The Duchess of Sussex while pregnant at the the Fashion Awards 2018

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The treatments to indulge in...

Its pure countryside splendour at Thyme, a Cotswolds retreat with acres of herbs, pretty flowers and rolling meadows, home to a blissful spa with an outdoor freshwater swimming pool. The Aurelia skincare line is used in the spa treatments, which take place in a light and airy room with the late summer breeze flooding in through open windows, along with the sounds of birds chirping. The full body pregnancy massage is light yet deeply relaxing. Oils with a reviving citrus base are massaged into ones skin, followed by a foot, scalp and neck massage. The treatment is finished with rose quartz (prized for its depuffing qualities) gently rubbed across the face, for lymphatic drainage. Expect to pad back to the achingly chic antique-filled bedrooms, swathed in a dressing gown, feeling perfectly serene.The Peaceful Pregnancy Massage - 70 for 75 minutes - at the Thyme treatment rooms. Bedrooms at Thyme start at 250 per night. Nr, Lechlade GL7 3NX / 01367 850174 / thyme.co.uk

In Belgravia at the Renee Lapino Clinic, state-of-the-art pregnancy pampering is the order of the day. As part of the antenatal offering, clients can climb into a high-tech pair of galoshes, wired up to the mains (reminiscent of The Wrong Trousers in Wallace and Gromit), and lie back on the bed while the trousers gently pulse and massage the legs to rid them of water retention and heaviness, for 30 soothing minutes, as an equally high-tech facial takes place. Iris, the therapist, first scrubs your face with a cranberry-based enzyme gel for exfoliation, then steams your pores before a gentle manual extraction of blackheads. Useful, since a surge of pregnancy hormones can throw the skins equilibrium off balance, leading to congestion and breakouts. Then heat-activating gel is slathered on the face, followed by radio and LED frequency (only offered from the second trimester onwards) to stimulate collagen production. Finally, theres a lymphatic Chinese Gua Sha massage to rid the face of unwelcome pregnancy puffiness and improve circulation.New Mummy Pregnancy Facial - 195. Length 1 hour. Body balancer, applied simultaneously, is an extra 65. Renee Lapino at Neville Hair & Beauty, 5 Pont St, London SW1X 9EJ / 020 7235 3654 / nevillehairandbeauty.net

The spa at the Corinthia in Westminster looks just like a Bond villains lair: an underground bunker with lashings of black marble and roaring fireplaces, ice fountains, sleep pods accessed through secret doors and even an amphitheatre sauna. On arrival water is served on a silver salver and a high-tech facial recognition machine takes your temperature, for Coronavirus compliance. Once in the clear, the Espa Blissful Maternity massage begins with a hot towel hand cleanse, then rosehip exfoliator is gently scrubbed into ones back, followed by an indulgent rosehip massage oil kneaded across the back, chest and belly. (Rosehips are packed with vitamin C, E and B, and contain a substance to help combat stretch marks and inflammation). Mercifully, tired cramp-afflicted pregnant legs are soothed, too, before the treatment finishes with a neck rub and a nourishing hair mask being massaged into the scalp. It is the ultimate in cosseted, luxury relaxation.Espa life at the Corinthia: Espa Blissful Maternity - duration 90 mins - 240. The Corinthia Hotel, Whitehall Pl, Westminster, London SW1A 2BD / 020 7321 3050 / espalifeatcorinthia.com

Set in the basement of East Londons hottest hotel is the Neds Cowshed spa, a stylish beauty haven. Low-lit treatment rooms have a calming, earthy palette of beige and browns, while a high-tech massage bed has every conceivable adjustment for comfort - perfect for supporting weary pregnant bodies. The maternity Full Body Care treatment starts with a foot soak and scrub. Then, sitting upright on a stool and leaning into the cushion laden bed, therapist Pavlina kneads your back with the Cowshed range, especially designed for pregnancy (lotions without essential oils, some of which the NHS recommends women avoid as they can cross the placenta). For the next stage, moving onto the bed theres a massage with Mother Stretchmark Balm, containing seabuckthorn to help prevent stretchmarks, followed by a vigorous dry body brushing across the legs, belly and chest, to exfoliate and aid the bodys circulation, rejuvenating tired skin. Leave feeling buffed and renewed. Full Body Care: 90min - 200. Cowshed at The Ned: 27 Poultry, London EC2R 8AJ / 020 3828 2000 / thened.com

A holistic approach to facials is on offer at the smart Marylebone clinic Avicenna. Its founder Sana Khan offers in-depth skin consultations for clients, which involves computer imaging to detect sun damage, pigmentation and skin texture, highlighting deficiencies in the dermis and leading to a plan of action. For the maternity facial, the focus is on balancing out hormone spikes in the skin that you find in pregnant women (an overload of testosterone is thought to lead to more breakouts, for example). Sana avoids harsh acids and rather than adhere to a template facial, she adapts the treatment to what the client most needs. For dry skin, she starts with a double cleanse and applies a moisture surge of hyaluronic acid serum (which has a function of retaining water). The next stage is extraction with a needle to clear skin congested with blackheads and impurities, before applying a hyaluronic mask. After the hours session skin looks plump and dewy. Avicenna Wellbeing Pregnancy Facial - 180. Duration 1 hour. 30 b, Nottingham Pl, Marylebone, London W1U 5NP / 020 7935 3057 / avicennawellbeing.com

The products to try...

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Pregnancy beauty treatments mum-to-be luxury spas and products - Tatler

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In a season when we would usually be out cheering on our local sports teams, we are spending more time at home and repeating a new mantra: Wash your hands, practice social distancing, wear a mask.

But what if you could play offense instead of defense to fend off colds and viruses? What if adjusting your daily habits could build your immunity to help your body fend off illness, not only this year but every year?

Thats not only possible, says Katie Moksnes Bowman, its something she encourages her patients to do every day.

Stress is the number one way we increase inflammation in the body, says Moksnes Bowman, a licensed acupuncturist and Doctor of Acupuncture and Chinese Medicine (DACM) for Northwestern Health Sciences University. She says inflammation can affect digestion, sleep patterns, pain, and your bodys immunity.

The key to improving your immunity is to reduce inflammation in your body.

The amount of stress that has been created from the pandemic is causing issues for people physically and emotionally, she says. In Chinese medicine, your digestion matters, sleep matters, your immune system matters.

When I am in practice with a patient, we talk about sleep, bowels, diet and movement at every single treatment. I really want to work with them where theyre at.

She sees patients ranging from professional athletes to seniors with mobility issues and everyone in between, so there is no one-size-fits-all approach to treatment.

In Chinese medicine, we really view the body as a whole, she says. For example, if a patient has shoulder pain, Moksnes Bowman proceeds knowing the shoulder does not work independently from the rest of the body.

"The amount of stress that has been created from the pandemic is causing issues for people physically and emotionally. In Chinese medicine, your digestion matters, sleep matters, your immune system matters." Kate Moksnes Bowman, Northwestern Health Sciences University

If you are not digesting your foods properly, if youre not getting a good nights sleep, she says, I can do a ton of work on your shoulder, but its not going to repair well.

To help patients improve their health and build their immunity, she suggests small changes in diet and exercise, such as drinking enough water, reducing caffeine and sugar consumption, adding anti-inflammatory foods to their diet, and getting more movement every day.

I am not going to overhaul your whole diet, she says. If you do not want to stop eating pizza, I cannot make you stop eating pizza. But she might suggest that you try goat cheese on your pizza or sample a cauliflower crust.

I see myself as a reminder person, she says. I have patients come in and I say, How did your diet go this week? Did you eat something green? That means a plant, you know, not a green Jolly Rancher.

That question always gets a laugh, but the point is that little changes can make a difference in reducing inflammation and improving immunity.

When we are talking about diet and exercise, both of those things reduce inflammation and so does sleeping. Sleeping is a time to repair your body, Moksnes Bowman says. Asked what tops her list as the most important step, she says: Its not a hierarchy for me. Its more of a circle than a list, because all of those things are going to influence the next thing.

Small adjustments in diet and exercise are something patients do on their own between clinic visits, where Moksnes Bowman and other practitioners offer a range of therapies, from acupuncture and massage to cupping, Gua Sha, herbal medicine and even recipes to help improve your immunity.

If you have a lot of stress and are getting the common cold five times a winter, I would suggest you consider herbal medicine, she says. She advises against buying supplements in the grocery aisle. Seek a health professional who is specialized before taking Vitamin D, C or Elderberry syrup. They are all really good things, but theyre not always the right thing for everybody. Its always important to make sure you are taking the right amount.

Creating good sleep habits and a good sleeping environment are important, too. If you are on your phone or watching TV at night, the blue light from the device stimulates a part of the brain that doesn't allow you to fall asleep as well, she says.

Improved diet and exercise, combined with acupuncture or other types of Chinese medicine, can reduce inflammation over time by increasing blood flow and releasing endorphins, which Moksnes Bowman describes as that calm, happy hormone. That is our own bodys way of reducing pain in the body.

And that calm, happy hormone can lead to a good nights sleep, as described in a text from one of Moksnes Bowmans patients, who said: I cant believe how much my sleep improved by getting acupuncture.

The results arent anecdotal, she says. Sleep-tracking devices demonstrate that acupuncture can improve sleep; they record how well and deeply you are sleeping and if you are waking frequently during the night.

And while youre getting those extra ZZZs, your body is resting and fortifying its immunity.

One of the side effects of social distancing and working from home has been an increase in loneliness. Moksnes Bowman says that after a brief shutdown of the NWHSU Bloomington Clinic several months ago, she noticed two things when the clinic reopened: Patients who had missed appointments were in pain, and they were lonely.

People wanted to talk for so long, she says. I made my treatments a bit longer so patients could just talk, because people were feeling lonely.

She and other practitioners frequently refer patients to therapists, Tai Chi or Pilates instructors or others when they see an opportunity to help the patient move, relax or sort things out. Taking a deep breath and getting some release is also good for building a sense of well-being.

Think of amping up your immune system as the ultimate DIY project. Add some green to your diet, make sure you drink enough water, cut out some caffeine and get enough sleep for starters, and then add some acupuncture or massage. Together those steps can help fortify your immunity.

And keep in mind that this year, none of that replaces the need to frequently wash your hands, socially distance wherever possible and wear a mask when its not.

___________________________________________________________________________

Located in Bloomington,Northwestern Health Sciences Universityis a pioneer in integrative natural health care education, offering degree programs in chiropractic, acupuncture, Chinese medicine, massage therapy, medical assisting, medical laboratory programs, post-bac/pre-health, radiation therapy, and B.S. completion. At press time, itsBloomington clinicis open to the public and services include chiropractic care, Chinese medicine, massage therapy, naturopathic medicine, Bloomington Clinic offers integrative, natural care for the entire family in one location.

Each monththe Bloomington Clinic providers host a Provider Talks webinar that discusses topics from foot health to the ABZzzzs of Sleep to Promoting Health through the Seasons. Learn more about the webinar serieshere.

Telemedicine is a convenient way to care for yourself during these unprecedented times. Appointment times vary depending on the service. Providers are part ofNorthwestern Health Sciences University, a non-profit industry leader in integrative and natural healthcare education that provides access to the latest evidence and state-of-the-art technology so you get the natural solutions you truly need.

See more content fromNorthwestern Health Sciences University.

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Add plenty of fiber-rich vegetables to your diet to help you stay full for longer.

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There's no shortage of strategies and tips out there to help you lose weight. But what if you want to avoid putting on weight in the first place?

Forty-two percent of U.S. adults today are affected by obesity, which is defined as having a body mass index (BMI) of 30 or more, according to data from the Centers for Disease Control and Prevention (CDC). That percentage has gone up since 2000 and it's predicted to increase even more, per a December 2019 analysis from the New England Journal of Medicine (NEJM).

The factors behind our growing obesity rates are complex, to say the least. But there are plenty of proven ways to keep your weight in check. Here's what you can do starting right now to reduce your risk for obesity.

Why Obesity Prevention Is So Important

It's no secret that having too much body fat can be bad for your health. But when you consider the laundry list of conditions for which obesity increases your risk, the importance of being at a healthy weight really hits home. According to the CDC, people with obesity are more likely to experience:

You'll greatly improve your health by losing weight, of course. But you're better off avoiding gaining too much weight in the first place. Once you are living with obesity, it becomes harder to get back to a healthy weight, per a September 2015 study in the American Journal of Public Health.

"If you're seriously overweight, your body naturally seeks a larger number of calories in order to maintain that weight. And that larger amount of food is what your brain says you need, so you eat more. It's really a vicious circle," explains Scott A. Cunneen, MD, director of metabolic and bariatric surgery at Cedars-Sinai Medical Center in Los Angeles, and author of Weighty Issues: Getting the Skinny on Weight-Loss Surgery.

That's not to say it's impossible to get to a healthier size far from it. While you can always work to lose weight, "health professionals are realizing that prevention is better than cure when it comes to managing your weight," says weight-management expert Naveen Gupta, MD.

The 10 Best Ways to Prevent Obesity

If prevention is the best medicine for obesity, what exactly should you be doing to keep your weight in check? Science shows it all comes down to forming healthy lifestyle habits and sticking with them.

There's a genetic component to obesity, and you may be more prone to gaining weight easily if your family members have obesity, per the CDC. But genes aren't everything environmental changes are also a key factor, Dr. Gupta says. You can always take measures to keep your weight in a healthy place.

Here are 10 evidence-based steps to help prevent weight gain.

1. Pay Attention to Portions

Watch your portion size, even if you're eating something healthy, since excess calories will be stored as fat.

Image Credit: Westend61/Westend61/GettyImages

If you keep just one thing in mind about weight gain, it should be this: When you eat more calories than your body needs for energy, the extra gets stored as fat.

"Portion control is one of the most important things for maintaining your weight," says Keri Gans, RDN, CDN, author of The Small Change Diet.

That's true even for healthy foods. Whether it's pepperoni pizza or brown rice with tofu and veggies, eating more than you need will ultimately cause your weight to go up. Paying attention to how you feel as you're eating and stopping when you're satisfied is one way to avoid taking in too much food, per the CDC.

Also: Get familiar with what recommended portion sizes actually look like. Very often, they're smaller than you think.

Another strategy is to fill more of your plate with fruits and vegetables so you get what feels like a generous portion for fewer calories. "Instead of a huge bowl of pasta, for instance, cut the portion of pasta in half and add lots of veggies to bulk up the dish," Gans says.

2. Have More Fruits, Vegetables and High-Fiber Foods

Simply eating a fiber-rich diet around 30 grams per day may be enough to help you manage your weight, per February 2015 research in the Annals of Internal Medicine.

"High-fiber foods take longer to digest and may help to stabilize blood sugars, resulting in increased satiety levels," Gans explains. And the more satisfied you feel after eating, the less likely you'll be to scrounge for a snack later on.

Whole grains, beans and even nuts and seeds can all be good sources of fiber. But when it comes to weight, fiber-rich produce like berries, apples, pears and non-starchy vegetables are an especially weight-friendly choice, per analysis published in September 2015 in PLOS Medicine. Not only do they serve up plenty of roughage, they're also very low in calories.

3. Cut Back on Sugar, Refined Flour and Processed Snacks

The more junky snacks you eat, the more likely you are to have obesity, per an October 2016 study published in the American Clinical Journal of Nutrition.

Not only are things like cookies, crackers, chips and baked goods high in empty calories, but the fact that they're low in fiber and high in refined carbs means they'll spike your blood sugar and leave you hungry again shortly after eating, per Harvard Health Publishing.

That's not to say you can never have a brownie or a cupcake again. But it's worth learning to enjoy them in a healthier way.

"Instead of removing chocolate from your diet altogether, try having one square right after a meal, which can potentially stop a craving before it gets out of control," Gans says.

4. Stop Drinking Soda (Yes, Even Diet Soda)

Opt for beverages without any sweeteners, such as sugar-free iced tea or plain old H2O, in place of soda.

Image Credit: pilipphoto/iStock/GettyImages

Drinking a single sweetened beverage like soda, juice or sweetened tea each day could result in a weight gain of up to five pounds in a year, according to the Harvard T.H. Chan School of Public Health. That's because sweetened drinks are high in sugary calories but don't actually fill you up so you don't compensate for those calories by eating less.

Soda is "a well-known enemy of weight-control success," Dr. Cunneen says.

And while diet soda is calorie-free, it may not be a better choice when it comes to managing your weight, according to March 2015 findings published in the Journal of the American Geriatrics Society.

"The artificial sweeteners found in diet soda may trick the body into reacting as if it were real sugar, so that the inclination is generated to eat other sugar-laden food," Dr. Cunneen explains.

5. Slash Your Screen Time

The more TV and screen time you log each day, the more likely you are to be overweight. Sitting in front of a screen prompts your body to store fat instead of burning it for energy, Dr. Gupta explains. It might make you more likely to eat more snacks, too.

Simply cutting back on screen use has been shown to help people lower their BMIs, per a December 2009 study in the Archives of Internal Medicine.

There's a good chance that doing so will encourage you to naturally move more: Without the TV on, you might find yourself going for a walk or finally clearing out that closet. And the more you move, the more fat your body will burn, Dr. Gupta says.

Along with regular workouts, look for simple ways to move more throughout the day.

Image Credit: eternalcreative/iStock/GettyImages

Speaking of curbing screen time, it's worth finding ways to incorporate more activity into your day overall. Aim to get at least 150 minutes of moderate exercise per week, which breaks down to around 30 minutes per day, per the CDC.

But that's really just a bare minimum. "Studies indicate that activity needs to increase to one hour a day to lose any significant weight," Dr. Cunneen says. "The more you move, the better you'll do," he says.

That's not to say you need to log hours and hours at the gym every day. Take up a hobby that you love that gets your heart pumping like hiking, playing tennis or riding your bike. And think about ways to incorporate more movement into everyday activities, like walking to do errands instead of driving or meeting a friend for a stroll instead of grabbing lunch together.

7. Make Most of Your Food at Home

Restaurants tend to add more fat, salt and sugar to their food and offer much bigger portions than you'd serve yourself at home, resulting in higher-calorie meals.

"Cooking at home gives you more control over the amount of food you're served," Gans says. In fact, those who eat home-cooked meals five times a week or more are 28 percent less likely to be overweight compared to those who eat at home less than three times a week, according to August 2017 research in the International Journal of Behavioral Nutrition and Physical Activity.

No need to avoid dining out altogether. But it's worth saving restaurant meals for special occasions and adopting strategies to help you avoid overeating.

"Get into the habit of ordering a side of vegetables with your meal, then eating only half your entre and taking the other half home," Gans suggests.

8. Get Your Stress Under Control

You might not realize it, but your mood can have a major influence on what and how much you eat.

"When we're stressed we're more likely to grab something on the go with no regard to how healthy it is," Dr. Gupta says. "We're also more likely to overeat or overindulge." Over time, that can add up to excess pounds.

Taking steps to manage your stress can help. Adults with obesity who participated in an eight-week stress management plan including things like deep breathing and guided imagery lost significantly more weight compared to those who didn't, per a December 2018 study in the Journal of Molecular Biochemistry. Plus, they also experienced less depression and anxiety.

Make a grocery list that includes everything you'd need to make a week's worth of meals.

Image Credit: SDI Productions/E+/GettyImages

Mapping out every item on your menu every single day is unrealistic. But making food choices on the fly ups the chances that you'll opt for something quick or convenient (hello, takeout!), which might not always be the best option for your weight.

"The more you're prepared, the less likely you are to make unhealthy choices," Gans says.

Before going shopping for the week, try outlining your breakfasts, lunches, dinners and snacks and making a grocery list based on what you need to make complete meals. "For example, don't just buy a piece of chicken. Also buy the veggie you'd have it with and a carbohydrate like a sweet potato," Gans says.

Keeping your pantry and freezer stocked with wholesome staples can give you easy, healthy options for those times when you haven't had a chance to plan. For instance, you can make a quick dinner with a box of whole-wheat pasta, a can of chickpeas and a bag of frozen veggies in about the same amount of time it would take for a pizza delivery order to arrive.

If you're not logging the recommended seven to nine hours of shut-eye per night, start.

"A healthy sleep pattern is essential in maintaining a healthier weight and overall good health," Dr. Cunneen says. On the flip side, adults who regularly snooze for less than seven hours a night have higher body mass indexes and are more likely to develop obesity, per an October 2018 review in BMJ Open Sport and Exercise Medicine.

"When you sleep less and spend more hours awake, the hunger hormone ghrelin increases and the satiety hormone leptin decreases," Dr. Cunneen explains. That means it takes more food to make you satisfied. And chances are you won't be munching on salad to fill your belly.

When you're sleep deprived, you're more likely to gravitate toward comforting high-carb, high-calorie fare like cookies or mac and cheese, according to the Mayo Clinic.

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Obesity Prevention: The 10 Best Ways to Help Prevent Obesity - LIVESTRONG.COM

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WHOI marine chemist Ken Buesseler (right), one of the authors of the study, deploys a sediment trap used to study the biological carbon pump during a 2018 expedition in the Gulf of Alaska.

Alyson Santoro, University of California Santa Barbara

The ocean plays an invaluable role in capturing carbon dioxide (CO2) from the atmosphere, taking in somewhere between five to 12 gigatons (billion tons) annually. Due to limited research, scientists aren't sure exactly how much carbon is captured and storedor sequesteredby the ocean each year or how increasing CO2 emissions will affect this process in the future.

A new paper published in the journalScience of the Total Environment from the Woods Hole Oceanographic Institution (WHOI) puts an economic value on the benefit of research to improve knowledge of the biological carbon pump and reduce the uncertainty of ocean carbon sequestration estimates.

Using a climate economy model that factors in the social costs of carbon and reflects future damages expected as a consequence of a changing climate, lead author Di Jin of WHOI's Marine Policy Center places the value of studying ocean carbon sequestration at $500 billion.

"The paper lays out the connections between the benefit of scientific research and decision making," says Jin. "By investing in science, you can narrow the range of uncertainty and improve a social cost-benefit assessment."

Better understanding of the ocean's carbon sequestration capacity will lead to more accurate climate models, providing policymakers with the information they need to establish emissions targets and make plans for a changing climate, Jin adds.

With co-authors Porter Hoagland and Ken Buesseler, Jin builds a case for a 20-year scientific research program to measure and model the ocean's biological carbon pump, the process by which atmospheric carbon dioxide is transported to the deep ocean through the marine food web.

The biological carbon pump is fueled by tiny plant-like organisms floating on the ocean surface called phytoplankton, which consume carbon dioxide in the process of photosynthesis. When the phytoplankton die or are eaten by larger organisms, the carbon-rich fragments and fecal matter sink deeper into the ocean, where they are eaten by other creatures or buried in seafloor sediments, which helps decrease atmospheric carbon dioxide and thus reduces global climate change.

Rising carbon dioxide levels in the atmosphere, a result of human activity such as burning fossil fuels, warms the planet by trapping heat from the sun and also dissolves into seawater, lowering the pH of the ocean, a phenomenon known as ocean acidification. A warmer, more acidic ocean could weaken the carbon pump, causing atmospheric temperatures to riseor it could get stronger, with the opposite effect.

"When we try to predict what the world is going to look like, there's great uncertainty," says Buesseler, a WHOI marine chemist. "Not only do we not know how big this pump is, we don't know whether it will remove more or less carbon dioxide in the future. We need to make progress to better understand where we're headed, because the climate affects all of humanity."

Buesseler added that efforts like WHOI's Ocean Twilight Zone initiative and NASA's EXport Processes in the global Ocean from RemoTe Sensing (EXPORTS) program are making important strides in understanding the ocean's role in the global carbon cycle, but this research needs to be vastly scaled up in order to develop predictive models such as those used by the Intergovernmental Panel on Climate Change (IPCC). Current IPCC models do not account for change in the ocean's ability to take up carbon, which Buesseler said affects their accuracy.

Though the paper's assessment doesn't account for the cost of a global research program, Buesseler said that investment would be a small fraction of the $500 billion expected benefit. The authors warn that this savings could also be viewed as a cost to society if the research does not lead to policy decisions that mitigate the effects of climate change.

"Just like a weather forecast that helps you decide whether or not to bring an umbrella, you use your knowledge and experience to make a decision based on science," Jin says. "If you hear it's going to rain and you don't listen, you will get wet."

- This press release was originally published on theWHOI website

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What's the Value of Studying the Ocean's Biological Carbon Pump? - Lab Manager Magazine

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A new study provides drug developers with clues about how to extend healthy lifespan without severely restricting calorie intake.

Scientists have known for some time that restricting calorie intake in laboratory animals can extend their lifespan and reduce their risk of developing diseases of older age, such as cancer, heart disease, diabetes, and Alzheimers disease.

Some studies suggest that calorie restriction may have health benefits for humans, too. However, achieving and maintaining a calorie restricted diet is challenging for the vast majority of people.

Identifying a drug that can mimic the metabolic effects of calorie restriction has, therefore, been an important goal of research into life extension.

One of the striking effects of calorie restriction is that it leads to a fall in core body temperature. However, it has been unclear what contribution this makes to the diets health benefits.

Its not easy to discern whats driving the beneficial changes of calorie restriction, says Prof. Bruno Conti, Ph.D., of the Scripps Research Institute in La Jolla, CA. Is it the reduced calories on their own or the change in body temperature that typically happens when one consumes fewer calories? Or is it a combination of both?

Some research does suggest that the reduction in core temperature contributes to the diets beneficial effects and is not simply a side effect.

Mice engineered to have a lower core body temperature live longer than normal mice, for example, regardless of whether their calorie intake is restricted.

Other studies have found that people with a naturally low body temperature tend to live longer compared with those whose core temperature is closer to the norm for humans.

To identify chemicals that might contribute to these health benefits, Prof. Conti and his colleagues compared the metabolites products of metabolism of mice housed at 22C with those living in 30C conditions. The researchers fed all of the mice a calorie restricted diet.

At 30C, the bodies of both mice and humans reach thermoneutrality. At this point, their internal temperature balances the ambient temperature, making it difficult to reduce body temperature.

Scientists believe that thermoneutral conditions reduce some of the health benefits of calorie restriction.

Therefore, Prof. Conti and his team reasoned that comparing calorie restricted mice housed at these different temperatures would reveal the metabolites responsible not only for reducing body temperature but also for extending lifespan.

Specifically, they analyzed levels of metabolites in the animals blood and their hypothalamus, which is the part of the brain responsible for regulating feeding behavior and body temperature.

In comparison with mice allowed to eat as much as they wanted, calorie restriction induced the hypothalamus to produce larger quantities of a range of metabolites when the ambient temperature was 22C but not when it was 30C.

The researchers then used artificial intelligence to single out which of these metabolites were likely to be biologically relevant.

Two metabolites that stood out were nitric oxide, a signaling molecule that dilates blood vessels, and an opioid called leucine enkephalin.

In further experiments on calorie restricted mice, they demonstrated that both chemicals play a role in temperature control.

These metabolites, and others that the researchers identified, could provide pointers for developing drugs that offer people the life extending benefits of calorie restriction without the need to follow an arduous diet.

The study findings feature in the journal Science Signaling.

The authors note that their experiments involved reducing the calorie intake of mice to 50% of their usual intake over a period of 8 days. This restriction is more extreme than the usual calorie restriction that scientists use in lifespan experiments (60% of usual intake or more).

They write that further research will be necessary to confirm that milder, longer lasting diets have similar effects on metabolism.

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Can a drug mimic the life extending effects of calorie restriction? - Medical News Today

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The Federal Government is threatening to build a gas power plant in New South Wales if the electricity sector does not commit to replacing coal-fired power stations that are being retired.

With the coal-fired Liddell Power Station in the Hunter Valley due to shut down in 2023, the Federal Government is worried there will not be enough dispatchable power, given the sector's focus on building wind and solar farms.

The Federal Government will demand electricity generators come up with a plan for 1,000 megawatts of new dispatchable energy in time for the end of 2023.

If it is not satisfied with the private sector's commitments by the end of April next year, Prime Minister Scott Morrison is vowing to intervene directly in the market.

"We won't risk the affordability and reliability of the NSW energy system and will step in unless the industry steps up," Mr Morrison said.

The Federal Government has tasked Snowy Hydro Limited with drawing up plans for a gas generator in the Hunter Valley at Kurri Kurri.

The Federal Government's National COVID Coordination Commission has a lot of gas industry players involved, and it appears to be showing in its policy recommendations.

Mr Morrison will press the Government's case for more non-renewable power generation in a speech to business and industry in Newcastle on Tuesday.

Energy Minister Angus Taylor said the market needed to focus on new, dispatchable power, arguing current plans fall "far short of what is required".

"Over the last decade, the private sector has not built a single new reliable power plant in NSW," Mr Taylor said.

"The Government has always been clear we need to see life extension or like-for-like replacement of Liddell.

"If industry steps up, we'll step back."

The potential for a taxpayer-backed, gas-fired power plant comes as the Federal Government turns its eye to the troubled gas market.

The east coast gas market has boomed under the development of Queensland's coal seam gas fields over the last decade.

But while that has made for a profitable liquefied natural gas export market, Australian commercial and industrial gas users have continued to pay high prices.

The Federal Government will announce a sweep of measures aimed at addressing that imbalance, including:

The Federal Government is promoting the initiatives as moves that will both lower gas prices and create jobs.

The Australian Competition and Consumer Commission (ACCC) has long raised concerns that local commercial and industrial users are paying more for gas than exporters are selling it for on international markets.

A domestic gas reservation policy has not been ruled out, nor has building terminals for importing gas.

The Government's focus on gas is expected to draw the ire of the renewable energy sector and environmental groups, which point to significant improvement in the capacity of wind and solar power to support the nation's electricity needs.

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Federal Government threatens to build gas plant if electricity sector doesn't replace retiring coal-fired power stations - ABC News

Recommendation and review posted by Bethany Smith

Electromechanical engineering specialist Houghton International has agreed a game-changing deal with Siemens Energy which will see it take over the former blade manufacturing factory at the birthplace of the steam turbine, the CA Parsons Works in Heaton.

The 120,000sqft of world-class engineering space will be used to consolidate five of the company's operational sites alongside its existing pump repair facility currently housed on the site, also creating significant room for further growth. The move represents a massive milestone for the company, which has experienced rapid growth over the past five years and will create a best in class facility from which to service its growing domestic and international customer base.

Positioning itself for future growth in emerging markets, the company also intends to retain its large machine facility on Shields Road adjacent to new workshop to service an increased demand for larger repairs from around the UK, providing a total combined footprint over 135,000sqft.

In a further coup, the factory will be named The Ronnie Mitten Works after one of the company's founders, Ron Mitten, who's technical legacy still brings work into the business each day, well over a decade after he sadly passed away in 2007.

Ron Mitten's son, Michael Mitten, the current CEO of Houghton International, said: I am truly delighted and equally honoured to be taking over such a prestigious site, and to be allowed to hoist my dad's name above the door really is the cherry on the cake for me. I want to thank the team at Siemens Energy for having the confidence in us to take on the site and allowing us to name it after my dad. He'd be blown away by the notion that his name will be sat alongside that of Charles Parsons.

I'm also delighted to be able to announce such an exciting phase in the company's development, and some positive news for the North East. It's a massive deal for us, one that cements our home for the next 25 years, and gives us one of the largest rotating electrical machine service centres in Western Europe. Now we need to fill it up with work. We envisage that we will be creating new jobs very soon, and will need great people to help us achieve our mission to be the best in the world at what we do.

The expansion is a huge opportunity for Houghton International and is the result of many years of hard work to grow the business, our workforce and our customer base to get to this point. To do so at such a critical economic time means we'll be perfect placed to take full advantage of the post-Covid economic boom that I'm certain will happen, especially in renewable energy and the shift towards the electrification of mass transportation.

The consolidation will improve efficiency across the business, offer greater opportunities for training and cross skilling staff, enable us to adapt to changing market conditions faster and further improve the service we offer to customers.

This is a huge step change for the business and the investment we are making now will further support Houghton International's reputation as a market leader regionally, nationally and internationally.

The move into the new site is currently underway with the aim of having the whole business relocated by the end of the year. Alongside providing extra space for Covid-19 physical distancing, the additional capacity created by the move will also enable the company to create dedicated R&D and training facilities, further investing in the future.

Specialising in the monitoring, maintenance, repair and life extension of electromechanical assets around the world, Houghton International operates across a range of sectors including power generation, water, oil & gas, rail and industrial and manufacturing. The company has grown incrementally over the past 36 years.

Currently owned by Siemens Energy, the CA Parsons Works work site has been home to world class engineering since the start of the 20th century. Being co-located on the site alongside Siemens Energy presents an excellent opportunity for ongoing collaboration between two complementary companies to reinvest in the vacant facility and continue its strong heritage into the future.

-Ends-

Media contact:

Tiffany Scott, Marketing and Business Development Director, Houghton InternationalTel: 0191 234 3000Email: tiffany.scott@houghton-international.com

Notes to editors:

Houghton International pioneers technical and commercial innovation in the repair, maintenance and life extension of electro mechanical assets around the world, servicing a broad range of sectors including power generation, renewables, industrial, water, oil and gas, marine and rail.

We develop long-term partnerships with worldwide brands by listening to our customers' needs, understanding the markets in which they operate and how they add value to their customers, we tailor our investments and business structure to deliver value that exceeds expectations.

As a privately owned family company we value our independence and have a culture of innovation and continuous improvement. That's why our customers keep coming back to us.

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North East engineering company investing in future growth with move to 120000sq ft CA Parsons Works site in Newcastle - OilVoice

Recommendation and review posted by Bethany Smith

The U.S. Air Force has selected Northrop Grumman Corp. NOC as its company of choice for replacing the nations aging intercontinental ballistic missile (ICBM) system. Consequently, Northrop secured a $13.3 billion deal for performing the engineering and manufacturing development (EMD) phase of the Ground Based Strategic Deterrent (GBSD) program.

Notably, Boeings BA Minuteman II ICBM was thus far the United States chosen land-based nuclear deterrent.

Northrop won the EMD award for GBSD program after completing a highly successful three-year technology maturation and risk reduction (TMRR) phase-one effort as part of the competition. Notably, the team of highly-experienced defense majors involved in the GBSD program, including Lockheed LMT, Textron TXT and L3Harris Technologies LHX, has achieved all TMRR design review milestones on time and on cost.

Moreover, per USSTRATCOMs Statement to Congress, the GBSD Analysis of Alternatives provided decisive analysis that continued life extension of the Minuteman III will be more costly than a replacement system. Also, as more modern deterrent systems become the need of the hour, the existing Minuteman II might not address future challenges and threats to the nations current ICBM force.

While the Minuteman has served as the backbone of the nations ICBM force since 1962, its aging infrastructure, and asset attrition require a comprehensive weapon system replacement beginning in 2028. While this heightened the need for replacement, the U.S. Air Force has remained focused on sustaining its ICBM force at the lowest reasonable cost.

So the cost-effectiveness of the GBSD program along with its state-of-the-art features must have persuaded the U.S. Air Force to choose it as the next nuclear deterrent of the country.

Boeing walked out of this ICBM-replacement competition in December 2019, citing lack of cost competitiveness, as stated by a Reuters report. This was because the jet giant felt it to be difficult to submit a bid for the competition, wherein the cost of replacement was being set at $85 billion by the Pentagons Cost Assessment and Program Evaluation office.

In fact, in a letter to the U.S. Air Force, chief executive of Boeing Defense Space and Security, Leanne Caret said that Northrops Orbital ATK takeover in 2018, which strengthened the companys missile portfolio, might have boosted Northrops cost competitiveness compared to Boeings.

While Northrops Orbital ATK acquisition did boost the company to offer its GBSD program at a cost efficient level, lets not forget the fact that Boeing has already been suffering a cash crunch, following the grounding of its 737 Max fleet since March 2019.

Notably, Boeings operating cash outflow was $2.45 billion at the end of 2019 against cash inflow of $15.32 billion at the end of 2018. Its free cash outflow totaled $4.28 billion at 2019 end against cash inflow of$13.60 billion at the end of 2018. So, by December, when the final bid for the ICBM replacement competition was supposed to be submitted by Boeing, its management had a pretty good picture at hand about the companys weak cash position.

Thus, the impact that 737 grounding had on Boeings cash reserve might have also influenced the companys decision to walk out of the bid.

Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportNorthrop Grumman Corporation (NOC) : Free Stock Analysis ReportThe Boeing Company (BA) : Free Stock Analysis ReportLockheed Martin Corporation (LMT) : Free Stock Analysis ReportTextron Inc. (TXT) : Free Stock Analysis ReportL3Harris Technologies Inc (LHX) : Free Stock Analysis ReportTo read this article on Zacks.com click here.

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Are Costs the Sole Reason Behind Boeing's Loss to Northrop? - Yahoo Finance

Recommendation and review posted by Bethany Smith

Pringles Minis Shelf Life: Its fair to say that few product launches in recent years have matched Pringles Minis for impact in the vending sector, writes PV Editor Ian Reynolds-Young. Expectations were high when the introductory announcement was made seven months ago and then in February, when we reported on the initial sales of the product and ARNs Lyndsey Boutflour told us, we have already taken pre-orders for 4,218 cases for Pringles Minis Original and Sour Cream & Onion.

The product was selling through as quickly as it was selling out. Jane McDonald of Excel Vending said, the reaction to Pringles Minis was astonishing. We generated over 1,000 comments on Facebook and around 600 on Twitter in the first 12 hours after going live! I think the success is a good measure of Pringles popularity and the appetite consumers have for the brand-new Pringles Minis.

It was as though Minis Mania had descended on the UK. All was set fair for Kelloggs crowd-pleaser to break any sales record you could name. And then Well, we all know what happened in March.

In May, I asked a vending operator friend of mine how bad things really were and he told me, its not the end of the world, but we can see it from here.

Slowly more slowly than the government would like people are returning to work. Fingers crossed; offices, factories and schools will emerge from isolation in the coming weeks and transport hubs will once again be busy.

But nothing is for sure, nothing is nailed on. Operators and indeed, wholesaler Automatic Retailing Northern, (ARN) are understandably wary of over stocking products, when there remains a danger that Best Before dates will expire. Whilst it may be some time before Pringles Minis delivers the level of sales through vendings favourite wholesaler that it achieved in Q1, the news that, after an exhaustive series of tests, Pringles Minis Shelf Life is now 11 months from the date of production, should give buyers a much-needed confidence boost as they consider their orders.

Well take any good news right now, Lyndsey told us. Pringles Minis already had the edge on the traditional crisps brands with 9 months of shelf life, so with Pringles Minis Shelf Life extended for an extra couple of months its as though the insurance policy has been improved. Sales in Q1 were out of this world but those numbers seem irrelevant now. We see Pringles Minis as one of the products that will bring consumers back to vending machines and kick-start the industry

As the gradual return to work or education continues, the one thing we can be sure of is that, however difficult the circumstance may be, consumers will once again make their favourite drinks and snacks part of their day; and Pringles Minis Shelf Life extension gives operators a welcome additional safety net in trying times.

More on Pringles Minis on Planet Vending, HERE

More on ARN on Planet Vending, HERE

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Pringles Minis' Shelf Life Is Now 11 Months From The Date Of Production - Planet Vending

Recommendation and review posted by Bethany Smith

Spiderman and CRISPR-Taming Chemist Amit Choudhary both tell us that "with great power comes great responsibility". In Amit's case, he speaks of power and responsibility with CRISPR gene editing technology.

Today, the gene editing tool CRISPR-Cas9 serves as a "genetic 'find and replace' function," that allows one to search and cut a DNA sequence at its precise location.

Yet, this powerful tool must be used with great responsibility, given that a misstep could have irreversible consequences. Amit has pioneered precision tools - small molecule inhibitors, activators, and shredders - to control Cas9 activity. Having successfully fine-tuned CRISPR activity with first generation technologies, Amit is eager to pave the way for everyone to benefit from this gene editing technology safely and responsibly.

Amit's journey with precision control tools for CRISPR-Cas9 demonstrates that responsible use of technology allows us to build solutions that are both effective and finely tuned.

See the original post here:
The Power of CRISPR Cas9 Comes With Great Responsibility - Technology Networks

Recommendation and review posted by Bethany Smith

In November 2018, at a gene-editing summit hosted by scientific societies from the U.S., the U.K., and Hong Kong, a Chinese researcherannouncedthat he had created the worlds first genetically modified babies.He Jiankuifully expected to be celebrated for a scientific breakthrough; hementionedthe Nobel Prize. Instead, he was almost universally condemned.

Key figures associated with theU.S. National AcademiesandU.K. Royal Societyjoined in thecriticismbut did not reject heritable genome editing. Instead, they objected to the Chinese researchers timing. It was too soon, they said. It hadnt been done as they thought it should have been. But according to the researcher now being called a rogue, it was theNational Academies 2017 reportthat had given him the green light for his experiments.

In the aftermath of this headline-grabbing debacle, the scientific societies decided on a do-over. They declared it time to define a rigorous, responsible translational pathway toward clinical use of heritable genome editing. Theyset upa carefully selectedinternational commissionwith themandateto map the scientific details ofhowdesigner-baby technology could be brought to the fertility clinic.

This mandate was flawed from the start. The idea that now is the time to set aside the deeply controversial question ofwhetherheritable genome editing should be done at all so that a small group of experts can settle the nitty-gritty details ofhowit should take place is entirely backward. It flies in the face of the widely shared acknowledgment that scientists alone cannot make this decision; that we must have wide-ranging and inclusive public discussions aimed at buildingbroad societal consensus. It undermines policies in some70 countriesaround the world that prohibit heritable genome editing. And its a slap in the face to the manyscientists,biotech executives,human rights and social justice advocates, and others who support a moratorium or ban on altering the human germline.

The commissions 225-pagereport, released on Sept. 3, does have some strong points. It is more cautious than the previous report, recommending that heritable genome editing should initially be allowed only in the exceedingly rare cases where embryo screening for severe genetic conditions would not be an option. And it paints a vivid picture of the significant technical hurdles facing those eager to pursue heritable human genome editing: shortfalls in the editing tools, in the technologies necessary to test safety and efficacy, even in our understanding of the genetics underlying most heritable diseases.

These findings ought tolay to restthe unfounded assumption that engineering the genomes of human embryos will soon be safe and effective. But even the most cautious considerations of technical safety cant stand-in for the fundamental point that the decision about whether to allow heritable genome editing should be driven by our values, not settled by the science.

The commission claims they are not endorsing heritable genome editing, merely constructing maps of the technological path in case a country should wish to use them. At best, this puts the cart before the horse and sends both horse and cart down a one-way road.

Heritable genome editing cant be separated from its real-world consequences. There are already clear signs that legalizingit would lead to reproductive tourism, jurisdiction shopping, andmission creep. As an example, the U.K.sapprovalof so-called mitochondrial donation for a small number of women with certain mitochondrial DNA diseases wasquickly followedby fertility clinics inUkraine,Spain, and Greeceoffering this high-risk technique, with no evidence of effectiveness, for general and age-related infertility.

A similar trajectory is all too easy to foresee if heritable genome editing is approved, even for limited circumstances. Especially where fertility services are offered on a for-profit basis, its unlikely that any boundaries would hold. We could soon see fertility clinics marketing genetically upgraded embryos, tempting parents-to-be with ads about giving their child the best start in life. From there, a normalized system of market-based eugenics could emerge, exacerbating already existing discrimination, inequality, and conflict.

Amid our multiple ongoing crises, it would be easy to overlook another report on still speculative biotechnology. But this one represents a profoundly consequential step, one that tries to settle in advance the coming decision about whether to engineer genes and traits passed on to future children and generations. Its another attempt to focus discussion on the science, while minimizingthe complex social realities in which scientific and technological developments unfold.

KatieHassonis program director on genetic justice andMarcyDarnovskyis executive director of theCenter for Genetics and Society,a non-profit organization based in Berkeley, California that works to encourage responsible uses and effective governance of human genetic and assisted reproductive technologies.

Excerpt from:
Are we mapping a path to CRISPR babies? | TheHill - The Hill

Recommendation and review posted by Bethany Smith

Sept. 14, 2020 12:00 UTC

BOSTON & BORDENTOWN, N.J.--(BUSINESS WIRE)-- Alexion Pharmaceuticals Inc.. (NASDAQ:ALXN) and Caelum Biosciences, Inc. today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200914005234/en/

In AL amyloidosis, misfolded amyloid proteins can build up in many organs throughout the body, including the heart and kidneys, causing significant damage to these organs and impairing their function. While current treatments address the bone marrow disorder that creates the misfolded amyloid proteins, there are no approved therapies for the significant organ damage the disease causes, said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from these organs. Data from Phase 1 studies suggest that this treatment approach may improve organ function and long-term survival. We look forward to investigating this further in the Phase 3 clinical program.

AL amyloidosis is particularly devastating when it affects the heart, with median survival in these patients of less than one year following diagnosis, said Michael Spector, President and Chief Executive Officer of Caelum. Long-term survival data from AL amyloidosis patients treated with CAEL-101 in the Phase 1a/1b study showed that 78 percent were still alive after a median follow-up time of more than three years. We recognize the urgent need for new treatments that address the organ damage caused by AL amyloidosis and are working together with the AL amyloidosis community and Alexion to advance the Phase 3 clinical program as quickly as possible.

About the CARES Phase 3 Clinical Program

The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and nave to standard of care (SoC) treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan, and Australia.

In each study, participants are being randomized in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks. This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment. Patients will continue follow-up visits every 12 weeks.

The primary study objectives are overall survival and the safety and tolerability of CAEL-101. Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures (Kansas City Cardiomyopathy Questionnaire Overall Score & Short Form 36 version 2 Physical Component Score) and cardiac improvement (Global Longitudinal Strain, or GLS).

Phase 2 Study Results

The Phase 2 open-label dose escalation study was conducted to investigate higher doses of CAEL-101 than had been evaluated in Phase 1 studies with a primary objective to identify the best dose to advance into Phase 3 development. The study evaluated the safety and tolerability of CAEL-101 in 13 AL amyloidosis patients at three study sites who received up to 1000 mg/m2 of CAEL-101 (two times the Phase 1 dose) administered in combination with SoC treatment. The study met its primary objectives, supporting the safety and tolerability of CAEL-101 and the selection of the 1000 mg/m2 dose for the Phase 3 study.

Phase 1a/1b Long-Term Follow-Up Results Presented at ISA 2020

As previously reported, the Phase 1a/1b study of CAEL-101 was the first clinical trial to demonstrate improvement in cardiac function via GLS after treatment with an amyloid fibril targeted therapy in AL amyloidosis patients with amyloid cardiac involvement. New long-term follow-up data from the Phase 1a/1b study will be presented at the virtual International Symposium on Amyloidosis (ISA), September 14 to 18, 2020, in the poster titled, Long term follow-up of patients with AL amyloidosis treated on a phase 1 study of Anti-Amyloid Monoclonal Antibody CAEL-101 (Abstract #342, Divaya Bhutani, M.D., et. al, Columbia University Medical Center). These data demonstrate 78 percent survival (15/19) at a median follow-up of more than three years (37 months) in AL amyloidosis patients treated with CAEL-101 as well as durable organ response among evaluable patients, further supporting the advancement of CAEL-101 into Phase 3 development.

About CAEL-101

CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in 27 patients with relapsed and refractory AL amyloidosis who had previously not had an organ response to standard of care therapy. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded immunoglobulin light chains produced by plasma cells aggregate and form fibrils that deposit in tissues and organs. This deposition can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure. Current standard of care includes plasma cell directed chemotherapy and autologous stem cell transplant, but these therapies do not address the organ dysfunction caused by amyloid deposition, and up to 80 percent of patients are ineligible for transplant.

AL amyloidosis is a rare disease but is the most common form of amyloidosis. There are approximately 22,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.

About Alexion

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.

[ALXN-P]

About Caelum Biosciences

Caelum Biosciences, Inc. (Caelum) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelums lead asset, CAEL-101, is a novel antibody for the treatment of patients with amyloid light chain (AL) amyloidosis. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Caelum was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.caelumbio.com.

Forward-Looking Statement

This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion and Caelum, including statements related to: the safety and efficacy CAEL-101 as a treatment for AL amyloidosis; CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from the heart, kidney and other organs; data from the Phase 1 studies suggest that the treatment approach may improve organ function and long-term survival and enrollment of the Phase 3 trials. Forward-looking statements are subject to factors that may cause Alexion's and Caelums results and plans to differ materially from those expected by these forward looking statements, including for example: the anticipated safety profile and the benefits of the CAEL-101 may not be realized (and the results of the clinical trials may not be indicative of future results); the inability to enroll and complete the Phase 3 trial; results of clinical trials may not be sufficient to satisfy regulatory authorities; results in clinical trials may not be indicative of results from later stage or larger clinical trials (or in broader patient populations); the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to discontinue sales of the product (or halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates); the severity of the impact of the COVID-19 pandemic on Alexions or Caelums business, including on commercial and clinical development programs; unexpected delays in clinical trials; unexpected concerns regarding products and product candidates that may arise from additional data or analysis obtained during clinical trials or obtained once used by patients following product approval; future product improvements may not be realized due to expense or feasibility or other factors; delays (expected or unexpected) in the time it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; inability to timely submit (or failure to submit) future applications for regulatory approval for our products and product candidates; inability to timely initiate (or failure to initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by regulatory agencies regarding our products and product candidates; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us; the risk that third party payors (including governmental agencies) will not reimburse for the use of our products at acceptable rates or at all; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; adverse impacts on supply chain, clinical trials, manufacturing operations, financial results, liquidity, hospitals, pharmacies and health care systems from natural disasters and global pandemics, including COVID-19 and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended June 30, 2020 and in their other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005234/en/

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Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis - BioSpace

Recommendation and review posted by Bethany Smith

The MemorialCare Heart & Vascular Institute at Long Beach Medical Centeris expanding its leadership team with accomplishedSouthern Californiacardiologist,David Shavelle, M.D., being named medical director of adult cardiology. Dr. Shavelle is bringing his extensive leadership experience in cardiology to this new role that will provide leadership and strategic direction for adult cardiology programs, as well as oversight for the interventional catheterization laboratories.

Dr. Shavelle, a Millikan High School (Long Beach, Calif.) graduate, is returning toLong Beachwith more than 20 years of cardiology practice, research leadership, and teaching experience. He joins Long Beach Medical Center from KeckMedical Center at the University of Southern California, where he served as the Director of Interventional Cardiology while leading a multitude of clinical research trials, including several focused on implanted devices for heart failure. He plans on increasing the availability ofclinical research trialsfor cardiology patients at Long Beach Medical Center.

The MemorialCare Heart & Vascular Institute has a rich history of research and pioneering new treatment techniques, says Ike Mmeje, chief operating officer, Long Beach Medical Center.

Dr. Shavelles passion for research makes him a perfect fit to continue that legacy and find the next cutting-edge treatment for our cardiology patients.

MemorialCare Heart & Vascular Institute facilities are among the most comprehensive centers for diagnosis, treatment and rehabilitation of cardiac disease, providing groundbreaking care for complex heart conditions, including myocardial infarction, heart failure, arrhythmias and peripheral vascular disease. In addition to his hopes to expand research opportunities, Dr. Shavelle plans on expanding the programs for heart failure and structural heart disease.

I am excited to join the MemorialCare Heart & Vascular Institute at Long Beach Medical Center, says Dr. Shavelle. My dad was a physician here, and many of my mentors and fellows are at Long Beach Medical Center. Im looking forward to creating more collaboration among cardiologists, surgeons, residents and the entire team to expand the already comprehensive cardiology care available to the community.

After earning his medical degree from theUniversity of California, Los Angeles(UCLA), Dr. Shavelle completed his internal medicine internship and residency at Harbor-UCLA Medical Center. He completed General Cardiology Fellowship at theUniversity of Washingtonand Interventional Cardiology Fellowship at Harbor-UCLA Medical Center/Good Samaritan Hospital. Dr. Shavelle served as Associate Professor at both the David Geffen School of Medicine atUCLAand the Keck School of Medicine at theUniversity of Southern California. He alsoserveson the editorial boards for theJournal of Cardiovascular Pharmacology and Therapeutics, Current Medical Research and Opinion and Cardiology Clinics.

The MemorialCare Heart & Vascular Institute delivering nearly 20,000 cardiovascular diagnostic tests and treatments last year continues to push the boundaries of discovery with many firsts. These began 70 years ago when world-renowned cardiologist, researcher and educator, the lateMervyn Ellestad, M.D., co-invented at Long Beach Medical Center the modern-day maximum stress test to detect heart disease. Today, millions of exercise stress tests performed annually save hundreds of thousands of lives globally.

It is amazing how the field of cardiology has grown and how many treatment options are available through minimally invasive techniques, says Dr. Shavelle. Many of these new treatment options have come from research trials, and Im looking forward to expanding the opportunities for patients in theLong Beacharea. The studies we have in the pipeline include trials with stem cells and heart failure devices.

Read more here:
David Shavelle, MD, Named Medical Director of Adult Cardiology for the MemorialCare Heart & Vascular Institute at Long Beach Medical Center -...

Recommendation and review posted by Bethany Smith

Sept. 14, 2020 10:45 UTC

BOTHELL, Wash. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced two new strategic oncology collaborations.

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The companies will globally develop and commercialize Seattle Genetics ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the agreement, Seattle Genetics will receive a $600 million upfront payment and Merck will make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6 billion.

Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics will receive $125 million from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65 million.

Collaborating with Merck on ladiratuzumab vedotin will allow us to accelerate and broaden its development program in breast cancer and other solid tumors, including in combination with Mercks KEYTRUDA, while also positioning us to leverage our U.S. and European commercial operations, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The strategic collaboration for TUKYSA will help us reach more patients globally and benefit from the established commercial strength of one of the worlds premier pharmaceutical companies.

These two strategic collaborations will enable us to further diversify Mercks broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible, said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.

Ladiratuzumab Vedotin Collaboration Details

Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600 million upfront and make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2 billion.

The closing of the equity investment is contingent on completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

TUKYSA Collaboration Details

Under the terms of the agreement, Merck has been granted exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial.

Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Seattle Genetics will continue to lead ongoing TUKYSA global development planning and operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory.

Seattle Genetics will receive from Merck $125 million as an upfront payment and is eligible to receive progress-dependent milestones of up to $65 million. Seattle Genetics will also receive $85 million in prepaid research and development payments to be applied to Mercks global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of TUKYSA in Mercks territory.

The financial impact of these collaborations is not included in Seattle Genetics 2020 guidance.

Seattle Genetics Conference Call Details

Seattle Genetics management will host a conference call to discuss these collaborations today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Seattle Genetics website at http://www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or +1 412-717-9224 (international). The conference ID is 10147850.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1. Most metastatic breast cancers express LIV-1, which also has been detected in several other cancers, including lung, head and neck, esophageal and gastric. Ladiratuzumab vedotin utilizes Seattle Genetics proprietary ADC technology and consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker. This novel ADC is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response by induction of immunogenic cell death.

About TUKYSA (tucatinib)

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth. TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In addition, TUKYSA received approval in Canada, Singapore, Australia and Switzerland under the Project Orbis initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners. A marketing application is under review in the European Union.

TUKYSA is being evaluated in several ongoing clinical trials and additional studies are planned. Current trials include the following:

For additional information, visit http://www.clinicaltrials.gov.

TUKYSA Important Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

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 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

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

Classical Hodgkin Lymphoma

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High 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 (mut/Mb)] 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.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

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Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations - BioSpace

Recommendation and review posted by Bethany Smith

Two years after acquiring the gene therapy company AveXis, Novartis has renamed it Novartis Gene Therapies to underscore the potential value of developing such treatments for genetic diseases.

This decision was based partly on the success of Zolgensma, originally developed by AveXis, as a gene therapy for spinal muscular atrophy (SMA) that is approved in the U.S., Japan, Europe, and Brazil as an intravenous infusion.

Novartis sees tremendous potential in the future of gene therapy, and weve seen the impact gene therapy can have on so many lives, Vas Narasimhan, CEO of Novartis, in a saidpress release. With the creation of Novartis Gene Therapies, we will continue to advance our gene therapy pipeline for rare genetic diseases, to accelerate the delivery of transformative innovation in areas of high unmet need, and to reimagine medicine for patients all around the world.

Zolgensma targets the underlying cause of SMA, deliveringa working copy of theSMN1gene which is mutated in SMA to motor neurons, the nerve cells that control muscle contraction.

This therapy, the worlds most costly treatment at $2.125 million for one-time use, relies on a genetically engineered virus, called adeno-associated virus (AAV) 9, to transport a workingSMN1 transgene (so-called because its DNA comes from an external source) directly to motor neurons.

In the U.S., the treatment is approved for patients with all SMA types up to the age of 2, given in a single, hourlong intravenous infusion. In Europe, it is approved for those weighing up to 21 kg (about 46 lbs), with a clinicaldiagnosisoftype 1SMA or up to three copies of theSMN2gene.

To date, 600 patients worldwide have been treated with Zolgensma, either through clinical trials, managed access programs, or its commercial availability, Novartis said in its release.

Regularly decisions are expected in Switzerland, Canada, Australia, Argentina, and South Korea this year or in early 2021, it added.

The company has placed a priority on AAV-delivered gene therapies to treat other disorders.The Novartis Gene Therapies research group is reported to be working on treatments for people with Rett syndrome, those with a genetic form of amyotrophic lateral sclerosis (ALS), and withFriedreichs ataxia.

Our patients and their families are the motivation for everything that we do, and under the banner of Novartis Gene Therapies, our dedicated team will continue to create a lifetime of possibilities to people suffering from rare genetic diseases, said David Lennon, president of Novartis Gene Therapies who formerly led AveXis. Becoming Novartis Gene Therapies symbolizes the importance of our gene therapy advances for the future of Novartis and our industry leadership at large.

By unifying the Novartis and AveXis brands, Novartis intends to establish a global presence for Novartis Gene Therapies, Zolgensma, and for potential gene therapies to come.

Total Posts: 85

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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AveXis Now Known as Novartis Gene Therapies, Focus of Continuing Work - SMA News Today

Recommendation and review posted by Bethany Smith

-- Webcast conference call to be held on Monday, Sept. 28, 2020 at 8:30 a.m. Eastern Time --

-- Additional poster presentations at WMS will highlight data from Sareptas RNA and gene therapy programs --

CAMBRIDGE, Mass., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that new data from its most advanced gene therapy programs will be presented at the WMS25 Virtual Congress, the 25th International Annual Congress of the World Muscle Society, being held Sept. 28 Oct. 2.

Sarepta will host a webcast and conference call on Monday, Sept. 28, 2020 at 8:30 a.m. ET, to discuss the results, which include two-year functional data from Study 101 of SRP-9001 for Duchenne muscular dystrophy and 18-month functional results from Cohort 1 in the study of SRP-9003 for Limb-girdle muscular dystrophy Type 2E.

This will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentationsand will be archived there following the call for one year. Please connect to Sarepta's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 6793650. Please specify to the operator that you would like to join the "Long-term Functional Data from Sareptas Gene Therapy Programs call.

In total, Sarepta will present 16 abstracts at this years meeting. All posters will be available on-demand throughout the Congress beginning on Monday, Sept. 28 at 7:00 a.m. EST. The full WMS25 Virtual Congress program is available here: https://www.wms2020.com/programme/.

Gene Therapy:

RNA Platform:

Natural history and other presentations:

Presentations will be archived under the events and presentations section of the Sarepta Therapeutics website at http://www.sarepta.comforone year following their presentation at WMS25.

AboutSarepta TherapeuticsAt Sarepta, we are leading a revolution in precision genetic medicine and every day is an opportunity to change the lives of people living with rare disease. The Company has built an impressive position in Duchenne muscular dystrophy (DMD) and in gene therapies for limb-girdle muscular dystrophies (LGMDs), mucopolysaccharidosis type IIIA, Charcot-Marie-Tooth (CMT), and other CNS-related disorders, with more than 40 programs in various stages of development. The Companys programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visitwww.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of Information

We routinely post information that may be important to investors in the 'For Investors' section of our website atwww.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Sarepta Therapeutics, Inc.

Investors: Ian Estepan, 617-274-4052, iestepan@sarepta.com

Media: Tracy Sorrentino, 617-301-8566, tsorrentino@sarepta.com

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Long-term functional data from Sarepta Therapeutics' Most Advanced Gene Therapy Programs to be Presented at Upcoming Annual Congress of the World...

Recommendation and review posted by Bethany Smith

LONDON--(BUSINESS WIRE)--The new Soft Tissue Repair Market Research from Technavio indicates Positive and Superior growth in the short term as the business impact of COVID-19 spreads.

"One of the primary growth drivers for this market is the rising incidence of accidental injuries, says a senior analyst for Healthcare at Technavio. As the markets recover Technavio expects the soft tissue repair market size to grow by USD 10.44 million during the period 2020-2024."

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About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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COVID-19, Soft Tissue Repair, Tissue Repair, Soft Tissue Fixation Devices and Accessories, Cell Therapy, and Tissue Scaffold

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New Soft Tissue Repair Market Research Highlights Recovery Path for Businesses from COVID-19 based on Cell Therapy and Tissue scaffold Products |...

Recommendation and review posted by Bethany Smith

Sep. 14 /CSRwire/ - CRB is proud to announce that theAmicus TherapeuticsResearch and Gene Therapy Center facility has wonEngineering News-Record(ENR) MidAtlantics 2020 Best Projects (Award of Merit) in the Healthcarecategory.

Two panels of industry judges reviewed more than 80 projects located throughout the region, including Delaware, Maryland, Pennsylvania, Virginia, West Virginia, and the District of Columbia. Projects were scored on the ability of the project team to overcome challenges, contribution to the industry and community, project innovation, safety, and construction/designquality.

Amicus is a biopharmaceutical company that discovers and develops medicines for rare diseases. Its global research and gene therapy center of excellence consolidates Amicus five research departments into a unified space on the top two floors of a 14-story tower. The research workplace is the convergence of technical laboratories, office, and amenity spaces. The design creates spaces that connect science, people andpurpose.

Our team provided architectural, engineering, and lab design to realize our clients vision: a standout research facility that would attract and retain top researchers, promote collaboration, and break down barriers between employees to rapidly advance these potentially life-saving therapies through the drugpipeline.

To read more about the ENR 2020 Best Projects,click here.

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Amicus Therapeutics Wins 2020 ENR Regional Award for Best Project - CSRwire.com

Recommendation and review posted by Bethany Smith

VANCOUVER, B.C., Sept. 14, 2020 /PRNewswire/ -- The Global Femtech Marketis expected to reach USD 60.01 Billion by 2027, according to a new report by Emergen Research. Demand for the femtech industry is motivated mainly by the growing burden of both chronic and infectious diseases among the world's female population. An increase in the number of health problems relating to women would stimulate competition for technologically innovative healthcare solutions. Growing women's emphasis on reproductive health and sexual empowerment in developing economies would further encourage development in the industry.

Increasing awareness among women of the detection and management of early illness as part of the patient care program would improve the market outlook. Various efforts by government and other agencies in developing countries to raise awareness of women's health would accelerate the development of the industry. Furthermore, an increasing tendency towards daily preventive care check-ups, as well as the advancement of user-friendly technology to track individual health problems, may prove beneficial to the developments in the women's health industry.

While more and more people today choose to be more transparent about their health concerns and treatment, in some of the lesser developed regions, women's health issues remain stigmatized. For these places, Femtech applications are likely to be favored because the scanning is less invasive and more secure. Increasing population growth is related to being one of the main factors behind the case.

Request free sample of this research report at: https://www.emergenresearch.com/request-sample/37

Key Highlights From The Report

Read more at: https://www.emergenresearch.com/industry-report/femtech-market

For the purpose of this report, Emergen Research has segmented into the Global Femtech Market on the basis of type, end-use, application, and region:

Type Outlook (Revenue: USD Billion; 2017-2027)

End Use Outlook (Revenue: USD Billion; 2017-2027)

Application Outlook (Revenue: USD Billion; 2017-2027)

Regional Outlook (Revenue, USD Billion; 2017-2027)

Find more research reports on healthcare and pharmaceuticals industry, by Emergen Research:

Regenerative Medicine MarketRegenerative Medicine Market By Product (Tools, Therapeutics), By Therapeutic Category (Musculoskeletal, Dermatology, Immunology & Inflammation, Cardiovascular), and By Applications (Wound Care, Musculoskeletal Disorders, Ocular Disorders), Forecasts to 2027

Next-Generation Sequencing MarketNext-Generation Sequencing Market by Technology (Whole Exome, Whole Genome, Others), By Workflow (Sequencing, Pre-Sequencing, Others), By Application (Consumer Genomics, HLA Typing, Others) and By End-Use (Academic, Clinical, Others), Forecasts to 2027

RFID in Healthcare MarketBy Product (Tags, Systems & Software) and By Application (Asset Tracking, Patient Tracking, Pharmaceutical Tracking, Blood Tracking, Others), Forecasts to 2027

Non-Invasive Prenatal Testing MarketBy Method, By End-Use, By Application, By Region, Forecasts to 2017-2027

Viral Vector and Plasmid Manufacturing MarketBy Vector Type (Retrovirus, Adenovirus, Others), By Workflow (Upstream, Downstream), By Disease (Cancer, Genetic Disorders, Others), By Application (Gene Therapy, Retailers) and By End-User, Forecasts to 2027

Interoperability Solutions in Healthcare MarketBy Level (Foundational, Structural, Semantic), By Product Type (Services, Solutions), and By Application (Diagnostics, Treatments, Others), Forecasts to 2027

About Emergen Research

At Emergen Research, we believe in advancing with technology. We are a growing market research and strategy consulting company with an exhaustive knowledge base of cutting-edge and potentially market-disrupting technologies that are predicted to become more prevalent in the coming decade.

With market-leading insights and an in-depth understanding of leading and niche technologies, our solutions address the most pertinent questions for your business needs. A major technological shift has been witnessed towards creating a 'Circular Economy,' fuelled by factors, such as the increased adoption of bio-based materials, along with other methods for achieving carbon neutrality. We are conversant in technologies, viz., Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR), Robotic Process Automation (RPA), Smart Manufacturing, Internet of Things (IoT), Big Data Analytics, Machine learning, Nanotechnology, Edge Computing, Blockchain Technology, Cloud Computing, Vehicle Electrification, Advanced Maintenance Analytics, and Predictive Maintenance, among other prevalent and emergent technologies.

Contact Us:Eric LeeCorporate Sales SpecialistEmergen Research | Web: https://www.emergenresearch.comE-mail: [emailprotected]

Read full Press Release at :https://www.emergenresearch.com/press-release/global-femtech-market

SOURCE Emergen Research

Original post:
Femtech Market to Reach USD 60.01 Billion By 2027 | CAGR of 15.6%: Emergen Research - PRNewswire

Recommendation and review posted by Bethany Smith

September 14, 2020 NIH contracts to explore radiation countermeasures, Alzheimers medication, and convalescent plasma, Mission Bio gets $70M for single cell multi-omics technology, and more.

$300M: Series D for New Materials

Science and material innovation company Zymergen (Emeryville, Calif.) has announced $300M in new investment to accelerate its delivery of revolutionary, high performance materials. The investment includes initial Series D funding led by Baillie Gifford, joined by Baron Capital Group and one of the worlds largest sovereign wealth funds, as well as additional growth financing from Perceptive Advisors. A number of current investors are also returning, and Zymergen expects to raise additional capital in Q4 as part of a Series D round. Zymergen develops and launches better performing products more sustainably and for a fraction of the cost and time that it typically takes using incumbent techniques. A unique combination of biology, chemistry, machine learning and lab automation underpins Zymergens powerful proprietary platform, driving the companys ability to discover, design and commercialize never-before-seen materials.

$270M: Series C for Multiomics Blood Testing for Cancer

Freenome (South San Francisco, Calif.) announced an oversubscribed $270M Series C financing to accelerate the PREEMPT CRC clinical trial for Freenomes blood test for colorectal cancer screening and precancerous lesion detection, advance a pipeline of blood tests for both the early detection and early intervention of additional cancers, and continue building the companys proprietary multiomics platform. PREEMPT CRC is an FDA registrational study launched in May 2020 to support approval by the U.S. Food and Drug Administration (FDA) for the first front-line blood test to help the 45 million people who are currently not up-to-date on colorectal cancer screening guidelines in the U.S. The Series C financing was led by new investor Bain Capital Life Sciences and existing investor Perceptive Advisors. They were joined by a group of other new investors, including Fidelity Management & Research Company, LLC, Janus Henderson Investors, Farallon Capital Management, Rock Springs Capital, Cormorant Asset Management, EcoR1 Capital, LLC, Catalio Capital Management, and the Colorectal Cancer Alliance.

$100M: Radiation Countermeasures

SRI International (Menlo Park, Calif.) has been awarded a seven-year contract of up to $100 million from the National Institutes of Healths (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to support the research and development of radiation/nuclear medical countermeasures (MCMs). Under the contract, SRI Biosciences, a division of SRI International, will provide facilities, expertise, and capabilities to advance the development of MCMs for the mitigation or treatment of acute radiation syndromes as well as the treatment of delayed effects from acute radiation exposure (ARS/DEARE) and internal radionuclide contamination. SRI researchers will also support NIAIDs ongoing biodosimetry efforts.

$74M: Five-Year NIH Grant To Test Alzheimers Meds

Alzheon (Framingham, Mass.) has announced today that the U.S. National Institute on Aging (NIA) has awarded the company a grant expected to total $47 million over 5 years to support a Phase 3 clinical study with ALZ-801, an oral agent that blocks the formation of neurotoxic soluble amyloid oligomers. The study will enroll Early AD patients, who have two copies of the apolipoprotein e4 allele (APOE4/4). AD patients with this genetic profile have been shown to have a higher risk of rapid disease progression and to be responsive to agents targeting pathogenic amyloid oligomers.

$70M: Series C for Single Cell Multi-Omics Technology

Mission Bio (South San Francisco, Calif.) announced $70 million in its Series C financing led by Novo Growth, the growth equity arm of Novo Holdings. Soleus Capital also joins the round, along with earlier investors Mayfield, Cota, and Agilent, bringing the companys total funding to more than $120 million. The funds will be used to scale its single-cell multi-omics technology, the Tapestri Platform, to expand the companys reach in more effective clinical trials for novel cancer treatments, as well as characterization for cell and gene therapy.

$50M: Decentralized Research

THREAD (Durhan, NC) received additional capital commitment of up to $50 million from strategic health care investors, Water Street Healthcare Partners and JLL Partners. The companys latest capital infusion builds on a year of significant growth and investments in its platform and services to advance decentralized research approaches for large-scale, Phase Ib - IV global clinical trials. To date, THREAD has supported more than 100 decentralized studies. The company will continue to invest in expanding and enhancing its innovative platform and supporting services.

$40M: Decentralized Clinical Trials

Science 37 (Los Angeles) has closed an oversubscribed $40 million funding round. Existing investors Lux Capital, Redmile Group, and PPD, Inc. led the round, and are joined by existing investors Novartis, Amgen, Sanofi Ventures, GV, and Glynn Capital. Notable new investors include LifeSci Ventures and Mubadala Ventures. Science 37 will use the new capital to support its rapid growth, expand its technology platform, and accelerate its global expansion effortsfurther strengthening its ability to help sponsors execute decentralized trials and enable patients to participate in trials from anywhere, without the burden of traveling to a traditional clinical site.

$34M: NIH Grant for Nationwide Study of Convalescent Plasma

Vanderbilt University Medical Center (Nashville, Tenn.) has been awarded a one-year, $34-million grant by the National Center for Advancing Translational Sciences, part of the National Institutes of Health, to conduct a nationwide study of "convalescent plasma" as a treatment for COVID-19. The randomized, controlled trial will test whether infusions of plasma, the liquid part of blood collected from COVID-19 survivors, can help other hospitalized patients with COVID-19. The study will recruit 1,000 participants in approximately 51 sites across the country. The goal is to complete enrollment by October 31, and report results by November.

$25.5M: Series B for Healthcare Interoperability

Bridge Connector (Nashville, Tenn.), an interoperability company changing the way health care communicates, today announced it has raised $25.5 million in Series B financing. The latest round, led by Axioma Ventures, was joined by all existing investors, including veteran investor Jeff Vinick, and brings Bridge Connectors total funding to over $45 million. After achieving over 1000% year-over-year growth in 2019, the investment will further support the companys increasing market share in health care interoperability and growth of Destinations, a new integration-platform-as-a-service (iPaaS) that connects health data systems using use-case-based interoperability blueprints to speed integrations with major vendors. Bridge Connector provides a suite of vendor-agnostic integration solutions and a full-service delivery model, helping health care vendors, providers, and payers more easily share data between disparate systems, such as electronic health records (EHRs) or patient engagement solutions.

$12M: Cloud Clinical Data Platform

Castor (Hoboken, New Jersey) has announced a $12 million funding round led by Two Sigma Ventures with participation from Hambrecht Ducera Growth Ventures and existing investor INKEF Capital. Castors clinical data platform that simplifies the clinical trial process, from recruitment to analysis, for researchers globally. Its used by more than 50,000 users across academia and commercial research, powering more than 4,000 studies with more than 2,000,000 enrolled patients across 90 countries. 192 medical device, biotech, and pharmaceutical companies and contract research organizations (CROs) are using Castors platform. Castor made its platform freely available for all non-profit COVID-19 research starting in February.

$11.8M: Series A for Digital Sedation

Oncomfort (Brussells), the Belgian inventor of and leader in Digital Sedationa method for relieving patients' pain and anxiety without medicationhas completed a 10 million Series A funding round co-led by two prominent institutional investors: Debiopharm and Crdit Mutuel Innovation. Oncomfort plans to use this investment to develop its innovative digital therapy solutions and accelerate its international expansion in Europe and the US. Founded in 2017, Oncomfort invented Digital Sedation, a completely new method for relieving patients' pain and anxiety through treatment with clinically proven sessions of therapeutic Virtual Reality. Since the launch of the Sedakit for Digital Sedation in Benelux and France in June 2019, over 30,000 patients have been treated and have had their pain and anxiety relieved before, during, and after interventions in many clinical fields such as anesthesia, oncology, interventional radiology and cardiology, as well as pediatrics.

$9.94M: Five Year NIH Grant for Rare Genetic Diseases

Baylor College of Medicine (Houston, Tex.) has received a five-year, $9.94 million grant from the National Institutes of Health for the new Center for Precision Medicine Models to facilitate the study of rare genetic diseases. The center will use precision animal models of a patients or group of patients specific genetic variation and study why the change causes disease and how the disease can be treated. The center will take nominations for genetic variants to model from patients, patient groups, clinicians, researchers, and NIH-funded consortiums like the Undiagnosed Diseases Network and the Centers for Mendelian Genomics. An accepted disease-causing genetic variant must previously be identified in order to be considered for modeling. After a case is submitted, the centers clinical and bioinformatics teams will independently assess the genetic variant for likelihood of causing disease. Next, the modeling team will decide if a precision model organism can be produced for that particular genetic change and whether appropriate resources are available within the center to study the disease. A final decision about whether to select the case will be made based on likely clinical benefit to the patient.

$3M: Series of Grants from Society to Improve Diagnosis in Medicine

The Society to Improve Diagnosis in Medicine (SIDM) is issuing the first of three grant rounds, totaling $3 million, as part of the organizations DxQI Seed Grant Program. The initial awards are up to $50,000 for 17 organizations testing interventions to improve the quality, accuracy, and timeliness of diagnoses. The 17 grantees awarded in this round are: Advocate Aurora Health; Atrium Health; The Atrium Health Levine Childrens Hospital; Beth Israel Deaconess Medical Center; Brigham Health/Brigham and Womens Hospital; The Johns Hopkins University School of Medicine; Kaiser Permanente East Bay; Maine Medical Center; McMaster University; MedStar Health; Northwell Health; Northwestern Memorial HealthCare; Tufts Medical Center and Floating Hospital for Children; The University of Michigan and Hurley Medical Center; The University of Texas Health Science Center at San Antonio & University Health System; The University of Pittsburgh School of Medicine, and The Veterans Education and Research Association of Michigan and VA Ann Arbor Healthcare System.

$1.5M: Regulatory Information Management Solutions

Rimsys (Pittsburgh, Penn.) closed a $1.5 million investment round, led by Allos Ventures. The financing round will support Rimsys penetration of the MedTech Regulatory Information Management market through planned expansions of its product offering, sales, and marketing execution. Rimsys solution seamlessly integrates with MedTech manufacturers existing quality management systems, product lifecycle management systems, and sales and distribution software systems. Rimsys robust digital platform, with its intuitive user interface and global intelligence, enables its customers to meet market entrance requirements and grow internationally. John McIlwraith, managing director at Allos Ventures will join Rimsys board of directors.

$1.3M: AI for Drug Repurposing for COVID-19

Relation Therapeutics (London), a drug development company driven by data science and machine learning (ML), has announced Project RE, which will apply Relation Therapeutics and its partners technology to the identification of repurposed drug combinations as potential therapeutic candidates for COVID-19. Funding for Project RE is provided by a $1.3 million grant from the Bill & Melinda Gates Foundation to Relation Therapeutics. Project RE will focus on finding therapies to tackle viral entry and replication and is co-led between Mila (Quebec AI Institute) and Relation Therapeutics, with the overall scientific direction by Mila founder Professor Yoshua Bengio. The project will also create a platform to develop therapies that appropriately modulate the immune response through distinct stages of infection with oversight from Relations Chief Medical Officer, Dr. David Roblin.

$356,000: AI for Microbiome-Disease Link

BioLizard (Ghent, Belgium) received a 300,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to leverage its world-leading expertise in bioinformatics, AI and machine learning, to establish the causal link between the human microbiome and disease. Collecting data from the broadest set of microbes, patient background and interactions, BioLizard is building a framework using state-of-the-art bioinformatics and AI tools to evaluate causal links in the human microbiome, purely from data. This will allow evaluation of whether microbe A causes disease B or if theyre only distantly related, thereby requiring a refining of focus.

$100,000: COVID-19 Fast Grant for Enzymes Critical to SARS-CoV-2 Replication

Dr. Christopher Basler, professor and director of the Center for Microbial Pathogenesis in the Institute for Biomedical Sciences at Georgia State University, has received a $100,000 COVID-19 Fast Grant to study enzymes that are critical for the replication of SARS-CoV-2, the virus that causes COVID-19. Basler is exploring several small molecule inhibitors that would block formation of membranes needed for SARS-CoV-2 infection. These include enzymes such as VPS34, long chain fatty acyl-coA synthetase and fatty acid synthase. Drugs that affect cell membranes and lipids are being pursued as treatments for other medical conditions, including cancer, diabetes and obesity. Early data from the Basler lab suggest such drugs might be effective to slow SARS-CoV-2.

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Follow the Money: Alzheimer's Meds, Single Cell Multi-Omics Technology - Bio-IT World

Recommendation and review posted by Bethany Smith

While there is no cure for blindness and macular degeneration, scientists have accelerated the process to find a cure by visualizing the inner workings of the eye and its diseases at the cellular level.

In an effort led by UW Medicine, researchers successfully modified the standard process of optical coherence tomography (OCT) to detect minute changes in response to light in individual photoreceptors in the living eye.

The results were published Sept. 9 in Science Advances.

We have now accelerated the life cycle of vision restoration, said lead author Vimal Prabhu Pandiyan, a ophthalmology researcherat the University of Washington School of Medicine.

The study was fundedin partby the National Eye Institutes Audacious Goals Initiative, which embraces bold ideas in helping people to see better.

The OCT modifications outlined in the study will help researchers who want to test therapiessuch as stem cells or gene therapy to treat retinal disease. They now have the tools to zoom in on the retina to evaluate whether the therapy is working.

Corresponding author Ramkumar Sabesan, a UW assistant research professor of ophthalmology, said the only wayto objectively measure the eye currently is to look at a wide retinal area. Sabesan said researchers currently can attach electrodes on the cornea but it captures a large area with around 1 million cells. Now they are talking about nanometers, or one billionth of a meter a small fraction of the size of a cell, providing orders of magnitude improvement.

Since photoreceptors are the primary cells affected in retinal generation and the target cells of many treatments, noninvasive visualization of their physiology at high resolution is invaluable, the researchers wrote.

Cone photoreceptors are the building blocks of sight, capturinglight and funneling information to the other retinal neurons. They are a key ingredient in how we process images and patterns of light falling on the retina.

Optical coherence tomography has been around since the 1990s. In this study, researchers used OCT with adaptive optics, line-scanning and phase-resolved acquisition to deliver the concept of Thomas Youngs interference to the human eye. With the ability to zoom in on the retina at high speeds, they found that cone photoreceptors deform at the scale of nanometers when they first capture light and begin the process of seeing.

As Sabesan explained: You can imagine a picture that looks visually and structurally normal. But when we interrogate the inner working of the retina at a cellular scale, we may detect a dysfunction sooner than what other modalities can do. A doctor then can prescribe medication to intervene early or follow the time-course of its repair via gene therapy or stem cell therapy in the future.

We will now have a way to see if these therapies are acting in the way they should, Sabesan said.

The study also involved researchers at Stanford University, University of California,Berkeley, and University of California, Riverside.

The study was funded by NIH grants U01EY025501, EY027941, EY029710, EY025501, and P30EY001730; Research to Prevent Blindness Career Development Award; Foundation Fighting Blindness; Murdock Charitable Trust; Burroughs Welcome Fund Careers at the Scientific Interfaces; and Unrestricted grant from the Research to Prevent Blindness.

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Seeing the eye like never before | Newsroom - UW Medicine Newsroom

Recommendation and review posted by Bethany Smith

DUBLIN, Sept. 14, 2020 /PRNewswire/ -- The "17th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production" report has been added to ResearchAndMarkets.com's offering.

The 2020 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations' current and projected future capacity and production.

This report's data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.

In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks.

Key Topics Covered:

CHAPTER 1: INTRODUCTION AND DISCUSSION1-1 Introduction: The Pharmaceutical and Biopharmaceutical Industries1-2 Current Status and Market Trends1-3 Market Potential1-4 Biopharmaceuticals and Biosimilars in the Pipeline1-5 Global Biopharmaceutical and Recombinant Protein/MAb Markets1-6 Biopharmaceutical Markets by Product Class1-7 Animal Derived Products and Biopharmaceuticals1-8 Future Trends in the Biopharmaceutical Industry1-9 Future Biopharmaceutical Market Trends

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE2-1 Cell and Gene Therapy - Future of Bioprocessing2-2 Continuous Processing - Present and Future Challenges2-3 China and Asia's position in Global Bioproduction2-4 Intersection of Biopharma and Small Pharma: Small Molecule Manufacturing Lessons for a New Industry2-5 Upstream and Downstream Biologics Manufacturing: Mapping the Future Challenges and Trends2-6 Suppliers' Contributions to Bioprocessing Advances2-7 Contract Manufacturing's Contributions to Bioprocessing Advances2-8 Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board2-9 China's Advances in Global Biopharma and Bioprocessing: A 10-year Projection on Need for Quality Improvements

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING3-1 Industry Trends in 20183-2 Budget Issues in 20183-3 Operational Changes3-4 New Bioprocessing Products Development Opportunities in 20183-5 Factors in Biomanufacturing Creating Improvements3-6 Cost-Cutting Actions & Development Timelines (2016 data)3-7 Average Cost per Gram Recombinant Protein3-8 Assay Development3-9 Perfusion Operations and Continuous Bioprocessing Operations Issues3-10 Perfusion Operations and Continuous Bioprocessing Trends3-11 Discussion3-12 Cell and Gene Therapy Platforms3-13 Selecting Bioreactors in New Facilities (2017 data)3-14 Discussion: Industry Trends and Issues

CHAPTER 4: CAPACITY UTILIZATION4-1 Capacity Utilization Trends4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers4-3 Capacity Utilization: U.S. vs. Western European Manufacturers4-4 Respondents' Current Total Production Capacity4-5 Discussion: Capacity Trends4-6 Range of Titers with mAb Production4-7 Discussion: Capacity and Industry Trends

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS5-1 Current Capacity Constraints5-2 Expected Capacity Constraints 210 Respondents' Expectations of Capacity Constraints by 20235-3 Factors Impacting Future Production Capacity5-4 Key Areas to Address to Avoid Future Capacity Constraints5-5 Discussion

CHAPTER 6: FUTURE CAPACITY EXPANSIONS6-1 Planned Future Capacity Expansions

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING7-1 Current Outsourcing by Production System7-2 Future Outsourcing7-3 Outsourced Activities in Biopharmaceutical Manufacturing7-4 Critical Outsourcing Issues7-5 CMOs' Problems with Their Clients7-6 Country Selections for International Outsourcing (Off-shoring) of Biomanufacturing7-7 Offshoring Trends7-8 5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring

CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING8-1 Use of Disposables and Single-Use Systems8-2 Leachables and Extractables8-3 Reasons for Increasing Use of Disposables & Single-Use Systems 3268-4 Factors That May Restrict Use of Disposables8-5 Suppliers' Expectations for Standards Setting Bodies8-6 Need for Single-use Sensors, and Bioreactor Attributes8-7 Satisfaction with Single-use Device Vendors8-8 Single Use Operations and Trends8-9 Discussion of Single-use Bioprocessing

CHAPTER 9: DOWNSTREAM PURIFICATION9-1 Impact of Downstream Processing on Capacity9-2 Specic Purication Step Constraints9-3 Downstream Purication Issues9-4 mAb Purication Capacity Estimates9-5 New Downstream Processing Technologies9-6 Improvements to Downstream Operations9-7 Discussion

CHAPTER 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING10-1 Quality Initiative Implementation10-2 Hurdles to Implementing Process Analytical Technology10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing10-4 Primary Cause of Batch Failures, Percentages of Failures10-5 Quality Problems in BioManufacturing Attributed to Vendors10-6 Discussion

CHAPTER 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING11-1 Hiring Trends11-2 Hiring in 2023: 5-year Trends11-3 Hiring Challenges Today11-4 Training in Biopharmaceutical Manufacturing11-5 Intersection of Biopharma and Small Pharma11-6 Discussion

CHAPTER 12: New Methods: Continuous and Process Intensification, Cell and Gen12-1 PerfusionAreas of Involvement12-2 Trends in Fill-Finish and Related Bioprocessing Capacity12-3 Current Fill-Finish Trends12-4 Discussion

CHAPTER 13: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES13-1 Demographics13-2 Growth Rate of Sales by Suppliers13-4 Budget Issues and Problems Faced by Industry Suppliers13-5 Cost Cutting Actions by Vendors13-6 Problems Clients Have with Their Vendors13-7 Vendor Expansion Plans13-8 New Technology Areas in Development by Vendors13-9 Sales Staff Training 502 Days of Training Provided13-10 Biopharma Vendors' Financial Outlook for 201813-11 Discussion of Biopharma Suppliers

For more information about this report visit https://www.researchandmarkets.com/r/3bdm10

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Bio-pharmaceutical Manufacturing Capacity and Production Report 2020: Comparison of Production by Biotherapeutic Developers and Contract...

Recommendation and review posted by Bethany Smith

Silence Therapeutics Appoints Mark Rothera as President and Chief Executive Officer

Experienced biotech executive to lead the next phase of growth

14 September 2020

LONDON, Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN (Silence or the Company), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, today announces the appointment of Mark Rothera as President and Chief Executive Officer (CEO) and Board member, effective immediately. Iain Ross, who has been Executive Chairman since December 2019, has today assumed his previous position of Non-Executive Chairman.

Mr. Rothera brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of commercial and operational leadership, including driving the successful build of multiple biotech companies, predominantly in the field of rare or specialty diseases. Prior to joining Silence, Mr. Rothera served as CEO of Orchard Therapeutics (Orchard), where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programmes into a leading gene therapy company with seven clinical-stage programmes and fully integrated capabilities. Under his leadership, Orchard completed an initial public offering of American Depositary Shares on the Nasdaq Global Market and during his tenure that company secured more than $600 million in financing and grew from a market capitalization of $250 million to more than $1.7 billion at its peak.

Prior to Orchard, Mr. Rothera served as Chief Commercial Officer of PTC Therapeutics (PTC), where he helped transition that company from a privately held R&D biotechnology company to a publicly traded, commercial-stage company with a global footprint, including the successful launch of two rare disease therapies. He also previously served as Global President of Aegerion Pharmaceuticals Inc. and Vice President and General Manager of commercial operations at Shire Human Genetic Therapies for Europe, Middle East and Africa. Mr. Rothera received an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

Based out of Silences New York City office, Mr. Rothera will lead the continued global expansion of the Company. His appointment follows the completion of Silences Nasdaq listing on 8 September 2020 and aligns with the strategy of increasing the Companys presence in the United States.

Iain Ross, Chairman of Silence Therapeutics plc, said: "On behalf of the Silence Board and the entire Silence team, I welcome Mark to the Company. Following a thorough search, Marks appointment reflects his proven leadership skills and strong track record in growing successful biotechnology companies and building shareholder value. I believe he will now provide the leadership necessary to grow Silence into a leading international biotechnology company built upon our innovative siRNA technology platform, proprietary product pipeline and validating industry partnerships.

On a personal note, and on behalf of the Board, I would like to thank the management team and staff at Silence for their support, hard work and tremendous resilience during the current COVID-19 pandemic and over the past nine months whilst I have been Executive Chairman. The Company has made great strides during this period, and is now in a strong position, both operationally and financially, and ready for Mark to take the helm.

Mark Rothera, President and CEO of Silence Therapeutics plc, added: It is an honour to take the role of leading Silence at this time in the Companys history. I believe the Company is poised to capitalise on its important siRNA technology platform, pipeline and research capabilities built over 18 years, and position itself as a leader in the RNAi field. The Company has made great strides under Iains leadership and I look forward to working with the Board, the management team and Silence employees to build upon this momentum.

Director disclosures

The following information is being disclosed pursuantto Rule 17 and paragraph (g) of Schedule 2 of the AIM Rules for Companies.

Mark Rothera

Full name and age: Mark Andrew Rothera (aged 58)

Current Directorships or Partnerships:Genpharm

Previous Directorships or Partnerships in the last 5 years:Orchard Therapeutics plcPTC Therapeutics International LimitedAlliance for Regenerative Medicine

No further information in connection with his appointment is required to be disclosed under Schedule Two, paragraph (g) of the AIM Rules for Companies.

Enquiries:

About Silence TherapeuticsSilence Therapeutics is developing a new generation of medicines by harnessing the bodys natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silences proprietary technology can be used to engineer short interfering ribonucleic acids (siRNAs) that bind specifically to and silence, through the RNAi pathway, almost any gene in the human genome to which siRNA can be delivered. Silences wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of Lipoprotein(a) and SLN124 to address beta-thalassemia and myelodysplastic syndrome. Silence is also developing SLN500 in partnership with Mallinckrodt Pharmaceuticals to reduce the expression of the C3 protein for the treatment of complement pathway-mediated diseases. Silence maintains ongoing research and collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals and Takeda. For more information, please visit: https://www.silence-therapeutics.com/

The person who arranged for the release of this announcement on behalf of the Company was Rob Quinn, Chief Financial Officer.

Forward-Looking StatementsCertain statements made in this announcement are forward-looking statements, including with respect to the Companys clinical and commercial prospects. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

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Silence Therapeutics Appoints Mark Rothera as President and Chief Executive Officer - GlobeNewswire

Recommendation and review posted by Bethany Smith

Report Ocean announces the release of Cell and Gene Therapy Market research report. As per Report Ocean, the market is expected to grow at a healthy pace in the coming years. Leading market vendors are focusing on the development of their mergers & acquisitions with the main aim of providing a broad geographical presence to multiple industries. Most players are anticipated to adopt three key business strategies to cement their position in the market, i.e. expanding product portfolio, facilitating product differentiation, and participating in mergers and acquisitions.

Industry challenges together with the latest developments in the technological developments of the Cell and Gene Therapy Market have been elaborated on in the market intelligence report. It also provides a detailed picture of the trends of the changing industry structure and the challenges that are faced by various industry participants. The report elaborates on the major challenges that the participants of the said market could possibly across the globe.

Request Free Sample Report athttps://reportocean.com/industry-verticals/sample-request?report_id=mai52690

The outbreak of Covid-19 has brought in uncertainties and disruptions for the present and future of several businesses across the globe. The pandemic has claimed both lives and livelihoods, there leaving little or no hope till a vaccine for Covid-19 arrives. However, analysts at Report Ocean make a careful and meticulous assessment of the present situation and disruptions caused by the virus in the supply chain to draw estimates, projections and avenues of growth for the Cell and Gene Therapy Market.

The objectives of this study are to define, segment, and project the size of the Cell and Gene Therapy Market based on company, product type, end user and key regions.

Competitive Landscape:

The report also includes several valuable information on the Cell and Gene Therapy Market, derived from various industrial sources. The report studies the competitive environment of the Cell and Gene Therapy Market report is based on company profiles and their efforts on increasing product value and production.

Key parameters which define the competitive landscape of the Cell and Gene Therapy Market:

Revenue and Market Share by Player

Production and Share by Player

Average Price by Player

Base Distribution, Sales Area and Product Type by Player

Concentration Rate

Manufacturing Base

Mergers & Acquisitions, Expansion

Market Segmentation:

The major factors are also being considered while studying the various market segmentation. Some of the key factors are study of demand and supply of Cell and Gene Therapy Market, common interests and market share of the global Cell and Gene Therapy Market market across various geographies.

Geographical Analysis

Geographically, this report is segmented into several key regions, with sales, revenue, market share, and Cell and Gene Therapy Market growth rate in these regions, from 2015 to 2026, covering;

North America (U.S. and Canada)

Europe (UK, Germany, France, Russia, Italy and Rest of Europe)

Asia-Pacific (China, Japan, India, Malaysia, Singapore, Philippines, Indonesia, Thailand, Vietnam)

South America (Brazil, Argentina, Mexico, and Rest of South America)

The Middle East and Africa (Saudi Arabia, United Arab Emirates, Turkey, Egypt, South Africa, Nigeria)

Some of the Major Highlights of TOC covers:

Cell and Gene Therapy Market Production, Revenue (Value), Price Trend by Type

Production and Market Share by Type

Revenue and Market Share by Type

Price by Type

Cell and Gene Therapy Market Analysis by Application

Consumption and Market Share by Application

Cell and Gene Therapy Market Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Country

Production, Revenue, Price and Gross Margin

Cell and Gene Therapy Market Manufacturing Analysis

Key Raw Materials Analysis

Market Concentration Rate of Raw Materials

Manufacturing Cost Analysis

Labor Cost Analysis

Manufacturing Cost Structure Analysis

Manufacturing Process Analysis of XYZ

Industrial Chain, Sourcing Strategy and Downstream Buyers

Cell and Gene Therapy Market Industrial Chain Analysis

Raw Materials Sources of Cell and Gene Therapy Market Major Players in 2019

Downstream Buyers

Market Dynamics

Market Drivers

Restraints

Opportunities

Increased Demand in Emerging Markets

Challenges

Porters Five Forces Analysis

Cell and Gene Therapy Market Forecast

Production, Revenue Forecast

Production, Consumption, Export and Import Forecast by Region

Production, Revenue and Price Forecast by Type

Consumption Forecast by Application

Note In order to provide more accurate market forecast, Cell and Gene Therapy Market report will be updated before delivery by considering the impact of COVID-19.

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Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe, and Asia.

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COVID-19 Impact and Recovery Analysis - Cell and Gene Therapy Market 2020-2026 - The Market Chronicles

Recommendation and review posted by Bethany Smith

Global Exosome Therapeutic Market By Type (Natural Exosomes, Hybrid Exosomes), Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others), Therapy (Immunotherapy, Gene Therapy, Chemotherapy), Transporting Capacity (Bio Macromolecules, Small Molecules), Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others), Route of administration (Oral, Parenteral), End User (Hospitals, Diagnostic Centers, Research & Academic Institutes), Geography (North America, Europe, Asia-Pacific and Latin America)

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

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Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for an Analyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

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Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process.

The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

The major players covered in the report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

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About Data Bridge Market Research:

An absolute way to forecast what future holds is to comprehend the trend today!

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Exosome Therapeutic Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 - Good...

Recommendation and review posted by Bethany Smith