StemCell Therapy

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Here are the top new hypergrowth industries Im focused on right now. My research shows all of them will soon have their breaking out moment in 2021:

1.Synthetic Biology

Synthetic biology is a brand-new sector where breakthrough technology allows scientists to program living things. Im sure youve seen the DNA double helix before.

Source: edn.com

DNA is basically your bodys unique set of instructions. Its what makes you, you. Your unique DNA makeup determines what you look like, how your body functions. Think of DNA as the source code of every living thing on Earth. Synthetic biology gives us the tools to edit and create the DNA of an organism to get it to do something entirely new. Basically, it allows scientists to alter the makeup of living things.

How does it work? In short, engineers design sequences of DNA on computers. Then they physically print out those sequences and insert them into living things. This can then add beneficial character traits to a living thing.

For example, scientists already use it to make self-fertilizing plants. Joyn Bio used fake DNA to modify the microbes of plants so they can pull nitrogen gas from the air and convert it into fertilizer. Using synthetic biology, scientists have also created a reliable source of artemisinin which is used in malaria vaccines.

Fake meat pioneer Beyond Meat also harnessed this new technology to create more realistic veggie burgers. It was first to use a DNA coding sequence from soybeans to create meat that looks and tastes like beef but is actually made from vegetables.

In short, this breakthrough tech allows scientists to reprogram the operating system of plants and other organisms. Synthetic biology is hands down the most cutting-edge industry on earth right now. Just as Intels microchips and IBMs computers underpinned Americas computing revolution,Twist BiosciencesDNA synthesis platform provides the building blocks for the biology revolution.

2.Genomics

DNA carries your genetic information. Think of it as a set of instructions for your body. Mapping your DNA allows scientists to decipher your bodys unique set of instructions. By learning the secrets hidden within your DNA, doctors can tell what diseases youre likely to get. This allows them to catch problems earlier and diagnose them more accurately.

In fact, the use of DNA mapping in healthcare is exploding right now. A new prenatal test based on DNA mapping can detect hard-to-find problems with babies inside their mothers wombs. Its the fastest-growing medical test in American history.

Invitae(NVTA)is using these breakthroughs to turn Americas healthcare system on its head. In short, its building an alternate healthcare industry around DNAor geneticinformation.

By the end of 2020, Invitae will have mapped the DNA of almost one million Americans. And its creating a system where this information is used in our healthcare decisions. For example, most cancers have a genetic link. In other words, mapping DNA can help detect the disease early. And when it comes to cancer, an accurate and timely diagnosis can literally save your life.

But right now, many cancers go largely undetected. Invitae is working to change this. I see genetic mapping ushering in the era of personalized medicine in America. If you havent heard about this yet, you will soon.

In short, DNA mapping will allow you, as an individual, to know which diseases youre most at risk for. Knowing this, youll better understand the perfect foods, the perfect drugs, and the perfect exercise regimen, just for you.

But thats only stage one. The genomics industry is evolving from mapping our DNA to editing it. Gene editing promises to transform how we treat and cure disease. Humans have between 20,000 and 25,000 genes that carry the DNA instructions for our bodies. But devastating diseases like cystic fibrosis and sickle cell anemia are caused by just one error.

Gene editing is making cures for certain diseases possible for the first time in history. It has the potential to cure thousands of diseases like cystic fibrosis, Huntingtons, sickle cell anemia, and hemophilia.

Space has always been a business dominated by governments. The Space Race between America and the Soviet Union kicked off back in the 1950s. And since then, the US government has pumped $600+ billion into NASA. That dwarfs the $20 billion that private companies have invested in space.

But over the past decade, theres been a quiet revolution in the space industry. The advent of reusable rockets and innovative launch methods have slashed the cost of going to space. The cost to launch a satellite into orbit has dropped more in the past 10 years than in the entire history of space!

Rapidly declining costs are transforming space travel into a thriving business. In fact, private space investment has jumped 400% since 2013. Elon Musks intergalactic company SpaceX has launched 20+ resupply rockets to the International Space Station over the past few years. And earlier this year SpaceX sent its first two astronauts into space on its Crew Dragon capsule. It was the first privately built rocket and capsule ever to put humans into space.

Amazon founder Jeff Bezos is also pushing private space exploration forward. His company, Blue Origin, recently won a NASA contract to put Americans back on the moon. In short, the era of private space exploration is here. Over the coming years, tourists will fly into outer space, companies will figure out how to mine asteroids, and companies likeMaxar Technologies (MAXR)will continue to improve their fleets of spy satellites.

Over the past decade, investors have poured a record $26 billion into 535 space companies globally. Last year alone $5.8 billion was investeda new record. In fact, data from the Space Foundation shows the space economy generated $415 billion in revenue last year. Current industry projections peg the 2040 global space economy at between $1 and $3 trillion.

And keep in mind, government activity in space is growing once again. The Commerce Department revitalized the Office of Space Commerce, which was established over 30 years ago to help enable commercial space activities. Last December, Congress approved a $738 billion defense policy bill to create a Space Force, the sixth branch of the US military.

The core idea of artificial intelligence (AI) is a machine that learns and thinks just like you or me. Most important, it learns all by itself, without human intervention. But please understand, AI isnt one single all-knowing machine like you see in the movies. Instead, it describes intelligent computers that do ultra-specific tasks.

For example, right now machines are learning to see for the first time ever. This is the basis of the flourishing computer vision industry. Medical imaging disruptor Paige is using computer vision to revolutionize the way we diagnose cancer. Paige fed millions of real-life medical images into its computer program and taught it to detect early signs of tumors.

And it recently tested the system by scanning 12,000 medical images for potential tumors. It had never seen these images before, yet achieved near-perfect accuracy. In other words, this computer has learned to recognize cancerous tumors better than human doctors. Paige is just one example of machines performing like superhuman doctors.

Stanford researchers recently built a computer that scans MRIs to detect Alzheimers disease with 94% accuracy. Other teams are teaching computers to drive. Amazon recently acquired top self-driving car startup Zoox for $1.2 billion. Zooxs computer on wheels is so good at driving it can zip through San Franciscos busy streets without a human driver.

Then you have firms developing checkout-free grocery stores, which turns your local Whole Foods into a giant supercomputer. Earlier this year, Amazon launched its Dash Cart. The shopping cart uses computer vision algorithms and sensors to identify the items in the cart. So you can simply grab items, throw them in the cart, and walk out.

In short, these are all world-changing technologies that will make many folks rich. Many new, unique disruptions are hiding underneath the misleading banner of AI.

Do you remember when every company had a dedicated payroll department?Now most businesses outsource it to companies like Paylocity and Paycom. In fact, offloading your payroll department makes total sense. Why do it yourself when you can pay a specialist to do it for less?

And as businesses outsourced their payroll needs, Paylocity and Paycoms stocks surged. This outsourcing phenomenon isnt just confined to payroll anymore. All kinds of functions that used to be done in-house like accounting, web design, IT support, and data storage are being offloaded now. For example, most companies that need to build a website no longer hire a whole web design team. Instead, they pay firms like Shopify and Wix to handle all their online needs.

Firms still employ armies of accountants to look after their finances. But this is rapidly changing. An upstart called BlackLine has created software that automates most accounts payable and receivable jobs. It now counts major firms like Nike, Costco, and Dominos as customers. And its stock has shot up 300%+ in the past couple years.

Remember when every office in America had a dedicated server room? The in-house IT department would look after the companys systems. And ensure hackers couldnt steal valuable data.

IT departments are now shrinking rapidly. Instead of employing dozens of workers to stop hackers, companies now simply pay cybersecurity firms likeOktaandZscalera monthly fee to protect their networks.

Then you have a company likeSmartsheet, which is automating much of what project managers used to do. Its app basically allows teams to collaborate, manage, and report on work in real time. And its stock has surged 150%+ over the past couple months.

All these jobs used to be done by in-house employees. Now they are being outsourced to specialist firms. And the firms pioneering new software products have been among the best-performing stocks in the entire market.

Get my report"The Great Disruptors:3 Breakthrough Stocks Set to Double Your Money".These stocks will hand you 100% gains as they disrupt whole industries.Get your free copy here.

Originally posted here:
The Top Five Hypergrowth Industries I'm Targeting In 2021 - Forbes

One of AI's key strengths is that it is able to process vast and complicated data in short amounts of time, and help automate routine tasks to reduce the level of human intervention needed

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December23, 20205 min read

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Cancer incidence continues to grow worldwide. As per the latest figures from WHOs cancer database GLOBOCAN, 19.3 million new cases of cancer were reported in 2020.This figure is expected to rise to 27.5 million new cancer cases diagnosed each year by 2040. Thus, cancer will remain a key global health issue and utilize a significant chunk of our healthcare resources.

Many countries such as India face challenges in terms of limited healthcare resources available to treat the swelling number of cancer cases. The ratio of patients seeking care for cancer to the availability of cancer specialists is very high compared with developed countries. Indian oncologists, on average, treat a much larger number of cancer patients than their Western counterparts. The pathologist-patient ratio is also highly skewed, and hence the cancer care infrastructure in India faces enormous time pressure, with doctors having to examine a staggering amount of information to make treatment decisions, for every single cancer patient. The result is overcrowded health care facilities and long waiting periods in hospitals equipped to deal with cancer.

This is where artificial intelligence (AI) can be a game changer. One of AIs key strengths is that it is able to process vast and complicated data in short amounts of time, and help automate routine tasks to reduce the level of human intervention needed.

Application to image analysis allowing better screening and more efficient diagnosis

Early detection of cancer is the key to saving the lives of patients. A group at MIT developed a new deep learning-based prediction model that can forecast the development of breast cancer up to five years in advance. Their model was trained on mammograms and patient follow-up data to identify patterns that would not be obvious to or even observable by human clinicians. The results have so far shown to be far more precise, especially at predictive, pre-diagnosis discovery.

Wholeslide imaging is becoming routine in developed countries, which has resulted in the accumulation of digital pathology images and allowed the application of deep learning to pathological diagnosis. A deep learning convolutional neural network, or CNN, developed by a team from Germany, France and the US can diagnose skin cancer more accurately than dermatologists. In a recently reported study, the software was able to accurately detect cancer in 95 per cent of images of cancerous moles and benign spots, whereas a team of 58 dermatologists was accurate 87 per cent of the time.

Personalized medicine

By applying AI and machine learning to multiple data sourcesomics data, electronic health records, sensor/wearables data, environmental and lifestyle dataresearchers are taking first steps toward developing personalized treatments for diseases from cancer to depression. Here, AI is in action today and making great strides in cancer treatment by leveraging patient medical history and tumour characteristics to help generate multiple treatment options.

Various AI/ML models for breast cancer prognosis have successfully transitioned to clinical use. These models help accurately determine the risk of a patient suffering from a relapse, based on which treatment can be personalized. If a breast cancer patient has a low risk of relapse, then they could potentially avoid chemotherapy and all its side-effects. Other localized cancer treatments such as radiation are also increasingly relying on AI. Radiation oncologists are already using AI-driven software to create plans for personalized radiation therapy.

In the near future, AI/ML can mine large datasets (scans, blood work-up, patient follow-up from thousands of patients at one time) to detect early signs of patients who are responding to treatment, and those who are not.

Drug development

AL/ML can be applied in multiple stages of new drug discovery including designing the chemical/protein structure of drugs, target validation, investigating drug safety and managing clinical trials. The hope is that use of AI/ML in drug discovery will not only help significantly reduce thecost ofintroducing new drugs tothemarket, but also make the drug discovery process faster (currently 10-15 years including clinical trials) and more cost-effective (currently costs almost $1 billion per new drug). Companies today use deep learning software to sift through millions of possible molecules in a day or two, which would normally take months via traditional methods.

In conclusion, some AI solutions have already been deployed in clinical practice, but the industry has a long way to go.

In my opinion, AI should be seen as something that can help cancer specialists spend less time on routine tasks, reduce variability and human error rather than replace the specialists altogether. AI can sift through large data sets and aid in decision making rather than be a standalone tool for diagnosing or treating patients in a completely unsupervised environment. Also, we must ensure that the data going in to make the AI based algorithms must be of the highest quality/standards to ensure we get the most accurate algorithms in return.

With all the fears about AI making many jobs redundant, oncology could be a great example of how humans and technology can work together rather than against each other.

Read this article:
AI In Cancer Care: How It's Making a Difference In Treatment And Care - Entrepreneur

Shahid Akhter, editor, ETHealthworld, spoke to Mayur Abhaya, MD & CEO, LifeCell International, to know more about the latest advancements in Stem cell industry and how it has recovered from the Covid challenges.Impact and challenges of Covid-19 on the Stem cell industry ?One of the biggest issues faced by the stem cell industry during the pandemic was the transport of the cells after collection at birth. It needs to reach the lab within 72 hours and in the case of bone marrow stem cell from donation all the way until it reaches the patient that also has to be completed within 72 hours. The bone marrow cells cannot be handed over in courier. It has to be manually hand carried and that created a huge logistics hurdle were transplants significantly reduced in numbers because of the availability of donors and the transport issues around it.

What are the current global trends in the Stem Cell Industry at large?The recent clinical progress that has been made in the medical space of stem cell transplantation is that now cord blood is considered as a better source than bone marrow cells. This was found in a research study based in US, published in 2020. They have also shown that stem cells from the cord blood can now be used across many conditions with the same treatment protocol. Besides that, the preparation of the patient is different in different conditions but now they have simplified that and reduced the risk of death to a very, very low number. So the cord blood is preferred, as the outcomes are improving.How has Life Cell managed the scenario during the pandemic? Do let us know your challenges and the way forward plan?One of the biggest issues during the pandemic was transport, especially the flight operations because we heavily depend on them for moving the samples across the country. We had to revert to an alternate plan where we had to transport these samples through a relay network from one city to another, through a road network. Luckily LifeCell has operations across the country covering more than 250 cities. So still we had the ability to ensure that our commitment of getting the samples to the lab within those 72 hours was very much possible.

Another major milestone during this pandemic that we were able to help was to support a transplant were a child having Aplastic Anaemia needed not one but two cord blood units for the transplant and within the family they couldnt find a match. Luckily because of the LifeCell network and the inventory size of 50,000 units we were able to meet the requirements of the transplant and happy to share the outcome was very successful. So LifeCell ensures that we have appropriate training for its paramedical staff and they are also provided with the appropriate personal protective gears. There are restrictions on the entry of the team inside during the collection we work with the medical staff in the collection rooms, in the operation theatres to ensure a smooth and a well organised collection and even at the lab we have protocols that ensures hygiene and safety within the team and, the operating rooms we have for processing are also well managed.

Your future plans to ensure the smooth collection of Cord Blood?To ensure business continuity we have our teams located very close to our lab itself, you know, so about 100+ member team are placed within a Kilometer of the operating facility. We have adequate stocks, lots of the testing and the processing, consumables that we use are imported. We, at least, maintain 3 month inventory. We also have onsite power back up systems which include a month of diesel supply, month of liquid nitrogen supply and the teams also have a plan that we have a back site also with arrangements done. If for any reason we have cut off of the Chennai centre we have arrangements with an alternate lab to ensure the continuity of the operations

Link:
Stem cells from cord blood can now be used across many conditions: Mayur Abhaya, MD & CEO, LifeCell Internat.. - ETHealthworld.com

Findings from the International, Prospective ALCL-Relapse trial [NCT00317408] showed that allogeneic SCT after reinduction chemotherapy can lead to survival improvements in children and adolescents with high-risk relapsed or refractory anaplastic large cell lymphoma (ALCL), provide more insight into how to treat this population.

For patients with early-relapsed ALCL, data showed that autologous SCT wasnt effective.

Current standard chemotherapy reaches an event-free survival (EFS) of 70% at 5 years in children with ALCL, the study authors wrote. Retrospective data on the outcome of pediatric relapsed ALCL show a survival after relapse of more than 50%. In addition, there is no consensus on the optimal treatment approach in relapse, they explained.

Designed by the European Inter-Group for Childhood Non-Hodgkin Lymphoma, the prospective, stratified, multinational clinical trial was opened for patients at sites in 5 countriesthe United Kingdom, Germany, Austria, Switzerland, and the Czech Republic.

Patients were stratified according to the time of relapse, CD3 expression, and prior vinblastine therapy to 3 different consolidation approaches: allogeneic hematopoietic stem cell transplantation (SCT), autologous SCT, or vinblastine monotherapy.

Those whose disease progressed during frontline therapy (very high risk) or with a CD3-positive relapse (high risk) received allogeneic SCT after reinduction chemotherapy. Patients with a CD3-negative relapse within 1 year after initial diagnosis or prior exposure to vinblastine (intermediate risk) received autologous SCT after carmustine, etoposide, cytarabine, and melphalan (BEAM). However, this arm was terminated prematurely, and patients received vinblastine monotherapy instead. Patients with a CD3-negative relapse more than 1 year after initial diagnosis (low risk) received by weekly vinblastine monotherapy (6 mg/m2; maximum, 10 mg) for 24 months.

Investigators analyzed 105 patients; most were male and had ALK-positive tumors. The median age was 12.4 years and median time from initial diagnosis to relapsed/refractory disease was 8.5 months. Patients were recruited from April 2004 to February 2014 and the median follow-up time was 8.1 years.

At 5 years, overall survival (OS) in patients with central nervous systemnegative disease was 78% 4% and EFS, the primary endpoint, was 53% 5%.

Before termination of autologous SCT, EFS rates of patients in the very-high- (n = 17), high- (n = 26), intermediate- (n = 32), and low- (n = 21) risk groups were 41% 12%, 62% 10%, 44% 9%, and 81% 9%. The respective OS rates were 59% 12%, 73% 9%, 78% 7%, and 90% 6%.

Analyzing only the patients in the intermediate-risk group consolidated per protocol by autologous SCT, EFS and OS of 23 patients were 30% 10% and 78% 9%, respectively. The 5 patients with intermediate risk receiving vinblastine monotherapy experienced relapse again.

Compared with data from retrospective analyses, the survival of patients with refractory or relapsed ALCL reached 75% in our prospective trial, demonstrating that relapsed ALCL remains a curable disease, the study authors wrote.

The main limitation to the study was the implementation of the trial as treatment recommendation only in some countries, noted the authors. While recommendations were followed in approximately 90% of patients in the very high risk and high-risk groups, only 70% of patients in the intermediate risk group received autologous SCT, they explained.

Overall, investigators determined that patients with high-risk relapsed disease can benefit from allogeneic SCT and offer a chance for cure.

A long-term remission rate of 81% by outpatient vinblastine monotherapy, with low risk for late effects in patients with a late relapse was also observed by investigators. However, the monotherapy wasnt effective for early relapses.

Patients with early relapsed ALCL dont benefit from consolidation by autologous SCT or vinblastine monotherapy, the authors wrote. However, they may benefit from clinical trials testing a consolidation approach including new targeted therapies. Targeted agents should be tested as reinduction for all but late relapses. Given the efficacy of vinblastine in relapse, this shift-of-paradigm approach should be tested for low-risk patients front line.

More:
Allogeneic SCT Benefits Children and Adolescents With Relapsed Anaplastic Large Cell Lymphoma - OncLive

Its time to look back at some of the stories that interested Calvinayre.com readers. Here are the top five stories from the life section that captured the imagination of readers in 2020.

Turn on the Red Light if you want better eyesight

Red lights arent initially associated with healthy eyesight; most people associate red lights with negative situations stop lights, warning lights and even the red-light district. An article that appeared in The Journals of Gerontology puts a positive spin on red lights. The study found that exposure to red lights for a few minutes each day keeps eyesight in better shape as we age.

Next Jeopardy! host odds: Ken Jennings favored over TV hosts

The passing of famed television host Alex Trebek meant that Jeopardy would need a new host. Ken Jennings was chosen to step into the large shoes of Trebek, at least part time, but will he be the permanent host?

Stem Cell Therapy already helping Madonna and Mike Tyson stay young

Mike Tyson and Madonna both swear by stem celling therapy. The Material Girl made the headlines for undergoing stem cell therapy to fix a busted knee. Former heavyweight champ Tyson used the therapy to help him stay youthful. In Tysons case, it seems to have done the trick with a trilogy fight against Evander Holyfield on the cards for 2021.

Ten years in the digital trenches: life as a CalvinAyre.com writer

An industry favourite, Steve Stradbrooke took a quick walk down memory lane to celebrate a decade as a senior writer at Calvinayre.com. Stradbrooke was one of the first on the team in the early days of Calvinayre.com. Buy him a pint to hear some of his stories from the wild west days of Costa Rica to Black Friday.

NASA to give the moon Internet access, SpaceX to give it to Earth

Well end this on a positive note for 2020. Its good to know when we do our first trip to the moon, well have decent internet access. NASA partnered with Nokia to create a cellular network for the moon, while Elon Mush and SpaceX have been creating an internet network from satellites.

Check out the rest of our 2020 year in review.

Read this article:
CalvinAyre.com's most read life stories of 2020 - CalvinAyre.com

Passengers testing positive moved to separate quarantine units.

In line with a Health Ministry directive, several States have stepped up efforts to trace and test persons who have flown in or transited from the United Kingdom between November 25 and December 23, for a more infective version of the COVID-19 virus. Flights between India and the U.K. remain suspended till December 31.

Eleven persons, on board four flights, tested positive for COVID-19 in Delhi and are now admitted to the government-run LNJP Hospital. The Delhi government has also asked the hospital to create a separate isolation unit for passengers from the U.K. who test positive.

Coronavirus | New virus strain increases transmissibility, not severity: V.K. Paul

Around 950 passengers from London were tested at the airport and 11 of them were found positive, according to Genestrings Lab, which conducted the testing. A further 50 people were put under quarantine. Positive samples have been sent to the National Centre for Disease Control for genome sequencing.

In Tamil Nadu, the Health Department tracked 2,724 arrivals from or through the U.K. on different routes to the State from November 25 to December 23.

We found that 179 were double entries. The reconciled figure of those from the U.K. to the State is 2,724. Of this, till Wednesday, we have tracked 996 persons. We have lifted samples from 516 persons. So far, 203 samples have returned negative for COVID-19, Health Secretary J. Radhakrishnan said.

Coronavirus | U.K. strain unlikely to affect efficacy of vaccines, say scientists

The Health Department is also monitoring 111 persons who had moved to a different district after returning. As of Thursday, only one person a 25-year-old man who had returned from the UK by air via Delhi had tested positive and is undergoing treatment in Chennai.

In Kerala, eight persons have tested positive for COVID-19, from amongst the 1,609 travellers from the UK, who reached Kerala between December 9 -23.

As part of the intensified surveillance that has been initiated in the State, health officials have traced a total of 2,116 passengers from UK who arrived in the State till December 23.

Explained | The new coronavirus variant in Britain

All 1,609 passengers were tested using RT-PCR and they will be followed up for the next 14 days. Even those who tested negative will be re-tested using RT-PCR after the quarantine. Apart from the eight passengers who tested positive, their household contacts will also be tested using PCR.

The nasopharyngeal samples from the eight persons who have tested positive for COVID-19 will be sent to the National Institute of Virology, Pune for genome sequencing so that we may identify the virus strain. We have also identified DBT-inStem (Institute for Stem Cell Science and Regenerative Medicine), in Bangalore as another location where we can do genome sequencing, the official said.

A total of 1,016 of the 2,127 U.K. returnees who arrived in Karnataka from December 1 till December 22 have been tested. Out of them six have tested positive and their samples have been sent for genome sequencing.

No home isolation is allowed for passengers from the U.K. who test positive, irrespective of symptoms, till their genome sequencing is completed. Three persons have so far have tested positive and their genome sequencing results are awaited. The sequencing of the positive samples (done to ascertain if they are infected with the new strain of the virus) is likely to take at least four days.

Coronavirus | All international passengers arriving in Karnataka without COVID-19 negative report to be tested

Till then, those who test positive will be isolated in a separate unit in an institutional isolation facility, Jawaid Akhtar, Additional Chief Secretary (Health and Family Welfare) told The Hindu.

Seven persons, of a total 1,200, who had flown in to Hyderabad either directly or via U.K. since December 9, have tested positive for the coronavirus. The samples of these seven positive cases are being sent to the Centre for Cellular and Molecular Biology (CCMB) Hyderabad to check whether the affected persons had the mutated U.K. strain.

Coronavirus | New, more contagious strain in U.K. does not appear to be deadlier: Vivek Murthy

A press release later said officials were trying to trace the primary contacts of positive cases. The health status of those who tested negative was also being monitored. Out of 1,200 UK returnees, as many as 846 persons were traced and tested. Barring the seven, all others tested negative.

A woman who returned from the UK to Rajahmundry has been kept in isolation after testing positive. Overall, information is being gathered on 68 persons who have returned to Andhra Pradesh from the U.K. The Health Department sounded an alert on the likelihood of the spread of the new viral strain on Tuesday and stressed the need for enhanced epidemiological surveillance.

The Chittoor district administration received a list of 38 passengers who came from London via New Delhi and Bengaluru on Thursday. Efforts are on to know more details about them, according to District Medical and Health Officer (DMHO) M. Penchalaiah, who said surveillance teams had been formed to trace them.

(With Bureau inputs)

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Coronavirus | Over 6,000 travellers from U.K. traced across States - The Hindu

In 2007, scientists developed a method to determine the sexes of Atlantic walruses using only their jaws' size and shape. Researchers have now put that sexing (identification of an organism's sex) method to the test with Pacific walruses.

There was some doubt about whether this technique would work for one, Pacific walruses are significantly larger than their Atlantic counterparts. This size difference shows even in individual body parts, including the mandibles.

Yet, the team, led by Nathan Taylor at the University of Alaska, Fairbanks, persisted in applying the sex identification strategy since, if successful, it would significantly reduce the time and financial commitment needed for researching preserved, unidentified walrus specimens. To distinguish between male and female Pacific walruses, they measured the length and height of the jawbone, the minimum jawbone depth (from about the middle point of the jaw to the back), and jaw thickness.

A female Pacific walrus and a calf

USFWS via Wikimedia

The scientists had to be mindful of whether the jawbones were "not fully fused" (not fully developed, unique to juvenile walruses) or "fused" (fully developed, the sign of a mature walrus). Walruses with partially fused mandibles were likely to yield misleading results.

For example, jaws from male walruses that had not yet fully fused were similar in dimensions to mature females' jaws. To ensure the results were accurate, they could only include fully matured, fused specimens.

After measuring 67 modern specimens (33 of which were male, 24 belonging to females, and ten unknown) and 11 archaeological samples, the researchers concluded that jaw size is indeed a reliable body part to distinguish between male and female walruses. The most significant differences were jaw length and thickness, with females notably smaller in both categories.

A male Pacific walrus

Joel Garlich-Miller, USFWS, via Wikimedia

With the original sexing method now confirmed to work for Pacific walruses, scientists will be better prepared to perform several types of analyses, including measuring stable isotopes, trace elements, and hormones in study animals, with greater confidence and less risk of misidentification.

This is a crucial finding, given the insufficient data on Pacific walrus populations, and will hopefully push conservation efforts for this species forward.

Link:
Exosomes act as messengers and decoys to save healthy cells from viral infection - Massive Science

These are pretty quiet times, Stevens said. I havent left the hotel since Ive been here. And obviously no one from our side can travel unless theyre part of our tested group every single day. All of that are parts of the new unique experiences of being on the road.

Teague said he was able to spend the day after Christmas with his family after all of them tested for negative for COVID-19.

This whole season has been weird, he said. Its had its challenges and curveballs. I leave (the hotel) and then I go home, so its a different experience for me. Its different for me because Im from here. I enjoy being here this long.

Stevens said the two-game series should be something the league considers beyond the pandemic. In January, the Celtics host the Orlando Magic for two straight games and travel to Philadelphia for two. In February, they host Atlanta for a pair.

It makes sense from a travel perspective, a health perspective, Stevens said. Its not just about the COVID health part; its also about the sleep and the opportunity to not overdo it. Theyre playing all the time and if we could lessen the miles of all these teams are traveling, I think thats really important. So I like the idea of a series.

No free throws for Tatum

Jayson Tatum has yet to attempt a free throw this season despite playing 69 minutes and attempting 50 shots through the first two games. Meanwhile reserve forward Semi Ojeleye has attempted seven, including six in the Christmas Day loss to the Brooklyn Nets.

The Celtics are hoping to find a way for Tatum to score easier points, and drawing shooting fouls would help boost what has been an inconsistent offense at times.

No. 1 is, youre always looking to take what the defense gives you, Stevens said. They are very dialed into him. Hes done a good job attacking the rim I thought against Brooklyn. He could finish better at the rim. Hes gonna be such a focal point I think weve talked about trying to get a few easier baskets. Any time you can get to the line its a good thing for us because he makes them. But his lack of getting to the line has a lot more to do with our spacing and our execution that it has with his game.

Free throw attempts arent only a Tatum problem. The Celtics entered Sundays game ranked 29th in the league in free throw attempts (15). Atlanta leads the NBA with 33.5 attempts per game.

Thompson update

Tristan Thompson was again in the starting lineup on a minutes restriction because of a strained left hamstring. He has been limited to 20-plus minutes in the first two games and the Celtics have not revealed when the restriction would be lifted.

Of course Id like to be on the floor with my teammates more but Ive got to trust the training staff, he said. As games go on, hopefully theyll take that restriction [off] , so I can go out and be myself.

Thompson is a plus defender but assigning him to Kevin Durant on Friday could be perceived as an impossible task. Thompson said he relished the matchup. Durant finished with 29 points.

Ive guarded LeBron (James), KD (Durant), Steph (Curry), Kawhi (Leonard), he said. Ill take that challenge every night, I trust myself. Its totally up to the training staff. Id love to play 30 minutes right now and go full speed and go full blast.

Walker on the floor

Kemba Walker traveled with the Celtics and went through a pre-game workout that consisted of shooting 3-pointers and free throws. According to Stevens, Walker has not done anything beyond individual work but Walker did look comfortable and nimble on his left knee, which received a stem cell injection in October. The Celtics initially said Walker would return in January but the club is expected to be cautious with his recovery and it could be several weeks before he returns to action.

Gary Washburn can be reached at gary.washburn@globe.com. Follow him on Twitter @GwashburnGlobe.

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Celtics adjust to two-game series designed to reduce team travel - The Boston Globe

Despite the rapid spread of the coronavirus disease 2019 (COVID-19) that plagued not only the oncology field but the healthcare system as a whole, the treatment options for patients with countless different solid tumors and hematologic malignancies were expanded with a number of new FDA approvals indicated throughout 2020. These approvals cover updates in lung, breast, gastrointestinal (GI), and genitourinary (GU) cancers, as well as a variety of hematologic malignancies and other solid tumors.

On Twitter, Targeted Oncology asks in a poll, In what field do you think had the most impactful additions to its armamentarium? The options include lung cancer, breast cancer, hematologic malignancies, and gastrointestinal cancers.

As the year comes to a close, the FDA continues to advance the field with more approvals coming through. On Friday, December 18, 2020, alone, the FDA granted 5 indications approval. These include ponatinib (Iclusig) for treatment of adult patients withs chronic-phase chronic myeloid leukemia who have become resistant or intolerant to therapy following at least 2 prior tyrosine kinase inhibitors (TKIs), osimertinib (Tagrisso) as adjuvant treatment of patients with nonsmall cell lung cancer (NSCLC) whose tumors harbor an EGFR exon 19 deletion or exon 21 L858R mutation for use following tumor resection, the triplet regimen selinexor (Xpovio) plus bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy, oral relugolix (Relumina) for the treatment of advanced prostate cancer, and a biosimilar to rituximab (Rituxan) was approved for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis, and microscopic polyangiitis.

These approvals follow many others that have provided hope throughout the year to physicians and healthcare providers across the United States, but 1 striking area of advancements worth noting this year is the recently approved Emergency Use Authorizations for 2 separate vaccinations for the prevention of coronavirus disease 2019 (COVID-19), which plagued the world, particularly impacting oncology practices treating immunocompromised, sick patients. These approvals, including the BNT162b2 vaccination and the mRNA-1273 Moderna COVID-19 Vaccine on December 18, 2020, demonstrate a crucial step in overcoming the pandemic.

We've learned this year what we can do quickly without being overly hasty, and I think COVID-19 was the ultimate impetus for unity, Mark Lewis, MD, director, GI Oncology, Intermountain Healthcare, told Targeted Oncology. At my center, which is not primarily a research institution, we've run almost 40 trials around COVID-19, largely in-patient, but also largely driven by the clinical need and queries of our intensivists, among others. It's shown us that given the right prompt, you can actually move pretty fast, and learn things very quickly.

Despite the challenges brought on by the pandemic, the healthcare system remained dedicated to keeping patients with cancer safe. Telehealth played a major role in this, as well as other adjustments physicians and cancer centers have made in light of this pandemic. These changes are not only keeping patients safe during these unprecedented times, but they lay the groundwork for the future of treating these patients better in the community setting.

I think we've learned what has to be done at a major research institution and what can be done either at a [community] center or even in the patient's home, said Lewis. Oncology, for a long time, unfortunately, has not been very patient-centric. The idea has been, you're sick, but you need to come to us. Obviously, there are still patients that absolutely have to make that effort to come see us, but on the flipside, we've learned what we can you do remotely and what we can do to bring treatment and research to the patient rather than the other way around.

One important update in the field of oncology in light of the COVID-19 pandemic was the FDAs approval of a new dosage for pembrolizumab (Keytruda) in April 2020, reducing the frequency of clinic visits for patients with cancer. The prior dosage for this immune checkpoint inhibitor was 200 mg every 3 weeks, which remains an approved dosing option, but the newly approved dose of 400 mg is administered every 6 weeks, which is approved across all indications whether the PD-1 inhibitor is given as a monotherapy or in a combination regimen. Pembrolizumab is approved across many disease types and has also gained tumor agnostic approvals over the last few years as well.

We have these really sweeping histology agnostic approvals, and I think the biggest 1 that comes to mind for me is the FDA setting eligibility for immune therapy at a tumor mutational burden [TMB] of greater than 10 mutations/megabase. I think that was pretty amazing, said Lewis. Just in the last couple years, we've seen this shift towards histology agnosticism, whether it's about NTRK fusion proteins, which have become a unicorn in oncology that every oncologist looks for, or we're talking about microsatellite instability [MSI]-high status and eligibility for pembrolizumab.

The immune checkpoint inhibitor pembrolizumab received approval in June 2020, for use in adult and pediatric patients with unresectable or metastatic solid tumors with tissue TMBhigh who have progressed on prior therapy and have no satisfactory alternative treatment options. This marks the second tumor-agnostic approval for the agent, following a prior approval from 2017, for the treatment of patients with MSIhigh or mismatch repair deficient solid tumors.

While we have these very broad indications, now we're also seeing every cancer become a rare cancer. One thing I've seen [more of] this year is selecting out molecular subsets of disease, and a great example is the approval of pralsetinib [formerly BLU-667; Gavreto] for RET-positive tumors, whether of the lung or the thyroid, Lewis said. I think we're seeing that across the categories, which is just site of origin largely, and you can see these mutations that might occur in both lung and thyroid, for the example of RET, and presumably be targetable with the same agent.

Pralsetinib (Gavreto)gained approval in September 2020 for the treatment ofRETfusion-positive NSCLC based on findings from the phase 1/2 ARROW study (NCT03037385), and a few short months later, the RET inhibitor also received approval for use in patients with advanced or metastaticRET-mutant medullary thyroid cancer, as well as those with RET fusion-positive thyroid cancer, also supported by the ARROW data.

Similarly, selpercatinib (formerly LOXO-292; Retevmo) capsules, was approved the treatment of patients with either lung or thyroid cancer who harborRETalterations. This therapy received approval in May 2020, marking it the first approved treatment to target RET. Specifically, the indications for selpercatinib include adult patients with metastatic RET fusionpositive NSCLC, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine (RAI)refractory, if RAI was appropriate.

Several new therapies gained approval in lung cancer in 2020 across a variety of subsets. In particular, capmatinib (Tabrecta) was approved in May 2020, for the treatment of patients with metastatic NSCLC whose tumors have aMETexon 14 skipping mutation based on the findings from the phase 2 GEOMETRY mono-I study (NCT02414139). This approval fills a gap in the landscape for patients with NSCLC since no other approved therapies target the MET exon 14 mutation in advanced disease.

In March 2020, the FDA approved durvalumab (Imfinzi) as a frontline treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care chemotherapy, etoposide and carboplatin, or cisplatin, offering a new therapeutic approach to a population of patients who have had limited treatment options up until recently. The approval was based on findings from the phase 3 CASPIAN study (NCT03043872), which showed overall survival (OS) analyses favored the durvalumab arm across patient subgroups compared with chemotherapy alone.

The field of breast cancer saw a number of new advances during the year of 2020, many of which impacting patients with metastatic and advanced disease. The FDA granted approval across a number of subsets of patients, including those with HER2-positive disease, triple-negative breast cancer (TNBC), and hormone receptor (HR)-positive disease.

In each of these areas, in the very recent past, there's been a marked expansion of therapeutic options, William J. Gradishar, MD, chief of hematology and oncology, department of medicine, Betsy Bramsen Professorship of Breast Oncology, professor of medicine (hematology and oncology), Northwestern University's Feinberg School of Medicine, told Targeted Oncology. We still have a lot of work to do, patients are still dying of metastatic breast cancer, but we've made significant progress in not only preventing recurrences from developing in patients with early-stage disease, but we've also extended the survival of patients who have metastatic disease.

The FDA granted approval in February 2020 to neratinib (Nerlynx) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who received at least 2 prior anti-HER2-based regimens in the metastatic setting. This approval was based on supportive findings from the phase 3 NALA trial (NCT01808573). This study showed a 24% reduction in the risk of disease progression or death compared with lapatinib (Tykerb) and capecitabine. Prior to this, neratinib was approved for use as extended adjuvant treatment in adult patients with early-stage HER2-positive disease following adjuvant trastuzumab-based therapy.

In combination with trastuzumab (Herceptin) and capecitabine, tucatinib (Tukysa) received FDA approval for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer in April 2020, including patients with brain metastases who have received at least 1 prior line of HER2-based therapy in the metastatic setting. This approval sparked a lot of excitement in the field, receiving its indication from the FDA 4 months ahead of the Prescription Drug User Fee Act (PDUFA) target action date. The oral, small molecule TKI of HER2 received its approval based on the phase 2 HER2CLIMB study (NCT02614794), which showed a 46% reduction in the risk of disease progression or death among heavily pretreated patients with unresectable, locally advanced, or metastatic HER2-positive disease.

An abundance of new drugs in the HER2 space is a great thing because we can go from 1 therapy to the next. For patients with advanced disease, tucatinib and neratinib are examples of that; these all expand the number of options we have for patients, and tucatinib in particular shows clear evidence of activity in the brain, which is critically important, Gradishar said. In the triple-negative space, sacituzumab govitecan [Trodelvy] is an example of an antibody-drug conjugate [ADC] that has activity, and then, of course, the approval of pembrolizumab has expanded the number of treatment options we have for patients with triple-negative disease.

In April 2020, sacituzumab govitecan received accelerated approval for the treatment of adult patients with metastatic TNBC who have received at least 2 prior lines of therapy for metastatic disease, based on the findings from the phase 3 ASCENT study (NCT02574455). The study demonstrated that sacituzumab govitecan, the first ADC approved specifically in mTNBC, had induced an objective response rate (ORR) of 33.3% (95% CI, 24.6%-43.1%), and the clinical benefit rate was 45.4%, which included stable disease for at least 6 months.

The immune checkpoint inhibitor pembrolizumab plus chemotherapy was approved for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1, and this news was joined by approval of the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx as a companion diagnostic for identifying patients likely to derive benefit from this therapy. The FDA granted this approval based on the findings from the phase 3 KEYNOTE-355 clinical trial (NCT02819518), which showed statistically significant and clinically meaningful improvement in the median progression-free survival (PFS) of 9.7 months with pembrolizumab and chemotherapy compared with 5.6 months in the chemotherapy-alone arm (HR, 0.65; 95% CI, 0.49-0.86; one-sided P =.0012).

Among other updates in breast cancer, the combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) by subcutaneous injection was approved by the FDA in June 2020 for the treatment of patients with HER2-positive breast cancer that has spread to other parts of the body, as well as for the treatment of adult patients with early HER2-positive breast cancer.This approval, which came 4 months ahead of the PDUFA date, is the first regimen approved for subcutaneous administration that contains 2 monoclonal antibodies. In the FeDeriCa study (NCT03493854), Phesgo was found to have comparable efficacy and safety to the intravenous regimen of pertuzumab and trastuzumab, meeting the studys primary end point of non-inferiority.

There have been a lot of fantastic FDA approvals in the hematologic malignancy space, and obviously, we have to think about multiple myeloma, said Naveen Pemmaraju, MD, associate professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, in an interview with Targeted Oncology. When I started out as a faculty 10 years ago, there were just not that many drugs approved, and so in the multiple myeloma space now as a consequence of 5 to 10 years of clinical trials, many of which were negative, we are seeing the appearance of some of these drugs.

Multiple myeloma saw approval of a number of new indications throughout 2020, including the May 2020 approval ofdaratumumab in combination with hyaluronidase-fihj (Darzalex Faspro) as treatment of adult patients with newly diagnosed or relapsed/refractory multiple myeloma, allowing a subcutaneous dosing of daratumumab. The regimen is approved under several indications for patients with multiple myeloma based on findings from the phase 3 COLUMBIA (NCT03277105) and the PLEIADES (NCT03412565) clinical trials. This approval offers patients a more convenient therapeutic option as the fixed-dose injection is administered in approximately 3 to 5 minutes, considerably reducing the treatment burden for these patients.

The immunoconjugate targeting B-cell maturation antigen (BCMA) belantamab mafodotin-blmf (GSK2857916; Blenrep) gained approval in August 2020, for the treatment of patients with relapsed/refractory multiple myeloma who previously received at least 4 prior lines of therapy, which should include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.This is the first anti-BCMA therapy available for these patients anywhere in the world, which was supported by a unanimous vote from the FDAs Oncologic Drugs Advisory Committee. Based on findings from the phase 2 DREAMM 2 clinical trial (NCT03525678) exploring 2.5-mg/kg and 3.4-mg/kg doses, the lower dose received the FDAs recommendation as an intravenous infusion given over approximately 30 minutes once every 3 weeks.

Selinexor, the only nuclear export inhibitor approved by the FDA for use in 2 hematologic malignancies, generated excitement in the field. This includes the triplet regimen of selinexor with bortezomib/dexamethasone in multiple myeloma that gained approval in December 2020, as well as the accelerated approval for single-agent treatment with selinexor in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, who have had at least 2 prior systemic therapies, including patients with DLBCL arising from follicular lymphoma. This marks the only single-agent oral therapy approved for patients with relapsed/refractory DLBCL.

We saw a lot of movement in the DLBCL space. Up until before CAR T was approved, frankly, we had almost nothing besides chemotherapy. Now in the span of a year, we not only have CAR T-cell therapy, but we have a couple of other agents including tafasitamab which is in combination with lenalidomide and is an active antibody against CD19, Andrew M. Evens, DO, MSc, of the Rutgers Cancer Institute of New Jersey, told Targeted Oncology. Selinexor is the other FDA-approved agent that is an option for patients, so its promising to me in a very difficult disease, especially when relapsed/refractory, just to have now a multitude of agents approved.

The combination of tafasitamab-cxix (Monjuvi) with lenalidomide (Revlimid) was approved for the treatment of adultpatients with relapsed/refractory DLBCL not otherwise specified, including disease arising from low-grade lymphoma and patients who are not eligible for autologous stem cell transplant. The accelerated approval was granted on the basis of findings from the phase 2 L-MIND study (NCT02399085) on the safety and efficacy, as well as the observational retrospective cohort RE-MIND study (NCT04150328) on the real-world use of tafasitamab, the CD19-directed monoclonal antibody.

The approval of tafasitamab and lenalidomide came up this year, and that was certainly a very exciting approval. It is a very innovative chemotherapy-free approach to treatment of patients with relapsed/refractory DLBCL, Alexey V. Danilov, MD, PhD, associate professor of medicine at the Oregon Health & Science University, said to Targeted Oncology. CAR T-cell therapy in mantle cell lymphoma [MCL] has been approved this year as well, and that is also life changing for patients with MCL, where we've had very limited options in those who progressed on ibrutinib or ibrutinib and venetoclax. That's a life-changing option.

The autologous CD19-directed CAR T-cell therapy brexucabtagene autoleucel (formerly KTE-X19; Tecartus) received FDA approval for the treatment of adult patients with relapsed or refractory MCL in July 2020, based on findings from the phase 2 ZUMA-2 clinical trial (NCT02601313). According to Evens, the ORR among the first 60 patients treated and followed for at least 7 months was 93% (95% CI, 84%-98%), and the overall ORR was 85%. The 1-year PFS rate was 61%, and the estimated 1-year OS rate was 83%. Findings demonstrated cytokine release syndrome was observed in 91% of patients with 15% being grade 3 or higher in severity and none being fatal. Neurologic events, another notable side effect associated with CAR T-cell therapy, were observed in 63% with 31% being grade 3 and none being fatal.

Not every patient needs next-generation sequencing, but there are some cancer types where you can make a strong argument that is becoming almost mandatory, said Lewis. A great example from this also would be biliary tract cancers. With cholangiocarcinoma and gallbladder cancer, we know that they are underneath the umbrella groups of highly targetable mutations, whether it's IDH1 or FGFR2. Now, thankfully, it's not just an academic exercise to find the mutation because now we have a drug to pair with it, so another FDA approval I would call attention to was pemigatinib [Pemazyre] for FGFR2-driven cholangiocarcinoma because when I started, there was literally 1 drug for biliary tract cancer, gemcitabine, and now slightly over a decade later, there are a host of possibilities.

Pemigatinib received approval in April 2020, for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma who harbor an FGFR2 fusion or rearrangement, representing the first approved treatment for this indication. Findings from cohort A of the phase 3 FIGHT-202 study (NCT02924376) supported this approval, demonstrating an ORR of 36% and a median duration of response of 9.1 months in the multicenter, open-label single-arm study.

The combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin) was approved as treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not had a prior systemic therapy, based on findings from the phase 3 IMbrave150 study (NCT03434379). This study demonstrated a reduced risk of death by 42% with the combination compared with sorafenib (Nexavar) alone (HR, 0.58; 95% CI, 0.42-0.79; P =.0006). Compared with standard of care sorafenib, this regimen is the first to markedly improve survival in the frontline setting for patients with HCC in several years.

In addition, the treatment landscape for patients withHCC was enriched with an approval in March 2020 of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) in patients who have been previously treated with sorafenib. This approval allows for a new second-line option for patients with advanced HCC that has demonstrated promising improvements in OS, according to findings from the phase 1/2 CheckMate-040 study (NCT01658878). This study showed the longest duration of OS in the second-line setting for advanced HCC tested in clinical trials.

Patients with colorectal cancer (CRC) also saw a couple of new additions to the armamentarium, with 1 notable approval being the combination of encorafenib (Braftovi) and cetuximab (Erbitux) as treatment for patients with metastatic CRC with aBRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. The combination received its approval from the FDA based on findings from the phase 3 BEACON CRC study (NCT02928224), which showed significant improvements in OS and a higher response rate compared with standard treatment. Shortly after this news, the FDA granted approval to the therascreen BRAF V600E Kit (therascreen BRAF V600E RGQ PCR Kit) as a companion diagnostic for this regimen.

In the field of GU cancers, the FDA granted several approvals in 2020, providing more treatment options and hope for physicians treating patients with various diseases. In particular, several approvals in prostate cancer stood out, as well as the first and only approval of an immunotherapy that has demonstrated significant overall survival (OS) benefit in the frontline setting in a phase 3 study of bladder cancer; the FDA granted approval to frontline maintenance avelumab (Bavencio) as treatment of patients with locally advanced or metastatic urothelial carcinoma who have not progressed with frontline platinum-based chemotherapy. Avelumab maintenance extended the OS by 50% compared with best supportive care in the phase 3 JAVELIN Bladder 100 study (NCT02603432).

Overall, in my opinion, this is practice-changing because right now instead of finishing chemotherapy frontline and waiting until progression happens, we can utilize avalumab based on this study as a switch maintenance frontline approach, Petros Grivas, MD, PhD, 1 of the principal investigators in the JAVELIN Bladder 100 trial, told Targeted Oncology.

The study demonstrated a 7.1-month improvement in the median OS with frontline avelumab maintenance and best supportive care versus best supportive care alone. The median OS was 21.4 months with avelumab (95% CI, 19.9-26.1) versus 14.3 months in the control arm (95% CI, 12.9-17.9), which was a statistically significant improvement with a 31% reduction in the risk of death in the overall population (HR, 0.69; 95% CI, 0.56-0.86; 2-sidedP= .001).

In prostate cancer, the approval of 2 PARP inhibitors excited the field. In May 2020, the FDA approved olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer(mCRPC) who have deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations and have progressed following prior therapy with a new hormonal agent. The approval of this PARP inhibitor was based on findings from the phase 3 PROfound clinical trial, which demonstrated a 66% reduction in the risk of disease progression or death with olaparib versus enzalutamide (Xtandi) or abiraterone acetate (Zytiga) in patients with BRCA1/2 or ATM mutations.

A few days prior to this approval, rucaparib (Rubraca) received FDA approval for adult patients with mCRPC who have a deleterious BRCA mutation (germline and/or somatic)-associated disease and have received prior androgen receptor-directed therapy and a taxane-based chemotherapy. The TRITON trials provided supportive data for this approval, exploring the use of rucaparib in patients with mCRPC and alterations in HRR-related genes.

Olaparib was approved in prostate cancer, and rucaparib also, so around summertime, there were 2 approvals issued by the FDA. The companion diagnostic was also approved for testing for the patients, said Maha Hussain, MD, who is the Genevieve E. Teuton Professor of Medicine in the Division of Hematology and Oncology, Department of Medicine, and deputy director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, in an interview with Targeted Oncology. What I'm looking forward to is more approvals from the FDA in prostate cancer. I have to say in my career time, the last 10 years have been really tremendous in terms of the approvals from the FDA in the castration-resistant space. It's exciting times. We've been set back by COVID-19, but I do think that we are on a move forward and an upward ladder, so to speak, in terms of better research, and looking forward to much better times and 2021 and onwards.

The FoundationOneLiquid CDx approval was expanded as a companion diagnostic for olaparib in November 2020. The test was initially granted approval in August 2020 for the indication of patients with any solid tumor. This olaparib indication followed news from October 2020, indicating FoundationOne CDx as a companion diagnostic to identify patients who may receive benefit from rucaparib, alectinib (Alecensa), or alpelisib (Piqray), which are approved in different solid tumors. In the prostate cancer space, the companion diagnostic is used to identify BRCA1/2 and ATM genes in patients with mCRPC who are eligible for treatment with olaparib.

There is a lot of excitement about PARP inhibitors, and there are many PARP inhibitors right now that are undergoing evaluation in prostate cancer, which is exciting, said Hussain. The research in prostate cancer has really blossomed in an incredible way at multiple fronts, and so I do think we're seeing acceleration in terms of the research and its outcomes.

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Experts Reflect on Most Impactful FDA Moves of 2020 in Solid Tumors, Hematologic Malignancies - Targeted Oncology

FDAs decision will enable CytoDyn to respond to ongoing requests for leronlimab until Phase 3 trial data is unblinded

VANCOUVER, Washington, Dec. 22, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a treating physician has received authorization from the U.S. Food and Drug Administration (FDA) to administer leronlimab for a COVID-19 patient under emergency IND (eIND).

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, We are very thankful the FDA is allowing severe-to-critical COVID-19 patients access to Vyrologix (leronlimab) again under eIND while we await the unblinding of data from our recently completed Phase 3 registrational trial. We are receiving daily requests from families seeking our drug for a loved one with COVID-19. In recent months, leronlimab received more than 60 eIND authorizations from the FDA, and during the pendency of our COVID-19 trials, we deferred seeking authorizations for eINDs in order to accelerate the pace of enrollment. Now that enrollment has been completed, we are pleased to be able to assist once again and remain hopeful the upcoming results of our Phase 3 trial will enable leronlimab to be more readily available for severe-to-critical COVID-19 patients.

CytoDyns Phase 2b/3 trial to evaluate the efficacy and safety ofleronlimabfor patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix (leronlimab) Following Full Enrollment in CytoDyn's Phase 3 Trial...

JERUSALEM and MUMBAI, India, Dec. 21, 2020 /PRNewswire/ -- VOTIS Subdermal Imaging Technologies, Ltd., an Israeli corporation, and ii Ventures Private Limited (iiV), an Indian company, announced today that they have entered into a memorandum of understanding to develop a system to screen the largely rural Indian population for peripheral artery disease (PAD). The devices, which allow for the early detection of the disease before tangible symptoms appear, will utilize the same technology that VOTIS is building into other devices intended for use in the US and Europe.

"PAD afflicts between 41 and 54 million Indians. Many of these people are impoverished, illiterate, and lack access to good healthcare," said Alfred Arambhan, Co-Founder and Mentor of iiV. "There is a great need for a system that is convenient, accurate, and affordable. We have found it in the VOTIS technology."

"In India, access to healthcare among the rural population is extremely limited," Mr. Arambhan explained. "Preventative healthcare is especially difficult to implement. In poor rural communities, preserving feet is crucial. Since rural life is agricultural, when someone loses a foot to amputation he is in a particularly desperate economic state, even as compared to the urban poor."

Mr. Arambhan continued, "India has been declared the Diabetic Capital of the world. Our initial plan is to establish VOTIS solutions in villages throughout India, and to create a robust and reliable platform for introducing and launching similar devices and solutions in the future. We are gratified that our plan has received encouragement and support from Governmental, private, and NGO sources in India."

"Our technology is especially suited for the Indian market," said Merrill Weber, Chief Executive Officer and President of VOTIS. "Our devices are entirely non-invasive and do not use X-rays (Roentgen) or other ionizing radiation. They are inexpensive and dependable. In India, the screening devices will enable easy, intuitive use. That will permit testing to be performed by technicians and nurses in the villages rather than medical doctors at hospitals or clinics. People found to have PAD will immediately be directed to specific locations where they can receive suitable medical treatment. With early disease identification and quick access to medical care, we expect incidence of PAD-related amputation to be reduced substantially."

Mr. Arambhan added, "We look to this plan to be a game changer in the Preventive Health Care Space in India."

The VOTIS devices use vascular optical tomographic imaging, or VOTI, an imaging technology developed under the leadership of Prof. Andreas Hielscher, professor and chair of the newly-formed Department of Biomedical Engineering at the New York University Tandon School of Engineering. The technology was developed in Prof. Hielscher's biophotonics and optical radiology laboratory, which he ran as professor of biomedical engineering, radiology and electrical engineering at the Fu Foundation School of Engineering and Applied Sciences at Columbia University.

VOTIS plans to release its devices commercially in 2022.

About VOTIS Subdermal Imaging Technologies, Ltd.

VOTIS Subdermal Imaging Technologies, Ltd. is an Israeli corporation that is developing a suite of devices that will be used to help diabetic patients keep their feet. The first device, the PedCheck, will be used to screen the feet of asymptomatic patients for PAD. If PAD is found, then the second device, the PedScan, will be used to stage and monitor disease progression and the impact of therapies applied by the patient's physician. The third device, the PedFlo, will be used during a revascularization procedure, in order to inform the practicing doctor regarding the level of blood flow in the foot. All three VOTIS devices use the same technology, software, and system architecture. They are safe, non-invasive, and free of ionizing radiation. More information is available at http://www.votis.net.

About ii Ventures Private Limited

ii Ventures Private Limited was Co-Founded and Mentored by Alfred Arambhan an early well-wisher of Israel India Business & Cultural relationship for the last 18 years. He is a Mumbai-based Serial Entrepreneur. Mr. Arambhan founded iiV to bring Israeli knowhow, technology, and experience to India in the Health, Agri, and Deep Tech space. iiV has been invited by a Singapore based US$50 Million fund to partner in their Business Plan. Mr. Arambhan's daughter, Pooja Armbhan, is CEO of iiV. She is an Israel-Asia Fellow who received her MBA from Tel Aviv University on a full scholarship from the Parasol Foundation.

For further information, contact: Merrill WeberTel.: (312) 340-0895Tel.: +972-(0)58-406-2386Email: merrillweber@votis.net

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SOURCE VOTIS Subdermal Imaging Technologies, Ltd.

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VOTIS Subdermal Imaging Technologies And ii Ventures Announce Plans To Develop Preventative Medicine Devices To Screen For Peripheral Artery Disease...

STEAMBOAT SPRINGS Fostering good health is about more than just avoiding COVID-19: from dealing with chronic pain to practicing self-care, here are tips from local providers for having a healthy new year.

An ounce of prevention: From cancer screenings to staying up to date on vaccinations, preventative medicine is a key part of fostering good health.

Were trying to reinforce healthy lifestyle habits to keep people healthy for decades to come, said Dr. Kevin Borgerding, an internal medicine physician in Steamboat Springs and a member of the medical staff at UCHealth Yampa Valley Medical Center. Its about disease prevention and health maintenance, or trying to maintain the best health we can for the long term so were not struggling as we mature.

Having a regular physical will help you ensure your health is on track. Recommendations on screenings, blood tests and vaccines vary by age and health conditions, so work with your provider to know whats best for you.

Address chronic pain: When overactive nerves are messaging theres pain even after an injury has healed, it can be helpful to address them with a multi-pronged approach to calming them down. That includes interventional steps such as neural stimulation, needling procedures and pain medication, as well as physical therapy, acupuncture, massage and behavioral health treatments.

Keep in mind that the increased stress and isolation at this time can be especially challenging for people dealing with chronic pain.

Anxiety can escalate pain. Social isolation can escalate pain. Lack of opportunities to exercise and recreate can escalate pain, said Amy Goodwin, a licensed professional counselor and behavioral health specialist with UCHealth Yampa Valley Medical Center. Its more important than ever for people to seek help when they need it.

Support your anxious child: In a year that seems filled with anxiety, you may find your child struggling.

Keep in mind that its normal for children to experience anxiety, as long as it is transient and can be calmed with reassurance from a parent.

But if a childs fear or worry is intense, doesnt resolve with reassurance, or interferes with how the child functions at home or school, they may have an anxiety disorder.

Anxiety is the most common emotional problem in children, affecting 8% of children ages 3 to 17, said Dr. Sheila Fountain, a pediatrician in Steamboat Springs and a member of the medical staff at UCHealth Yampa Valley Medical Center. That number increases to 25% if we look at just 13- to 18-year-olds.

Through a combination of cognitive behavioral therapy, a healthy lifestyle and sometimes medication, children struggling with an anxiety disorder often see signs of improvement in two to four weeks.

Practice self-care: Theres no doubt its been a stressful year, which makes finding ways to take care of yourself more important than ever. Self-care involves a range of efforts, from regular movement and healthy eating, to mental and social health.

Self-care will allow you to incorporate more fun into your life, to create more room for joy, said Molly Lotz, a behavioral health social worker with UCHealth Yampa Valley Medical Center. Youll feel better and your anxiety will decrease.

When incorporating self-care into your routine, start small and dont forget the fun parts, such as incorporating play and laughter.

And remember that taking care of yourself allows you to better care for those you love.

If our tank is empty, something is going to suffer our health, our relationships, Lotz said. But if were prioritizing what we need and what makes us feel healthy and good, then were automatically more available for the other people in our lives.

Susan Cunningham writes for UCHealth Yampa Valley Medical Center. She can be reached at cunninghamsbc@gmail.com.

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Monday Medical: Tips for a healthy New Year - Steamboat Pilot and Today

TipRanks

Semiconductors are one of the modern worlds essential industries, making possible so much of what we rely on or take for granted: internet access, high-speed computers with high-speed memory, even the thermostats that control our air conditioning there isnt much, tech-wise, that doesnt use semiconductor chips.With the end of 2020 in sight, its time for the annual ritual of evaluating the equities for the New Year. Wells Fargo analyst Aaron Rakers has cast his eye on the chip industry, tagging several companies as likely gainers next year.The analyst sees several factors combining to boost demand for chips in 2021, including cloud demand, new gaming consoles, and a market resolution to the future of the PC segment. Overall, however, Rakers expects that memory chips and 5G enabled chips will emerge as the drivers of the industry next year. The analyst expects that semiconductor companies, as a group, will see between 10% and 12% growth over the next 12 months.Thats an industry-wide average, however. According to Raker, some chip companies will show significantly higher growth, on the order of 30% to 40% in year ahead. We can look at those companies, along with the latest TipRanks data, to find out what makes these particular chip makers so compelling.Micron Technology (MU)Among the leading chip makers, Micron has staked out a position in the memory segment. The company has seen its market cap expand to $78 billion this year, as shares have appreciated 32% year-to-date. The surge comes on a product line heaving on computer data storage, DRAM, and flash storage.Look back at 2020, Micron has seen revenues increase each quarter, from $4.8 billion in Q1 to $5.4 billion in Q2 to $6.1 billion in Q3. Earnings came in at 87 cents per share, up from 71 cents in Q2 and 36 cents in Q1.The calendar third quarter was Microns 4QFY20, and the full fiscal year showed a decline due attributed to the COVID pandemic. Revenue came in at $21.44 billion, down 8.4% year-over-year, and operating cash flow fell to $8.31 billion from $13.19 billion in FY19. During this past quarter, Microns 1QFY21, the company announced the release of the worlds first 176-layer 3D NAND chip. The new chip promises higher density and faster performance in flash memory, and the architecture is described as a radical breakthrough. The layer count is 40% higher than competing chips.Looking ahead, Micron has updated its F1Q21 guidance, predicting total revenue of $5.7 billion to $5.75 billion. This is a 10% increase from the previous guidance.Wells Fargo's Aaron Rakers calls Micron his top semiconductor idea for 2021. He points out a deepening positive view on the memory, and in particular the DRAM industry. DRAM accounts for approximately two-thirds of Microns revenue and over 80% of the companys bottom-line profits. In addition, Rakers notes Microns technology execution 1Znm DRAM leadership; recently outlined 1nm ramp into 2021, as well as Microns move to 176-Layer 2nd -gen Replacement Gate 3D NAND to drive improved cost curve. We would also highlight Microns execution on graphics memory (e.g., GDDR6X), Multi-Chip Packages (MCPs), and High-Bandwidth Memory (e.g., HBME2) as positives.In line with these comments, Rakers rates Micron shares a Buy, along with a $100 price target. This figure suggests room for 41% growth in 2021. (To watch Rakers track record, click here)Micron has 24 recent reviews on record, breaking down to 19 Buys, 4 Holds, and 1 Sell, and giving the stock a Strong Buy from the analyst consensus. Shares are priced at $70.96, and recent appreciation has pushed them almost to the $74.30 average price target. But as Rakers outlook suggests, there may be more than just 4.5% upside available here. (See MU stock analysis on TipRanks)Advanced Micro Devices (AMD)With $6.5 billion in total sales last year, and a market cap of $110.7 billion, AMD is a giant company but it doesnt even crack the top five of the worlds largest chip makers. Still, AMD has a solid position in the industry, and its x86 processors provide stiff competition for market-leading Intel (INTC). AMD shares have shown solid growth this year, and are up 101% as 2020 comes to a close.The share growth rides on the back of steady revenue gains since the corona crisis peaked in Q1. AMDs Q3 top line came in at $2.8 billion, up 55% from the $1.8 billion recorded in the year-ago quarter and beating the forecast by 10%. Earnings, at 37 cents per share, were up 220% year-over-year. The company credited the growth to solid results in the PC, gaming, and data center product lines, and boasted that it was the fourth consecutive quarter with >25% yoy revenue growth.AMD announced last month a new product for the scientific research market, the Instinct MI100 accelerator. The new chip is billed as the worlds fasted HPC GPU, and the first such x86 server to exceed 10 teraflops performance.Covering AMD for Wells Fargo, Rakers wrote: We remain positive on AMDs competitive positioning for continued sustained gradual share gains in PCs We also believe AMDs deepening data center GPU strategy with new Instinct MI100 GPUs and the release of RoCM 4.0 software platform could become increasingly visible as we move through 2021. AMDs roadmap execution would remain an important focus 7nm+ Ryzen 4000-series, new RDNA Radeon Instinct data center GPUs (MI100 / MI120), and the 3 rd -gen 7nm+ EPYC Milan CPUsRakers stance supports his Buy rating, and his $120 price target implies a 30% one-year upside to the stock.The Moderate Buy analyst consensus view on AMD reflects some residual Wall Street caution. The stocks 20 recent reviews include 13 Buys, 6 Holds, and 1 Sell. AMD shares are selling for $91.64, and like Micron, their recent appreciation has closed the gap with the $94.71 average price target. (See AMD stock analysis on TipRanks)Western Digital Corporation (WDC)Closing out the Wells Fargo picks on this list is Western Digital, a designer and manufacturer of memory systems. The companys products include hard disk drives, solid state drives, data center platforms, embedded flash drives, and portable storage including memory cards and USB thumb drives. WDC has had a tough year in 2020, with shares down 19% year-to-date. Still, the stock has seen gains in November and December, on the heels of what was seen as a strong fiscal 1Q21 report.That earnings report showed $3.9 billion in revenue, which was down 3% year-over-year, but the EPS net loss, at 19 cents, was a tremendous yoy improvement from the 93-cent net loss in the year-ago quarter. The earnings improvement, which beat the forecast by 20%, was key for investors, and the stock is up 30% since the quarterly report. The company also generated a solid cash flow in the quarter, with cash from operations growing 111% sequentially.Wells Fargos Rakers acknowledges WDCs difficulties in 2020, but even so, he believes that this is a stock which is worth the risk.Western Digital has been our toughest constructive call of 2020 and while we believe calling a bottom in NAND Flash (mid/2H2021?) remains difficult and WDs execution in enterprise SSDs will remain choppy, our SOTP analysis leaves us to continue to believe that shares present a compelling risk / reward. We continue to believe that Western Digital can drive to a ~$7/sh.+ mid-cycle EPS story; however, we continue to think a key driver of this fundamental upside will not only be a recovery in the NAND Flash business, coupled with WDs ability to see improved execution in enterprise SSDs, but also a continued view that WDs HDD gross margin can return to a sustainable 30%+ level, Rakers opined.To this end, Rakers rates WDC a Buy along with a $65 price target. Should the target be met, investors could pocket gains of 29% over the next months Where does the rest of the Street side on this computer-storage maker? It appears mostly bullish, as TipRanks analytics demonstrate WDC as a Buy. Out of 11 analysts tracked in the last 3 months, 7 are bullish, while 4 remain sidelined. With a return potential of 9%, the stocks consensus target price stands at $54.44. (See WDC stock analysis on TipRanks)To find good ideas for tech stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Deep Longevity Adds Three Medical Organizations To Its Growing Longevity Network: Healthy Hire Healthy Retire, International Medical Clinics and Peak...

Moderator

Joseph Eron, MDProfessor of Medicine, Division of Infectious DiseasesUniversity of North Carolina School of MedicineChapel Hill, NC

Panelists

Allison L. Agwu, MD, ScMAssociate Professor of Pediatric and Adult Infectious DiseasesJohns Hopkins University School of MedicineBaltimore, MD

Ian Frank, MDProfessor of MedicineUniversity of Pennsylvania Perelman School of MedicinePhiladelphia, PA

Colleen F. Kelley, MD, MPHAssociate Professor of Medicine, Division of Infectious DiseasesEmory University School of MedicineAtlanta, GA

Julia Marcus, PhD, MPHInfectious Disease EpidemiologistAssociate Professor, Department of Population MedicineHarvard Medical School and Harvard Pilgrim Health Care InstituteBoston, MA

New antiretroviral drugs with unique mechanisms of action and delivery provide promising options for treatment and pre-exposure prophylaxis (PrEP) of HIV infection and may improve adherence in certain subgroups of individuals. However, the development of an effective vaccine remains elusive, according to experts who participated in a recent Contagion Peer Exchange panel.

Emerging Treatment Options for HIV

Fostemsavir (formerly BMS-663068/GSK3684934), a prodrug whose active metabolite (temsavir) is a first-in-class attachment inhibitor that binds directly to the viral envelope glycoprotein 120 near the CD4+ binding site,1 was approved by the FDA on July 2, 2020, for adults living with HIV who have tried multiple HIV medications and whose infection cannot be treated with other therapies because of resistance, intolerance, or safety reasons.2 This approval was based largely on results from a phase 3 trial, which showed a virologic response (HIV-1 RNA <40 copies/mL) at week 48 in 54% of patients with heavily pretreated, multidrug-resistant HIV infection who received fostemsavir plus optimized background therapy.3 Session moderator Joseph Eron, MD, said that its oral dosing is advantageous over ibalizumab, which is dosed intravenously, although he said that fostemsavir will probably be limited for patients with few or no treatment options.

Allison Agwu, MD, added that long-acting injectable and oral agents, capsid inhibitors, and monoclonal antibodies are also being studied in the HIV space, as are alternative delivery approaches, such as subcutaneous injections, pumps, implants, and patches. However, she pointed out that access to and the cost of these novel options will be key issues moving forward, particularly when currently available oral agents are highly effective for suppressing HIV viral load in the majority of cases.

The discussions well have to have on how and who and where are going to be very important, said Agwu. It doesnt mean we shouldnt have those discussions because for the people who are living with HIV, these are maybe life-saving, game-changing remedies for them.

Long-Acting Injectable Therapies to Treat HIV

The panelists discussed potential uses and challenges with the long-acting injectable therapy containing cabotegravir (an HIV-1 integrase strand-transfer inhibitor) and rilpivirine (a non-nucleoside reverse-transcriptase inhibitor), which is injected in 2-mL doses in the gluteus medius every 4 weeks for the maintenance of virologic suppression in patients who are initiating or transitioning therapy. Although the FDA declined to approve the combination in December 2019 due to concerns related to chemistry manufacturing and controls, the drug manufacturer (ViiV Healthcare) stated that no related safety issues have been reported and the safety profile of the products has not changed. ViiV Healthcare submitted another new drug application that was accepted in April 2020.

Colleen Kelley, MD, said that a benefit of long-acting injectable dosing is that it may help reduce the internalized stigma for many individuals living with HIV who take a daily oral medication. Its a constant reminder when you have that pill bottle on your bathroom stand that says, I am HIV positive, she noted.

However, the panelists pointed out potential drawbacks with long-acting injectables, such as the risk for drug resistance in patients who miss injections and the possible need to modify the clinic set-up to ensure availability of nursing staff when patients are receiving injections.

Although there may be some adherence problems that get solved by the injections, I think that there are other adherence risks that get created, said Ian Frank, MD. Itll be more incumbent upon us as providers to ensure that our patients are coming in at the appropriate frequency, and we may need to modify our practices.

Long-Acting Injectables as Pre-Exposure Prophylaxis

Long-acting injectable therapy with cabotegravir may provide a discreet option for PrEP that does not require daily dosing, according to a recent interim analysis of the phase 2b/3 HPTN 083 trial (NCT02720094).4 The interim results from the trial showed that cabotegravir injection every 8 weeks was superior to daily oral emtricitabine/tenofovir (Truvada) for preventing HIV acquisition in cisgender men who have sex with men and transgender women who have sex with men.4

To have population-level effectiveness, long-acting injectable PrEP needs to cater to a population of individuals who are eligible for and interested in receiving it but are not interested in daily oral PrEP, according to Julia Marcus, PhD. If the only people who are interested in long-acting PrEP are people who are already taking daily PrEPits not going to have any population-level effectiveness, she said.

Marcus added that identifying individual barriers to receiving oral PrEP is important to assess whether long-acting injectable PrEP is appropriate for them, noting that it would be more likely to benefit an individual who forgets to take daily medications than one who has difficulty with coming into the clinic.

If their [issue is] that they dont want to be coming into the clinic every 3 months, long-acting injectables may not help them, she said. They may have to come in even more.

Other individuals who may be good candidates for long-acting injectable PrEP include those for whom having oral medication may put them at risk for bodily or emotional harm, such as people in unequal power relationships, commercial sex work, or homeless living situations, said Eron and Marcus. Individuals who use injectable drugs or are on methadone maintenance may also be good candidates for PrEP if they come in frequently for syringe changes, said Marcus.

Agwu added that long-acting injectable PrEP could also expand the options in the armamentarium for a given patient at different times of their life.

If a patient has to go abroad for 2 months, maybe thats the time to get your shot, she said. You dont have to worry about taking your pills to Morocco.

She said that further work is needed to optimize system and administration issues and improve practices for delivering long-acting injectable therapy in the clinic. Eron concluded that further research to ensure the efficacy and demedicalization of PrEP is important to improve uptake, as the perception that PrEP care is more intensive than HIV care continues to persist among individuals who are eligible for PrEP.

Preventative and Therapeutic HIV Vaccines

Although the phase 2b/3 HVTN702 trial (NCT02968849), which studied the RV144 Thai vaccine regimen for the prevention of HIV infection in South Africa, was recently discontinued because of a lack of efficacy, Kelley said that this outcome does not mark the end of the journey for finding an effective vaccine, which will be the key to ending the HIV epidemic.

Theres still more work to be done and no reason to lose hope, she said. Were thinking about monoclonal antibodies and long-acting antiretrovirals in place of a traditional vaccine.

Kelley said that researchers are getting closer to identifying what the immune system needs to do to protect itself from HIV infection. If these neutralizing antibodies are the key, how do we make our human immune system create those neutralizing antibodies? .Thats been extremely difficult to do, she said. We can make the antibodies outside the person, but we cant make the person produce the antibodies. This is the biggest barrier right now.

Frank added that therapeutic vaccines are also being investigated as a strategy for curing HIV, with cure defined in the context of doing something other than requiring people to take regular antiretroviral therapy to control the virus replication. Specifically, the goal of a therapeutic vaccine is to improve the individuals immune response against the infection to enable the withdrawal of antiretroviral therapy and promote an improved immune response to control virus replication, said Frank. He concluded that although therapy and prevention continue to improve, the absence of an effective vaccine and a cure are the real vacuum in HIV prevention and treatment, respectively.

Advice for Physicians Treating Patients with HIV

At the conclusion of the exchange, the panelists discussed tips for physicians in the screening, diagnosis, and treatment of patients living with HIV. Agwu stressed the importance of asking patients about risk factors for HIV, including sexual activity, and testing and offering PrEP for patients at high risk. Kelley added that in addition to routine discussions about sexual health, maintaining consistency in the treatment of each patient and identifying other issues that are common to those living with HIV, such as other sexually transmitted infections, is important.

Marcus added that discussing sexual health in an open-ended, nonjudgmental, patient-centered way is important for optimal communication with patients and that communicating the U = U (undetectable = untransmissible) message can be transformative for them.

Frank concluded that although undetectable viral load is often the primary focus of antiretroviral therapy, providers should also consider additional factors, such as comorbid conditions, when optimizing HIV therapy and managing overall care for patients.

Its important that we remind our patients that they may have other medical conditions, or they may develop other medical conditions, and those medical conditions may pose as great a risk, if not a bigger risk, than their HIV disease, said Frank. I have many patients with uncontrolled hypertension and uncontrolled diabetes and lipids that are high. I tell them that theyre going to die of a heart attack or a stroke or be on dialysis long before they ever get a complication of their HIV. Dying of a heart attack with an undetectable viral load isnt my goal of their treatment. Its not just about their HIV.

References

1. Langley DR, Kimura SR, Sivaprakasam P, et al. Homology models of the HIV-1 attachment inhibitor BMS-626529 bound to gp120 suggest a unique mechanism of action. Proteins. 2015; 83(2):331-350. doi:10.1002/prot.24726

2. FDA approves new HIV treatment for patients with limited treatment options. Press release. FDA. July 2, 2020. Accessed October 13, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-limited-treatment-options.

3. Kozal M, Aberg J, Pialoux G, et al; BRIGHTE Trial Team. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382(13):1232-1243. doi:10.1056/NEJMoa1902493

4. Long-acting injectable form of HIV prevention outperforms daily pill in NIH study. News release. National Institutes of Health. July 7, 2020. Accessed October 13, 2020. https://www.nih.gov/news-events/news-releases/long-acting-injectable-form-hiv-prevention-outperforms-daily-pill-nih-study

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Emerging Options for Treatment and Prevention of HIV Infection - Contagionlive.com

Dale Carnegie of North Dakota and Northwest Minnesota has new ownership

FARGO, N.D. Bethany Berkeley is now the CEO and co-owner of Dale Carnegie of North Dakota and Northwest Minnesota. She partners with Katie Munion, who is the chief transformation officer and co-owner.

Both women begin this journey with strategic focus, a wealth of experience and grateful hearts. Theyve been in the business and know the industry. Prior to ownership, Berkeley was the managing partner and president, and Munion was the vice president of training and quality.

They are excited to continue offering the core Dale Carnegie courses and in-house customized training solutions with a specialized focus on communication and interpersonal skills, presence and storytelling, sales and customer service excellence, leadership training for new and aspiring managers and experienced managers. All solutions are offered in versatile formats: in-person (socially distanced at minimum capacity), live-online, or blended.

They represent clients primarily in the manufacturing, distribution, engineering, construction, government, agriculture, technology, finance, and professional service industries. They also have a new space to collaborate and facilitate training solutions -- the Railyard at 1630 1st Ave. N. in Fargo.

Enclave welcomes two new team members

FARGO, N.D. Ashley Kossan has joined Enclave as accounts payable & receivable specialist.

A graduate of North Dakota State University, Kossan brings experience as an accountant, mortgage loan officer and royalties analyst. Originally from Minot, N.D., she previously served as an accountant at Legendary Capital.

Enclave also has hired Travis Golobich as assistant project manager.

A native of Coon Rapids, Minn., and a graduate of North Dakota State University, Golobich joins Enclave with more than seven years of experience in project management. Previously, he served as project manager at Moorhead Electric.

In his role at Enclave, Golobich will assist in collaborating with the construction and design teams, sub- contractors, and clients to ensure timely project delivery within budget.

Essentia Health hires new health provider

FARGO, N.D. Essentia Health welcomes Dr. Olayinka David Ajayi

Dr. Olayinka David Ajayi has joined the Essentia Health team in Fargo, where he specializes in hyperbaric medicine. Hyperbaric oxygen therapy is a noninvasive, painless procedure that uses 100% oxygen in a pressurized chamber to improve the bodys natural healing process, treat carbon monoxide poisoning and other FDA/UHMS approved medical conditions.

Dr. Ajayi received his medical education at the University of Ibadan College of Medicine, Nigeria. He earned his masters degree in public health and completed a residency in public medicine at Emory University Public Health, Atlanta, Ga.

His fellowship in undersea and hyperbaric medicine was completed at Hennepin Healthcare in Minneapolis, Minn. Dr. Ajayi is board certified by the American Board of Medical Specialties in public health and general preventative medicine.

Alerus hires new senior business advisor and senior financial guide

FARGO, N.D. Alerus has welcomed Brad Loween as senior business advisor. In this role, Loween serves as the trusted point of contact for business clients, delivering comprehensive financial advice to help them achieve their financial wellness goals.

Loween works closely with experts across Alerus to serve business clients holistic financial needs and ensure access to the companys full suite of diversified services.

Loween has nearly a decade of experience in the financial industry, with expertise in wealth management and business banking. He holds a bachelors degree in biology from Montana State University and served 21 years in the North Dakota National Guard, including deployments to Afghanistan and Kosovo.

He is a volunteer for the Fargo Moorhead West Fargo Chamber of Commerces Military Affairs committee and the Department of Defenses Employer Support of the Guard and Reserve program. He also serves as a board member for Rebuilding Together of Fargo-Moorhead.

Alerus also has welcomed Isaac Bumgardner as senior financial guide. In this role, Bumgardner is responsible for assisting clients in identifying their specific financial needs and providing comprehensive advice to help them achieve their financial wellness goals.

He works closely with experts across Alerus to ensure each client has access to the companys full suite of diversified services.

Both of the new hires are based at Alerus office at 51 Broadway in Fargo.

Send your promotions and new hire information to aweeks@prairiebusinessmagazine.com.

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Prairie People: New hires and promotions - Grand Forks Herald

Two new clinical trials in the UK are examining whether administering an antibody combination after someone has already been exposed to the novel coronavirus could protect them from developing COVID-19, the disease caused by the virus.

The University College London Hospitals (UCLH) NHS Trust announced on Friday that it is running the trials at a new vaccine research center.

Both trials are examining AZD7442, a long-acting antibody (LAAB) combination developed by AstraZeneca.

The first study, called STORM CHASER, is examining whether the antibody can provide immediate and long-term protection to people recently exposed to the SARS-CoV-2 virus.

We know that this antibody combination can neutralize the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of COVID-19 in people who have been exposed when it would be too late to offer a vaccine, said study leader UCLH virologist Dr. Catherine Houlihan in a press release from the hospital.

STORM CHASER had recruited 10 people as of Friday. Key participants will include healthcare workers, students in group housing, patients exposed to anyone with the virus, residents of long-term care facilities and those in industrial or military settings.

THE SECOND study, called PROVENT, is examining whether people who may not respond to the vaccine, including immuno-compromised people, or at-risk groups, such as the elderly or those with preexisting conditions, may be helped by AZD7442, even prior to exposure.

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We will be recruiting people who are older or in long-term care, and who have conditions such as cancer and HIV, which may affect the ability of their immune system to respond to a vaccine," said UCLH infectious diseases consultant Dr. Nicky Longley, the head of the study. "We want to reassure anyone for whom a vaccine may not work that we can offer an alternative, which is just as protective.

Both UCLH studies will examine whether AZD7442 reduces the risk of developing COVID-19 and/or reduces the severity of the infection compared to a placebo.

Trial participants will be able to safely leave the study in order to get licensed vaccines if it is deemed medically beneficial, according to UCLH.

Antibodies are produced by the body to help fight infections. Monoclonal antibodies are artificially produced in laboratories for possible medical treatments in patients already infected with the virus and could provide protection before exposure as well.

While vaccines train the body over a matter of weeks to produce its own antibodies, antibody injections skip that step, aiming to provide immediate protection against viruses.

AZD7442 is a combination of two LAABs derived from recovering patients that were discovered by Vanderbilt University Medical Center and then licensed to AstraZeneca, according to the company, which then optimized the LAABs with half-life extension in order to increase the durability of the therapy for six to 12 months. The combination is also designed to reduce the risk of resistance developed by the virus.

In pre-clinical experiments published in Nature, the LAABs in AZD7442 were shown to block the novel coronavirus from binding with host cells, protecting against infection.

UCLH'S NEW Vaccine Research Center, which opened in December, is operating under the patronage of the National Institute of Health Research (NIHR) UCLH Biomedical Research Center and the UCLH Research Directorate, and represents an extension of the NIHR UCLH Clinical Research Facility led by Prof. Vincenzo Libri.

Libri is also a principal investigator on the Oxford/AstraZeneca vaccine trial and provides oversight of all COVID-19 vaccine/preventative treatment trials.

Mene Pangalos, AstraZeneca's executive vice president of BioPharmaceuticals Research & Development, stated in the UCLH release that AZD7442 has the potential to be an important preventative and therapeutic medicine against COVID-19, focusing on the most vulnerable patients."

"The STORM CHASER trial in particular is a unique approach, with enrollment initiated on site following the identification of a confirmed case to halt the spread of COVID-19 in the facility or community," Pangalos said. "We offer our appreciation and gratitude to everyone involved in these trials from the scientists, researchers and clinicians, to the trial participants and study sites as we all work together to help end this pandemic.

Antibody treatments have been evaluated since nearly the beginning of the pandemic.

In May, the Israel Institute for Biological Research (IIBR) completed a groundbreaking scientific development, identifying an antibody that neutralizes the coronavirus.

Maayan Jaffe-Hoffman, Anna Ahronheim and Idan Zonshine contributed to this report.

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Antibody study aims to protect those exposed to coronavirus from illness - The Jerusalem Post

A third of a lifetime is spent working, making a meaningful career a critical life decision. Having a consequential career is not about monetary gain for many hard-working Americans. On the contrary, it is about making a marked difference in the world. Take, for example, teachers, who shape the minds of future generations. While the entry-level annual salary for teaching is slim compared to other careers, it doesn't stop the thousands who pursue a career in education because they find great purpose in their profession.

Studies also show that those who love their work live longer, which is a priceless consideration when choosing a profession. Balancing out working a meaningful job and making the median full-time wage (around $50,000) can be challenging, but it's possible to live the dream and make a decent living at the same time. Stacker compiled a list of two-year degrees using 2020 data from Payscale on the most meaningful employment. Jobs are ranked by degrees whose graduates report having a high meaning job, with ties broken by highest mid-career pay.

Many of the degree programs and jobs listed are in the health care field, ranging from medical secretarial science to alcohol and drug studies. While some find meaning in providing administrative support, others find daily joy in performing diagnostic tests. All of the jobs listed assist the general public in one way or another, requiring an altruistic attitude.

Money certainly plays a small role in job satisfaction, with seven of the top 10 most meaningful jobs earning mid-career pay above $60,000 per year. Helping others won out over money however, as the top job on the list saw its professionals earn less than $50,000 by the mid-point of their careers.

Continue reading to find out the two-year degrees that go on to the most meaningful jobs.

You may also like: Highest-paying state for 50 different jobs

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2-year degrees that go on to the most meaningful jobs - Gwinnettdailypost.com

On Spatial Perspectives, host Dan Cui will have a one-on-one dialog with innovators and thought leaders in the growing Spatial Reality, or Spatial Computing, market. Cui will invite guests who can discuss the real world use cases of the technology and how it could benefit mankind while exploring any drawbacks and how they might be mitigated.

It is an undeniable fact that data affects our everyday lives. While data gets a bad rap in the news when associated with data breaches or privacy concerns, the collecting and analyzing of data can change lives. Stan Karpenko, Co-Founder & CTO at GiveVision knows this first hand. Dan Cui, Host, Spatial Perspectives, sat down with Karpenko to learn more about the true value of data.

GiveVisions goal is to make the lives of visually impaired people better with the help of their products and services. One such asset they provide to those who are visually impaired is a services product thats attached to their glasses that will allow the clinicians to have the ability to actually monitor their patient and provide new treatment regimes for that patient based on what they see happening on a daily basis.

When it comes to data, Karpenko feels it is a vital element of developing products that can help people. I think the data becomes the key part. I think the hardware becomes irrelevant over time, it will become a commodity. The real insights and the real values in the data, Karpenko said. He posed important questions like, can we effectively collect the healthcare data about the patient over a long period of time to make clinical decisions? Can we arrive at a point in time where we dont need the patient to call the doctor when they can feel the symptoms? Can we pick up the symptoms before they can feel them? So the entire sort of changing the career pathway is really what we see as the biggest opportunity facing the AR and VR world. I think, in reality, theres an enormous opportunity for AR and VR companies to develop products that will, just the same as smartwatch, become just a vehicle to collect healthcare data for the benefit of the patient, Karpenko explained.

He believes that those devices will be used for entertainment, or in our case as an enabler for them to do things. But as a byproduct of that, they will be able to watch for patients and inform the doctor when they need to see the patient before its too late. So thinking about preventative medicine if you like, Karpenko said.

For more insight into how data is a key element of progress, listen in to this weeks episode of Spatial Perspectives.

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Why Data is the Real Value Behind VR - MarketScale

Ignoring rabbis objections, and prompting fury from religious politicians, Israel vaccinated thousands of citizens on Shabbat.

The Health Ministry views all-week-long vaccination as key to achieving quick coronavirus protection part of a plan, which also involves 24-hour clinics, to vaccinate more than 150,000 a day.

This past Saturday, the first of the vaccination drive, all four healthcare providers carried on giving shots to the 60-plus public, albeit at significantly reduced capacity, they told The Times of Israel.

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MK Uri Maklev of United Torah Judaism slammed the Health Ministry for encouraging it. How will there be a blessing for the work of their hands, when they harm Shabbat and the [religious] public in such a serious manner? he asked rhetorically in a Haredi newspaper on Sunday.

A woman receives a coronavirus vaccine at a clinic run by the Meuchedet healthcare provider. (courtesy of Meuchedet)

The politician claimed that Health Minister Yuli Edelstein had promised him that there would not be Shabbat vaccinations, and attacked the justification given to administer them.

Edelstein said it was done so that the country can quickly deliver COVID-19 protection, and invoked the Jewish legal principle of saving a life, or pikuah nefesh, which trumps nearly all other religious requirements, including Shabbat. The coronavirus endangers all of us, the vaccines will save all of us, he said.

Hospital workers in protective gear are seen in the coronavirus ward at Ziv Medical Center in the northern city of Safed on October 7, 2020. (David Cohen/Flash90)

But many Orthodox Jews say that pikuah nefeshdoes not normally extend to preventative medicine. They put everything in the category of pikuah nefesh, Maklev said of Health Ministry leaders. We have seen in the past that many of their instructions did not stand up to scrutiny.

There is no prohibition on administering or receiving a vaccine on Shabbat, according to most rabbis, but they say clinics should stay shut because their operation involves other actions considered to desecrate the holy day of rest, like logging patient information on computers and operating other electrical items that are needed. They also express concern that people are made to break the religious rule against driving on Shabbat to make their appointments.

The chief rabbis have refused to back operation of vaccine centers on Shabbat for now. Currently, there is no permission to violate Shabbat for the sake of vaccination, Ashkenazi Chief Rabbi David Lau said on Thursday, according to Orthodox media.

Israels Ashkenazi Chief Rabbi David Lau at the Western Wall, in the Old City of Jerusalem, July 21, 2019. (Noam Revkin Fenton/Flash90)

He stressed that he supports vaccination, but argued that so long as clinics are not operating during every hour of every other day, working on Shabbat is not justified. For now, they should ramp up capacity without working Saturdays, he argued.

If and when clinics are vaccinating 24/6, it will be possible to consider also vaccinations on Shabbat, Lau said.

Even if the chief rabbinate eventually gives its blessing to Shabbat shots, there are indications that some influential ultra-Orthodox rabbis will remain steadfast in their objection to them.

The massively influential ultra-Orthodox halachic authority Rabbi Asher Weiss wrote that the situation is not urgent enough to consider vaccination an act of pikuah nefesh.

Rabbi Asher Weiss. (Gershon Ellinson/Flash90)

He was responding to questions from the UK and the US, so it is possible that he will issue another ruling regarding Israel. If he does not, Shabbat vaccination, even if part of a 24/7 campaign, is likely to remain taboo for a large part of the Israeli Haredi community, including politicians from Maklevs party, who revere the rabbi.

The one proviso in Weisss position was for people in high-risk categories, or who risk infecting people who are high-risk. If they have Shabbat appointments that cannot be moved without incurring delays, in some circumstances, he would allow them to be treated and even driven to the vaccination station in certain cases, though by a non-Jewish person, and not by a Jewish person who, in his estimation, is supposed to be observing Shabbat.

Religious objections are not stopping healthcare providers. A spokeswoman for Maccabi Healthcare Services told The Times of Israel that her nurses vaccinated 7,000 people on Shabbat, some of whom had appointments for next month and were offered to vaccinate earlier if they took Saturday appointments. Opposition from rabbis would not stop them during future weekends, she said.

Meuhedet gave 1,500 injections, mostly in Netanya and Tel Aviv. Leumit gave 2,000, mostly in central Israel. Clalit only operated in the Arab Jerusalem neighborhood of Sheikh Jarrah.

Weiss and Lau both hail from the ultra-Orthodox community. But while religious Zionist rabbis are often thought to take more lenient approaches than their Haredi counterparts, when it comes to this issue, they have not done so.

Rabbi Shlomo Aviner (Yossi Zamir/Flash90)

If they arent working at night, its serious but not urgent, leading religious Zionist Rabbi Shlomo Aviner told The Times of Israel on Sunday, saying no to Shabbat vaccinations. Like Lau, he said that if Israel were providing vaccinations 24/6, the answer might be different.

Aviner, one of the stricter rabbis of religious Zionism, said: The vaccine itself does not involve Shabbat desecration, but the actions around it are, giving examples of logging patient data on computers.

His observation that the injection itself does not transgress Shabbat reflects the laws as they are found in the book, Shemirat Shabbat Kehilchatah, widely viewed as the authoritative Orthodox laymans guide for Sabbath observance.

The Hebrew text from the religious guide, Shemirat Shabbat Kehilchatah, which says that there is no Torah prohibition on taking a regular vaccine on Shabbat. (Zak Jeffay)

Rabbi David Stav, chairman of the moderate Orthodox rabbinic alliance Tzohar, also said he cannot justify Shabbat vaccinations for now, apart from very high risk populations, but added that he hopes this will change.

I urge the government to decide how important it is to keep centers open, and if they are open 24/6, Im almost positive that rabbis would allow vaccination on the seventh day as well.

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MK warns of spiritual side effects as vaccination drive continues on Shabbat - The Times of Israel

Former Exeter University student and Love Island contestant Dr Alex George has opened up about dealing with grief and working though the coronavirus pandemic after the sudden death of his younger brother.

The A&E doctor, from Carmarthenshire, bravely spoke out about coming to terms with his loss in a year which has also seen him work 18-hour days for weeks on end balancing his role as a frontline medic with his role as a public health figure.

On July 24, Alex - who studied medicine at the University of Exeter - shared news of his 19-year-old brother's death in a heartbreaking post on social media.

Llyr, a talented student who was about to start medical school, took his own life.

Now Alex has spoken about his determination to help others with their mental and physical health to try and prevent other families from going through the pain that his family have endured over the last six months.

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Speaking to WalesOnline the 30-year-old said: "Its an up and down journey. I think what is interesting is that my life feels a bit like before and after there is this big line of separation.

"My memories feel very distant but I think thats part of a trauma like this. Grief is an ongoing thing.

"Especially with the pandemic, work, and obviously Im living alone, its not helping unfortunately. Saying youre allowed to bubble with other people is one thing but the reality is you dont see people very much.

"But Ive been able to see my family and I have a really good set of friends so we are getting through it. Its just about taking each day as it comes and trying to do something positive. I bury myself in my work quite a lot which is both a good and bad thing but it does help me in scenarios with things like this.

"[Christmas] will be tough, all of the firsts will be hard and Christmas will be really tough but well get through it. We dont have any other options. I would never wish this on anyone else you just have to accept its happened to you and do what you can with your life."

In the weeks and months after his brother's death Alex has not shied away from talking about a situation that to many people is simply unimaginable.

Speaking to Lorraine Kelly in September the former reality star described how he had been in a restaurant with friends in London when his dad phoned him with the news. In the emotional interview he went on to talk about how he and his brother Elliott had to drive together back to Wales sitting in silence, crying, and shouting in anguish during the unthinkable five-hour journey.

He has also spoken about the trolling he had endured and shared one message that read: "Your brother is dead, get off social media" to which Alex responded: "Imagine being this person. Im holding by a thread and you get people like this."

Despite everything, what Alex is determined to do is pay tribute to a younger brother who he describes as a "mini me" a conscientious, empathetic, and confident teenager and talented footballer who would have doubtlessmade a "very good doctor".

Alex said: " It is hard. At the moment [Llyr's] name is associated with a certain thing and suicide and its very very hard to separate that but we do do our best. Ive got pictures and stuff of him and we do try and laugh about certain things. I saw a meme and I just thought: 'Hed laugh at that' you have got to think about those things.

"I think its important to be open. I would never want to shy away from whats happened. With suicide theres no shame in it. Its the same as if someone has a heart attack its a very sad, preventable cause of death of course but its not something I would ever be ashamed of. Its happened we have to try and do something positive.

"Its hard enough to deal with it anyway but quite frankly in the public eye it's tough but also the amount of support Ive had is unbelievable. There is no doubt, really, people have been so kind I think social media gets a bad rep sometimes, even the media in general, but people have been very kind and supportive and thats helped me a lot."

It's not just online that Alex has received support however. When his mother Jane started knitting to help keep herself busy dozens of people from the Carmarthen community put in orders to buy her products, which will raise money for mental health charities. Then there are those who also volunteered to help, creating an "army of knitters" for the Welsh bank worker.

Alex added: "She started knitting to try and distract herself. She had that feeling of guilt you inevitably get in that scenario, especially as a mother or father. So she sat there and said: 'Ill knit to distract myself' and thought: 'Well, Ill try and sell some of this stuff'.

"Someone actually bought a pair of her gloves and then she thought 'People might buy this' and all of a sudden the orders started coming in.

"My dad is retired, my mum is still working in a bank but obviously is off on long-term leave and its really, really tough. If you sit still too long its not good for you. You need to keep busy its not good for you to not to be active mentally."

When it comes to keeping busy it would be difficult to overemphasise how hard Dr Alex has worked this year. Working in the A&E department of University Hospital Lewisham in south London he and his team have seen first-hand how hard the area has been hit by Covid-19. That's at the same time as the content Alex has been sharing with his combined two million followers on Instagram and YouTube talking about everything from vaccines to health and wellbeing advice.

In his podcast series, the Waiting Room, he and emergency medical consultant Dr Anna Colclough describe facing huge amounts of patients coming in and needing to be intubated both young and old. You can find more about that here.

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Alex, speaking in mid-December, said: "Lewisham was hit so hard and so early that we kind of realised that it was coming. The speed in which it happened and how unwell patients were coming in, it was obvious we had a big problem so there was a real realisation that something terrible was happening.

"Lewisham and south London has been very, very hard-hit. In fact we are going through a very difficult wave at the moment, we are really busy at the moment the hospital is full with a lot of Covid patients.

"Its been tough, its been really tough, but the sense of teamwork we have, weve pulled together, the camaraderie, we really are a team. Weve looked out for each other and supported each other so in many ways its been a reminder that there are other things in the world.

"Its something you look back on now and you think: 'At least I felt I was a part of it, at least I could do something positive'. I do feel that throughout the pandemic in hospital and through using my platform that I have helped people. And I do think I get some comfort from that.

"I love my job, its my passion, and I would feel very lost without it."

Talking about managing the second wave of the pandemic this winter, Alex added: " I gave so much in round one, Ive got to try and preserve a bit of energy the second time. It nearly killed me that first round.

"There were 18-hour days almost I did 22 weeks and I didnt take a single day off. I wasn't necessarily in A&E every day, I was going into A&E four or five days but Id be doing YouTube videos. PHE [Public Health England] were expecting us to do a huge amount of advisory stuff, most people would listen to doctors and not presenters, so the amount of responsibility to create this content was huge. Im a little bit burnt out. "

Despite everything this year has brought Alex is determined to remain positive for the new year ahead. Next year he hopes to transition into GP work as well as his A&E role a move into the preventative medicine he has become passionate about, especially giving advice around mental and physical health.

In May 2021 he will also celebrate the release of his first book Live Well Every Day a book addressing the modern health challenges we face and how little changes to our routines can make a big difference. According to Alex using the principles and advice in his book has helped him deal with his hardest days, from his time as a medical student to the monumental challenges he is now facing.

Explaining the thinking behind his book, he said: "The idea of the book came many years ago when I was at medical school.

"I ended up being on placement somewhere that I was a bit isolated and started feeling not myself. I stopped exercising, I started eating badly, I was sleeping quite badly, I wasnt really seeing friends. I wasnt doing the things that I knew were right for me and my mental health and my own happiness as well.

"I made changes, little changes I started going outside for a walk every day, I started exercising every day, I planned my own meals, healthy meals, I planned bedtimes, I had time off my phone, doing all those good things. I became quite isolated so I made a plan to call someone every night someone different, a friend, a family member, every night and chat with them.

"I found those changes, an accumulation of those changes, meant that I just felt so much happier and healthier and I think thats the premise of this book giving people those tools they can use to make small changes to their own lives that ultimately that will make changes to not just their mental health but physical health too.

"Most of the book I wrote through the pandemic actually. I felt quite inspired and quite driven to write it with everything that happened with my brother.

"The book isnt written for him in that sense but I do feel it was a huge motivating factor. I couldnt help him but maybe this book will help other people and hopefully can protect people from ending up in that scenario.

"He was very proud of it he was really excited about the book. I had written a bit of it and we had actually had the publishing contract and agreement and he was so excited the book was coming to life."

You can pre-order Live Well Every Day from retailers including Amazon, Waterstones, and WHSmith.

Samaritans (116 123) operates a 24-hour service available every day of the year. If you prefer to write down how youre feeling, or if youre worried about being overheard on the phone, you can email Samaritans at jo@samaritans.org.

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Love Island's Dr Alex George opens up about the hardest year of his life - Devon Live