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Head-To-Head Phase 3 Trial To Evaluate BTK Inhibitors in MCL – Targeted Oncology

Posted: August 18, 2021 at 2:40 am

The open-label, randomized BRUIN trial will compare LOXO-305 to investigators choice of either ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa). Approximately 500 patients will be enrolled in the study.

"MCL patients who have been treated with a covalent BTK inhibitor have very few therapeutic options, and outcomes are extremely poor. LOXO-305 has demonstrated a promising efficacy profile in these patients, a setting where we urgently need new therapies," said Michael Wang, MD, Puddin Clarke Endowed professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, in a press release.

The primary end point of BRUIN is progression-free survival (PFS), and the secondary end points include event-free survival, time to treatment failure, time to worsening of MCL-related symptoms, comparative tolerability, overall response rate (ORR), duration of response, and overall survival.

A confirmed diagnosis of MCL is required for inclusion in the study as well as being previously treated with at least 1 prior line of systemic therapy for MCL, having measurable disease per Lugano criteria, having an ECOG performance status of 0 to 2, and having adequate laboratory values at baseline.

In the case of prior treatment with an FDA-approved or investigational BTK inhibitor, patients are ineligible to enroll in the study. According to the criteria, patients are also excluded if they have a history of bleeding diathesis, stroke, or intracranial hemorrhage within 6 months of randomization, and prior allogeneic stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy within 60 days of randomization. In addition, patients with significant cardiovascular disease, and other comorbidities that may interfere with study treatment are not eligible to enroll.

Treatment with LOXO-305 has already shown promise for the treatment of 323 patients with previously treated B-cell malignancies. In the phase 1/2 BRUIN study, the use of the agent was investigated in patients with MCL, chronic lymphocytic leukemia/small lymphocytic leukemia, Waldenstroms macroglobulinemia (WM), and other B-cell malignancies. The patients were pretreated with a BTK inhibitor (95%), anti-CD20 antibody (98%), chemotherapy (92%), lenalidomide (Revlimid; 20%), autologous transplant (25%), CAR T-cell therapy (5%), and ASCT.3

According to data presented during the 2020 American Society of Hematology Annual Meeting, the ORR observed with LOXO-305 in 59 efficacy-evaluable patients from the MCL cohort was 52% (95% CI, 38%-65%), which included 14 complete and 15 partial responses. The median time to the first response in these patients was 1.8 months.

In the WM cohort of 19 efficacy-evaluable patients, the ORR observed was 68% (95% CI, 44%-87)%, which notably was similar in patients who were previously treated with a BTK inhibitor (69%; 95% CI, 39%-91%). Further, 4 out of 8 patients with follicular lymphoma had a response to LOXO-305, in addition to 75% of the evaluable Richter's transformation cohort, and 8 out of 35 patients with other B-cell malignancies, including diffuse large B-cell lymphoma and marginal zone lymphoma.

The most commonly reported adverse events (AEs) with LOXO-305 in the phase 1/2 BRUIN study were fatigue (20%), diarrhea (17%), and contusion (13%). Eight percent of patients had dose interruptions due to AEs, while 2.2% had dose reduction, and 1.5% permanently discontinued treatment with LOXO-305.

LOXO-305 was designed to overcome some of the limitations seen with current BTK therapies and we believe the promising efficacy and tolerability data demonstrate its potential to be an important new treatment option for MCL patients, said David Hyman, MD, chief medical officer of Loxo Oncology at Lilly, in a press release.

References:

1. Mato AR, Pagel JM, Coombs CC, et al. 542LOXO-305, a next generation, highly selective, non-covalent BTK inhibitor in previously treated CLL/SLL: results from the phase 1/2 bruin study. . Presented at: 2020 ASH Annual Meeting and Exposition. December 4-8, 2020; Virtual. Abstract 542.

2. Study of BTK inhibitor LOXO-305 versus approved BTK inhibitor drugs in patients withmantle cell lymphoma(MCL) (BRUIN-MCL-321). Clnicaltrials.gov. Accessed August 17, 2021. https://bit.ly/3CXTgu4

3. Loxo Oncology at Lilly announces updated data from the phase 1/2 BRUIN Clinical Trial for LOXO-305 in mantle cell lymphoma and non-Hodgkin lymphomas at the American Society of Hematology (ASH) Annual Meeting. News release. Loxo Oncology at Lilly. December 5, 2020. accessed August 17, 2021. https://prn.to/37QNw7a

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A Look Inside A Termite’s Gut Wins The 11th Annual Nikon Small World in Motion Competition – PRNewswire

Posted: August 18, 2021 at 2:39 am

Fabiancaptured this video using a research microscope from the 1970s, utilizing polarized light. He aimed to visually illustrate the symbiotic relationship between termites and these particular protists, to help audiences better understand the unseen role they play in our natural world. Fabian meticulously created an environment with a pH, chemical composition and temperature suited to keep the symbiontsalive. These symbionts are difficult to film due to their sensitivity to light and oxygen, and any slight changes to their environment can cause both the insect and the protists in its gut to perish.

"The most challenging part of capturing this video was finding the right solution for the creatures themselves," said Fabian. "I tried a lot of methods, even preparing my own saline solution. They're very sensitive to oxygen, so I had to remove as much gas from the solution as possible. It was very tricky, and I had to work fast. The video you're seeing is the result of months of trial and error, a lot of research and perseverance."

Protists are a wide and highly diverse array of single-celled organisms, but those featured in the winning video have formed a relationshipwith termites to process the cellulose they eat and help them derive nutrition from it and cycle carbon back into the soil. "Protists, while largely unknown to the generalpublic, are indeed the most abundant creatures on the planet," said Fabian. "There is a significant gap in our understanding aboutthese termite symbiontsand how this unique evolutionary relationship developed with its host, making it well worth exploring and presenting."

Fabian added, "The beautiful thing is that easy access to modern imaging and the internet has allowed those with an interest in microscopy to share their discoveries globally, across all boundaries of culture, language and age. The world is so small, and we can connect easily with anyone across the globe." Fabianhopes that his video will spark greater interest in Protists, as well as inspiring and encouraging more young peoples interested in STEM subjects.

"We're living in an amazing time when we have the ability to capture and share high-quality scientific imagery," said Eric Flem, Communications Manager, Nikon Instruments. "This year's winning entry highlights the power that microscopy has to connect like-minded individuals, educate others using engaging visuals, and spread scientific knowledge to the general public"

Second place was awarded to Dr. Stephanie Hachey and Dr. Christopher Hughes for their time-lapsed fluorescence microscopy video of an engineered human micro-tumor forming and metastasizing. In order to capture this video, stromal cells and cancer cells were introduced into a microfluidic platform under dynamic flow conditions and placed into a customized CO2 and humidity-controlled chamber. The platform was imaged every 15 minutes for 10 consecutive days.

The 2021 judging panel included:

For additional information, please visit http://www.nikonsmallworld.com, or follow the conversation on Facebook, Twitter @NikonSmallWorld and Instagram @NikonInstruments.

NIKON SMALL WORLD IN MOTION WINNERS

1st PlaceFabian J. WestonPennant Hills, New South Wales, AustraliaMicrofauna in a termite gutPolarized Light10X, 20X & 40X (Objective Lens Magnification)

2nd PlaceDr. Stephanie Hachey & Dr. Christopher HughesUniversity of California, IrvineDepartment of Molecular Biology and BiochemistryIrvine, California, USA10-day time-lapse of an engineered human micro-tumor forming and metastasizing. Vessels (red) support the growing tumor (blue).Confocal, Fluorescence10X (Objective Lens Magnification)

3rd PlaceAndrei SavitskyCherkassy, UkraineWater flea (Daphnia pulex) giving birth to cubsDarkfield4X (Objective Lens Magnification)

4th PlaceDr. Alexandre DumoulinUniversity of ZurichDepartment of Molecular Life SciencesZurich, SwitzerlandCommissural axons turning in an organized manner just after having crossed the midline of the central nervous systemConfocal40X (Objective Lens Magnification)

5th PlaceDr. Sachie Kanatani & Dr. Photini SinnisJohns Hopkins Bloomberg School of Public HealthDepartment of Molecular Microbiology and ImmunologyBaltimore, Maryland, USAInfected mosquito salivating fluorescently-labeled malaria parasites Confocal10X (Objective Lens Magnification)

HONORABLE MENTIONS

Sophie-Marie Aicher & Dr. Delphine PlanasInstitut Pasteur ParisDepartment of VirologyParis, le-de-France, FranceSARS-CoV-2 infection triggering cell fusion and cell death (red) in bat (Myotis myotis) brain cellsFluorescence, Phase Contrast20X (Objective Lens Magnification)

Richard AlbrechtAltenstadt, Bavaria, GermanyMosquito (Culex pipiens) laying eggsReflected Light, Stereomicroscopy5X - 20X (Objective Lens Magnification)

Bernard Allard & Didier BarbetClub Franais de MicroscopieSucy-en-Bry, FranceHydra and Trichodina parasitesBrightfield4X - 20X (Objective Lens Magnification)

Giulia L. M. Boezio & Dr. Radhan RamadassMax Planck Institute for Heart and Lung ResearchDepartment of Developmental GeneticsBad Nauheim, Hessen, Germany3-day old zebrafish (Danio rerio) showing the beating heart, aorta, and connecting vessels (endothelial cells: white; blood cells: red)Confocal40X (Objective Lens Magnification)

Dr. Dylan T. BurnetteVanderbilt University School of MedicineDepartment of Cell and Developmental BiologyNashville, Tennessee, USAEpithelial cells in cultureDifferential Interference Contrast (DIC)60X (Objective Lens Magnification)

Dr. Dylan T. BurnetteVanderbilt University School of MedicineDepartment of Cell and Developmental BiologyNashville, Tennessee, USADNA during cell division and deathConfocal60X (Objective Lens Magnification)

Dr. Nan-Shan Chang, Pei-Yi Chou, Yu-An Chen & Chen-Yu LuNational Cheng Kung UniversityDepartment of Molecular MedicineTainan, TaiwanMetastatic 231 breast cancer cells meet with L929 fibroblastsBrightfield10X (Objective Lens Magnification)

Yen Fook ChewWoodend, Waimakiriri, New ZealandA cladoceran (Chydorus sp.) moving on the cocoon of a caddisfly nymph prompting a reaction. The caddisfly spends its youth as an aquatic insect before leaving the water to become airborne.Darkfield4X (Objective Lens Magnification)

Yen Fook ChewWoodend, Waimakiriri, New ZealandHaving ingested nine Chydrorus, this oligochaete worm (Chaetogaster sp.) is having difficulty with the tenth, expelling it twice. This worm feeds by powerful suction rather like a vacuum cleaner.Darkfield, Polarized Light4X (Objective Lens Magnification)

Momir FutoRudjer Boskovic InstituteDivision of Molecular Biology / Laboratory of Evolutionary GeneticsZagreb, Grad Zagreb, Croatia5-day time-lapse of Bacillus subtilis biofilm growth and developmentStereomicroscopy0.65X (Objective Lens Magnification)

Dr. Jasmin Imran Alsous, Jonathan Jackson & Dr. Adam MartinSimons Foundation Flatiron InstituteCenter for Computational BiologyCambridge, Massachusetts, USANurse cells (cyan) contract and shrink in response to myosin waves (red) as they transport their contents to the egg cell in a fruit fly egg chamber.Confocal40X (Objective Lens Magnification)

Dylan Jones & Dr. Brian AtkinsonUniversity of NottinghamDepartment of Plant ScienceSutton Bonington, Leicestershire, United KingdomLaser ablation and reconstruction of pearl millet crown root Laser Ablation Tomography5X (Objective Lens Magnification)

Martin Kaae KristiansenMy Microscopic WorldAalborg, Nordjylland, DenmarkTardigrade showing individual muscle strands (muscles glow with different colors depending on the orientation to the light source)Polarized Light10X (Objective Lens Magnification)

Ana Gabriela MadrigalMcGill UniversityInstitute of ParasitologySte-Anne-de-Bellevue, QC, CanadaNeutrophils (type of white blood cell) rolling through mouse blood vesselConfocal20X (Objective Lens Magnification)

Dr. Alvaro MigottoCentro de Biologia MarinhaSo Sebastio, So Paulo, BrazilSea cucumberDarkfield1.6X - 40X (Objective Lens Magnification)

Danielle Parsons & Alan deHaasWonder ScienceLos Angeles, California, USATwo liquid crystals crystallizing on the same microscope slidePolarized Light20X (Objective Lens Magnification)

Dr. Eric Peterman & Jeff RasmussenUniversity of WashingtonDepartment of BiologySeattle, Washington, USADebris from degenerating axons (magenta) engulfed by an immune cell (cyan) in zebrafish (Danio rerio) skin Confocal25X (Objective Lens Magnification)

Wojtek PlonkaKrakow, Malopolskie, PolandTen day time-lapse of moss growthImage Stacking6X (Objective Lens Magnification)

Wojtek PlonkaKrakow, Malopolskie, Poland10-day time-lapse of Lobelia pendula seed developmentImage Stacking6X (Objective Lens Magnification)

Martina Schaettin & Dr. Fabian F. VoigtUniversity of ZurichDepartment of Molecular Life SciencesZurich, SwitzerlandFly-through of the nervous system of a 7-day old chicken embryoLight Sheet0.8X - 4X (Objective Lens Magnification)

Dr. Shinji ShimodeYokohama National UniversityManazuru Marne Center (MMCER)Manazuru-machi, Kanagawa, JapanPelagosphaera larva (planktonic larval stage) of sipunculid worms (peanut worms)Stereomicroscopy60X - 120X (Objective Lens Magnification)

Francesca StranoVictoria University of WellingtonSchool of Biological SciencesWellington, New ZealandSea slugsStereomicroscopy6X (Objective Lens Magnification)

Maria F. Ullo & Jeremy S. LogueAlbany Medical CollegeDepartment of Regenerative and Cancer Cell BiologyAlbany, New York, USAFluorescently tagged actin filaments flowing within a blebbing human melanoma cellDeconvolution, Fluorescence60X (Objective Lens Magnification)

Gaurav Upadhyay, Vedant Kumar & Dr. Rajneesh BhardwajIIT BombayDepartment of Mechanical EngineeringMumbai, Maharashtra, IndiaWater droplet bouncing over a superhydrophobic cantilever beamBrightfield7X (Objective Lens Magnification)

Wim van EgmondMicropolitan MuseumBerkel en Rodenrijs, Zuid Holland, NetherlandsMudflat diatomsBrightfield, Darkfield, Differential Interference Contrast (DIC), Reflected Light5X, 16X, 25X (Objective Lens Magnification)

Thomas A. Zangle & Soorya PradeepUniversity of UtahDepartment of Chemical EngineeringSalt Lake City, Utah, USA5-day time-lapse of rat hippocampal neurons showing development of networks and interconnections. Contrast enhanced to highlight neurites.Quantitative Phase Microscopy20X (Objective Lens Magnification)

About Nikon Small World Photomicrography CompetitionThe Nikon Small World Photomicrography Competition is open to anyone with an interest in photography or video. Participants may upload digital images and videos directly at http://www.nikonsmallworld.com. For additional information, contact Nikon Small World, Nikon Instruments Inc., 1300 Walt Whitman Road, Melville, NY 11747, USA, or phone (631) 547-8569. Entry forms for Nikon's 2021 Small World and Small World in Motion Competitions are available at https://enter.nikonsmallworld.com/

About Nikon Instruments Inc. Nikon Instruments Inc. is the US microscopy arm of Nikon Healthcare, a world leader in the development and manufacture of optical and digital imaging technology for biomedical applications. For more information, visit https://www.microscope.healthcare.nikon.com/ or contact us at 1-800-52-NIKON.

SOURCE Nikon Instruments Inc.

http://www.nikonsmallworld.com

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FV Clinics to begin offering Hormone Replacement Therapy – Le Mars Daily Sentinel

Posted: August 18, 2021 at 2:38 am

LE MARS Dr. Paul Parmelee was recently certified as a Bioidentical Hormone Replacement (BHRT) provider. He will offering BHRT (Pellet Therapy) beginning Aug. 18 in the Le Mars location of Floyd Valley Clinics.

BHRT is a personalized and natural approach to hormone replacement.

Appointments can be made by calling 712-546-3670.

Hormonal imbalances occur when there is too much or too little of a hormone in the bloodstream. Because of their importance, even the smallest hormonal imbalance can cause side effects throughout the body.

Signs and symptoms of hormonal imbalance in women include: fatigue, night sweats, hot flashes or flushes, decreased sex drive, weight gain, trouble sleeping, irritability, anxiousness, mood swings, low mood, and discomfort during intercourse.

Signs and symptoms of low testosterone and hormonal imbalance in men include: low sex drive, fatigue, loss of muscle mass, increased body fat (especially in the waist area), decreased bone mass, mood changes, low mood, irritability, brain fog, elevated blood sugar, stress, anxiousness, and high cholesterol.

If you are experiencing any of these symptoms and would like to learn more, your first step is to make an appointment with Dr. Parmelee. A patients hormone replacement eligibility will be determined during an office visit after conducting an extensive lab analysis.

If hormone replacement therapy would benefit the patient, the pellet will be inserted during an in-office visit. Once in the procedure room, an insertion site, usually somewhere around the upper buttocks, is numbed and a small incision is made. The hormone pellet is then inserted. When completed, the site is covered with a small bandage.

The pellet dissolves, and the body absorbs the contents over several months, leaving nothing behind to remove. After pellet insertion, you may continue most of your normal daily activities almost immediately.

Every patients symptoms are unique, so each journey is customized to fit those needs. Some patients report seeing improvement in as little as four weeks, but full optimization can take up to six months.

Everyone deserves to feel better no matter their age. If you are tired of dealing with the symptoms of hormone imbalance and want to take action, call today. Referrals are not necessary, but check with your insurance company to see if this service is covered. You may proceed at your own cost if you wish to receive treatment.

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TRT for low testosterone: Options, cost, and side effects – Medical News Today

Posted: August 18, 2021 at 2:38 am

Testosterone plays a vital role in a range of bodily functions, including muscle and bone health, cognition, red blood cell and sperm formation, and sexual and reproductive function in males.

However, testosterone levels can decline for various reasons, including stress, aging, and certain health conditions, such as hypogonadism.

This article discusses TRT in more detail, including who it is for, the types, how it works, how to get it, what to expect from it, and more.

TRT or androgen replacement therapy (ART) is a treatment that doctors give to males who have testosterone deficiency and are showing symptoms of hypogonadism.

Taking prescription testosterone helps restore the levels of this hormone in the blood, reversing the symptoms of low testosterone. People who take it may notice improvements in alertness, sexual function, energy, mood, and overall well-being.

Doctors prescribe TRT to males with hypogonadism. To receive a definitive diagnosis, blood tests must show that a person has low testosterone levels, which the American Urological Association notes as being below 300 nanograms per deciliter (ng/dl). The individual must also have other symptoms, such as fatigue, breast growth, and sexual dysfunction.

However, doctors do not usually recommend TRT as the first course of action for low testosterone levels, even for males who show such symptoms.

If other conditions or medications cause testosterone levels to drop, doctors usually treat the underlying condition before recommending TRT.

TRT is only available with a prescription. If a person presents with symptoms consistent with low testosterone levels, a doctor will only provide a prescription after taking a thorough medical history and performing physical and lab exams.

As hormone levels fluctuate depending on activity levels, diet, and the time of day, doctors usually take a blood test before noon on 2 consecutive days. They may sometimes also ask for imaging studies and additional tests, such as tests for luteinizing hormone and follicle stimulation hormone, to determine the cause of the low testosterone levels.

There are several ways to administer testosterone:

Injectable testosterone is an inexpensive and common form of TRT. A person can receive short-acting treatment, which involves a shot every 1 or 2 weeks, or long-acting treatment, in which the second shot is 4 weeks after the first, and all others are 10 weeks apart. The dosage and frequency of the treatment may vary depending on the person.

Doctors inject short-acting testosterone under the skin or muscle, while long-acting shots go in the gluteal muscles.

TRT can cause fluctuations in testosterone levels, which can affect energy levels, libido, mood, and the presence of symptoms such as breast tenderness.

People usually apply gels and creams on a daily basis. Gradual absorption causes more stable testosterone levels in the blood.

However, people using topical treatments must be careful to avoid skin-on-skin contact with other people for at least 6 hours after application. It is important to prevent the risk of transferring the medication onto other peoples skin because it may be dangerous for pregnant people and children.

Topical patches stick to the skin and stay in place for 24 hours until the next dose. The downsides to patches are that they are not cosmetically appealing and often cause skin irritations.

A person places a buccal patch above the upper teeth, and it releases testosterone over 12 hours. In comparison with oral medications, patches may be less toxic to the liver. However, these patches can cause headaches and gum and mouth irritation.

Testosterone pellets are small plastic pellets that doctors implant under the skin. The implant goes into a persons upper hip or buttock. The pellets dissolve slowly and can deliver TRT for 36 months.

Inserting implants is a minor inpatient surgical procedure. A doctor makes a small cut and then inserts the pellets in the fatty tissue below the skin. They perform the procedure under local anesthesia.

Learn more about testosterone pellets here.

Oral testosterone is a less common type of TRT that is more expensive and less practical. Its long-term use can potentially cause liver damage.

Most tablets also come with warnings about the drug causing hypertension and stroke. As a result, only individuals who cannot use other forms of TRT resort to taking testosterone by mouth.

A person applies nasal testosterone gel to the inside of the nose. They will need to do this three times a day at intervals of 68 hours, preferably at the same times every day. Some common reactions to this treatment include headaches, nosebleeds, a runny nose, and nasal discomfort.

TRT aims to restore a persons testosterone levels to normal. The individual can expect improvements in their blood testosterone levels within a week.

A person may also note other benefits, such as an increase in bone density and lean body mass, an improvement in well-being, and a boost to energy and libido. It may take from 4 weeks to several months to see positive changes.

TRT is typically a lifelong treatment. Once a person starts TRT, their doctor will continually monitor their response to treatment. People need to have routine checkups at least every 612 months to assess their blood testosterone levels.

A doctor will also monitor changes in symptoms and side effects at 3 and 6 months after the initial treatment and then annually.

TRT costs range from $150 to $1,500 per month and vary depending on various factors, including:

In addition to the possible short-term side effects, TRT may also cause health risks. The Endocrine Society recommends that people with the following conditions do not start using TRT:

It also states that the treatment is unsuitable for males who wish to conceive in the near future.

Males aged 40 years older, preadolescent people, and those with migraine or epilepsy may require special considerations.

The Food and Drug Administration (FDA) explains that the benefits and safety of TRT for treating low testosterone levels due to aging are not known. The organization requires that testosterone products carry warnings mentioning the possible risk of stroke and heart disease.

A 2017 review found that men undergoing TRT have a higher risk for cardiovascular events such as stroke.

Other side effects of taking testosterone include:

High cholesterol may also be a side effect. However, a 2021 study suggests that TRT may improve total cholesterol levels.

The current scientific literature suggests that TRT worsens breast and prostate cancer. However, TRT may offer benefits to people with early stage prostate cancer without stimulating the recurrence or progression of cancer.

The following are commonly asked questions:

TRT costs range from $150$1,500 per month depending on the type of TRT, the mode and frequency of administration, and the insurance coverage.

Yes. Most insurance companies cover all forms of TRT. However, there may be out-of-pocket costs.

Although TRT offers benefits to people with low testosterone levels, it can cause many short-term side effects. It may also put people who take TRT in the long term at increased risk of liver and heart problems.

TRT treatment length is indefinite unless the low levels are due to an underlying cause that is treatable.

TRT is a common treatment for low testosterone levels, but it is not suitable for everyone.

People who are considering TRT need a prescription and proper guidance from a doctor.

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Ladies, Here’s How to Prevent Top 7 Threats to Your Health – Baptist Health South Florida

Posted: August 18, 2021 at 2:37 am

Two out of every three caregivers in the U.S. are women. That means they provide daily or regular support to children, adults, or people with chronic illnesses or disabilities, says the U.S. Centers for Disease Control and Prevention (CDC). But while women tend to care for others, they tend to sacrifice their own physical or mental health, the CDC adds.

Many of the top health threats to women can be prevented, including the top causes of death among adult women in the U.S. heart disease, cancer, chronic lower respiratory disease, stroke, Alzheimers disease and unintentional injuries. Women tend to be underdiagnosed with heart disease, the No. 1 cause of death for both men and women.

During the COVID-19 pandemic, surveys found that women reported skipping preventive health services, such as their yearly check-up or routine tests, more so than men. Usually, that trend is reversed, with women tending to their healthcare needs more. But during the pandemic, more women took on roles as teachers in their homes and caregivers for elderly family members..

Nonetheless, primary care doctors warn that women who put off taking care of their own health to care for others often end up with conditions that could have been treated more easily in their earlier stages.

Women need to take some time to make sure they get their regular checkups and necessary health screenings, depending on their age and overall health, said Kamaljit Kaur, M.D., a family medicine physician with Baptist Health Primary Care. Even if we only see them once a year for their checkups, we can see subtle changes that could indicate a risk for developing or the presence of disease.

A checkups blood work can show the presence of an infection with elevated white blood cells, anemia or internal bleeding with too few red blood cells, high blood sugar that may indicate diabetes, and thyroid, kidney and liver function. A mental health screening can reveal depression, anxiety and sleep disorders, which can lead to other health problems.

We also discuss vital lifestyle factors such as weight management, proper nutrition and regular exercise to keep risk factors under control for heart disease, diabetes and other potentially serious conditions, said Dr. Kaur.

Here are the top threats to womens health:

Unhealthy diet

The foods you eat affect your health. Eating healthier can lower your risk of heart disease and stroke, diabetes and other chronic conditions.

Not enough exercise

Being physically active is good for your heart and overall health, including mental health. People who are not active have double the risk of heart disease and stroke, and higher risk diabetes, dementia, and some cancers. Exercise is one of the most vital steps you can take to better health.

Unhealthy weight

Most people struggle with their weight at some point in their lives. Being overweight can lead to high blood pressure, high cholesterol, diabetes and sleep apnea. Obesity can double your chance of heart disease. Consult with your doctor about lifestyle modification and the ideal weight range for you.

Smoking

Smoking triples the risk of dying from heart disease and stroke in middle-aged women. Quitting is one of the best things you can do to prevent heart disease and stroke.

Stress

If you feel regularly pressured because of workloads at home and the office, your physical well-being, lifestyle habits, and mental health will suffer and so can your immune system and the ability to fight off disease. Take steps to reduce stress.

Too much alcohol

Heavy drinking and binge drinking are risk factors for high blood pressure, heart disease and stroke. Alcohol may also cause problems by interacting with your medications.

Birth control and hormone replacement therapy (HRT)

Medications that contain estrogen the female hormone increase the risk of heart attack, stroke and mini-stroke (TIA). Consult with your doctor about these medications and their side effects.

Tags: Baptist Health Primary Care, women's health

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Puppies Puppies (Jade Kuriki-Olivo) on transition, retrospection, and year of protest – Artforum

Posted: August 18, 2021 at 2:37 am

Puppies Puppies (Jade Kuriki Olivo), Brain on Estrogen, progesterone, spironolactone, Truvada, Advil and Marijuana, 2018, cow brain, marijuana leaf, progesterone, estrogen, spironolactone, prep and pain killers. Photo: Courtesy the artist.

Jade Kuriki Olivos retrospective at the Kunsthaus Glarus in Switzerland brings together the Brooklyn-based artists work from the past decade. On view through August 22, the show maps the evolution of her practice as she transitioned from working under the guise of Puppies Puppies to living as an openly trans woman. Here, Olivo reflects on this transformation and discusses refusing to hide, the turning point represented by this exhibition, and the weekly Stonewall Protests for Black Trans Liberation that have kept her going over the past year.

I WAS HIDING from the world for a long time. In some ways, it was because it was so terrifying to beor even think about beinga trans woman. It felt like jumping off a cliff when I decided that it was what I wanted and needed in life.

Trans women have been consistently erased from historyour voices have been erasedso it is revolutionary for me, and for every trans person, especially BIPOC, gender-nonconforming, and two-spirit people, to be in control of the way our voices go out into the world. I still dont do many interviews, but unlike beforewhen my ex-husband or someone else would speak for me and I would be in a costume or sleeping on a sleeping pillnow I speak for myself. It means something very differentto be hidden as a trans woman. At other points in history, I wouldnt have been able to exist. So when I came out, I exposed myself fully and physically in a nude performance in Paris as a way of saying, Im here and Im not going to hide anymore. I couldnt be out as a trans woman and have hiding be a part of my work. I also wanted to document the changes in my body as my hormone-replacement therapy continued.

This is part of the arc of my exhibition at the Kunsthaus Glarus. It was emotional pulling this show together because I really wanted people to understand the evolution thats happened within me. The show covers eleven years of work. I called it a retrospective because I was thinking about how the amount of time that one is given, that a person is allowed to exist, is different for different people. Trans women often dont live as long as other people. It creates a different way of relating to time. Its definitely more precious for me, also having had a brain tumor.

The show marks a new way of making work for me. Ive always worked with other artists, so collaboration is nothing new, but Im moving into a more curatorial rolebecoming a conduit or a pathwayso that I can give a platform to other artists, especially a growing family of trans/GNC/2S+ artists. Going forward, when an institution asks me to do a solo show, I will invite another artist to do their own solo show, and they can decide how or if they want that to be associated with me. This is the direction I want to go in, and Im doing sex work and figuring out a way to survive so I can keep moving toward it. This new chapter begins with Bri Williams and Elliot Reeds exhibitions opening at Glarus in September.

Next to giving other artists I believe in space to express themselves, Stonewall Protests is the part of my life I am most passionate about. Stonewall is organized by Qween Jean and Joela Rivera, who have been holding weekly demonstrations for the past year in the wake of the murder of George Floyd. They are really the civil-rights leaders of now. Ive been protesting since the age of sixteen, but when I finally found Stonewall Protests at thirty-one, I was like, Oh my God, you found your family and your home. I also found a reason to keep going at a time when my art practice was not fulfilling me. It is a healing space. Stonewall is first and foremost a leading formation within the current Black Trans Lives Matter movement. The protests relate in some ways to the ballroom scene, which was founded by Black and Latinx trans women in New York City, specifically in Harlem, and brings that culture to protesting. An amazing group of bikers called Riders4Rights block intersections so the space can become a dance floor where people are able to express themselves to their fullest and feel safe enough to do so. There are different chants and a drum line and music made by a fantastic group called Musicians United NYC. A huge part of the Stonewall protests are mutual-aid events which emphasize the need to support one another, as well as the communities some Stonewall protesters live or grew up in.

In different Indigenous histories, trans people have been identified as healers or helpers, and Im drawn to this way of existing as a kind of sacred work. This is a practice I became familiar with through my father, who was Indigenous and taught me what he knew, and from my chosen Indigenous queer family members over time. In articulating all this, and thinking about when art and life blend together, Ive been really grateful to reflect on this evolution. As Puppies Puppies, I was making meme videos, really concealed from the world in this little shell. And now this is whats happening. Its my life and Im here.

As told to Camila McHugh

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Health tips from Dr. Oz and Dr. Roizen for 8-17-21 – The Dispatch – The Commercial Dispatch

Posted: August 18, 2021 at 2:37 am

Attitude and action to win over this past years challengesLive long and prosper. That famous line from the Vulcan Mr. Spock (played by Leonard Nimoy) should be your motto for the coming year. And heres how to do it despite the recent news about just how tough its been.

A study that looked at 29 folks, ages 90 to 100, uncovered two powerful secrets to longevity: acceptance of and recovery from things you cant change and an impulse to fight for the things you can alter. This is valuable information especially now that life expectancy in the U.S. is falling.

COVID-19 contributed to a decline in life expectancy from age 78.8 in 2019 to age 77.3 in 2020, according to the National Center for Health Statistics. In addition, more than 93,000 people died from drug overdoses a 30 percent increase over 2019. Homicides and deaths from diabetes and chronic liver disease also made major dents in longevity.

So what can you do to buck this trend?1. Get vaccinated pronto. 100 percent of the deaths from COVID-19 in June in Maryland were among nonvaccinated people.

2. Reassert control over your health. See your doctor for checkups and tests, especially if you have diabetes or other chronic conditions and nonalcoholic fatty liver disease. Reach out to support groups if you have alcohol- or substance-related disorders or suicidal thoughts and behavior.

3. Revamp your nutrition and your physical activity routine. Nutrition influences everything from longevity to mood. Theres great guidance in Dr. Mikes book What to Eat When and at DoctorOz.com, click on OZtube/Body.

If you arent getting vaccinated for yourself do it for your pet!When John Legend did the ad This Shot Is Our Shot to encourage people to get a COVID-19 vaccine and then put his inoculation up online, he was thinking about all the heartache that could be prevented by protecting folks from contracting the sometimes-fatal infection. But we bet John and his wife Chrissy Teigen who posted info on her shot on Facebook didnt know what a huge benefit their inoculations would be to their bulldogs Pablo, Penny and Pippa and their poodle named Petey.

It turns out that when a pet owner gets COVID-19, 67 percent of housecats and 43 percent of dogs also become infected. Thats the conclusion of researchers from Canadas University of Guelph, who did a study of 48 cats and 54 dogs from 77 households in which an owner had been diagnosed with COVID-19. Their paper, presented at the European Congress of Clinical Microbiology & Infectious Diseases 2021, found that while most infected pets were asymptomatic, 20 percent of the dogs experienced lack of energy and loss of appetite, a cough or diarrhea; 27 percent of cats ended up with a runny nose and difficulty breathing.

The researchers advice: If you get COVID-19, stay away from your pet, and dont allow it to sleep with you. Also smart: If you have COVID-19 in your house, keep your pet away from other people and pets. Once a cat or dog becomes infected, pet-to-pet and pet-to-human transmission cannot be ruled out say the researchers.

How to stay cool in a heat waveMartha and the Vandellas sang about the torment of a Heat Wave in their 1963 hit: Its like a heat wave/burnin in my heart/ Its like a heat wave/Its tearin me apart. They did a pretty good job of predicting the effect of the scorching temperatures the U.S. has been experiencing this summer.

At least 67 weather stations from Washington State through New Mexico have recorded their hottest temperatures ever, according to the National Weather Service. And as risky as that is for the earths and peoples future, it also poses an immediate threat to you. High temperatures can cause dehydration, heatstroke, heat exhaustion and heat cramps; strain the cardiovascular and respiratory systems; and even increase interpersonal conflict. Research also shows strong links between climate crises and development of depression, anxiety and PTSD. So how can you stay cool, calm and collected when its steamy outside?

BIG NEWS: Dont use an electric fan when the indoor air temperature is over 95 degrees. The breeze can actually cause your body to gain heat instead of losing it!

If you have air conditioning, use it or go to an air-conditioned building or cooling center. For locations, Google cooling centers (and the name of your town). And (duh!) wear lightweight, light-colored, loose-fitting clothing.

In a cool environment, drink a tall glass of plain water every couple hours. In the heat, have a water bottle with you and sip every 10-15 minutes. Nothing sugary.

Exercise (keep doing it!) indoors in a cool place.

Think, sweat, think sweat that may delay dementiaBrute strength: 6 feet 9 inch tall Game of Thrones actor Hafthor Bjornsson set a world deadlifting record by lifting 1,104 pounds. Brain power: Dr. Sho Yano has an IQ of 200, started college at age 9 and earned an M.D. and Ph.D. by the time he was 21.

Imagine if such brains and brawn were found in one person. Well, they can be in you! And you dont have to hold the worlds record in both strength and intelligence to get the benefits of that combination: a reduced risk of Alzheimers and a healthier cardio and respiratory system. So heres how to harness the benefits.

A study in the journal Neurology followed 1,978 people, average age 80, and found that doing simple cognitive exercises such as reading, writing letters, playing card games and doing puzzles may delay the onset of Alzheimers disease by up to five years. And brain workouts later in life not as a younger person are what delayed the participants cognitive decline.

While youre strengthening your brain, pay attention to your body. Another research team found that one year of moderate- to vigorous-intensity aerobic walking two to three times a week for 30 minutes gradually increasing to four to five times weekly with two sessions of high intensity improves cardiorespiratory fitness, cerebral blood flow, memory and executive function in folks with mild cognitive impairment. The researchers say that also may reduce your risk of Alzheimers. We say combine brains and brawn and youll have a win-win well into your 80s and 90s!

The alpha and omega-3 of a longer lifeAn adult male bear on Kodiak Island in Alaska eats more than 6,000 pounds of salmon a year; females gobble up about half of that. And without any bagels! Fortunately, to get the remarkable benefits of eating omega-3-rich foods, you only need to eat a 3- to 6-ounce serving of salmon regularly. Dr. Mike loves salmon burgers even for breakfast. For lunch or dinner, he adds olives and broccoli or grilled vegetables.

A new study in the American Journal of Clinical Nutrition looked at data from blood tests on more than 2,200 people over age 65 for an average of 11 years. The researchers from The Fatty Acid Research Institute in the United States and colleagues in universities in the U.S. and Canada found that folks with high levels of omega-3 fatty acids in their blood saw an increase in life expectancy of almost five years. Thats a huge increase in longevity from simply enjoying incredibly tasty foods.

The alpha and omega-3 of your choices: In every 3.5-ounce serving, wild salmon has 2,260 milligrams, herring 2,366 milligrams, sardines 1,480 milligrams and anchovies 2,113 milligrams. Flaxseed delivers 7,260 milligrams per tablespoon; and chia seeds and walnuts dish up 5,060 milligrams and 2,570 milligrams per ounce respectively. The benefit of adding these foods (in human size portions) is clear. According to the study author: It reinforces the idea that small changes in diet in the right direction can have a much more powerful effect than we think, and it is never too late or too early to make these changes.

Shades of brain healthIn 1986, when Cyndi Lauper sang True Colors I see your true colors shining through/I see your true colors and thats why I love you/So dont be afraid to let them show she had no idea just how important it was for everyone to put those true colors on display on their breakfast, lunch and dinner plates! But a new study in the journal Neurology reveals the power of colorful fruits and vegetables to protect you from cognitive decline as you get older.

The study, led by renowned Harvard nutrition researcher Walter Willet, followed almost 50,000 men and women, average age 51 at the start of the study, for 20 years. It revealed that eating flavonoid-rich, colorful foods such as apples; celery; red, blue and purple berries and grapes; hot and sweet peppers; eggplant; plums; carrots; citrus fruits; and even thyme and parsley can reduce your risk for encroaching dementia by 20 percent.

The study found that taking in 600 milligrams of flavonoids a day is what it takes to help combat cognitive decline 3.5 ounces of strawberries dishes up around 180 milligrams; a medium apple, 113 milligrams. In the U.S., adults only get about 200 to 250 milligrams a day, just a bit above the study group with the lowest intake and greatest risk of cognition problems.

If you make an effort to increase your intake, youll gain flavonoids neuroprotection. They also turn out to be anti-inflammatory and anti-diabetic. So make your life a bowl full of cherries and other colorful flavonoid-rich foods.

Foods that damage your immune strengthKryptonite immobilizes Superman. Spider-Mans archenemy, Venom, changes from predator to weakling at the sight of a flame. And you? Well, it turns out certain foods have superpowers that weaken your immune system, transforming you from super-germ fighter to a target for everything from the common cold to COVID-19. The most immune-weakening consumables are:

Excess alcohol. Whether its a daily overdose or you binge once a week, youre increasing your risk for pneumonia and acute respiratory stress syndromes. That could potentially impact the outcome of COVID-19. It also leads to slower recovery from infection and post-op complications.

Too much salt. That causes a cascade of events, starting with the kidneys excreting excess sodium and ending with a reduction in your bodys ability to fight bacterial infections. As little as 6 extra grams a day has that effect. Your daily average should be below 3 grams a day.

Added sugar. As little as 3.5 ounces (thats in a 16-ounce Coke, a Big Mac and a slice of pecan pie) can reduce the ability of immune cells to neutralize bacteria for up to five hours.

Highly processed foods. Stripped of fiber, these alter the mix of microbes in your gut biome, where 70 percent to 80 percent of immune cells hang out, making them less able to battle viruses. Getting adequate fiber (25 to 30 grams daily) has been shown to strengthen your flu-fighting powers. Whole cereals, veggies and fruit, and beans are go-to sources plus they supply vitamins A and C, folate and bioactive compounds that also boost immune health.

Playing hooky from your statin? Look for some new alternativesThere are over 1 million students in the New York City public school system, and more than 22 percent of them are chronically absent from the classroom (pre-pandemic). Thats not good for their future. But even more adults around 50 percent fail to show up for their life-saving daily dose of a statin. Now, that really threatens their future.

Fortunately, there are new cholesterol-fighting medications that even your doc might not be aware of, according to a new JAMA Insights Clinical Update. So if youre not taking your prescribed statin or your lousy LDL cholesterol level is too high, ask about trying one of the following drugs on its own or with a statin. Most are covered by insurance if youre statin resistant or have had statin myopathy from two different statins.

PSCK-9 inhibitors. A monoclonal antibody administered by injection every two to four weeks, it reduces LDL by 50 percent to 60 percent and is well-tolerated. Check to see if your insurance covers it.Ezetimibe. An inexpensive generic, this cuts intestinal absorption of cholesterol and reduces LDL levels by 10 percent to 20 percent. Good in combo with a statin.

Bempedoic acid. It lowers LDL by about 20 percent with few side effects. Its not yet known how much it reduces the risk of atherosclerotic-related cardiovascular disease; check price and insurance coverage.

Icosapent ethyl. An omega-3 fatty acid that, when added to statin therapy for patients with high triglyceride levels, can reduce atherosclerotic cardiovascular disease risk by 25 percent. Highly variable out-of-pocket cost.

As you age you may need fewer calories but more nutrientsThe worlds oldest magic trick, acetabula et calculi, reportedly dates back to early Rome. Today, its known as cups and balls and while there are endless variations, it all comes down to trying to figure out how small balls pop in and out of three upside-down cups unseen.

Making sure you get enough nutrition as you get older also requires a sleight of hand. You need extra nutrients to protect your strength, cognition, immune function and bone, eye and heart health, while you take in fewer calories daily. Here are four nutrients you should pack into every day.

Calcium: For bone health, aim for three servings a day of fat-free dairy, two servings daily of dark leafy greens like kale, spinach and collards. Also good: canned fish, like sardines.

Vitamin D: Get a good daily dose from fish such as salmon, mushrooms and fortified foods. Get your blood level checked: Most folks need a supplement too. It helps with immune function and bone strength.

Vitamin B12: Essential for nerve and blood cell health, its in fortified whole-grain cereals, lean meat and fish. A blood test will show if you need a supplement.

Protein: Whole grains and legumes, tofu, fish, nuts and lean poultry can deliver the protein you need to gain and maintain muscle mass and function. A 150- to 160-pound senior might need 65 to 70 grams daily. That could come from 6 ounces of salmon (40 grams), 3 ounces of white meat turkey (24 grams) and 1 cup of brown rice (5 grams).

The amazing power of diet to cool menopause hot flashesIn 2014, then 61-year-old Emma Thompson joked about her hot flashes as she accepted a best actress award from the National Board of Review for her role in Saving Mr. Banks: Its such a cold night. You know, its the first time Ive been actively grateful for the menopause. Sound familiar?

Around 85 percent of postmenopausal women say symptoms such as hot flashes, palpitations and insomnia define the months or years around the cessation of menstruation. Many just tough it out, because for years they were told to take hormone replacement therapy, then told, No, hormone therapy is too risky, then, that its really OK if done immediately after menopause and for no more than 10-20 years (the correct information in our opinion if you also take low-dose aspirin).

Too bad this new study, led by Physicians for Responsible Medicines founding president Neal Barnard, wasnt around sooner. Its a real game changer. During the 12-week study, the research published in the journal Menopause found that a plant-based diet, rich in soy, reduces moderate-to-severe hot flashes by 84 percent! Close to 60 percent of participants became totally free of moderate-to-severe hot flashes and women who experienced mild hot flashes saw them decrease by 79 percent.

The diet that produced these remarkable results was low-fat and vegan, based on fruits, vegetables, whole grains and legumes, reduced intake of added oils and fatty foods, and heres the kicker 1/2 cup of cooked non-GMO soybeans daily. In our humble opinion, this diet deserves to be adopted by any woman whos contending with menopause symptoms.

Mehmet Oz, M.D. is host of The Dr. Oz Show, and Mike Roizen, M.D. is Chief Wellness Officer and Chair of Wellness Institute at Cleveland Clinic. To live your healthiest, tune into The Dr. Oz Show or visit http://www.sharecare.com.

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Xeris Pharmaceuticals Announces FDA Acceptance of its IND Application for XeriSol Levothyroxine (XP-8121) for the Treatment of Hypothyroidism – Yahoo…

Posted: August 18, 2021 at 2:37 am

Currently recruiting healthy participants

CHICAGO, August 11, 2021--(BUSINESS WIRE)--Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the Food and Drug Administration (FDA) has allowed the Investigational New Drug Application (IND) for its XeriSol levothyroxine for hypothyroidism to proceed. The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine in a subcutaneous injection for the treatment of hypothyroidism. The Phase 1 study will characterize Pharmacokinetics (PK) and evaluate the safety and tolerability of XP-8121 in healthy participants.

"Levothyroxine is one of the most widely prescribed drug products in the United States. However, due to the many challenges associated with oral formulations there remains an area of significant unmet need. We believe that a potentially weekly subcutaneous injection of XeriSol levothyroxine can mitigate many of these challenges and improve compliance. The Phase 1 study is the first step toward addressing this unmet need," said Kenneth E. Johnson, PharmD, Xeris Senior Vice President of Global Development and Medical Affairs.

"The FDA acceptance of our XP-8121 further underscores the applicability of our XeriSol technology and progress of our pipeline. We will continue to invest in our pipeline in therapeutic areas where we have an established commercial footprint," said Paul R. Edick, Chairman and CEO of Xeris.

About Levothyroxine and Hypothyroidism

The thyroid gland is responsible for the synthesis, storage, and release of metabolic hormones including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood.

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Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. The goal of therapy is restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life [Winther et al, 2016]. The treatment of choice for correction of hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most widely prescribed drug products in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients undergoing treatment with oral levothyroxine cannot be underestimated. It has been reported that nearly 40% of patients undergoing treatment with oral levothyroxine are either over- or under-treated [Laurent et al, 2018] due to factors that include, but are not limited to, drug formulation, use of the drug with food, adherence to the drug, use of concomitant medications, and pre-existing medical conditions. Many patients failing to reach target TSH levels are generally managed by simply increasing their levothyroxine daily dose [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index [Vita et al, 2014], meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered to a patient; thus, the titration of levothyroxine oral drug may be a tailored and incremental process.

About Xeris Pharmaceuticals, Inc.

Xeris (Nasdaq: XERS) is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke in the U.S. Its proprietary XeriSol and XeriJect formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Xeris is headquartered in Chicago, IL. For more information, visit http://www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or results from planned clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing and likelihood of the consummation of the Strongbridge Biopharma acquisition, the timing or likelihood of expansion into additional markets, the timing or likelihood of identifying potential development and commercialization partnerships, the potential utility of its formulation platforms and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the impact of COVID-19 on its business operations, its reliance on third-party suppliers for Gvoke and Ogluo, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the "Risk Factors" section of the most recently filed Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the "SEC"), as well as discussions of potential risks, uncertainties, and other important factors in Xeris subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210811005814/en/

Contacts

Investor Contact Allison WeySenior Vice President, Investor Relations and Corporate Communicationsawey@xerispharma.com 312-736-1237

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My bosses were happy to destroy me the women forced out of work by menopause – The Guardian

Posted: August 18, 2021 at 2:37 am

In 2019, Maras weekly performance review meetings grew intolerable; she would sit in a cramped conference room with her supervisors only to be told that she wasnt performing well enough. I felt like a child, says Mara, who is 48, lives in Hampshire and works and works as a public servant. They would tell me off. Theyd say: You wont meet this deadline, will you? You didnt put a paragraph in this document.

A year earlier, Mara had had a hysterectomy, to alleviate her endometriosis. Afterwards, in surgically induced menopause, she began to experience debilitating brain fog, anxiety and depression. I was drowning, she says. I was overwhelmed. I couldnt see or think. Doctors prescribed antidepressants and oestrogen gel, but nothing helped. Mara could barely function at work. I couldnt retain anything, she says. I had no memory. I couldnt see or think clearly enough to do my work. I had no confidence at all. I thought I was useless.

Mara told her supervisors she had depression and anxiety, and submitted a doctors note, but they put her on a first warning. At the time she didnt realise her depression was linked to the menopause - all she knew was that she needed help. (In the autumn of 2019, a specialist explained that her symptoms were caused by the menopause, and provided her with a doctors note explaining this to her employers, but they continued to monitor her performance, as theyd done previously.)

Every week, she had to attend a meeting with her supervisors, where theyd tell her that, once again, she had failed to meet the standard expected. By the summer of 2019, Mara couldnt cope any more.

That weekend, she spent a sunny afternoon with her husband and son at a local fair. The following day, she woke up and drove to a nearby motorway bridge. She sat on a patch of grass and ignored the fact her phone was vibrating with texts from her concerned husband. Instead, she spent a few hours assessing what she felt, then, were her options. It wasnt that I wanted to die, she says. I needed to die. Work wasnt ever going to stop doing what they were doing to me. And I was so ashamed to be so incompetent at my job.

She stood up and approached the bridge, feeling completely empty. She peered over the side, then realised, to her dismay, that the bridge wasnt high enough. I thought, she says, if I jump, I will survive. And there was no way I wanted to survive. And that is the only reason I am alive today. Because it wasnt high enough.

Maras story is an extreme example of the devastating impact the menopause can have on womens jobs and their mental and physical health. Its really difficult to collect data on how many women may be leaving the workplace due to the menopause, says Dr Vanessa Beck, an expert in work and organisation at the University of Bristol, because its not something people tend to talk about in exit interviews. Even if women were asked about the menopause when leaving companies, Beck isnt sure it would help. Im not convinced that women would disclose, she says. Theres a lot of shame.

Some data does exist, however. A 2019 survey from Bupa and the Chartered Institute of Personnel and Development (CIPD) found that 59% of working women aged 45 to 55 who were experiencing the menopause reported that it had a negative impact on them at work, with the most common issues including a reduced ability to concentrate, and feeling more stressed and less patient with clients and colleagues. The same survey estimated that 900,000 women had so far left their jobs, due to menopausal symptoms.

Meanwhile, a survey of 1,132 women from Newson Health Menopause and Wellbeing Centre, also published in 2019, found that over 90% of respondents felt that menopausal or perimenopausal symptoms were affecting their performance at work, and one-third of women had considered reducing their working hours or even leaving their job as a result. Also, earlier this month, the Guardian reported on the growing number of women taking their employers to tribunal, claiming unfair dismissal and sex discrimination due to their experience of the menopause.

In July, the House of Commons women and equalities committee launched an inquiry into menopause and the workplace. These are women in the prime of their lives, says the committees chair, Caroline Nokes MP, in their late 40s and 50s, who should be in senior positions ... These are the people who should be the trailblazers and role models for younger people in the workplace.

Almost uniformly, women experiencing menopausal symptoms at work struggle to talk openly about it. Quite simply, its embarrassing. Theres a stigma around it, says Rachel Weiss, founder of The Menopause Cafe, a safe space where men and women can gather to talk about the menopause. Being an older woman is not viewed as a positive thing in our society.

It is not hard to see why many women would not want to disclose that they are menopausal or perimenopausal at work. Menopausal women are too often represented as figures of fun, to be excoriated or mocked. I remember a senior civil servant using the term menopausal as if it was some kind of insult, says Nokes. You wouldnt be able to discriminate against black or gay people in that way and use their status and who they are as an insult. But it is seen as OK when were talking about women of a certain age.

Using the word as a slur can create a toxic working environment for women. Every little mistake I made, says Sukie Stratton, a 51-year-old insurance investigator from Gloucestershire, people would say: Oh, you must be in the menopause. That was during her short stint in 2019 as a trainee police officer (not for Gloucestershire police).

She realised early on that her age might be a problem. One of my trainers came up to me, Stratton remembers, and said: I am worried about you, because youre in your late 40s. You wont be able to do the night shift. I said: Why not? She said: Because youll be menopausal, wont you? You wont be sleeping and youll be tired all the time.

Even though Stratton did not even have menopausal symptoms, the comments were constant. When her colleagues saw her sweating in her cumbersome body armour, they would make jibes about hot flushes. If she made a minor mistake, they would assume it was memory loss. One of the final straws was when a relief sergeant referred to Stratton as a bloody knackered menopausal woman in front of an office full of her peers.

Stratton emailed HR, but she says they didnt respond to her emails. One morning, she was on patrol. It was 4am, and she was sitting in the van, talking to a trusted colleague. She confided in him. He told her, candidly: This is how it is. You will never get anywhere, she remembers. Stratton realised he was right. All the women her age had been moved to desk jobs, or sent to rural offices with little chance of promotion. She handed in her notice.

I felt massive disappointment, she says. Because Id always wanted to join the police, and Id held the police in high regard. I couldnt understand why theyd dismiss someone who was capable. They seemed to think that being menopausal meant that I wasnt up to the job.

Not all women, of course, are driven out by such rank discrimination. Others, including Mara, leave because they feel unsupported by employers. But a third cohort of women leave because the very thought of disclosing their menopausal status to their employers is too horrifying to consider.

Cara, who is 46 and lives in Wiltshire, walked away from her job in higher education in November 2020 due to the perimenopause. I wasnt actively forced out, Cara says, but I didnt feel like I had any choice, or options. Cara had low mood, brain fog, muscle and joint pain. Id find it hard to concentrate on stuff I would be sailing through normally, she says. Worst of all was the loss of sleep. There would be some nights where I would get no sleep, she says. A good night would be four hours.

Cara handed in her notice because she felt unable to perform at the level she had previously. I wasnt giving my best, she says. I felt isolated and embarrassed and I didnt want to get to a point where my job did suffer, and someone would say something. I felt I wasnt able to do the job I had done for all those years at the same level. I ask Cara why she didnt ask her employers for extra support. I felt ashamed, is the reply.

This self-enforced silence is common among the women who attend Weisss menopause cafes. What we find, she says, is that a lot of women arent talking to anyone else about their menopause symptoms. They wonder if theyre going mad, or if theres something wrong with them. Women may feel mortified by some symptoms such as menstrual flooding (very heavy bleeding), and feel that it is easier to quit than endure the mortification of explaining to their supervisors why they cant be more than a few metres from a toilet.

Physically, says Dr Helen Douglas, 49, from Glenshee in the Scottish Highlands, I didnt feel well enough to stand on my feet all day. Douglas went into surgical menopause in 2013, aged 41, after a hysterectomy for endometriosis and uterine fibroids. At the time, she managed a forensic laboratory. It was stressful, she says. The sort of job where you need attention to detail.

Afterwards, Douglass stomach was swollen, making it impossible to get into her clothes, and she had persistent bleeding. Mentally, she wasnt doing well. I wasnt sleeping, she says. I had anxiety and my hands would shake. Memory issues. I was short-tempered and irritable. I just wanted to tell everyone where to go. If someone cancelled a meeting at short notice, Douglas would internalise the anger until it led to a panic attack, she says.

She had suffered from depression in the past, and at the time, she didnt realise her symptoms were menopause-related. I thought it was just a bad episode of depression again, Douglas says. She resigned in 2014. I couldnt do it any more, she says. Id been having recurrent thoughts of ending my life.

Yet the outlook for women approaching the menopause in the workplace is not totally bleak. The stigma is abating. Over the last year or so women have been much more open about it than ever before, says Nokes. Women like Davina McCall [who recently made a documentary on the subject for Channel 4] have spoken about their own experiences honestly.

Nokes is willing to practise what she preaches. I am prepared to say I think I probably am perimenopausal, she says. I have horrific night sweats. She recently had to alter the bedding she uses. Ive got the thinnest duvet on my bed ever, Nokes says. But at least Im not waking up at 3am, dripping in sweat.

Many believe the NHS needs to improve its offering to menopausal women. We need a multidisciplinary team to look after women after the menopause, says Douglas. Rather than seeing it as a gynaecological issue, women should be referred to someone who has a handle on the mental health side of things.

Mara believes GPs could also do with better training: it was only through reading menopause support forums online that she learned about a drug called utrogestan, a form of hormone replacement therapy. I rang my doctor, she says, and she prescribed it, and literally overnight I started feeling better. My husband noticed within 48 hours. He said: Are you on new medication? Youve turned nice again.

Another obvious solution would be menopause-friendly workplaces. Douglas advocates for companies to have specific policies around it. It would be really helpful if there was a menopause-in-the-workplace champion, she says, someone women knew they could go to. Simple adjustments switching uniforms from synthetic fibres to natural fabrics. Having free and frequent access to bathrooms, in case women are flooding.

Some employers are ahead on this. The water company Severn Trent was the first UK employer to specifically introduce a menopause policy. The CIPD has subsequently published guidance for employers on addressing the menopause at work, while last year the Wales TUC published a toolkit.

Deborah Garlick of the training provider Menopause in the Workplace began offering menopause training to employers in 2016. We organised our first menopause in the workplace conference, says Garlick, and people thought we were bonkers. But then some very large employers said, Why didnt we know this? And thats how we got started.

Part of the select committees forthcoming work will be to evaluate whether UK discrimination law is fit for purpose on the menopause. Do we need to make menopause a protected characteristic, in the same way that maternity leave currently is? asks Nokes.

Under existing law, menopausal women are protected because age, sex and disability are protected characteristics under the 2010 Equality Act. But because menopause is not specifically protected, women have to pick the characteristic they want to take a case under, Beck says.

Nokes says she is open-minded about introducing such legislation. This is impacting 50% of the population, Nokes says, and its pushing them out of the workplace. So maybe it should be a protected characteristic. Regardless of whether or not legislation is introduced, Beck urges employers to make adjustments for older women. Theres the business case, she says. Its costly to replace an experienced worker. But its about more than that its the right thing to do. If you are a good employer, you should want to support your workers.

The hope is that, with time, more enlightened employers, and government intervention if necessary, no woman should ever have to go through what Mara endured. I was a person with value, and they were happy to destroy me and get rid of me, because of the menopause, Mara says. Thankfully, with the help of medication, her symptoms have abated. My energy levels are a bit low, she says, but Im almost there.

After five years out of the workforce, living on savings and focusing on her mental health, Douglas, likewise, has found a new vocation, as a writer and menopause awareness activist. I dont regret leaving my old job, she says thoughtfully. Its taken a lot of time and work to get to a place where I am comfortable saying that. But what I do now can make a positive difference. Its more satisfying.

Some names have been changed.

In the UK and Ireland, Samaritans can be contacted on 116 123 or by emailing jo@samaritans.org or jo@samaritans.ie. In the US, the National Suicide Prevention Lifeline is 1-800-273-8255. In Australia, the crisis support service Lifeline is 13 11 14. Other international helplines can be found at befrienders.org.

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My bosses were happy to destroy me the women forced out of work by menopause - The Guardian

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I worry that men won’t find me attractive if I get my breasts removed – Metro.co.uk

Posted: August 18, 2021 at 2:37 am

My breasts are not huge, but theyre undeniably there (Picture: Shutterstock / nito)

When I close my eyes, I imagine myself with a flat chest and the scars from top surgery still visible and I feel strength and power of being my best, truest self.

However, when I open them, I see a chest that is anything but flat. Im looking at a body with hips and curves and breasts that are partially hidden by a 34G bralette.

Although I want top surgery,as abisexualtransgender man, Im anxious that men wont find me attractive if I get a subcutaneous mastectomy the medical term for the procedure.

I have a huge amount of dysphoria, which is defined by theGender Identity Clinic(GIC) as the distress experienced by those whose gender identity feels at odds with aspects of their body and/or the social gender role assigned to them at birth.

I experience it most acutely around my breasts, struggling daily with the disconnect between how my body looks in my head and how it looks in the mirror.

Its not the clich of having been born in the wrong body so much as people assuming that everyone with a body like mine must be a woman. The discomfort is sharp and painful and reverberates through me: everything feels wrong.

Its been 18 months since I began the process of socially transitioning: coming out to the people around me as trans, asking people to respect my pronouns, and changing the way I present to the world.

Even before I had fully acknowledged my own transness and that I wasnt cisgender (meaning my gender identity is not the same as the gender I was assigned at birth when a doctor looked at my genitals) I had begun to think about the kind of medical transition I wanted.

Stepping into my gender has shown me how important pursuing hormone replacement therapy (HRT) and surgery are for me.

My breasts are not huge, but theyre undeniably there. I dont remember when they developed, because for most of my childhood and teenage years, I was scared of my body and ignored it as much as possible.

Some days it feels like my whole body is shouting its wrongness at me until I want to cry. Yet even as I came out to my GP and asked for a referral to a Gender Identity Clinic, a tiny part of my brain worried at how getting top surgery would change the way people saw me.

Strangers will be more likely to see me as a man after top surgery of course, which is what I want. It can be incredibly painful to go through life being misgendered, and sometimes the thought that people see a woman when they look at me makes me want to tear my skin off. The three to five year waiting list for surgery feels interminable.

So why does a small part of me care that I might be less attractive if I have the gender affirming surgery that it often feels like my whole body is yearning for?

I am already a man, albeit one with breasts that I often forget I have

The answer, while not pretty, is simple: its because Ive spent my whole life being tolda cisnormative (the harmful assumption that everyone is cisgender), heteropatriarchal society both indirectly and explicitly that my worth is based on my desirability to straight, cisgender men. It feels deeply unfeminist and a betrayal of my own queer identity to admit that.

As a bisexual trans guy, I have no interest in sleeping with straight, cis men yet the need to centre their desire persists.

As someone whose body is automatically sexualisedby men who feel entitled to it, with or without my consent, Ive learned to reclaim that.

I feel so powerless when I am cat-called in the street. Theres fear, yes, but theres also shame that twists red-hot inside me when a group of laughing men shout are you legal yet? after me as I walk away with my whole body shaking.

I know that men are attracted to my breasts though Ive experienced more sexual harassment while wearing shorts or crop tops so I find it empowering to pick out tight or low-cut tops to emphasise my breasts.

Even now, dressing in ways that show off my cleavage can still feel good: owning my sexuality feels powerful because it is something that society has told me to be ashamed of.

When I have top surgery, I can imagine myself standing taller. Not because Im free from the sexualisation of being a person with breasts, but because I will have made my body undeniably mine in a way that feels like a raised middle finger to that shame. Its a rejection of who I should be for who I really am.

I dont want to take testosterone or have top surgery to become a man. I am already a man, albeit one with breasts that I often forget I have. I want top surgery because I want my body to feel right in the way the rest of me does since stepping into my transness, yet I still trip up over the anxiety that men will no longer find me attractive without my breasts.

That anxiety shows that as much as Ive spent the last six years immersing myself in queer and feminist culture, I still have the flawed yet fundamental belief that my worth is based in how much straight, cis men want to have sex with me.

I hate how much I believe that lie. It horrifies me that I dont even want to have sex with straight, cis men yet I still cant seem to shake it. How many choices must women (and other people affected by misogyny) make every day because weve been conditioned that our own wants should be secondary?

We can reframe getting nails done as self-care and we can find that wearing high heels gives us confidence even though they hurt our feet, but those choices are not independent of patriarchal repercussions.

Adjusting everything from our behaviour to our breasts is the price we pay for being taken seriously in a society that revolves around the axis of straight, cis mens desire. And when were still punished for not falling in line with the male gaze, it becomes even harder to de-centre that desire and stand steady in our own self-worth.

Despite how inaccessible gender-affirming healthcare is, truly internalising the belief that I have value beyond my desirability might actually be harder. Even when not if I get top surgery, thats something that Im going to have to keep working on.

Do you have a story youd like to share? Get in touch by emailing James.Besanvalle@metro.co.uk.

Share your views in the comments below.

MORE : Transgender man faces gruelling body dysphoria and is desperate for top surgery

MORE : Coming out as transgender during lockdown feels like Im in limbo

MORE : Elliot Page says undergoing top surgery as part of transgender journey has been life changing and lifesaving

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I worry that men won't find me attractive if I get my breasts removed - Metro.co.uk

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