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Archive for April, 2020

A difficult road on this Easter – News-Press Now

Sunday, April 12th, 2020

One assumes that Easter Sunday included an element of risk in the days of Agatha of Sicily.

Agatha was born about 80 years before the Battle of Milvian Bridge, an event that marked the beginning of Constantines acceptance of Christianity in the Roman Empire.

She lived during a time of persecution. Noted for her great beauty, Agatha suffered imprisonment in a brothel, torture and death for her devotion to God and her refusal to renounce a commitment to sexual abstinence.

In our modern world, with modern conveniences and freedoms, its easy to forget how much Christians have suffered for their faith, how things havent always come easily. Agatha had the Roman establishment to worry about, and her contemporaries in Nigeria have Boko Haram.

Its no secret that people of other faiths suffer unjustified persecution, sometimes at the hands of Christians. Its also true that a virus doesnt discriminate and cant be equated with systematic targeting of those who profess a particular creed.

But on this day, its worth noting that this is an Easter Sunday like no other. St. Joseph experienced martial law during the Civil War and shared in national deprivations during World War II, yet the churches remained open as places of community and prayer.

Not so today, because of a virus that requires limits on public gatherings, so as to protect the health of those who would much rather be shoulder-to-shoulder inside a church. For all the talk of golf courses, restaurants and economic consequences, this is surely one of the most difficult sacrifices in our city and nation.

In other cities, some talked of risking their lives to attend Easter services. While the sentiment is understandable, the potential risk to others would seem to negate the message on this day.

At home today, a believer might feel a certain kinship to the two disciples who failed to immediately recognize the risen Christ on the Road to Emmaus. Luke fails to name one of them, a skillful literary device that allowed generations of readers to relate to this unknown disciples blindness.

Today, just like on the Road to Emmaus on the first Easter, what you seek is there, but it is harder to find while you watch services on a computer. Tomorrow, the focus turns back to science, where legions of doctors, nurses and other health professionals labor amid great personal danger to save patients and rid our communities of this virus.

Instead of complaining, take a moment on Easter Sunday to thank these selfless health workers for the dedication and sacrifice that will allow us to once again travel, shop, study and worship when and where we want.

After all, Agatha of Sicily is a patron saint of nurses.

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A difficult road on this Easter - News-Press Now

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‘What It’s Like To Have Usher Syndrome And Become Blind And Deaf’ – Women’s Health

Sunday, April 12th, 2020

My younger brother, Tyler, and I were both born with a moderately severe hearing loss. Without hearing aids, I can only hear high-intensity sounds like lawn mowers and car horns, and I cant make out conversation-level sounds unless people are super close to me.

Fortunately, after my diagnosis when I was young, I was fitted with hearing aids, which gave me close to normal hearing. My quality of life significantly improved, but living with a hearing impairment still came with plenty of challenges. My hearing aids would short out if they got even a little bit wet (even from sweat), and it was hard to accurately listen and stay engaged in group conversations.

Despite these obstacles, I always took great comfort in knowing my hearing aids would be enough to guide me through life. And I always had my vision, I thought at the time. That all changed during the spring of my sophomore year of high school, in 2010.

At first, I didnt think much of it, but I still remember the moment I realized something was seriously wrong. It was around 9:30 p.m. on a school night, and I was out with the girls on my tennis team. Carrying out a local tradition, we were sneaking across my hometown to the houses of some players on the boys tennis team in order to toilet paper their yards in celebration of the next days match.

One of the last houses we headed to was in a more rural part of town. We were crouched down in the bushes outside the house, about to throw some paper, when we suddenly heard the front door open. Immediately, my teammates got up and started sprinting. I turned to follow, but amidst the pine trees and bushes, I could barely see what was in front of me. Thankfully, one of my teammates ran back to grab me, and I simply pretended I had stopped to tie my shoe.

That was the first time I realized that my eyes didn't seem to adjust well to the darkness of the night. After that, I started to become more aware, noticing that my eyes didn't even adjust to the diminished light as the sun began to set. The breaking point for me, finally, was when it occurred to me that I hadnt seen the stars in a really long time. The next clear night, I went outside and sure enough, I could no longer see the stars at all.

As most people do when somethings wrong with their health, I Googled every terrifying explanation for why I couldnt see at night. After several different eye doctor appointments, my parents eventually brought me to Massachusetts Eye & Ear in Boston to get checked out.

Usher syndrome is a rare genetic condition that causes combined and progressive deafness and blindness. And shortly after my diagnosis, my 15-year-old brother Tyler received the same one via genetic testing, but he had yet to experience any symptoms of vision loss.

Our diagnosis came as a complete shock to my family. Wed never heard of Usher syndrome. Around the world, only about three to 10 in 100,000 people have this disease, according to the National Organization for Rare Disorders (NORD).

Usher syndrome is rooted in a genetic mutation that causes retinitis pigmentosa (RP), a disease that progressively destroys the cells in your eyes retina, and interferes with the development of crucial sound receptor cells in your inner ear. There are three clinical types of Usher syndrome, which are defined by the severity of the symptoms as well as the age in which the person starts experiencing hearing and vision loss. Since my brother and I have Usher syndrome type 2, the doctors dont know if we will go completely deaf, but it is certain that we will continue to lose our vision until there is nothing left.

Even though I had just found out I would eventually go blind and potentially deaf, I still had time to do something about it, time to live my life as fully as I could during the years that I still had my daytime vision.

Today, eight years after my diagnosis, my hearing loss remains moderately severe. Unlike with Usher syndrome types 1 and 3, which always lead to profound or total deafness, the doctors still dont know if or when my hearing could start to worsen with type 2. Its a little unnerving, to say the least.

My night vision, on the other hand, has significantly deteriorated. I can no longer drive at night, so every day I look up the sunset time in order to schedule my activities accordingly. In the last eight years, Ive had to rely heavily on friends, family, and, if I have spare money, ride-sharing apps. In the evening, Im always fumbling around my apartment in order to locate things like my phone, the light switch, or the doorway.

During the day, I also cant see in any dimly lit environments, like restaurants with low lighting, many bars (clubs are an automatic no for me now), movie theaters, and even airplanes when the shades are lowered.

The vision loss component of Usher syndrome begins with night blindness, followed by a narrowing of the visual field into tunnel vision. The final stage is total blindness. These days, I have a few blind spots during the day, most noticeably in my peripheries. This means my visual field is narrowing and moving in the direction of tunnel vision.

As my vision continues to deteriorate, I understand that the challenges I face on a daily basis will only increase. Not only am I continuing to learn how to deal with my disabilities, as they impact all areas of my life, but I'm also figuring out how to mitigate the emotional weight they hold. Its been particularly difficult not knowing how quickly my vision will disappear.

Doctors cant tell me exactly when I won't be able to see at all, but the general guidance from the medical community is that those with my type of Usher syndrome will have very little vision left in their 30s and 40s. However, I know several members of the Usher syndrome community that fall outside of this parameter. Some lose their vision sooner, while others get a few extra years. Regardless, I will likely lose most of my vision over the next five, 10, maybe 15 years. A silver lining: My vision wont be completely gone in a matter of months or anything.

Knowing there is presently no cure for Usher syndrome is another emotional burden. Ive had to learn how to tell both old and new friends what was happening to me. But to this day, many people in my life still dont know. I haven't mastered how to start that difficult conversation.

When Im not working as a marketing manager and pursuing my MBA at Vanderbilt University, I spend at least 30 minutes every day, if not more, researching all of the places I want to go and planning overly detailed itineraries.

In early 2016, I went to Iceland on a mission to see the northern lights. I spent four hours searching for the lights, unsure if my vision had deteriorated so much that it was too late for me to see them. I broke down crying when I finally saw the lights dancing across the sky just outside of Reykjavik.

The next November, I ventured off to Asia for the first time to experience one of my other most incredible visual memories to date: the annual festival of Yi Peng. In Chiang Mai, the largest city in northern Thailand, I watched as thousands upon thousands of lanterns were simultaneously released into the night sky in order to let go of misfortunes and make wishes for the new year. Witnessing this was indescribably beautiful and emotional as I released my greatest wish that one day a cure would be found for Usher syndrome.

From trekking across Europe to checking Bali, Indonesia, off of my bucket list, Im grateful for the motivation Usher syndrome has given me to live my life in the moment. I recently started a travel blog, Wanderlight Moments, to share my experiences and hopefully inspire others to also travel the world, despite lifes unexpected challenges. Whether its Usher syndrome or something entirely different, life is full of struggles that we all face every single day. We are not alone in our adversity.

At first, I didnt hide from the news, despite the extra anxiety it provoked. I saw the footage of what was going on in the frontlines at the hospitals. I saw the first responders, grocery store employees, gas station attendants, construction personnel, delivery drivers, and businesses struggling to stay safe, help one another, and survive.

Im one of the millions of people staying at home to do their part. I see the economic devastation produced by this virus. Putting food on the table and paying this months rent is a luxury. Emotionally, Im having a hard time holding up these days, and I'd be lying if I said otherwise. But my inability to travel for a year of my life in which I still have my eyesight is a pain I just have to get over. In the midst of everything happening, sometimes I tell myself: My individual situation doesnt matter.

All of that being said, one of my mentors has also reminded me that it is okay to give myself permission to grieve my own loss in the midst of novel coronavirus. Ive lost something that was such a core part of who I am and the primary way that I cope with this terrible disease I have. Valuable time in which I still have my vision will be spent in self-quarantine, and I have to come to terms with that.

Embracing the grief process has also allowed me to find strength in developing a new approach for 2020 and onward. Even though I cannot physically travel, I am now spending my extra free time planning future trips, possibly for 2021 and 2022. Im finding joy envisioning myself in bucket-list destinations, like the Galapagos and New Zealand, as I draft detailed itineraries that, even if not followed exactly, will save me significant time later on. I also started digging into my old trip archives in order to document my previous travels on my blog and better preserve those visual memories, too.

For so long I was focused on creating visual memories around the world that I neglected the value in forming visual memories at home. Recently, my siblings and I moved back in with my parents, so I am cherishing every moment I have to spend time with loved ones and see their faces. Deep down, Im beginning to fear the day in which I will no longer see the faces of those I love.

When I look back on 2020, I dont want it to be a year just spent in quarantine. I dont want it to be a year in which I wasted precious time with my vision. No matter where I am in the world, I will make the most of the eyesight I have left. I know that one day I will get to travel again. In the meantime, I will create new visual memories right here at home, with family.

As I look into the future and picture my life with Usher syndrome, there are so many unknowns. I know it wont always be easy, but I am determined to never let this disease hold me back from traveling and living my life. Above all else, I am deeply committed to raising awareness of Usher syndrome. I hope one day we will find a cure.

If youd like to learn more about Usher syndrome, treatments, and research, please visit the Usher Syndrome Society website.

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'What It's Like To Have Usher Syndrome And Become Blind And Deaf' - Women's Health

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NICARAGUANicaragua News and AnalysisThe exported cases of covid-19 to Cuba reveal epidemiological blindness in Nicaragua – Nicaragua News

Sunday, April 12th, 2020

In the last 15 days, the Cuban Ministry of Public Health (Minsap) confirmed the spread of covid-19 in three Cubans who presented symptoms after returning from Nicaragua. This could reveal an epidemiological blindness on the part of Nicaraguas Ministry of Health (Minsa) since up to now the State has not recognized them, nor has it announced to investigate them.

You argue one case. Two cases even, but already three cases, and from a sister nation, leaves you in no doubt. Cuba is a strategic military and political ally of the (Nicaragua) Government and they are the first to sell us out, said epidemiologist lvaro Ramrez.

The first case exported from Nicaragua to Cuba was confirmed on March 27, 2020. It was a 54-year-old woman who arrived on the island on March 16 and 10 days later presented symptoms.

Regarding this case, Nicaraguas newly appointed Minister of Health, Martha Reyes, assured that it could be a confusion.

I believe that they (the Cubans) are reviewing it because in our case the information we had is that she left on the 16th and the first case that we have reported was on the 18th, Reyes said when questioned in an interview with Channel 10.

The second case was on April 3, that of a 38-year-old woman, who returned to Cuba on March 23 and began to manifest symptoms on March 31.

The third case was on April 7, but the day the man returned to Cuba from Nicaragua is yet unknown.

According to epidemiologist, Leonel Argello, each of the cases would have to be analyzed to confirm that they were actually infected in Nicaragua since the virus was present in both countries.

Then, it would be necessary to identify whether these Cubans were detained in quarantine upon arrival on the island, because otherwise there is the possibility that they could become infected there, added Argellot.

If you have a case of a person who has been in both places, it is more comfortable for you to accept that it is community (infection) and start taking measures. A well-prepared hospital can decrease mortality. A well-prepared population can decrease the number of infections. Prevention measures should be taken without cases, during cases and after cases. There is no scientific argument that prevents you from starting a very strong information campaign, insisted the expert.

The rate of infection by the new coronavirus has three stages: Imported, non-imported cases and community cases, at this point the virus is already in part of the population and is transmitted from person to person in public spaces.

In Nicaragua, according to the Government, no community cases have been reported. But it is unknown what the data is based on to affirm it.

In epidemiology you can only say that there is no community transmission when the tests have been done and there is sufficient evidence that there is no virus on the streets. Otherwise, everything is a fantasy , explained Dr. Ramrez.

These tests should be done on a sample of the population in different sectors of the country and if the tests are negative, it could be affirmed with certainty that there are no community cases.

So far, the tests that Nicaragua has done are only in people suspected of covid-19.

All the countries in the region have shown progressive growth and are now starting with exponential growth. Nicaragua included. Not to investigate is epidemiological blindness. Not look to not find. And while they do not show the quantified evidence, the numbers of how many tests have been done, how they have been done, what type of tests they are using, it cannot be said that there is no community transmission, added the epidemiologist.

On Monday, the Ortega regime received a shipment of 26,000 rapid tests to detect covid-19. This was a donation from the Central American Bank for Economic Integration (CABEI), financed with funds from a Regional Contingency Plan, agreed by the presidents and heads of state of the Central American Integration System (SICA).

However, it is unknown when and how the tests will be carried out. As well as the data of how many tests have been done throughout the country to rule out coronavirus cases.

For his part, epidemiologist, Leonel Arguello, pointed out that the important thing is to start a strong prevention campaign to combat this pandemic.

Actually, I look ridiculous to be saying that it is imported or community-based because strong prevention measures must be taken now; you dont have to have community cases to start a strong prevention campaign, he points out.

Read the original article in Spanish at Confidencial.com.ni.

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NICARAGUANicaragua News and AnalysisThe exported cases of covid-19 to Cuba reveal epidemiological blindness in Nicaragua - Nicaragua News

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Loss of taste, smell ‘early symptom of infection’ – Bangkok Post

Sunday, April 12th, 2020

A medical official is collecting a sample from a taxi driver for a Covid-19 test in Samut Prakan province last week. (Photo: Somchai Poomlard)

A group of surgeons has urged doctors to pay special attention to signs of 'smell blindness', which affects many Covid-19 patients at the onset of the symptoms.

Two-thirds of the patients infected with the new coronavirus experience this specific condition, said Prof Dr Saowarot Phattharaphakdi, chairwoman of the Royal College of Otolaryngologists (Head and Neck Surgeons) of Thailand.

More and more studies have found a link between Covid-19 infections and anosmia - smell blindness, she said.

Anosmia was found to be more common in patients with mild symptoms of Covid-19, she said, adding that the rate of anosmia in this group is as high as 30%.

The college is urging doctors to look for loss of taste and smell in the patients they treat.

The first known Covid-19 infected patient who also experienced anosmia in Thailand was a person in Sakhon Nakhon who had returned from Phuket where she worked, said Prof Dr Saowarot.

Also, a 22-year-old woman in Prachin Buri who was recorded as the province's fifth Covid-19 case said she also temporarilylost her sense of smell.

She said she had dined out on March 21 with friends and two days later was surprised to find herself unable to smell anything or taste food.

She thought she had an allergy until March 26 when she learned the one of her friends had the virus.

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Link between Covid-19 infections and smell blindness – The Thaiger

Sunday, April 12th, 2020

Deaths from the Covid-19 coronavirus in the US topped 20,000 yesterday (20,577 to be precise), surpassing Italy, previously the worlds hardest-hit country. It was a grim start to the Easter holiday weekend on which US President Donald Trump had earlier hoped to reopen the country. With the report of 1,863 new deaths nationally yesterday, the US has reached two grim milestones all 50 states are now in a state of emergency, and the US outbreak is the deadliest in the world.

Italy has still lost more people per capita: with a population of 60 million, roughly 31 of every 100,000 people there have been killed by the virus. In the US that ratio is 5. If the US death toll were to match the ratio in Italy, more than 100,000 Americans would die.

But after two months of extreme social distancing and devastating losses, Italys crisis seems to be gradually subsiding; the daily number of new cases has fallen by almost half since the peak in late March. The US is still on an upward trajectory of its pandemic curve, with the number of new cases increasing nearly every day.

Estimates on how many people will end up dying in the US have fluctuated in recent weeks as new data continues to pour in from various attempts at mathematical modelling. A leading projection model from the University of Washington has forecast about 60,000 deaths, far fewer than the 100,000 to 240,000 deaths that were projected in a White House press release less than 2 weeks ago. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, had this to say

The real data are telling us that it is highly likely that were having a definite positive effect by these mitigation things that were doing, this physical separation, so I believe we are gonna see a downturn in that. And it looks more like the 60,000 than the 100,000 to 200,000.

As Americans desperately seek assurance that the country has a path out of its crisis, the official response has been fractured and uncertain.

In his daily briefings and private calls with officials, US President Trump has sought a strategy for resuming business activity by the end of April. But leaders in states with some of the biggest outbreaks caution against actions that they say could lead to another spike in cases and prolonging the crisis.

In an interview on Friday night, Fauci said he hoped the nation would find a real degree of normality by November.

The US is still stepping up its response to the virus, albeit delayed by politics and states vs federal frictions. The Pentagon announced yesterday it will invest 133 million dollars to increase domestic production of N95 masks needed by health-care workers on the front lines of fighting the virus.

Across the country, Americans braced for the unthinkable: empty churches, silent ballparks, students struggling to learn over a Zoom connection, families without food, doctors desperate for protective equipment and an ever-growing list of the dead.

In an interview, Rev Timothy Cole, a priest at Christ Church in Washingtons Georgetown district, who was the districts first known Covid-19 patient, said this moment feels more like the darkness of Good Friday, when Christians believe Jesus died on the cross, than the rebirth celebrated by Easter Sunday.

SOURCES: USA Today

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Link between Covid-19 infections and smell blindness - The Thaiger

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Did Sandra Oh win at the 2019 Emmys, will she be in Killing Eve season 3 and is she married? – The Scottish Sun

Sunday, April 12th, 2020

SANDRA Oh has been bagging awards left, right and centre for her role as Eve Polastri in the incredibly successful Killing Eve series.

But was the former Grey's Anatomy actress able to beat out her co-star Jodie Comer for the Outstanding Lead Actress gong at the 2019 Emmy Awards? And what else has she starred in? We have all the details below.

4

Sadly for Sandra, she did not win the Outstanding Lead Actress in a Drama series at the 2019 Emmys.

But we're sure she didn't feel too bad about it because the gong went to her co-star and friend Jodie Comer.

The British actress was given the honour for her thrilling performance as everyone's favourite assassin, Villanelle.

The win was even more sweet for Jodie because it was her first time being nominated in the American awards show.

4

Sandra will be making a comeback on season 4 of Killing Eve as the titular character.

The entire season 4 will drop on BBC iPlayer tomorrow, Monday, 13 April, 2020 at 6am.

Fans are excited to see Eve Polastri chase the elusive Villanelle for yet another season.

Sandra, 48, was born on July 20, 1971, and is a Canadian actress.

Born to Korean immigrant parents, she was one of three children.

She rejected a four-year journalism scholarship at the Carleton University to study drama at the National Theatre School of Canada.

Sandra promised her parents that she would try her hand at acting for a few years and if it all failed she would return to university.

4

Sandra is best known for her role as Dr. Cristina Yang on Grey's Anatomy.

Her role on the medical drama won her a Golden Globe Award, two Screen Actors Guild Awards, andfive Emmy nominations.

However, that's not all as her credits as an actress are countless.

She also starred in the BBC America dramaKilling Eveas the MI5 agent Eve Polastri.

Sandra received an Emmy 2018 nomination within the Lead Actress in a Drama Series category for her work in Killing Eve and is up for a Golden Globe.

Her movie credits include The Princess Diaries (2001), Blindness (2008) and Rabbit Hole (2010).

In 2019, the actresshosted the Golden Globe awardsas the first host of Asian descent alongside Andy Samberg.

Apart from hosting it, she also accepted the award for Best Actress in a TV Drama for her part in Killing Eve.

This, together with her Golden Globe for Grey's Anatomy, made her the first woman of Asian descent to have multiple Golden Globes.

While many fans hope that Sandra might one day reprise her role as Christina, the actress has confirmed she won't be returning to the show for a cameo.

She made the revelation at the Killing Eve season 2 premiere in Hollywood.

The actress to Extra: "You know, I gotta tell you, you guys keep on asking me that question.

"I just got to tell you, creatively you have moved on and while I know, and I deeply appreciate it, because I feel it from the fans how much they love Cristina and that the show also still keeps Cristina alive, for me, [Killing Eve] is my home now."

She continued: "This is w here I am. I am Eve and that's where I plan to stay as long as the show will have me. And that's really where I want to be."

4

Sandra dated filmmaker Alexander Payne for five years before making it official.

The pair tied the knot on January 1, 2003.

However, following their separation in 2005, Sandra and Alexander officially divorced in late 2006.

The actress is now datingLev Rukhin.

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Sandra is worth $25 million, according to Celebrity Net Worth.

That equates to around 19.6 million.

Her wealth is downto the countless successful movies and television series she's been in.

Most notable of these are Grey's Anatomy, Arli$$, Blindness, and Killing Eve.

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Did Sandra Oh win at the 2019 Emmys, will she be in Killing Eve season 3 and is she married? - The Scottish Sun

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(2020-2025) Peripheral Neuropathy Treatment Market Estimated To Experience A Hike in Growth | Global Industry Size, Growth, Segments, Revenue,…

Sunday, April 12th, 2020

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(2020-2025) Peripheral Neuropathy Treatment Market Estimated To Experience A Hike in Growth | Global Industry Size, Growth, Segments, Revenue,...

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Sensory loss can lead to isolation and depression – Thehour.com

Sunday, April 12th, 2020

Sensory loss can lead to isolation and depression

DOTHAN, Ala. (AP) Caring for a 101-year-old man whos deaf and almost totally blind takes patience and understanding.

Its the kind of work Nancy Griffin finds rewarding.

As one of the caregivers with Wiregrass Area Home Instead Senior Care looking after the man and his wife, Griffin sees the challenges people with sensory loss face.

She also recognizes that creating a supportive environment to help them live a fulfilling life is vital.

To see how they enjoy each other every day, it makes your heart smile, Griffin said.

A recent survey by Home Instead found that approximately 83% of U.S. adults 65 and older are living with at least one diminished sense.

Sensory impairments can lead to feelings of isolation and depression, and diminish a persons quality of life.

One of the things we see with these challenges or deprivations in senses is that a lot of people become withdrawn because they cant communicate, said Liz Woodard, a community service representative with Home Instead. They cant hear or they cant see so they tend to isolate and withdraw.

A decline in any of the five senses taste, smell, touch, hearing and sight can affect a persons well-being.

One in 5 adults 65 and older have partially lost their sense of taste, Woodard said. It leads to poor nutrition, loss of appetite, which also leads to decline in our seniors.

A diminished sense of smell can cause some seniors to eat too little or too much.

Damaged nerves, known as neuropathy, in the hands and feet can cause tingling, numbness, weakness and pain. The damage makes walking and other tasks difficult.

If somebody has diabetic neuropathy or neuropathy caused by something else, their ability to feel the floor could lead to injury from them knocking and hurting and injuring their feet, Woodard said.

Inner ear problems can affect hearing and balance. Impaired vision reduces a persons ability to perform daily tasks and move about unaided.

Because your depth perception is off you may not see your slippers that are right there on the floor and trip over them, or your little dog, Woodard said.

SOURCE OF HELP

Impaired senses and mobility can be debilitating for older adults. Southern Alabama Regional Council on Aging provides services to enhance the independence of seniors in Barbour, Coffee, Covington, Dale, Geneva, Henry and Houston counties.

Alicia Anderson, a long-term care ombudsman at SARCOA, said the organization offers age play training that can be geared toward nursing homes, groups and the public.

It kind of simulates the aging process, Anderson said. It goes over things like visual impairment, hearing loss, dementia.

The training helps people understand what its like to have diminished capabilities. The sessions are useful for anyone who deals with the elderly or disabled.

Griffin started working with the couple in 2017. The man and his wife, who will turn 95 in late May, were in the hospital with the flu and were about to be discharged.

Thats when the daughter contacted Home Instead, because they were both weak and needed 24-7 care, Griffin said.

Caregivers provide a variety of services that allow seniors to remain in their homes.

We help them bathe. We fix their meals. We keep their home clean, she said.

Griffin said being paired with the couple was a godsend because theyre like my grandparents.

She discovered right off the bat that the wife ran the house.

You have to respect that youre going into their home, Griffin said. You have to respect them. You cant go in and start rearranging furniture or telling them what theyre going to do. You dont do that. You go in, you respect them, and you do what they ask you to do.

Woodard said that approach is essential.

Were working with adults, not children, Woodard said.

Part of the job involves knowing what a client can and cannot do. Sensory-impairment kits let caregivers experience the challenges faced by people with sensory loss and other conditions, whether its opening a pill bottle or dealing with impaired vision.

Because the client cant hear and has poor vision, caregivers devised ways to communicate with him.

We have three of the white boards that we use a dry-erase marker on, Griffin said.

Questions can be answered with hand taps a tap on the back indicating yes and a tap on the wrist indicating no.

Every day, the man and his wife enjoy a game of Scrabble.

That is their time, every afternoon around 3 oclock before the 5 oclock news, Griffin said.

The news is the only time their television is turned on.

Otherwise were interacting with them on a daily basis, Griffin said.

The client loves paint-by-number.

To be 101, his hand is extremely steady, Griffin said. You know how tiny the spots are on a paint-by-number? He gets into those lines; he is so steady.

He also enjoys playing card and dice games.

He likes to play craps of all things, and he usually wins, Griffin said.

The man used to be a world traveler. He was a bachelor until age 54 when he married his wife, who had been married before.

We have watched several times his disc of his traveling out West, down South, up North, Griffin said. He has climbed mountains.

The couples optimism is inspiring. Griffin said they give me the best day that I can possibly have, honestly. I am constantly learning from them.

MULTIDIMENSIONAL JOB

Woodard said being a caregiver means looking after more than just the physical needs.

Its great that even with these challenges were still able to socially engage and to have some fun and to have some quality of life even with these challenges that our seniors face, she said.

Home Instead offers free resources and tools on its agingsenses.com website to help people understand the challenges of sensory loss. The website includes tips on things you can do to protect your senses and has an interactive video that lets you experience baking with vision loss.

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Coronavirus Outbreak: Chemotherapy Induced Peripheral Neuropathy (CIPN) Market Strategies and Insight Driven Transformation 2020-2025 – Curious Desk

Sunday, April 12th, 2020

Chemotherapy Induced Peripheral Neuropathy (CIPN) MarketLatest Research Report 2020:

The Chemotherapy Induced Peripheral Neuropathy (CIPN) report provides an independent information about the Chemotherapy Induced Peripheral Neuropathy (CIPN) industry supported by extensive research on factors such as industry segments size & trends, inhibitors, dynamics, drivers, opportunities & challenges, environment & policy, cost overview, porters five force analysis, and key companies

Download Premium Sample Copy Of This Report:Download FREE Sample PDF!

In this report, our team offers a thorough investigation of Chemotherapy Induced Peripheral Neuropathy (CIPN) Market, SWOT examination of the most prominent players right now. Alongside an industrial chain, market measurements regarding revenue, sales, value, capacity, regional market examination, section insightful information, and market forecast are offered in the full investigation, and so forth.

Scope of Chemotherapy Induced Peripheral Neuropathy (CIPN) Market: Products in the Chemotherapy Induced Peripheral Neuropathy (CIPN) classification furnish clients with assets to get ready for tests, tests, and evaluations.

Major Company Profiles Covered in This Report

Company I, Company II, Company III, Company IV and more

Chemotherapy Induced Peripheral Neuropathy (CIPN) Market Report Covers the Following Segments:

Segment by Type:Type I, Type II, Type III

Segment by Application:Application I, Application II, Application III

North America

Europe

Asia-Pacific

South America

Center East and Africa

United States, Canada and Mexico

Germany, France, UK, Russia and Italy

China, Japan, Korea, India and Southeast Asia

Brazil, Argentina, Colombia

Saudi Arabia, UAE, Egypt, Nigeria and South Africa

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Chemotherapy Induced Peripheral Neuropathy (CIPN) Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market.

Market Forecast:Here, the report offers a complete forecast of the global Chemotherapy Induced Peripheral Neuropathy (CIPN) Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

About Us:

We publish market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students.

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Diabetic Neuropathy Drugs Market Share, Growth by Top Company, Region, Applications, Drivers, Trends & Forecast to 2025 – Jewish Life News

Sunday, April 12th, 2020

QY Research has recently curated a research report titled, Global Diabetic Neuropathy Drugs Market Research Report 2020. The report is structured on primary and secondary research methodologies that derive historic and forecast data. The global Diabetic Neuropathy Drugs market is growing remarkably fast and is likely to thrive in terms of volume and revenue during the forecast period. Readers can gain insight into the various opportunities and restraints shaping the market. The report demonstrates the progress and bends that will occur during the forecast period.

Global Diabetic Neuropathy Drugs Market: Drivers and Restrains

The research report has incorporated the analysis of different factors that augment the markets growth. It constitutes trends, restraints, and drivers that transform the market in either a positive or negative manner. This section also provides the scope of different segments and applications that can potentially influence the market in the future. The detailed information is based on current trends and historic milestones. This section also provides an analysis of the volume of sales about the global market and also about each type from 2015 to 2026. This section mentions the volume of sales by region from 2015 to 2026. Pricing analysis is included in the report according to each type from the year 2015 to 2026, manufacturer from 2015 to 2020, region from 2015 to 2020, and global price from 2015 to 2026.

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Competitive Landscape:

The analysts have provided a comprehensive analysis of the competitive landscape of the global Diabetic Neuropathy Drugs market with the company market structure and market share analysis of the top players. The innovative trends and developments, mergers and acquisitions, product portfolio, and new product innovation to provide a dashboard view of the market, ultimately providing the readers accurate measure of the current market developments, business strategies, and key financials.

The key players covered in this studyPfizerNovartisJohnson & JohnsonEli LillyGlaxoSmithKlineBoehringer IngelheimTeva PharmaceuticalDaiichi SankyoAstellas Pharma

Market segment by Type, the product can be split intoCalcium Channel Alpha-2 Delta LigandSNRIs and TCAsOthersMarket segment by Application, split intoHospitalsDrug StoresOthers

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Diabetic Neuropathy Drugs status, future forecast, growth opportunity, key market and key players.To present the Diabetic Neuropathy Drugs development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Diabetic Neuropathy Drugs are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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A thorough evaluation of the restrains included in the report portrays the contrast to drivers and gives room for strategic planning. Factors that overshadow the market growth are pivotal as they can be understood to devise different bends for getting hold of the lucrative opportunities that are present in the ever-growing market. Additionally, insights into market experts opinions have been taken to understand the market better.

Global Diabetic Neuropathy Drugs Market: Segment Analysis

The research report includes specific segments such as application and product type. Each type provides information about the sales during the forecast period of 2015 to 2026. The application segment also provides revenue by volume and sales during the forecast period of 2015 to 2026. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

Global Diabetic Neuropathy Drugs Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, China, and Japan alone. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.

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Diabetic Neuropathy Drugs Market Share, Growth by Top Company, Region, Applications, Drivers, Trends & Forecast to 2025 - Jewish Life News

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Stem Cells and Chronic Kidney Disease | Mayo Clinic Center …

Saturday, April 11th, 2020

Millions of Americans have chronic kidney disease. Hundreds of thousands will progress to end stage kidney disease requiring either dialysis or kidney transplant. But research is underway to keep people from reaching that point.

Our goal is to take a look at how we can repair the diabetic kidney in terms of delaying the rate of progression of kidney failure, says LaTonya Hickson, M.D., a Mayo Clinic nephrologist.

Dr. Hickson is part of the research team looking at using stem cells to help regenerate failing kidneys.

We take these cells from our abdominal fat and we can inject them back into the body for them to do good, says Dr. Hickson. They basically tell the kidney or other organ systems that are impaired to wake up and get back to work and help heal that organ system.

While theres a lot more research ahead, Dr. Hickson is excited about the possibilities.

Listen to the Mayo Clinic Radio Health Minute and learn more about stem cells and chronic kidney disease in the video below:

Tags: chronic kidney disease, Dr. LaTonya Hickson, Mayo Clinic Center for Regenerative Medicine, Medical Research, Research, stem cells

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Stem Cells and Chronic Kidney Disease | Mayo Clinic Center ...

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Kidney Failure | Stem Cell Treatment in Tijuana Mexico

Saturday, April 11th, 2020

Current treatment options often fail due to the progression of renal disease. The pathology involves tubulointerstitial fibrosis, oxidative damage, glomerular fibrosis, and microvascular rarefaction. The kidneys have intrinsic regenerative capacity, which allows them to recover after minimal injury. The regenerative potential of these organs is limited, however.

Stem cell infusions are now being used to treat kidney failure with positive outcomes. Mesenchymal stem cells (MSCs) produce cytokines and growth factors that support hematopoiesis. These cells can transform into renal epithelial cells, functional mesangial cells, and tubular cells. Research shows that each stem cell viability is 95%, and injections work 99% of the time. MSCs have ability to reduce inflammatory response, reduce apoptosis, and increase renal function recovery.

Most chronic kidney disease patients are treated with stem cells and show improvement in the following areas:

Research:

Stem cells at R3 Stem Cell are harvested in a very safe process from consenting donors after a scheduled c-section. No babies or mother are harmed during the process. These cells possess unique immunomodulatory properties that relieve inflammation, and they can facilitate renal tissue repair. Several clinical studies have proved that stem cells are safe and effective for treating renal failure. Some research suggests that stem cells can change into ectodermal and endodermal lineages, and secrete growth factors, cytokines, and chemokines.

In a recent clinical study, researchers found that stem cells possessed a high potential for angiogenesis (vessel re-growth). In addition, investigators noted local tissue turnover and repair of kidney damage after stem cell therapy. The cells were also noted to go to the site of kidney injury. The stem cells are known to release dozens of active biological factors that act on local cell dynamics, reduce inflammation, lessen fibrosis, and recruit resident progenitor cells.

A phase 1 research study involved stem cell infusions given one week after kidney transplant surgery. The researchers found that they decreased graft rejection, and both patients had excellent kidney function at the 1-year follow-up evaluation. The patients also recovered faster from surgery, had less complications, and few adverse effects. Another similar study involving five people with renal failure involved administration of stem cell injections. Six months after transplant, a noted immunomodulatory effect was noted.

Another clinical study showed feasibility and safety of stem cell infusion for the treatment of renal disease. The study involved several cohort patients, as well as a control group. The stem cells were infused through the renal artery. At the 1-year follow-up, researchers noted a beneficial effect and reduced dosage requirement of immunosuppressive drugs. These clinical trials prove effectiveness and safety of stem cell therapy for renal diseases. Notable findings include improved resolution of tubular atrophy and interstitial fibrosis, as well as decreased risk of infection, positive effects of infusion, and lower incidence of acute rejection.

References:

Peired AJ, Sisti A, & Romagnani P (2016). Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. Stem Cells Int, 4798639.

Perico N, Casiraghi F, Introna M, Gotti E, Todeschini M, Cavinato RA, et al. Autologous mesenchymal stromal cells and kidney transplantation: a pilot study of safety and clinical feasibility.Clin J Am Soc Nephrol.2011;6:412422

Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, et al. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after renal transplantation: results of a phase I study.Stem Cells Transl Med.

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Kidney Failure | Stem Cell Treatment in Tijuana Mexico

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MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTHS NATIONAL HEART, LUNG AND…

Saturday, April 11th, 2020

NEW YORK, April 08, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Healths National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

Mesoblast Chief Executive Dr Silviu Itescu stated: This significant public-private partnership is a prime example of how the combined resources of industry and government can be leveraged to evaluate in a most efficient and rigorous manner the potential of innovative therapies to make a meaningful difference to patient outcomes.

CTSN Chairman Dr A. Marc Gillinov said: We are excited to work with Mesoblast to make a real impact on the high mortality associated with COVID-19. Thisrandomized controlled trialis in line with our mandate torigorously evaluate novel therapies forpublic health imperatives.

Professor and System Chair of Population Health Science and Policy and the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, Dr Annetine Gelijns, said: The COVID-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system.We are committed to evaluating whether Mesoblasts mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis.

ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs, with the inflammatory cytokines produced by the immune cells (cytokine storm) destroying the lung tissue. These inflammatory cytokines also can cause damage to other organs such as liver, kidney, and heart.

Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.

Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.

Mesoblast Chief Medical Officer Dr Fred Grossman said: The mortality rate in moderate to severe ARDS due to COVID-19 can be as high as 80%. Remestemcel-L has demonstrated safety, efficacy and significant survival benefit in aGVHD where inflammation is at the core, similar to ARDS from COVID-19. The mechanism of action of remestemcel-L demonstrated in aGVHD supports the evaluation of remestemcel-L to safely tame a similar cytokine storm in the lungs that leads to the high mortality in patients with COVID-19.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Story continues

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblast and its collaborators clinical studies; Mesoblast and its collaborators ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblasts ability to maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTHS NATIONAL HEART, LUNG AND...

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Merck Receives Priority Review from FDA for Second Application for KEYTRUDA (pembrolizumab) Based on Biomarker, Regardless of Tumor Type – Benzinga

Saturday, April 11th, 2020

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 16, 2020.

"From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "TMB has been an area of scientific interest to help identify patients most likely to benefit from KEYTRUDA. We look forward to working with the FDA throughout the review process to help bring KEYTRUDA monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited."

The application was based in part on results from the Phase 2 KEYNOTE-158 trial, which also supported Merck's 2017 FDA approval for KEYTRUDA as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. MSI-H is on the highest end of the TMB spectrum. Data from KEYNOTE-158 on the TMB-H patient population were presented at the European Society for Medical Oncology (ESMO) 2019 Congress.

About KEYNOTE-158

KEYNOTE-158 (NCT02628067) is a multicenter, multi-cohort, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks) in patients with solid tumors. Tissue TMB status was determined using the Foundation Medicine, Inc. FoundationOneCDx assay. Tumor response was assessed every nine weeks per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

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Merck Receives Priority Review from FDA for Second Application for KEYTRUDA (pembrolizumab) Based on Biomarker, Regardless of Tumor Type - Benzinga

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Weizmann Institute of Science Began to Conduct Coronavirus Testing Today – Mirage News

Saturday, April 11th, 2020

Well, unlike many news organisations, we have no sponsors, no corporate or ideological interests. We don't put up a paywall we believe in free public access to information. Although underresourced & primarily volunteer-based, we endeavour to provide the community with real-time access to true unfiltered news firsthand from primary sources. Our goal and mission is to provide free and alternative access to impartial information, fighting media monopolization and adhering to honesty, neutrality, fairness, transparency and independence in collection and dissemination of information. It is a bumpy road with all sorties of difficulties. (Media ownership in Australia is one of the most concentrated in the world (more on this!). Since the trend of consolidation is and has historically been upward, fewer and fewer individuals or organizations control increasing shares of the mass media in our country. According to independent assessment, about 98% of the media sector is held by three conglomerates. This tendency is not only totally unacceptable, but also to a degree frightening). Learn moreWe can only achieve this goal together. Our website is open to any citizen journalists and organizations who want to contribute, publish high-quality insights or send media releases to improve public access to impartial information. You and we have the right to know, learn, read, hear what and how we deem appropriate.If you like what we do & would like to buy us a coffee (or lots of coffees), please know it's greatly appreciated. All donations are kept completely private and confidential.Thank you very much in advance!

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Weizmann Institute of Science Began to Conduct Coronavirus Testing Today - Mirage News

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A new, inhaled siRNA therapeutic option for asthma – Advanced Science News

Saturday, April 11th, 2020

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After more than 20 years of research, we are now witnessing a breakthrough of small interfering RNA (siRNA)-based therapies. In 2018, the first-ever siRNA drug, Onpattro, reached the market, followed by the approval of Givlaari in 2019, and many other clinical trials are in progress.

Holding the potential to treat a wide range of diseases from cancer to immunological disorders, siRNA therapeutics have received plenty of attention. With the support of a suitable delivery system, they can be directed to downregulate a specific target gene. Both approved siRNA drugs Onpattro and Givlaari are only able to reach the liver, however. Other organs that can be treated by loco-regional administration, such as the lung, are, in principle, good targets for siRNA therapies as well.

In this view, siRNA-baseddrugs could not only act as an ally in the battle against the current COVID-19pandemic but also against other severe lung diseases such as asthma. Despitethe great advances in asthma treatment, this disease still represents an unmetmedical need in about 510% of patients.Moreover, most of the available drugs work symptomatically rather than causally.

In a recent article published in WIREs Nanomedicine and Nanobiotechnology, Domizia Baldassi and Tobias Keil, graduate students in Prof. Olivia Merkels research group at the University of Munich, discuss the groups advances towards developing a nanocarrier that can deliver siRNA into T cells in the lung.

The aim of T-cell delivery is downregulation of GATA-3, the transcription factor of T helper 2 (TH2) cells overexpressed in asthmatic patients, which is recognized as a key factor in the asthmatic inflammatory cascade. Based on their observation that transferrin receptor is overexpressed in activated T cells, the researchers sought to find a virus-like tool to target activated TH2 cells specifically and efficiently in a receptor-mediated manner.

They accomplishedthis goal by creating a conjugate formed by transferrin and low-molecular-weightpolyethylenimine (Tf-PEI). On the one hand, they used a well-known cationic polymerto electrostatically interact with the negatively charged siRNA and protect itfrom degradation during the journey through the airways. And on the other hand,transferrin served as a targeting moiety to mediate a specific, targeteddelivery of siRNA only to activated T cells.

Since theendosomal escape is considered the rate-limiting step in cytoplasmaticdelivery of nanoparticle-based therapies, improving this aspect of theformulation was the focus, and Tf-PEI was blended with a second conjugatecomposed of melittin and PEI (Mel-PEI). Melittin is a well-known membranolyticagent from bee venom that was chemically modified to react in a pH-dependentmanner.

The researchersexploited the intrinsic lytic characteristic of the peptide to improve therelease of siRNA into the cytosol, reaching knockdown levels as high as 70% exvivo. But further steps such as the validation of these results in vivo on anasthma mouse model are needed, as well as possible alternative polymericmaterials.

In the process of developing a new pharmaceutical product, it is crucial to keep the administration route in mind. Spray drying is the most straightforward technique to produce inhalable particles for pulmonary delivery, according to the researchers. In a proof-of-concept study, they obtained nano-in-microparticles by spray drying PEI-pDNA polyplexes together with a cryoprotectant agent. After seeing promising results, their studies to obtain a dry powder formulation of siRNA-based polyplexes are ongoing.

Ultimately, both research fields will be combined and hopefully result in a new therapy for the treatment of severe, uncontrolled asthma and many other lung diseases, concluded Baldassi, Keil, and Merkel.

Reference: Tobias W. M. Keil et al. T-cell targeted pulmonary siRNA delivery for the treatment of asthma. WIREs Nanomedicine and Nanobiotechnology (2020). DOI: 10.1002/10.1002/wnan.1634

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Global Nano Therapy Market- Industry Analysis and Forecast (2020-2027) – Publicist360

Saturday, April 11th, 2020

Global Nano Therapy Market was valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 8.6% during a forecast period.

Global Nano Therapy Market

Market Dynamics

Nanotechnology is the manipulation of matter on an atomic, molecular, and supramolecular scale. Nanotherapy is a branch of Nano medicine that includes using nanoparticles to deliver a drug to a given target location in the body so as to treat the disease through a process called as targeting.

This report provides insights into the factors that are driving and restraining the global Nano Therapy market. Nanotherapy is also referred to as targeted therapy, which offers to transport the molecules to the affected cells to treat the disease without affecting other negative effects on the healthy cells. Nanoparticles allow for multiple functional groups to be added to the surface. Each of the functional groups contributes to the effectiveness of this method of therapy and deliver its components in a controlled way once it gets to the target cells/tissue. Nano therapy is considered as recent technology for some diseases, which are implemented with the help of submicron-sized molecular devices or nanoparticles. Nanoparticles can improve the drug accessibility in the body with strength, drag out the medication, and can upsurge the half-life of plasma and boost the drug specificity. These are the factors driving the growth of the Nano therapy market.

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As compared to the conventional methods, this method has increased more popularity owing to its high accuracy when it comes to administering therapeutic formulations. The market is thriving, with around 250 Nano-medical products being verified or used for humans. Though, with Nano therapy, the carrier is protected from degradations, which allows it to reach given target cells in the body for a local reaction. Nano therapy is considerably used in the treatment of diseases like cancer, diabetes, and cardiovascular diseases. A recent study by the Journal of Diabetes and Metabolic diseases has stated that the incidence of MS ranged from 30.5 to 31.5% in China and 35.8 to 45.3% in India.

However, an absence of controlling standards in the examination of Nano therapy and high expenditure of treatment are several of the major factors that are restraining the growth of the Nano therapy market during the forecast period.

Global Nano Therapy Market Segment analysis

Based on Type, the Nanomaterial segment is anticipated to grow at a CAGR of 20.8% during the forecast period. The nanomaterial is the materials with at least one exterior dimension in the size range of nearly 1 to 100 nanometers. The nanomaterial is intended for developing novel characteristics and has the potential to improve quality of life. The nanomaterial is generally used in cosmetics, healthcare, electronics, and other areas currently. Unceasing development and innovation in the field are impelling the growth of the global nanomaterials market. The amazing chemical and physical properties of materials at the nanometer scale allow novel applications. For instance, energy conservation and structural strength improvement to antimicrobial properties and self-cleaning surfaces. Nanotechnology is being increasingly efficient by spending mainly on R&D activities which are resulting in the development of current technologies and innovations with reference to the new materials.

Global Nano Therapy Market Regional analysis

North America region dominated the Nano therapy market with US$ XX Mn in 2019. The availability of technology, increasing healthcare spending, and government funding for research and development are some of the factors boosting the growth of the Nano therapy market in the region. Europe is expected to follow the Americas and bring in the second leading market share for Nano therapy throughout the forecast period. Europe is mainly driven by awareness and improvement in the nanotechnology sector.

Recent Developments

In 08 May 2019- Cisplatin cis-(diammine) dichloridoplatinum (II) (CDDP) is the first platinum based complex approved by the food and drug administration (FDA) of the United States (US). Cisplatin is the first line chemotherapeutic agent used alone or combined with radiations or other anti-cancer agents for a broad range of cancers such as lung, head and neck.

In May 2019- A new study conducted by scientists from the Indian Institute of Technology, Bombay, have designed hybrid nanoparticles to treat cancer. These nanoparticles are made from gold and lipids. These nanoparticles respond to light and can be directed inside the body to release drugs to a targeted area, and are biocompatible, meaning theyre not toxic to a human body.

In September 2019, researchers at Finlands University of Helsinki, in partnership with the bo Akademi University and Chinas Huazhong University of Science and Technology developed an anti-cancer nanomedicine useful for targeted cancer chemotherapy.

The objective of the report is to present a comprehensive analysis of the Global Nano Therapy Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers.The report also helps in understanding Global Nano Therapy Market dynamics, structure by analyzing the market segments and project the Global Nano Therapy Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Nano Therapy Market make the report investors guide.Scope of the Global Nano Therapy Market

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Global Nano Therapy Market, By Type

Nanomaterial and Biological Device Nano Electronic Biosensor Molecular Nanotechnology Implantable Cardioverter-DefibrillatorsGlobal Nano Therapy Market, By Application

Cardiovascular Disease Cancer Therapy Diabetes Treatment Rheumatoid ArthritisGlobal Nano Therapy Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Nano Therapy Market

Selecta Biosciences Inc. Cristal Therapeutics Sirnaomics Inc. Nanobiotix Luna CytImmune Science Inc. NanoBio Corporation Nanospectra Biosciences Inc. Nanoprobes Inc. NanoBioMagnetics.n.nu Smith and Nephew NanoMedia Solutions Inc. Nanosphere Inc. DIM Parvus Therapeutics Tarveda Therapeutics

MAJOR TOC OF THE REPORT

Chapter One: Nano Therapy Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Nano Therapy Market Competition, by Players

Chapter Four: Global Nano Therapy Market Size by Regions

Chapter Five: North America Nano Therapy Revenue by Countries

Chapter Six: Europe Nano Therapy Revenue by Countries

Chapter Seven: Asia-Pacific Nano Therapy Revenue by Countries

Chapter Eight: South America Nano Therapy Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Nano Therapy by Countries

Chapter Ten: Global Nano Therapy Market Segment by Type

Chapter Eleven: Global Nano Therapy Market Segment by Application

Chapter Twelve: Global Nano Therapy Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Nano Therapy Market Report at: https://www.maximizemarketresearch.com/market-report/global-nano-therapy-market/54507/

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Global Nano Therapy Market- Industry Analysis and Forecast (2020-2027) - Publicist360

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Scope of veterinary medicine embraces animals and their people – Walla Walla Union-Bulletin

Saturday, April 11th, 2020

As we all are learning to cope with our current, ever-changing new normal I want to offer some musings and things I have learned through this coronavirus pandemic crisis. It is my sincerest hope that as you read this column, you, too, are overcome with love and compassion for our collective, human and animal suffering and rebounding resilience.

Veterinary medicine has always been touted as a career for animal lovers. However, anyone who remains in the field knows that to be successful one must enjoy interacting with people. After all, pets are always accompanied by their owners.

One of the things I have always loved about general practice is the ability to develop bonds not only with my patients but also their families. I enjoy hearing about the familys joys and triumphs. I have always tried to focus my interactions not only on presenting facts, guidance, and honesty; but also through a lens compassion and understanding for the family.

COVID 19 has shown me that I never realized how much I would miss these interactions until I couldnt be there for my clients in person.

I never realized how much I would miss being able to hug a client during a euthanasia or when were trying to make a difficult decision.

I miss being able to introduce myself to new clients by shaking their hand and inviting them into the exam room.

I miss being able to spend time in the exam room with clients talking them through my exam findings in real time. I miss helping seniors carry their pets to their cars. I even miss letting kids use my stethoscope to listen to their pets heartbeats.

Because at the end of the day yes my job is to do medicine, it is to be a veterinarian. But the best part of my job has, and always will be, interacting with clients and their pets.

The best part is that I get to help maintain and foster a deeper human animal bond through teaching the importance of what were trying to do.

Please know that our curbside check-ins and the way we are structuring appointments is to maintain public health and safety.

However, we feel the absence and change too. May we never take for granted again the power of a hug, a handshake and in-person conversation. I, for one, never will again.

Danielle Carey, a doctor of veterinary medicine, is an associate veterinarian at the Animal Clinic of Walla Walla.

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Scope of veterinary medicine embraces animals and their people - Walla Walla Union-Bulletin

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Vets recruited to work in UK hospitals during coronavirus outbreak – The Guardian

Saturday, April 11th, 2020

NHS trusts are recruiting vets to help relieve pressure on health service staff as hospitals struggle to cope with the coronavirus pandemic.

About 150 vets are volunteering as respiratory assistants with Torbay and South Devon NHS foundation trust, while Hampshire hospitals NHS foundation trust has invited vets, veterinary nurses and dentists to apply for jobs.

Hospitals are being stretched by the scale of the outbreak, which has yet to reach its peak. Pressures are being exacerbated by staff absences due to healthcare workers having contracted the virus or self-isolating because of a suspicion they may have it.

The respiratory assistants at Torbay and South Devon will be unpaid, according to the Health Service Journal, which first reported their recruitment. The Guardian understands they were undergoing training via Zoom on Thursday. They will not be making decisions about triage, intubation or withdrawal of medical treatment, the trust confirmed.

A spokesperson said: We have received many offers of voluntary help from veterinary staff who have valuable skills that can be used to support frontline staff who are dealing with respiratory problems.

A job advert for bedside support workers at Hampshire trust, whose recruitment drive was first reported by Vet Times, says that successful applicants will be paid between 17,000 and 42,000, with vets, veterinary surgeons and dentists in a higher salary band than veterinary or dental nurses.

A spokesperson for the trust said: Following a number of offers of help from skilled professionals working outside the NHS, such as vets and dentists, we have developed a bespoke role called a bedside support worker.

This is a role we have created in response to the coronavirus pandemic, which will support our brilliant staff in critical care and on medical wards, who are all working tirelessly to respond to this unprecedented challenge.

Patient care remains our top priority, and only those who are assessed to have the appropriate transferable skills, education and training will temporarily join our team.

Vets have been contributing to the crisis effort in other ways. On Thursday, Willow Farm vets, a team that works across northern England, said it had donated 4,000 protective gowns, amid concerns about a shortage of personal protective equipment for hospital staff. It followed VetPartners, based in York, which said on Monday that it was donating masks, aprons, gloves and ventilators to the health service.

Dr Rachel Dean, director of clinical research and excellence in practice at VetPartners, said some ventilators used on animals were the same as those used on humans, particularly on children.

The Royal College of Veterinary Surgeons issued advice to its members on Wednesday about how they could best help during the Covid-19 pandemic, recommending that they consider assisting the livestock production, meat hygiene and food import/export industries before volunteering with the NHS.

The colleges registrar, Eleanor Ferguson, said: If local NHS trusts do choose to employ veterinary professionals to undertake roles that are not reserved by law to licensed doctors, nurses or other regulated professionals, they must be satisfied that the individual has the skills and competencies to do that role.

However, any veterinary professionals employed in these roles should not misrepresent their position to patients and must be careful not to hold themselves out as a licensed medical doctor or nurse.

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Vets recruited to work in UK hospitals during coronavirus outbreak - The Guardian

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MSU veterinary school ranks third in the nation, top 10 in the world – MSUToday

Saturday, April 11th, 2020

Michigan State Universitys College of Veterinary Medicine was ranked eighth in the world and third in the United States among veterinary schools in the latest global ranking from educational data specialists Quacquarelli Symonds, or QS.

At a time when everyone is being challenged by the COVID-19 pandemic and good news is a hot commodity, our college takes special pride in the high-quality of education we deliver to our students, said Birgit Puschner, dean of the College of Veterinary Medicine. Our DVM program is a testament not just to our students and educators, but to our entire community alumni, donors, staff, and our health and research partners that supports us, no matter the context or conditions we face.

The veterinary colleges prominent ranking continues on its upward trajectory the college was ranked eleventh in 2019 and 2018, 12th in 2017 and 15th in 2016.

MSU also retains its number one rank among the six colleges of veterinary medicine in the Big Ten, a union of world-class academic institutions that share a common mission of research, graduate, professional and undergraduate teaching and public service. Six of the 30 veterinary programs in the United States are in the Big Ten.

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MSU veterinary school ranks third in the nation, top 10 in the world - MSUToday

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