StemCell Therapy

Despite significant progress in treating cancer in recent years, the need for further improvements has persisted particularly for some of the most challenging forms of the disease, such as lung cancer. Lung cancer is one of the most common cancers, and is the leading cause of cancer death in both men and women.

The majority of lung cancer cases are non-small cell lung cancer (NSCLC), a complex disease that can affect each patient differently. Most cases of NSCLC are not diagnosed until the disease is advanced meaning it has metastasized or spread which can make it more challenging to treat.

The impact of lung cancer, and advanced NSCLC in particular, continues to be felt across our communities, explained Andrea Ferris, president and chairman of LUNGevity Foundation. While every persons experience with the disease is unique, many patients hope they can retain a sense of normalcy in their lives and are seeking more treatment options that offer a chance at a longer life.

Research Driving New Progress for Certain Patients

Researchers have accelerated their pursuit of new and differentiated approaches that address this critical unmet need, focusing on options that may offer patients a chance at a longer life. One area of research that has shown potential is combining treatments, such as immunotherapies, for certain patients with previously untreated advanced disease.

Hossein Borghaei, D.O., chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia explains, Progress in treating advanced lung cancer has led to more options for patients with newly diagnosed advanced NSCLC. Some of the most recent developments in the field of immunotherapy are particularly exciting.

One example is the U.S. Food and Drug Administrations approval of the first and only dual immunotherapy approach for newly diagnosed patients. Opdivo (nivolumab) is a prescription medicine used in combination with Yervoy (ipilimumab) for adults with advanced stage NSCLC that has spread to other parts of your body (metastatic) and tests positive for PD-L1 and do not have an abnormal EGFR or ALK gene.

Opdivo can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see Important Facts about side effects for Opdivo and Yervoy below.

Opdivo and Yervoy work with your immune system to help fight cancer in two ways. Yervoy stimulates the kind of cells that help fight cancer, while Opdivo may help these cells to find and fight the cancer cells again. While doing so, Opdivo and Yervoy can also affect healthy cells. These problems can sometimes become serious or life threatening and can lead to death. These problems may happen anytime during treatment or even after treatment has ended. Some of these problems may happen more often when Opdivo is used in combination with Yervoy.

Clinical Trial Findings: A Chance to Live Longer

Opdivo + Yervoy was studied in a clinical trial and compared to platinum-based chemotherapy among certain patients with previously untreated, advanced NSCLC that tested positive for PD-L1.

In the trial, 396 patients received Opdivo + Yervoy and 397 patients received platinum-based chemotherapy. Patients who were treated with Opdivo + Yervoy lived longer than those treated with platinum-based chemotherapy:

In the trial, 396 patients received Opdivo + Yervoy and 397 patients received platinum-based chemotherapy. Patients who were treated with Opdivo + Yervoy lived longer than those treated with platinum-based chemotherapy:

An additional analysis showed:

The data supporting this dual immunotherapy approach are encouraging, particularly as one third of the patients who responded to treatment with Opdivo + Yervoy were still alive at three years, said Dr. Borghaei. Further, Opdivo + Yervoy offers a non-chemotherapy option, which can be important to some patients.

The most common side effects of Opdivo, when used in combination with Yervoy, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. Please see Important Facts about side effects for Opdivo and Yervoy below.

Evolving Outlooks and Adapting Support for Patients

Facing a lung cancer diagnosis and beginning treatment can be life-altering in many ways and todays unique environment as a result of the coronavirus has brought about additional considerations for patients, caregivers and the broader healthcare community, with telemedicine and other forms of remote support playing an increasingly vital role.

Patients should know there are resources available and ways to stay connected, even during times when maintaining physical distance from others is important, said Ferris. We have transformed many of our patient support and education offerings into virtual formats, which we are updating frequently to provide the most recent information and reach and connect as many people as possible.

Dr. Borghaei also urges patients to reach out to their doctor or care team to learn about and take advantage of available remote support offerings. Advances in cancer research are still happening every day, with Opdivo + Yervoy being one example. Its as important as ever that people diagnosed with lung cancer speak with their doctor to fully understand their treatment options. While how we deliver care might look different now in some ways, our commitment to helping patients live longer hasnt changed.

To learn more about Opdivo + Yervoy, please visit http://www.Opdivo.com.

INDICATION

OPDIVO (nivolumab) is a prescription medicine used in combination with YERVOY (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

ImportantSafetyInformationforOPDIVO(nivolumab) + YERVOY (ipilimumab)

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Serious side effects may include:Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath. Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness. Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual; and decreased energy.Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine. Kidney problems, including nephritis and kidney failure.Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite. Skin problems.Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes. Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck. Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.

Additional serious side effects observed during a separate study of YERVOY alone include: Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet. Eye problems.Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.

Get medical help immediatelyif you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including: Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.

Pregnancy and Nursing: Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. Females who are able to become pregnant should use an effective method of birth control duringtreatmentand for at least 5 months after the last dose. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy. Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869. Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose.

Tell your healthcare provider about: Your health problems or concerns if you: have immune system problems such as autoimmune disease, Crohns disease, ulcerative colitis, lupus, or sarcoidosis; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions. All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection;headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatchor call 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Medication Guide forOPDIVO and YERVOY.

2020 Bristol-Myers Squibb Company.

OPDIVO and YERVOY are registered trademarks of Bristol-Myers Squibb Company.

7356US2001251-01 08/20

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The Science of Survival: Evolving Research in Advanced Non-Small Cell Lung Cancer - Reuters

When Eimear Smyth passed away, her family promised her that they'd raise awareness for stem cell donation in the most fun way possible.

The West Belfast woman was 22 when she was diagnosed with Hodgkins Lymphoma and died just three years later after complications from a Donor Stem Cell transplant.

Today, Eimear's family and friends continue to raise awareness for stem cell donation, organ donation and blood cancer as part of Eimear's Wish.

From fundraisers to pink glazed donuts, everything the Smyth's have done in memory of Eimear has been fun, so they decided to take things up a notch and create a Gin brand named after the woman who taught them so much in life and death.

Speaking to Belfast Live, Eimear's dad Sean said the Gin has proved popular from across Ireland and beyond.

"Eimear's Wish Gin has taken a life of its own, people are really interested. We are getting requests from all over, and then when people try it they're asking for me. And the Wolf and Whistle in West Belfast are actually going to run a cocktail for us too.

"Our Eimear loved lemon and strawberry sherbet so they have agreed to run a pink lemon sherbet cocktail in memory of Eimear, and it launched on September 4 so we are looking forward to that.

"Everything we want to do, and have done in the past has been fun. See standing and shaking a bucket saying 'give me your money,' we don't want to do that. And we don't want to make it sad, because there is enough sadness in the world.

Eimear just loved dancing, and her social life. She loved coffee and donuts and now and again would take a wee Gin. She wasn't a big drinker but she would love having a Gin named after her.

"And the idea is to create a legacy for Eimear and to get people talking about stem cell donation, blood cancer and organ donation."

Eimear's Wish are asking for a 30 charitable donation which will be divided equally between Action Cancer, Cancer Fund for Children and Anthony Nolan Stem Cell - and in turn you'll get a bottle of Eimear's Gin.

All three charitable groups have helped Eimear and the Smyth family throughout their darkest days.

"Action Cancer was very, very good to us. Cancer Fund for Children looked out for Eimear and Anthony Nolan are helping to raise that awareness," said Sean.

"There are not enough people in Northern Ireland on the stem cell list, especially from the BAME community. If you are a white European, there's a 70% chance that you will find a match, but if you are from the Black, Asian, Minority Ethnic community that chance is 20% because your tissue is more difficult to match. So we need more people from those backgrounds to join.

"Before Eimear, I didn't know much about stem cell donation, I didn't know that stem cell and bone marrow was the same thing. I always thought it was two separate things.

"Our problem was that Eimear was only 22. She had just graduated and was taking the year out to get the money to go on to do a PGCE to become a teacher. She didn't smoke and rarely drank, she had a good healthy lifestyle. No cancer in my side of the family or Eimear's mummy's side. If that can happen to Eimear, it can happen to anyone, and that was really frightening.

"Awareness if one part of it, but the other part is to get better facilities, more age appropriate facilities for our young people who are going through this."

Throughout her illness, Eimear was treated in the City Hospital.

Hailing the medical care his daughter received, Sean says he would like to see more "age appropriate settings" for young adults for treatment.

"Eimear couldn't open the window to feel air on her skin when she was there. The TVs don't work. There's nowhere for relatives to sleep and there is one small fridge for 24 people. The facilities are from 1986. It is a horrible place to die.

"People have got to understand that we do not have age appropriate care for teenagers and young adults. They're sitting beside a 70-year-old man who is also ill, it's not fair on either patient to be in that situation.

"Eimear lived in Leeds and was treated in St James' Hospital and the unit she was in was brilliant. It was for patients aged 17-24. You walk in and there's a fully stocked kitchen for parents. The wards are a four people maximum. The far end of the ward is a youth club, it has snooker tables, jukeboxes, all the games consoles.

"The outpatients come for their chemo and their friends come with them for company. It is brilliant but we have nothing here. If we hadn't been in England we wouldn't have known the difference, we would have just thought it was the norm.

"The environment isn't nice at all. These are our kids. They're told those three words 'you've got cancer' and that is heartbreaking. The only thing I want is for the young people to be able to look at something other than beige colour walls. They deserve better.

"Nothing will ever bring my daughter back, but if we can make it a bit easy for another family or child, then we'll do that - it was Eimear's Wish."

For more information on how to donate, how to order a bottle or Eimear's Wish Gin or to stock it in your premises CLICK HERE.

You can register as a stem cell donor with the Anthony Nolan Trust or DKMS.

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Eimear's Wish Gin helping Belfast family pay tribute to daughter and raise awareness for Stem Cell Donation - Belfast Live

About 40 Maryland life sciences organizations are working on creating and assembling COVID-19 vaccines and therapeutics, improving diagnostic tests, and giving clinical examination and technical support to guarantee safe and viable health care delivery.

The University System of Maryland and Johns Hopkins University have likewise committed a great many dollars toward examination, testing, and clinical preliminaries. The University of Maryland School of Medicine recently started stage three testing of a COVID-19 immunization.

Up to now, Marylands life sciences companies have secured more than $3 billion for the advancement of a vaccine for SARS-CoV-2, the infection that causes COVID-19.

Gaithersburg-based Novavax was granted $1.6 billion through Operation Warp Speed to finish late-stage clinical developments, set up large scale manufacturing, and deliver 100 million vaccine dosages as early as the end of 2020. It has also secured $388 million from the international Coalition for Epidemic Preparedness Innovations and $60 million through a U.S. Department of Defense contract to support vaccine creation.

Rising BioSolutions, headquartered in Gaithersburg with three manufacturing facilities in Baltimore and Rockville, has agreements with AstraZeneca, Johnson and Johnson, Novavax, and Vaxart and also with Operation Warp Speed for the sum of $1.5 billion to help COVID-19 vaccine development and production.

Bethesda-based Longhorn Vaccines and Diagnostics won a $225 million Department of Homeland Security contract to transport clinical examples to testing labs.

Altimmune, headquartered in Gaithersburg, has a $4.7 million contract with the U.S. Army Medical Research and Development Command and is working with Rockville-based Vigene Biosciences on a single-dose intranasal COVID-19 vaccine.

The University System of Maryland and Johns Hopkins University have been working from the start of the pandemic on medical responses to combat COVID-19. Johns Hopkins has devoted $6 million in support of about 260 scientists and researchers working on more than two dozen projects involving COVID-19. In addition, Hopkins School of Medicine is conducting more than 100 clinical studies to develop COVID-19 diagnostics and, with $35 million from the U.S. Department of Defense, is working with the Bloomberg School of Public Health to test the efficacy of blood plasma from COVID-19 survivors as a viable treatment alternative.

The University System of Maryland faculty are working to develop a rapid COVID-19 test and are conducting a clinical trial of experimental stem cell therapy to reduce death in the sickest patients. The University of Maryland School of Medicine will receive up to $3.6 million over the next year from the Defense Advanced Research Projects Agency to test hundreds of drugs, approved and marketed for other conditions, to see whether any can be repurposed to forestall and treat COVID-19.

On the day of our first coronavirus cases, I said that Maryland was home to some of the top health research facilities in the world, and vowed that we would be a part of developing treatments and perhaps even a vaccine for this deadly virus, said Governor Larry Hogan in a statement. I want to commend our world-class life sciences community, our universities, and federal research labs for working together to fight this unprecedented global pandemic. Our state will continue to lead on the road to recovery.

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Nearly 40 Maryland companies are working to beat COVID-19 - Baltimore Fishbowl

to her legions of fans, Lynn Gunn Gunnulfsen made the jump from star to icon years ago.

As the vocalist of dark pop-rock purveyors PVRIS, she spent the bands first two albums, 2014s White Noise and 2017s All We Know of Heaven, All We Need Of Hell, speaking frankly about her own battles with depression, turning reflections of self-doubt and the complexities of relationships into arena-sized slices of electronic fizz. Shes campaigned for LGBTQ+ rights and become a figurehead for countless devotees who have adopted her songs as anthems of bravery and resilience.

The only person who doesnt seem to have grasped the pull of her star power is Gunn herself although thats changing with the release of PVRIS fearless new record, Use Me.

When she announced the album back in March, Gunn revealed that, from day one, shes consistently downplayed her true role as PVRIS sole creative force. Shes been responsible for everything from the bands sound to songwriting, visuals and driving production, but has preferred to share the spotlight with her bandmates, bassist Brian Macdonald and lead guitarist and keyboardist Alex Babinski. With Use Me, though, she says shes finally allowing herself to take credit for PVRIS ever-growing list of achievements.

It feels so good, she says on the phone line from her home in LA, referring to her unmasking as a lifting of the veil. She adds: This had to happen for me to continue wanting to do this. With all the work I was putting into this next record, it felt really weird and uncomfortable to be giving equal credit to everyone. Brian and Alex have always been incredibly supportive of my vision over the years, but I never felt comfortable opening up and owning that role. It made me feel apathetic towards the project.

You need only look at the promotional photos for Use Me, in which Gunn stands defiantly alone, without her bandmates, to see that newfound confidence in action, but she baulks at the suggestion that this is her going solo. Its quite similar to Tame impala and Florence + The Machine; were still very much a band, she says. Everythings operating the same as it always has, its just being presented differently. Her sense of empowerment is plastered all over Use Me.

Wide awake. Just cut the head off of a snake, she sings on the opening line of euphoric, disco-influenced first track, Gimme a Minute, a lyric that finds her looking forward to the future, having let go of the anxieties that plagued her career until now. The new music is also a break with the past, leaning more heavily on the PVRIS lustrous pop inclinations than its predecessors. The bands trademark brooding darkness still bubbles underfoot, but this time its buried beneath slick, vivid production and playful, clubby electronica.

Use Me was originally slated to arrive back in May, but as Covid-19 tightened its grip across the world, the bands label, Reprise/Warner Records, pushed the release to July. After the death of George Floyd in police custody in May, and the subsequent outpouring of shock and revolt and global renewal of the Black Lives Matter movement, Gunn decided that releasing new music would be a distraction from the bigger issues at hand.

In a statement posted to the bands Twitter account in July, she announced that the album would be further delayed: Self-promotion can wait for now and I want to make room and hold space for the conversation and message of the Black Lives Matter movement to continue.

She tells NME today: This moment in time is a paradigm shift and awakening for a lot of people. But theres so much work to do. It has to be lifelong commitment in order to see change.

Gunn recognises that healing the divisions of a splintered America will be a mountainous challenge, but shes inspired by the passion shes seen fighting for change online and out on the streets. In this, shes inspired by the tireless efforts of Gen-Z. We want a better future and are down and willing to be part of that shift, she says. Its so palpable and intense and real. I think the best thing you can do right now, instead of being apathetic and pretending that you dont care, is do care. Youve got to give a shit, you know?

Gunn is now 26, and was only 19 when she wrote the bands debut.When that album was released in 2014, the impact was instant, racking up millions of streams on Spotify and YouTube thanks to gloomy, yet jubilant synth-pop bangers such as St. Patrick and You And I. The record catapulted the band across the globe on a punishing tour schedule, which included high-profile US arena dates with Fall Out Boy, Bring Me The Horizon and Muse. Within three years, they had been booted from clubs onto festival main stages.

The full band, comprise of Gunn, bassist Brian Macdonald and lead guitarist and keyboardist Alex Babinski. Credit: Lindsey Byrnes

Yet success took its toll. By the time Gunn finally sat down to write 2017s All We Know of Heaven, All We Need of Hell, she was knackered and in a dark place, suffering with depression, which shes described as a downward spiral.

Years of constant gigging had damaged her voice, almost leading the band to cancel the tour of their second album while she worked with a vocal coach to retrain herself to sing. In the end, the band ploughed on with the promotion, but Gunns confidence had nosedived and onstage she seemed a reluctant frontwoman, hiding behind a guitar. In later interviews she admitted that she felt exposed and vulnerable.

Around the same time, she was diagnosed with Crohns disease, while in November 2019 it was confirmed that she was also battling an autoimmune disease, ankylosing spondylitis. The diagnoses, she says, came as a strange kind of relief after four years of pain and discomfort.

It has to be lifelong commitment in order to see [social] change

I didnt know what was wrong, she says. I was having a really difficult time getting out and into my bunk every morning and night and waking up with stomach pains. With autoimmune disease, theres a general fatigue and brain fog that comes with chronic inflammation, so a lot of the time Id be really unfocused or really tired. I was hard on myself about it.

Over time, Gunn has found her confidence again. Ive been really on top of my mental and physical health for the last few years, she says. I feel like Ive been in a really good head space for quite a while, which Im really grateful for.

Working with a small team of medical practitioners, including a herbalist, an acupuncture doctor and a womans specialist, who together have slowly but surely helped her to heal and rebalance, she now follows a what she dubs a crazy protocol.

I have up to 20 supplements I need to take, and different droplets, flower essences and plant stem cells, she says. I think theres 16 and you have to take all of them at different points throughout the day. The result has been transformative: Im determined to experience no symptoms in the next five years. Im ready to whoop its ass.

After a few turbulent personal years, Use Me represents a fresh start in many ways. While writing the album she upped sticks to Los Angeles, a move initially borne out of necessity. With an increased focus on protecting her physical and mental health following her Crohns diagnosis, it was clear that her usual approach shuttling back and forth between her home in New York and LA studio sessions had become unworkable. But no-one was more surprised than Gunn to find that her new home city was a genuine source of solace.

Ive always had a love-hate [relationship] with LA, she reveals. Ive had really good things happen here and difficult emotional situations happen here, so for a long time [the city] felt really dark. When I moved here, I was going through a pretty rough time, but I instantly loved it. All my best friends are out here, and I guess it feels like home.

By the time she made the move, she had already written three songs for the album the anthemic Death Of Me, the glossy Old Wounds and the vibrant Hallucinations, which were all released as part of the Hallucinations EP released in October 2019. The latter was penned during writing sessions with hotshot songwriter Amy Allen (whos worked with the likes of Halsey and Harry Styles) and Nashville-based Use Me producer, JT Daly. The remaining songs were finished in Dalys Nashville studio.

If 2017s All We Know of Heaven, All We Need of Hell was a cleansing experience that found Gunn crawling towards the end of the tunnel, its successor captures the moment that she finally emerged from the other end and into the light.

Inner peace is hard to find she sings on the opening line of euphoric, disco-influenced first track, Gimme a Minute, which refers to her overcoming recent emotional and physical upheaval. Over the glassy synths of Deadweight, she discusses walking away from negative mindsets and toxic relationships, sighing, I cant take it over and over / Deadweight hanging off of my shoulders.

[Those songs] capture the chaos of the last two years, she says. Theres so much that Ill never be probably able to share. Youve got to keep changing and growing. If someone or something is attacking you negatively, sometimes youve just got to have the power and the courage to walk away from it.

Is this a reference to long-time drummer Justin Nace, who left the band back in January? At the time the split seemed amicable, but was the shift a result of PVRIS new way of working, with Gunn stepping into the spotlight as band linchpin?

[Our new songs] capture the chaos of the last two years

Sort of, but it was a natural thing that needed to happen, says Gunn hesitantly, seeming reluctant to be drawn on the details. A lot of personal stuff [happened] that Im not going to mention here. Hes never been an official member [of PVRIS] so I dont think its that big a thing to touch on. We love him very much and wish him the best, but now is the time for change and growth for both parties.

The album closes with a reworked version of its titular track, which was put together during lockdown, featuring rising rapper and Kanye West protge 070 Shake. It was such a last-minute blessing from the heavens. I swear, says Gunn. Weve never had a featured artist on an album [before]. Theres never been anyone I was particularly excited about or felt compelled to collab with. I think shes real deal and a really special artist. Her album [070s excellent 2020 record Modus Vivendi] is very experimental, abstract, cool and weird and it takes risks.

Thats something I always want to do with PVRIS so its very aligned creatively. I think shes out in Colorado and as soon as she confirmed it was happening, she ended up having to drive an hour to a studio to track it, sent it over and it was perfect right away. Its a collaboration our fans didnt know they wanted, but hopefully they do now.

PVRIS live in London in February, Credit: India Fleming

Back in February, NME watched the band celebrate their live return to the UK, after two years away, at an intimate London show. As Gunn perched behind a keyboard during Heaven and danced across the stage watched by thousands of adoring eyes, there was no sign of the vocal issues and subsequent nerves that had plagued her in the past. Covid might have stolen that momentum, but Gunn is no longer content to remain trapped inside her inside her chrysalis.

I just want to be real and transparent, she insists. Growing up, I never really had a good example of the artist I am, and the role I take in the band. I just want to show this is an option for anyone who might be a similar position and inspire other people to do the same.

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PVRIS: Sometimes youve got to have the power and the courage to walk away - NME

Company Announcement

Copenhagen, Denmark; August 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR studyThe Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

Company Announcement no. 38CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces Janssen Granted U.S. FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or...

Transparency Market Research (TMR)has published a new report titled, Autologous cell therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalautologous cell therapy marketwas valued atUS$ 7.5 Bnin2018and is projected to expand at a CAGR of18.1%from2019to2027.

Get PDF Sample Copy of Report: (Including TOC, List of Tables & Figures, Chart) :https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=715

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Rise in Prevalence of Neurological Disorders & Cancer and Others to Drive Market

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Bone Marrow Segment to Dominate Market

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North America to Dominate Global Market

Competitive Landscape

Read our Case study at :https://www.transparencymarketresearch.com/casestudies/innovative-medical-device-manufacturing-start-up

The global autologous cell therapy market has been segmented as follows:

More Trending Reports by Transparency Market Research 1.https://www.prnewswire.com/news-releases/bronchitis-treatment-market-to-reach-us-4-7-bn-by-2026high-prevalence-of-air-pollution-drives-growth-transparency-market-research-301003635.html

2.https://www.biospace.com/article/personal-mobility-devices-market-rising-in-various-regions-owing-to-increased-geriatric-population/

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Autologous Cell Therapy Market Along With Covid-19 Impact Analysis and Business Opportunities Outlook 2027 - Scientect

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Multiple Studies Suggest Lasting Immunity to COVID-19 After Infection

Although probably not enough time has passed to know definitively, several studies are now suggesting that even mild cases of COVID-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B- and T-cells.

Things are really working as theyre supposed to, Deepta Bhattacharya, an immunologist at the University of Arizona, and an author of one of the studies, told The New York Times.

Its difficult, probably impossible, to predict how long those immune responses will last, but many of the researchers believe the results are promising for long-term protection.

This is exactly what you would hope for, Marion Pepper, an immunologist at the University of Washington and an author of a study currently being reviewed by the journal Nature. All the pieces are there to have a totally protective immune response.

Pepper notes that the protective effects cant be completely evaluated until there is proof that people exposed to the virus a second time can fight it off. But the data suggests the immune system is indeed able to fight resistance a second time. Some of this qualification comes from unconfirmed reports of people being reinfected by the virus.

Antibody responses are typically relatively short-lived, disappearing from the blood weeks or months after being produced. Generally, the majority of the B-cells that produce antibodies die off, too. But the body keeps some longer-lived B-cells that are able to manufacture virus-fighting antibodies should the immune system be triggered by re-exposure to the virus. Some stay in the bloodstream while others wait in the bone marrow where they manufacture small numbers of antibodies that can sometimes be observed years, even decades later. Several studies, some by Bhattacharya and Pepper, have identified antibodies at low levels in the blood months after people recovered from COVID-19.

The antibodies decline, but they settle in what looks like a stable nadir, Bhattacharya said. These have been observed about three months after symptoms show up. The response looks perfectly durable.

Additional studies, including one published in the journal Cell, have isolated T-cells from recovered patients that can attack SARS-CoV-2. In laboratory studies, the T-cells produced signals to fight the virus and cloned themselves in large numbers to fight the potential infection.

This is very promising, said Smita Iyer, an immunologist at the University of California, Davis, who was not involved in the new studies, but has researched immune responses to the novel coronavirus in rhesus macaques. This calls for some optimism about herd immunity, and potentially a vaccine.

It's still has not been definitely determined if milder cases of COVID-19 will lead to long-term or even medium-term immunity. There have been some studies that suggest it does not and some newer studies suggesting it does. Iyer notes that the recent paper indicates, You can still get durable immunity without suffering the consequences of infection.

This idea is reinforced by Eun-Hyung Lee, an immunologist at Emory University who was not involved in these studies. He told The New York Times, Yes, you do develop immunity to this virus, and good immunity to this virus. Thats the message we want to get out there.

Why Seasonal Flu Vaccines Only Last a Year

As most everyone knows, flu vaccines only last about a year. Some of this is related to viral mutations. But in fact, the actual immunity itself caused by the vaccine does not appear to last longer than a year, even though the flu vaccine increases the number of antibody-producing cells specific for the flu in the bone marrow. Researchers out of Emory Vaccine Center found that for most newly-generated plasma cell lineages, between 70 and 99% of the cells were gone after one year, but that the levels of antibody-secreting cells in blood correlated with long-term response in the bone marrow.

Gut Bacteria Can Help Immuno-Oncology Therapies

Researchers with the University of Calgary identified gut bacteria that help our immune system fight cancerous tumors. This also helped provide more information about why immunotherapy works in some cases, but not others. By combining immunotherapy with specific microbial therapy, they believe they can help the immune system and immunotherapy be more effective in treating three types of cancer: melanoma, bladder and colorectal cancers. They found that specific bacteria were essential for immunotherapy to work in colorectal cancer tumors in germ-free mice. The bacteria produced a small molecule called inosine that interacts directly with T-cells and together with immunotherapy.

An Online Calculator to Predict Stroke Risk

Scientists at the University of Virginia Health System developed an online tool that measures the severity of a patients metabolic syndrome, a mix of conditions that includes high blood pressure, abnormal cholesterol levels and excess body fat. With it, they can then predict the patients risk for ischemic stroke. The study discovered that stroke risk increased consistently with metabolic syndrome severity even in patients that did not have diabetes. The tool is available for free at https://metscalc.org/.

A Link Between Autism and Cholesterol

Researchers at Harvard Medical School, Massachusetts Institute of Technology (MIT) and Northwestern University identified a subtype of autism that is the result of a cluster of genes that regulate cholesterol metabolism and brain development. They believe this information can help design precision-targeted therapies for this specific type of autism and improve screening efforts for earlier diagnosis of autism. They analyzed the DNA from brain samples that they then confirmed with the medical records of autistic individuals. They found that children with autism and their parents had significant alterations in lipid blood. However, there is much more to be understood, emphasizing the complexity of autism, which is affected by a variety of genetic and environmental factors.

Researchers Grow First Functioning Mini Human Heart Model

Investigators with Michigan State University grew the first miniature human heart model in the laboratory that is complete with all primary heart cell types and a functioning structure of chambers and vascular tissue. They utilized induced pluripotent stem cells which were obtained from consenting adults and created a functional mini heart in a few weeks. The primary value was in giving them an unprecedented view into how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, said Aitor Aguirre, senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

Another area of focus is that improving on the final organoid will help with future research. Current heart organoids are not identical yet to human hearts and so are flawed in their use as research models.

More:
Research Roundup: Lasting Immunity to COVID-19 and More - BioSpace

This year, in many ways, has seemed the ideal time to get heavily, extravagantly into fillers. Human contact is still largely outlawed, so if it all blows up in your face (as it can do, quite literally), it is socially acceptable to hide behind a mask. Besides, some studies have drawn a correlation between the hours spent looking-but-not-actually-looking at yourself in Zooms tiny thumbnail (were my eyes always this far apart? Or this close together?) and the uptick in cosmetic procedures post-lockdown.

But, if you do decide to get a little Botox and perhaps some tear-trough fillers, too, while youre at it you may have to contend with Dr Michael Mosleys not-angry-but-disappointed face, as he visits a tweakment clinic near you in two-parter The Truth About Cosmetic Treatments (BBC One). Mosley, who is on most other TV shows where a bit of judgment is de rigueur (see also: Channel 4s Lose a Stone in 21 Days) is here to see whether the rise in nonsurgical treatments could be doing more harm than good. But first, time to ask some people on the street whose fault this all is. The Kardashians and Kylie Jenner? I for one am shocked that some of the most famous people on the planet could be influencing our behaviour.

The rest of the programme isnt so much The Truth About Cosmetic Treatments as A Largely Negative But Ultimately Commonsense Guide to Them. Do use Google. Dont get Botox in the back of a car. Do not pass go, do not collect 200. Co-presenter Mehreen Baig, a blogger and journalist, is mostly good cop, telling us that people should get tweakments if they want them and if they will make them feel better about themselves. She visits a doctor offering nonsurgical rhinoplasty, increasing the volume of noses with fillers while making them appear smaller. She listens kindly while a group of middle-aged women undergo newfangled microneedling and drink some kind of collagen Capri Sun to see if they can roll back the years. She even watches as fat is extracted from the body of a heavily sedated woman called Kim, to be harvested for stem cells, which are then injected back into her face. Sure, Baig is visibly revolted as she watches, but it could be worse: remember that period in the early 00s when it seemed as if every celebrity was drinking their own wee?

Meanwhile, Mosley is, if not bad cop, then largely disapproving cop. He considers the pitiful case of Emma, a woman whose bungled lip filler left a huge pouch of skin around her mouth, which she describes, unappetisingly, as the sausage. People can do tweakments anywhere, with no qualifications, he reminds us, so its important to check out peoples credentials. The issue here, though Mosley doesnt get into it, isnt so much that people dont go running to the General Medical Council before booking lip fillers, its that they trust a friend or acquaintance, and are tempted by cheap deals.

If Mosley is the not-angry-but-disappointed parent, the kind who said: Now, why have you gone and done that? when you got your earlobes pierced, he at least decides to make his own apathy towards tweakments clear, undergoing a heat gun treatment to stimulate his skin, and then complaining that it has merely left him looking like he has bad sunburn.

You have seen at least 80% of this programme in some shape or form at least 1,000 times before about self-esteem, safety, social media and not getting fillers from someone in their garden shed. Perhaps the most interesting, if undeveloped, section was on preventive measures and whether people in their 20s need to be getting Botox at all. (The answer was probably not but where was the scientific modelling, the kind dedicated to finding out Mosleys exact skin age, to find out whether that should be definitely not?)

The second episode focuses on bum lifts and steroid-taking lads, and is sure yet again to hammer home the already well-known risks of doing anything other than sitting in a darkened room until the end of time. More helpful, perhaps, would be a programme that descended, if only slightly, from the moral high ground and stopped wrinkling its nose something that is sure to speed up the ageing process.

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The Truth About Cosmetic Treatments review a format in need of a facelift - The Guardian

SAN FRANCISCO, CA / ACCESSWIRE / August 24, 2020 / Tribe Public announced today that Dietrich Stephan, Chief Executive Officer of NeuBase Therapeutics, Inc. (NASDAQ:NBSE), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, will present at Tribe Public's Presentation and Q&A Webinar Event at 8 am pacific/11 am eastern on Wednesday, August 26th, 2020. During this complimentary, 30-minute event, Dr. Stephan will introduce the NeuBase's next-generation gene silencing technology and discuss the company's progress with treatment candidates in Huntington's Disease (HD) and Myotonic Dystrophy (DM1). A question and answer session will follow the presentation. To register to join the complimentary event, please visit the Tribe Public LLC website: http://www.tribepublic.com, or send a message to Tribe's management at research@tribepublic.com to request your seat for this limited capacity Zoom-based event.

Dietrich A. Stephan, Ph.D. is an industry veteran who is considered one of the fathers of the field of precision medicine, having trained with the leadership of the Human Genome Project at the NIH and then going on to lead discovery research at the Translational Genomics Research Institute and serve as professor and chairman of the Department of Human Genetics at the University of Pittsburgh. Dr. Stephan has identified the molecular basis of dozens of genetic diseases and published extensively in journals such as Science, the New England Journal of Medicine, Nature Genetics, PNAS, and Cell. In parallel, Dr. Stephan has founded or co-founded more than ten biotechnology companies and has advised numerous other companies. These companies are backed by top-tier investors such as Sequoia Capital, KPCB, Thiel Capital, and Khosla Ventures as well as corporate partners such as Life Technologies, Pfizer, and Mayo Clinic. Notably, Dr. Stephan founded NeuBase Therapeutics in August 2018, took it public in 2019, and has since grown the company to market capitalization to the tune of hundreds of millions of dollars. Dr. Stephan received his Ph.D. from the University of Pittsburgh and his B.S. from Carnegie Mellon University.

ABOUT TRIBE PUBLIC LLCTribe Public LLC is a San Francisco, CA-based organization that hosts complimentary worldwide webinar & meeting events in the U.S. Tribe's events focus on issues that the Tribe members care about with an emphasis on hosting management teams from publicly traded companies from all sectors & financial organizations that are seeking to increase awareness of their products, progress, and plans. Tribe members primarily include Institutions, Family Offices, Portfolio Managers, Registered Investment Advisors, & Accredited Investors. Website: http://www.tribepublic.com.

ABOUT NEUBASE THERAPEUTICSNeuBase Therapeutics, Inc. is developing the next generation of gene silencing therapies with its flexible, highly specific synthetic antisense oligonucleotides. The proprietary NeuBase peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform allows for the rapid development of targeted drugs, increasing the treatment opportunities for the hundreds of millions of people affected by rare genetic diseases, including those that can only be treated through accessing of secondary RNA structures. Using PATrOL technology, NeuBase aims to first tackle rare, genetic neurological disorders. NeuBase is continuing its progress towards developing treatment candidates in Huntington's Disease (HD) and Myotonic Dystrophy (DM1.)

CONTACT:

Tribe Public, LLC.John F. Heerdink, Jr.Managing Partnerjohn@tribepublic.com

SOURCE: NeuBase Therapeutics, Inc.

View source version on accesswire.com:https://www.accesswire.com/603092/NeuBase-Therapeutics-CEO-Dietrich-A-Stephan-PhD-to-Present-at-Tribe-Publics-Presentation-and-QA-Webinar-Event-on-August-26-2020

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NeuBase Therapeutic's CEO, Dietrich A. Stephan, Ph.D., to Present at Tribe Public's Presentation and Q&A Webinar Event on August 26, 2020 - BioSpace

A woman spits into a tube so that her saliva can be tested for the presence of the novel coronavirus.

By Robert F. ServiceAug. 24, 2020 , 5:00 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

First, a technician pushes a pencil-length swab to the very back of your nasal passages. Then you pay $100 or more, and wait days for an answer. But faster, cheaper, more pleasant ways to test for the novel coronavirus are coming online. This month, the U.S. Food and Drug Administration granted emergency use authorization for two tests that sample saliva instead of nasal fluid, and more innovations are likely after FDA relaxed rules to allow new tests to be adopted more quickly. One candidate was announced last week: an experimental test, potentially faster and cheaper, that analyzes saliva in a new way.

There is real promise here, says Anne Wyllie, a microbiologist at Yale University who helped develop one of the new tests authorized this month. Takanori Teshima, chief of laboratory medicine at Hokkaido University, who also reported successful results testing saliva, agrees. It will have a big impact worldwide.

When SARS-CoV-2, the respiratory virus that causes COVID-19, emerged in December 2019, researchers scrambled to develop tests to detect the virus. Initially, they turned to a long-trusted technique for diagnosing respiratory infections: looking for viral genetic material in mucosal fluid, thought to be the best hunting ground for a respiratory virus, collected from deep in a patients nasal passages. Thats where the 15-centimeter swab comes in. The swab goes into a plastic tube with a chemical mixture that stabilizes the virus during transport to a diagnostics lab. There, technicians extract its genetic material and load it into a machine to carry out the polymerase chain reaction (PCR), which amplifies snippets of genetic material unique to the virus.

The procedure accurately identifies infections about 95% of the time. But the test is uncomfortable and, because collecting the swab requires close contact with patients, it puts medical personnel at risk of contracting the virus. Nobody wants to do that job, Teshima says.

Testing saliva for SARS-CoV-2 was no sure thing. Studies with other respiratory diseases showed saliva tests identified only about 90% of people for whom swab tests indicated an infection. But the appeal of an easier and safer test for the new coronavirus led researchers to try. People being tested simply drool into a bar-coded plastic tube, seal it, and drop it in a pouch thats shipped to a lab for PCR analysis. Because the procedure directly tests the fluid responsible for transmitting the virus between people, it may give a better indication of who is most contagious, says Paul Hergenrother, a chemist at the University of Illinois, Urbana-Champaign (UIUC), who led his universitys saliva test development.

As early as 12 February, researchers in Hong Kong and China reported inClinical Infectious Diseasesthat they couldidentify SARS-CoV-2 from salivain 11 of 12 patients whose swabs showed virus. Since then, groups in the United States, Singapore, and Japan have confirmed and further simplified the procedures, cutting out costly steps such as adding specialized reagents to stabilize the virus during transport and extract the genetic material.

In May, Wyllie and Yale colleagues teamed up with the National Basketball Association, which provided $500,000 to develop Yales saliva test; the test is now used for frequently testing players. On 4 August, the Yale team posted a preprint on medRxiv that said its saliva testagreed with swab results 94% of the time, at a cost of as little as $1.29 per sample, roughly 1/100 as much as commercial swab-based tests. On 15 August, FDA granted emergency approval for the SalivaDirect test, so that other FDA-approved labs can use the protocol. Last week, the agency extended approval to the UIUC test given its similarity to the Yale test. UIUC is now using its saliva test to test all 60,000 students, faculty, and staff twice a week, so they can isolate infected individuals as quickly as possible. Testing saliva makes sense scientifically, and it makes sense logistically, Hergenrother says.

Anew saliva test for RNA viruses, such as Zika and SARS-CoV-2, was reported last week inScience Advancesby researchers at the University at Albany. It could be even faster and cheaper because it does not need expensive lab equipment such as PCR machines. Rather than amplifying RNA to identify the virus, the approach uses snippets of DNA that bind to short, unique sections of RNA and change them from linear strands to loops. That alters how the RNA behaves in a common lab procedure known as gel electrophoresis, making it easy to detect. This is innovative, Wyllie says.

A relaxation of FDA rules announced last week could lead to still more variants. The new rules allow approved clinical labs to use tests they have developed without any additional approval step. In a tweet, Michael Mina, an epidemiologist at Harvard Universitys T.H. Chan School of Public Health, called FDAs decision Huge news!! because it would encourage labs to develop novel tests. It may also help speed development ofrapid tests that look for viral proteinsrather than genetic materialan efficient way to screen large numbers of asymptomatic people.

We dont need one test to be the end all and be all, Wyllie says. We just want options.

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New drool-based tests are replacing the dreaded coronavirus nasal swab - Science Magazine

A man in Hong Kong who recovered from COVID-19 was reinfected with the virus four-and-a half months later in the first recorded instance of a second infection, researchers at the University of Hong Kong said on Monday.

The findings suggest the disease can infect multiple times despite herd immunity.

According to the researchers, a genetic analysis showed that these two successive infections of the same patient had been caused by two different strains of the SARS-CoV-2 virus, responsible for COVID-19.

The 33-year-old man was first diagnosed with COVID-19 in late March but tested positive again while being tested after he returned to Hong Kong from Spain via Britain on August 15.

But he was found to be infected with a different coronavirus strain the second time around and was asymptomatic.

The two viral signatures were said to be "completely different", and belonged to different coronavirus lineages, or clades.

The first closely resembled strains collected in March and April, and the second strain matched the virus found in Europe -- where the patient had just been visiting -- in July and August.

"Our study proves that immunity for COVID infection is not lifelong -- in fact, reinfection can occur quite quickly," said Kelvin Kai-Wang To, a microbiologist at Hong Kong University's Faculty of Medicine and lead author of a forthcoming study that details the findings.

"COVID-19 patients should not assume after they recover that they won't get infected again," he told AFP.

To also said those who have overcome the virus should still practice social distancing, wear masks and practise hand washing.

Experts have voiced different opinions on how alarmed people should be at the new findings, which will be published in the peer-reviewed medical journal Clinical Infectious Diseases.

"This is a worrying finding for two reasons," said David Strain, a clinical senior lecturer at the University of Exeter Medical School.

"It suggests that previous infections are not protective. It also raises the possibility that vaccinations may not provide the hope that we have been waiting for."

If antibodies don't provide lasting protection, "we will need to revert to a strategy of viral near-elimination in order to return to a normal life", he said.

But others say the new case is likely to be rare. .

"It is to be expected that the virus will naturally mutate over time," said microbiologist Brendan Wren of the London School of Hygiene & Tropical Medicine.

"This is a very rare example of re-infection and it should not negate the global drive to develop COVID-19 vaccines."

The virus has killed over 800,000 people worldwide and there has been an uptick of new infections after many countries lifted lockdown measures.

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Hong Kong man becomes first patient reinfected with COVID-19, say researchers - Euronews

(Reuters) - The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Hong Kong man has first documented COVID-19 reinfection

A 33-year-old man who had recovered from a severe case of COVID-19 in April was infected again four months later in the first documented instance of human reinfection, University of Hong Kong researchers said on Monday. In August, after returning from a trip to Europe, he was diagnosed again - but with a different strain of the virus. While the first infection landed him in the hospital, the second produced no symptoms. Genetically, the first virus was closely related to strains collected in March/April while the second was closely related to strains collected in July/August, the researchers wrote in a report seen by Reuters. "Our findings suggest that SARS-CoV-2 may persist in the global human population as is the case for other common-cold associated human coronaviruses," they said in a statement. "Since the immunity can be short lasting after natural infection, vaccination should also be considered for those with one episode of infection," researchers said. "Patients with previous COVID-19 infection should also comply with epidemiological control measures such as universal masking and social distancing," they added. The report has been accepted for publication in Clinical Infectious Diseases. (bit.ly/34v5Lii; reut.rs/3l823Rv)

Low oxygen in COVID-19 pneumonia linked to vascular widening

Widened small blood vessels in the lungs appear to be linked with the low oxygen levels seen in COVID-19 respiratory failure, a small study suggests. Researchers made the discovery by injecting saline with tiny microbubbles into the veins of 18 critically ill COVID-19 patients and tracked the bubbles using ultrasound. Normally, the bubbles would travel through the heart and enter the lungs, but would not get through the lungs because they would not fit through the capillaries. In more than 80% of these patients, however, the bubbles passed through the lungs and reached the blood vessels of the brain, which means the lung's capillaries were abnormally dilated, researchers reported earlier this month in the American Journal of Respiratory and Critical Care Medicine. The more bubbles that made their way beyond patients' lungs, the lower their oxygen levels, researchers said. This "may explain the disproportionate low oxygen levels seen in many patients with COVID-19 pneumonia," coauthor Dr. Hooman Poor of the Mount Sinai - National Jewish Health Respiratory Institute in New York City told Reuters. Researchers should consider testing drugs that would cause these patients' pulmonary blood vessels to constrict, he suggested. An editorial published in the journal on Friday points out that with dilated pulmonary blood vessels, a higher-than-usual volume of blood flows into the brain, which "raises the question of whether increased neurologic complications of COVID-19 could be related" to the dilation observed by the researchers. (bit.ly/32jSLsZ; bit.ly/3jeHtwL)

Genetic barcodes may help monitor coronavirus mutations

"Genetic barcodes" can help track how the new coronavirus spreads and mutates, researchers said on Saturday in the International Journal of Infectious Diseases. Based on the organization, or sequence, of the genetic code of the virus, the researchers identified 11 distinct SARS-CoV-2 "barcodes" that represent different clades, or lineages, descended from a common viral ancestor. "We were able to assign approximately 94% of the global sequenced genomes to one of the clades," Arnab Pain of King Abdullah University of Science and Technology in Saudi Arabia told Reuters. Different continents have different variations, his team found. The subtle differences in the genetic sequences represented by the barcodes may affect virus infectivity or illness severity, he noted. Most of the genetic profiles available for the study were from North America and Europe, with COVID-19 cases from other regions under-represented. The researchers plan to regularly update the barcodes. "This is a dynamic process, and some virus clades/subclades may eventually die-off in the future, and new clades may form," Pain said. "We will continue to monitor the viral mutations in the global scenario and share our observations with the scientific community." (bit.ly/31mZVNK)

Open tmsnrt.rs/3a5EyDh in an external browser for a Reuters graphic on vaccines and treatments in development.

Reporting by Nancy Lapid; Editing by Bill Berkrot

Original post:
First COVID-19 reinfection case reported; low oxygen levels linked to widening blood vessels in lungs - Reuters

By The Canadian Press on August 24, 2020.

CALGARY Alberta has become the third province in Canada to offer a promising treatment for individuals with specific types of leukemia and lymphoma.

The provincial government, in partnership with the Alberta Cancer Foundation, has earmarked $15 million for the program, commonly known as CAR T-cell therapy.

CAR T-cell therapy genetically reprograms a persons immune cells to attack cancer cells in the body and then after the genetic mutations happen in the laboratory infuse back into the patient, Alberta Health Minister Tyler Shandro said at a news conference in Calgary.

Its provided when conventional treatments are ineffective and the cancer reoccurs.

Alberta will be the third province to offer CAR T-cell therapy, which is also available in Ontario and Quebec.

Shandro said the therapy will be available to about 60 patients a year and the cost is about $400,000 per individual.

He said the funding will be used to conduct a clinical trial with CAR T-cells manufactured in Alberta at three sites: the Cross Cancer Institute, Tom Baker Cancer Clinic and Alberta Childrens Hospital.

The money will also pay for nursing staff, training and education for health-care workers, patient education and psychosocial support, lab and diagnostic imaging, and followup care.

Shandro said the results of the treatment have been positive.

CAR T-cell therapy trials have demonstrated durable remissions and potential cures in about 50 per cent of adults and 80 per cent of children and young adults. We want to provide Albertans with the same recovery opportunities, he said.

Treatment using cells manufactured in the U.S. is expected to begin by wintertime at the Tom Baker Cancer Centre, with the Alberta Childrens Hospital and Cross Cancer Institute to follow.

CAR T-cell therapy is a game-changing treatment that offers some patients their only chance to survive cancer, said Alicia Talarico, president of the Leukemia and Lymphoma Society of Canada.

Martha Kandt, from Lacombe, Alta., said she was given three months to live and sought the treatment in the U.S.

As a family, we decided the risk was worth it, to see if the treatment would work. I recently had a PET scan and I am in remission. Im so pleased this treatment is going to be available to Albertans who need it.

This report by The Canadian Press was first published on Aug. 24, 2020.

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Alberta the third province to offer promising leukemia and lymphoma treatment - Medicine Hat News

Prime editing is the gene-editing method that can insert, delete and do base swapping accurately. Prime editing also termed as genetic word processor precisely select the target DNA and replace genetic code. Targeting 75,000 different mutations and correcting 89% of genetic defects will drive the demand for prime editing. In 2017, the first gene editing in the human body was attempted. Gene editing in a patient with Hunters syndrome was tested for safety and concluded reliable shreds of evidence. Superior target flexibility and editing precision with minimal errors make Prime editing first preference over the other conventional technique such as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). Application of prime editing in reversing Genetic disease will be a milestone in gene editing.

Increasing prevalence of genetic disease creates a huge opportunity for prime editing market. Successful preliminary results with a genetic disease like Tay Sachs and Sickle cell anaemia will drive the prime editing market. Technological advancements providing minimal error with this technique will fuel the growth of prime editing. Decreased cost of DNA sequencing will propel prime editing market for research and commercialization. Arising ethical and safety concerns will make prime editing highly regulated sector. This may limit the scope and can restraint the growing market. Detrimental effect on Genetic diversity due to genetic engineering in one way may limit the market scope.

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The global Prime Editing market is classified on the basis of application and end user:

Based on application, Prime Editing Market is segmented into following:

Based on end user, Prime Editing Market is segmented into following:

Prime Editing is the most recent invention has created a buzz in the market. Firms accessing conventional genome engineering technologies have rolled plans of transitioning to this new technology. The restructuring by the firms is either by building upon the technological capabilities or by merging or acquiring the firms which hold expertise in prime editing. Inscripta, one of the most innovative company has launched the worlds first benchtop platform for digital genome engineering. Inscriptas Onyx device that was launched in October 2019, will enable genome editing at an unprecedented scale and cheaper rate. In 2019, Beam Therapeutics collaborated with a premium start-up in prime editing segment Prime Medicine for Prime Editing Technology. Beam therapeutics holds expertise in precision genetic medicine using base editing technology. The market consolidation activities my giants depict that genome editing will be the largest revenue-generating segment for prime editing market.

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North America will drive the market for Prime Editing due to high prevalence of genetic disease and technological advancement in the U.S. and Canada. One in every 27 Jews, is carrying Tay Sachs disease gene. After North America, Europe is leading in patient pool for genetic diseases such Hemophilia and Cystic fibrosis. The genetic disease pool will drive the adoption for Prime editing treatments in this region. Asia-Pacific will remain at steady growth for Prime Editing market due less disease prevalence and focus on other therapies. Latin America and Middle East and Africa region will boost the market owing to the disease prevalence.

Examples of some of the market participants in Prime Editing market identified across the value chain Beam Therapeutics Inc., Precision BioSciences, Inscripta, Inc, Horizon Discovery Ltd., Sangamo Therapeutics, Inc., CRISPR Therapeutics., Intellia Therapeutics, Inc., and others

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Global Prime Editing Market to Witness Rapid Development During the Period 2020 2030 - Lake Shore Gazette

Most people are familiar with the concept of undergoing general health checks. This might mean that your doctor talks to you about your medical history and lifestyle including diet, physical activity, alcohol intake and smoking history. This is part of providing holistic care to identify and address risk factors to prevent disease. Health checks are also performed as part of national screening programs, such as the national cervical cancer screening program, which aim to detect and treat disease early.

However, a less familiar form is the general or full body health check that not only involves a comprehensive clinical assessment, but also includes performing a whole battery of laboratory, genetic and imaging tests in a person who does not feel ill and has not sought care. General health checks are a common element of health care in some countries and purport to be able to detect disease early, prevent disease from developing, and provide reassurance. In Australia this type of comprehensive full body health check-up may be offered to company executives or directly advertised to the general public, targeting the worried well.

But do these full body check-ups truly deliver on their stated aims and are there any potential downsides?

In the article below, Dr Romi Haas and Professor Rachelle Buchbinder describe how testing asymptomatic people to screen for a range of diseases as part of these types of general health checks can be dangerous. They outline what people need to know before consenting to such checks and suggest improved regulation of public advertising could help in ensuring the judicious and informed use of screening.

This article is published as part of theTOO MUCH of a Good Thingseries, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration betweenWiser HealthcareandCroakey.

To follow the series, bookmarkthis link, and follow#WiserHealthcareon Twitter.

One-page advertorials are appearing in Australian and regional newspapers for something called HealthScreen, with the headline The future of medicine is here now. HealthScreen is a direct-to-consumer service that conducts a variety of assessments that search or screen for signs of disease in people who are not displaying any signs or symptoms (asymptomatic).

These general health checks offered by HealthScreen cost AU$2,000 and include Magnetic Resonance Imaging (MRI) scans for 20 of the most common cancers, coronary heart disease and stroke risk assessments, genetic screening, laboratory tests and sleep health evaluation. The $2,000 cost is not covered by Medicare or private health insurance. It is also only an initial cost: it does not include the associated cost of the inevitable additional tests as well as treatments that will follow for many people.

A quick Google search has revealed that HealthScreen is not alone in offering comprehensive general health checks. In Melbourne alone, similar services are also offered by Epworth HealthCheck, Life First, Mens Health Melbourne and National Institute of Integrative Medicine.

HealthScreens promotions say they aim to identify medical conditions that are likely to reduce life expectancy before the onset of symptoms or any indication of a problem. They promise their clients will know they are doing everything possible to take control of your health and longevity. Framed this way, parting with $2,000 to future-proof your life might sound quite appealing to those who can afford the cost. But can it truly be this easy or is it too good to be true?

This type of screening is highly likely to lead to further tests. This is because screening tests like these are not designed to be diagnostic, but rather to identify people who are at higher risk of developing a disease so they can have further diagnostic testing. Positive screening tests require confirmatory tests to definitively rule in or rule out disease.

In fact, in December 2019, HealthScreen reported that so far the doctors have found hidden problems in every patient.

So what is the evidence that finding hidden problems is beneficial in future-proofing your life?

This is not simply a question of cost. Before consenting to undergo such general health checks, it is important to be fully informed about both the potential benefits and the potential harms of undergoing such a comprehensive check-up.

The best available evidence evaluating the benefits and harms of these types of health checks indicates they are unlikely to be beneficial. A recent update of a Cochrane review included 17 trials, 15 of which reported outcome data from more than 250,000 people in total. As well as a comprehensive clinical assessment, the trials assessed various combinations of blood, urine and lung function tests, electrocardiograms, cancer screening, and vision and hearing assessments.

It found high-certainty evidence that general health checks have little or no effect on either overall mortality or death from cancer, and moderate-certainty evidence that they probably have little or no effect on fatal or non-fatal heart attacks or strokes. General health checks offered by various organisations are therefore not evidence-based; they have not been shown to increase life expectancy.

As well as being unlikely to be beneficial, full body general health checks in asymptomatic people can potentially be harmful. The main harms are overdiagnosis, detrimental psychological effects, negative effects on health behaviours (for example, failure to quit smoking due to reassurance of good health), complications related to follow-up tests, and unnecessary treatments.

No screening test is one hundred percent accurate. There is always a trade-off between sensitivity (correctly identifying when you do have a problem) and specificity (correctly identifying when you dont have a problem). Tests with high sensitivity but low specificity have a higher chance of false positive results (saying you have the disease when you dont).

A positive screening test always requires further confirmatory or diagnostic tests. A false positive result cannot help you because you do not have the disease but it can harm you from unfounded worry and stress. Tests with high specificity but low sensitivity have a higher chance of false negative results (missing people who have the disease). False negative results can provide false reassurance, delay detection of disease, lead to legal action and reduce public confidence in screening programs.

Overdiagnosis is another harm that should be considered when weighing up the potential harms and benefits of full body general health checks. This occurs when a test leads to a diagnosis that would never have caused any symptoms or problems within a persons lifetime.

In cancer testing, for example, this can happen because a tumour may grow so slowly that a person dies of something else before it starts to cause symptoms, a tumour may not grow at all or a tumour may even disappear without treatment. In each of these cases the diagnosis has no direct benefit since no treatment is needed.

However, the diagnosis can cause harm through unnecessary psychological distress, adverse effects associated with unnecessary further testing (overtesting) and unnecessary treatment including surgery (overtreatment), and unnecessary medical costs. A recent study has estimated that in Australia nearly one in five cancers diagnosed in men and one in four cancers diagnosed in women are overdiagnosed cancers.

HealthScreen uses state-of-the-art medical imaging such as MRI and CT scans to look for hidden problems in people. While these types of tests were not evaluated in the trials included in the Cochrane review, paradoxically, the use of such sensitive testing technology has been identified as a major source of overdiagnosis.

Because they are so sensitive, they can detect minute tissue changes that may not ever cause any symptoms. For example, there is evidence to suggest that very small thyroid papillary tumours are being overdiagnosed and overtreated in people who have no symptoms but have been tested for some other reason with a CT scan, MRI scan or ultrasound.

These scans also detect degenerative findings that commonly occur with age. For example, degenerative changes in the low back, knee and shoulder are seen with ageing in people with and without symptoms, and are mostly benign. If full body checks find these changes in people without symptoms, it can lead to unwarranted diagnoses, cause worry and lead to unnecessary treatment.

There is also concern that screening the genes of healthy people may cause a whole new wave of unnecessary diagnoses. This is because genetic testing is often unable to determine if a person will show symptoms or whether the condition will progress over time.

One example of harm that may arise from full body general health checks is treating high levels of uric acid detected in the blood in people without symptoms. While allopurinol is the mainstay of treatment for gout (a form of arthritis causing painful joints), prescribing this treatment solely on the basis of a high uric acid is not recommended.

In a large population-based study, people taking allopurinol were 10 times more likely to end up in hospital because of a severe skin reaction than in those who did not take allopurinol. And two out of every 10,000 of these people died from the reaction.

It seems HealthScreen is not alone in advertising the benefits of their services without adequate consideration of the potential harms.

A recent project by Professor Ken Harvey at the Monash University School of Public Health and Preventive Medicine known as the whack-a-mole project has resulted in a considerable number of individual complaints against claims made about therapeutic goods and services being upheld. This means that the manufacturer or service provider had made claims for a product or service which were not supported by evidence.

Greater regulation of direct-to-the-public advertising for whole body health checks in Australia may be needed. At the very least, companies such as HealthScreen should ensure their advertising includes outline of the potential harms as well as the potential benefits of participating in their services.

Healthscreens Medical Director, Dr David Badov, was invited to address the concerns laid out in this article. His response can be found here.

Dr Romi Haas is a Postdoctoral Research Fellow at the Monash Department of Clinical Epidemiology, Cabrini Institute, part of the Monash University Department of Epidemiology and Preventive Medicine. Her research focuses on understanding and developing ways to reduce overdiagnosis and overtreatment of musculoskeletal conditions.

Prof Rachelle Buchbinder AO is an Australian NHMRC Senior Principal Research Fellow and Director of the Monash Department of Clinical Epidemiology at Cabrini Institute and Monash University. She is a rheumatologist and clinical epidemiologist who combines clinical practice with research in a wide range of multidisciplinary projects relating to arthritis and musculoskeletal conditions.

This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare andCroakey.org.

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

Bookmark this link and follow #WiserHealthcare on Twitter.

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Weighing up the potential benefits and harms of comprehensive full body health checks - Croakey

By Priyanka Sharma

New Delhi: In a first in India, the country's top medical research body is working to create an Indian Council of Medical Research (ICMR) vaccine portal, as a repository for all information related to vaccine development in India. The ICMR vaccine portal would be made public by the next week.

In the first stage, the ICMR vaccine portal will reflect the information on COVID-19 vaccine in India. However, with time, the web portal will be strengthened with data available for all the vaccines used to prevent various diseases.

"The Central government along with the ICMR is making all best efforts to combat coronavirus pandemic. Wearing masks, hand-hygiene and social distancing are preventive measures but at the same time vaccine development is another important aspect which will be updated on the ICMR vaccine portal," said Dr Panda.

The scientist added that the ICMR vaccine portal will be made public by the next week.

It may be noted that three COVID vaccine candidates are in India which are in different phases of the clinical study.

The first is--inactivated virus vaccine, which is the 'Bharat Biotech Vaccine', being developed in collaboration with Indian Council of Medical Research (ICMR).

Similarly, the second is a 'DNA vaccine' of pharma giant called Zydus Cadila.

According to the scientist, the ICMR vaccine portal will have sections like-COVID-19 vaccine, India's initiative, International Symposium and FAQ for the general public (which would be presented in regional language).

The vaccine portal will also fetch the information related to COVID-19 vaccine from the World Health Organisation (WHO) as available on their website.

So far, India has reported 29,75,702 coronavirus cases with 55,794 people died due to the infection. In the last 24 hours, the country has seen 69,878 cases and 945 deaths as per the Union Health Ministry data.

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Soon, India will have its dedicated vaccine portal: ICMR - ETHealthworld.com

The researchers wanted to turn those awakened stem cells into cartilage. The recipe that worked was to treat the stem cells with bone morphogenetic protein, which is used to help fuse bones.

The scientists also used a drug called Avastin, which prevents the stem cells from getting a blood supply. Unlike bone and bone marrow, cartilage has no blood supply, and the drug helped stimulate the stem cells to turn into cartilage.

The investigators provided the drugs directly to the ends of bones, putting them in a gel.

The cartilage that grew in the mice not only looked like normal but lasted for four months, a quarter of the animals lifetimes. Dr. Chan and Dr. Longaker envision a time when doctors will be able to resurface arthritic joints or, even better, to treat people who are just beginning to develop arthritis, perhaps staving off the sort of damage that even joint replacements cannot fix.

If the strategy works in humans, then early treatment may be the best approach, Dr. Marx said.

Arthritis deforms joints and changes bones, he said. By the time people have hips or knees replaced, irreversible damage may be done. Legs may be bowed, bones damaged.

You cannot totally turn back the clock, Dr. Marx said. At that point, he said, adding cartilage will not fix it.

He worries, though, that orthopedists may not wait for rigorous studies the method of awakening the dormant cells is relatively simple, and the drugs required are already on the market.

Faced with a patient with aching knees, orthopedists may be tempted to say, Lets try this. You dont have much to lose, Dr. Marx noted.

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Cartilage Is Grown in the Arthritic Joints of Mice - The New York Times

Treat-to-target and safe tapering strategies should continue to be essential in the management of rheumatoid arthritis (RA) during the coronavirus disease 2019 (COVID-19) pandemic, according to a commentary published in Lancet Rheumatology.

The National Institute for Health and Care Excellence COVID-19 guidelines suggested that face-to-face patient consultations should be avoided, unless patients present with a disease flare; patients with stable disease should be treated remotely. However, the definition of stable disease may be misguided, the authors of the commentary noted. Even amid the pandemic, treat-to-target strategies should be preserved to maximize the number of patients achieving remission.

Treat-to-target refers to arthritis management that prioritizes low disease activity or remission. With treat-to-target, patients set specific management targets and undergo frequent laboratory tests and clinical examinations. If disease targets are not met, different treatment strategies are adopted. Research has suggested that up to 50% of patients can achieve remission through treat-to-target.

While focused efforts may be taken to mitigate COVID-19 risk, rheumatologists should prioritize treat-to-target for their patients. Although patients with minimal disease activity or remission may be good candidates for remote management, patients who have yet to reach their treatment goals should be considered for clinic visits.

Patients undergoing dose tapering may also require clinic visits, the authors added. Clinical examination of the joints is often necessary to detect flares. In addition, in the context of the pandemic, some patients may be self-tapering because of fears of their drugs increasing the risk for COVID-19. While early observational data has suggested that disease-modifying antirheumatic drugs do not increase risk for COVID-19, research is still ongoing. Clinicians should make every effort to monitor patients who are tapering and minimize the risk for disease flares.

Ideally, development of one-stop shop clinics may be the best way to manage RA while minimizing hospital contact. While efforts to maintain physical distancing are essential, patients with RA should not have to endure disease flares as a result.

Treat-to-target and safe tapering strategies should continue to be essential in the management of rheumatoid arthritis, regardless of new approaches that streamline the patient experience and reduce the number of hospital visits, the authors concluded.

Yeoh SA, Ehrenstein MR. Are treat-to-target and dose tapering strategies for rheumatoid arthritis possible during the COVID-19 pandemic? Lancet Rheumatol. 2020;2(8):e454-e456.

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Maintaining Treat-to-Target Strategies for Rheumatoid Arthritis During the COVID-19 Pandemic - Rheumatology Advisor

Arthritis pain can lead to a number of debilitating symptoms that patients will want to try and avoid.

The condition can make life more difficult when carrying out simply, everyday tasks.

It's crucial that if you develop signs of arthritis, you speak to a doctor as soon as possible to try and find a treatment to relieve your pain.

One of the best ways to avoid arthritis pain is to eat more broccoli, it's been claimed.

READ MORE: Arthritis pain - common household sauce you should avoid

"Although there is no diet cure for arthritis, certain foods have been shown to fight inflammation, strengthen bones and boost the immune system," said the Arthritis Foundation of Asia.

"Adding these foods to your balanced diet may help ease the symptoms of your arthritis.

"Rich in vitamins K and C, broccoli also contains a compound called sulforaphane, which researchers have found could help prevent or slow the progression of osteoarthritis.

"Broccoli is also rich in calcium, which is known for its bone-building benefits."

You could also lower your risk of arthritis by eating more red beans, added the Arthritis Foundation.

They could lower your chances of arthritis symptoms as they're rich in fibre.

Fibre is a crucial nutrient that helps to lower the amount of C-reactive proteins in the body.

These proteins are a marker of inflammation, which have been linked to heart disease, diabetes, and even rheumatoid arthritis.

Common arthritis symptoms include joint pain, inflammation, and restricted movement.

There are two key types of arthritis in the UK; osteoarthritis and rheumatoid arthritis.

Osteoarthritis is the most common type of arthritis to be diagnosed in the UK - around nine million people are believed to have osteoarthritis.

Rheumatoid arthritis, meanwhile, is an auto-immune disease that has been diagnosed in about 400,000 individuals.

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Arthritis pain - the best vegetable to lower your risk of joint pain and inflammation - Express

The incidence and prevalence of rheumatoid arthritis (RA), the most common autoimmune inflammatory arthritis, is increasing worldwide; in 2014, RA affected an estimated 1.28 to 1.36 million adults.1 A growing body of research has indicated that compared with patients without RA, those with RA are disproportionately affected by psychiatric disorders, particularly anxiety and depression.2,3 Psychiatric disorders in patients with RA not only affect functioning and quality of life, but they have been associated with poorer RA outcomes, including a greater frequency of flares, lower odds of achieving remission, and increased mortality.4

Psychiatric comorbidities in RA lead to higher rates of healthcare utilization. In a retrospective cohort study by Carol Hitchon, MD MSc, clinician scientist at the University of Manitoba in Winnipeg, Canada, and colleagues,5 an analysis of health records of 12,984 patients with RA and 64,510 matched control participants for the period between 2006 and 2016 showed that patients with RA with vs without comorbid psychiatric disorders (depression, anxiety, bipolar disorder, or schizophrenia) received more types of medications, had more ambulatory physician visits and hospitalizations, and greater length of hospital stays. Investigators concluded that managing psychiatric comorbidities effectively may reduce utilization among patients with RA.

We spoke with Dr Hitchon who suggested that the presence of psychiatric disorders can complicate treatment decisions and subsequent outcomes. We know that psychiatric comorbidity [affects] how people experience pain and this may or may not be associated with joint inflammation, she added. This type of pain may be treated differently than if the pain is due to joint inflammation. Psychiatric disorders can also complicate the assessment of RA activity, since low mood or depression can influence the patient-reported components of standardized instruments such as disease activity score in 28 joints.6

Depression, the most common psychiatric comorbidity of RA, has been estimated to occur in 9.5% to 41.5% of patients with RA.2,7 A recent meta-analysis concluded that 16.8% of patients with RA had comorbid major depressive disorder (MDD), based on pooled estimates from studies that identified depression with psychiatric interviews, the gold standard for diagnosis.7 The reasons for the prevalence of depression in patients with RA typically include the adverse effects that chronic pain, fatigue, and functional limitations have on social roles and quality of life.4

We also spoke with Melissa Withers, PhD, MHS of the USC Institute on Inequalities in Global Health at the University of Southern California Keck School of Medicine, who noted that the pain and limitations associated with RA can negatively affect many aspects of patients lives. They may not be able to participate in the things that used to bring them joy, like hobbies, social interactions, or a job. Patients are especially at risk for depression and anxiety when they are first diagnosed with RA. You can imagine they hear that they are facing a debilitating, degenerative, long-term illness. So it can be very upsetting. It brings a lot of fear of what their futures will be like.

Shared inflammatory pathways are also widely believed play a role in the frequent co-occurrence of depression and RA. Studies have shown that proinflammatory cytokines implicated in RA, such as tumor necrosis factor (TNF) , interleukin (IL)-6 and IL-1, are overexpressed in patients with depression compared with healthy control participants.4 In addition to causing chronic joint inflammation and damage to the cartilage and bone, excessive levels of these cytokines may contribute to depression by having detrimental effects on neuroendocrine function, neurotransmitter metabolism, and brain structures. Increased serum and/or plasma concentrations of C-reactive protein, often seen in RA populations, are also present in patients with depression or anxiety.6

An analysis of audio recordings taken at patient visits for RA showed that rheumatologists rarely brought up the topic of depression, even among patients whose depressive symptoms were moderate to severe.8 Dr Withers recommended that rheumatologists incorporate depression identification and management into patient care plans, especially since patients may not know that a rheumatology visit is an appropriate time to bring up mental health issues. It is critical to screen patients regularly for depression and other disorders and to follow those with scores that suggest mild depression to determine if the depression worsens over time, she said. If the patient scores indicate depression or a psychiatric disorder, the rheumatologist can then refer them for consultation with a mental health professional.

Lekeisha Sumner, PhD, ABPP, a licensed clinical psychologist with a board certification in clinical health psychology and author of several papers on the psychosocial aspects of rheumatologic diseases, stated that depression and anxiety are grossly underdiagnosed and treated in rheumatologic diseases despite their high prevalence. The provider-patient relationship is key in health outcomes and especially important when discussing sensitive topics that have historically been stigmatized, she advised. Leveraging rapport with your patient to ask about how their emotional strain presents at each visit invites them to give voice to the often-silent suffering that they commonly experience. Keep in mind that some of your patients will likely have alexithymia, which not only complicates their recovery but makes it more difficult for them to identify and process their emotions. Dr Sumner recommended that rheumatologists use simple screening tools such as the Generalized Anxiety Disorder and Patient Health Questionnaire to assess mental health.

Conceptualizing symptoms of anxiety and depression as par for the course in RA conditions is ill-advised as they contribute to increased burden on the patient, diminishes overall functioning, increased pain sensitivity, affects long-term disease activity, remission, response to treatment, and quality of life, Dr Sumner noted. Recognize that your patient has likely experienced difficulties with sexual functioning, ability to earn a living and engage in daily activities with ease, resulting in shifts in identity and confidence to effectively self-manage their condition. Targeting immunologic alterations will help alleviate psychiatric distress, along with using a multidisciplinary approach to care that includes mental health professions are all key to disease management and promoting adaptive adjustment and coping.

The rest is here:
An Overview of Psychiatric Comorbidities in Rheumatoid Arthritis - Rheumatology Advisor