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Zeiss has conducted a poll in partnership with Intelligent Instructor magazine to survey driving instructors on vision and driving, with a focus on the eyesight of learner drivers.

Conducted as part of Road Safety Week (November 16-22), the poll found that 75% of learner drivers have experienced problems with glare from headlights.

It also revealed that 71% of learner drivers have had problems with heavy rain and 91% have had problems with dazzling sunlight.

A total of 87% of driving instructors felt that learner drivers needed an eye test and 90% said they thought everyone should have an eye test before learning to drive.

Paul Hopkins, professional services manager at optometrist at Zeiss Vision Care UK, said: As we head into winter there is more likelihood of drivers facing these challenging conditions due to shorter days and worsening weather. Glare and dazzle caused by car headlights at night can be a real challenge when driving. Disability glare from headlights is of particular concern as this can affect visual performance which can seriously impact driving performance.

With this in mind eye care practitioners must take care to ensure we are fully meeting this challenge. Regular eye tests and lenses that support the visual needs of drivers are key for ensuring people feel confident when driving in all conditions.

See the rest here:
Survey reveals eyesight struggles of learner drivers - Optician Online

A WREXHAM optician is calling on drivers to take care of their eyes as part of a national safety campaign.

Five people die every day on the UKs roads on average and someone is injured every four minutes - with drivers eyesight often playing a contributory factor, according to Specsavers.

Research shows that poor vision increases a drivers risk of crashing as it limits their ability to recognise hazards and impacts reaction time.

That is why this Road Safety Week (November 16 to 22), road safety charity Brake has partnered with Specsavers to raise awareness of the importance of looking after our sight, particularly when driving.

John Kamaluddin, store director at Specsavers Wrexham, said: "Having good eyesight is one of the most basic requirements of safe driving.

"It means drivers will be able to spot potential dangers, see pedestrians and other vehicles, read road signs and judge speed, distance and movement. Without this, there can be catastrophic consequences on the road.

"While an eye test plays a part in being granted your drivers licence in that you must be able to read a number plate from 20 meters away eyesight can change over time, especially as we get older.

"This is why it is so important to have regular eye checks, not only to address any changes in short or long-sightedness but also because an optician can spot sight-threatening conditions that you may not be aware of, such as cataracts, macular degeneration or glaucoma."

Research during lockdown found that cyclists and pedestrians faced almost double the risk of being seriously injured on city roads, caused by drivers increasing their speed due to a decrease in congestion with the same effects potentially happening in other cities throughout the country.

Joshua Harris, Brake director of campaigns, said: Its self-evident that one of the fundamental for safe driving is good eyesight and being able to see the road ahead clearly.

"The earlier a driver can spot a hazard on the road, the quicker they will be able to stop and avoid a crash. When it comes to safe driving, good eyesight and safe speed go hand-in-hand, thats why were delighted to be partnering with Specsavers on Road Safety Week 2020 under the theme No Need to Speed."

Motorists are being encouraged to make sure to discuss any difficulties with their optician so that they can ensure they have the right lenses to suit their needs and lifestyle.

For more information visit https://www.specsavers.co.uk/glasses/glasses-lenses/anti-glare-driving-glasses-road-safety

Original post:
Opticians advise Wrexham residents to keep their eyes on the road - LeaderLive

A MONKLANDS optician has teamed up with a road safety charity to raise awareness of the importance of people looking after their sight, particularly when driving.

The link between Specsavers and Break comes as research revealed five people die every day on the UKs roads, and someone is injured every four minutes, with drivers eyesight often a contributory factor.

Specsavers Airdrie and Coatbridge director Laura Mullett said: Having good eyesight is one of the most basic requirements of safe driving. It means drivers will be able to spot potential dangers, see pedestrians and other vehicles, read road signs and judge speed, distance and movement.

Without this, there can be catastrophic consequences on the road.

While an eye test plays a part in being granted your drivers licence in that you must be able to read a number plate from 20 meters away, eyesight can change over time, especially as we get older.

This is why it is so important to have regular eye checks, not only to address any changes in short or long-sightedness but also because an optician can spot sight-threatening conditions that you may not be aware of, such as cataracts, macular degeneration or glaucoma.

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Monklands optician and road safety charity team up to tackle vision problems on the road - Daily Record

By Staff | on November 13, 2020

Dog owners take their furry friends health very seriously. Like their human companions, dogs can experience health problems that seemingly come out of nowhere. But unlike the men and women who take care of them, dogs cannot call the doctor when something is bothering them. That responsibility rests on the shoulders of their owners.

A dogs eyes can be a window into the animals overall health. According to the pet care professionals at Memphis Veterinary Specialists & Emergency, serious conditions such as liver disease, diabetes, and autoimmune diseases can all present indicators in a dogs eyes. The American Kennel Club Canine Health Foundation says that dogs can experience physical and/ or behavioral problems when theyre experiencing eye trouble.

A host of factors can contribute to vision problems in dogs. Age is one such factor, but diseases such as diabetes and hereditary conditions, including progressive retinal atrophy, also can lead to visual impairment. Before dog owners can work with veterinarians to determine the cause of their furry friends vision loss, they must first learn to recognize signs of impairment. The AKC notes that some of these signs may be obvious while others are more subtle.

Bumping into walls or furniture: Thisis a clear indicator that a dog is experiencing vision problems. Dog ownerswho notice this is happening evenwhen theres nothing to obstruct theirdogs path should book a vet appointment immediately. Trouble locating food or toys: Mostdogs love to eat and drink and playwith their toys. So, a sudden inabilityto find food or water bowls or a favoritetoy could indicate the dog is havingvision problems. Reluctance to jump on or off acouch: This symptom can be less noticeable than bumping into furniture orhaving trouble finding food. Dogs that

once loved to jump on or off a couchbut now stick to the floor may be doingso due to impaired vision and the fearof not being able to see where theyrejumping. Clinginess: The AKC notes that somedogs cling to their owners as theyexperience vision loss. Aggressiveness: Dogs may begin toshow aggression as they experiencevision loss. Thats because the lossof their eyesight can make them feelvulnerable, leading some to act offensively as a defense mechanism. Physical indicators/behaviors: Dogowners should be on the lookout forred, puffy or swollen eyes. In addition, Memphis Veterinary Specialists &Emergency notes that some dogs maypaw at their face in response to visionloss.

Vision loss in dogs can be caused by many things. The first step to helping dogs overcome diminished vision is recognizing its symptoms.

More here:
Signs that dogs are having vision problems - Hometown Focus

Is your eyesight worse since lockdown began (again)? Thanks to hours spent staring at Zoom and losing chunks of sleep to 3am procrastinating, my eyes have definitely been feeling the strain.

And interestingly Im not the only one, with leading online glasses retailer, Glasses Direct discovering 1 in 5 Brits believe their vision has declined during lockdown.

The brand's Vision Survey found that women are suffering the most; from the 28% battling tired and sore eyes, to the 24% experiencing headaches. Not to mention, the 28% of participants who've been having trouble falling asleep, most likely exacerbating all the other aches and pains.

Just before lockdown 2.0, I found myself at the opticians. My main issues being dry, tired eyes and a headache from scrolling Insta and replying to emails.

Optician and Head of Professional Services at Glasses Direct, David Hutchfield explains, It is no surprise that screen time has increased during the pandemic, whether it's working from home in front of a laptop all day, reconnecting with friends and family on video calls, or binging boxsets on Netflix. This increased screen time, and the added stresses of lockdown, has inevitably taken its toll on peoples eye health.

Obviously theres no way were giving up Netflix, so what would help?

David reckons there are simple steps we can take, to keep our eyes in tip top condition and prevent side effects like itchy eyes, headaches and blurry vision. Alongside taking a break from screens where possible and trying to get a good nights sleep, he recommends specialist digital blue light lenses.

Protecting your eyes from UV rays with good quality sunglasses is another eye health priority. A pair that blocks out at least 99% of UVA and UVB rays will protect your eyes from any sun exposure, which can both accelerate eye ageing and be a contributing factor in cataracts.

Another practical tip for minimising screen time strain is the 20/20/20 technique (in 2020, we know). Every 20 minutes look at an object at least 20 feet away for at least 20 seconds to help relax your eyes. Itll give your eyes a mini break from concentrating and in turn, ease the eyesight tension causing headaches or blurred vision.

To be honest, were up for anything thatll tackle our Zoom fatigue.

Dry eyes can be the result of a few things, including not drinking enough water, lack of fresh air and not giving your eyes enough of a rest to rehydrate. (Guilty as charged.) It's an obvious one, but a good nights sleep will do wonders for your whole body, including giving your eyes a break, which helps to keep them hydrated. Failing that, invest in some eye drops. Ensuring you feel refreshed will prevent those creepy tired twitches too. Which lets face it, is a very weird sensation.

So arm yourself with the tips above to help shift the headaches ASAP. As for me? Im planning some digital blue light lenses so my online shopping habit can continue...

See the original post:
How Lockdown Has Affected Our Eyesight And How To Fix It - GLAMOUR UK

WITH a white cane in hand and a little faith, Mohamad Khazaen Mat Nasir put on a blindfold and stepped into the world of the visually impaired.

The 28-year-old teacher gamely tried moving around on his own.

Mohamad Khazaen using a white cane to walk while blindfolded.

He was taking part in the World Sight Day 2020 celebration held at St Nicholas Home (SNH) in Jalan Bagan Jermal, Penang.

This is a whole new experience for me.

I never imagined that it would be this difficult to move around without eyesight.

It has definitely embedded an awareness in me that I have been taking my eyesight for granted all these while.

Visitors learning how the visually impaired use their sense of touch to handle currency notes.

Having a blindfold on does not only restrict movements but also takes away a lot of the experiences one can have, he said when met at the event.

Mohamad Khazaen, who experienced walking on raised pavements designed for the visually impaired within the home, said he learnt how the visually impaired navigated their surroundings.

This is new to me. I learnt a lot today.

During the event, some representatives from various schools and government agencies such as the police, Fire and Rescue Department, state Welfare Department and Penang Island City Council took part in station games and watched displays at the educational booths.

A visitor threading beads while blindfolded at a station game booth.

They wore blindfolds while trying to carry out activities like picking up rocks and stones, walking, drawing and feeling items in boxes.

SNH assistant general manager Elsey Akop said the theme for this years celebration was Hope in Sight.

This is the first time that we are holding this event through invitation only.

In previous years, it was always open to the public but due to Covid-19, we had to follow certain SOPs and thus scale it down.

As such, we invited only representatives.

The aim is to raise awareness on the importance of eye health.

Elsey: The aim is to raise awareness on the importance of eye health

We also invited an optometrist to give a talk.

We hope the representatives will benefit from the talk and share what they have learnt with those around them.

Association of Malaysian Optometrists Penang chapter president Khew Jong Mei, who gave the talk, said it was important for the public to be aware of eye health and how to prevent vision impairment.

It is best for children above the age of three to get an eye check-up annually so underlying issues can be detected and early treatments or vision therapy can be carried out.

The rest is here:
Walking in the shoes of the blind - The Star Online

Xulane is a brand-name prescription birth control patch thats applied once per week for 3 weeks each month. Each day, the patch releases 150 micrograms (mcg) of progestin and 35 mcg of ethinyl estradiol, a type of estrogen.

Like other forms of birth control, the patch is a highly effective form of hormonal contraception. But unlike oral contraception, where you take pills every day, Xulane works by delivering hormones through the skin via a bandage-like patch.

Hormonal contraception, including birth control patches, has evolved so much so that serious side effects are relatively rare.

However, theres still a risk for side effects while taking Xulane. Your chances of experiencing more serious ones depend on certain underlying risk factors. Some effects may be temporary, while others might be more long-term.

Make sure you understand all of the potential side effects associated with Xulane, and talk with your doctor to determine whether this form of birth control is best for you.

All types of hormonal birth control carry a risk of side effects. These are primarily related to estrogen.

At 35 mcg per day, Xulane contains about 60 percent more estrogen than the average oral contraceptive. Thus, you may be at an increased risk for estrogen-related side effects.

Some of the most common side effects of the Xulane birth control patch include:

Most of these side effects are temporary and usually go away within 3 months after your body gets used to the hormones in Xulane. You should call your doctor if the symptoms last longer than this or if theyre severe.

Its also possible to experience little to no side effects while using the birth control patch.

Xulane may increase your risk for serious but rare side effects. These include:

Your risk for rare or deadly side effects is greater if you take the patch while smoking and are over the age of 35. Obesity may also increase these risks.

There are also possible long-term side effects of Xulane to consider, such as:

Hormonal birth control, including the patch, can increase your risk for:

Xulane may increase such risks even more due to its higher estrogen content. You shouldnt use Xulane if you have a history or a risk for these conditions.

Your risk for serious side effects may also be greater if you have:

Being overweight and smoking may increase these risks, especially if youre over 35.

The makers of Xulane dont recommend their product for women who have a body mass index (BMI) of over 30. Using this patch may increase the risk for blood clots in such cases.

Also, this patch may not be effective in women who weigh 198 pounds or more. They may need to consider another method of birth control.

Xulane isnt recommended if you have any of the following health conditions:

If youre having surgery, stop taking Xulane 4 weeks beforehand. This will help decrease the risk of blood clots. You may need to wait at least 2 weeks after surgery to start taking your patch again.

You shouldnt take Xulane if you currently use certain hepatitis C medications that contain:

These medications can increase certain liver enzymes in your blood that indicate liver damage.

Ask your doctor about Xulane if you take thyroid hormone replacement medications or antiseizure drugs. These may interfere with the hormones in the patch, making them less effective overall.

Certain herbs may also interact with the birth control patch, such as St. Johns wort. Talk to your doctor about all herbal supplements youre currently taking before using Xulane.

All forms of birth control carry the risk of side effects, but the estrogen content in Xulane may increase such concerns if you already have certain risk factors. A doctor can help you determine which is the safest and most effective form of birth control for you.

You should also talk with a doctor before taking Xulane if youre nursing. Its possible for the patch to decrease milk production. Small amounts of Xulane may also be present in breast milk, which may be passed on to your baby.

If youre interested in taking Xulane after delivering a baby, you must wait at least 4 weeks and must not be breastfeeding.

Xulane is a progestin- and estrogen-containing birth control patch you wear every day for 3 weeks. You change out the patch for a new one each week.

Like other birth control methods, Xulane carries a risk of side effects. Most are mild and temporary, but you should be aware of the more serious risks and call your doctor right away if you experience any unusual symptoms.

Dont stop taking Xulane without talking with a doctor first.

See original here:
Xulane Side Effects: Common, Rare, and Long-Term - Healthline

Another day, another win for Mercks blockbuster Keytruda.

The FDA has granted accelerated approval for the cash cow combined with chemotherapy in triple negative breast cancer, giving the drug the green light in its 18th different cancer. Mondays new indication comes for patients with PD-L1-expressing tumors with a Combined Positive Score of at least 10.

Merck noted that due to the nature of the accelerated approval, the thumbs up is contingent upon confirmatory trials.

Data for the approval first came back in February, when the Keynote-355 trial demonstrated Keytruda plus chemo significantly improved progression-free survival compared to chemo by itself. The study showed that, in the target population with a CPS of at least 10, the combination reduced the risk of disease progression or death by 35% with a median PFS of 9.7 months, against 5.6 months in the placebo arm.

On safety, the February data showed 2.5% of all patients in the drug arm saw fatal adverse events, including cardiac arrest and septic shock, with serious side effects appearing in 30% of patients. Keytruda was discontinued due to adverse events in 11% of patients.

Frontline triple negative breast cancer is a particularly difficult indication to treat, as the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. Its one of the rare fields in which Roches PD-L1 Tecentriq has enjoyed a head start over Keytruda and Opdivo, the leaders in the checkpoint race, as Tecentriq is approved in combination with Abraxane for this indication.

Back in May 2019, Merck conceded a failure in the arena after a Phase III study flopped on overall survival. But a few months later, the pharma turned things around after discovering a neoadjuvant regimen of Keytruda and chemo followed by Keytruda monotherapy after surgery induced a higher pathological complete response rate.

Though execs presented that as a positive, some analysts didnt paint as sunny a picture. This past February, when the Keynote-355 topline data was first published, SVB Leerinks Daina Graybosch pointed out that because only patients with a CPS of at least 10 appeared to benefit, instead of a score of at least 1, it wont be able to treat as broad a population as Tecentriq. Roche, she noted, also has about a two-year head start.

A Merck spokesperson also had this to say about the CPS and IC percentages:

In TNBC, we measure PD-L1 with a combined positive score (CPS). The CPS includes staining for tumor cells, as well as tumor-infiltrating immune cells and it is not a percentage. We believe CPS 10 is roughly equivalent to how Roche scores PD-L1+ patients (IC>=1% based on the SP142 assay) on tumor-infiltrating immune cells (IC). The prevalence of the PD-L1 positive population in TNBC whether by CPS of greater than or equal to 10 or IC of 1% is both about 40%.

Keytruda is already one of the best-selling drugs in the world, having notched roughly $3.9 billion in the first half of 2020 alone. Some have predicted the drug may overtake AbbVies Humira as the top seller within the next few years, with the most optimistic estimate pegged for $22.2 billion in sales by 2025.

Here is the original post:
UPDATED: Merck's Keytruda nets another approval, this time in triple negative breast cancer. Can it catch up to Tecentriq? - Endpoints News

DetailsCategory: AntibodiesPublished on Friday, 13 November 2020 13:04Hits: 719

STOCKHOLM, Sweden I November 13, 2020 I Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH) in children under 18 years of age in Europe. The negative opinion was given after the re-examination requested by Sobi after the initial opinon in July 2020.

This recommendation by the CHMP is disappointing given the significant unmet medical need which exists for patients with pHLH who have no approved therapies in Europe. During the re-examination we worked extensively with physicians and patients and were able to resolve some but not all of the concerns raised by EMA, said Ravi Rao, Head of R&D and Chief Medical Officer at Sobi. We are confident about the clinical profile of emapalumab and our focus is now on increasing access for patients in other regions and developing new indications for this medicine.

About primary HLHPrimary HLH is a rare syndrome that typically presents in infancy but can also be seen in adults and is associated with high morbidity and mortality. In spite of some treatment advances, there continues to be a very high unmet medical need in particular in patients that have failed conventional therapy as there are no approved treatment options outside the US. In the US, emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH. Over 100 patients have been treated in the US and the benefit/risk profile continues to be favourable.

About emapalumabEmapalumab is a monoclonal antibody that binds to and neutralises interferon gamma (IFN). In the US, emapalumab is indicated for the treatment of adult and paediatric (new-born and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Emapalumab is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). For more information please see http://www.gamifant.com including the full US Prescribing Information. In September 2020, emapalumab received Orphan Drug Designation (ODD) by the FDA for prevention of graft failure following haematopoietic stem cell transplantation.

About SobiTMSobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobis revenues amounted to SEK 14.2 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at http://www.sobi.com.

SOURCE: Sobi

Continue reading here:
The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH | Antibodies | News Channels - PipelineReview.com

With its origins in the late 1990s, lab-grown or cultured meat, is produced by providing stem cells extracted from the muscle of an animal with a suitable growth medium and nutrients, enabling them to proliferate and then differentiate to form muscle tissue. Creating meat in this way could help to address some of the environmental and ethical issues associated with livestock farming, as well as offer health benefits to consumers.Pairing cellular agriculture with genetic engineering could also enable the development of novel foods, with non-native features, that may be nutritionally enhanced. In a study recently published in Metabolic Engineering, researchers from Tufts University engineered bovine cells to endogenously produce phytoene, lycopene and -carotene, and found a reduction in lipid oxidation levels when this cultured meat was cooked.

Technology Networks had the pleasure of speaking to Andrew Stout, lead author of the study, to learn how these cells were created and explore the benefits of engineering in the abilities to produce additional nutrients. Andrew also discussed some of the challenges that are so far limiting the wider commercialization of cultured meat and how this may change in the future.

Anna MacDonald (AM): Can you give us an overview of the process by which the cow cells were engineered to produce the carotenoids?Andrew Stout (AS): To do this, we inserted three genes into the cells which encode enzymes that convert native compounds into carotenoids. Specifically, the first gene in this pathway (phytoene synthase) takes a native chemical and turns it into the carotenoid phytoene. The second gene (phytoene desaturase) turns some of that phytoene into a second carotenoid called lycopene. And the third gene (lycopene cyclase) turns some of that lycopene into a third carotenoid called beta-carotene. In that way, we're able to get cow cells to produce three different carotenoids that aren't naturally produced in bovine tissue. To engineer the cells, we used a system called the Sleeping beauty transposon system. This system is essentially a "cut and paste" tool which randomly cuts open the cells' genomes and inserts new DNA which we provide (in this case, the genes for carotenoid-producing enzymes).

AM: Why were beta-carotene, phytoene and lycopene chosen in particular?AS: There were several reasons for this. The first and most important was their role as dietary antioxidants. A key mechanistic link between red meat consumption and colorectal cancer is through lipid oxidation. This oxidation leads to the production of free radicals that can interact with tissue in the colon, damage cellular DNA, and ultimately contribute to cancer formation. Antioxidants can act to "quench" those free radicals, thus potentially inhibiting their cancer-causing potential. As carotenoids are powerful antioxidants, they offer a promising target for improving the nutritional features of cell-cultured meat.

Other reasons include the importance of beta-carotene as a vitamin A precursor, previous demonstrations of phytoene synthase efficacy in mammalian cells, and also as a sort of homage to golden rice, the first major demonstration of using genetic engineering to nutritionally enhance a food product.

AM: Were there any side-effects as a result of the nutritional engineering?AS: There were a few. The most obvious was a reduction in growth rate in bovine satellite cells that were engineered with carotenoid-producing enzymes. This would have negative implications for production processes if it proves to be unavoidable. Interestingly, though, in immortalized mouse muscle cells, this reduction in growth rate wasn't seen. Instead, cells producing carotenoids actually grew faster than non-engineered cells. One explanation for this could be that immortalized cells are more "robust" and are more amenable to engineering than the primary (non-immortalized) cow muscle cells we used. It's possible that immortalized cow cells would show growth-effects more like those seen in the mouse cells, which would turn this production down-side into a production up-side. Another side effect we saw was a change in color of the cells -- they took on a reddish tinge with the production of the carotenoids. I don't think this is really a "positive" or "negative" effect, but it is pretty interesting. Other potential side-effects that would need to be looked into would be the effects of carotenoids on cell differentiation, on the prevalence of other nutrients (e.g., cholesterol, etc.), and on flavor, texture, aroma, etc.

Karen Steward (KS): Why do you think you saw lower levels of lipid oxidation when the cell cultured meat was cooked compared to conventional meat?AS: Since carotenoids are antioxidants, they act to quench oxidation in cells during storage, cooking, etc., so we would expect lower lipid oxidation if the cells are producing carotenoids and therefore increasing the total cellular level of antioxidants.

KS: What do you see are the benefits of engineering in the abilities to produce additional phytonutrients to beef cells, as opposed say to having a traditional steak with some vegetables? Is there a risk that in providing these nutrients through meat intake a diet would consequently lack fibre which could impact gut health?AS: This is a fun question! I think we're an extremely long way from actually being able to use this technology to replace vegetables on our plates (and anyways, what a culinarily boring world that would be!) I like to think of this technology not as a replacement of vegetables, but an enhancement of meat. For instance, not all vegetables are high in carotenoids, so if you can get those nutrients from another source in your meal, then your overall consumption of them can increase. Also, the roll of carotenoids in specifically inhibiting oxidation in meat can act to mitigate some of the negative health implications of meat consumption without aiming to reduce vegetable consumption. As a final note, I'd like to think of this work as really just the tip of the iceberg of what's possible. There are so many options for enhancing meat with this or similar technologies--enhanced flavor, therapeutic activity, enhanced smell, etc. I think there's a world of totally novel foods that are possible and that would expand our culinary palette, not reduce it.

KS: Is there any need to start with cow cells? Could you essentially start with any cell type or are there limitations?AS: No need at all! I think this would likely work for all mammalian cells, and there's a strong chance it would work for avian and fish cells as well. We wanted to work with bovine cells because beef is such a major contributor to meat-associated greenhouse gas production and is one of the main red meats consumed around the world. As such, I think it's a really important target for all cultured meat work, including nutritional engineering.

AM: What challenges are so far limiting the wider commercialization of cultured meat?AS: The key hurdles are cost and scale. The field needs to reduce the cost of growth media (likely by reducing the cost of growth factors, reducing cellular reliance on growth factors, finding growth-factor alternatives, or other creative solutions), and to increase the scalability of cell culture (increased growth rate, increased maximum cell density, etc.). There are certainly plenty of other challenges, such as regulatory and consumer reception, demonstration of nutritional and food-quality value, and demonstration of food-safety, but I think that right now cost and scale still reign supreme.

AM: Where do you see the future of cellular agriculture headed?AS: A good question! I'll answer for two slightly different technologies.

First, for cultured meat specifically:

I think in the near future, the field is heading towards a bit of a "realignment" or specification in terms of goals, expectations, hype, etc. I think that this can be seen in some of the ways that companies are starting to look at their products with a bit more nuance, such as looking at the possibility of hybrid cell-based/plant-based products, which could overcome some of the cost/scale barriers of a fully cell-cultured product. Beyond that, I like to think that there will be an expansion of creative solutions to problems, or creative new ways of thinking about cell cultured meat. This could come in the form of looking at agricultural waste products for cell culture components, exploring novel genetic strategies to improve growth / reduce cost, or looking into alternate culture strategies / bioreactors.

Then for cellular agriculture more generally:

I think cellular agriculture in general, while certainly offering its own challenges and hurdles, is a lot further along the developmental pathway than cultured meat. I'm thinking here of products that are already on the market and demonstrably feasible such as recombinant milk proteins (Perfect Day Foods), recombinant collagen proteins (Geltor, Inc.), or recombinant proteins to improve plant-based products (Impossible Foods). I think these technologies are going to continue coming out and coming down in cost, allowing a bunch of new awesome products to come out and accelerate the development of plant-based or fermentation-derived products.

Andrew Stout was speaking to Anna MacDonald and Dr Karen Steward, Science Writers for Technology Networks.

Read the original here:
Taking Cultured Meat to the Next Level - Technology Networks

Approximately 15-20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer, said Dr. Hope Rugo, director of Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. Notably, in KEYNOTE-355, KEYTRUDA was combined with three different chemotherapy regimens: paclitaxel, nab-paclitaxel or gemcitabine and carboplatin. The approval of KEYTRUDA in combination with chemotherapy gives physicians an important new option for appropriate patients.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

Todays approval is a significant milestone, as it represents the first approval for KEYTRUDA in the breast cancer setting, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. In the study supporting this approval, KEYTRUDA in combination with paclitaxel, nab-paclitaxel or gemcitabine and carboplatin significantly improved progression-free survival for patients with advanced triple-negative breast cancer whose tumors express PD-L1 with CPS greater than or equal to 10 compared with the same chemotherapy regimens alone.

Data Supporting the Approval

The accelerated approval was based on data from KEYNOTE-355 (ClinicalTrials.gov, NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial conducted in 847 patients with locally recurrent unresectable or metastatic TNBC, regardless of tumor PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting. Patients were randomized (2:1) to receive either KEYTRUDA (200 mg on Day 1 every three weeks) or placebo (on Day 1 every three weeks) in combination with the following chemotherapy; all medications were administered via intravenous infusion:

Randomization was stratified by chemotherapy treatment (pac or nab-paclitaxel vs. gem and carbo), tumor PD-L1 expression (CPS 1 vs. CPS <1) according to the PD-L1 IHC 22C3 pharmDx kit and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). Assessment of tumor status was performed at Weeks 8, 16 and 24, then every nine weeks for the first year and every 12 weeks thereafter. The main efficacy outcome measure was PFS as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ tested in the subgroup of patients with CPS 10. Additional efficacy outcome measures were overall survival, as well as objective response rate (ORR) and duration of response (DOR) as assessed by BICR.

The study population characteristics were: median age of 53 years (range, 22 to 85), 21% age 65 or older; 100% female; 68% White, 21% Asian and 4% Black; 60% ECOG PS of 0 and 40% ECOG PS of 1; and 68% were post-menopausal. Seventy-five percent of patients had tumor PD-L1 expression CPS 1 and 38% had tumor PDL1 expression CPS 10.

In KEYNOTE-355, efficacy results were in patients who were PDL1 positive with a CPS 10 (n=323) and randomized to receive KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo compared with the same chemotherapy regimens alone. KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo (n=220) reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.49, 0.86]; p=0.0012), with a median PFS of 9.7 months (95% CI, 7.6, 11.3) versus 5.6 months (95% CI, 5.3, 7.5) with the same chemotherapy regimens alone (n=103). For PFS, 62% (n=136) of patients experienced an event with KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo versus 77% (n=79) with the same chemotherapy regimens alone. For patients who received KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo, the ORR was 53% (95% CI, 46, 60), with a complete response rate of 17% and a partial response rate of 36%. For patients treated with the same chemotherapy regimens alone, the ORR was 40% (95% CI, 30, 50), with a complete response rate of 13% and a partial response rate of 27%. Median DOR was 19.3 months (95% CI, 9.9, 29.8) with KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo versus 7.3 months (95% CI, 5.3, 15.8) with the same chemotherapy regimens alone.

In the study, the median duration of exposure to KEYTRUDA was 5.7 months (range, 1 day to 33.0 months). Fatal adverse reactions occurred in 2.5% of patients (n=596) receiving KEYTRUDA in combination with chemotherapy, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with pac, nab-paclitaxel, or gem/carbo. Serious adverse reactions observed in 2% of patients were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued for adverse reactions in 11% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (1%) were increased alanine aminotransferase (ALT) (2.2%), increased aspartate aminotransferase (AST) (1.5%), and pneumonitis (1.2%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 50% of patients. The most common adverse reactions leading to interruption of KEYTRUDA (2%) were neutropenia (22%), thrombocytopenia (14%), anemia (7%), increased ALT (6%), leukopenia (5%), decreased white blood cell count (3.9%), and diarrhea (2%). The most common adverse reactions (all grades 20%) for KEYTRUDA in combination with pac, nab-paclitaxel or gem/carbo were: fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).

About Triple-Negative Breast Cancer (TNBC)

Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

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

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

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

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

Gastric Cancer

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

Esophageal Cancer

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

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

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

Triple-Negative Breast Cancer

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

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

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

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

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

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

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

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

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

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

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

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Read more:
FDA Approves Merck's KEYTRUDA (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic...

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Market Definition

Transfection is an approach to produce exogenous nucleic acids such as DNA, RNA or oligonucleotide into cells. Such nucleic acids can be transferred by polymeric or lipid transfection reagents which promote the cellular absorption. This method is widely used for genomic studies (cell representation, testing, RNA interference, in vitro research) but can be conducted for bio-production (vaccine and protein manufacturing) or medicinal reasons (animal cell treatment). Nucleic acid delivery to cells can be accomplished by distinct physical techniques, such as electroporation, sonoporation or microinjection; however, these procedures are comparatively hazardous to cells. Transfection with chemical substances is a better option for maintaining healthy cell feasibility.

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Transfection Technologies Report displays data on key players, major collaborations, merger & acquisitions along with trending innovation and business policies. The report highlights current and future market trends and carries out analysis of the effect of buyers, substitutes, new entrants, competitors, and suppliers on the market. The key topics that have been explained in this Transfection Technologies market report include market definition, market segmentation, key developments, competitive analysis and research methodology. To accomplish maximum return on investment (ROI), its very essential to be acquainted with market parameters such as brand awareness, market landscape, possible future issues, industry trends and customer behavior where this Transfection Technologies report comes into play.

The Segments and Sub-Section of Transfection Technologies Market are shown below:

Segmentation: Global Transfection Technologies Market

By Transfection Method

Cotransfection

Electroporation

Cationic Lipid Transfection

In Vivo Transfection

By Applications

Virus Production

Protein Production

Gene Silencing

Stem Cell Reprogramming & Differentiation

Stable Cell Line Generation

Market Size Segmentation by Re gion & Countries (Customizable):

North America (Canada, United States & Mexico)

Europe (Germany, the United Kingdom, BeNeLux, France, Russia & Italy)

Asia-Pacific (Japan, South Korea, China, India & Southeast Asia)

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Middle East & Africa (United Arab Emirates, Egypt, Saudi Arabia, Nigeria & South Africa)

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Market Drivers

Surge in research & development in the field of cell based therapies is contributing to the growth of the market

Massive funds by government and private players is boosting the growth of the market

Growing occurrences of cancer diseases is propelling the growth of the market

Increasing number of obese and overweight population is driving the growth of the market

Market Restraints

Cost of transfection technology instruments is hampering the growth of the market

Hazard of negative reaction with the cell is hindering the growth of the market

Home brew reagents restricts sale of business supply which is restricting the growth of the market

Strategic Points Covered in Table of Content of Global Transfection Technologies Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Transfection Technologies market

Chapter 2: Exclusive Summary the basic information of the Transfection Technologies Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Transfection Technologies

Chapter 4: Presenting the Transfection Technologies Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying market size by Type, End User and Region 2010-2019

Chapter 6: Evaluating the leading manufacturers of the Transfection Technologies market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries (2020-2027).

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Transfection Technologies Market is a valuable source of guidance for individuals and companies in decision framework.

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Transfection Technologies Market Size Research Reports Global Industry, Share, In-Depth Qualitative Insights, Explosive Growth Opportunity|| Lonza,...

Theglobal market for exosome diagnostics and therapeuticsshould grow from $34.7 million in 2018 to $186.2 million by 2023, with a compound annual growth rate (CAGR) of 39.9% for the period of 2018-2023.

Report Scope:

This report represents a current and important business tool to evaluate new commercial opportunities in the exosome diagnostic, therapeutic and research tool markets. The geographic scope of this study covers the U.S. and companies worldwide. This market is complex and consists of a number of different sectors, each affected differently by scientific and technological development. The report identifies the main positive and negative factors in each sector and forecasts further trends and product and assay development in every category of this industry.

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Report Includes:

106 tables An overview of the global market for exosome diagnostics and therapeutics Analyses of global market trends, with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023 Description of immunological compatibility, cargo capabilities and other intrinsic therapeutic activities of exosomes Details of isolation and detection techniques and description of reagents and tools used for exosome research Evaluation of exosomal proteins and nucleic acids as diagnostic biomarkers and discussion of their impact on microRNA, liquid biopsy and stem cell research industry Information on bioinformatics databases for exosome research and product development, including as ExoCarta, Vesiclopedia and EVpedia Company profiles of the prominent players, including Codiak BioSciences, Evox Therapeutics Ltd., Exosome Diagnostics Inc., HansaBioMed Life Sciences Ltd. (Lonza), NonoSomiX Inc., and System Biosciences (SBI)

Summary

Initially, exosome particles were considered garbage molecules secreted by cells. Today, many researchers are convinced that these tiny vesicles have unlimited potential in diagnostics and therapeutics, especially in oncology treatments.

By definition, exosomes are small membrane sacs/vesicles, approximately 30 to 100 nanometers (nm) in diameter, that are released by both healthy and cancerous cells. Substances from cell cytoplasmsuch as genomic DNA, various RNA species, proteins and lipidsare encapsulated into exosomes and shed into the extracellular environment.

Research shows that all fluids in the human body contain exosomes, which can transfer cytoplasmic ingredients to other cells either locally or at distant sites. Once they reach the recipient cells, cytoplasmic ingredients can alter their biology. Thus, exosomes are widely being adopted by several end users, including hospitals, diagnostics centers and research institutions.

Scientists believe that various biomolecules in exosomes can be profiled and, consequently, may serve as useful biomarkers for different diseases. Nucleic acids such as RNA or DNA can be isolated from exosomes and further analyzed by various techniques. This is now efficiently done with the use of software provided by key players. The software used in exosome therapeutic and diagnostic applications are used for extraction, isolation and other purposes.

Overall, the market for the exosome approach can be divided into three main segments: product, application and end user. The overall market is estimated to be worth $REDACTED million (see Summary Table below), with the potential to increase to $REDACTED million in the next five years with a compound annual growth rate (CAGR) of REDACTED%.

This report evaluates the diagnostic market affected by exosome research and the further potential of exosome-based tests and assays. Indeed, an exosome approach represents the opportunity to expand and develop the liquid biopsy market, a growing sector in cancer diagnostics. Thus, increasing cancer prevalence worldwide generates huge opportunities for the liquid biopsy market. As per Our World in Data, about 42 million people worldwide had cancer in 2016, a more than two-fold increase from 1990. This report also highlights developments in therapeutic and drug development sectors. There is a significant potential for using exosome depletion as a way of treating disease; cancer-generatedexosomes can inhibit the immune response and stimulate angiogenesis, the development of new blood vessels. Consequently, if these exosomes are removed, tumor growth might be inhibited, and anticancer agents can work more efficiently.

In addition, there is a potential for exosomes to be used as targeted delivery vehicles of therapeutic molecules to cancer cellsfor example, delivering small interfering RNA-specific molecules (siRNA) for a particular oncogene expressed in a tumor cell. As per the U.S. National Library of Medicine, cell-based exosomes have a large number of roles and targets. Also, various studies have shown that exosomes have the potential to deliver various types of cargo to target cells efficiently.

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Exosome Diagnostics And Therapeutics Market Worldwide Industry Analysis and New Market Opportunities Explored - The Daily Philadelphian

MicroRNA are small endogenous RNA that regulates gene-expression post-transcriptionally. MicroRNA are abundantly found in the mammalian types and target approximately 60% of the genes of the human and other mammals. MiRNA reverse transcription are crucial regulators of gene expression and promising candidates for biomarker development. A single miRNA can target hundreds of mRNAs and influence the expression of many genes. Further, miRNA reverse transcription involved in many allergies diseases including eosinophilic esophagitis, asthma and many others which is likely to increase the demand for MicroRNA Reverse Transcription. Current methodologies used for MicroRNA reverse transcription such as RNA-sequencing, microarrays and quantitative PCR.

Increasing prevalence of Cancer, neurological disorder and others are expected to drive the MicroRNA reverse transcription market. MicroRNA reverse transcriptase is found to be associated with immune system, cancer stem cell and androgen receptor expression properties in triple negative breast cancer. In addition, MicroRNA reverse transcriptase market is expected to rise exponentially due to further development in genomics technologies and computational approaches. Further, therapeutics demonstration in preclinical studies using these molecules is anticipated to increase the R&D investment in the coming years. Furthermore, there are various kits available such as the TaqMan, MicroRNA reverse transcriptase is specifically designed to generate specific cDNA, for the use with the TaqMan MicroRNA Assays is also expected to increase the growth of MicroRNA reverse transcriptase market.

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Accurate delivery of these molecules to an intracellular site such as nucleus and cytosol and also limited research infrastructure in emerging market are expected to hinder the growth of MicroRNA reverse transcriptase market.

The global MicroRNA reverse transcription market is classified on the basis of components type, methods, application, end user and region.

Based on Components Types, MicroRNA Reverse Transcription Market is segmented into the following:

By Products Type:

By Services Type:

Based on Methods, MicroRNA Reverse Transcription Market is segmented into the following:

Based on Application, MicroRNA Reverse Transcription Market is segmented into the following:

Based on End User, MicroRNA Reverse Transcription Market is segmented into the following:

Global MicroRNA Reverse Transcription market is segmented on the basis of components type, methods, application, end user and region. On the basis of product type, consumables are expected to represent the leading share in the MicroRNA Reverse Transcription market. On the basis of methods, quantitative PCR is expected to increase the demand for MicroRNA Reverse Transcription which is used to diagnose diseases, match criminals crimes and identify bacteria. Furthermore, on the basis of application, shifting focus on pipeline research for infectious and cancer attributed to their high occurrence and failure rate of existing treatment processes can further propel growth followed by neurological and cardiovascular disorders. On the basis of end user, academic and research institutes are expected to enhance effectiveness of microRNA drug technology which is likely to witness maximum growth forecast period.

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Geographically, the MicroRNA Reverse Transcription market is segmented into regions such as Latin America, Europe, North America, South Asia, East Asia Middle East & Africa and Oceania. North America is projected to emerge as prominent market in the MicroRNA Reverse Transcription market due to several factors such as increasing prevalence of chronic and acute disease, access to advanced technologies and rising demand for preventive medical care followed by Europe. Asia pacific is the expected to show lucrative growth due to increasing access to advanced technologies, geriatric population, increasing disposable incomes and also demand for advanced diagnostic procedure. However, unmet needs for MicroRNA Reverse Transcription is expected to drive the Middle East and Africa.

Some of the major key players competing in the MicroRNA Reverse Transcription market are Sigma Aldrich Corp., Thermo Fisher Scientific, Inc., Agilent Technologies, Illumina, Inc., Bio-Rad Laboratories Inc., System Biosciences LLC, HTG Molecular Diagnostics, Inc., GeneCopoeia, Inc. and New England Biolabs, Inc.

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Latest updated Report gives analysis of Circulating Tumor Cells market overview, scope, market risks, market driving force and market opportunities. Circulating Tumor Cells competitive situation, sales, revenue and global market share of top manufacturers working in Circulating Tumor Cells industry are analyzed clearly by landscape contrast

The Global Circulating Tumor Cells Market divides the industry on the basis of the regions by growth, product types and applications, over the forecast period (2020-2027) of the Circulating Tumor Cells market. It analyzes every majorfacts of the global Circulating Tumor Cells by specifications of the product, restraints, challenges, andgrowth opportunities. Company profiles of the major leading player with Circulating Tumor Cells investment forecast, latest technology trends,and future forecast. Detailed global understanding of the Circulating Tumor Cells market based on present and future size(revenue) and Circulating Tumor Cells market prediction plot in the form of a list of charts and tables, pie-charts to assist aspirants and major market players in making significant and growing choices.

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The research mainly covers Circulating Tumor Cells market in North America (United States, Canada and Mexico), Circulating Tumor Cells Europe industry (Germany, France, UK, Russia and Italy), Asia-Pacific (Southeast Asia, China, Korea, India and Japan), Circulating Tumor Cells South America industry (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa). The Circulating Tumor Cells report also performs SWOT (Strengths, Weaknesses, Opportunities, and Threats) with XX CAGR values, and XX USD of past(2015-2019) and Circulating Tumor Cells forecast(2020-2027) on the basis of growth and market condition following with the size of Circulating Tumor Cells market.

The Global Circulating Tumor Cells market reportcomprises variouskey manufacturers, application analysis and type analysis:

Key players of the global Circulating Tumor Cells market:

BioceptAdnagenNanostring TechnologiesApoCellCanopus BioscienceMiltenyi BiotechVitatexIkonisysRarecells DiagnosticsCreatv MicrotechIV Diagnostics

Market Segment Analysis

By Types:

Ex-Vivo Positive SelectionIn-Vivo Positive SelectionNegative SelectionMicrochips & Single Spiral Micro Channel

By Applications:

Tumorigenesis ResearchEMT Biomarkers DevelopmentCancer Stem Cell ResearchOthers

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Global Circulating Tumor Cells market report figure out a detailed analysis of key Circulating Tumor Cells market players by referencing their company profiles, supply/demand study, sales margin, gross margin and year to year revenue to have Circulating Tumor Cells industry better share over the globe. Circulating Tumor Cells market report also includes development.

The Global Circulating Tumor Cells industry research report analyses the supply, sales, production, and market status comprehensively. manufacturing market shares and sales market shares are analyzed along with the analysis of capacity, production, sales, and revenue.

Table Of Content Described:

1. Circulating Tumor Cells Industry Synopsis

2. Global Circulating Tumor Cells Market Size by Segmentation (2020-2027)

3. Circulating Tumor Cells Leading Manufacturers Company Profiles

4. Global Circulating Tumor Cells Market Competitive Study by Players

5. US Circulating Tumor Cells Market Development Status and Overview

6. Europe Circulating Tumor Cells Market Improvement Status and Overview

7. Africa Circulating Tumor Cells Market Development Status and Overview

8. South-America Circulating Tumor Cells Market Improvement Status and Overview

9. Asia-pacific Circulating Tumor Cells Market Development Status and Overview

10. Southeast Asia Circulating Tumor Cells Improvement Status and Overview

11. Circulating Tumor Cells Market Forecast by Regional Analysis, And By Segmentation (2020-2027)

12. Dynamics of Circulating Tumor Cells Market

13. Circulating Tumor Cells Market Growth Factors Study

14. Research Conclusions

15. Appendix

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Global Circulating Tumor Cells Market 2020 Analysis and In-Depth Research on Market Dynamics, consumption by Regional data, Trends, Investigation and...

The global Live Cell Imaging Market study offers a compilation of the current, historical, and future outlook of the industry as well as the factors responsible for market growth. With a SWOT analysis, the business study highlights the weaknesses, strengths, opportunities, and threats of each Live Cell Imaging Market player in a comprehensive way.

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Under the COVID-19 outbreak analysis, this report provides analysis of import, supply chain, and export to future influence on the industry and regional government policies. Enterprise competition pattern, detailed analysis about market status, advantages and disadvantages of enterprise products, macroeconomic policies and regional industrial layout characteristics, industry development trends have also been included. The trends of product sales channel will be offered as well.

Considering COVID-19, this report offers a complete and exhaustive analysis on how the epidemic has pushed transformation and reform in the industry. The market study can help understand the market expansion and strategies for business accordingly. In the strategy analysis, it gives insights from market positioning marketing channel to potential growth strategies, thereby providing an in-depth analysis for new entrants or existing competitors in the Live Cell Imaging industry.

Key Players: Becton, Dickinson and Company, Carl Zeiss, and Leica Microsystems..

The market analysis on the Live Cell Imaging offers a birds eye view of the current proceeding within the Live Cell Imaging Market. The market analysis report has incorporated an analysis of various factors that augment the markets growth. It constitutes restraints, trends, and drivers that transform the market in either a negative orpositive manner.

Live Cell Imaging Market

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This market analysis also offers the scope of different segments and applications that can actually impact the market in the future. The thorough information is based on present trends and historic milestones. The market analysis mentions the volume of sales by region from 2015 to 2026. A thorough evaluation of the limitations included in the market analysis portrays the drivers and gives room for strategic planning.

Global Live Cell Imaging Market: Segment Analysis

Each type offers information about return sover the forecast period of 2018 to 2028. The sales method segment also offers revenue by volume and sales over the forecast period of 2018 to 2028. Understanding the segments helps in classifying the importance of various factors that support market growth.

Following are the segmentation covered by the market study: By Product (Equipment, Consumables, and Software and Services), By Application (Cell Biology, Developmental Biology, Stem Cell Biology, Drug Discovery)

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The market analysis report includes a thorough study of various factors that determine regional growth such as environmental, economic, social political status, technology, and region. Market analysis has studied the data of sales, revenue, and manufacturers of each region. The market analysis provides region-wise volume and revenue for the forecast period of 2016 to 2028. This market analysis will support the market participants to understand the potential worth of investment in a particular region.

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Global Live Cell Imaging Market: Competitive Landscape

This market analysis report classifies numerous key manufacturers of the industry. It supports the reader in understanding the policies and collaborations that the industry participants are focusing on in order to combat competition in the industry. The comprehensive market analysis offers a note worthy microscopic look at the industry. The market analysis can classify the footprints of the manufacturers by giving the global revenue of manufacturers and sales by manufacturers, and the global price of manufacturers over the forecast period of 2018 to 2028.

Major Aspects covered in the Report are

Further, the report provides niche insights for a decision about every possible segment, helping in the strategic decision-making process and market size estimation of the Live Cell Imaging Market on a regional and global basis. Unique research designed for market size estimation and forecast is used for the identification of major companies operating in the market with related developments. The report has an exhaustive scope to cover all the possible segments, helping every stakeholder in the Live Cell Imaging Market.

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Live Cell Imaging Market By Applications, Types, New Technology Opportunity Analysis And Forecast: 2020 2028 - TechnoWeekly

ByPeter M. Vishton, PhD,William & MaryEdited by Kate Findley and proofread byAngelaShoemaker, The Great Courses DailyNew research shows that exercise and SSRIs both help with reducing depression. Photo By Tero Vesalainen / ShutterstockDefying Conventional Wisdom

It may be that the key to reducing depression is to make more neurons. This is called neurogenesis.

The conventional wisdom for many decades in neuroscience was that the brain produced neurons only early in development. By later childhoodcertainly by the onset of pubertyit was believed that your brain had produced all of the neurons that it ever would.

Its long been understood that the brain continues to alter the patterns of connections between existing neurons throughout our lives and the strengths of those existing connections are altered by our experiences. In terms of the production of completely new neurons, that was presumed not to happen in the human brain.

If a peripheral neuron is destroyedfor example, if someone suffers a bad injury to a fingerit will often heal itself. In the central nervous system, though, neurons seem not to regenerate after they are destroyed.

This is, to a large extent, true, but several teams of researchers in the 1980s and 1990s found evidence for adult neurogenesisthe creation of new neurons. The results were first found not in humans, actually, but in songbirds and, later, rats.

The basic technique for doing this is ingenious. A mildly radioactive label is injected into the bloodstream of the animal; that is, a label thats designed to adhere to the animals DNA.

In later microscopic imaging of the brain tissue, the labeled DNA can then be seen. When the body makes a new cellany cells now, not just brain cellsit does so via a process called mitosis.

The cell makes a copy of its own DNA, along with other critical internal components of the cell, and then dividessplitting in two to create a copy of itself. After a cell has undergone this mitosis, the labeled DNA looks different in very predictable ways. Essentially you can see where the brain has been making new cells during the time between the labeling injections and when the imaging takes place.

Amazingly, the brains of many animals seem to make new neurons on a pretty regular basis. The original work was done with songbirdsbirds like canarieswho typically learn new songs every spring.

As they undergo this seasonal learning process, their brains change in size substantially to support this new learning. The new cells are created, recruited into learning circuits, and then used just like older cells are.

In humans, it seems that new neurons are actually not produced in most brain regions. They might be, but, if they are, the neurogenesis is very slow and perhaps rare. There is now good evidence, however, that a neuron creation process takes place in at least two parts of the human brain; parts where rapid learning seems to take place.

The first is called the striatum; this is a subcortical part of the brain thats central to implementing your responses to positive and negative reinforcements. When fighting procrastination, for example, you get that shot of pleasure when you complete something.

That nucleus accumbens is one subpart of this larger striatum region. Just like songbirds, this is a part of the brain where continual learning and restructuring takes place.

The other region where rapid neurogenesis seems to take place in humans is in the hippocampus. This is a part of the brain thats critical for many important cognitive functions.

Our internal mental map of the surrounding environment seems to be implemented in this part of the brainincluding our sense of where we are on that mental map. Our ability to form new long-term memories is implemented in the hippocampus as well.

People who suffer damage to the hippocampus can often remember many things that took place in their earlier life, but, after suffering the hippocampus injury, they lack the ability to remember new names, new places, new eventsthis is a condition called anterograde amnesia.

A particular region of the hippocampus seems to hang on to a stock of undifferentiated neuronal cellsessentially stem cells. When it uses some of them, the stock is replenished.

Throughout our lives, these stem cells are converted into functioning neurons and incorporated into the regular function of the hippocampus. The precise details of how this takes place is still a bit of a mystery.

What we do know is that neurogenesis takes place. Something else we know is that it doesnt take place nearly as much in people who suffer from depression symptoms.

Several studies have found that people who suffer from major depression for several months actually have measurable smaller hippocampus regions. If the hippocampus reduces the rate at which it produces new neurons for an extended period, it will begin to shrink. This directly fits this notion that depression is related to a low rate of neuronal production in the hippocampus and other areas of the brain associated with learning and arousal.

We also know that patients who take antidepressant medications dont typically experience an immediate recoverytheir mood doesnt immediately improve when they start to take a SSRI drug. Usually, the positive impact of the medication doesnt kick in for several weeks.

This is a bit surprising if depression is all about the neurotransmitters. The effects of those on serotonin and other neurotransmitters really shouldnt take many weeks; it should take place over the course of hours or days at the most.

Interestingly, it also takes a few weeks for the brain to start producing new neurons more rapidly again. The neurogenesis and depressive symptoms seem to follow about the same timeline. Again, it seems that depression might be very much about neuron production.

All of this sounds like the story might be winding down. Depression is strongly associated with reduction in neurogenesis. Increase neurogenesismaybe with drugs, or maybe with exerciseand depression goes away.

Peter M. Vishton is Associate Professor of Psychology at William & Mary. He earned his PhD in Psychology and Cognitive Science from Cornell University. Before joining the faculty of William & Mary, he taught at Northwestern University and served as the program director for developmental and learning sciences at the National Science Foundation.

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Neurogenesis: The Missing Link When Treating Depression - The Great Courses Daily News

Maryland, US headquartered company, Orgenesis, is championing a model that aims to bring down those costs it works with partner hospitals throughout the commercialization process.

The companys CGT platform, consisting of a pipeline of licensed cell and gene therapies, scientific expertise, customised processing systems, and an ecosystem of healthcare providers and research institutes, is designed to provide a pathway for groundbreaking autologous therapies to become commercially available on an industrial scale and at prices accessible to large populations.

Orgenesis business model is one focused on decentralization, enabling precision medicines to be prepared on-site at hospitals. In this way, we can really expedite cell and gene therapy development, said Orgenesis CEO, Vered Caplan.

With operations in the US, Europe, Israel and South Korea, Orgenesis has now created an international network of point of care (POCare) centers to serve patients directly in the hospital setting.

Beyond the US, we have POCare centers in many countries in Europe such as Greece, the Netherlands, Belgium, Slovenia, Italy and Spain; we also have centers in Israel, in Korea and in India and we will be starting up soon in Dubai,said the CEO.

The goal is to make gene and cell therapies feasible for large numbers of patients, said Caplan. We used to work as a contract development and manufacturing organization (CDMO) but we sold that business to Catalent at the beginning of the year.

The centralized processing and supply chain model only served to create a frustrating working environment, with plenty of constraints, said the Orgenesis lead.

We realized very quickly that we couldnt really ramp up to large scale relying on that kind of centralized model, particularly for autologous products, which represent most of the market today. It takes six months to train someone to work in a high-grade cleanroom there is a lot of work and expense involved in that and there is a limited number of patients that can be treated in such cleanrooms the utilization rate is very low - it [centralized processing and supply] is a very inefficient and costly way to supply and to develop medicine there is so much manual work involved, she told BioPharma-Reporter.

The company had been working for a number of years, investing a huge amount of effort in developing a range of automation solutions to supplant those manual processes, as well as building its mobile CGT processing labs and units (OMPULs), she said.

We had been fielding so many requests from hospitals that wanted to collaborate with us, asking us to make or scale up their CAR-T and other therapies. We realized that in order to get this done, we needed to take a decentralized approach and that we needed to provide a solution, not only for one hospital, but for every hospital that wanted these type of therapies; and we saw that such a model brings down the price of the therapy tremendously.

A hospital gives Orgenesis a license to work on the therapy, on the processing; production of the final product is automated and supplied via an on-site point-of-care processing unit. Orgenesis then sets about democratizing the treatment,making it available to any hospital in its POCare network.

The company says the final customized, automated processing system it has developed, with the integrated specific therapy, solves a variety of processing and cost hurdles. It results in a lower required grade of cleanroom, it simplifies facility management requirements, it enables multi-batch processing per cleanroom, which means reduced technical staffing. Moreover, the localized processing eliminates the many logistical difficulties associated with traditional, centralized manufacturing and transport.

Overall, it is said to provide faster turnaround, increased safety, and improved quality control management on-site.

Hospitals really want to supply CGTs, while patients are reading about such treatments and making inquiries of healthcare providers, she added.

Ours is really a combined licensing and service model.

We are like Uber. If you have a car, you want to make some extra revenue, you call up Uber and it gives you the network, the technology and all the operating procedures to be a taxi driver. That is very much what we do in terms of hospitals we give them the ability to be biotech companies, because this is not the standard thing they do, they dont want to take responsibility for cell and gene therapy it is too much for them. They want to treat patients, but they want to have that local supply, so we give them the technology and the capabilities to do that. We give them regulatory support for clinical trials, we give them CRO support, we give them a network - so they can function and do what they need to do, which is to undertake research and treat patients.

Orgenesis intends to leverage its network of regional partners to advance the development and commercialization of its therapeutic pipeline. Towards this end, it said its partners have committed to funding the clinical programs. In turn, the company typically grants its partners geographic rights in exchange for future royalties, and a partnership with Orgenesis to support the supply of the targeted therapies. Through this model, Orgenesis has already signed contracts, which it expect to generate over US$40M in revenue over the next three years, if fully realized.

On the therapeutic front, Orgenesis is focused on several key verticals, including immuno-oncology, anti-viral, and metabolic/auto-immune diseases.

It recently acquired Koligo Therapeutics, with the aim of leveraging Koligos 3D-V bioprinting technology across its POCare Platform. That technology, which utilizes 3D bioprinting and vascularization with autologous cells to create biodegradable and shelf-stable three-dimensional cell and tissue implants, is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.

In February this year, Orgenesis announced that it has entered into a collaboration agreement with the John Hopkins University to utilize the POCare platform to develop and supply a variety of CGTs including cell-based immunotherapy technologies.

And the University of California, Davis (UC Davis) joined its POCare network in January. The collaboration will involve the scale up and integration of UC Davis lentiviral vector process.

Today we are very much in validation mode. Most of the therapies in this space, and the ones we have licensed from the hospitals I think we have about 25 today are all at different stages of clinical development. Some have been used to treat patients but that has all been done under hospital exception.

When we adopt a therapy into the network, we run it through the entire R&D, formal clinical and regulatory processes as [our goal] is a harmonized process, to have the same standard [in our closed systems] at our [POCare] centers, whether that is in Germany or Korea, said the CEO.

Excerpt from:
Orgenesis CEO talks disruption: 'We are the Uber of the cell and gene therapy space' - BioPharma-Reporter.com

Nov. 16, 2020 12:30 UTC

- Highly innovative genome editing technology platform accelerates and broadens ElevateBios cell and gene therapy enabling technologies

- LifeEDIT Therapeutics to develop its own pipeline of potentially life-transforming therapeutics

- LifeEDIT Therapeutics to leverage its novel gene editing platform with strategic partners including ElevateBio portfolio companies

CAMBRIDGE, Mass. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- ElevateBio, a Cambridge-based cell and gene therapy holding company, and AgBiome, a leader in developing innovative products from the Earth's microbial communities, today announced that LifeEDIT Therapeutics has joined ElevateBios growing portfolio of therapeutic, technology and manufacturing companies. LifeEDIT Therapeutics combines a highly innovative genome editing platform, derived from AgBiomes massive proprietary microbial library, with ElevateBios proven expertise in the discovery and development of new cell and gene therapies. LifeEDIT will continue to develop internal cell and gene therapies while further strengthening its platform of diverse genome-editing enzymes and provide gene editing expertise to strategic partners including ElevateBio portfolio companies. AgBiome retains rights for gene editing in agriculture, animal health, and diagnostics.

Genome editing technologies have revolutionized the way we develop cell and gene therapies and regenerative medicines, said Mitchell Finer, Ph.D., President, ElevateBio BaseCamp, and newly appointed Chief Executive Officer, LifeEDIT Therapeutics. However, in order to realize the promise of, and democratize, these highly innovative therapeutic approaches, the field needs to access novel RNA-guided nucleases and base editors that offer greater specificity and broader genome coverage, which LifeEDIT can provide. LifeEDITs genome editing platform is one of the most versatile in the field and was the natural fit as we continue to build a world leading cell and gene therapy offering.

Members of ElevateBio will join the newly formed LifeEDIT Therapeutics management team, which will continue to benefit from its existing visionary scientific leadership and research team. The combined executive team will include:

Over the last 18 months we have built a truly unique platform of numerous RNA-guided nucleases with diverse PAM requirements, for which weve been able to show functional activity, said Tedd Elich, Ph.D., Chief Scientific Officer, LifeEDIT Therapeutics. The wide range of gene editing enzymes across our platform increases our ability to target any genomic sequence of interest and will allow us to tackle some of the most challenging diseases, bringing desperately needed, potentially curative, therapies to patients in need.

"AgBiome's GENESISTM platform is built on our microbial collection, their complete genome sequences, and our industry-best data science platform to identify new useful functions, said Eric Ward Co-Chief Executive Officer, AgBiome. This unique resource formed the basis for the many genome editing technologies that are now part of LifeEDIT Therapeutics. We look forward to continuing to collaborate with the LifeEDIT team as they build a world-class pipeline of clinical candidates and bring a broad array of genome editing technologies to innovators across the biotechnology industry."

About Genome Editing and LifeEDIT Therapeutics Platform

Genome editing technologies have revolutionized the way cell and gene therapies and regenerative medicines are discovered and developed by allowing genetic material to be removed, added, or altered at specific locations in the genome. While these technologies are in widespread use experimentally, enzymes that offer broader coverage and greater specificity are needed for creating novel cell and gene therapies.

To meet the need for better genome editing approaches, LifeEDIT Therapeutics has built one of the worlds largest and most diverse arrays of novel RNA-guided nucleases (RGNs) and base editors that are active in mammalian cells. These RGNs were developed using AgBiomes proprietary collection of more than 90,000 microbes and their complete genomes. LifeEDIT Therapeutics is investigating these proprietary RGNs, which are sourced exclusively from non-pathogenic organisms, to develop new gene editing tools with higher fidelity, novel functionality, reduced immune response risk, and easier delivery. LifeEDIT Therapeutics nuclease collection also has a broad range of Protospacer Adjacent Motifs (PAMs) short sequences that must follow the targeted DNA sequence in order for the enzyme to make cuts that offer unprecedented access to genomic loci of interest. The LifeEDIT Therapeutics RGNs offer flexible editing options which encompass knock-out and knock-in capabilities, transcriptional regulation, and base editing when coupled with its proprietary deaminases.

LifeEDIT Therapeutics next generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies. In addition to developing its own pipeline of cell and gene therapies, LifeEDIT Therapeutics will continue to build its platform of novel nucleases, provide gene editing expertise to strategic partners and ElevateBios portfolio companies, and form other third-party partnerships to discover and develop new therapies.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and translational research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners, are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Emerson Collective, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

About AgBiome

AgBiome partners with the microbial world to improve our planet. AgBiome discovers and develops innovative biological and trait products for crop protection. The proprietary GENESIS discovery platform efficiently captures diverse, unique microbes for agriculturally relevant applications, and screens them with industry-best assays for insect, disease, and nematode control. Through its commercial subsidiary, AgBiome develops and sells proprietary crop protection solutions. The first of these, Howler, is a revolutionary fungicide for disease control in a broad variety of crops. AgBiome and Genective recently formed a strategic partnership to establish a new leader in insect traits, a market with over $5 billion in annual opportunities. AgBiome has a global R&D collaboration with Elanco Animal Health Incorporated (NYSE: ELAN), to develop nutritional health products for swine. AgBiomes investors include Polaris Partners, ARCH Venture Partners, Fidelity Investments Inc., UTIMCO, Pontifax AgTech, Innotech Advisors, Syngenta Ventures, Leaps by Bayer, and Novozymes. For more information, visit http://agbiome.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005105/en/

Excerpt from:
ElevateBio and AgBiome Announce LifeEDIT Will Join ElevateBio's Portfolio of Innovative Cell and Gene Therapy Companies - BioSpace

UCB has struck a deal to buy gene therapy startup Handl Therapeutics. The takeover, which was disclosed alongside a separate gene therapy collaboration, positions UCB to accelerate its push into genetic medicines.

In recent years, UCB has quietly built out its genetic medicine capabilities, buying Element Genomics for a small sum in 2018 while hiring gene therapy specialists and creating plans to refurbish an ex-Eli Lilly R&D site to support its aspirations in the area. Those efforts have been overshadowed by the big-ticket gene therapy deals struck by UCBs peers but point to its interest in the space.

UCB stepped up its gene therapy expansion on Thursday with two deals. UCB has bought Handl for an undisclosed sum to gain control of technology platforms designed to facilitate the development of AAV gene therapy treatments for complex neurodegenerative diseases.

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Handl was founded by Florent Gros, a Novartis veteran, and Michael Linden, an AAV expert who set up the Pfizer Genetic Medicine Institute in London. Working out of Leuven, Belgium, Handl has used the expertise and connections of Gros, its CEO, and Linden, its CSO, to identify and license technologies from Spain, Chile, the U.K. and Belgium.

The Chilean and Spanish academic centers that struck licensing deals with Handl put out statements about their work, disclosing an interest in treating diseases including Alzheimers, amyotrophic lateral sclerosis and Parkinsons. Handl entered into a manufacturing contract with Novasep earlier this month, securing support as it wraps up ongoing IND-enabling studies and moves into the clinic.

As part of UCB, the Handl team will continue to work on that program and other projects from its base in Leuven. UCBs international research teams will collaborate with the Handl group.

UCB disclosed the Handl takeover alongside details of a collaboration with Lacerta Therapeutics, a Florida-based AAV gene therapy startup. The deal gives UCB access to Lacertas pipeline of CNS gene therapies. Lacerta will handle research, preclinical and early process development, leaving UCB to focus on IND-enabling studies and subsequent manufacturing work and clinical development.

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UCB inks Handl buyout to boost nascent gene therapy unit - FierceBiotech