StemCell Therapy

Scientists have concluded a Phase 3 trial of a revolutionary gene therapy treating patients with a common form of mitochondrial blindness, and the results surprised them despite treating only one eye, the gene therapy improved vision in both eyes in 78% of participants. The results suggest the treatment is incredibly promising for a condition in which most legally-blind patients would never recover their vision.

Conducted on 37 patients with Leber hereditary optic neuropathy (LHON), the trial involved a gene therapy using a virus vector to modify genes within the patients retinal cells. The results were published in the journal Science Translational Medicine.

LHON affects around 1 in every 50,000 people, with some patients experiencing significant vision loss in a matter of weeks. People affected by the disease will likely lose vision in one eye before subsequent vision loss in the other within 2-3 months. Treatments are limited to visual aids and attempted rehabilitation but have limited success. Typically, just 20% of patients will recover vision and it is extremely rare to recover vision greater than the worst score possible on a standard eye chart (20/200).

As someone who treats these young patients, I get very frustrated about the lack of effective therapies, said senior investigator Dr Sahel, a professor of ophthalmology at the University of Pittsburgh, in a statement.

These patients rapidly lose vision in the course of a few weeks to a couple of months. Our study provides a big hope for treating this blinding disease in young adults.

The treatment aims at correcting a common mutation within the MT-ND4 gene. MT-ND4 is a core subunit in a protein associated with mitochondria, and a mutation marked m. 11778G>A is thought to be associated with blinding neuropathy. Similarly, mutations in MT-ND4 may also be related to several other brain conditions, although these are not the same as the mutation targeted in this study.

37 patients were injected with the adenovirus-based therapy in one eye and a sham injection (a placebo or, in this case, fake injection) into the other. The trial was randomized and double-blind across multiple centres, which make it the gold-standard of clinical trials. After 48 and 96 weeks, the participants were tested for vision changes and whether they showed signs of improvement using a standard Snellen eye chart (the ones with rows of smaller and smaller letters).

The researchers found that, on average, vision was improved by 15 letters (3 lines on the chart) after 96 weeks, which is an extremely impressive result. However, to the surprise of the researchers, the sham-treated eyes also saw an average improvement of 13 letters. Those that were in the early stages of disease and still losing their vision when they joined the study saw an even better improvement, being able to see 28.5 letters more in the treated eyes on average.

We expected vision to improve in the eyes treated with the gene therapy vector only. Rather unexpectedly, both eyes improved for 78% of patients in the trial following the same trajectory over 2 years of follow-up. Said Dr Yu-Wai-Man, neuro-ophthalmologist at CambridgesDepartment of Clinical Neuroscience.

To decipher how this treatment improved both eyes, the researchers conducted a subsequent study on primates. After injection in the same way as the study above, they found the viral vector was present in cells throughout the eye that was not treated, although the mechanism in which this occurs needs confirmation.The researchers suggest that the viral vector may have transferred across neurones via interocular diffusion, and hence there was an improvement in vision in both eyes.

The results suggest an extremely promising new treatment for a rare but debilitating form of blindness. Further trials are expected to take place to confirm the results, and there are some outstanding limitations of the trial. For example, there was not a control group with this exact mutation, so the researchers could not directly compare to the treatment.

Saving sight with gene therapy is now a reality. The treatment has been shown to be safe and we are currently exploring the optimal therapeutic window. Said Dr Yu-Wai-Man.

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Gene Therapy Unexpectedly Improves Vision In Both Eyes Of Patients Suffering A Form Of Blindness - IFLScience

AN ISLANDER with limited sight has published her first book written on typewriters in lockdown.

Shanklin resident Anna Southwell not only realised her 24-year long dream of publishing the first book in her Island-based

young childrens fantasy series Oliver Gruffle, but she kept a solemn promise she made to her late husband.

She is delighted to have Oliver Gruffle Secrets of Harmony Haven Book 1: The Runaways published.

She said: I first came up with the idea 24 years ago. Ive been evolving the stories all along, adding different ones. Im up to 12 so far. I just cant stop inventing stories. Im obsessed with it now.

With this coronavirus, I was kept busy and I didnt go into depression or anything like that from being alone, because I was in my magical world, typing away and thinking of new stories.

The one thing Ive always loved is the Island and thats why I wanted to base the stories here.

"I hope when children read these books, they can come to my little world and enjoy them as much as Ive enjoyed writing them.

Annas Oliver Gruffle stories feature animals and other fantasy characters from her imagination, all inspired from her real passion for animals.

I had a lovely Border collie dog called Kim, and she was very wise, and she seemed to know every emotion you felt.

"I was never allowed any animals as a child. I was always wanting a pet. I remember riding a bike on the Island and discovering some wild feral kittens and it was a hard lesson to learn that I could not keep them.

"My last cat I owned as an adult was from a rescue home.

Anna, formerly a secretary and typist for an Island builders merchants in Ryde, explained the challenge of writing the books with her sight impairment.

I wrote them all on a typewriter. I got through so many typewriters because I just bash away at them, but to be quite honest, because Im visually impaired now, I know exactly where the keys are from my touch-typing days so its been a lifeline for me to continue to write new stories and correct ones Ive written in the past and bring them up to date.

Anna hasnt let her sight problems affect her, although it was a shock when she was first diagnosed.

She said: One day my eyesight suddenly got very bad and I woke up one morning and I had completely lost sight apart from vision in my right eye.

"Then I woke up another morning with blurred vision, so I had to go straight up the hospital, and they diagnosed macular vision in the right eye, but I have still got a small amount of vision in that eye."

She has benefitted from getting involved with Sight for Wight.

Anna also cared for her late husband, who had dementia. She would read him her stories.

She said: "I would read to him and do all the voices and he would sit there, thrilled to bits. He said to me, The one thing I want you to do, is try to get this into print for children to enjoy.

The book is published by Beachy Books Partner Publishing. Copies are on sale at Isle of Wight Traders in Newport or available to order via the Beachy Books website beachybooks.com

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Shanklin author with limited sight publishes children's book keeping promise to late husband - Isle of Wight County Press

The globalEyesight Test Equipment Marketresearch report enlists the vital and practical information with regards to market situation. The present scenario of Eyesight Test Equipment market, along with its previous performance as well as future scope are covered in the report. This eases the users understanding of the market thoroughly, while also gaining knowledge about market opportunities and the dominant players Johnson & Johnson Vision Care.Inc., Shenzhen Certainn Technology, Heine, Nidek Co., Ltd., Hoya Corporation, EyeNetra, Essilor International, Seiko Optical Products Co., Ltd., Bhavana MDC, Carl Zeiss AG, Heidelberg Engineering GmbH, Abbott Medical Optics.I in the Eyesight Test Equipment market.

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The beginning of the report summarizes the market with the definition of the overall Eyesight Test Equipment market.

The following section includes Eyesight Test Equipment market segmentation Portable, Stationary. Segmentation is done on the basis of application, type, end-user industries, and several such factors among others.

We have strived to include sub-segments Children, Adults, The older in segmentation section, wherever possible. Also included are details regarding the dominant segments in the worldwide Eyesight Test Equipment market.

The global Eyesight Test Equipment market has also been classified on the basis of regions. On the basis of the regional diversification, details regarding market share and size have also been obtained.

In the succeeding part, growth factors for the Eyesight Test Equipment market have been elucidated. This section also explains the technological advancements made to improve market size and position. Also enlisted is the information pertaining to the end-use industries for the Eyesight Test Equipment market.

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Eyesight Test Equipment Market COVID-19 Impact Analysis

As the world is still dealing with COVID-19 situation, many of the countries have slowly started to revive its economic situation by starting its trade and businesses. There has been enormous loss in these few months both in terms of economy and human lives. As the WHO has already suggested that there are very less chances that the virus will completely go, hence we will have start living with it. Many of the drug companies are getting positive response of their COVID-19 vaccines, but there is still time for its availability in the global market.

There are 15 Sections to show the global Eyesight Test Equipment market

Sections 1, Definition, Specifications and Classification of Eyesight Test Equipment , Applications of Eyesight Test Equipment , Market Segment by Regions;Section 2, Assembling Cost Structure, Crude Material and Providers, Assembling Procedure, Industry Chain Structure;Sections 3,Technical Data and Manufacturing Plants Analysis of Eyesight Test Equipment , Capacity and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;Sections 4, Generally Market Analysis, Limit Examination (Organization Fragment), Sales Examination (Organization Portion), sales Value Investigation (Organization Section);Sections 5 and Six, Regional Market Investigation that incorporates United States, China, Europe, Japan, Korea and Taiwan, Eyesight Test Equipment segment Market Examination (by Sort);Sections 7 and Eight, The Eyesight Test Equipment Segment Market Analysis (by Application) Major Manufacturers Analysis of Eyesight Test Equipment ;Sections Nine, Market Trend Analysis, Regional Market Trend, Market Trend by Product Type Portable, Stationary Market Trend by Application Children, Adults, The older;Sections 10, Regional Promoting Type Investigation, Worldwide Exchange Type Examination, Inventory network Investigation;Sections 11, The Customers Examination of global Eyesight Test Equipment;Sections 12, Eyesight Test Equipment Research Findings and Conclusion, Appendix, system and information source;Sections 13, 14 and 15, Eyesight Test Equipment deals channel, wholesalers, merchants, traders, Exploration Discoveries and End, appendix and data source.

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Particulars Of The Global Eyesight Test Equipment Market Research Report

Further part in the report enlists the restraining factors for the Eyesight Test Equipment market growth. The restraints are explained comprehensively and with details in order that the client can comprehend how these factors are affecting the global Eyesight Test Equipment market and how such factors can be tackled effectively using suitable measures.

Also, regional study and analysis of global Eyesight Test Equipment market focused on in the report. Here, the major regions with Eyesight Test Equipment market establishment have been explained thoroughly. Due to this, our clients will have clarity in understanding the booming markets as well as the potential Eyesight Test Equipment markets in the near future.

The concluding section relates to the conclusions and observations regarding the global Eyesight Test Equipment market.

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Global Eyesight Test Equipment Market Proceeds To Witness Huge Upswing Over Assessment Period by 2025 - The Courier

The facility will include expanded vision research laboratories and a state-of-the-art conference center. Bringing everyone together under one roof will facilitate interactions between researchers and physicians across disciplines to promote the collaborations necessary for translational studies. Completion is expected in late 2021.

When it comes to the Doheny Eye Institutes planned move to new headquarters in Pasadena, it could be said we havent have seen anything yet.

The renowned institute, which started in 1947 as the Doheny Eye Foundation, so named in honor of its optically impaired founder Carrie Estelle Doheny, wife of the prominent Los Angeles oilman Edward L. Doheny, is moving out of its Los Angeles location and is currently remodeling a new headquarters at 150 N. Orange Grove Blvd., the former home of Avery Dennison Corp.

Reconstruction of the complex is expected to be completed in the third quarter of 2021.

Once that happens, the institute and the UCLA Stein Eye Institute will be offering patient care, vision research, and education in the field of eye care. This affiliation combines the strengths and reputations of two of the nations top eye institutions to advance vision research, education and patient care in California.

According to institute Executive Director Marrissa Golberg, the move cant come soon enough.

In the U.S. alone, by age 65 one in three people will have some vision-impairing eye condition, Goldberg said in a prepared statement.

In a world where the stakes of our work are ever-increasing, we are committed to delivering on our promise to further the conservation, improvement and restoration of human eyesight, Goldberg said.

This bench-to-bedside approach is vital to improve the quality of lives in our immediate community and around the world, she said.

The seven-acre Pasadena campus, according to the statement, has been designed to enhance Donahenys capabilities for fundamental discoveries that fuel ideas for clinical trials, new treatments, and cures. Laboratories will be equipped to accelerate research and discovery in key areas, including artificial intelligence, regenerative medicine, gene-based therapies, and imaging diagnostics.Once reconstruction is complete, a state-of-the-art conference center will house educational programs, including seminars, conferences, symposia, and lectures. The facility will also enable remote collaborations to meet current demands and evolving opportunities to advance vision research and education.Our new home in Pasadena will allow us to bring everyone together under one roof to facilitate interactions between researchers and physicians to promote the collaborations necessary for translational studies, Goldberg said.

For more information, visit doheny.org.

Get all the latest Pasadena news, more than 10 fresh stories daily, 7 days a week at 7 a.m.

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Doheny Institute's Future Vision Sciences Campus in Pasadena Expected to be Operational by Q3 2021 - Pasadena Now

LONDON--(BUSINESS WIRE)--Gyroscope Therapeutics Limited, a clinical-stage gene therapy company focused on diseases of the eye, today announced the company has entered a sponsored research agreement with the University of Pennsylvania and the Penn Center for Advanced Retinal and Ocular Therapeutics (CAROT) to develop gene therapies for serious eye diseases that can lead to permanent vision loss. Gyroscope has an exclusive option to the intellectual property associated with, and arising from, the research conducted under the agreement.

A team of researchers from CAROT and Gyroscope will work together to explore specific gene therapy targets for glaucoma, optic neuritis and retinitis pigmentosa. The CAROT team is led by Jean Bennett, M.D., Ph.D., the F.M. Kirby Professor of Ophthalmology, along with Ken Shindler, M.D., Ph.D., an Associate Professor of Ophthalmology and Ahmara Ross, M.D., Ph.D., an Assistant Professor of Ophthalmology, of the Perelman School of Medicine.

Too many people around the globe face a life with limited vision or complete blindness because current treatment options for many serious eye diseases are so limited, said Khurem Farooq, Chief Executive Officer, Gyroscope. Gene therapy has the potential to be a completely new way of approaching these diseases, and we are very excited to work with Jean and the team of world leaders in ophthalmic gene therapy research at the University of Pennsylvania to evaluate new targets for these conditions.

Our team is passionate about the potential of gene therapies for people with serious eye diseases, said Dr. Bennett. We are looking forward to furthering our research in glaucoma, optic neuritis and retinitis pigmentosa, which combined currently cause a devastating loss of vision for millions of people around the world.

Glaucoma is a leading cause of irreversible blindness globally. An estimated 80 million people have glaucoma worldwide, and this number is expected to increase to more than 111 million by 2040.1 There is no cure for glaucoma. If it is caught early, people with glaucoma can be treated with surgery or medication to help control the disease. Because glaucoma typically does not cause pain, it often progresses silently and is not diagnosed until the optic nerve is irreparably damaged.

Retinitis pigmentosa (RP) refers to a group of rare genetic retinal diseases that cause progressive loss of night and peripheral vision. The condition is often diagnosed in childhood or adolescence and can lead to legal, and sometimes complete, blindness. An estimated 300,000 people worldwide have RP, mainly caused by a genetic variant inherited from one or both parents.2

Optic neuritis occurs when the optic nerve is damaged as a result of inflammation. Symptoms of optic neuritis include temporary vision loss in one eye and pain with eye movement. Optic neuritis is closely associated with multiple sclerosis (MS): It is the first sign of MS in 20% of patients and occurs during the course of the disease in 50% of MS patients.3

About Gyroscope: Vision for Life

Gyroscope Therapeutics is a clinical-stage gene therapy company developing gene therapy beyond rare disease to treat diseases of the eye that cause vision loss and blindness. Our lead investigational gene therapy, GT005, is currently being evaluated in Phase II clinical trials for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), a leading cause of blindness. GT005 is designed to restore balance to an overactive complement system by increasing production of the Complement Factor I protein. GT005 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of people with GA.

Syncona Ltd, our lead investor, helped us create a leading gene therapy company combining discovery, research, drug development, a manufacturing platform and surgical delivery capabilities. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness. For more information visit: http://www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.

1 Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90.

2 Cowen Equity Research Therapeutic Categories Outlook: Comprehensive Study. 2020 Feb;P.2334.

3 Kale N. Optic neuritis as an early sign of multiple sclerosis. Eye Brain. 2016;8:195-202.

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Gyroscope Therapeutics and the University of Pennsylvania Announce Research Agreement to Develop Gene Therapies for Serious Eye Diseases - Business...

Biomilq was on the brink of shuttering when Strickland and Egger were promised $3.5 million in funding from a group of investors led by Breakthrough Energy Ventures, which Bill Gates had established to back technologies that could reduce carbon emissions. Upending the formula industry held the promise of doing just that. As the spring of 2020 gave way to summer, the money arrived in Biomilqs bank account.

Biomilq is not the only company aiming to make a new kind of baby formula. Using a broadly similar approach, TurtleTree Labs in Singapore eventually hopes to replace all milk currently on the market, according to cofounder Max Rye. In addition to other projects, the company is working to create fortifiers that can be added to formula to duplicate the properties of breast milk. Some formulas are already fortified with proteins and carbohydrates derived synthetically or from cows milk. Another cofounder, Fengru Lin, explains that, in contrast to Biomilq, TurtleTree plans to work with the formula industry and hopes to get its products to market in 2021.

Meanwhile, Helaina, a company based in New York, will emulate breast milk through fermentation. Laura Katz, the companys founder, plans to use microbes to synthesize the milks constituent compoundsproteins, carbohydrates, and fatsand then recombine them into a nutritious liquid. Since similar processes have already won approval from the US Food and Drug Administration for products like Impossible Burgers, which are made from fermented soy protein, she hopes to face fewer regulatory hurdles than her competitors. Like Strickland and Egger, she is motivated by indignation at the lack of options for new parents.

I think the best thing we can do is support women to breastfeed, Katz says. But if thats impossible, mothers deserve something better than current infant formula. She adds, I see all this innovation happening in cell-based meat production for people who just want to eat a burger, but the products that we feed babies have stayed static over the past 20, 30 years.

None of these propositions will be scientifically simple, in part because relatively little is known about breast milk. Most studies of human mammary epithelial cells tend to focus on their role in breast cancer rather than milk production.

As for the milk itself, its a rich and bewildering stew of thousands of chemicals. We know nutritionally about the proteins, the carbohydrates, and the fat in there. We know about some particular bioactive molecules in there, like oligosaccharides [complex sugars that feed healthy bacteria in a babys gut], IgA [the main antibody found in breast milk], bile-salt-stimulated lipase [an enzyme that aids in the digestion of fats]these things that people always bring up as being good in breast milk, says Tarah Colaizy, the research director of the Human Milk Banking Association of North America, who also teaches at the University of Iowa. But, she notes, breast milk also contains short strands of RNA, whose presence was only discovered in 2010, and whose role in infant development is not yet well understood.

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Startups are racing to reproduce breast milk in the lab - MIT Technology Review

Many people around the world live with conditions that affect the liver, including cirrhosis, nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease, liver cancer, liver failure, and hepatitis (1).

Every year, liver disease accounts for nearly 2 million deaths worldwide (2, 3).

Risk factors for liver disease include heavy alcohol intake, high blood sugar levels, obesity, high blood pressure, viruses, elevated triglyceride and cholesterol levels, and more (4, 5).

Liver disease is treated in a number of ways, including medication, nutritional therapy, immunotherapy, lifestyle change, surgical resection, and even liver transplant in end stage liver disease (6, 7, 8, 9).

In addition to standard treatments, many people turn to alternative therapies, including herbal supplements, in hopes of improving and protecting their liver health. In fact, around 65% of people in the United States and Europe with liver diseases take herbal supplements (10).

Here are the 10 best herbs that have been shown to improve liver health.

Many herbs, including some on this list, may be unsafe for those with certain liver conditions.

Some herbs have been connected to liver damage and other complications, which is why its critical to check with your healthcare provider before adding any herbal supplements, including the ones on this list, to your diet.

Silymarin, often called milk thistle, consists of a group of compounds extracted from milk thistle (Silybum marianum) seeds, including silybin, silychristin, and silydianin (10).

Milk thistle has been used for over 2,000 years to treat bile duct and liver conditions, and research shows that it may have liver-protective properties (11).

It has been suggested that silymarin has strong antioxidant effects and may help promote liver cell regeneration, reduce inflammation, and benefit those with liver disease. However, results from human studies have been mixed (12).

For example, some studies have shown that taking a silymarin supplement may help protect against liver disease progression, prolong life in people with alcoholic cirrhosis, and enhance overall quality of life in people with liver disease (13, 14, 15, 16).

Yet, other studies indicate that silymarin is no more effective than placebo treatments, highlighting the need for additional research (13, 17, 18, 19).

Regardless, silymarin is considered safe and has not been associated with adverse side effects, even when used at high doses (19).

Silymarin may benefit people with certain liver conditions, including alcoholic cirrhosis. Still, more research is needed.

Ginseng is a popular herbal supplement known for its powerful anti-inflammatory properties (20).

A number of test-tube and animal studies have demonstrated that ginseng has antioxidant effects and may help protect against liver injury caused by viruses, toxins, and alcohol. Plus, it may boost liver cell regeneration after surgery (21).

Whats more, some human studies have shown that ginseng treatment may improve liver function and reduce fatigue and inflammation in people with liver disease and liver dysfunction (22, 23, 24).

For example, a 2020 study in 51 men with elevated levels of alanine transaminase (ALT), a marker for liver damage, found that those who took 3 grams of ginseng extract per day for 12 weeks experienced significant reductions in ALT, compared with a placebo group (24).

Levels of gamma-glutamyl transferase (GGT), another marker for liver damage, were also reduced significantly (24).

Although these results are promising, more research investigating the effects of ginseng on liver health is needed.

When used on its own, ginseng is thought to be relatively safe for liver health. However, ginseng has the potential to react with medications, which can lead to liver injury and other potentially dangerous side effects (25, 26, 27).

Ginseng may help protect against liver damage and is generally considered safe. Yet, it has the potential to react with certain medications, which can lead to dangerous side effects.

Although it isnt technically an herb, green tea and its main polyphenol compound epigallocatechin-3-gallate (EGCG) are often included in literature reviews focusing on herbal remedies for liver conditions (28).

Some studies have found that supplementing with green tea extract may help treat those with liver disease.

A study in 80 people with nonalcoholic fatty liver disease (NAFLD) found that supplementing with 500 mg of green tea extract per day for 90 days significantly reduced the liver damage markers ALT and aspartate aminotransferase (AST) (29).

Although the placebo group also noticed a reduction in AST and ALT levels, they were not significant (29).

Another 12-week study in 80 people with NAFLD observed that those who took 500 mg of green tea extract daily experienced significant improvements in AST, ALT, and inflammatory markers, compared with a placebo. The treatment also reduced fatty changes in the liver (30).

Green tea intake has likewise been shown to protect against various liver conditions, including liver cancer, hepatitis, cirrhosis, fatty liver (hepatic steatosis), and chronic liver disease (31).

While drinking green tea is considered safe for most people, in rare cases, green tea extract supplements have been linked to acute liver injury (32).

Green tea and green tea extract have been linked to powerful liver-protective effects. Keep in mind that green tea extract has been associated with liver injury in rare cases.

Although chewy candy often comes to mind when thinking of licorice (Glycyrrhiza glabra), its really an herb with powerful medicinal properties (33).

Licorice root has been shown to have anti-inflammatory, antiviral, and liver-protective effects in scientific studies (33).

The main active component in licorice root is the saponin compound glycyrrhizin, which is commonly used in traditional Chinese and Japanese medicine to treat many ailments, including liver disease (33).

Some studies have demonstrated that treatment with licorice extract may benefit those with certain liver conditions.

A study in 66 people with fatty liver disease found that supplementing with 2 grams of licorice root extract per day for 2 months significantly reduced ALT and AST, compared with a placebo treatment (34).

In another small study, 6 healthy people took a glycyrrhizin product before drinking vodka every night for 12 days, and 6 people only drank vodka nightly for 12 days.

In the vodka-only group, liver damage markers, including ALT, AST, and GGT, significantly increased. In the glycyrrhizin group, these markers did not significantly increase, suggesting that glycyrrhizin may help protect against alcohol-related liver damage (35).

Although these findings are promising, more research is needed.

Whats more, some people are more sensitive to licorice, and the chronic use of licorice products can result in dangerous side effects, including high blood pressure and low blood levels of potassium (36).

Licorice supplements may benefit those with NAFLD and protect against alcohol-related liver damage. Its important to note that certain people may be more sensitive to licorice supplements, as well as that they can lead to adverse side effects.

Turmeric and its main active component curcumin have been linked to a variety of impressive health benefits.

Its well documented that turmeric has powerful anti-inflammatory, antioxidant, and anticancer properties, which makes this herb a popular choice for those with liver disease (37).

A study in people with NAFLD demonstrated that daily treatment with 500 mg of a curcumin product for 8 weeks significantly reduced liver fat content and levels of AST and ALT, compared with a placebo group (38).

Another study in 70 people with NAFLD found that those who supplemented with 500 mg of curcumin and 5 mg of piperine per day for 12 weeks had significant reductions in ALT, AST, LDL (bad) cholesterol, and inflammatory markers, compared with a placebo group (39).

Piperine is a compound found in black pepper that enhances curcumin absorption.

It was also observed that the curcumin treatment significantly improved NAFLD severity, compared with the placebo group (39).

Supplementing with turmeric and curcumin is generally considered safe. However, some cases of acute liver injury have been reported. Still, its unclear whether these cases were due to the contamination of curcumin products or the products themselves (40).

Studies show that turmeric supplements may help treat NAFLD and reduce inflammation. Turmeric is generally considered safe, but some cases of liver injury have been reported.

Although garlic is botanically considered a vegetable, its a popular component of many herbal remedies. Its packed with potent antioxidant and anti-inflammatory plant compounds, such as allicin, alliin, and ajoene, which may help support liver health (41, 42).

A 2020 study in 98 people with NAFLD found that those who took 800 mg of garlic powder per day for 15 weeks experienced significant reductions in ALT, AST, LDL (bad) cholesterol, and triglyceride levels, compared with a placebo group (42).

Whats more, 51% of the participants in the garlic group showed improvements in the severity of liver fat accumulation, compared with just 16% of the control group (42).

Another study in over 24,000 adults found that men who consumed raw garlic over 7 times per week had up to a 29% reduced risk of developing fatty liver disease. Although raw garlic intake was inversely associated with NAFLD in men, this association was not seen in women (43).

Additionally, a study linked raw garlic intake to a lower risk of liver cancer. Eating raw garlic twice or more per week was associated with a 23% reduced risk of liver cancer, compared with consuming raw garlic less than twice per week (44).

Although raw garlic is generally considered safe, concentrated garlic supplements may induce liver injury in some people (45).

Raw garlic and garlic powder have liver-protective properties and may improve liver health in those with NAFLD. Eating raw garlic may protect against liver cancer. Garlic is generally considered safe but may cause liver injury in some people.

Ginger root is a popular culinary ingredient and also commonly used as a medicinal treatment for many health conditions, including liver disease.

A 12-week study in 46 people with NAFLD found that supplementing with 1,500 mg of ginger powder per day significantly reduced ALT, total and LDL (bad) cholesterol, fasting blood sugar, and the inflammatory marker C-reactive protein (CRP), compared with placebo treatment (46).

Another study observed similar results. People with NAFLD who supplemented with 2 grams of ginger for 12 weeks experienced significant reductions in ALT, GGT, inflammatory markers, and fat accumulation in the liver, compared with a placebo group (47).

Ginger root contains powerful compounds, including gingerols and shogaols, that help inhibit inflammation and protect against cellular damage, which may help support liver health. Plus, ginger may help protect your liver against toxins like alcohol (48, 49).

Ginger is generally considered safe, even for those with liver conditions. However, you should always check with your healthcare provider before supplementing with high-dose ginger products (50).

Taking ginger supplements may help reduce liver damage and lower cholesterol, blood sugar, and inflammation in people with NAFLD. Ginger is generally considered safe.

In addition to the treatments listed above, many other herbs have been linked to improved liver health.

Danshen is a substance thats commonly used in traditional Chinese medicine. Its the dried roots of the herb Salvia miltiorrhiza Bunge. Human and animal studies have shown that danshen may have positive effects on liver health.

Animal studies indicate danshen may help protect against alcohol-related liver disease and promote liver tissue regeneration, while some human studies suggest danshen injections may help treat liver fibrosis when used alongside other herbal remedies (51, 52, 53).

Ginkgo biloba is a popular herbal supplement that has been linked to improved liver health. For example, a rodent study showed that ginkgo biloba injections reduced liver fibrosis and enhanced liver function (54).

Although ginkgo biloba has been associated with mild adverse side effects, it hasnt been linked to liver injury specifically (55).

Astragalus is an edible herb commonly used in traditional Chinese medicine. Its loaded with medicinal compounds, including saponins, isoflavonoids, and polysaccharides, which have powerful therapeutic properties (56).

Its generally considered safe and hasnt been associated with liver injury. However, it can interact with certain medications (57).

Rodent studies indicate that astragalus may help protect against fibrosis and high fat diet-induced fatty liver when used alone or in combination with other herbs (58, 59, 60).

Danshen, ginkgo biloba, and astragalus have all been associated with improved liver health in some animal and human studies. However, more research is needed.

Although some herbal treatments may help treat or prevent liver conditions, its critical for anyone interested in using herbal remedies for liver health to speak with a qualified healthcare provider first.

This is because many herbal treatments have been shown to be toxic to the liver and may be dangerous to take, especially for those with liver diseases or other medical conditions (61).

In fact, herbal medicines have been associated with liver damage and even death. Both singular herbs and herbal mixtures have the potential to cause serious damage to your liver (62).

Whats more, herbal supplements can be contaminated with heavy metals, pesticides, pharmaceuticals, and bacteria that can harm your liver (63).

Additionally, many herbs can interact with common medications, which can lead to liver injury and even death (63).

Even though certain herbs may be safe for you to use, many others arent, so you should always check with your healthcare provider before taking any herbal supplement.

Because many herbs can cause liver damage and interact with common medications, you should always check with your healthcare provider before taking any herbal supplement, especially if you have a condition that affects the liver.

Certain herbs have been associated with improved liver health, making them a popular natural remedy choice for those with liver conditions, as well as those who want to support their liver health.

Although some herbal supplements are considered safe and may even treat certain liver diseases, many others can harm liver health.

If you have questions about herbal therapies for liver disease or are interested in taking herbal supplements in hopes of supporting your liver health, always consult a knowledgeable healthcare provider for advice.

See the rest here:
The 10 Best Herbs for Liver Health: Benefits and Precautions - Healthline

Dr. Faye Yin

Dr. Faye Yin

Melanoma is a serious and life-threatening form of cancer that begins in the skin but can spread rapidly if not treated early. We sat down with board-certified oncologist Dr. Faye Yin, an oncologist at Jersey City Medical Center, to learn more about this disease, its causes and risk factors, and why its important to protect yourself from excessive sun exposure even during the cold winter months.

What are the main risk factors for developing melanoma?

Ultraviolet, or UV, light exposure is the major risk factor. Melanoma is associated with both UVB rays, which are present in sunlight, and UVA rays, which are generated by tanning beds. Other risk factors include the presence of moles on the skin. Most are benign, but those with excessive moles should consult a dermatologist, especially if they observe any changes. Often, a mole will be removed as a precautionary measure. Age is also a risk factor; the older the person, the higher the risk. People with fair skin, freckles, and lighter hair are also more susceptible, which is why melanoma is more common in white and light-skinned people. Other risk factors include family history and the presence of a weakened immune system. Those with xeroderma pigmentosum, or XP, a rare genetic disorder, are particularly at risk because the condition affects the ability of skin cells to repair themselves after UV light exposure.

What should people do if they have any of these risk factors?

As with most risk factors impacting health, there are things you can change, and things you cannot. You cant change your skin color or family history, and you cant avoid getting older. But you can limit your exposure to UV rays. A popular catchphrase that I tell my patients, which has been promoted by the American Cancer Society, is Slip, Slop, Slap, and Wrap. Slip on a shirt, slop on some sunscreen, slap on a hat, and wrap on some sunglasses. I also recommend that people avoid using tanning beds and sun lamps. Teaching children about sun safety is especially important, because they tend to spend more time outdoors and can burn more easily. It is also important for people with risk factors to pay closer attention to their skin. Keep an eye out for abnormal moles or other skin features that appear to be unusual or changing over time, and consult a dermatologist if necessary.

Can sunlight still be dangerous during winter?

Yes whether youre skiing or just going for a walk, it is great to enjoy the sun and being outdoors in the winter, but its just as important to protect yourself from excess sun exposure in winter as it is in summer. Harmful ultraviolet rays are present year-round. They can even filter through dark cloud coverage to reach your skin, increasing your risk of melanoma. Some people may experience a bad sunburn on a winter vacation, especially if they ski in high altitudes, because UV rays are usually more intense in higher regions with a thinner atmosphere. When youre outside, any uncovered areas of your body are exposed to UV rays. So, its important to wear sunscreen even in the winter months.

Is smoking a risk factor for developing melanoma, and if so, is it mostly if youre currently smoking (for instance, what if you smoked for years and stopped?)

As an oncologist, every day I tell my patients: dont smoke! Smoking is a contributing factor for many cancers, and I believe that it also affects overall skin health; I can often look at someones skin and tell whether they smoke. That having been said, we dont have evidence that smoking directly contributes to melanoma. But I always encourage patients not to smoke to stay healthy and minimize their cancer risk.

Why does having a weakened immune system count as a risk factor for melanoma?

Having a weakened immune system increases the risk of melanoma and other cancers. I have worked with many patients whose immune systems have been compromised, either by illness or in some cases due to medical treatment for other conditions. For example, immunosuppressive drugs are used after stem cell and organ transplants, to prevent the body from rejecting the transplant. Certain diseases also compromise the immune system, such as HIV. A weakened immune system increases cancer risk for two reasons. First, because the body has less ability to detect and destroy cancer cells. And secondly, because the body is more susceptible to infections that may lead to cancer.

Is gender a risk factor? If so, do we know why?

In the United States, men typically have a higher rate of melanoma than women, though this varies by age. Before age 50, the risk is higher for women, and after age 50, the risk is higher in men. We believe that this discrepancy relates to the fact that men are likely to spend more time in the sun over the course of their lifetimes. I also think that women are more likely to wear sunscreen than men, so this may play a role. In addition, men tend to have thicker skin with less fat beneath it and more collagen, and some research shows that this can make the skin more susceptible to sunlight damage. Also, some studies have shown that estrogen, which is more prevalent in women, can increase resistance to melanoma.

Are older people at higher risk for melanoma?

The risk of melanoma increases as you age. The average age for a melanoma diagnosis is age 65. But melanoma is not uncommon even among those younger than age 30. In fact, it is one of the most common cancers in young adults, especially young women. Melanoma is also more common in younger people whose families have a history of melanoma.

How does having a family history of having melanoma impact someone?

Family history is definitely a melanoma risk factor; the risk is higher among those who have one or more first-degree relatives who have had melanoma. About 10 percent of people diagnosed with melanoma have a family history. Families tend to have shared lifestyle habits, such as more frequent sun exposure, and in addition they typically have similar skin types and share certain genetic characteristics. You cant change your skin color or your genes, but you can change some factors. If you know that you are higher risk, and have a family history, pay close attention to your skin. Avoid excessive sunlight and tanning beds, and consult a dermatologist if you have concerns.

Why is UV light exposure a risk factor?

Numerous studies have shown that sun and UV light exposure is a major melanoma risk factor, especially for children and teens. Research shows that early sun exposure can damage the DNA in skin cells. Melanocytes are the cells that produce melanin, which gives skin its pigmentation, and damaging these cells can start the path to melanoma. Melanoma commonly occurs on the thighs of women, and on the trunks of men, as well as on arms and faces, which are the areas that most often receive chronic sun exposure in young people. In addition to limiting UV light exposure, people should also examine their own skin at least monthly, especially if there are high risk factors. If you see something unusual, such as a large mole or a spot youre not sure about, I will often encourage patients to take a photograph of it. You might not notice small changes over time because you get accustomed to them. But if you take a picture of a spot on your skin and compare it a month or a few months later, and you see a change, you should see a dermatologist.

See more here:
The facts about the danger of melanoma - The Hudson Reporter

Following the Food and Drug Administration (FDA)s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine on Friday, many patients with cancer who are actively receiving treatment, and those who no longer have signs of active disease, are sure to have questions as to what they should know about the vaccine.

In fact, Dr. Debu Tripathy, chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center and editor in chief of CURE, said he and his colleagues were getting questions about the distribution of the vaccine prior to its authorization by the FDA and Centers for Disease Control and Prevention.

We have been getting questions more and more frequently; all our patients want to know what the schedule is for when they might get a vaccine, said Tripathy in an interview with CURE.

To address any questions patients with cancer and survivors may have regarding the vaccine, CURE recently spoke with Drs. Debu Tripathy and Roy Chemaly, chief infection control officer and a professor in the department of infectious diseases, infection control and employee health at The University of Texas MD Anderson Cancer Center.

On Monday, the first of many high-risk health care workers started receiving the vaccine across the United States. Many frontline workers will continue to receive it over the next several weeks, including those who work directly with patients with cancer who are at a high risk for infection.

After those frontline workers, there is a process for which patients will begin to receive the vaccine, according to Tripathy.

Patients with underlying conditions at high risk for complications of COVID-19 infection will likely be a top priority to receive the vaccine. However, for patients with cancer receiving therapy, in particular, those receiving more intensive therapies like a stem cell transplant, there are still some details that need to be ironed out.

We haven't gotten into the nitty gritty in terms of how we're going to divide (the vaccine) to some extent, said Tripathy. We're going to have the physicians be involved in prioritizing this based on their knowledge because they're the ones who know the patients the best.

Chemaly also noted that the vaccine will likely be administered to patients on a case-by-case basis.

Now for cancer patients who are still under active treatment with chemo or radiation, or early after stem cell transplantation, there is no data on how effective the vaccine is, and should it be used, he said. So we're going to be a little bit more cautious and take it case by case to recommend these vaccines to our cancer patients, as we wait for more data to come out from the general population, then see how safe it is and how effective (it is) in order to really extrapolate to our cancer patients.

If a patient is no longer receiving active treatment and there are no signs of active cancer, Chemaly said, they should have a good response to the vaccine, and it will likely be safe for them to receive it as well.

Now, for other patients who (are) still in the follow-up period, not really called survivors of cancer, we're going to probably provide some guidance, for example, for recipients of a stem cell transplantation. If it's been six months from allogeneic transplantation, they're stable and recovering well from after transplant, then it is probably be safe to give it to these patients, he said. Autologous transplant could be three months from the transplantation if they have no active issues, if they are still in remission and they're stable enough to receive a vaccine.

As with any vaccine, Tripathy said, some people will have reactions, but at least there are data from healthy individuals that can be shared with patients with cancer. When those data are shared with patients with cancer, however, there will be some unknowns. For instance, will patients with cancer be able to generate antibodies and develop the same protection, and might there be unique side effects that this patient population will experience.

These are things that we will have to learn as we go, and we will, Tripathy said. As the cancer centers and practices start immunizing their patients, were going to be tracking their outcomes.

In fact, just like with any drug that receives FDA approval, there will be a process for reporting and compiling any side effects that occur when a patient receives the vaccine.

As for the individuals who developed severe allergic reactions to the vaccine in the United Kingdom, Chemaly noted that those individuals had a history of anaphylaxis, or severe allergic reactions to different antigens. And two out of those three individuals who experienced the severe reactions were already carrying an EpiPen (epinephrine), which helps to combat serious allergic reactions.

And we're prepared to intervene if someone develop(s) this kind of reaction when we give the vaccine, Chemaly said.

Everyone not just patients with cancer should expect to follow all the public health measures from wearing a mask to social distancing and frequent hand hygiene for at least another six months to one year even if vaccinated, according to Chemaly.

We need to create herd immunity (because) without herd immunity, we're not going to eliminate this virus, he said. Second, even if (you) get (a) vaccine, (it) doesn't mean (youre) not going to be exposed to the virus in the community or in your workplace. At that point, you may carry the virus and not getting sick from it or get admitted to the hospital but (you) can still transmit the virus to other people. This why masking is still so important.

Chemaly said hes received questions from patients and employees every day about their worry of receiving the vaccine. And while he said its understandable, he assures the public that the trials have been conducted under a microscope, meaning so many eyes have been watching everything that has happened.

No one is hiding anything, he said. Based on that, I advise my patients, my colleagues (and) other health care workers in the health care setting, that, what we know is (the vaccine is) safe and is effective there is no long-term side effect up to two or three months from receiving the vaccine. I, myself, feel very comfortable taking it, and I'm going to be lining up to get the vaccine as soon as it is available.

I think that we are witnessing an incredible moment in history where we rallied to do something that had never been done, and that is to get a vaccine from scratch in less than one year, Tripathy said. That is a pretty astounding technologic feat that not many people would have believed it was possible when all this started that in this short period of time; we did it.

Now, its up to patients to make an informed decision as to whether to get the vaccine, although the available data point to its potential effectiveness.

Nothing works unless you get the vaccine, he said. If you don't get the vaccine, all of this was for nothing.

However, Tripathy acknowledged why some people may be concerned and reluctant to receive the vaccine.

Things have happened in medical history where that might give some people pause, he said. There's a lot of concern about people that are underserved and minorities because there is a history of them not receiving fair treatment when it comes to medicine and clinical trials. And so, we have to go the extra mile to reassure patients. But we can't pretend that we can reassure people 100%. Just like many other decisions you make in life, you take the best information you have and you make a recommendation for other people or for yourself. All we can do is be truthful, present our recommendations and hope that a majority of people do get vaccinated.

For more news on cancer updates, research and education, dont forget tosubscribe to CUREs newsletters here.

Originally posted here:
What Patients With Cancer, Survivors Need to Know About the Emergency Use Authorization of COVID-19 Vaccine - Curetoday.com

18 months into the first serious clinical trials of CRISPR gene therapy for sickle cell disease and beta-thalassemiaand all patients are free from symptoms and have not needed blood transfusions.

Sickle cell disease (SCD) can cause a variety of health problems including episodes of severe pain, called vaso-occlusive crises, as well as organ damage and strokes.

Patients with transfusion-dependent thalassemia (TDT) are dependent on blood transfusions from early childhood.

The only available cure for both diseases is a bone marrow transplant from a closely related donor, an option that is not available for the vast majority of patients because of difficulty locating matched donors, the cost, and the risk of complications.

In the studies, the researchers goal is to functionally cure the blood disorders using CRISPR/Cas9 gene-editing by increasing the production of fetal hemoglobin, which produces normal, healthy red blood cells as opposed to the misshapen cells produced by faulty hemoglobin in the bodies of individuals with the disorders.

The clinical trials involve collecting stem cells from the patients. Researchers edit the stem cells using CRISPR-Cas9 and infuse the gene-modified cells into the patients. Patients remain in the hospital for approximately one month following the infusion.

Prior to receiving their modified cells, the seven patients with beta thalassemia required blood transfusions approximately every three to four weeks and the three patients with SCD suffered episodes of severe pain roughly every other month.

All the individuals with beta thalassemia have been transfusion independent since receiving the treatment, a period ranging between two and 18 months.

Similarly, none of the individuals with SCD have experienced vaso-occlusive crises since CTX001 infusion. All patients showed a substantial and sustained increase in the production of fetal hemoglobin.

15 months on, and the first patient to receive the treatment for SCD, Victoria Gray, has even been on a plane for the first time.

Before receiving CRISPR gene therapy, Gray worried that the altitude change would cause an excruciating pain attack while flying. Now she no longer worries about such things.

She told NPR of her trip to Washington, D.C: It was one of those things I was waiting to get a chance to do It was exciting. I had a window. And I got to look out the window and see the clouds and everything.

MORE: MIT Researchers Believe Theyve Developed a New Treatment for Easing the Passage of Kidney Stones

This December, theNew England Journal of Medicinepublishedthe first peer-reviewed research paperfrom the studyit focuses on Gray and the first TDT patient who was treated with an infusion of billions of edited cells into their body.

There is a great need to find new therapies for beta thalassemia and sickle cell disease, saidHaydar Frangoul, MD,Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute, HCA Healthcares TriStar Centennial Medical Center. What we have been able to do through this study is a tremendous achievement. By gene editing the patients own stem cells we may have the potential to make this therapy an option for many patients facing these blood diseases.

READ: For the First Time in the US, Surgeons Pump New Life into Dead Donor Heart for Life-Saving Transplant

Because of the precise way CRISPR-Cas9 gene editing works, Dr. Frangoul suggested the technique could potentially cure or ameliorate a variety of diseases that have genetic origins.

As GNN has reported, researchers are already using CRISPR to try and treat cancer, Parkinsons, heart disease, and HIV, as well.

Source: American Society of Hematology

Read the original here:
Every Patient Treated With CRISPR Gene Therapy for Blood Diseases Continues to Thrive, More Than a Year On - Good News Network

In March 2020, the World Health Organization declared COVID-19, the disease caused by the SARS-CoV-2 virus, a pandemic.

Since then, COVID-19 has affected tens of millions of people around the world, leading to new discoveries about the symptoms that can accompany the disease.

Recently, multiple case studies have suggested that persistent hiccups may be a potentially rare and unusual manifestation of COVID-19.

In this article, well discuss whether hiccups are a sign of the new coronavirus, when to contact your doctor about frequent hiccups, and other important information you should know about COVID-19.

According to the research, it is possible that hiccups are a rare sign of COVID-19.

In one recent 2020 case study, a 64-year-old man was found to have persistent hiccups as the only symptom of COVID-19.

In this situation, the subject of the study visited an outpatient clinic after experiencing a bout of hiccups for 72 hours.

Both blood testing and lung imaging were performed. They revealed evidence of infection in both lungs and low white blood cells. Follow-up testing for COVID-19 revealed a positive diagnosis.

In a different 2020 case study, a 62-year-old man was also found to have experienced hiccups as a symptom of the new coronavirus.

In this case, the subject had been experiencing hiccups for a period of 4 days before presentation to the emergency room.

Upon admission, further testing showed similar findings in their lungs, as well as low white blood cells and platelets. Again, testing for COVID-19 confirmed a positive diagnosis.

It is important to note that the studies mentioned above are only two individual case studies. They only demonstrate a potentially rare side effect of COVID-19.

More research is still needed to determine the link between chronic hiccups and the new coronavirus.

Hiccups are quite common and happen when your diaphragm involuntarily spasms or contracts. Your diaphragm is your muscle directly beneath your lungs that separates your chest from your abdomen.

Hiccups can be caused by everything from eating to swallowing air to stress, and much more.

While they can be somewhat annoying, hiccups are rarely a sign of anything dangerous. Generally, hiccups only last a few minutes although in some cases, they have been known to last for hours.

According to the National Health Service, hiccups that last longer than 48 hours are considered a cause for concern and should be addressed by a doctor.

Medical treatment options for hiccups are generally reserved for people with chronic hiccups that dont resolve on their own. Some of these treatment options may include:

For most people, hiccups will resolve on their own they generally only become a concern if they become chronic or cause other health concerns.

You should talk with a doctor if your hiccups last longer than 48 hours, as this may be a sign of an underlying health condition.

You may also need to talk with a doctor if your hiccups cause you to be unable to eat, breathe, or do anything else you would typically be able to do.

According to the Centers for Disease Control and Prevention (CDC), the most common symptoms of COVID-19 include:

Symptoms of COVID-19 can appear anywhere from 2 to 14 days after exposure to the SARS-CoV-2 virus. Depending on the severity of the disease, the symptoms can range from asymptomatic (no symptoms at all) to severe.

In some situations, COVID-19 can cause uncommon symptoms that are not listed above, such as dizziness or rash.

Even rarer, case studies like those mentioned above have shown how other unusual symptoms can be a sign of the new coronavirus.

If you are experiencing new symptoms and concerned that you may have developed COVID-19, speak with your doctor as soon as possible for testing.

While not everyone needs to be tested for COVID-19, the CDC recommends getting tested if:

There are two types of testing available for COVID-19: viral testing and antibody testing. Viral testing is used to diagnose a current infection, while antibody testing can be used to detect a past infection.

Tests are available nationwide at most local or state health departments, doctors offices, and pharmacies. Some states also currently offer drive-thru testing and 24-hour emergency testing when necessary.

We all play an important role in preventing the spread of the SARS-CoV-2 virus. The best way to reduce your risk of contracting, or spreading, this new coronavirus is to practice personal hygiene and physical distancing.

This means following the CDC guidelines for preventing the spread of COVID-19 and being mindful of your own health and testing status.

Staying informed about current and developing COVID-19 news is also important you can keep up to date with Healthlines live coronavirus updates here.

Below, youll find some CDC recommended guidelines to protect yourself and prevent the spread of COVID-19:

According to the CDC, in December 2020, a vaccine from Pfizer was granted emergency use authorization and approval for a vaccine from Moderna is expected to follow.

It may take months before most people have access to this vaccine, but there are also treatment options available.

The current treatment recommendation for mild cases of COVID-19 is recovery at home. In more severe cases, certain medical treatments may be used, such as:

As the COVID-19 situation continues to develop, so do new treatment options to help combat the disease.

Many of the symptoms of COVID-19 are commonly experienced among people who have developed the disease. However, research has suggested that some people may experience other rare and unusual symptoms.

In two recent case studies, persistent hiccups were the only outward sign of the new coronavirus. While this indicates that hiccups may be a potential symptom of COVID-19, more research is needed on this rare side effect.

Excerpt from:
Are Hiccups a Sign of the New Coronavirus? - Healthline

The Covid-19 can damage the heart both directly and indirectly, and lead to complications ranging from inflammation of the heart (myocarditis), injury to heart cells (necrosis), heart rhythm disorders (arrhythmias), heart attack, and muscle dysfunction that can lead to acute or protracted heart failure, experts said.

Covid-19 is a vascular disease that injures heart cells and muscle. It also leads to the formation of blood clots, both in the microvasculature and large vessels, which can block blood supply to the heart, brain and lungs and lead to stroke, heart attack and respiratory failure, said Dr Ravi R Kasliwal, chairman of clinical and preventive cardiology department at Medanta -The Medicity Hospital.

Also Read: Few Covid-19 deaths in Indias old-age homes, survey finds

A US study using MRI found cardiac abnormalities in 78 of 100 patients who had recently recovered from Covid-19, including 12 of 18 asymptomatic patients. Sixty patients had ongoing myocardial inflammation consistent with myocarditis, found the study, which was published in the Journal of American Medical Association Cardiology in July.

Even people with mild disease or no symptoms can develop life-threatening cardiovascular complications. Whats worrying is that this holds true for healthy adults with no pre-existing risk factors, which raise their risk of complications, said Dr Kasliwal, who recommends that everyone who has recovered from Covid-19 be screened for heart damage

Cardiac trouble

Extensive cardiac involvement is what differentiates Sars-CoV-2, the virus that causes Covid-19, from the six other coronaviruses that cause infection in humans, writes cardiologist Dr Eric J Topol, founder, director and professor of molecular medicine at the Scripps Research Translational Institute in La Jolla, California, in the journal Science.

The four human coronaviruses that cause cold-like symptoms have not been associated with heart abnormalities, though there have been isolated reports linking the Middle East Respiratory Syndrome (MERS) caused by MERS-CoV) with myocarditis, and cardiac disease with the Severe Acute Respiratory Syndrome (SARS) caused by Sars-CoV.

Also Read| Extraordinary uncertainties: Harvard prof on Covid-19, impact on mental health

Sars-CoV-2 is structurally different from Sars-CoV. The virus targets the angiotensin-converting enzyme 2 (Ace2) receptor throughout the body, facilitating cell entry by way of its spike protein, along with the cooperation of proteases. The heart is one of the many organs with high expression of Ace2. The affinity of Sars-CoV-2 to Ace2 is significantly greater than that of SARS, according to Dr Topol.

Topol notes the ease with which Sars-CoV-2 infects heart cells derived from induced pluripotent stem cells (iPSCs) in vitro, leading to a distinctive pattern of heart muscle cell fragmentation evident in autopsy reports. Besides directly infecting heart muscle cells, Sars-CoV-2 also enters and infects the endothelial cells that line the blood vessels to the heart and multiple vascular beds, leading to a secondary immune response. This causes blood pressure dysregulation, and activation of a proinflammatory response leading to a cytokine storm, which is a potentially fatal systemic inflammatory syndrome associated with Covid-19.

Persisting problems

Studies have found that injury to heart cells reflected in blood concentrations of a cardiac muscle-specific enzyme called troponin affects at least one in five hospitalised patients and more than half of those with pre-existing heart conditions, which raises the risk of death. Patients with higher troponin amounts also have high markers of inflammation (including C-reactive protein, interleukin-6, ferritin, lactate dehydrogenase), high neutrophil count, and heart dysfunction, all of which heighten immune response.

The heightened systemic inflammatory responses and diminished blood supply because of clotting, endotheliitis (blood vessel inflammation), sepsis, or hypoxemia (oxygen deprivation) because of acute lung infection leads to indirect cardiac damage, said Dr Kasliwal.

The cardiovascular damage associated with Sars-CoV-2 infection can persist beyond recovery. Since the virus affects the heart as much as the respiratory tract, further research is needed to understand why some people are more vulnerable to heart damage than others.

See the rest here:
Covid-19 can have impact on heart too, say experts - Hindustan Times

First Overall Survival Analysis for KEYTRUDA Plus LENVIMA Combination in a Phase 3 Study in Advanced Endometrial Cancer

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in OS, PFS and ORR versus chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel). The safety profile of the KEYTRUDA plus LENVIMA combination was consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, and plan to present these results at an upcoming medical meeting.

Women with advanced endometrial cancer are faced with high mortality rates and limited treatment options following initial systemic therapy, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. These are the first results from a Phase 3 trial of a combination regimen including immunotherapy in advanced endometrial carcinoma that have shown a statistically significant improvement in overall survival, progression-free survival and objective response rate versus chemotherapy. Merck and Eisai are dedicated to continuing to research the KEYTRUDA plus LENVIMA combination and discover new approaches to address unmet needs for devastating diseases such as endometrial carcinoma.

We are encouraged by the data observed in KEYNOTE-775/Study 309, which represent a possible step forward for patients impacted by advanced endometrial carcinoma and support the results seen in the advanced endometrial cancer cohort of KEYNOTE-146/Study 111, said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As more clinical data from the LEAP (LEnvatinib And Pembrolizumab) program are revealed, we cannot help but be energized by the trajectory of our collaboration with Merck and the benefits we hope to provide to patients together. Most importantly, we are grateful for the trust that the patients and healthcare professionals who participated in this trial have shown us.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administrations (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This accelerated approval was based on tumor response rate and durability of response and was the first approval granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Under Project Orbis, Health Canada and Australias Therapeutic Goods Administration (TGA) granted conditional and provisional approvals, respectively, for this indication.

Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in 13 different tumor types across 20 clinical trials, including a Phase 3 trial evaluating the combination in the first-line setting for patients with advanced endometrial carcinoma (LEAP-001).

About KEYNOTE-775/Study 309

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial ( ClinicalTrials.gov , NCT03517449 ) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following at least one prior platinum-based regimen. The dual primary endpoints are OS and PFS, as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Select secondary endpoints include objective response rate (ORR) by BICR per RECIST v1.1 and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were non-MSI-H or pMMR, and 130 patients had tumors that were MSI-H or dMMR. Patients were randomized 1:1 to receive:

About Endometrial Cancer

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2018, it was estimated there were more than 382,000 new cases and nearly 90,000 deaths from uterine body cancers worldwide (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In the U.S., it is estimated there will be almost 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys 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 industrys largest immuno-oncology clinical research program. There are currently more than 1,300 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 patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

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 HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

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. 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 (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 or Mismatch Repair Deficient 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.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

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).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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 TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently 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. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

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 an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

See the original post:
KEYTRUDA Plus LENVIMA Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective...

COVID-19 is currently the leading cause of death in the United States killing more people each day than heart disease or cancer.

To help stem the tide of this life-threatening disease, scientists around the world have been working to develop vaccines.

Last week, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first of these vaccines, developed by Pfizer and BioNTech.

The EUA allows for the distribution of the Pfizer-BioNTech COVID-19 vaccine across the United States. This vaccine has been developed to prevent COVID-19 in people age 16 years and older.

Getting 2 doses of the vaccine may drastically reduce your chances of developing COVID-19.

Even if youve had COVID-19, getting the vaccine may help prevent reinfection and lower your risk of getting sick again.

Were really happy to have a safe and effective tool [against COVID-19], Dr. Iahn Gonsenhauser, chief quality and patient safety officer at The Ohio State University Wexner Medical Center in Columbus, Ohio, told Healthline.

Were encouraging everybody to explore their opportunity to access the COVID vaccine as soon as thats made available to them, he said.

When someone develops COVID-19, their immune system learns to recognize the virus and begins to produce antibodies to fight against it.

If that person recovers from the disease, they may have immunity against reinfection with the virus for a period of time afterwards.

However, questions remain about how long that immunity lasts.

We dont know how long the immunity triggered by infection persists, and someone infected in the spring may no longer be immunologically protected now in December, Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, New York, told Healthline.

It does stand to reason that somebody with COVID-19 infection is likely immune for 3 to 4 months at least, he said, but we dont have firm data to support this yet.

Cases of reinfection with the virus that causes COVID-19 have been reported.

Getting vaccinated may help to strengthen immunity against COVID-19.

In an ongoing clinical trial, Pfizer and BioNTech have studied their vaccine in people with and without a history of exposure to the virus.

Their research to date has found the vaccine is 95 percent effective at preventing COVID-19.

Their findings suggest it may help prevent reinfection in people who have already been exposed to the virus, as well as lowering the risk of infection in people with no history of exposure.

Data from the phase 2/3 trial for the Pfizer-BioNTech vaccine suggest that the vaccine is safe and likely effective in persons with previous evidence of SARS-CoV-2 infection, said Dr. Miriam Smith, chief of infectious disease at Long Island Jewish Forest Hills in Queens, New York.

[The] vaccine should be offered to all persons regardless of history of prior symptomatic or asymptomatic infection, she said.

The Centers for Disease Control and Prevention (CDC) currently advises that people with a known history of COVID-19 may wait up to nearly 90 days after their prior infection to get vaccinated, if they prefer to do so.

While more research is needed, available evidence suggests that reinfection with this virus is rare within 90 days of initial infection.

If someone currently has active symptoms of COVID-19, the CDC recommends they wait to get vaccinated until theyve recovered and met the criteria for ending isolation.

The Pfizer-BioNTech COVID-19 vaccine carries some risk of side effects.

However, ongoing research suggests the side effects tend to be mild and short-lived.

The way that we generally approach these questions in healthcare is through risk-benefit analysis, Gonsenhauser said.

In this case, the risk of some adverse response to the vaccine is low, and the benefit of knowing that you have a potentially extended or refreshed immunity to COVID is significant, he said.

With that, were recommending that people get the vaccine, even if theyve already had a COVID exposure and infection, he continued.

The most commonly reported side effect associated with the Pfizer-BioNTech COVID-19 vaccine is pain around the injection site.

Some people who received the vaccine developed other side effects such as fatigue, headache, and muscle aches, which tend to resolve within a day or so.

The risk of severe adverse events following the vaccine appears to be very low. However, some groups of people might face higher risk of adverse reactions than others.

For example, if you have a history of severe allergic reaction to any of the ingredients contained in the vaccine, the FDA recommends that you not receive it.

Talk with your doctor to learn more about the potential benefits and risks of getting vaccinated against COVID-19.

More here:
Even if You've Had COVID-19 You Still Need the Vaccine - Healthline

SynDevRx is working to address the unmet medical need in the field of metabo-oncology by developing treatments for cancer patients who are overweight or have systemic metabolic dysfunction. Technology Networks recently spoke with Jim Shanahan,co-founder, vice president of business development and director of SynDevRx, to explore the impact of metabolic dysfunction on treatment outcomes and learn more about the companys lead compound SDX-7320.Laura Lansdowne (LL): Could you tell us about the link between cancer and metabolic hormone dysfunction?Jim Shanahan (JS): It is commonly understood that obesity increases the risk for certain cancers. What drives this effect has to do with adipose (fat) tissue, which produces a variety of hormones and cytokines that, when dysregulated (as in obesity), stimulate tumor growth and metastasis. Two of the most common and potent metabolic drivers of cancer are insulin and leptin.Insulin, produced by the pancreas in response to elevated blood glucose, stimulates tumor growth via the PI3K/Akt/mTOR pathway. Insulin resistance, often seen in people who are obese or even simply those who have excess visceral adipose tissue (i.e., belly fat) is a pathological state where peripheral tissues (i.e., liver, adipose tissue, skeletal muscle) are less responsive or unresponsive to insulin, leading to chronically high levels of fasting insulin. In the US, an estimated 88 million people have insulin resistance and in the UK, an estimated 12 million are at risk for Type 2 diabetes. This is not a new problem; almost 20 years ago, Dr Pamela Goodwin, a leader in the field, reported that High levels of fasting insulin identify women with poor outcomes in whom more effective treatment strategies should be explored. A large recent study of > 20,000 post-menopausal women showed a significantly increased risk of cancer-specific mortality with elevated insulin resistance. Despite the abundance of research showing insulin is a bad actor in cancer, insulin levels are rarely ever measured in cancer patients.Leptin is an adipocyte-derived hormone whose levels are in direct proportion to fat mass. Leptin acts as a primary regulator of normal metabolic physiology and energy metabolism. The binding of leptin to its specific receptor activates multiple signaling pathways, including the Janus kinase 2(JAK2)/ signal transducer and activator of transcription 3 (STAT3), insulin receptor substrate (IRS)/phosphatidylinositol 3 kinase (PI3K), SH2-containing protein tyrosine phosphatase 2 (SHP2)/mitogen-activated protein kinase (MAPK) and 5' adenosine monophosphate-activated protein kinase (AMPK)/ acetyl-CoA carboxylase (ACC), in the central nervous system and peripheral tissues. Importantly many of these pathways are validated oncogenic pathways commonly targeted by cancer drugs since they overlap with growth factor signaling (e.g., VEGF and bFGF, Her2). More recently it was found that leptin receptors are highly expressed on cancer cells and leptin has been shown to increase cell proliferation, inhibit apoptosis, promote angiogenesis and induce anti-cancer drug resistance. These characteristics are associated with a subset of cells in both liquid and solid tumors known as cancer stem cells (CSCs), or tumor-initiating cells, leading to the formation of metastatic lesions.Conversely, in patients with metabolic dysfunction, the secretion of a key protective adipokine called adiponectin, is reduced. Adiponectin increases insulin sensitivity, thereby reducing levels of fasting insulin. Through its receptor interactions, adiponectin may exert its anti-carcinogenic effects including regulating cell survival, apoptosis and metastasis via a plethora of signaling pathways. Adiponectin has also been shown to directly inhibit tumor growth and counter-act the tumor-promoting effects of leptin. Furthermore, levels of circulating adiponectin are inversely associated with survival outcomes in breast cancer.The role that metabolic syndrome and metabolic hormones play in cancer is significant yet frequently ignored and entirely underappreciated.LL: Some anti-cancer drugs can cause metabolic dysfunction what impact does this have on efficacy and overall treatment success?JS: The short answer is that metabolic dysfunction (independent of origin) has a decidedly negative impact on treatment outcomes and patient quality of life. Many common anti-cancer treatments induce insulin resistance, obesity, Type 2 diabetes and metabolic syndrome, such as doxorubicin, Taxol, platinum-based drugs, aromatase inhibitors, gonadotropin-releasing hormone agonist as well as newer targeted therapies, such as the PI3K inhibitor Piqray (alpelisib, Novartis), mTOR inhibitors and steroids among others. What is emerging is an understanding that these treatment-induced metabolic complications blunt the impact of the anti-cancer treatment itself and can even cause treatment resistance. Hyperglycemia and the subsequent hyperinsulinemia are common in cancer treatment. Yet, insulin levels, which are highly stimulative to many cancers, are rarely monitored and therefore rarely treated. Its an oversight in clinical practice that needs to be remedied urgently.LL: How can metabolic dysfunction and cancer growth be counteracted pharmacologically?JS: At the moment, there are no drugs for targeting tumors sensitive to metabolic hormones. This is the gap in cancer treatment we are targeting with our lead drug SDX-7320. As a stopgap, many oncologists give their patients metformin, as it has been shown to have a modest effect on cancer treatment-induced metabolic dysfunction and may even improve cancer outcomes. Occasionally, oncologists refer their cancer patients to endocrinologists for more acute metabolic care via anti-diabetic drugs like SGLT2 inhibitors. While these anti-diabetics may have clinical utility in helping control hyperglycemia, they generally have only a modest effect on hyperinsulinemia/insulin resistance or high circulating leptin levels. As difficult as they are to maintain, diet and exercise are still the best weapons in the battle against cancer treatment-induced metabolic dysfunction.LL: Can you tell us more about the companys lead compound SDX-7320, in terms of its design, mechanism of action, the indications it is being investigated for and the clinical programs currently underway?JS: SynDevRxs lead compound is SDX-7320 a polymer-drug conjugate consisting of a small molecule MetAP2 inhibitor attached via a peptide linker to a high molecular weight polymer backbone. SDX-7320 is itself inert, but in vivo, the pharmacologically active small molecule fumagillol-derivative is released from the polymer/peptide linker upon contact with lysosomal enzymes. The concept behind the drugs design was to improve the safety profile of the active small molecule by preventing it from crossing the bloodbrain barrier a known and challenging side effect of MetAP2 inhibitors. Another objective of the polymer-conjugation approach was to improve its drug-like properties, as fumagillin is unstable and poorly soluble.The active small molecule is based on fumagillin, a natural product isolated from the fungus Aspergillus fumigatus Fresenius. Fumagillin and its derivatives are potent and selective inhibitors of the enzyme, MetAP2. Covalent modification of MetAP2 by the fumagillin pharmacophore not only inhibits the aminopeptidase activity of MetAP2, but also results in decreased turnover and thus the accumulation of the inhibited protein. This results in multiple beneficial downstream effects including cell cycle arrest, modified angiogenic growth factors, improvements to the tumor immune micro-environment and amelioration of dysregulated metabolic hormones.The polymer conjugation technology yields a number of advantages of SDX-7320 over traditional small molecule fumagillin-based MetAP2 inhibitors, for example dramatically superior water solubility, excellent stability, and a highly favorable PK profile which allows for a patient-friendly dosing schedule and administration by subcutaneous injection a first for a polymer-drug conjugate. Additionally, the high average molecular weight of SDX-7320 has proven effective at minimizing the historic, class-specific CNS adverse effect observed with small-molecule fumagillin analogs.Interestingly, our expectations for the polymer-drug conjugate were that we would see absolute doses increase significantly, with respect to the small molecule doses. Decades of polymer-drug conjugation research suggested doses should increase by as much as 10x (compared to the small molecule) with little to no change in safety. In fact, we saw the opposite. In multiple head-to-head experiments, we saw greater activity with lower doses of the conjugate (in absolute drug weight terms) compared to the small molecule and with a better safety profile.SDX-7320 is being developed for the treatment of cancers that are sensitive to metabolic hormones, with our first indication being breast cancer. A Phase 1 trial of SDX-7320 was completed in 2020, in patients with advanced solid tumors. The results of this trial defined the recommended Phase 2 dose and schedule as well as demonstrated favorable effects on metabolic and angiogenic biomarkers. Clinical trials are planned in combination with standards of care in triple-negative breast cancer (TNBC) as well as in ER+/Her2- breast cancer in combination with a PI3K inhibitor (Piqray/alpelisib) in patients with a PIK3CA mutation.Jim Shanahan was speaking with Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.

Read more here:
The Link Between Cancer and Metabolic Dysfunction - Technology Networks

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to significantly improve the scientific community's insight into type 1 diabetes (T1D) through Diamyd Medical's contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Measures Initiative (TOMI) T1D integrated database.

The Phase III trial evaluated the use of the diabetes vaccine Diamyd, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. It is funded by the world's leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations' strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these robust data sets from industry led trials is critical to TOMI-T1D's work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.

"Progress towards the establishment of approved therapies for people with T1D is critically reliant on participation from our partners in industry with their data", said Simi Ahmed and Elizabeth Robertson, on behalf of the charity partnership.

"This is indeed a right step in that direction", said Colin Dayan, lead PI at Cardiff University.

"We are thrilled that Diamyd Medical is taking a leading role and championing precompetitive collaborations advancing type 1 diabetes regulatory science solutions", said Inish O'Doherty Executive Director at C-Path. "Their data will help in the construction and evaluation of a clinical trial simulation tool to assist in the development of novel therapies for type 1 diabetes patients".

"We are very honored to be part of this important collaboration -involving key stakeholders within the type 1 diabetes landscape, said Ulf Hannelius, President & CEO of Diamyd Medical. "As we are moving into an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high quality data will be integral to maximizing these efforts".

To learn more about the TOMI-T1D project visit: https://c-path.org/programs/tomi-t1d/

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent, and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact and uniting on a national stage to pool resources, passion and energy. We collaborate with academic institutions, policymakers and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

About Diabetes UK

1. Diabetes UK's aim is creating a world where diabetes can do no harm. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health condition in the UK - more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support people living with diabetes can lead a long, full and healthy life. For more information about diabetes and the charity's work, visit http://www.diabetes.org.uk

2. Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not managed well, both type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in people of working age in the UK and is a major cause of lower limb amputation, kidney failure and stroke.

3. People with type 1 diabetes cannot produce insulin. About 10 per cent of people with diabetes have type 1. No one knows exactly what causes it, but it's not to do with being overweight and it isn't currently preventable. It's the most common type of diabetes in children and young adults, starting suddenly and getting worse quickly. Type 1 diabetes is treated by daily insulin doses - taken either by injections or via an insulin pump. It is also recommended to follow a healthy diet and take regular physical activity.

4. People with type 2 diabetes don't produce enough insulin or the insulin they produce doesn't work properly (known as insulin resistance). Around 90 per cent of people with diabetes have type 2. They might get type 2 diabetes because of their family history, age and ethnic background puts them at increased risk. They are also more likely to get type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can be years before they realise they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. In addition, tablets and/or insulin can be required.

For more information on reporting on diabetes, download our journalists' guide: Diabetes in the News: A Guide for Journalists on Reporting on Diabetes (PDF, 3MB).

About Diamyd Medical

Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale metastudy as well as in the Company's European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd. Diamyd Medical also develops the GABA-based investigational drug Remygen as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO

Phone: +46 736 35 42 41

E-mail: ulf.hannelius@diamyd.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392

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SOURCE Diamyd Medical AB

Company Codes: Frankfurt:DMN, ISIN:SE0005162880, Munich:DMN, Stockholm:DMYD, Stockholm:DMYD-B.ST

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes -...

Adroit Market Research published a new research report of Global Opthalmology Pacs Market 2020-2026 presents a widespread and elementary study of the market including key business insights and the analysis of subjective views related to the market. The global Opthalmology Pacs market report examines the market position and viewpoint of the market worldwide, from various angles, such as from the key players point, geological regions, types of product and application. This Opthalmology Pacs report highlights the key driving factors, constraint, opportunities, challenges in the competitive market. It also offers thorough Opthalmology Pacs analysis on the market stake, classification, and revenue projection. The Opthalmology Pacs market report delivers market status from the readers point of view, providing certain market stats and business intuitions. The global Opthalmology Pacs industry includes historical and futuristic data related to the industry. It also includes company information of each market player, capacity, profit, Opthalmology Pacs product information, price, and so on.

The report includes the most important industry information while highlighting vital and valuable data. The report provides learning of various factors such as Opthalmology Pacs market growth, consumption volume, market trends, and business price structures throughout the forecast amount from 2020 to 2026. A detailed study report is accessible for the beneficial of audience and stakeholders. It studies the market dynamic factors including the drivers, restraints, trends, and opportunities of the global market. The report also analyze the competitive landscape of the business. Opthalmology Pacs Market is growing at high CAGR during the forecast period 20212027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Get the PDF Sample Copy of this report @ https://www.adroitmarketresearch.com/contacts/request-sample/608?utm_source=PT

Highlights of The Global Opthalmology Pacs Market Report: A clear understanding of the Opthalmology Pacs market supported growth, constraints, opportunities, encountered challenges, technological advancements, practicable study. The market review for the global market is done in context to region, share, and size. Analysis of evolving market segments in addition to a complete study of existing market segments. The performance of the market throughout 2020-2026 is being forecasted during this report. The data has been categorized and summarized based on types, regions, companies, and applications of the product. The report has examined cutthroat developments such as agreements, expansions, new product launches, and mergers in the market

Global Opthalmology Pacs market is segmented based by type, application and region.Based on Type, the market has been segmented into:

By End-Use, market is segmented into:

HospitalsAmbulatory Surgical Center (ASCS) & Specialty ClinicsOthersBy Type, market is segmented into:

Standalone PACSIntegrated PACSBy Delivery Model, market is segmented into:

Cloud/ web based modelsOn-premise modelsOthers

Browse the complete report @ https://www.adroitmarketresearch.com/industry-reports/opthalmology-pacs-market?utm_source=PT

Top Leading Key Players are:

Topcon Corporation, IBM corporation, Carl Zeiss Meditec AG, EyePACS, Heidelberg Engineering and more.

This detailed report also highlights key insights on the factors that drive the growth of the market as well key challenges that are expected to hamper the market growth in the forecast period. Keeping a view to provide a holistic market view, the report describes the market components such as product types and end users in details with explaining which component is expected to expand significantly and which region is emerging as the key potential destination of the Opthalmology Pacs market. Moreover, it provides a critical assessment of the emerging competitive landscape of the manufacturers as the demand for the Opthalmology Pacs is projected to increase substantially across the different regions.

Key Questions Answered in the Report:1. What is the size of the overall Opthalmology Pacs market and its segments?2. What are the key segments and sub-segments in the market?3. What are the key drivers, restraints, opportunities and challenges of the Opthalmology Pacs market and how they are expected to impact the market?4. What are the attractive investment opportunities within the Market?5. What is the Opthalmology Pacs market size at the regional and country-level?6. Who are the key market players and their key competitors?7. Market value- chain and key trends impacting every node with reference to companies8. What are the strategies for growth adopted by the key players in Opthalmology Pacs market?9. How does a particular company rank against its competitors with respect to revenue, profit comparison, operational efficiency, cost competitiveness and market capitalization?10. How financially strong are the key players in Opthalmology Pacs market (revenue and profit margin, market capitalization, expenditure analysis, investment analysis)?11. What are the recent trends in Opthalmology Pacs market? (M&A, partnerships, new product developments, expansions)

Table of Content:1. Industry Overview of Opthalmology Pacs.2. Manufacturing Cost Structure Analysis of Opthalmology Pacs market.3. Specialized Information and Manufacturing Plants Investigation of Opthalmology Pacs.4. Capacity, Production and Revenue Analysis.5. Price, Cost, Gross and Gross Margin Analysis of Opthalmology Pacs by Regions, Types and Manufacturers.6. Consumption Volume, Consumption Value and Sale Price Analysis of Opthalmology Pacs industry by Regions, Types and Applications.7. Supply, Import, Export and Consumption Analysis of Opthalmology Pacs Market.8. Major Manufacturers Analysis of Opthalmology Pacs industry.9. Marketing Trader or Distributor Analysis of Opthalmology Pacs.10. Industry Chain Analysis of Opthalmology Pacs.11. Development Trend Analysis of Opthalmology Pacs Market.12. New Project Investment Feasibility Analysis of Opthalmology Pacs.13. Conclusion of the Opthalmology Pacs Industry.

For Any Query on the Opthalmology Pacs Market: https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/608?utm_source=PT

About Us :

Contact Us :

Ryan JohnsonAccount Manager Global3131 McKinney Ave Ste 600, Dallas,TX 75204, U.S.APhone No.: USA: +1 972-362 -8199 / +91 9665341414

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Opthalmology Pacs Market Global Innovations, Competitive Analysis, New Business Developments and Top Companies Global Forecast to 2026 - LionLowdown

In a bid to give access to health services to people belonging to every strata of the society, December 12 is celebrated as the Universal Health Coverage Day all across the world. The theme of 2020 is Health for all: protect everyone. To end this crisis and build a safer and health systems that protect us all now. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana is the Government of Indias attempt in the direction of Universal Health Coverage and it bridges the gender gap by providing access to healthcare services to women. It is to be noted that of all the hospital admissions, 49.8% of the treatment(insights.pmjay.gov.in) hasbeen availed by women.

The 2018 Gender Gap Index of the World Economic Forum and its sub-index, Health and Survival ranked India at 108th position in the overall index and 147th out of 149 in the sub-index. Here is how Ayushman Bharat PM-JAY is empowering women in accessing healthcare services

* Families with no adult male members is one of the deprivation criteria foridentifying target beneficiaries, which will ensure the reach of the scheme to a large number of women.

* Cap of five beneficiaries from a family in earlier schemes worked against women. It was seen that families prefer to prioritise the male members over females, excluding them from availing free health care benefits. Ayushman Bharat PM-JAY does not have any ceiling on number of family members hence the right to free healthcare under the scheme is being equally exercised by male and female members of the family.

* Being a man or a woman has significant impact on health due to biological and gender related differences. The packages include a large number of health conditions that exclusively, or primarily, affect women.

* Under Ayushman Bharat, individual e-cards are being issued which gives every female beneficiary an individual sense of entitlement to claim their right to free healthcare.

Women-specific DATA points:

* Top 5 states, where women are availing higher number of treatments:

1. Tamil Nadu

2. Kerala

3. Chhattisgarh

4. Karnataka

5. Andhra Pradesh

* Top 5 specialities availed by women:

1. General Medicine

2. Obstetrics & Gynaecology

3. General Surgery

4. Medical Oncology

5. Opthalmology

6. Infectious Diseases

A lot of beneficiaries feel grateful to have been given a new lease on life and resident of Gurgaon, Santosh is one of them. Aged 44, she, her three children and her ageing in-laws were all dependent on her husband, whose sudden demise further threw the family into distress. Santosh took up the baton, where her husband left off and filled the void. The family slowly began healing and on the road to recovery. Just when things were getting back to normal, Santosh noticed that she was finding it hard to climb up and down the stairs.

However, a sense of sacrifice and service prevented her from doing anything about it. Besides, she did not want to cause anxiety in the family again. She continued as if nothing had happen, hiding her pain and discomfort and turning a blind eye to her condition.

Soon, she got to know about Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY); Haryana Health Protection Mission and the various benefits that were available under this health scheme. Since, her pain was becoming unbearable, she decided to go to a hospital and get checked. She found out that she had two blocked valves in her heart and needed immediate surgery. This timely intervention truly saved her and helped her secure the future of her children.

Besides bridging gender gap, PM JAY has been immensely successful in providinghealthcare services to the needy. As per the latest government data, 1.4 crore cashless treatments worth INR. 17, 535 crores across 24,653 (Public: Private = 54:46) empaneled hospitals have been approved under the scheme. Also, the scheme is at the forefront of battling the pandemic right now. Currently, the COVID 19 testing and treatment numbers are 10,23,651.

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Universal Health Coverage Day: Nearly 50% of the treatments under PMJAY are availed by women! - Zee Business

Milestone Scientific Inc (NYSEAMERICAN: MLSS) is a medical device research and development (R&D) group.

It designs and patents innovative injection technology and specializes in dynamic pressure sensing, which allows medics to know what the pressure at the tip of needle is at any time.

The company is advancing computer-controlled drug delivery systems that offer significant efficiency and patient comfort gains in the medical and dentistry fields.

Its wand product for dentistry, which is the group's biggest revenue earner, makes an injection at the dentist a lot more comfortable. The numbness is contained on a single tooth rather than a whole portion of the mouth.

In the medical solutions space, the firm has a CompuFlo Epidural Instrument for epidural injections, which has a 99% success in locating the epidural space on the first attempt. Done manually, the procedure can be cumbersome and time-consuming. The company believes the epidural system will become the new standard of care.

The addition to the system (for catheter patients) is its CathCheck technology which is also gaining traction.

Milestone also has a Compuflo training product to help medical students master epidurals. Milestone's CompuFlo Intra-Articular Instrument has been proven successful in administering medicaments into the intra-articular space.

The group is also looking at future products in the cosmetic surgery, opthalmic and neurosurgical sectors.

In a statement at the end of November, the group's president Arjan Haverhals said the firm's dental business continued to recover and he saw growth in dental sales during the fourth quarter of 2020.

"While we are not back to pre-pandemic levels, I am pleased to report our sales continue trending in the right direction and we anticipate revenue in the fourth quarter of 2020 to be a minimum of $1.7 million," he said.

Haverhals said such a haul in revenue would represent a 40% sequential increase versus the 3Q, which follows a 718% increase for the 3Q compared to the 2Q of 2020. And this does not include recent sales to the companys Chinese distributor of about $450,000, which will be recorded as revenue when the inventory is resold by the distributor.

We are encouraged by the current trends in both the USA and around the world, which has improved our cash flow and provides us greater financial stability along with the necessary funds for marketing and sales to continue the growth in the dental sector, he told investors.

Earlier last month, the group posted third quarter financials (to September 30), which showed revenue of $1.2 million compared to the $1.9 million it posted in the same quarter in 2019. The net loss was narrowed to $1.5 million, or $0.02 per share, versus the $2.8 million, or $0.06 a share, it posted in the comparable year-ago quarter.

In October, Milestone was awarded a group purchasing agreement with Premier, a leading group purchasing organization, with around 4,100 US hospitals and 200,000 other providers within its network.

Milestoneis also expanding its trials in major hospitals and medical schools and partnering with key opinion leaders to approach the purchasing departments of hospitals together

The company ended the three-month period with over $14 million of cash on hand, which will support marketing and other ongoing activities, it added.

President Arjan Haverhals spoke to Proactive in November this year and said the company was in good financial shape with no plans to raise capital in the short, or mid-term.

"With the cash at hand, the recovery of the dental business, we have a burn rate of about US$320,000 per quarter, and hen also with the anticipated sales of the CompuFlow, the epidural system, and the CathCheck, we really look forward to become cash positive next year."

Contact the author at [emailprotected]

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Milestone Scientific, the pressure sensing specialist, has cash in bank and eyeing growing dental sales - Proactive Investors USA & Canada

NHS Lothian revealed yesterday it had been informed that despite an agreement in 2018, the government was not in a position to fund a replacement for Edinburghs Princess Alexandra Eye Pavilion now or in the foreseeable future.

At First Ministers Questions, Lothian Conservative MSP Miles Briggs said: Plans for a replacement for the 50 year-old Eye Pavilion were at an advanced stage and contracts were awarded some two years ago. Will the First Minister personally intervene today and restore this vital funding for our NHS?

Ms Sturgeon said she was not sure the situation was quite as Mr Briggs had described. But she said she would look into it further and write to him.

She added: As is the case for governments across the UK, funding is constrained, we have to make difficult choices about funding but making sure we have fit-for-purpose, state-of-the art health facilities in every part of the country is a priority.

The new hospital was planned to be located close to the Royal Infirmary at Little France, replacing the existing pavilion in Chalmers Street, which was opened in 1969. The current building was deemed unfit for purpose several years ago.

In an email to key groups yesterday, NHS Lothian opthalmology programme manager Kathleen Imrie said in 2018 the health board had been invited by the Scottish Government to prepare an outline business case, hew hospital design plans were developed and the business case was submitted in May 2019.

We have now received the formal response from the Scottish Governments which is that unfortunately, they are not in a position to fund a new Eye Hospital now or in the foreseeable future.

I am sure you will share our disappointment at this news, especially given the enthusiasm and commitment shown by yourselves as service users, carers, and partner organisations and staff in progressing the design in support of the business case.

Despite this setback, delivery of safe, effective and efficient eye care, remains a key priority for NHS Lothian. Alternative accommodation options will be looked at, including a review of feasible modern service models. The input from service users and the significant multi-professional redesign work undertaken to date will act as a solid foundation for this.

After the festive period we will re-group to agree how we now move forward.

Mr Briggs said it was totally unacceptable that the government had refused funding for the re-provision of the Princess Alexandra Eye Pavilion.

NHS Lothian have made it clear to SNP ministers that a new eye hospital is urgently needed in Lothian.

SNP ministers have received record funding from the UK government for our health service, which they have mismanaged and not used on vital services such as a new Princess Alexandra Eye Pavilion hospital.

For too long SNP ministers have underfunded NHS Lothian and it is now clear that patients are paying the price.

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Plea to Nicola Sturgeon after Scottish Government withdraws funding for Edinburgh's new eye hospital - Edinburgh News