrx.com

Vision Medical, Inc.

Founded in 2013, VisionMedical, Inc. develops, manufactures, and marketsmedical and aesthetic technology for the medical and aesthetic marketsfor worldwide distribution.Vision Medical's first commercial product, theSmartGraft Hair Restoration System, incorporates an award-winning Automated Follicular Unit Extraction (FUE) system for men and women.Featuring theindustry's first closed harvesting system, SmartGraft allows physicians to harvestgrafts more efficiently while keeping grafts moist prior to implantation. http://www.SmartGraft.com.

CONNECT WITH US

Instagram: @SmartSolutionsRXTwitter: @SSolutionsX Facebook: @SmartSolutionsRXinc

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SOURCE SmartSolutions RX, Inc.

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(Reuters Health) - Babies who are born too early may be more likely to develop diabetes as children and young adults than full-term infants, a new study suggests.

In a study of children up to age 18, those born before 37 weeks gestation were 21% more likely that those born at full term to develop type 1 diabetes, the less common form of the disease that typically appears in childhood or young adulthood. Kids born prematurely were also 26% more likely to develop type 2 diabetes in childhood.

And preemies were 24% more likely to develop type 1 diabetes and 49% more likely to develop type 2 diabetes by the time they were 43 years old.

Preterm birth interrupts normal development of multiple organ systems, including the pancreas where insulin-producing cells are formed, which may potentially contribute to later development of diabetes, said lead study author Dr. Casey Crump of the Icahn School of Medicine at Mount Sinai in New York City.

Pregnancy normally lasts about 40 weeks, and babies born after 37 weeks of gestation are considered full-term. Babies born prematurely - earlier than 37 weeks - often have difficulty breathing and digesting food in the weeks after birth. Preemies can also encounter longer-term challenges such as impaired vision, hearing and cognitive skills, as well as social and behavioral problems.

Some previous research suggests that preemies have an increased risk of developing so-called insulin resistance, a failure to respond normally to the hormone insulin.

In type 1 diabetes, the pancreas cant produce insulin. In the type 2 form of the disease, which is often linked to obesity and aging, the body cant properly use or make enough insulin to convert blood sugar into energy.

For the current study, researchers examined data on almost 4.2 million babies born in Sweden from 1973 to 2014. Most were followed until they were at least 22 years old.

Overall, 0.7% of the babies in the study population went on to develop type 1 diabetes and just 0.1% developed type 2 diabetes, the researchers report in Diabetologia.

Parents should know that most children who were born preterm will have good health in childhood and adulthood, Crump said by email. However, they also have modestly increased risks of diabetes that persist into adulthood.

Overall, the risk tended to be higher for preemie girls. Boys who arrived early were about 20% more likely to develop type 1 diabetes during the study, while girls had about a 30% greater likelihood.

With type 2 diabetes, female preemies were 60% more likely to develop this disease during childhood than full-term babies, while preemie males didnt have an increased risk. For young adults in the study, women who were preemies had a 75% increased risk of type 2 diabetes and men who were preterm had a 28% increased risk.

Many people in the study had siblings included in the analysis. Shared genetics and family circumstances appeared to explain some, but not all, of the increased risk of diabetes for preemies.

The study wasnt designed to prove whether preterm birth influences susceptibility to diabetes.

Even so, the results underscore that preemies need to take steps to prevent diabetes later in life, said Ciaran Phibbs of the VA Palo Alto Health Care System and Stanford University School of Medicine in California.

The home environment is an important factor, especially for type 2 diabetes, Phibbs, who wasnt involved in the study, said by email. This includes things like diet and exercise habits, which can impact the risk of obesity, which is higher for preemies than for full-term babies and is a risk factor for diabetes, he said.

Individuals who were born preterm can help prevent diabetes by following a healthy lifestyle across the life course, including a healthy diet, regular physical activity, and maintaining a normal weight, Crump advised.

SOURCE: bit.ly/2LCQrpq Diabetologia, online December 3, 2019.

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Preemies face higher risk of diabetes as children and young adults - Reuters

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Only recently have scientists applied such techniques to bringing endangered wildlife species back from the brink of extinction.

December 8, 2019 by EarthTalk Leave a Comment

By Doug Moss and Roddy Scheer

Dear EarthTalk: Can fertility techniques pioneered for humans or other animals be used to try to bring back endangered wildlife species?

James E., Richmond, VA

No doubt, humans have come a long way in engineering medical solutions to our own fertility problems. The most common techniques to help people have babies today include: using medication to stimulate unresponsive ovaries to develop mature eggs; artificial insemination whereby healthy sperm is placed directly into a womans uterus and conception happens normally thereafter, and In Vitro Fertilization (IVF), which entails combining eggs and sperm outside the body and then inserting one of the resulting fertilized embryos (so-called test tube babies) into the womans uterine cavity and letting the rest of the pregnancy proceed to term naturally.

While such techniques have helped millions of couples around the world bear healthy babies, only recently have scientists applied such techniques to bringing endangered wildlife species back from the brink of extinction. The genetics of human fertility can give a better understanding of fertility in more exotic species, reports Dr. Sherman Silber, a pioneering human fertility expert at St. Lukes Hospital in Chesterfield, Missouri who has had success applying the lessons learned on humans to animals.

To date, Silber and his colleagues have helped a half dozen leading U.S. zoos maintain healthy populations of chimpanzees, gorillas, South American bush dogs, Mexican wolves, orangutans and Mongolian wild horses using surgical techniques, artificial insemination, IVF and gestational surrogacy (whereby another female besides the genetic mother carries the pregnancy to term).

We have frozen ovaries in animals that are destined to die off for later ovary transplantation back to related species to be able to increase their population, reports Silber, who has of late been ramping up efforts to bring back dwindling populations of still-wild endangered species.

Another leading light in the field is Thomas Hildebrandt, who heads the reproduction management program for Berlins Leibniz Institute for Zoo and Wildlife Research and is well known among wildlife veterinarians for his pioneering work in endangered species insemination. Hildebrandt, who helped conceive upwards of 50 endangered elephant calves by artificially inseminating their mothers is now focusing his attention on trying to rescue the Northern White Rhino using IVF techniques. Rampant poaching in the 1970s and 1980s and surging demand in Asia for rhino horns decimated the animals populations in Africaonly two individuals, Fatu and Najin (both female and incapable of carrying babies due to health complications) remain alive today; the last male, Sudan, died in March 2018.

Now Hildebrandt and colleagues want to bring them back. They froze the sperm from Sudan and four other males before they died and hope to combine it with eggs harvested from Fatu and Najin while using less endangered but genetically similar Southern White Rhino females as pregnancy surrogates. While this baby step wont be enough to achieve the genetic diversity required to create a sustainable long-term population, Hildebrandt hopes it can open funders eyes to the possibility of actually reviving populations of Northern White Rhinos and other species through stem cell research and other techniques researchers havent even dreamed up yet.

This post was previously published on earthtalk.org and is republished here with permission from the author.

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Another set of female innovation leaders are making headlines as we move into another week of innovators to know.

This week's set of who's who include a startup founder trying to change the world, a passionate PhD with a story of failure to tell, and a biomedical engineer enhancing health tech in Houston.

A Houston mom is working hard on her startup so that next summer, breastfeeding moms can swim in style and worry free. Courtesy of Orolait

On the surface, it may seem that Houston mom Ana Carolina Rojas Bastidas has a passion for fashion, as she's created and is fundraising for a new-mom specific line of swimwear. But really, she's on a mission to give breastfeeding women back their dignity with her startup, Orolait.

"I decided to build this company to challenge and change the way we depict one's breastfeeding journey," Bastidas says on the website. "I stand on the pillars of advocacy, education, and inclusion. You will see the sizing and advertising featuring all shapes, sizes, and shades because each of us is so different and that is what makes us so incredible and I am going to unapologetically celebrate that in the most ethical way I know how." Read the story.

Brittany Barreto founded the first nationwide DNA-based dating app, and she shares her story of its unexpected, and unavoidable, downfall. Photo courtesy of Pheramor

After dedicating three long years to her startup that began as an idea in college, Brittney Barreto is saying goodbye to Pheramor. Barreto explains how her DNA-based dating app got pulled from the Apple app store following policy changes, and how it left her with no choice but to shutter the operation.

Now, Barreto has big plans for funding femtech, and is learning a lot in her new role at Capital Factory. She's already able to do more for other founders and create a bigger impact.

"I realized that over the past two years, I had already been ad hoc coaching and mentoring founders and loving it," Barreto says. "Now, I was doing it and getting paid for it, on a bigger scale, and with more resources. I knew it was the journey I wanted to continue down." Read the full story.

From robots and accelerator programs to her favorite health tech startups, Emily Reiser of the TMC Innovation Institute joins the Houston Innovators Podcast. Photo courtesy of Emily Reiser

Emily Reiser has known for most of her life that she's wanted to work in health tech in some capacity. On the Houston Innovators Podcast, she explains how she combined her early interest in health care with her affinity with engineering inspired by her parents.

Now, she continues to check both those boxes at the Texas Medical Center's Innovation Institute, which has evolved a ton over the past year.

"In 2019, we had a lot of big changes around our team and our leadership," she says on the podcast. "That enabled us to take a bigger breath and a bigger pause to say, 'How are we really doing? And how could we be doing better?'" Read the full story and stream the podcast.

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3 Houston female innovators to know this week - InnovationMap

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"These guidelines are as inclusive as possible, wherever there's strong, unbiased evidence to back up our recommendations," said Mary B. Daly, MD, PhD, FACP, Fox Chase Cancer Center, Chair of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "The guidelines include genes that have been found to increase cancer-susceptibility. These NCCN Guidelines still have a strong focus on BRCA1 and 2 mutations, but also now include other high and moderate penetrance genes associated with breast, ovarian, and pancreatic cancer. We continuously review any new data on genes that might increase a person's risk of getting cancer or impact the effectiveness of their treatment."

The updated guidelines are concentrated around simplified criteria to clarify the genetic testing process. For example, in a newly-added guide for individuals of Ashkenazi Jewish ancestry who have not been diagnosed with cancer, genetic testing may be offered for the three Ashkenazi Jewish founder mutations in the context of a long-term research study, regardless of family history. These individuals should be encouraged to consult with a cancer genetics professional.

The NCCN Guidelines for Genetic/Familial High-Risk Assessment are organized by both disease and syndrome type, and also now include streamlined information on appropriate subsequent steps for persons who meet criteria for genetic testing. The panel acknowledges that genetic mutations can impact the approach to cancer treatment, and the guidelines now state that testing may be clinically indicated if it will aid in systemic therapy decision-making.

"Genetic testing is becoming increasingly utilized in oncology because of its potential to impact surgical decisions and chemotherapy," explained Robert Pilarski, MS, LGC; MSW, Licensed Genetic Counselor, Professor, Clinical Internal Medicine, The Ohio State University Comprehensive Cancer Center, Vice-Chair of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "At the same time, the complexity of this testing is increasing, with a growing number of genes and tests available,a limited understanding of the management implications of some of the newer genes, and even uncertainty over the implications of mutations in well-established genes in some situations (for example in a condition known as 'mosaicism,' in which the mutation is not present in all of the cells of the body). Because of this, the NCCN Guidelines continue to highlight the critical importance of genetic counseling for patients prior to undergoing genetic testing to ensure that patients are fully informed of the test implications."

Pilarski also offered an important word of caution about the potential risks from direct-to-consumer genetic testing: "More and more patients are presenting to clinic having already had themselves tested through direct-to-consumer labs. Providers need to be aware that the tests offered by many of these labs are not equivalent to traditional genetic testing, and the results may need to be confirmed in another laboratory before being used for clinical care."

The guidelines recommend all pancreatic cancer patients get genetic testing, and the recent update now includes more information about which genes are associated with pancreatic cancer recommendations. Genetic testing in pancreatic cancer can help determine which treatments would be most effective (e.g. PARP inhibitors) and if family members would benefit from screening and preventive action.

"There's been an explosion of recent data showing that roughly 4-10% of individuals with pancreatic cancer harbor inherited genetic mutations, including BRCA1, BRCA2, ATM, the Lynch syndrome genes, and others," said Matthew B. Yurgelun, MD, Dana-Farber/Brigham and Women's Cancer Center, Member of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "Such data have, surprisingly, shown that classic 'high-risk' features of inherited cancer risk (e.g. young age at diagnosis, strong family histories of cancer) are often absent in individuals with pancreatic cancer who carry these mutations. Based off of these data, there is now a compelling reason for all individuals with pancreatic cancer to be offered genetic counseling and germline testing for such variantsparticularly given the possibility that their at-risk family members could greatly benefit from known, effective cancer risk-reducing interventions (e.g. surgical removal of the ovaries for female BRCA1/2 mutation carriers). Emerging data have also begun to suggest possible benefits to pancreatic cancer screening in select high-risk individuals who harbor such mutations. These new guidelines address many of the important nuances and limitations of this exciting and rapidly evolving body of literature."

The NCCN Guidelines for Genetic/Familial High-Risk Assessment are created and maintained by an interdisciplinary panel of experts from the alliance of 28 leading cancer centers that comprise NCCN. NCCN panels also include patients and advocates to make sure treatment recommendations meet the needs of people with cancer and their caregivers.

"Participating on the NCCN panel allows FORCE to share the real-world experiences of patients making complex, and often agonizing medical decisions about hereditary cancer treatment and risk management," said Sue Friedman, DVM, Executive Director, Facing Our Risk of Cancer Empowered (FORCE), Member of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "As an advocacy organization for people and families affected by hereditary cancer, we see the importance of having standardized guidelines. These guidelines are a critical piece of informed decision-making; we frequently direct our community to NCCN for up-to-date, clear, and credible information developed by experts in the field."

NCCN Guidelines are the recognized standard for clinical policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer careincluding physicians, nurses, pharmacists, payers, patients and their familieswith the ultimate goal of improving patient care and outcomes. In addition to covering at least 97 percent of cancers affecting patients in the United States, there are also NCCN Guidelines for detection, prevention, risk-reduction (including smoking cessation), supportive care (including the management of pain, distress, and fatigue), and guidelines for specific populations (including children and young adults).

NCCN Guidelines are available free-of-charge for non-commercial use at NCCN.org, or via the Virtual Library of NCCN Guidelines App.

About the National Comprehensive Cancer NetworkThe National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world.

The NCCN Member Institutions are: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients. Media, visit NCCN.org/news. Follow NCCN on Twitter @NCCN, Facebook @NCCNorg, and Instagram @NCCNorg.

Media Contact: Rachel Darwin267-622-6624darwin@nccn.org

SOURCE National Comprehensive Cancer Network

http://www.nccn.org

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As the total number of e-cigarette and vaping-related injuries (EVALI) reaches2,291 across all 50 states, researchers in California are unveiling a new potential danger of vaping: cobalt lung.

The news comes from acase studypublished in the European Respiratory Journal this week which focuses on a 49-year-old woman in California who developed the rare disease after vaping for just six months. The woman, a dog trainer by trade, sought out medical help when she began experiencing symptoms like shortness of breath and coughing which aligned with the pneumonia-like cases of EVALI.

Although doctors initially thought she may have had vaping illness, the womans lungs showed something else, the distinct scarring of lung tissue that is typically only seen in those who work with hard metals. The condition technically known hard-metal pneumoconiosis is a rare but serious disease of the lungs associated with inhalational exposure to tungsten or cobalt dust, according to the NIH.

After observing her lung tissue, the researchers from the University of California, San Francisco performed tests on her vaping product, which contained the hard metal cobalt, among others. In a statement released to reporters, the researchers expressed shock at the development.

"Exposure to cobalt dust is extremely rare outside of a few specific industries, Rupal Shah MD, assistant professor of medicine in the division of pulmonary, critical care, allergy, and sleep medicine at the University of California, San Francisco,said. This is the first known case of a metal-induced toxicity in the lung that has followed from vaping and it has resulted in long-term, probably permanent, scarring of the patient's lungs.

In an interview with Yahoo Lifestyle, Kirk Jones MD, clinical professor of pathology at the University of California, San Francisco said hes only seen three previous cases of cobalt lung in his entire career, including one involving a sawmill worker and another in a dental worker. Its always been kind of a work-related disease so it was peculiar in this patient because they didnt have any exposures that we knew of, Jones tells Yahoo Lifestyle. Until we tested the vaping device.

The vaping device the woman was using, called the ZenPen, was found to have e-cigarette liquid containing nickel, aluminum, manganese, and lead and a metal coil used to heat the liquid. As a result of inhaling this, Jones says the white airspaces of the lung that allow oxygen to flow had been filled up with inflammatory cells.

She had less room in her lungs to breathe, says Jones. The woman was reportedly treated with steroids and has regained half of the function she lost in her lungs, but will likely have permanent scarring.

Jones says EVALI and cobalt lung develop differently. With the EVALI cases, patients suffer an acute collapse and damage of the lung that comes on pretty quickly, probably over a few hours, he explains. Whereas our case is more of an immune reaction. It's kind of an allergic reaction...to the metal found in people who are susceptible to cobalt and the disease would develop over the course of weeks or months.

The researchers are spreading the word about the case of cobalt lung in part because they fear its not the only one. I think that cobalt is probably in a lot of these e-cigarettes, says Jones. Maybe a small percentage of patients that use them will end up with the disease and probably already have, but it hasn't been recognized yet.

Related Video: It Is Not Harmless: Dentists Voice Concern Over Vaping

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Woman's e-cigarette habit leads to her 'cobalt lung' diagnosis an incurable disease found only in metal workers - Yahoo Lifestyle

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Four-Year Data Continue to Show Superior Progression-Free Survival of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma with 31 Percent Reduction in the Risk of Progression or Death

Additional Analysis from ECHELON-2 Phase 3 Clinical Trial Evaluating ADCETRIS Plus CHP Chemotherapy Also Featured at ASH Annual Meeting

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin). These analyses were presented at the 61st Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2019 in Orlando, Fla. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma and expressed on the surface of several types of peripheral T-cell lymphomas (PTCL).

The ECHELON-1 analysis highlighted a four-year update of the phase 3 clinical trial in a poster presentation. ECHELON-1 is evaluating ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) compared to ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine and dacarbazine) in patients with Stage III or IV frontline classical Hodgkin lymphoma.

The ECHELON-2 phase 3 clinical trial data were presented in an oral session at ASH and focused on the outcomes of the subset of patients who underwent consolidative stem cell transplant. ECHELON-2 is evaluating ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) compared to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in frontline CD30-expressing PTCL.

For decades, the standard of care for the treatment of frontline Hodgkin lymphoma has been combination chemotherapy, called ABVD. Unfortunately, approximately 30 percent of patients with advanced stage Hodgkin lymphoma do not respond or relapse following treatment with this therapy, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. The four-year update from the ECHELON-1 trial continues to support the robust and durable frontline treatment benefit of ADCETRIS plus AVD, including in both Stage III and IV disease settings, compared to ABVD across subgroups, regardless of PET2 status. These data reinforce ADCETRIS plus AVD as a treatment option that should be offered to all newly diagnosed advanced stage patients with Hodgkin lymphoma.

Updated data from the ECHELON-1 trial and further insights from ECHELON-2 build upon our continued understanding of the potential ADCETRIS offers patients with CD30-positive lymphomas, said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. Were especially encouraged by the promising four-year follow-up ECHELON-1 results being presented at ASH, as approximately one in three patients with advanced Hodgkin lymphoma do not achieve long-term remission after standard frontline therapy.

Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma (cHL): 4-Year Update of the ECHELON-1 Study (Abstract #4026, poster presentation on Monday, December 9, 2019)

As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) compared to the control arm of ABVD as assessed by independent review facility (IRF; hazard ratio (HR), 0.77; p=0.035). A four-year post-hoc exploratory analysis was conducted to examine PFS outcomes per investigator assessment in the intent-to-treat population of 1,334 patients, including results by PET2 status, age, stage and prognostic risk scores. Results include:

More than 45 countries and regions have approved ADCETRIS in combination with AVD for the treatment of patients with previously untreated Stage III or IV Hodgkin lymphoma. The U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial in which the primary endpoint was modified PFS. In February 2019, the European Commission (EC) approved ADCETRIS for the treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD.

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant (Abstract #464, oral presentation on Sunday, December 8, 2019)

As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per blinded independent central review (HR, 0.71; p=0.0110). In addition, the overall survival benefit in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR, 0.66; p=0.0244). A post-hoc exploratory analysis evaluated the impact of consolidative stem cell transplant in the ECHELON-2 study for the patients who achieved CR treated with ADCETRIS plus CHP. In the ADCETRIS plus CHP arm, this included 38 patients in CR who received a stem cell transplant and 76 patients in CR who did not. Key findings of this analysis include:

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,110 cases of Hodgkin lymphoma will be diagnosed in the United States during 2019 and 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) utilizes the companys industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has a late-stage pipeline including enfortumab vedotin for metastatic urothelial cancer, currently being reviewed for approval by the FDA, and tisotumab vedotin in clinical trials for metastatic cervical cancer, which utilize our proprietary ADC technology. In addition, tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer and in clinical development for metastatic colorectal cancer. We are also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in peoples lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer antihyperglycemic medications as clinically indicated.

Most Common (20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Carefully monitor patients during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Szary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use with caution in other CD30+ CTCL patient types.

Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONS

Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia. If neutropenia develops, refer to dosing recommendations for neutropenia (see SmPC section 4.2). Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS, but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

Monotherapy: The most frequent adverse reactions (10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was 1%. Adverse events led to treatment discontinuation in 24% of patients.

Combination Therapy: In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced Hodgkin lymphoma, the most common adverse reactions ( 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased. Serious adverse reactions occurred in 36% of patients. Serious adverse reactions occurring in 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%). Adverse events led to treatment discontinuation in 13% of patients.

Seattle Genetics Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ADCETRIS for patients with previously untreated stage III or IV classical Hodgkin lymphoma and patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL). Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to factors such as utilization and adoption of the approved treatment regimen by prescribing physicians, competitive conditions including the availability of alternative treatment regimens, the availability and extent of reimbursement, the risk of adverse events and adverse regulatory action. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Takeda Important Notice

For the purposes of this notice, press release means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (Takeda) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, Takeda is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words we, us and our are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Takeda Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takedas future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as targets, plans, believes, hopes, continues, expects, aims, intends, ensures, will, may, should, would, could anticipates, estimates, projects or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takedas estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takedas global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takedas operations and the timing of any such divestment(s), any of which may cause Takedas actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takedas results, performance, achievements, or financial position, see Item 3. Key InformationD. Risk Factors in Takedas most recent Annual Report on Form 20-F and Takedas other reports filed with the U.S. Securities and Exchange Commission, available on Takedas website at: https://www.takeda.com/investors/reports/sec-filings/ or at http://www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takedas future results.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191209005169/en/

Contacts

Seattle Genetics: Media Monique Greer (425) 527-4641 mgreer@seagen.com

Investors Peggy Pinkston (425) 527-4160 ppinkston@seagen.com

Takeda: Japanese Media Kazumi Kobayashi kazumi.kobayashi@takeda.com +81 (0) 3-3278-2095

Media outside Japan Sara Noonan sara.noonan@takeda.com +1-617-551-3683

Read more here:
Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019...

Recommendation and review posted by Bethany Smith

A new study from theNational Institutes of Healthfinds that women who use permanenthairdye and chemical hair straighteners are at a higher risk of developingbreast cancer and the risk is particularly high for black women.

The study, published on Dec. 4 in theInternational Journal of Cancer, looked at hair product use over a 12-month period in more than 46,000 women ages 35-74 all of whom have asisterdiagnosed with breast cancer. The researchers found that permanent hair dye use in black women was associated with a 45 percent higher risk of breast cancer, while white women had a 7 percent higher risk, according to the study.

Using these hair dyes more frequently upped that risk: Black women using permanent hair dye every five to eight weeks or more was associated with a60 percent higher riskof breast cancer, compared to an 8 percent increased risk for white women.

Chemical hair straighteners were also associated with a greater risk of breast cancer. Women who used the treatment every five to eight weeks or more were about 30 percentmore likelyto develop breast cancer; the risk was similar in both black and white women.

Its not entirely clear why breast cancer risk is especially elevated in black women using permanent hair dye. In general, black women have higher rates of the disease than white women before age 40, and are more likely to die from breast cancer at every age, according to theAmerican Cancer Society.

But hair dye alone is likely not at fault. Elizabeth Arena, MD, a surgical oncologist specializing in breast cancer atSurgery Group of Los Angeles, tells Yahoo Lifestyle that there are multiple factors that affect breast cancer risk. It cannot be attributed to one specific cause, so I would not attribute the difference in cancer rates seen in this study to use of hair products alone, Arena says.

She adds: The study did not describe in detail the products that the participants used so it is difficult to fully compare. In theory, different products, with different chemical components, may be designed for people of different racial backgrounds, which could contribute to the different cancer rates, while different hair types may take up the dyes differently as well.

Hair dyes a popular product used by more than one-third of women over age 18 and about 10 percent of men over age 40 contain more than 5,000 different chemicals, some of which are reported to be carcinogenic (cancer-causing) in animals, according to theNational Cancer Institute.

Many hair products contain endocrinedisrupting compounds and carcinogens potentially relevant to breast cancer, the study authorsnoted. Products used predominantly by black women may contain more hormonallyactive compounds.

They added: These results suggest that chemicals in hair products may play a role in breast carcinogenesis.

However, more research is needed to determine which chemicals are problematic. It is very difficult to say if there is a specific chemical in hair dye or hair straighteners that increases the risk of breast cancer, Arena says. This observational study is just a starting point for investigating potential cause and effect. It does not show a direct link at this point, and the study participants did not identify which hair products were specifically used. Past studies in animals have shown concern for ammonia in hair products, whileparabens, which are found in some dyes, are concerning for potential hormonal, estrogen-like effects.

Several studies have looked at possible connections between cancer and hair dye. However, according to theNCI, the research is mixed: Although some studies have linked the personal use of hair dyes with increased risks of certain cancers of the blood and bone marrow, such as non-Hodgkin lymphoma (NHL) andleukemia, other studies have not shown such links. Studies ofbreastand bladder cancer have also produced conflicting results.

Added the NCI: Researchers who reviewed data from 14 studies of female breast cancer and hair dye use published between 1977 and 2002 found that dye users had no increase in the risk of breast cancer compared with nonusers.

That said, the institute also noted that, given the widespread use of hair dye products, even a small increase in risk may have a considerable public health impact.

First, its worth noting that the women in the study all have a family history of breast cancer (a sister diagnosed with the disease), which puts them at a higher risk in general. In many patients, it is related to their genetics and family history rather than environmental exposures, says Arena.

"I think it's important for women, particularly African American women, not to panic every time a study comes out,"Doris Browne, MD, a medical oncologist and former president of the National Medical Association, tellsNPR. "But it should raise questions for our primary care providers."

Arena agrees, adding, Based on this observational study alone, I do not think women should be overly concerned. This study is an interesting starting point for further research, but you cannot draw any final conclusions from a preliminary study like this.

For those who are concerned particularly for women (and men) with a family history of breast cancer they should have a conversation with their primary care physician. For women at higher risk for breast cancer, it is always good to speak with a breast specialist further to discuss your risk factors and lifestyle modifications further, says Arena.

If youre considering stopping the use of permanent hair dyes, the study also found that semi-permanent hair dye, as well as temporary dyes, did not up the risk of breast cancer.

There are also several ways that women can reduce their breast cancer risk namely, maintaining a healthy lifestyle, which is similar health advice to what doctors recommend for other diseases, such as eating a healthy diet, exercising regularly, limiting alcohol intake and reducing stress.

Arena adds, I also strongly recommend regular screening for breast cancer because early detection is the most effective way to treat the disease should it occur.

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Study links permanent hair dye to increased risk of breast cancer, particularly among black women - Yahoo News

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Dec. 7, 2019 19:00 UTC

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced updated and long-term follow-up analyses from two clinical trials evaluating ADCETRIS (brentuximab vedotin) and OPDIVO (nivolumab) in frontline Hodgkin lymphoma (HL) patients aged 60 years and older and in relapsed or refractory classical HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS and OPDIVO are not approved in combination for the treatment of HL. Results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla.

We continue to evaluate ADCETRIS in combination with novel therapies, such as checkpoint inhibitors, with the goal of identifying new options for CD30-expressing lymphomas where there is high unmet need, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. These data presentations at ASH reinforce our strong commitment to the ADCETRIS clinical development program, potentially moving into new patient populations and novel combination treatment strategies.

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged 60 Years (Abstract #237, oral presentation at 2:30 p.m. ET on Saturday, December 7, 2019) Data were presented from an updated analysis from the phase 2 clinical trial evaluating ADCETRIS in combination with OPDIVO as frontline therapy for HL patients aged 60 years and older. Data were reported from 21 patients, and the median age was 72 years. The majority of patients (76 percent) had stage III/IV disease at the time of diagnosis. These results will be highlighted in an oral presentation by Christopher A. Yasenchak, M.D., Willamette Valley Cancer Institute and Research Center/US Oncology Research, Ore., and include:

Two-Year Follow-up Results from the Phase 1-2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (Abstract #238, oral presentation at 2:45 p.m. ET on Saturday, December 7, 2019) Data were reported from 93 patients with relapsed or refractory classical HL after failure of frontline therapy who received the combination regimen of ADCETRIS plus OPDIVO. After completion of the fourth cycle of treatment, patients were eligible to undergo an autologous stem cell transplant (ASCT). The median age of patients was 34 years. These results will be highlighted in an oral presentation by Alison J. Moskowitz, M.D., Memorial Sloan Kettering Cancer Center, NY, and include:

About Classical Hodgkin Lymphoma Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,110 cases of Hodgkin lymphoma will be diagnosed in the United States during 2019 and 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) utilizes the companys industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has a late-stage pipeline including enfortumab vedotin for metastatic urothelial cancer, currently being reviewed for approval by the FDA, and tisotumab vedotin in clinical trials for metastatic cervical cancer, which utilize our proprietary ADC technology. In addition, tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer and in clinical development for metastatic colorectal cancer. We are also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNINGPROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Most Common (20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

Forward Looking Statements Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential uses and benefits of ADCETRIS (brentuximab vedotin) in combination with OPDIVO (nivolumab) in frontline Hodgkin lymphoma (HL) patients age 60 years or older and in relapsed or refractory classical HL under staggered and concurrent dosing schedules, the therapeutic potential of ADCETRIS in these indications and the companys clinical development plans. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include potential lack of efficacy or risk of adverse events associated with the use of ADCETRIS in certain clinical settings and the difficulty and uncertainty of pharmaceutical product development. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Opdivo is a registered trademark of Bristol-Myers Squibb Company.

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Seattle Genetics Announces Updated Data of ADCETRIS (Brentuximab Vedotin) in Combination with OPDIVO (Nivolumab) in Frontline and Relapsed or...

Recommendation and review posted by Bethany Smith

I have a few goals in mind when I put together an outfit, and looking polished is one of my main sartorial objectives. So when I shop, I tend to gravitate toward those inherently sophisticatedseparatesto keep my wardrobe as elevated as possible. While I have a slew of go-to items in my arsenal to incorporate into my "refined, grown-up-feeling" looks (like sleek turtlenecks and tailored trousers), there's actually a range of 2020 trends that have polished-feeling qualities that I'm interested in testing out.

And believe it or not, some of the most stylish and sophisticated fashion people are actually already on board with these must-try trends because I've been spotting many in question all over my Instagram feed over the last few weeks.On that note, keep scrolling to check out the next-wave refined trends I'm lovingas seen on some of the chicest women. And because I strongly believe said looks will bring a polished spin to any of your outfits, I also shopped out each trend for all of you elegant ladiesout there.

A tailored silhouette will bring a sophisticated feel to any vibe, and the almighty vest is one of those old-school yet seemingly fresh pieces to achieve that look. Whether worn as part of a three-piece suit or worn on its own with a blouse, the waistcoat is one piece Im looking forward to spotting more and more in 2020.

Pixie Market Vest ($98)

Topshop Blush Vest ($75)

Iro Holz Belted Leather Vest ($1400)

Pointed pumps and sleek ankle boots can act as the finishing touch to an especially refined look, but non-basic loafersthose with chunky block heels and with glossy details like patentwill no doubt rise up to be the It shoe silhouette amongst the fashion crowd. While I love the idea of wearing the footwear style with cropped trousers and a jacket, Im also into these loafers because they can bring that unexpected polish to a cool denim-and-sweater vibe as well.

Michael Michael Kors Declan Kilte Fringe Pumps ($129)

Halogen Isabelle Pointy Toe Pumps ($100)

Louise Et Cie Lanton Loafer Pump ($83)

While the upgraded trench coat isnt necessarily a new trend, its one thats entering the spotlight in an even more noteworthy way next year. Designers from Sacai to Oscar de la Renta showcased a range of reimagined cuts with asymmetrical designs, unexpected pattern-blocking, and more. Fashion girls (and myself) are champions of this look for its classic yet modern sensibilities.

ASOS DESIGN Trench Coat ($119)

Leandra x Mango Detachable Gilet Trench ($300)

Court & Rowe Plaid Lined Double-Breasted Trench Coat ($299)

Its no secret that tossing on a blazer will add polish to an outfit. While the slouchy styles of the 2010s will hold their own, theres one micro-trend Im particularly feeling as an alternativethe collarless blazer. Cropping up among the cool set, this updated silhouette feels modern and a bit more relaxed than a traditional blazer paired with a tee and trousers or over a turtleneck with a midi skirt.

Bevza Olive Jacket ($626)

Pixie Market Square Neckline Jacket ($139)

H&M Textured-Weave Jacket ($55)

This bold trend is clearly incredibly popular now, but as designers from Khaite to Tory Burch proved on the S/S 20 runways, the look will be bigger (literally) than ever next year as a statement-making way to enhance a silhouette. Fashion girls seem to lean into the trend in the form of colorful cardigans or in playful midi dresses.

& Other Stories Square-Neck Jacquard Top ($89)

ASTR the Label Ruched Front Midi Dress ($85)

Tibi Cozette Sweater ($350)

Yes, a standard white button-down is timeless in theory, but Bevza, Pyer Moss, and more made a strong case for the reworked white shirt in their S/S20 collections. Here Im talking about cuts with extra-long sleeves, cropped hems, and so on. Like I just mentioned, the white shirt will always bring sophistication, but the amped-up versions will bring that forward polish that just feels so right.

Topshop Layered Ruffle Blouse ($55)

Ganni Statement Collar Poplin Shirt ($145)

New Look Peplum Shirt ($37)

Fashion people embraced leather separates this season, and the lookone typically reserved for fall and winterwill have a moment come spring 2020 as well. While the classic black moto jacket will be a forever-staple in my eyes,Im gravitating towardthose leather trenches and wrap jackets in rich hues.

Leith Faux Patent Leather Trench Coat ($149)

Club Monaco Ohwen Leather Jacket ($595)

Eloquii Trench Coat ($180)

Next, check out four cheap and chic outfits to test out this winter.

This article originally appeared on Who What Wear

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7 Refined Trends for All the Stylish Grown Women Out There - Yahoo Lifestyle

Recommendation and review posted by Bethany Smith

By Lisa Rapaport

(Reuters Health) Babies who are born too early may be more likely to develop diabetes as children and young adults than full-term infants, a new study suggests.

In a study of children up to age 18, those born before 37 weeks gestation were 21% more likely that those born at full term to develop type 1 diabetes, the less common form of the disease that typically appears in childhood or young adulthood. Kids born prematurely were also 26% more likely to develop type 2 diabetes in childhood.

And preemies were 24% more likely to develop type 1 diabetes and 49% more likely to develop type 2 diabetes by the time they were 43 years old.

Preterm birth interrupts normal development of multiple organ systems, including the pancreas where insulin-producing cells are formed, which may potentially contribute to later development of diabetes, said lead study author Dr. Casey Crump of the Icahn School of Medicine at Mount Sinai in New York City.

Pregnancy normally lasts about 40 weeks, and babies born after 37 weeks of gestation are considered full-term. Babies born prematurely earlier than 37 weeks often have difficulty breathing and digesting food in the weeks after birth. Preemies can also encounter longer-term challenges such as impaired vision, hearing and cognitive skills, as well as social and behavioral problems.

Some previous research suggests that preemies have an increased risk of developing so-called insulin resistance, a failure to respond normally to the hormone insulin.

In type 1 diabetes, the pancreas cant produce insulin. In the type 2 form of the disease, which is often linked to obesity and aging, the body cant properly use or make enough insulin to convert blood sugar into energy.

For the current study, researchers examined data on almost 4.2 million babies born in Sweden from 1973 to 2014. Most were followed until they were at least 22 years old.

Overall, 0.7% of the babies in the study population went on to develop type 1 diabetes and just 0.1% developed type 2 diabetes, the researchers report in Diabetologia.

Parents should know that most children who were born preterm will have good health in childhood and adulthood, Crump said by email. However, they also have modestly increased risks of diabetes that persist into adulthood.

Overall, the risk tended to be higher for preemie girls. Boys who arrived early were about 20% more likely to develop type 1 diabetes during the study, while girls had about a 30% greater likelihood.

With type 2 diabetes, female preemies were 60% more likely to develop this disease during childhood than full-term babies, while preemie males didnt have an increased risk. For young adults in the study, women who were preemies had a 75% increased risk of type 2 diabetes and men who were preterm had a 28% increased risk.

Many people in the study had siblings included in the analysis. Shared genetics and family circumstances appeared to explain some, but not all, of the increased risk of diabetes for preemies.

The study wasnt designed to prove whether preterm birth influences susceptibility to diabetes.

Even so, the results underscore that preemies need to take steps to prevent diabetes later in life, said Ciaran Phibbs of the VA Palo Alto Health Care System and Stanford University School of Medicine in California.

The home environment is an important factor, especially for type 2 diabetes, Phibbs, who wasnt involved in the study, said by email. This includes things like diet and exercise habits, which can impact the risk of obesity, which is higher for preemies than for full-term babies and is a risk factor for diabetes, he said.

Individuals who were born preterm can help prevent diabetes by following a healthy lifestyle across the life course, including a healthy diet, regular physical activity, and maintaining a normal weight, Crump advised.

SOURCE: https://bit.ly/2LCQrpq Diabetologia, online December 3, 2019.

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Preemies face higher risk of diabetes as children and young adults - Physician's Weekly

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GLEN MILLS, Pa., Dec. 10, 2019 /PRNewswire/ --SmartSolutions RX, Inc. announces the launch of a new scientifically based, drug-free hair support system LOCKrx, which includes both ingestible and topical Healthy Hair Programs that create the ideal environment to maintain hair follicle cycle and growth.

Hair thinning and hair loss are a pervasive problem, affecting an estimated 80 million men and women in the U.S. Smoking, diet, stress, environment and genetics all contribute to hair loss, as well as the hormone DHT which shrinks the hair follicle and is the primary cause of loss in male and female pattern baldness. The current treatments often come with unwanted side effects and take months to generate results.

LOCKrx is a drug-free hair treatment system that addresses scalp health, both internally and externally, that directly impacts hair growth and quality.

"When formulating LOCKrx, we meticulously designed and tested both ingestible and topical ingredients that are scientifically proven to reduce the inflammation associated with damaged hair follicles and thereby improve quality of the hair," said Cynthia Rager, President and COO of Vision Medical, Inc. "Our topical LOCKrx solutions include specific growth factors clinically shown to play a key role in the hair follicle growth pathway as well as to enhance wound repair and skin regeneration, all of which improve scalp skin health, while also playing a vital role in the proliferation of skin and hair cells."

LOCKrx is available as both internal and external treatment plans, designed to work synergistically to promote healthy scalp skin and hair growth.

"Growthfactors possess the ability to stimulate hair growth through variousmechanistic pathways," said Richard Jin, M.D., Ph.D., Hair Regeneration Specialist, RJClinical Institute. "We have experienced very positive results when combiningthese with platelet rich plasma therapy to promote new and existing hairgrowthas well as using it as an alternative to PRP. This has helped us treat the mostcommon form of hair loss known as androgenetic alopecia, as well as increasethickness and density of hair in post-transplant patients."

LOCKrx Inside Healthy Hair Programis a 3-step, 6-week ingestible plan that uses unique marine and botanical ingredients, amino acids, and vitamins to address total body inflammation.

1. DEFENSE Gut Health - Prebiotic supplement that includes mineral-rich blue green algae and proven anti-inflammatory botanicals curcumin, aloe, licorice and beta-glucan to address gut health in powdered form.

2. BLOCK Hair Loss- Follicle-enrichment supplement formulated with the LOCKrx proprietary blend of botanicals, adaptogens, marine collagen, and saw palmetto to help support hair growth and block conversion of testosterone to DHT, one of the major causes of hair loss in male and female pattern baldness.

3. GUARD Healthy Hair Tabs- Premier blend of complexed Vitamin B plus biotin in the most bio-available form.

LOCKrx Outside Healthy Hair Programis a combination of clinical and at-home applications of growth factor solutions that support and balance the scalp microbiome, while enhancing the environment for healthy hair growth:

VisionMedical, Inc. has exclusive physician distribution rights for LOCKrx.

Smart Solutions RX, Inc.

Smart Solutions RX, Inc. formulates, develops, manufactures and distributes products for medical aesthetic applications to hair and skin. A blend of scientific research and innovative formulation and delivery systems are the hallmark, as evidenced in the LOCKrx brand for healthy hair support. Medical aesthetic protocols and workshops are integrated into the superior customer support program. http://www.smartsolutionsrx.com

Vision Medical, Inc.

Founded in 2013, VisionMedical, Inc. develops, manufactures, and marketsmedical and aesthetic technology for the medical and aesthetic marketsfor worldwide distribution.Vision Medical's first commercial product, theSmartGraft Hair Restoration System, incorporates an award-winning Automated Follicular Unit Extraction (FUE) system for men and women.Featuring theindustry's first closed harvesting system, SmartGraft allows physicians to harvestgrafts more efficiently while keeping grafts moist prior to implantation. http://www.SmartGraft.com.

CONNECT WITH US

Instagram: @SmartSolutionsRXTwitter: @SSolutionsX Facebook: @SmartSolutionsRXinc

SOURCE SmartSolutions RX, Inc.

http://www.smartsolutionsrx.com

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SmartSolutions RX Launches LOCKrx, A Drug-Free Support System Fighting To Keep Hair Thick and Healthy - PRNewswire

Recommendation and review posted by Bethany Smith

Separation of church and state has long shaped the relationships of public institutions.

And despite its recent collaborations, the University of California is not exempt.

Currently, the UC is contracted with Dignity Health, a Catholic health care nonprofit corporation, to provide university care for more patients and medical student training. Unsurprisingly, this has sparked concerns statewide from physicians and students over how religiously affiliated hospitals undermine health care for LGBTQ+ groups and women.

Dignity Health operates under the Ethical and Religious Directives for Catholic Health Care Services, which uses religious ideology as a basis to determine the conduct of on-site operations. These directives directly limit physicians ability to conduct procedures permitted outside of these limitations, such as lifesaving womens health services. And because of this partnership, those restrictions apply to on-site UC physicians.

Earlier this year, protests amongst physicians, students and activist groups broke out at UCSF and UCLA in response to the contracts potentially expanding UC-wide. The protests found success in San Francisco, and UCSF ended affiliation discussions with Dignity Health in May. At UCLA, the contracts still stand.

If state health care institutions are secular, treatment is mandated to be equal no matter patients beliefs, gender or orientation.

But currently, the UC subjects itself to the hospitals religious doctrine and enables religious influences in health care, even if it means restricting access for women and LGBTQ+ people. Whether or not these doctrines impact the performance of UC physicians one time or every time, an overarching religious presence potentially influencing medical decisions is unacceptable.

Because when religiosity facilitates discrimination in health care, it must be contested by the UC system.

Earlier this year, it was reported that 24 out of 39 Dignity hospitals reject the use of gender-affirming practices such as hormone therapy and surgeries. But access to LGBTQ+-supportive health care goes beyond what occurs under the knife.

Nina Sheridan, a fourth-year molecular, cell and developmental biology student and UCLA Sexperts co-director, said refusing such procedures can invalidate the identity of transgender individuals.

Not offering any sort of gender-affirming type of health care leads to the erasure of these communities, because youre negating the importance of treating their bodies the way that they want their bodies to be treated, Sheridan said.

And with every UC contract that doesnt address these barriers, the UC is complacent in this erasure.

Evan Minton, a transgender patient, was denied his scheduled hysterectomy the day before the procedure. In a California appellate court case, Minton claimed he was denied care because of his gender identity, while Dignity Health claimed the procedure violated its ethical and religious directives, which include sterilization.

Although the directives do not explicitly discriminate against services that affirm gender identity, flexible interpretations of these standards allow Catholic hospitals to justify their refusal of treatment.

And the LGBTQ+ community isnt the only one hurt by Dignitys religious doctrines. Education and resources for womens sexual health range from limited to nonexistent for example, institutions are prohibited from condoning or promoting contraceptives.

If theyre not being completely transparent about birth control options and are not talking about it in the best interest of the patient, that completely eradicates an educational aspect of health care that should be available to every single woman, Sheridan said.

This includes education about how birth control can be used to regulate menstrual symptoms, treat polycystic ovary syndrome and prevent ovarian or uterine cancer. Outright denial of birth control isnt just affecting womens sexual health it restricts their access to health care education and their ability to treat outstanding medical conditions.

And while abortion might be a more divisive topic, these restrictions have unintended consequences especially when abortive measures serve to ensure the safety of a womans life.

This means a miscarrying patient with a fetal heartbeat can be denied a lifesaving procedure, such as uterine evacuation, by a closed-door ethics committee. Their physician can make a few choices: wait for the heartbeat to stop and risk bleeding out or septic infection, transport the patient to the closest hospital despite having the necessary lifesaving equipment or violate protocol altogether. And according to a UCSF study, these are choices many physicians had to make under the constraints of the ethical and religious directives.

Its a choice that can mean life or death for the patient.

Our relationships with other entities that facilitate health services and clinical training at non-UC facilities support our mission of meeting patients unmet needs and training the health care workforce California needs, said a spokesperson for the UC.

The necessary symbiotic relationship between public institutions and nonprofits is obvious, and while the UC insists its physicians will make the right medical calls despite the directives, there are dangerous implications of having religious limitations in the medical field.

Some of the language in the agreements may not sufficiently reflect our values and expectations, and we are working to address legitimate concerns that have been raised, said a spokesperson for UCLA Health and the David Geffen School of Medicine at UCLA.

Every hospital, no matter its religious beliefs, should have access to experts and professionals like those from the UCs. A statement from Dignity Health said dissolving these partnerships would be detrimental to certain communities and theyre not wrong. Dignity Health has every right to conduct its operations within the framework of its religious doctrine something that draws certain people to these hospitals.

But it shouldnt come at the cost of restricting potentially lifesaving operations or making patients afraid of disclosing their sexual orientation or gender identity.

The UC claims to support womens health and the LGBTQ+ community but has yet to negotiate a contract that can ensure health care without the inhibiting influence of religious doctrine.

Increasing contracts is integral to providing health care for all.

But when it comes at the cost of equal access for women and LGBTQ+ members, its time to go back to the drawing board.

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UC's affiliation with Dignity Health unfairly places restrictions on health care - Daily Bruin

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To reverse a medical abortion, some doctors have prescribed progesterone. A new study raises fresh doubts about the approach. Photo Researchers, Inc./Science Source hide caption

To reverse a medical abortion, some doctors have prescribed progesterone. A new study raises fresh doubts about the approach.

A study designed to test the effectiveness of a controversial practice known as "abortion pill reversal" has been stopped early because of safety concerns.

Researchers from the University of California, Davis, were investigating claims that the hormone progesterone can stop a medication-based abortion after a patient has completed the first part of the two-step process.

For the study, the researchers aimed to enroll 40 women who were scheduled to have surgical abortions. Before their surgical procedures, the women received mifepristone, the first pill in the two-medication regimen that's used for medical abortions. The women were then randomly assigned to receive either a placebo or progesterone, which advocates claim can block the effects of mifepristone.

But researchers stopped the study in July, after only 12 women had enrolled. Three of the women required ambulance transport to a hospital for treatment of severe vaginal bleeding.

The researchers decided the risk to women of participation was too great to continue with the study. The study was unable to show what, if any, effectiveness progesterone has in reversing a medical abortion.

The results raise concerns about the safety of using mifepristone without taking misoprostol, the second step in the medication-based abortion regimen.

Advocates for abortion pill reversal have succeeded in having it written into law as an option to be discussed in mandatory pre-abortion counseling in several states, including Kentucky, Nebraska and Oklahoma.

Opponents have said there wasn't sufficient evidence to support the approach. Now, there's evidence that it could cause harm.

"Encouraging women to not complete the regimen should be considered experimental," says Dr. Mitchell Creinin, a professor of obstetrics and gynecology at UC Davis and the lead researcher on the study. "We have some evidence that it could cause very significant bleeding."

The results of the trial were published online Thursday in the journal Obstetrics and Gynecology.

Medication-based abortions use a combination of two medicines mifepristone and misoprostol that patients usually take 24 hours apart. Mifepristone is a progesterone blocker. Misoprostol makes the uterus contract. Studies suggest that 95% to 98% of women who take both drugs in the prescribed regimen will end their pregnancy safely.

Proponents of the abortion-reversal treatment offer the hormone progesterone to patients after they have taken mifepristone but have then decided they don't want to complete the abortion. A group of researchers published a small case series about the protocol, claiming it prevents the abortion from taking place.

The research has been criticized for having serious methodological flaws. Most OB-GYNs including the professional group the American College of Obstetricians and Gynecologists oppose the practice, saying it's "not supported by science."

At least seven states, however, legally require abortion providers to tell patients about progesterone treatment for stopping a medication-based abortion midway through.

This advice, Creinin says, may put patients at risk for life-threatening bleeding.

"It's not that medical abortion is dangerous," he says. "It's not completing the regimen, and encouraging women, leading them to believe that not finishing the regimen is safe. That's really dangerous."

Although Creinin acknowledges that his study was limited by its premature termination and small sample size, he hypothesizes that taking mifepristone without misoprostol may be especially risky later in the first trimester of pregnancy. All three patients with severe bleeding were at least 56 days into their pregnancies.

The women who experienced hemorrhage included one who received progesterone and two who received a placebo. Of the remaining participants, two left the study because of side effects and completed their planned surgical abortions.

Women in both the progesterone and placebo groups had some evidence that their pregnancies continued. Four patients who took mifepristone and then received progesterone had pregnancies with cardiac activity on ultrasound. Two patients who got the placebo also had gestational cardiac activity.

Creinin says that because the study was cut short, it wasn't big enough to answer the question it set out to. There simply aren't enough data, he says, to know if the progesterone treatment is effective at preventing a medication-based abortion from taking place.

"Does progesterone work? We don't know," he says. "We have no evidence that it works."

Mara Gordon is a family physician in Camden, N.J., and a contributor to NPR. You can follow her on Twitter: @MaraGordonMD.

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San Antonio Breast Cancer Symposium, December 11, 2019

Newswise WASHINGTON (December 9, 2019) Women who receive palbociclib (Ibrance ) to treat their advanced breast cancer and have a gene alteration that can lead to a condition known as benign ethnic neutropenia (BEN), can safely receive the drug without major concerns of developing infections associated with neutropenia, or low white blood cell counts, say Georgetown Lombardi Comprehensive Cancer Center researchers. African American women have a higher incidence of BEN than other races and have been underrepresented in trials testing this medicine so palbociclibs safety in this population wasnt fully known.

This clinical trial result will be presented in a poster session at the San Antonio Breast Cancer Symposium on December 11, 2019, in San Antonio, Texas.

Many clinical trials require patients to have normal white blood cell counts at enrollment. Specifically, clinical trials of palbociclib have shown that women can develop neutropenia (low neutrophil counts) while taking the drug and therefore be at increased risk of infection. Neutrophils are a type of white blood cell and they are usually one of the first types of white blood cells to reach a site of infection. The lack of infection-fighting white blood cells is often an emergency situation. A BEN diagnosis carries a very low risk of infection, yet women may be given reduced dosages of palbociclib due to lower neutrophil counts even though their infection risk is low.

The phase II PALINA trial, conducted at Georgetown Lombardi and four other centers, used advanced DNA testing at the start of the trial to determine if women had the gene alteration that leads to BEN. The women took palbociclib pills and an estrogen-lowering pill (letrozole) for a maximum of one year. They were then followed to determine if their BEN status affected their safety when taking palbociclib.

Problematically, African American women and women of African descent have higher rates of death due to breast cancer than white women and their representation in clinical trials has been historically lacking, said Filipa Lynce, MD, a physician researcher at Georgetown Lombardi Comprehensive Cancer Center who treats patients at MedStar Georgetown University Hospital. It was important for us to demonstrate that African American and other women with BEN can, and should, receive the same treatment regimen, in this case palbociclib, for their breast cancer as other women.

The trial enrolled 35 women from Washington, D.C., Baltimore, Chicago and Philadelphia. This current analysis showed that of the 33 women who were tested, 58% had the gene alteration that is associated with lower neutrophil counts. None of the patients in this trial progressed to neutropenia that led to a fever, nor did any of the women discontinue their treatment due to infections. Nearly half of the women did develop a high, but not life-threatening level of neutropenia, resulting in delays in taking their medications.

We are now more confident that palbociclib can be taken safely by African American and other women with BEN, as long as their white blood cell counts are regularly monitored, said Lynce. Our results also point out the need to design trials that enroll women with different ancestries and reflect our patient population so that study outcomes can be applicable to as many women as possible.

###

In addition to Lynce, authors from Georgetown University and its clinical partner MedStar Health, include R. Zhuo, M. Blackburn, C. Gallagher, T. Wu, P. Pohlmann, A. Dilawari, S. Tiwari, A. Chitalia, R. Warren, M. Tan, A. Shajahan-Haq, and C. Isaacs. Additional authors include O. Hahn, University of Chicago, M. Abu-Khalaf, Thomas Jefferson University, Philadelphia, PA, and M. Mohebtash, MedStar Franklin Square Cancer Center, Baltimore, MD.

The authors report the following disclosures relevant to this study: F. Lynce: C; A; AstraZeneca, Jounce, Celgene, BMS, Inivata (unpaid). C; A; BMS, Pfizer, Genentech/Roche, Immunomedics, Calithera, Chugai, Regeneron, Tesaro (Research to the Institution). R. Zhuo: None. M. Blackburn: None. C. Gallagher: None. O. Hahn: None. M. Abu-Khalaf: C; A; Novartis. M. Mohebtash: None. T. Wu: None. P. Pohlmann: C; A; Personalized Cancer Therapy, Sirtex, CARIS Life Sciences. F; A; Dava Oncology, Genentech/Roche, ASCO. C; A; Genentech/Roche, Pfizer, Cascadian Therapeutics. O; A; Immunonet BioSciences. O; A; Intellectual property: Immunological compositions as cancer biomarkers and/or therapeutics. A. Dilawari: None. S. Tiwari: None. A. Chitalia: None. R. Warren: None. M. Tan: None. A. Shajahan-Haq: None. C. Isaacs: C; A; AstraZeneca, Pfizer, Novartis, Genentech and PUMA. F; A; Genentech.

This research was supported by grant from Pfizer, Inc.

Poster P1-19-20: Safety of palbociclib in African American Women with Hormone Receptor Positive HER2 Negative Advanced Breast Cancer and Benign Ethnic Neutropenia: PALINA study

About Georgetown Lombardi Comprehensive Cancer Center Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute (NCI) as a comprehensive cancer center. A part of Georgetown University Medical Center, Georgetown Lombardi is the only comprehensive cancer center in the Washington D.C. area. It serves as the research engine for MedStar Health, Georgetown Universitys clinical partner. Georgetown Lombardi is also an NCI recognized consortium with John Theurer Cancer Center/Hackensack Meridian Health in Bergen County, New Jersey. The consortium reflects an integrated cancer research enterprise with scientists and physician-researchers from both locations. Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic, translational and clinical research, patient care, community education and outreach to service communities throughout the Washington region, while its consortium member John Theurer Cancer Center/Hackensack Meridian Health serves communities in northern New Jersey. Georgetown Lombardi is a member of the NCI Community Oncology Research Program (UG1CA239758). Georgetown Lombardi is supported in part by a National Cancer Institute Cancer Center Support Grant (P30CA051008). Connect with Georgetown Lombardi onFacebook(Facebook.com/GeorgetownLombardi) andTwitter(@LombardiCancer).

About Georgetown University Medical CenterGeorgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMCs mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or care of the whole person. The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health.Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter).

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Palbociclib is Safe for Women with Advanced Breast Cancer Who Have Unique Gene Alteration - Newswise

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It is obvious that a mother taking medication for her illness is concerned about the possible side effect of these drugs upon her child through breast milk. She seeks information from doctors and health workers. The main issue is whether the medication she is taking could harm her baby with toxic components transmitted through breast milk. The national breastfeeding guideline of Bangladesh states to continue or encourage breastfeeding rather than withdrawing it in almost every condition.

There are certain medications which can be transmitted through breast milk. Again, some organisms responsible for disease causation could transmit disease through breast milk. Drugs which can be excreted via breast milk are mainly anti-cancer drugs, anti-thyroid drugs, some psychiatric drugs, some antibiotics and some hormone replacement therapies etc.

Breastfeeding is contraindicated if a mother is taking anti-cancer drugs, anti-thyroid drugs and any medications containing radioactive components. Even in these conditions, emphasis should be given in collecting another mothers milk rather than starting formula or cows milk. If a mother is taking anti-psychotic or even anti-convulsant drugs she must continue her breastfeeding. Some health workers and even doctors fail to deliver the information that very negligible amount of drug product is transmitted to breast milk, and withdrawing breastfeeding could also be more harmful.

The same is applicable for some antibiotics like sulphonamides, cotrimoxazole, fansidar (anti-malarial drug) and dapsone (used in leprosy and lupus). Possible side effect in a baby is jaundice which should be observed. The mother must consult with her physician for taking alternative drugs (as there might be the scope of another safer drug) if she is taking antibiotics like chloramphenicol, tetracycline, metronidazole, quinolones etc. Oestrogen containing contraceptive and thiazide diuretics (used in hypertension) decrease breast milk supply. Alternative drugs should be prescribed in these conditions.

Counselling and support might help in motivating a diseased mother to continue breastfeeding even while under medication. Nothing is a substitute or better than breast milk. Bangladeshs national agenda is to promote breastfeeding and improve exclusive breastfeeding rate so that we can decrease morbidity and mortality in infants and children stepping toward a healthier and better future.

The writer is a Registrar at the Institute of Child and Mother Health (ICMH), Dhaka. Email: ahadnann@gmail.com

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Mothers medication and breastfeeding - The Daily Star

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Susan Desmond-Hellmann, the longtime researcher and executive who helped lead Genentech to develop the first gene-targeted cancer therapies, is stepping down after 5 years as CEO of the Bill & Melinda Gates Foundation.

Stepping down as CEO of@GatesFoundationis, without a doubt, the toughest decision of my career, she wrote in the first of a series of tweets announcing and reflecting on her departure. But one of my mantras is take your own pulse first. Over the last few months, Ive done just that and concluded that I need to slow down.

Mark Suzman, the foundations president of Global Policy & Advocacy and chief strategy officer, will now take over as the new CEO. Suzman joined the foundation 12 years ago and takes the new role officially on February 1, 2020.

Desmond-Hellmann was named CEO of the massive charity in 2013, after years at the top of Genentech and a stint as the first woman chancellor of the University of California San Francisco. She was the first physician to lead the foundation and during her tenure launched what was billed as the first nonprofit biotech, the Gates Medical Research Institute, a move she recalled as one of her top achievements.

Recently, the longtime researcher cut down on work outside the foundation and said today she was leaving to focus on herself and her family.

Desmond-Hellmann got her start in medicine as a kid, hanging around and sometimes bookkeeping at the drugstore her parents owned in Reno, Nevada. In later years, she talked about how watching her father interact kindly with the people who came in made her want to become a doctor. After she graduated from the University of Nevada, she took an intern job at UCSF in 1982, her formative years as a physician spent at the beginning and center of the AIDS/HIV crisis. After several years working on the virus and Kaposis sarcoma, she and her husband Nicholas Hellmann, also a young UCSF doctor moved to Uganda to do similar work.

We were approached by the Rockefeller Foundation to study heterosexual HIV transmission in Africa, so my husband Nick and I sold our Honda Civics, sublet our apartment, and hopped on a plane, she recalled toReuters in July. We were extremely isolated. When we came back from Uganda, we never complained about anything ever again.

She fell into drug development two years after they returned to Nicholas home state of Kentucky, when they both took positions at Bristol-Myers Squibb in Connecticut in 1993. She worked on Taxol, a chemotherapy drug originally derived from Pacific yew bark and first FDA-approved shortly before her arrival.

It was like I had been training my whole life for that job, Desmond-Hellmanntold the New York Timesin 2011.

At the time, Genentech hadnt developed any cancer drugs. The legacy biotech brought Desmond-Hellmann back to San Francisco in 1995 to help build that pipeline and promoted her to chief medical officer the following year.

Arthur Levinson, the CEO of Genentech during her tenure, described her to the New York Times as a shrewd executive, who was able to use her oncology and statistical background to choose the best drugs and was also able to tell researchers when their projects werent being chosen.

Shes a very nice person, so this did not come naturally to her, Levinson said. But she got it quickly. She became a tough leader, tough in a positive sense. She was willing to make tough calls without much difficulty.

Over 14 years at Genentech, she oversaw the development of Avastin and Herceptin, the first gene-targeted cancer therapies.

She left the company when it was bought out by Roche in 2009, leaving as head of product development, and soon went on to become chancellor of UCSF (where there was a brief controversy over her tobacco investments, which she immediately sold off.). She joined the Gates Foundation in 2014.

As CEO she oversaw a bevy of public health programs and, in 2018, the launch of the Gates Medical Research Institute in Cambridge, MA, luring executives from Novartis and Merck and other top biotech firms to fill out the leadership team.

The institute launched with a budget of $100 million and targets the Gates Foundation had long pursued: malaria, tuberculosis, and diarrheal diseases. The idea was to help directly develop drugs that the market wasnt incentivizing, including a malarial vaccine. Their first big project is testing if a booster shot of Bacillus Calmette-Gurin, the tuberculosis vaccine already given to infants, could help improve immunity for adolescents.

What keeps me awake is we have all this capital, we have all this opportunity and we better get something done, Desmond-Hellmann told Forbes last year. We better do some good in the world, or I will not feel good about leading in the Gates Foundation.

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UPDATED: Sue Desmond-Hellmann says it's time for her to leave the Gates Foundation. Strategy chief Mark Suzman will now take the helm - Endpoints News

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More than a year ago, the world was shocked by Chinese biophysicist He Jiankui's attempt to use CRISPR technology to modify human embryos and make them resistant to HIV, which led to the birth of twins Lulu and Nana.

Now, crucial details have been revealed in a recent release of excerpts from the study, which have triggered a series of concerns about how Lulu and Nana's genome was modified.

CRISPR is a technique that allows scientists to make precise edits to any DNA by altering its sequence.

When using CRISPR, you may be trying to "knock out" a gene by rendering it inactive, or trying to achieve specific modifications, such as introducing or removing a desired piece of DNA.

Gene editing with the CRISPR system relies on an association of two proteins. One of the proteins, called Cas9, is responsible for "cutting" the DNA. The other protein is a short RNA (ribonucleic acid) molecule which works as a "guide" that brings Cas9 to the position where it is supposed to cut.

The system also needs help from the cells being edited. DNA damage is frequent, so cells regularly have to repair the DNA lesions. The associated repair mechanisms are what introduce the deletions, insertions or modifications when performing gene editing.

Jiankui and his colleagues were targeting a gene called CCR5, which is necessary for the HIV virus to enter into white blood cells (lymphocytes) and infect our body.

One variant of CCR5, called CCR5 32, is missing a particular string of 32 "letters" of DNA code. This variant naturally occurs in the human population, and results in a high level of resistance to the most common type of HIV virus.

Jankui's team wanted to recreate this mutation using CRISPR on human embryos, in a bid to render them resistant to HIV infection. But this did not go as planned, and there are several ways they may have failed.

First, despite claiming in the abstract of their unpublished article that they reproduced the human CCR5 mutation, in reality the team tried to modify CCR5 close to the 32 mutation.

As a result, they generated different mutations, of which the effects are unknown. It may or may not confer HIV resistance, and may or may not have other consequences.

Worryingly, they did not test any of this, and went ahead with implanting the embryos. This is unjustifiable.

A second source of errors could have been that the editing was not perfectly efficient. This means that not all cells in the embryos were necessarily edited.

When an organism has a mixture of edited and unedited cells, it is called a "mosaic". While the available data are still limited, it seems that both Lulu and Nana are mosaic.

This makes it even less likely that the gene-edited babies would be resistant to HIV infection. The risk of mosaicism should have been another reason not to implant the embryos.

Moreover, editing can have unintended impacts elsewhere in the genome.

When designing a CRISPR experiment, you choose the "guide" RNA so that its sequence is unique to the gene you are targeting. However, "off-target" cuts can still happen elsewhere in the genome, at places that have a similar sequence.

Jiankui and his team tested cells from the edited embryos, and reported only one off-target modification. However, that testing required sampling the cells, which were therefore no longer part of the embryos - which continued developing.

Thus, the remaining cells in the embryos had not been tested, and may have had different off-target modifications.

This is not the team's fault, as there will always be limitations in detecting off-target and mosaicism, and we can only get a partial picture.

However, that partial picture should have made them pause.

Above, we have described several risks associated with the modifications made on the embryos, which could be passed on to future generations.

Embryo editing is only ethically justifiable in cases where the benefits clearly outweigh the risks.

Technical issues aside, Jiankui's team did not even address an unmet medical need.

While the twins' father was HIV-positive, there is already a well-established way to prevent an HIV-positive father from infecting embryos. This "sperm washing" method was actually used by the team.

The only benefit of the attempted gene modification, if proven, would have been a reduced risk of HIV infection for the twins later in life.

But there are safer existing ways to control the risk of infection, such as condoms and mandatory testing of blood donations.

Gene editing has endless applications. It can be used to make plants such as the Cavendish banana more resistant to devastating diseases. It can play an important role in the adaptation to climate change.

In health, we are already seeing promising results with the editing of somatic cells (that is, non-heritable modifications of the patient's own cells) in beta thalassemia and sickle cell disease.

However, we are just not ready for human embryo editing. Our techniques are not mature enough, and no case has been made for a widespread need that other techniques, such as preimplantation genetic testing, could not address.

There is also much work still needed on governance. There have been individual calls for a moratorium on embryo editing, and expert panels from the World Health Organisation to UNESCO.

Yet, no consensus has emerged.

It is important these discussions move in unison to a second phase, where other stakeholders, such as patient groups, are more broadly consulted (and informed). Engagement with the public is also crucial.

Dimitri Perrin, Senior Lecturer, Queensland University of Technology and Gaetan Burgio, Geneticist and Group Leader, The John Curtin School of Medical Research, Australian National University.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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New Details About The Infamous 'CRISPR Babies' Experiment Have Just Been Revealed - ScienceAlert

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We live in a time when science and technology are having an impact on our society in more and more ways. And the decisions that shape how these new fields of knowledge develop ultimately affect all of us.

When I studied biology in high school, I didnt learn about DNA for a very simple reason. The work of Francis Crick, James Watson, Rosalind Franklin and others who unlocked the structure of the basic code of life was still years away. The idea of engineering human beings? Well, that was firmly the stuff of science fiction, like Aldous Huxleys dystopian novel Brave New World (published a year after my birth). It seemed as likely as, say, going to the moon.

There are a few inferences you can make from this framing of my life. One is that I have been on the planet for a while. The other is the speed of change in what we know about what life is, and how we can control it, has accelerated at a rapid rate. Now we as a species are on the precipice of being able to manipulate the very building blocks of human evolution, not to mention wield unpredictable change on the greater world around us. Even as I commit that thought to paper, I pause in awe at its implications.

I have lived through eventful times and my job as a journalist has been to chronicle wars, presidents and sweeping social movements such as civil rights. I have seen a world in flux, but when I try to peer into the future I come to the conclusion that this story of humankinds ability to understand life on its most intimate level and be able to tinker with it for our benefit or detriment is likely to be the biggest one I will ever cover.

We are living in one of the greatest epochs of human exploration and it will shape our world as profoundly as the age of the transoceanic explorers. It is just that the beachheads on which we are landing and the continents we are mapping comprise a world far too small to see with the naked eye. Some of it is even invisible to our most powerful microscopes.

This brings me to a term that has become a big part of my life over the last few years: Crispr. Perhaps you know of it. Perhaps you dont. When I first heard of it, I thought it might be a new brand of toaster. I now know its an extremely powerful tool for editing genes in seemingly any organism on Earth, including humans. Scientists doing basic research have been uncovering the mechanisms of life for decades. They have been creating tools for modifying individual genes but Crispr is one of those revolutions where what researchers thought might be possible in the distant horizon is suddenly available now. Its cheap, its relatively simple and its remarkably precise.

I immediately knew that this was a story that needed telling. Human Nature, the resulting film full disclosure, I am executive producer came out of our conversations with scientists. They tend not to be the type of people who hype things but when they talk about Crispr you can feel the urgency in their voices. This is something you need to know about. All of you. If you are worried about your health or the health of your children. If you are concerned about how we might need to engineer our planet in the face of the climate crisis. If you are in finance, law or the world of tech. This will shape all of it.

And as we grapple with the unintended consequences of the internet and social media, as we try to make progress against a heating planet, I humbly submit that we as a species tend not to be good at thinking through where we are going until a crisis is already upon us. I fervently hope with Crispr that we can start the conversation sooner. That we can start it now. Thats why we made the film.

To be clear, we are probably a long way from designing babies to be more intelligent or more musically inclined. Life is just too complex for that, at least right now. More immediately, there is so much about this technology that is very exciting. As someone who remembers a time when my classmates were struck down with childhood diseases for which we now have vaccines, I know science can have profound applications for human health. Crispr could cure genetic diseases such as sickle cell and Huntingtons. It is being tested against cancers and HIV. It could also potentially be used to make crops more drought-resistant or food more nutritious.

On the other hand, we are walking closer to a world Aldous Huxley foresaw. What does it mean to be human? Where should we draw the boundaries beyond which we dare not cross? The inspiring researchers we talked to for the film know that the ethical and moral questions this technology raises are not for them to decide. Science has given us the tools, but not the answers. This is up to us, all of us. We need to be informed. We need to be honest with whats real and whats not. And we need to add our voices to a global conversation. Thats part of our responsibility as humans living on Earth today.

Dan Rather is one of the USs most feted journalists. He anchored CBS Evening News for 24 years

Human Nature is in UK cinemas now before a university town tour in the new year, wondercollaborative.org/human-nature-documentary-film/#screenings . It will be shown on BBC Storyville in spring/summer 2020

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Gene editing will let us control our very evolution. Will we use it wisely? - The Guardian

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Bengaluru: What must it have felt like to be a cotton spinner or an iron maker in England in the 1820s in the midst of an industrial revolution? Exactly 200 years later, we may be on the verge of another era of momentous change: the internet revolution. With internet access expanding dramatically post the early 1990s, a slew of new technologies have now matured to a point where fundamental change constantly seems to be right around the corner.

On the doorstep of a brand new decadethe 2020swhat new frontiers may Artificial Intelligence (AI) or gene editing open up? Will we soon have robot bosses? Will mixed reality change the way we consume entertainment and sports? Will we be able to cure 90% of all genetic diseases by the end of the decade? We take a look at five technologies that could alter India and the world. This may not be a definitive or even exhaustive list, but it is a list of things that could change the way we live, work, and play sooner than we think.

Mixed reality

Imagine watching a football match, not on your TV but on a virtual reality (VR) headset that streams the match live and projects interesting stats on the fly with the help of augmented reality (AR). Mumbai-based VR startup Tesseract, now owned by Mukesh Ambanis Reliance Jio, is promising a future like that with its Quark camera, Holoboard headset, and the high internet speeds of Jio Fiber. Similarly, a Hyderabad-based mixed reality startup called Imaginate enables cross-device communication over VR and AR wearables for better enterprise collaboration in the industrial sector.

Despite the much-hyped yet unmet expectations from the likes of Google Glass, Microsoft HoloLens and Facebooks Oculus, Tesseract and Imaginate simply underscore how the fusion of AR and VR technologies the combination of which is popularly known as Mixed Reality or MR is coming of age and is no longer in the realm of just sci-fi movies like Blade Runner 2049, where Officer K played by Ryan Gosling develops a relationship with his artificial intelligence (AI) hologram companion Joi.

For instance, AI-powered chatbots today can not only conduct a conversation in natural language via audio or text but they can be made more powerful with a dose of mixed reality. Last May, Fidelity Investments created a prototype VR financial advisor named Cora to answer client queries using a suite of tools from Amazon Web Services. Researchers in Southampton have built a device that displays 3D animated objects that can talk and interact with onlookers.

The Chinese government-run Xinhua News Agency has the worlds first AI-powered news anchor, whose voice has been modelled to resemble a real human anchor working for the agency. Going a step further, Japan-headquartered DataGrid Inc. uses generative adversarial networks (GANs) to develop its so-called whole body model automatic generation AI" that automatically generates full-length images of non-existent people with high resolutions.

Nevertheless, challenges abound when dealing MR-and AI-powered robots, humanoids, and human avatars. For one, whenever a company generates human bodies and faces, concerns over deep fakes and cheap fakes will always rear their heads. Second, data collection will continually raise concerns over security and privacy. Third, theres always the concern regarding the fairness of an AI algorithm when it is deployed to do human tasks like giving financial advice. Last, but not the least, theres also the question of whether AI bots should be allowed to pose as humans. This will continually pose a challenge and opportunity for technologists and policy makers.

Future of solar

Heliogen, a company that has billionaire philanthropist Bill Gates as one of its investors, says it has created the worlds first technology that can commercially replace fuels with carbon-free, ultra-high temperature heat from the sun. With its patented technology, Heliogens field of mirrors acts as a multi-acre magnifying glass to concentrate and capture sunlight.

This is just a case in point that solar technologies have evolved a lot since they first made their debut in the 1960s. For instance, solar roadwayspanels lining the surface of highwayshave already popped up in the Netherlands. Floating solar, on its part, is providing a credible option to address land use concerns associated with wide scale solar implementations. A French firm called Ciel et Terre, for instance, has projects set up in France, Japan, and England. Other parts of the world, including India and California in the US, are piloting similar floating solar initiatives.

Space-based solar technology is another exciting arena. India, China and Japan are investing heavily in these technologies right now. The Japan Aerospace Exploration Agencys (JAXA) Space Solar Power Systems (SSPS) aims to transmit energy from orbiting solar panels by 2030. Further, researchers at the VTT Technical Research Centre in Finland have used solar and 3D printing technologies to develop prototypes of what they have christened as energy harvesting trees".

With solar power cheaper than coal in most countries in the world, its worth scaling up these technologies.

Indians and robot bosses

Between 400 and 800 million individuals around the world could be displaced by automation and would need to find new jobs by 2030, predicted a December 2017 survey by consultancy firm McKinsey. The Future of Jobs 2018 report by the World Economic Forum (WEF) suggests that 75 million jobs may be lost to automation by 2022, but adds that another 133 million additional new roles will be created.

Given that many of the automated jobs are being taken away by AI-powered chatbots and intelligent robots, would humans eventually have to work for a robo boss? This, however, may not be as big a concern as it is made out to be. According to the second annual AI at Work study conducted by Oracle and Future Workplace, people trust robots more than their managers. The study, released this October, notes that workers in China (77%) and India (78%) have adopted AI over 2X more than those in France (32%) and Japan (29%). Further, workers in India (60%) and China (56%) are the most excited about AI, while men have a more positive view of AI at work than women.

Oracle and Future Workplace also found that 82% of the workers believe robot managers are better at certain tasks, such as maintaining work schedules and providing unbiased information, than their human counterparts. And almost two-thirds (64%) of workers worldwide say they would trust a robot more than their human manager. In China and India, that figure rises to almost 90%.

On the other hand, the respondents felt managers can outdo robots when it comes to understanding their feelings, coaching them, and creating a healthy work culture. Whether humans eventually serve a robo boss or not remains to be seen. However, we can be certain of one thing: in the near future, we will increasingly see humans collaborating with smart robots.

Future of payments

Everyone can be a merchant, and every device can be an acceptance device," Accenture noted in its 2017 Driving the Future of Payments report. This trend has only accelerated over the last two years, especially with banks coming to terms with the fact that young customers, especially those living in urban areas, prefer net banking and mobile banking and would seldom, or never, want to visit a bank branch if offered that choice.

Bitcoin and cryptocurrency investors, for instance, have not lost faith in this disruptive currency despite the run with volatility, and despite the industry being viewed with a lot of suspicion by most governments around the world, including India. Fintechs too, with their innovative technology solutions like AI-powered bots and contactless payments to name a few, have only made the payments ecosystem more inclusive, disruptive, and challenging. In India, especially, the governments Aadhaar-enabled payments system and the Unified Payments Interface (UPI) have revolutionized the payments ecosystem. The total volume of UPI transactions in the third quarter of calendar 2019 touched 2.7 billiona 183% rise over the same July-September quarter a year ago. In terms of value, UPI clocked 4.6 trillionup 189% over the same period a year ago, according to the Worldlines India Digital Payments Report-Q3 2019.

However, the number of transactions done on mobile wallets was 1.04 billiononly a 5% rise over the previous year period.

QR codes, according to the report, will continue to be used for payments, and the internet of things (IoT) is set to dominate micro payments by transforming connected devices into payment channels, though the pace of adoption of 5G by countries like India will be the key.

Nevertheless, cash that has been in existence for over 3000 years in different forms is not going to disappear in a hurry. Trust and security will continue to remain the operative words in digital payments.

Making sense of gene editing

When Dolly the sheep made news for becoming the first mammal ever to be cloned from another individuals body cell, many expected human cloning to follow soon. Dolly died over 16 years ago, and subsequently animals, including monkeys and dogs, continue to be cloned successfully. Yet, no human being has yet been cloned in real life.

While human cloning, which may or may not eventually happen, is bound to raise a lot of alarm bells given the moral implications surrounding the issue, the fact is that human genomes, or genes, are being routinely edited in a bid to find solutions for what are today considered to be incurable genetically inherited diseases.

Researchers are using a gene editing tool known as CRISPR-Cas9. CRISPR, which stands for Clusters of Regularly Interspaced Short Palindromic Repeats, is a tool that allows researchers to easily alter DNA sequences and modify gene function. The protein Cas9 (CRISPR-associated, or Cas) is an enzyme that acts like a pair of molecular scissors capable of cutting strands of DNA.

CRISPR-Cas9 is primarily known for its use in treating diseases like AIDS, amyotrophic lateral sclerosis (ALS), and Huntingtons disease. Two patients, one with beta thalassemia and one with sickle cell disease, have potentially been cured of their diseases, reveal results from clinical trials that were jointly conducted by Vertex Pharmaceuticals and CRISPR Therapeutics. The results released this November involved using Crispr to edit the genes of these patients.

Researchers are now looking to extend its use to tackle famine, lend a hand in creating antibiotics, and even wipe out an entire species such as malaria-spreading mosquitoes. Further, by genetically engineering a persons bone marrow cells, researchers can reprogram their immune and circulatory systems. Some new cancer treatments are based on this. Moreover, looking at the DNA of the collection of microbes in your gut can help with digestive disorders, weight loss, and even help understand mood changes.

Closer home, scientists at the Institute of Genomics and Integrative Biology (IGIB) and the Indian Institute of Chemical Biology (CSIR-IICB) are trying to correct genetic mutations in their laboratories using CRISPR Cas9 with encouraging preliminary results. But due to regulatory and ethical concerns, it may take a while before they can use this on humans.

IGIB also sells CRISPR products such as Cas9 proteins and its variants to educational institutes at reduced prices in a bid to encourage use of the technology.

The US Food and Drug Administration (FDA), on its part, considers any use of CRISPR-Cas9 gene editing in humans to be gene therapy and rules that the sale of DIY kits to produce gene therapies for self-administration is illegal. India, too, has banned the use of stem cell therapy for commercial use following concerns over rampant malpractice".

CRISPR-Cas9, thus, remains a work in progress and countries should have policies to govern its use. Meanwhile, one can watch out for an upgrade to CRISPR called Prime, which theoretically has the ability to snip out more than 90% of all genetic diseases.

Read more:
Five technologies that may alter India in 2020 - Livemint

Recommendation and review posted by Bethany Smith

One of the most popular methods for inserting therapeutic genes into cells to treat disease is to transport them using a virus that has been stripped of its infectious properties. But those noninfectious viruses can still sometimes touch off dangerous immune responses.

A team from Johns Hopkins Medicine is proposing an alternative method for transporting large therapies into cellsincluding genes and even the gene-editing system CRISPR. Its a nano-container made of a polymer that biodegrades once its inside the cell, unleashing the therapy. The researchers described the invention in the journal Science Advances.

The team, led by biomedical engineer Jordan Green, Ph.D., was inspired by viruses, which have many properties that make them ideal transport vehicles. They have both negative and positive charges, for example, which allows them to get close to cells. So Green and his colleagues developed a polymer containing four molecules with both positive and negative charges. They used it to make a container that interacts with the cell membrane and is eventually engulfed by it.

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The Hopkins researchers performed four experiments to prove the nanocontainers would travel into cells and deliver complex therapies once inside. First, they packaged a small protein into the polymer material and mixed it with mouse kidney cells in a lab dish. Using fluorescent tags, they confirmed that the protein made it into the cells. Then they repeated the experiment with a much larger medicinehuman immunoglobulinand observed that 90% of the kidney cells received the treatment.

From there, they made the payload even bulkier, packaging the nanocontainers with the gene-editing system CRISPR. With the help of fluorescent signals, they were able to confirm that CRISPR went to work once inside the cells, disabling a gene 77% of the time.

"That's pretty effective considering, with other gene-editing systems, you might get the correct gene-cutting result less than 10 percent of the time," said graduate student Yuan Rui in a statement.

Finally, the Hopkins researchers injected CRISPR components into mouse models of brain cancer using the polymer nanocontainers. Again they saw evidence that successful gene editing had occurred.

Developing improved methods for gene therapy is a priority in the field. In October, for example, scientists at Scripps Research described a way to use a small molecule called caraphenol A to lower levels of interferon-induced transmembrane (IFITM) proteins, which could, in turn, allow viral vectors to pass more easily into cells. And earlier this year, an Italian team described a method for including the protein CD47 in lentiviral vectors to improve the transferring of therapeutic genes into liver cells.

The next step for Hopkins researchers Rui and Green is to improve the stability of the nanocontainers so they can be injected into the bloodstream. They hope to be able to target them to cells that have certain genetic markers, they reported.

See the article here:
Hopkins team invents non-viral system for getting gene therapy into cells - FierceBiotech

Recommendation and review posted by Bethany Smith

In the middle of November, Editas Medicine (NASDAQ:EDIT) and Celgene (NASDAQ:CELG) announced changes to a development pact originally formed in 2015 with Juno Therapeutics, which is now part of Celgene. The agreement was amended in 2018, too, so the fact that changes were made wasn't necessarily big news. Editas received a $70 million upfront payment for executing the amended agreement, which was interpreted as the main takeaway from the announcement.

The announcement barely registered with investors and few gave it much thought for too long, especially after promising early results from the first clinical trials using a CRISPR-based medicine were announced by CRISPR Therapeutics days later.

But revisiting the amended collaboration agreement, and specifically what changes were made, hints at the long-term development plans of Editas Medicine. In short, it now has full control over an important class of immune cells. Whether that means the gene-editing pioneer lands another major development partner or goes full-steam ahead alone, investors can't overlook the significance.

Image source: Getty Images.

The basic scientific goal of the collaboration hasn't changed. Editas Medicine will use its gene-editing technology platform to engineer T cell receptors (TCR), while Juno Therapeutics will leverage its immunotherapy leadership to develop the engineered cellular medicines in clinical trials.

Why engineer TCRs? Immune cells rely on their receptors to identify targets, such as pathogenic bacteria and cancer cells. But immune cell receptors can be confused by molecules secreted within the tumor microenvironment, forcing them to halt their attack. They can also incorrectly attack an individual's own cells to trigger an autoimmune disease. A more recent concern stems from cellular medicines derived from a donor. Since the donor cells present different receptors compared to what the recipient's native T cells carry, the recipient's immune system (correctly) identifies the immunotherapy as a foreign substance, attacks it, and renders it less effective and less safe.

Therefore, it makes sense to engineer TCRs to create more potent and stealthier immunotherapies that are less likely to be tricked. Editas Medicine and Celgene still intend to do just that, albeit with subtle, yet important, differences to their development agreement.

Consideration

Previous Agreement (2015, 2018)

Amended Agreement (2019)

Focus

Cancer

Cancer and autoimmune diseases

Types of cells

CAR-T cells, alpha-beta T cells, gamma-delta T cells

Alpha-beta T cells

Juno Therapeutics exclusivity

Editas Medicine prohibited from all other work with CAR-T and TCRs in oncology

Editas Medicine prohibited from all other work on alpha-beta T cells and T cells derived from pluripotent stem cells

Upfront payment

$57.7 million (includes milestones collected under agreement)

$70 million

Milestone potential

$920 million plus tiered royalties

$195 million plus tiered royalties

Data source: SEC filings.

Essentially, Editas Medicine and Celgene have scaled back their original agreement in cancer and expanded their work to include autoimmune diseases. The most important detail is that the amended agreement allows the gene-editing pioneer to pursue the development of gamma-delta T cells, which were previously under the exclusive control of Juno Therapeutics. What does that mean?

Image source: Getty Images.

Without getting too far into the weeds, there are two main types of TCRs: alpha-beta and gamma-delta. The name refers to the molecular structure of the receptor, but that's not the important part.

Gamma-delta T cells, which comprise only about 5% of the T cells in your body, are thought to be one of the missing links in our understanding of the immune system. They're a mysterious bunch, but there could be significant value residing in the knowledge gaps.

These unique immune cells are governed by their own unique set of rules (relative to their alpha-beta peers) and straddle the innate immune system (what we're programmed with at birth) and adaptive immune systems (what's programmed as we encounter new environments throughout life). Gamma-delta T cells could be tinkered with in gut microbiome applications, to treat cardiovascular diseases, and to neutralize antibiotic-resistant infections. But the nearest commercial target of the mysterious immune cells is likely to be treating solid tumor cancers.

They possess potent anti-tumor activity where current immunotherapies fail, such as attacking cancer cells that lack tumor-specific antigens to target or that have become immune to checkpoint inhibitors. In fact, there's a link between certain cancer outcomes and the activity of specific gamma-delta T cells.

Given that, why would Celgene amend the agreement to ditch the rare subset of immune cells? Well, in August 2019, Celgene inked with a start-up called Immatics to develop engineered TCRs. The start-up's platform is based on gamma-delta tech.

Don't feel too bad for Editas Medicine, though. SEC filings reveal that the gene-editing pioneer didn't receive any money from the original collaboration deal with Celgene in the first nine months of 2019. That suggests the work had stalled or that the amendment was being hammered out for some time. The gene-editing pioneer wrestled back control of the tech and took a $70 million upfront payment to boot. While the potential milestone payments in the amended agreement are significantly lower than the originally promised bounty, Editas Medicine can offset that by signing a lucrative collaboration deal with a new partner.

There should be plenty of interest. Fellow gamma-delta T cell developer Adicet Bio recently landed an $80 million series B round funded in part by Johnson & Johnson, Regeneron,Samsung Biologics(not the same company as the electronics powerhouse), and Novartis. There's also Immatics, GammaDelta Therapeutics, and a handful of other start-ups making noise in the space.

Some competitors are directly engineering gamma-delta cells, and others are developing molecules to trigger the immune cells into action. Editas Medicine believes it has the edge, as it has a relatively precise and efficient method for engineering immune cells: gene editing.

The amended collaboration deal between Editas Medicine and Celgene received relatively little attention from investors. Perhaps that was a good thing, as Wall Street likely would have overreacted to the reduced scope of development and milestones. But investors that take the time to understand the details might be intrigued by the new research avenue for the gene-editing stock.

Can Editas Medicine become a leading force in gamma-delta T cell development? Perhaps. While it isn't the only company wielding a gene-editing platform, and CRISPR gene editing isn't the only type of gene editing, the company is well-positioned to take advantage of the opportunity. Investors will have to wait to see how (or if) the development strategy evolves around the new tech.

See the original post here:
Celgene Gave This Tech Back to Editas Medicine, but It Could Prove Valuable - The Motley Fool

Recommendation and review posted by Bethany Smith

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WASHINGTON DC, United States (AFP) In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering by editing her genome.

Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research gene therapy.

I have hoped for a cure since I was about 11, the 34-year-old told AFP in an e-mail.

Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency.

Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 pronounced Crisper a new tool informally known as molecular scissors.

The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

This is one patient. This is early results. We need to see how it works out in other patients, said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

But these results are really exciting.

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

It's all developing very quickly, said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the co-founder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Cures

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not such as making normal red blood cells, in Victoria's case, or making tumour-killing super white blood cells for a cancer patient.

Crispr goes even further; instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union.

They join several other gene therapies bringing the total to eight approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

Twenty-five, 30 years, that's the time it had to take, he told AFP from Paris.

It took a generation for gene therapy to become a reality. Now, it's only going to go faster.

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a breakthrough period.

We have hit an inflection point, said Carrie Wolinetz, NIH's associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to US$2 million meaning patients face gruelling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion and fighting a general infection.

You cannot do this in a community hospital close to home, said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Bioterrorism

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal and his excommunication from the scientific community when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

That technology is not safe, said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr scissors often cut next to the targeted gene, causing unexpected mutations.

It's very easy to do if you don't care about the consequences, Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American biohackers injecting themselves with Crispr technology bought online.

Not everyone is a biologist or scientist, she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops?

Charpentier thinks that technology generally tends to be used for the better.

I'm a bacteriologist we've been talking about bioterrorism for years, she said. Nothing has ever happened.

Now you can read the Jamaica Observer ePaper anytime, anywhere. The Jamaica Observer ePaper is available to you at home or at work, and is the same edition as the printed copy available at http://bit.ly/epaperlive

Originally posted here:
2019: The year gene therapy came of age - Jamaica Observer

Recommendation and review posted by Bethany Smith

In its latest trading session, CRISPR Therapeutics AG (NASDAQ:CRSP) spiked up by 2.3% here is what that looked like (as of 2019-12-09):

Whats the reason for these moves? To understand this better, it is helpful to analyze some technical indicators. As we see it, you should pay the most attention to the following:

A Money Flow Index (MFI) of 100.0, a Relative Strength Index (RSI) of 50.0, a True Strength Index (TSI) of 100.0, a Moving Average Convergence Divergence (MACD) of -0.016, an Average Directional Movement Index (ADX) of unknown, an Average True Range (ATR) of 1.429, an Accumulation/Distribution Index (ADI) of 1.429, an On-Balance Volume (OBV) of 557.672, and a Chaiikin Money Flow (CMF) of -70.71. 2.492

Now lets plug these indicators in. Consulting Trading View, we can conclude the following:

That is what an analysis of technical indicators seems to indicate for CRISPR Therapeutics AG (NASDAQ:CRSP). Note this is technical analysis only! You should do fundamental research as well, and do not just rely on this we take no responsibility for any losses incurred if you buy or sell based on the above.

More here:
CRISPR Therapeutics AG (NASDAQ:CRSP) Spiked Up 2.3% Here's Why - Lateral Line

Recommendation and review posted by Bethany Smith