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With a little TLC, Vanessa Cross has smashed her weight loss aims – Reality Titbit – Celebrity TV News

Posted: March 31, 2022 at 1:58 am

Vannessa Cross shared her weight loss journey on TLCs 1000-lb Best Friends. Since filming began, we can confirm that she has shed some serious pounds as a result of her sheer determination to improve her life.

The 1000-lb Sisters spin-off followed Vannessa and her bestie Meghan as they embarked on a journey to lose weight. Together, they weighed a combined weight of over 1,000 pounds, and so decided to adopt a healthier lifestyle.

Vannessa explained in the trailer for the new show that she has found it impossible to stick to a diet, however, went on to say that she is sick of being fat and tired at her then-weight of 448 lbs.

Since then though, she has drastically changed her life around and has dropped to under 400 pounds. Weve even seen pictures on the TLC stars Instagram to prove it. Drum roll please

When Vannessa weighed over 400 pounds, fans praised the TLC star for her confidence to wear whatever she likes, including a bikini she wore during a vacation. In a bid to improve her life though, she decided to take up exercise.

Vannessa explained that both her and her co-star have been dealing with our weight since junior high, followed by Meghan saying they are big as hell. Between the besties, they used to weigh around 1000-lbs combined.

For the past 43 years, she admitted she has done nothing but stretch her body to its max, but the 1000-lb Best Friends cast member was able to reduce it and become the woman she always wanted to be.

In the last six years in particular, her weighthas fluctuated between 350 and 500 pounds, which began with the death of her husband. She first weighed in at 441.6 pounds, after previously losing 20 pounds six months before.

Vannessa claimed that she could not healthy because she could not afford the food. However, that didnt stop her from taking up regular exercise with her best friend Meghan in tow.

After several hard-earned weeks of determination, she managed to get under 400 lbs and was approved for weight loss surgery. Vannessa admitted that not being to eat scared her and claimed she was nervous ahead of the procedure.

With the support of Meghan, and her other two best friends Tina and Ashley, she underwent the bariatric surgery she strived for. The main man behind her progress is Dr. Procter, who assisted her on her diet and exercise program.

Vannessa has declared that she can now live the next 40 years as normal. Following the procedure, she has clearly kept the weight off and looks more transformed than ever on her Instagram page.

She has even shared snippets of her diet, including some super-baked chicken wings, and continues to pay regular visits to Dr. Procter. Just a week ago, Vannessa said he has been busy while waiting in line to see him.

The last scale weight we heard about Vannessas progress revealed she had gotten down to 398 lbs, a massive drop from her heaviest at around 500 pounds. Plus, her confidence is like never before, as she is always smiling!

Her face and neck appear significantly slimmer in her latest photos, which is all thanks to her commitment to exercising and eating healthier than she has ever done in the past.

WATCH 1000-LB BEST FRIENDS ON TLC EVERY MONDAY AT 10/9C

AND GET FREAKY WITH US ONINSTAGRAMANDFACEBOOK

Celine is a journalist with over five years of experience in the media industry and the chief staff writer on Reality Titbit. After graduating with a degree in Multimedia Journalism she became a radio newsreader and reporter, before moving into her current role as a reality TV writer.

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With a little TLC, Vanessa Cross has smashed her weight loss aims - Reality Titbit - Celebrity TV News

Lanarkshire twins smashed weight loss target and are now starting their own Slimming World groups to help others – Daily Record

Posted: March 31, 2022 at 1:58 am

Twin sisters from Lanarkshire who lost three stone between them are now helping others achieve their weight loss dreams.

Janis Gardiner and Valerie Bowie only started their transformation six months ago after admitting being stuck in a rut during lockdown.

The heart breaking loss of their dad left them turning to food for comfort - but when they realised how much weight they'd gained from looking at a photo of themselves, they decided it was time to make a change.

The Lanarkshire Live app is available to download now.

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The twins then turned to their local Slimming World group and managed to lose 1.5st each, having received "lots of help and support, without judgement" along the way.

Having trained as consultants with the weight loss organisation, they've now bravely started a brand new career and are ready to inspire many more locals to reach their goals.

Members at the Blantyre group in St Andrews Church are getting ready to welcome Janis as their new consultant when she takes over the group on Saturday, April 23.

And Valerie is opening her own group in Bellshill at Orbiston Bowling Club on Thursday, April 21.

Janis told Lanarkshire Live : Obesity is becoming such a huge issue across the UK. When I first joined Slimming World as a member, I never dreamed I would end up helping other people to lose weight - now I just cant wait to get started.

"After losing 1.5st and completing my training, its a privilege for me to be able to pass on the experience, insight and understanding that helped me, so that I can give my members the support they need to get to target.

"As someone who has lost weight myself I know the challenges people can face, which is why, along with the group, I will be there to support every one of my members all the way to their chosen target weight."

Valerie added: Like a lot of slimmers, I had tried to lose weight so many times before by following numerous diets but they were never sustainable because Id always get tired of restricting what I ate.

"I thought I was destined to struggle with my weight for the rest of my life, but when I came to Slimming World it was different. I never felt like I was on a diet.

"The eating plan encourages you to eat lots of tasty, filling foods like pasta, rice, potatoes and lean meat and fish, you are never hungry and no foods are banned so theres no deprivation.

"I couldnt believe Id found a way to lose weight without starving myself.

Slimming World isnt just about changing what you eat. Becoming more active is important too."

Valerie added: "As a consultant, its my role to create that warm, supportive atmosphere to get people sharing their ideas and experiences to help others - its going to be great fun!

Sixty five per cent of the Lanarkshire population is now overweight or obese, and Janis and Valerie say their new role has never been more important.

Janis Slimming World group will be held at St Andrews Church in Blantyre every Saturday at 9am from April 23 and Valeries group will be held in Orbiston Bowling Club in Bellshill every Thursday at 7pm from April 21.

For more information or to join contact Janis on 07908 734 942 for Blantyre and Valerie on 07908 735 207 for Bellshill or just come along.

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Lanarkshire twins smashed weight loss target and are now starting their own Slimming World groups to help others - Daily Record

UC: Causes and risks of overweight and weight loss tips – Medical News Today

Posted: March 31, 2022 at 1:58 am

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD). It is an autoimmune condition in which the immune system mistakenly attacks the large intestine, causing inflammation and ulcers inside its inner lining. Weight loss is often associated with UC, but some people with the condition may experience weight gain.

Alongside weight changes, the common symptoms of UC include diarrhea, blood in the stool, pain in the abdomen, abdominal cramping, and rectal bleeding.

Some people may also experience fatigue, fever, nausea, or vomiting.

In this article, we examine the possible causes of weight gain with UC. We also discuss how people with UC can lose weight, if necessary.

Several factors may cause a person with UC to experience weight gain. A 2016 study reported that 1540% of people with IBD also have obesity.

UC itself does not necessarily cause weight gain, with researchers stating that there is no known association between IBD and obesity. However, many factors relating to UC may cause weight gain, such as certain medications that doctors prescribe to treat the condition.

During a UC flare, people may reach for more convenient and less nutritious foods, resulting in weight gain. Flares may also lead to a person participating in less physical activity, which may contribute to them gaining weight.

Additionally, some evidence suggests possible shared environmental risk factors between IBD and obesity.

Although many people may think of UC as a condition that causes weight loss, it can also contribute to weight gain. There are many reasons for this, including:

Some people may find it difficult to motivate themselves to exercise when they are experiencing a flare of symptoms.

Although people with UC should continue exercising regularly, they may find that lower energy levels prevent them from being active. Healthcare professionals can suggest the most suitable forms of exercise to attempt during a flare.

Corticosteroids, such as prednisone, are medications that reduce inflammation.

One possible side effect of prednisone, as well as other corticosteroids, is weight gain. Weight gain may continue even after a person stops taking the medication, and it can be challenging to reverse.

Other medications to treat UC also have links to weight gain, such as anti-tumor necrosis factor-alpha drugs.

No specific food or diet will help everyone who experiences weight gain from UC lose weight. However, the following weight loss tips may help people moderate their weight.

People with UC should eat a nutritious, well-balanced diet full of nutritious foods, including:

When experiencing a flare, a person may tolerate moderate portion sizes of the following foods:

Specific diets that a person may wish to discuss with a healthcare professional include:

Some people with UC may experience malnutrition due to their body not absorbing all the vitamins and minerals that they consume. These individuals should discuss any significant changes in their diet with a healthcare professional.

People experiencing a UC flare may eat unhealthy junk foods for convenience rather than seeking out healthier alternatives.

Stocking cupboards and the refrigerator with quick, nutritious foods that are enjoyable can help people make food choices that are better for their health and prevent them from snacking on nonnutritious foods.

Researchers have found that some foods may be more likely than others to cause a person with UC to experience a flare. Some of these foods, such as those high in sugar and fat, can also contribute to weight gain.

By reducing their consumption of foods high in sugar and fat, people with UC may prevent weight gain and decrease flares.

Some people with IBD find that cutting out gluten helps improve their symptoms. However, no research currently proves this claim. Furthermore, the Crohns & Colitis Foundation notes that gluten-free products often contain a higher fat content, contributing to weight gain.

Drinking a glass of water about half an hour before meals can help people feel fuller and eat fewer calories. People who drink water before meals may lose up to 44% more weight than people who do not, according to an older study from 2009.

This habit is also beneficial because it is crucial for people with UC to stay hydrated due to the loss of fluids from diarrhea.

As well as allowing the brain time to detect satiety, chewing more slowly and thoroughly ensures that the body breaks down food before it reaches the stomach and gastrointestinal (GI) tract.

By chewing slowly, a person is also less likely to introduce air pockets into their GI tract, which can cause gas and discomfort for people with UC.

According to the Centers for Disease Control and Prevention (CDC), adults should aim for at least 150 minutes of moderate intensity physical activity or 75 minutes of vigorous intensity physical activity each week to lose weight or maintain a moderate weight.

Going for a short daily walk could help people lose weight and prevent weight gain. Regular physical activity can help improve sleep, memory, and the ability to think and learn.

Other strategies that may help someone lose weight include:

Although people do not usually associate weight gain with UC, it is not uncommon for the condition to have this effect. People with UC may need to monitor their weight to counteract any weight loss or gain due to the condition.

Some people with UC may be unable to lose weight due to their medications. Others may have difficulty getting enough exercise when their symptoms flare up.

If necessary, people with UC can try to lose weight by:

Maintaining a moderate weight is key to reducing the risk of developing several other health conditions.

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UC: Causes and risks of overweight and weight loss tips - Medical News Today

Weight Loss: These 5 Delicious Low-Carb Breakfast Recipes Will Be Ready In 20 Mins – NDTV Food

Posted: March 31, 2022 at 1:58 am

For those of us who have been trying to lose weight, we know how challenging it can be. While we spend time exercising and counting our calories, we realise how important it is to have a well-balanced diet. Slowly and steadily, we change our routine and start indulging in healthier things. But bringing this change can be tricky. Finding out what recipe works and what would be easy to make is a hassle. There are many trial and error dishes that we make at home. So, to make your work easy, here we bring you some delicious low carb breakfast recipes to try out. These recipes are common foods that we eat every day. However, we have given them a low carb twist to ensure that it doesn't affect your weight loss journey! Check out the recipes below:

Also Read:Weight Loss: 5 Healthy Diet Facts That Anyone Wanting To Lose Weight Must Know

1. Spinach Omelette:

This omelette recipe is loaded with the nourishment of spinach and egg, as well as the cheesy delight of mozzarella. This cheese omelette is an effortless and quick breakfast item that can be a terrific addition to your low-carb diet.

2. Keto Upma:

Nothing is simpler than preparing a wonderful plate of veggie upma. This upma is also made with cauliflower and gradually simmered with vegetables and spices. You can experiment and play around with flavours as you like.

3. Apple And Chia Seed Smoothie:

This fantastic, healthful smoothie can be made with only three basic ingredients in about five minutes. Apple chia seeds smoothie contains the benefits of chia seeds and apple, which is strong in fibre and helps increase metabolic levels.

4. Thepla:

While traditional Gujarati thepla is prepared with wheat flour, the keto thepla is made with flaxseed dough and dried methi water. This low carb keto thepla will quickly become a favourite of yours.

5. Keto Poha:

Keto poha contains grated cauliflower florets rather than flattened rice. You can also use cauliflower stem instead of potatoes in the dish to make it healthier and tastier. Mix in veggies of your choice and have a delicious breakfast in no time.

So, what are you waiting for? Try out these low carb breakfast recipes and keep your weight in check!

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Weight Loss: These 5 Delicious Low-Carb Breakfast Recipes Will Be Ready In 20 Mins - NDTV Food

Woman secretly loses five stone in weight while her husband is away with the military – Yahoo Lifestyle UK

Posted: March 31, 2022 at 1:58 am

Charlie Whitford lost almost five stone in weight while her husband was on military duty. (Collect/PA Real Life)

A mum has lost nearly five stone after secretly starting a new weight loss regime while her husband was overseas with the military.

Charlie Whitford, 35, from Benson, Oxfordshire, underwent an entire body transformation during the five months her husband Adam, 37, was in Afghanistan, dropping four dress sizes and losing around a third of her body weight.

Whitford found her weight started creeping up after eating the same portion sizes and military-inspired diet as her husband.

My husband always eats big portions, because hes so active," she explains. "Hes very into being in shape and has to be for his job.

Ive never been a big fan of exercise, but I hate to see someone eating more than me, because I like to have big meals, so I would make us the same sized portions.

Read more: Woman loses 10 stone in weight after beating addiction to mayonnaise

Whitford was a size 18 before she started her weight loss journey. (Collect/PA Real Life)

But while her husband compensates for his high calorie intake with daily workouts to stay in shape for his role as a nurse in the RAF, Whitford saw her size increase.

By 2020, she was a dress size 18, weighed 14st 5lb and had a body mass index (BMI) of 32.3, which is officially classed as obese. The NHS healthy range is between 18.5 to 24.9.

At the time I didnt feel great about my body," she says. "In the summer of 2020 the kids were joking one day and called me fatty which made me cry.

The turning point came in August 2020 as her husband was leaving for Afghanistan.

I knew hed be gone for a few months, so I thought it was a good opportunity for me to lose weight without him being here and eating larger portions, she explains.

He loves to snack on chocolate and ice-cream late at night and I would always give in and snack with him.

Without him there, it was a perfect time to start eating well.

Whitford changed her diet and exercise regime while her husband was away. (Collect/PA Real Life)

Read more: Creator of 5:2 diet shares two easy exercises to aid weight loss

Having downloaded the weight loss app, Noom, Whitford also began recording her calories in a food diary.

Story continues

I had tried loads of other diets in the past, but trying to restrict what I eat never works for me," she explains. "I knew I needed more psychological help for any change to be sustainable.

I started checking how many calories I was eating every day and cut back on the crisps and chocolate snacks. Instead I snacked on fruit.

With the help of the app, she also worked on her weight loss mindset, training herself to be more mindful when it comes to eating.

It helped me to better understand myself and how my brain works when it comes to food," she says. "I found it really useful and it helped me to stay focussed.

Whitford with her three children, Morvern, Wilfred and Elizabeth. (Collect/PA Real Life)

Read more: The NHS' 12-week weight loss plan explained

The supermarket worker also upped her exercise levels.

After dropping the kids off at school, which is about half a mile away, Id take the long way home so that Id walk about 5km every morning," she says.

At first, it didnt feel like much but, over time, combined with the calorie counting, I started to notice the weight dropping off.

By the time her husband arrived back home in February 2021, Whitford had lost 4st 12lb, weighed a healthy 9st 7lb and wore a dress size 10.

When Adam got home he was gobsmacked, he couldnt take his eyes off me and kept lifting me up in the air, she says.

I spoke to him nearly every day while he was away, but I didnt find it hard to hide the weight loss from him.

Ive never really carried weight on my face and when we video called it would just be my face on the screen that he could see, so he had no idea until he got home.

Whitford with her husband, Adam, before and after her weight loss. (Collect/PA Real Life)

Since her husband's return, Whitford has maintained her new diet and exercise regime.

I no longer eat the same large meals as him," she says.

If were having spaghetti Bolognese for dinner, then Ill have the sauce with salad and vegetables.

We dont eat completely different meals and I dont deprive myself, but we have variations of the same meal and I just have a smaller portion.

Though her weight has increased slightly, to 10st, she attributes that to gaining more muscle as she now includes weekly pole fitness classes into her fitness routine.

Whitford says her weight loss has had an impact on the whole family.

The changes Ive made have been great for me and for my marriage, too," she explains. "Im a lot happier and I think its made us happier as a couple.

"Its like a new relationship in a lot of ways because of how much my outlook on life has changed."

Read more: Woman loses 13 stone without ditching carbs: 'I was a heart attack waiting to happen'

She has now taken up pole fitness. (Collect/PA Real Life)

She says her three children, Morvern, 11, Wilfred, nine and Elizabeth, three, have also noticed a difference in her attitude.

"They see that Im a lot less stressed and grumpy and tired," she adds. "I have more energy for playing with the kids or taking them out for the day, and being more present and mindful has made me a better mum.

Whitford's diet before

Breakfast three or four slices of toast with peanut butter

Snacks crisps or biscuits

Lunch one and a half cheese toasties

Snacks crisps or chocolate

Dinner lasagne or curry

Snacks two slices of toast

Whitford's diet now

Breakfast one slice of toast

Snack banana

Lunch salad with couscous and meat-free chicken

Snack apple

Dinner salad and vegetables with a spoonful of Bolognese

Snack one slice of toast

Additional reporting PA Real Life.

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Woman secretly loses five stone in weight while her husband is away with the military - Yahoo Lifestyle UK

FDA Approves Oral Testosterone Replacement Therapy for Hypogonadism – Pharmacy Times

Posted: March 31, 2022 at 1:57 am

Estosterone undecanoate (Tlando; Antares Pharma, Inc) is indicated as testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone in adult patients.

The FDA has approved the oral drug estosterone undecanoate (Tlando; Antares Pharma, Inc) for testosterone replacement therapy (TRT) for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult patients.

The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of Tlando, said Robert F. Apple, president and chief executive officer of Antares Pharma, in a press release. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both Tlando and Xyosted and support our future growth with an expanded commercial portfolio. We look forward to launching Tlando commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.

Male hypogonadism is an endocrine disorder in which the body is unable to produce enough testosterone. The condition is estimated to affect approximately 35% of men 45 years of age and older, as well as 30% to 50% of men with obesity or type 2 diabetes.

Tlandois indicated for TRT in adult males with conditions such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The safety and efficacy of Tlandohas not been established in males under 18 years of age.

Antares Pharma said it will seek to launch Tlandoin the second quarter of 2022 to provide a complementary treatment option for patients and clinicians

We believe Tlandos oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of Xyosted, Tlando and Nocdurna that will continue to deliver solutions for improved patient care, said Joe Renda, senior vice president, Commercial of Antares Pharma, in a press release.

Reference

Antares Pharma Announces FDA Approval Of TLANDO, an Oral Treatment for Testosterone Replacement Therapy Commercial launch expected in 2Q 2022. Antares Pharma. [news release]. March 29, 2022. https://www.biospace.com/article/releases/antares-pharma-announces-fda-approval-of-tlando-an-oral-treatment-for-testosterone-replacement-therapycommercial-launch-expected-in-2q-2022/

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FDA Approves Oral Testosterone Replacement Therapy for Hypogonadism - Pharmacy Times

About the Advanced Age Management Medina Testosterone Replacement Therapy in Medina, OH – Digital Journal

Posted: March 31, 2022 at 1:57 am

Medina, OH: The safe and effective hormone therapy at Advanced Age Management targets people with various health issues, including weight gain, tiredness, declining sex drive, and depressed mood. For men over 35 years, these health problems could result from low testosterone levels and other hormonal issues. That is why the trt center is happy to work with all symptomatic patients. The wellness center for men is well-equipped to offer Hypothyroidism Therapy, Hormone Replacement Treatment, Erectile Dysfunction Treatment, and Low T Symptoms. Other treatments offered by Advanced Age Management are Testosterone Replacement Therapy and Growth Hormone Releasing and Medical Peptide Therapy.

For over 15 years, Advanced Age Management has served patients from varied backgrounds, including professional athletes. The advanced treatment facility for men is owned and managed by John Kocka M.D., a board-certified physician and age management specialist. Dr. Kocka is board-certified in Age Management from the American Academy of Anti Aging, Age Management Medical Group and physician-certified by the Cenegenics Medical Institute. He is a member of the International Hormone Society, International Society for the Study of the Aging Male and the American College of Sports Medicine. He is a trusted authority in testosterone replacement therapy.

Hormone Replacement Therapy (HRT) is a process of replenishing naturally produced hormones among men. The process usually happens when men age and may lead to increased pain and aches, insomnia, sleep disturbance, and slower metabolism, which often leads to increased body fat and other health complications. The pros of choosing Advanced Age Management include an opportunity to work with a leading doctor, access to comprehensive and tailored treatment solutions, and ongoing support from in-house physicians.

The HRT treatment for men plays a vital role in revitalizing sex drive, building muscle mass, and promoting the production of red blood cells. For men with low testosterone levels, the treatment can go a long way to promote vitality, health, and enhance the quality of life. Dr. Kocka begins treatment by creating a custom treatment solution. Treatments such as medina testosterone replacement therapy are supplemented by healthier habits, such as exercise, improved diet, and quality sleep.

Another critical treatment offered by Advanced Age Management is Vitamin B12 and other Amino Acid Treatments. The cost of treatment varies depending on the type of treatment and personalized medical treatment plans. Patient reviews posted on the website paint a picture of an advanced treatment facility that is highly recommended for its friendly and knowledgeable staff and excellent treatment facilities.

To get in touch with the treatment experts at Advanced Age Management, call 216.471.8220, or visit them at 1188 Medina Rd R18, Medina, OH, 44256. The clinic is keen to address health concerns and improve quality of life. They operate Monday to Friday at different hours, between 8:00 am to 5:30 pm.

Media Contact

Company NameAdvanced Age ManagementContact NameJohn Kocka, M.D.Phone216.471.8220Address1188 Medina Rd R18CityMedinaStateOHPostal Code44256CountryUnited StatesWebsitehttps://www.lowtohio.com/

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About the Advanced Age Management Medina Testosterone Replacement Therapy in Medina, OH - Digital Journal

FDA Action Alert: A Very Busy Week for Drug Application Decisions – BioSpace

Posted: March 31, 2022 at 1:57 am

Sarah Silbiger/Getty Images

The U.S. Food and Drug Administrationhas a very busy week ending the month of March and moving into April. Heres a look.

Bristol Myers Squibbs Reblozyl for Anemia in Beta Thalassemia Patients

Bristol Myers Squibbhad atarget action dateof March 27, 2022, for its supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) for anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The agency requested additional data, which BMS supplied, and the FDA called it a major amendment andaddedthree months to the target action date. The PDUFA date is now June 27.

The drug is a first-in-class erythroid maturation agent. It is being jointly developed by BMS and Merck via Mercks acquisition of Acceleron. It is already approved in the U.S. for anemia in adults with beta thalassemia who require regular RBC transfusions. It is also approved for anemia failing an erythropoiesis-stimulating agent and requires two or more RBC units over eight weeks in adults with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Antares Tlando for Testosterone Replacement Therapy

Antares Pharmaand Lipocine have atarget action dateof March 28 for itsresubmissionfor its New Drug Application (NDA) for Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy. It was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males. The agency concluded the drug met all required efficacy, quality and safety standards needed for approval and will be eligible for final approval and marketed in the U.S. when the exclusivity period previously granted to Clarus Therapeutics for Jatenzo expires on March 27.

Mercks Keytruda for Advanced Endometrial Carcinoma

Merckhad atarget action dateof March 28 for its sBLA for Keytruda (pembrolizumab), its anti-PD-1 checkpoint inhibitor, as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after previous systemic treatment in any setting and are not candidates for curative surgery or radiation. Keytruda is already approved for adults and children with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed after previous treatment and have no satisfactory alternative treatment options. It wasapprovedfor this new indication on March 21.

Akebias Vadadustat for Anemia Due to Chronic Kidney Disease

Akebia Therapeutics has atarget action dateof March 29 for its NDA for vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia due to chronic kidney disease in adults on dialysis and not on dialysis. It is being developed with Otsuka Pharmaceutical Co.

In a June 1, 2021statement, John P. Butler, Akebias chief executive officer, stated, The acceptance of our vadadustat NDA filing marks another important milestone for Akebia and Otsuka, as we work to bring a new oral treatment option to patients living with anemia due to CKD.

Amylyxs ALS Drug to Be Reviewed by Advisory Committee

The FDAs Peripheral and Central Nervous System Drugs Advisory Committee isholdinga meeting on March 30 to discussAmylyx Pharmaceuticals NDA for sodium phenylbutyrate/taurursodiol powder for oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). The drug has been granted Priority Review.

There are few treatments approved for ALS, a devastating disease that impacts a persons ability to move, speak, eat and breathe,saidDr. Lahar Mehta, Head of Global Clinical Development of Amylyx, in February 2022. We look forward to a robust scientific discussion with the members of the advisory committee panel regarding the clinical data submitted to support our New Drug Application for AMX0035.

Gilead/Kites Yescarta for Second-Line R/R Large B-Cell Lymphoma

Kite, a Gilead Company, has atarget action dateof April 1 for its sBLA under Priority Review for Yescarta, its CAR T-cell therapy, for second-line relapsed or refractory large B-cell lymphoma (LBCL). The therapy was evaluated against the current standard of care in the Phase III ZUMA-7 study. With a median follow-up of two years, the trial hit the primary endpoint of event-free survival (EFS), demonstrating a 2.5-fold increase in patients who were alive at two years and did not require additional cancer treatment or experienced cancer progression, and a four-fold great median EFS compared to SOC.

Mercks Vaxneuvance Vaccine Against Pneumococcal Disease in Children

Merck has atarget action dateof April 1 for its sBLA for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age. It has Priority Review status. The sBLA is supported by Phase II and III trials data in pediatric populations.

Vaxneuvance has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine (PCV) currently available for this population, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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FDA Action Alert: A Very Busy Week for Drug Application Decisions - BioSpace

Below the Belt: Sexual Dysfunction Overlooked in Women With Diabetes – Medscape

Posted: March 31, 2022 at 1:57 am

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King's College London, UK.

There is also the "embarrassment factor" on the side of both the healthcare professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022 this week. Many women with diabetes "wouldn't necessarily know" that their sexual dysfunction "is related to their diabetes," she told Medscape Medical News.

For women, sexual health conversations are "often about contraception and pregnancy," as well as menstrual disorders, genital infections, and hormone replacement therapy. "As healthcare professionals, you're trained to focus on those things, and you're not really considering there might be sexual dysfunction. If women aren't aware that it's related to diabetes, you've got the perfect situation where it goes under the radar."

However, co-chair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and "integrated throughout the whole service" means that the problem can be identifiedand treatment offered.

The issue is that such integration is "very uncommon" and access needs to be improved, Cooke told Medscape Medical News.

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that "intimate activity is clearly beneficial for emotional and physical health," as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can "damage" blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affectsexuality and intimacy, leading to "sexual distress."

Moreover, Fosbury said female sexual dysfunction has been identified as a "major predictor" of depression, she added, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, UK, talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from "penetrative sex," Hannington said, with the goal being "enjoyment, not orgasm." Pleasure should be facilitated and the opportunities for "performance pressure and/or anxiety" reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had "never experienced orgasm," despite being in a same-sex relationship with Emily.

Marie's treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.

Fosbury reiterated that, in men, sexual dysfunction is "readily identified as a complication of diabetes" and is described as "traumatic" and "crucial to well-being." It is also seen as "easy to treat" with medication, such as that for erectile dysfunction.

It is therefore is crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

"Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients," she concluded.

No funding declared. No relevant financial relationships declared.

Diabetes UK Professional Conference 2022. Session: Sexual healing in the diabetes clinic. Presented March 28, 2022.

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Below the Belt: Sexual Dysfunction Overlooked in Women With Diabetes - Medscape

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Posted: March 31, 2022 at 1:55 am

Low-carb diets have been controversial for decades.

Some people assert that these diets raise cholesterol and cause heart disease due to their high fat content.

However, in most scientific studies, low-carb diets prove their worth as healthy and beneficial.

Here are 10 proven health benefits of low-carb and ketogenic diets.

Hunger tends to be the worst side effect of dieting.

It is one of the main reasons why many people feel miserable and eventually give up.

However, low-carb eating leads to an automatic reduction in appetite (1).

Studies consistently show that when people cut carbs and eat more protein and fat, they end up eating far fewer calories (1).

SummaryStudies indicate that cutting carbs canautomatically reduce your appetite and calorie intake.

Cutting carbs is one of the simplest and most effective ways to lose weight.

Studies illustrate that people on low-carb diets lose more weight, faster, than those on low-fat diets even when the latter are actively restricting calories.

This is because low-carb diets act to rid excess water from your body, lowering insulin levels and leading to rapid weight loss in the first week or two (2, 3).

In studies comparing low-carb and low-fat diets, people restricting their carbs sometimes lose 23 times as much weight without being hungry (4, 5).

One study in obese adults found a low-carb diet particularly effective for up to six months, compared to a conventional weight loss diet. After that, the difference in weight loss between diets was insignificant (6).

In a year-long study in 609 overweight adults on low-fat or low-carb diets, both groups lost similar amounts of weight (7).

SummaryAlmost without exception, low-carb diets leadto more short-term weight loss than low-fat diets. However, low-carb diets seemto lose their advantage in the long term.

Not all fat in your body is the same.

Where fat is stored determines how it affects your health and risk of disease.

The two main types are subcutaneous fat, which is under your skin, and visceral fat, which accumulates in your abdominal cavity and is typical for most overweight men.

Visceral fat tends to lodge around your organs. Excess visceral fat is associated with inflammation and insulin resistance and may drive the metabolic dysfunction so common in the West today (8).

Low-carb diets are very effective at reducing this harmful abdominal fat. In fact, a greater proportion of the fat people lose on low-carb diets seems to come from the abdominal cavity (9).

Over time, this should lead to a drastically reduced risk of heart disease and type 2 diabetes.

SummaryA large percentage of the fat lost onlow-carb diets tends to be harmful abdominal fat that is known to cause seriousmetabolic problems.

Triglycerides are fat molecules that circulate in your bloodstream.

It is well known that high fasting triglycerides levels in the blood after an overnight fast are a strong heart disease risk factor (10).

One of the main drivers of elevated triglycerides in sedentary people is carb consumption especially the simple sugar fructose (11, 12, 13).

When people cut carbs, they tend to experience a very dramatic reduction in blood triglycerides (14, 15).

On the other hand, low-fat diets often cause triglycerides to increase (16, 17).

SummaryLow-carb diets are very effective at loweringblood triglycerides, which are fat molecules that increase your risk of heartdisease.

High-density lipoprotein (HDL) is often called the good cholesterol.

The higher your levels of HDL relative to bad LDL, the lower your risk of heart disease (18, 19, 20).

One of the best ways to increase good HDL levels is to eat fat and low-carb diets include a lot of fat (21, 22, 23).

Therefore, it is unsurprising that HDL levels increase dramatically on healthy, low-carb diets, while they tend to increase only moderately or even decline on low-fat diets (24, 25).

SummaryLow-carb diets tend to be high in fat, whichleads to an impressive increase in blood levels of good HDL cholesterol.

Low-carb and ketogenic diets can also be particularly helpful for people with diabetes and insulin resistance, which affect millions of people worldwide (29, 30).

Studies prove that cutting carbs lowers both blood sugar and insulin levels drastically (31, 32).

Some people with diabetes who begin a low-carb diet may need to reduce their insulin dosage by 50% almost immediately (33).

In one study in people with type 2 diabetes, 95% had reduced or eliminated their glucose-lowering medication within six months (34).

If you take blood sugar medication, talk to your doctor before making changes to your carb intake, as your dosage may need to be adjusted to prevent hypoglycemia.

SummaryThe best way to lower blood sugar and insulinlevels is to reduce carb consumption, which may treat and possibly even reversetype 2 diabetes.

Elevated blood pressure, or hypertension, is a significant risk factor for many diseases, including heart disease, stroke and kidney failure.

Low-carb diets are an effective way to lower blood pressure, which should reduce your risk of these diseases and help you live longer (34, 35).

SummaryCutting carbs leads to a significantreduction in blood pressure, which should reduce your risk of many commondiseases.

Metabolic syndrome is a condition highly associated with your risk of diabetes and heart disease.

In fact, metabolic syndrome is a collection of symptoms, which include:

However, a low-carb diet is incredibly effective in treating all five of these symptoms (36, 37).

Under such a diet, these conditions are nearly eliminated.

SummaryHealthy low-carbdiets effectively reverse all five key symptoms of metabolic syndrome, aserious condition which increases your risk of heart disease and type 2diabetes.

People who have high bad LDL are much more likely to have heart attacks (38, 39).

However, the size of the particles is important. Smaller particles are linked to a higher risk of heart disease, while larger particles are linked to a lower risk (40, 41, 42).

It turns out that low-carb diets increase the size of bad LDL particles while reducing the number of total LDL particles in your bloodstream (43).

As such, lowering your carb intake can boost your heart health.

SummaryWhen you eat a low-carb diet, the size ofyour bad LDL particles increases, which reduces their harmful effects.Cutting carbs may also reduce the number of total LDL particles in yourbloodstream.

Your brain needs glucose, as some parts of it can only burn this type of sugar. Thats why your liver produces glucose from protein if you dont eat any carbs.

Yet, a large part of your brain can also burn ketones, which are formed during starvation or when carb intake is very low.

This is the mechanism behind the ketogenic diet, which has been used for decades to treat epilepsy in children who dont respond to drug treatment (44).

In many cases, this diet can cure children of epilepsy. In one study, over half of the children on a ketogenic diet experienced a greater than 50% reduction in their number of seizures, while 16% became seizure-free (45).

Very low-carb and ketogenic diets are now being studied for other brain conditions as well, including Alzheimers and Parkinsons disease (46).

SummaryLow-carb and keto diets have provenbeneficial in treating epilepsy in children and are being studied for theireffects on other brain conditions.

Few things are as well established in nutrition science as the immense health benefits of low-carb and ketogenic diets.

Not only can these diets improve your cholesterol, blood pressure and blood sugar, but they also reduce your appetite, boost weight loss and lower your triglycerides.

If youre curious to boost your health, one of these diets could be worth considering.

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