Archive for February, 2020
The chance of families having mostly boys or girls is ‘random’, study says – Stuff.co.nz
TATIANA KOSTAREVA/123RF
The probability of having children of the same gender is totally up to chance.
If you're hoping to replicate the family you grew up in that was mostly girls or all boys, genetics won't be on your side.
According to a new study, the probability of you having children of the same gender is totally up to chance.
Researchers from the University of Queensland have conducted a study published in the scientific journal Proceedings of the Royal Society B. It analysed of the population of Sweden since 1932 and debunked the myth that having all boys or all girls runs in the family.
It's been found that the gender of a family's children is essentially random.
READ MORE:* Women who hate bugs, lice find men with beards less attractive* Climate change will alter gender ratio of newborns, scientists say* Parents do have a favourite child and it's based on gender - study
"We found individuals don't have an innate tendency to have offspring of one or the other gender," said DrBrendan Zietsch, researcher from UQ's School of Psychology in a news release.
"The chances are more like 51 to 49 of having a boy, but the genes of the mother and father don't play any role. These findings have crucial implications for biological and evolutionary theories of offspring sex ratios."
To conduct the study, researchers reviewed data from Swedish population registers that included every Swede born since 1932. In total, 3,543,243 people and their 4,753,269 children were analysed as researchers linked all family members and tested whether the the sex of a person's children was tied to the sex of heir brother or sister's children.
The findings nix the often repeated idea that some families are more prone to having all boys and others typically wind up with girls.
123RF
If you're hoping to replicate the family you grew up in that was mostly girls or all boys, genetics won't be on your side.
"It was thought that rich or tall parents should have more boys and beautiful parents should have more girls," Zietsch said.
"It was also thought that parents' hormone levels at the time of conception were important. Our results rule out all these possibilities and suggest a rethink of offspring sex ratio theory is necessary to properly understand why offspring sex ratios appear to vary, for example, across countries."
The study comes more than a year after another one emerged from Japan in which scientists said that climate change will alter the ratio of the gender of newborns.
"For every society, for every year, the human being most likely to die (prematurely) is male infants. And that's true for every society that we have data for," University of California, Berkeley, professor Ray Catalano told CNN at the time.
-The Atlanta Journal-Constitution
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The chance of families having mostly boys or girls is 'random', study says - Stuff.co.nz
Is Intermittent Fasting Safe For Women? All Your Questions Answered – mindbodygreen.com
Because fasting may negatively affect a woman's hormones, there are related concerns about fertility. Some medical experts think that a woman's body may see fasting as a danger of impending starvation. As a result of this, they think the body inhibits ovulation since there wouldn't be enough nutrients to sustain a growing fetus.
However, there are other doctors, like Felice Gersh, M.D., who have opposing views. Gersh says, "Based on what we know now, my prediction is that short periods of fasting will actually enhance fertility."
So, who's right? Once again, the science isn't totally clearand most of the research has been done on animal models, instead of humans.
In one study, researchers looked at how three months of intermittent fasting affected female rats. They found that the rats not only lost 19% of their body weight, but they also had significant changes in their reproductive hormones. LH and kisspeptin levels went down, while estradiol levels went up.
However, another review looked at intermittent fasting in women with polycystic ovary syndrome, or PCOSa condition with infertility as one of its hallmark symptoms. The researchers hypothesized that intermittent fasting could actually improve fertility in women with PCOS by reducing levels of glucose, insulin, IGF-1, and IGFBP1.
According to the report, women with PCOS tend to have increased expression of IGF-1 and IGFBP1, two hormones that affect insulin production. When insulin levels get high, it triggers the body to make more androgen hormones, like testosterone, which makes it harder to get pregnant. On the other hand, when insulin levels go down, it can improve ovarian function.
Another study added on to this, concluding that short-term calorie restriction could actually increase LH levels in women with PCOS while simultaneously decreasing glucose, insulin, leptin, and testosterone.
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Is Intermittent Fasting Safe For Women? All Your Questions Answered - mindbodygreen.com
State resolution puts school start times, once considered in Park City, in the spotlight – The Park Record
The Utah Legislature has passed a resolution regarding high school start times that, while not binding, nonetheless brings the childhood development issue into the spotlight in school districts around the state including in Park City, where local school officials have spent significant time in recent years grappling with the topic.
Rep. Suzanne Harrison, D-Draper, introduced the legislation. As a physician and a mother of teenagers herself, she said the issue of sleep-deprived children is near and dear to her.
Anyone who has teens knows it is difficult to wake them up early in the morning, she said. But they arent lazy they are in a unique developmental period. They are undergoing a host of biological changes, including brain development and sleep changes.
Chief among those changes as they pertain to sleep is the bodys release of melatonin, the hormone that helps regulate a persons sleep cycle. In the average adult, melatonin starts kicking in around 9 p.m. For the average teenager, health experts say, the body doesnt release melatonin until 11 p.m. As a result, only one in 10 teens are getting the recommended nine hours of sleep.
And this is putting them at risk for serious mental health, physical health and academic risks, Harrison said.
Harrisons resolution, H.C.R. 3, encourages Utah school districts and charter schools to consider the possible benefits and consequences of a later start to the school day for high schools. After winning support in the House earlier this month, the resolution was approved in the Senate Friday, sending it to the governors desk.
The resolution is nonbinding it encourages districts to explore the change but doesnt mandate it. That, Harrison said, is by design. For one thing, she said, addressing sleep deprivation in teenagers requires a holistic approach. It isnt just the schools that need to adjust.
There are many things parents, families, communities and school districts can do to help our kids get more sleep, she said. Looking at school start times is one thing that studies have shown can help kids get more sleep and is an important public policy discussion to have.
For another, Harrison recognizes that a statewide mandated school start time is unworkable. Different communities have different needs. The emphasis, she said, is on local solutions.
Im hoping this resolution will encourage conversations at the local school district and community level to educate families about sleep science and have a local discussion about how to help our kids be as healthy and academically successful as possible, she said. This is not a mandate. Im asking for conversations and innovative ideas for helping our kids.
Harrison said she is looking forward to discussing the issue as a parent in her own community and seeing what works there.
I would love to see some reasonable shifts in start times where feasible, she said. I also hope this will spur innovative ideas and solutions. There is not a one-size-fits-all solution for this.
Harrison said in her research she has already seen some school districts make interesting changes to their schedules to allow their students to get more sleep.
Some school districts are offering options for first period to allow more students to sleep in, she said. Other districts have shifted the timing of core classes versus electives or PE classes to accommodate later school start times so student athletes miss electives or PE rather than core classes the few times a semester when they need to leave for competitions or games.
Other districts have found opportunities for improving efficiencies in transportation schedules or routes to help address transportation challenges in shifting times. The bright people in our communities and districts may come up with other ideas, but we wont discover them unless more communities have the conversation about sleep science and high school start times.
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State resolution puts school start times, once considered in Park City, in the spotlight - The Park Record
Best Foods That Help Migraines, Stress, and Beyond – Shape Magazine
Try: Fatty fish such as trout, sardines, and herring
How much? Have one four- to six-ounce serving two or three times a week. Or consult your doctor about taking fish-oil supplements.
Eating fatty fish, which are high in long-chain omega-3 fatty acids, may lower the body's production of prostaglandins, hormone-like chemicals that can induce inflammation and pain, causing migraines. (ICYMI, there is a difference between headaches and migraines.)
"We found that adolescents who took 1.25 grams of fish oil daily for two months experienced fewer headaches, which were less severe and didn't last as long," explains Zeev Harel, M.D., a researcher who has studied the topic of foods that help migraines and the director of Pediatrics and Adolescent Medicine at Community Health Services in Hartford, Connecticut.
Avoid: Processed meats, artificial sweeteners, red wine, chocolate, hard cheeses, and citrus. Research shows that 20 percent of migraine sufferers are sensitive to one or more of these foods.
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Best Foods That Help Migraines, Stress, and Beyond - Shape Magazine
Trans student-athletes bill heads to floor with ‘do pass’ recommendation – 6 On Your Side
BOISE, Idaho After two days of emotional testimony on H.B. 500 -- or the trans student athletes bill sponsored by Rep. Barbara Ehardt, R-Idaho Falls, and Sen. Mary Souza, R-Coeur dAlene -- the decision was finally made: the bill will head to the floor with a "do pass" recommendation. While Democratic members opposed, Idahos House State Affairs Committee voted on party lines today to advance it.
"I really appreciate the process. This has all been about preserving opportunities for girls and women in sports, and it's important. The state has an invested interest in doing this. I feel that we've done the right thing," said Ehardt, after the voice vote.
Democratic Assistant Minority Leader John McCrostie recently called the proposed legislation an effort to try to take the humanity of trans people.
Cricket Yager, who identifies as non-binary, says they attended Thursday morning's hearing to show support for the opposition. They say they feel the decision is "difficult to grapple with."
"I think the bill itself was pretty outrageous and it's oppressive. We have, like, centuries of violence against transgender people, and just queer people in general. My reaction is just kind of hopeless," said Yager.
H.B. 500 would ban transgender girls from playing on cisgender girls' high school and college sports teams. It would also subject them to physical examinations by a physician that would be used to determine gender. Rep. Elaine Smith, D-Pocatello, asked Ehardt if students would be subject to pelvic examinations; Ehardt said the process would glean information from non-invasive blood and urine samples.
"The invasive examinations that young athletes would be subjected to if this bill passes are barbaric and cruel, and violate an individual's privacy, said Mistie Tolman, Idaho State Director of Planned Parenthood Votes Northwest and Hawaii. Trans athletes are complex athletes whose determination, will, and dedication to their sport should be celebrated, not shunned."
As we previously reported, reps from the office of the Idaho High School Activities Association (IHSSA) say they have a pre-existing policy on trans athletes in high school sports, which came to them from the National Federation of High Schools. That policy requires trans women athletes who wish to participate on girls' teams to receive hormone therapy for a year, under a doctor's care. After completing 12 months of hormones, trans women are allowed to play alongside the gender they identify with.
If Ehardt's bill is passed, it could create some pretty big complications for state colleges and universities in Idaho that are members of the NCAA. The NCAA also requires its members to allow transgender athletes to participate in sports that align with their gender identity.
Transgender men may do so immediately, but similar to the National Federation of High Schools, the law for trans women in the NCAA is that they must undergo testosterone suppression therapy for a year before competing.
As 6 On Your Side previously reported, another Republican lawmaker, Rep. Christy Zito, R-Hammett, introduced a bill this session that would ban doctors from even providing hormone treatments to people under 18, so 6 On Your Side will keep you updated on that -- as well as on Ehardt's bill.
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Trans student-athletes bill heads to floor with 'do pass' recommendation - 6 On Your Side
Want to Transition? There’s an App for That – VICE
In plain white text atop a blue-to-pink gradient, Solace greets new users with a dictionary definition of its name: comfort or consolation in a time of distress or sadness. Its a fitting name for an app that aims to give trans people more information about various aspects of transitiona one-stop resource for people who know they are trans, but dont know how to be trans.
After entering some basic informationtheir name, their pronouns, and their location by statethe user is presented with some common transition goals, as Solace terms them. These include all of the major transition milestones like beginning hormone replacement therapy and updating the name and gender marker on ones passport, as well as seemingly mundane (but surprisingly difficult) tasks like buying the right bra.
The goal, according to Solace co-founder Robbi Katherine Anthony, is to help users make their transitions as easy as possiblesomething she wished she could be able to say about her own.
Transition is beautiful, but its also incredibly hard, Anthony told VICE.
Born in New Mexico, the 27-year-old software developer now lives in Spokane, Washington. She came up with the idea and designs Solace with fellow developer Patrick McHugh, and turned to Crowdbotics, a software company in Berkeley, to build out the app. As Solaces only full-time employees, Anthony and McHugh run an extraordinarily lean operation, bouncing between Anthonys home, her 1998 blue Honda CR-V, and whatever coworking space they might be working in on a given day. Its fly or die every single day here, said Anthony. But shes committed to making something that she hopes makes transition a little less confusing, a tool she would have appreciated if it had existed all those years ago.
My transition has been rough, she told VICE. But Ill be damned if I dont do everything in my power to help others avoid that.
Solace co-founders Patrick McHugh (L) and Robbi Katherine Anthony (R). Photo courtesy of Robbi Katherine Anthony.
Anthony said that one of the biggest hurdles she faced in the early stages of her transition was finding out how to transition in the first place. She blamed a lot of this inaccessibility on gatekeeping, a term that, in a trans context, often refers to the many ways in which a health care professional can refuse gender-affirming care to a trans patientsay, a doctor who wont prescribe hormones, or surgeon who wont operate on a woman he doesnt find attractive or cis-passing enough for his standards. Anthony told VICE that she experienced this kind of medical gatekeeping firsthand, but she also used the term to describe her experiences with other trans people.
Certain people in the community become gatekeepers of information, Anthony said. Transition is a model of oral tradition, but if you have to meet people in order to transition, that inherently limits transition to people who can access that network. Some people physically cannot do that or dont want to. That information is also highly anecdotal, which she said is a problem because it ignores how one persons circumstances are not analogous to another persons.
Solace disrupts that model, she continued. If the process could be reduced from finding the right gatekeepers to having a compendium that allows you to proceed on your own terms, I think it would be healthier.
I asked Anthony if creating Solace, an app designed to circumvent community gatekeepers, might turn her into the very trans community gatekeeper she set out to circumvent.
Thats a really fair question, Anthony said. Gatekeeping, in its most nefarious forms, requires folks to do some interaction in order to get information. Whether its being approved by a moderator to join a group, seeking out a time or space or venue based on terms dictated by someone else, or being forced to curry favor with someone for them to share informationthats gatekeeping in my book.
Solace, which launched in December 2019, is quite unlike any of the other trans-specific apps available through Apples App Store. Searching for trans or transgender on my iPhone turns up an endless scroll of dating apps for cis men trying to meet trans women and crossdressers with nearly illegibile, knockoff brand names like Tinded, Sinder, and Transdr. Theyre mostly godawful, Anthony said. Fetishizing trans people... transsexual dating dot this, and stuff. There are a few practical options that actually seem to have been designed with a trans user in mind, like audio recording apps to practice voice modification, crowdsourced safe restroom finders, and a selfie-driven transition tracker. But nothing is quite as comprehensive as Solace, which contains more than 180,000 words of text, according to Anthonys estimate.
The app gives users the ability to curate a custom checklist of transition tasks, which are divided into three categories: legal (updating your birth certificate, what you can do about workplace discrimination); lifestyle (coming out to your family, connecting with other trans people); and medical (facial feminization surgery, laser hair removal, family planning). Every item is comprehensive, containing lots of actionable information about the task at hand. The coming out to family entry, for example, includes both tips on what to do (write a coming out letter to each and every family member, ask to be called by your name and pronouns, be ready to explain what transgender means) along with general advice (make sure you are sober when you come out, be prepared to lose your housing or financial support).
Many of the resources are tailored to the users gender identity and location, as non-discrimination laws and the legal hoops one has to hop through in order to change the name and gender marker on their state-issued documents vary by state. For example, the page for updating your birth certificate in Arizona correctly notes that youll need an affidavit, a certified copy of a court order, a photo copy of a valid government-issued ID, a signed letter from your physician verifying that youve undergone a sex change operation, and a small fee. The page for Washington is significantly shorter, as the Evergreen State doesnt require surgery or a fee.
Solace is free to download and the creators have no intention of selling user data to third parties. We will never charge a penny, Anthony said. Were currently donor supported. We tap into foundation support, sometimes as grants. Were structured as a nonprofit. This community faces a disproportionate amount of poverty, so putting a paywall on this thing felt counterintuitive to what we were trying to do. And data-mining, she paused. Our stomachs turn at the thought of it.
Anthony declined to share how many people have downloaded Solace since launch, though she said she and McHugh are currently halfway to reaching their 2020 user goal. The app has had a number of updates since its December launch, like the addition of more detailed information regarding Medicaid coverage for trans care in different parts of the country. Anthony said that she also plans to integrate a news aggregator with articles about a variety of trans topics, implement dynamic pronouns within the apps copyto match the pronouns the user enters, and launch a mode for parents and guardians of trans kids.
Listening to Anthony talk, I couldnt help but think about how different my experience with transitioning has been. Its not that I havent had to seek out other trans people to find out who they see for laser hair removal or whether progesterones really worth the hype; Ive had to do all of those things. The difference is that I view them as positives rather than negatives. Ive found a lot of value in talking to other trans people about their experiences and sifting through their anecdotal experiences to figure out what might be right for me. Im deeply grateful for all the friendships Ive made and communities Ive joined after putting myself in uncomfortable, new social situations. I asked Anthony if she was concerned that an app like Solace might lead trans people away from their local communities. Its a byproduct were aware of, she said, but I wouldnt say that its a goal of ours.
Our entire ethos is about providing this community with agency, and part of agency is allowing people to access information on their own terms, she said.
Solace might not be of that much use to me, an extrovert in a major city whos already in community with other trans people (and my questions at this point of my transition are more existential than they are practicalless about how do I do this or how do I do that, and more about what do I do now). But it could be useful to people who dont know any trans people, or live in a part of the country with no visible local community, and might be particularly helpful for early transitioners or trans people who havent come out yet and are still trying to figure out where to begin.
Regardless of who makes use of Solaces many comprehensive resources, Anthony was clear about one thing: she doesnt want anyone to rely on the app forever. The ultimate sign of Solaces success is that the user deletes the app because they dont need it anymore, she said.
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Alternatives to Drinking: How to Relax Without Alcohol – LIVESTRONG.COM
When most people clean up their diets to lose weight or boost their overall health, one of the first things they're told to cut out is alcohol. After all, no amount of alcohol is particularly "good" for you, per an August 2018 analysis in The Lancet and it's certainly not low in calories, no matter which type you're sipping.
Meditation is one way to relax without alcohol.
Credit: Westend61/Westend61/GettyImages
But for many, a glass of wine or a cold beer at the end of a long workday is a go-to way to de-stress and unwind. And that's nothing to sneeze at, because lowering your stress levels can be key for weight loss, too.
While a casual drink may seem harmless, there's often a biological component at play that keeps alcohol at the top of the list of favorite de-stressors, Roger Adams, PhD, personal trainer, doctor of nutrition and owner of eatrightfitness, tells LIVESTRONG.com.
"At its basic level, alcohol of any kind is a depressant, meaning it slows down the activity and processes of the brain and central nervous system," Adams says. "If used only occasionally for stress relief, alcohol is likely to be quite effective in the short-term. However, we tend to need to consume more over time to get the same de-stressed feeling, so consumption is likely to increase."
This increased alcohol consumption over time can cause myriad health problems, including mood and behavior disruptions, high blood pressure, stroke, liver disease and even cancer, according to the National Institute on Alcohol Abuse and Alcoholism.
Many of us may find it difficult to relax without alcohol, but there are compelling health benefits to limiting your intake.
Credit: BrianAJackson/iStock/GettyImages
On the other hand, stress is also a major health issue. One March 2018 study in the journal Psychological Science found that even stress that is seen as small and insignificant can lead to health problems including heart disease, anxiety and depression, chronic pain and more.
Another November 2018 study in Neurology discovered that a high-stress lifestyle could lead to memory loss and brain shrinkage before the age of 50.
And, like alcohol, stress doesn't help your waistline either. Those who suffer from long-term stress are more likely to be obese, according to a study published February 2017 in the journal Obesity. The main culprit is cortisol, a stress-induced hormone that can encourage your body to hold onto fat.
In short: If both stress and drinking are bad for you, the healthiest lifestyle is one that includes less of both.
Luckily, there are plenty of stress-relieving solutions that can help you whittle your waistline and boost your health. Here, experts share their science-backed alternatives to drinking that can still help relieve stress.
Exposure to nature has a lot o benefits, including a better mental state of wellbeing as you leave all the noise of life behind, Adams says.
This was shown in an April 2019 study published in Frontiers in Psychology, which examined two biomarkers of stress when exposed to nature: salivary cortisol, a measure of the amount of stress hormone in the saliva, and alpha-amylase, digestive enzymes. They found that both stress biomarkers dropped in people when they were exposed to nature.
So instead of happy hour after work, suggest taking a walk or throwing a frisbee in the park with your pals, or simply take a walk through the trees after dinner instead of parking yourself on the sofa with a cold one.
Did you know that keeping a food diary is one of the most effective ways to manage your weight? Download the MyPlate app to easily track calories, stay focused and achieve your goals!
Meditation can be a powerful stress-reliever, according to a systematic review and meta-analysis published March 2014 in JAMA Internal Medicine. After reviewing 47 trials, the researchers concluded that mindfulness meditation can improve levels of anxiety, depression and pain as well.
Another study, published July 2019 in Scientific Reports, found that it takes as little as 40 days of meditating to change your brain waves enough to improve stress.
"Progressive relaxation meditation involves a guided experience where you relax each part of your body, as well as calm the inner chatter that often feeds stress and worry and keeps us too stimulated for sleep," Roseann Capanna-Hodge, PsyD, psychologist and certified integrative medicine mental health provider, tells LIVESTRONG.com.
One of the best parts about meditating is that it's easy to do anywhere all you need is a safe and quiet place to sit, reflect and calm your mind. If you're looking for a little guidance, consider downloading one of the many meditation apps out there, such as InsightTimer or Calm.
Practice yoga as a healthy alternative to alcohol for stress relief.
Credit: fizkes/iStock/GettyImages
Like meditation, yoga is a good alternative to drinking that can provide boundless benefits for the body and mind, particularly when it comes to reducing levels of stress, anxiety and depression, per a February 2018 study in the International Journal of Preventive Medicine.
"By performing yoga moves and breathing properly, you can promote your mental health through the relief of stress," Jamie Bacharach, medical acupuncturist and yoga practitioner, tells LIVESTRONG.com. "Due to its use of meditation-like posing and deliberate breathing, yoga has the ability to increase your own body awareness, relax the mind and give you a sharper focus, all of which contribute to optimized mental health."
Being mindful of one's surroundings and using visualization to reduce stress has become an increasingly popular technique. Though it sounds quite similar, visualization is different than mindfulness or meditation.
"Visualization involves actually visualizing what you want and honing in on one's authentic purpose to create goals around it," explains Dr. Capanna-Hodge. "It's a powerful way to not only get clarity on your goals but to help manifest them."
To incorporate visualization into your day-to-day, Dr. Capanna-Hodge suggests taking a few minutes to sit in a quiet place and visualize what you want to accomplish and pair it with action around those goals that move them to positive outcomes.
"Whether you have a goal to better manage stress or address a specific issue, intent-oriented visualization is a great way to create positive momentum by getting to the core of the issue and its resolution," she says.
"The lasting effects throughout the day of a short workout can provide the calming effect that you may be looking for in that after-work cocktail."
It might sound simple and it is but getting your heart rate up is one of the best ways to reduce the effects of stress.
When you exercise, your body amps up its production of the "feel-good" hormone known as endorphins, while stress does the complete opposite, explains Joseph De Santo, MD, board-certified physician and addiction specialist for the BioCorRx Recovery Program.
Indeed, in responses gathered for the American Psychological Association's Stress in America 2019 survey, a whopping 53 percent of adults reported that they feel good about themselves after exercising, and 30 percent reported feeling less stressed.
"No matter what you are doing, if you are moving, oxygen is getting to the brain more efficiently and endorphins are being released," Dr. De Santo says. "The lasting effects throughout the day of a short workout can provide the calming effect that you may be looking for in that after-work cocktail."
Using essential oils is one way to relax without alcohol.
Credit: JGI/Tom Grill/Tetra images/GettyImages
Essential oils not only smell nice, but they can have a beneficial effect on both your brain and body.
Lavender oil in particular, has been shown to help alleviate symptoms of anxiety, according to one July 2017 study published in The Mental Health Clinician.
"When essential oil molecules enter the nose or mouth, they pass to the lungs and eventually the brain and other parts of the body, stimulating the olfactory system, which is the part of the brain connected to smell," Dr Capanna-Hodge explains. "As the molecules reach the brain, they affect several regions, including the limbic system, which is linked to the emotions, our memory and attentional systems, as well as our hormone and immune systems, and can lower cortisol and stress levels."
She recommends using an infuser to disperse essential oils around your home or workplace to keep your stress levels low and your body relaxed.
This nutrient has numerous health benefits, including enhancing bone health and reducing one's risk for diabetes, heart disease and anxiety. It also has impressive stress-relieving perks, as shown in a May 2017 study published in Nutrients, which found magnesium supplementation to be beneficial in relieving anxiety as well as stress.
"By supplementing with magnesium, you not only calm the nervous system, you help your body combat stress and give it what it needs to work at an optimal level," says Dr. Capanna-Hodge.
You can take a magnesium supplement, but you can also score the nutrient in certain foods, particularly spinach, almonds, avocado, tofu and dark chocolate.
Keep in mind the recommended daily intakes for magnesium, according to the National Institutes of Health:
Most Americans (1 in 3) are not getting their fair share of shut-eye and it's having a negative affect on their health and overall wellbeing, according to the Centers for Disease Control and Prevention.
What's more: Oftentimes stress is the cause of inability to sleep well. A National Sleep Foundation poll found that 43 percent of young and middle-aged adults report difficulty sleeping at night as a result of stress at least once a month.
"Getting to bed and getting enough sleep for four to five REM cycles (typically six hours minimum) can provide your brain the healing time that allows it the chance to re-organize and refresh, so you don't carry stress over from the previous day," Dr. De Santo says.
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Alternatives to Drinking: How to Relax Without Alcohol - LIVESTRONG.COM
No. 477: In which the Suffolk IDA incentivizes and the double helix debuts plus, sticky buns for all! – Innovate Long Island
Just a word or two: Welcome to Friday, dear readers, as we wrap up another busy workweek and look forward to another well-earned weekend.
Its Feb. 21 out there, and before we begin, please speak up today is International Mother Language Day, the U.N.s multicultural salute to linguistic diversity.
For the bun of it: Sticky situation.
Going to extremes: Today is also National Grain-Free Day (a big one for the low-carb set) and National Sticky Buns Day (not so much).
And give a deserving someone a hug on National Caregivers Day, always the third Friday in February, honoring healthcare professionals who deliver long-term and hospice care.
Stop, thief: Today is also the 162nd anniversary of the worlds first electric burglar alarm, installed in Boston on Feb. 21, 1858.
Dental record: Dentist Lucy Hobbs became the first woman to obtain a DDS degree from an American university on this date in 1866.
Hobbs was required to attend only one semester at the Ohio College of Dental Surgery, thanks to credit earned during years of private practice (after initially being rejected by the college because she was a woman).
Lab work: The first U.S. institutional medical laboratory, the Hoagland Laboratory, opened in Brooklyn on this date in 1887.
Physician and founder Cornelius Hoagland sunk $150,000 of his own money, including $100,000 for construction and a $50,000 endowment, into what was also Americas first bacteriological lab.
Fizz, fizz:: Oh, what a relief it is.
Plop, plop: Alka-Seltzer, the all-purpose rumbly tummy treatment, made its commercial debut on Feb. 21, 1931.
Doubling down: And they wouldnt make their game-changing announcement for another week or so, but according to the story, controversial scientist James Watson and his longtime lab partner, Francis Crick, discovered DNAs double-helix structure on this date in 1953.
Bowl of cherries: Syndicated newspaper columnist and beloved American humorist Erma Bombeck (1927-1996) who also authored more than a dozen books, including several bestsellers would be 93 years old today.
Nina Simone: The high priestess of soul.
Also born on Feb. 21 were colorful English chemist John Mercer (1791-1866), who invented the mercerization process for textiles and was a color-photography pioneer; French fashion icon Hubert de Givenchy (1927-2018); jazz and R&B great (and civil rights crusader) Nina Simone (1933-2003); and Star Wars actor Anthony Daniels (born 1946), the only actor to appear in all nine of the Skywalker Saga films, as fussy droid C-3PO.
Going up: And take a bow, William McDonough the American architect, environmental engineer and pioneer of the upcycling movement (which takes mere recycling to the next level) turns 69 today.
Wish these and all the other Feb. 21 innovators a happy birthday at editor@innovateli.com. Well take the presents story tips and calendar items, all shapes and sizes, please and thank you.
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BUT FIRST, THIS
Sports model: Another week, another new vertical for supply-chain authentication specialist Applied DNA Sciences.
Just days after announcing DNA strand-producing spinoff company LineaRX would expand an existing collaboration with Italian partner Takis Biotech to take the fight to the dreaded 2019-nCoV coronavirus, the Stony Brook-based biotech is making its first-ever foray into the dietary supplements market with a new, multiyear deal that applies the DNA-based CertainT authentication solution to products containing Nitrosigine, a leading sports supplement produced by Westchester-based Nutrition21.
Nitrosigine (a bonded arginine-silicate, for those keeping score) has earned FDA New Dietary Ingredient status and is currently incorporated into some 250 consumer products. That places a premium on traceability and authenticity, according to Nutrition 21 VP Bill Levi, and led the manufacturer straight to Applied DNA. The scientific evidence provided by [the] CertainT platform will support these principles with verification of product compliance through the supply chain, Levi said Wednesday.
Running start: A leg up for minority- and women-owned business enterprises.
MWBE, start your engines: Albanys 2020 Regional MWBE Opportunities Expo Series, designed to encourage minority- and women-owned startups across the state, will get rolling next month with an all-day event on Long Island.
Sponsored by the Empire State Development Corps Division of Minority and Womens Business Development and supported by other state agencies and local partners, the expo series will feature panel discussions, MWBE certification workshops, details on the states MWBE Business Builder Boot Camp, access to regional Small Business Development Centers, expert government-contract procurement tips and other advice designed to help women and minorities start their own businesses, and succeed.
The series is scheduled to kick off March 20 at Farmingdale State College, with other expos scheduled throughout the year at Binghamton University, the University at Buffalo and Mohawk Valley Community College. More details on next months Farmingdale State expo right here.
TOP OF THE SITE
Incentivized: Theyre feeling motivated at the Suffolk County IDA, which is busily fortifying county employment on an incentives-package hot streak.
Hail to the chief: One of the hardest workers in all of Long Island innovation explains why the COO is usually an organizations most vital cog.
Easy does it: Love this newsletter? Us, too. Help us help you by sharing this one with your fellow innovators and urge them to subscribe for free, already. Its not hard.
ICYMI
The state approves new Long Island-based cardiac labs; the nation approves new Long Island-based craft-beer awards.
BEST OF THE WEST (AND SOMETIMES NORTH/SOUTH)
Innovate LIs inbox overrunneth with inspirational innovations from all North American corners. This weeks brightest out-of-towners:
From Wisconsin: Fitchburg-based biotech JangoBio leaps forward with sustainable stem-cell based therapies promising complete hormone restoration.
From Texas: Houston-based William P. Hobby Airport hastens international arrivals and departures with face-recognition biometric tech.
From Georgia: Atlanta-based IoT developer Digital Matter earns critical Verizon certifications with battery-powered global asset-tracking devices.
ON THE MOVE
Kaitlin Friedman
+ Kaitlin Friedman has joined Woodbury-based SterlingRisk Insurance as alternative market leader in the SterlingRisk Programs Department. She previously served as an account executive for HUB International in Woodbury.
+ ERASE Racism has announced two new hires: Nadia Jean-Franois, formerly a middle school teacher in Florida, is now the education equity coordinator, and Steve Glassroth, formerly an attorney in Alabama and Georgia, is now director of Housing Policy & Initiatives.
+ Jeremy Musella has joined Uniondale-based Forchelli Deegan Terrana as an associate in the Corporate/Mergers & Acquisitions and Veterinary practice groups. He previously served as an associate at Garden City-based Cullen and Dykman.
+ Mark Nuccio has been elected treasurer of the Walt Whitman Birthplace Association in Huntington Station. He is the founder and partner of Bethpage-based Design Edge Group.
+ Sean Miller has been elected treasurer of the Literacy Nassau Board of Directors in Wantagh. He is the store manager for TD Bank in Floral Park.
+ Islandia-based Lewis Johs Avallone Aviles has announced the promotion of two new partners: Amy Bedell, formerly senior counsel, and Annemarie Jones, formerly an associate.
BELOW THE FOLD
Breathe normally: There are better ways to deal with 2019-nCoV.
Healthy start: Successful startups must first learn these 10 valuable lessons.
Sick days: How companies around the globe are coping with the coronavirus.
Feeling better: How Big Tech is changing hospital operations (for the better).
Curing what ails you: The healthcare sector is just one of the cutting-edge industries tapping into the HIPAA- and HITECH-compliant IT services provided by Webair, one of the amazing firms that support Innovate LI. Check them out.
Canada is sinking into totalitarianism. The evidence is overwhelming – Lifesite
February 18, 2020 (American Thinker) To describe Canada as a totalitarian state-in-progress sounds like a gross and indeed absurd exaggeration. Yet many premonitory signs are present. In the words of political philosopher William Gairdner, author ofThe Book of Absolutes,The Great Divide, andThe Trouble with Canada, Canada has just crossed the red line between soft-socialism and soft-totalitarianism.
Gairdner has assembled a virtual mountain ofevidencefor his claim:Bill C-25seeking to impose diversity on all corporations; financial penalties against organizations that do not comply with government programs; a teeming brigade of government surveillance inspectors that is, spies: wage spies, speech spies, feminist spies, pay equity spies, Human Rights spies; paralegal bodies known as Human Rights Tribunals with the power to levy crippling fines, bankrupt families, and shut down businesses, impose prison time for contempt of court, and compel conformity via re-education.
The list goes on. Bill C-16 prohibits discrimination on the basis of gender identity and gender expression, which sounds unexceptionable except for the obvious fact that discrimination is in the eye of the offended beholder and the government enforcer. The bill effectively mandates that citizens address others by their preferred pronouns and transgender fantasies or else! Its zir, ze, zem, or zeir, or youre done for. Its Emily, not Brian, or your jobs in peril. TheOntario Human Rights Codestipulates that refusing to refer to a trans person by their chosen name and a personal pronoun that matches their gender identity ... will likely be discrimination in social areas like employment, housing, education, and so on. As Queens University law professor Bruce Pardy writes, human rights have become a weapon to normalize social justice values and delegitimize competing beliefs. There are other laws on the books, bills such asC-59, C-75, andC-76, that reduce and even criminalize freedom of expression, infringe on privacy rights, compromise due process, and render government transparency a thing of the past.
The assault against normalcy, common sense, civil rights, and charter freedoms gives no indication of relenting. Bill S-202, an act to amend the Criminal Code now before Parliament, would outlaw what the government misleadingly calls Conversion Therapy that is, by criminalizing parents, lawyers, physicians, and church leaders who object tostate-compelled hormone-drugging and genital mutilation procedures, the bill would effectively prevent minor children undergoing forced transgender operations, surgical and hormonal, from receiving the help they need. This whole agenda to sterilize and mutilate children, write the editors ofAction4Canada, is pure evil and in violation of ... the Charter of Rights and Freedoms, the Universal Declaration of Human Rights, The International Covenant on Civil and Political Rights,as well as a physicians ethicalcommitment promising to First, do no harm.
In an article for the National Post, columnistRex Murphy, one of that rare breed of truth-telling Canadian journalists, writes: This government, or the agencies of this government, are establishing a pattern of misusing the authority of the law. Among other instances of official malfeasance, Murphy skewers the Liberal governments fraudulent case against Rebel News founderEzra Levantfor publishing and promoting a book critical of Prime Minister Justin Trudeau,The Librano$, during the October 2019 election without registering the book with a government agency. Can anybody name any other book, ever, Murphy asks, which has been the subject of an investigation by the Commissioner of Canada elections? ... WillPEN Canada, defender of authors and journalists, take up the banner for Mr. Levant? Rhetorical questions, obviously.
As of this writing, new developments have come to the fore. Not satisfied with relying on the misapplication of electoral law or conducting dodgy prosecutorial attacks on individuals whom the party wishes to intimidate, silence, or arrest, Trudeaus Liberals are considering a motion requiring all news contentcreators to procure agovernment licensefor approved content, thus controlling public access to information. These are autocrats that Canada has empowered, writes spokesman forCanadians for Language FairnessGordon Miller (personal communication). Now we will pay the price.
Not content with such despotic measures, the CRTC (Canadian Radio-Television and Telecommunications Commission)proposesto identify news sites that are accurate, trusted, and reliable with the intent to enhance the diversity of voices. Truth be told, there are precious few accurate, trusted, and reliable news sites in Canada. As in the U.S., they are almost all parabellum outfits, taking dead aim at honest reporting. Moreover, we know that emphasizing diversity of voices is equivalent to the imposition of the grievance-driven identity-group and social justice model on public broadcasting while constraining factual reporting and bridling the dissemination of genuine news. It is, in effect, tantamount to a government monopoly on information, which, as Conservative shadow minister for industry and economic developmentMichele Rempel Garnerrightly warns, puts us in league with countries that control the media.
That the warning comes from a Conservative M.P. who, like the majority of her colleagues, has embraced many of the Liberals woke policies and progressivist attitudes shows how far gone we are. Indeed, the contagion has spread throughout the House. All of Canadas political parties signed on to Bill C-76, which received royal assent in December 2018 and imposes further restrictions on third-party speech during extended election periods. This is to be expected. Every political party steers to the Left, including, as noted, the Conservatives, who are essentially Liberal Lite. Trudeau is simply the most visible embodiment and effective bellwether of the political virus infecting the country.
The treatment ofOmar Khadris another case in point. A Canadian citizen and youngest son of an Al-Qaeda terrorist family who was detained at Guantanamo Bay for violations of the laws of war in Afghanistan, including killing American combat medic Christopher Speer, Khadr was repatriated to Canada and awarded a $10.5-million compensationsettlementby Trudeau. Although the issue is clouded and precise information is difficult to find, it appears likely that he remains on a no-fly list. No matter: Khadr recently flew first class to keynote a panel discussion at Dalhousie University in Nova Scotia.
The beleaguered Levantconfronted himwith a series of questions was he aware of a no-fly list? Did he donate a portion of his cash windfall to the widow of Dr. Speer? (Levant did not mention that Khadr haspurchaseda strip mall in Edmonton for a substantial portion of his payout.) Khadr is regarded as a Canadian hero who suffered at the hands of the dastardly Americans, while Levant is nothing but a gadfly, so it was no surprise to see Levant grilled by four policemen and unceremoniously escorted from the airport. They got the wrong guy, as the expression has it, but thats how things happen in a nascent police state.
Canadiancombat veteran Jeremy MacKenzie,who attended the event or tried to was livid with righteous fury, recalling his buddies who gave their lives in Afghanistan fighting the Taliban and the likes of the extended Khadr family. Responding toTrudeaus excusein reference to military veterans pensions that veterans are asking for more than the federal government can afford, MacKenzie fumes that, that notwithstanding, we will make Omar Khadr, the Taliban terrorist, a multi-millionaire. Canada, he proclaims, is not the country that I signed up to fight for and it is certainly not the country that those men and women died for. Like Levant, he was escorted from the premises an analogy for the dwindling remnant of patriotic Canadians being escorted from their country.
These are developments that should not be dismissed as mere desultory details. They add up. As Gairdner points out, soft totalitarianism is a considerable way from hard totalitarianism. But it all starts somewhere, and this week, the road got shorter. There is a sort of politicalMartini curveat work as Canada races to keep up with the Leftist conformity of the modern international elite. Regrettably, Canada has no Donald Trump or Viktor Orbn or Boris Johnson on the current political horizon. Nor is there a term limit on the office of prime minister, which suggests that a socialist troll and ideological jamoke like Justin Trudeau may be in power for years to come. The one party that promised a return to social, political, and fiscal sanity, Maxime Berniers The Peoples Party of Canada, was deep-sixed by the media and wiped out at the polls. That tells us all we need to know.
To say it cant happen here the title of Sinclair Lewiss 1935 novel, though he targeted the wrong constituency is an expression of overweening confidence and lack of historical awareness. One does not have to think back to the demise of the Weimar Republic in Germany. A mere glance at the European Unions unelected, bureaucratic authoritarianism, or a recognition of what the Democrat Party is demonstrably planning for the United States, should awaken us to the danger. To be awakened, we might remark, is the opposite of being woke. Canada stands as a vivid illustration of what would be in store for the U.S. under a Democrat administration.
It can happen here, and it is happening right now, right here, in Canada.
David Solways latest book isNotes from a Derelict Culture, Black House Publishing, 2019, London. A CD of his original songs,Partial to Cain, appeared in 2019.
Published with permission from the American Thinker.
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Canada is sinking into totalitarianism. The evidence is overwhelming - Lifesite
New Gene Therapies Institute Aims to Address Regulatory Barriers – HealthITAnalytics.com
February 20, 2020 -The Institute for Gene Therapies (IGT), a new advocacy foundation focused on policy issues surrounding gene therapies, recently launched with the goal of modernizing US regulatory and reimbursement framework for gene therapies.
According to IGT, the US health system currently spends about 85 cents of every healthcare dollar managing the symptoms of chronic diseases over a patients lifetime. With gene therapies, providers could alter patients non-functioning genes or replace absent ones, leading to long-lasting effects and potentially reshaping the way thousands of diseases are treated.
While traditional biologic and pharmaceutical medicines help manage the symptoms of disease over time, gene therapies target the cause of disease at the DNA level, creating lasting changes in the body. Some gene therapies are also designed to be one-time treatments that offer lifelong benefits.
IGT will work to educate stakeholders across the healthcare system about the potential for gene therapies to treat and cure common and rare chronic diseases, and advocate for policies that help ensure patients who need gene therapies can benefit from them.
Existing regulatory and reimbursement structures were established and adjusted over time to support pharmaceutical and biologic medicines, IGT noted, and need refining to accommodate the potential of gene therapies.
READ MORE: Data Mining Techniques Could Improve Cancer Gene Therapies
Many crippling conditions like Charcot-Marie-Tooth (CMT), which I was diagnosed with before the age of two take hold at a very young age, cut lives far too short or cause ongoing daily suffering, said Susan Ruediger, CEO of the CMT Research Foundation (CMTRF) and member of the IGT Patient Advocacy Advisory Council.
Like so many diseases, CMT currently has no cure. I am proud to stand with other leading patient advocates, members of the research community and companies that are developing gene therapies to help ensure patients can fully realize the benefits of these giant leaps toward treatments and cures.
The FDA has already approved four gene therapy products, and researchers are studying hundreds more in clinical trials for rare and common diseases, including many types of cancer, neuromuscular diseases, blood disorders and infectious diseases, and other conditions.
The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators, FDA Commissioner Stephen M. Hahn, MD, said in a statement.
We understand and appreciate the tremendous impact that gene therapies can have on patients by potentially reversing the debilitating trajectory of diseases. These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.
READ MORE: Genetic Sequencing Study Identifies 102 Genes Associated with Autism
The FDA has also released six final guidance documents on gene therapy manufacturing and clinical development of products. These documents incorporate input from stakeholders across the healthcare industry and make important strides in designing a modern structure for gene therapy development.
As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs, said Peter Marks, MD, PhD, director of the FDAs Center for Biologics Evaluation and Research.
Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review; including how these products work, how to administer them safely, and whether they will continue to achieve a therapeutic effect in the body without causing adverse side effects over a long period of time.
IGT will being together experts across the healthcare community, including corporate leaders, patient advocacy groups, and academic and scientific stakeholders, to ensure health policies reflect the latest advancements in gene therapies. The institute will also work to remove barriers that limit patient access to these therapies and promote sustainable, long-term solutions.
Experts will learn more about the value gene therapies bring to patients, their families, and the healthcare system as a whole. IGT will help advance chronic disease treatments and get to the root cause of some of the most debilitating, expensive conditions that affect patients throughout their lives.
READ MORE: 77% of Americans Are Optimistic About Genetics Research, Potential
The incredible scientific advancements in this space present unique opportunities to directly improve and save the lives of patients suffering from debilitating diseases, said IGT Chairman, and former Congressman Erik Paulsen.
This is not some far-off future patients are already benefiting from the first FDA-approved gene therapies. But we need policy to move faster toward this new reality where we can treat the causes of many diseases. The Institute for Gene Therapies and our members believe unique regulatory and reimbursement structures need to be established, novel development pathways need to be embraced and new value-based arrangements need to be tested.
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New Gene Therapies Institute Aims to Address Regulatory Barriers - HealthITAnalytics.com
BioMarin inches closer to a gene therapy first – BioPharma Dive
Dive Brief:
Though analysts continue to debate the particulars of a valrox launch, they generally expect the therapy to take a significant chunk of the hemophilia market. Cantor Fitzgerald found through a survey that doctors seem quite willing to prescribe valrox within a few years of its launch. SVB Leerink also saw patient and prescriber enthusiasm in its own research.
"We believe the hemophilia market may be less 'sticky' and more poised for disruption by next generation agents than is generally assumed based on historical behavior," SVB Leerink analysts wrote in an investor note last February.
For BioMarin, a market open for disruption could translate to big sales. According to Jefferies, consensus estimates on Wall Street put valrox sales at $44 million this year, growing to $190 million in 2021 and more than $1.3 billion in 2025. Last May, Jefferies said valrox accounted for 16% the value it modeled for BioMarin's stock price.
On the other end, valroxcould threaten leaders in the hemophilia drug space. Roche's blockbuster drug Hemlibra, which comes with convenient dosing and a high list price, looks particularly vulnerable. Survey data from Citi Research cited by BioMarin showed U.S. hematologists said they would switch close to 40% of their Hemlibra-treated patients to a gene therapy within three years of valrox's launch.
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BioMarin inches closer to a gene therapy first - BioPharma Dive
Orgenesis teams with John Hopkins’ in PoC deal – Bioprocess Insider – BioProcess Insider
John Hopkins University will use Orgenesis point-of-care processing technology for cell and gene therapy research in a collaboration announced this week.
The US research University has licensed access to Orgenesiss point-of-care (PoC) platform which as the name suggests is used to develop and process cell therapies in the clinic
Orgenesis CEO Vered Caplan said, Our POCare platform is designed to provide unique cell and gene therapy solutions in a cost effective, high quality and scalable manner, using closed systems and other advanced cell processing technologies at the point of care.
Image: Tingtingou/creativecommons
Caplan added the aim is to support John Hopkins Universitys growing development and processing needs in order to advance and accelerate cell and gene based clinical therapeutic research.
News of the collaboration comes weeks after Orgenesis sold Masthercell, its third-party cell and gene therapy business, to Catalent for $315 million (285 million).
At the time Orgenesis said it expects to use the net proceeds from the sale of Masthercell to grow its point-of-care cell therapy business
Caplan said, We decided it was the right time to sell Masthercell to maximize value for our shareholders, and focus our efforts around our POCare solutions, which we believe represent a major paradigm shift and will play a major role in the future of the cell and gene therapy market.
She explained that by helping healthcare providers switch from costly, centralized manufacturing models to a localized point-of-care model it can reduce costs and accelerate cell therapy development.
The point of care platform is designed to collect, process and supply cells within the patient care setting for various therapeutic treatments.
The aim is to reduce cost and complexity of supplying cell and gene therapies, as well as elevate quality standards by integrating automated processing.
John Hopkins University is the third institution to license use of the technology.
In January, Orgenesis announced the University of California, Davis will use the platform to develop, commercialize and supply cell and gene products and therapies.
Prior to that Orgenesis joint venture with Theracell signed an agreement with Greece-based Hygeia Group covering use of the platform at three hospitals owned by the latter organization.
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Orgenesis teams with John Hopkins' in PoC deal - Bioprocess Insider - BioProcess Insider
What Challenges Gene Therapy Technologies May See in Next 5 Years: Bluebird bio, Adaptimmune, GlaxoSmithKline, Merck – Nyse Nasdaq Live
Gene Therapy Technologies Market: Evaluation, Epidemiology & Market Forecast 2027
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Gene Therapy Technologies Epidemiology
A snapshot on the marketed and pipeline emerging drugs, along with comprehensive insight on emerging treatments based on their safety & efficacy results, mechanism of action, route of administration, therapeutic potential, regulatory success, launch dates, and other factors. This section also covers latest news which includes agreements and collaborations, approvals, patent details and other major breakthroughs.
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Market forecast specifically base on Y- o -Y growth rate. Data projection and future performance of each segment is scrutinize based on key aspects produced from primary and secondary research result. Thus, data projection exhibits the assumption on how the market performs under microeconomic and macroeconomic parameters. Our market forecasting technique represents strategic conclusions which can play a crucial role for our clients in making strategic marketing plans.
Regional Analysis
This segment provides the country-specific information, along with historical and current patient pool and forecasts for prevalent/ incident cases, as well as diagnosed and treatable patient particulars.
Gene Therapy Technologies Market Size and Segmentation
This segment of the report focuses on Important Key Questions: What is the size of the total & addressable market for Gene Therapy Technologies? This question will help and give you answers whether the market is big enough to be interested in your business. Admissible and detailed patient sagmentations provided for each and every Indication, enabling to evaluate the commercial potential of the market.
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Key Leaders in Gene Therapy Technologies industry, developing new products to meet the unique needs according to demands, technology and market trends. Such innovations ranging from new product designs, utilization of novel materials that could ameliorate existent fallibility. Such activities will support the strong development of this industry, augmenting the market growth.
Key Players Mentioned in This Research Report:
Bluebird bio, Adaptimmune, GlaxoSmithKline, Merck, Celgene, Shanghai Sunway Biotech, BioCancell, Shenzhen SiBiono GeneTech, SynerGene Therapeutics, OncoGenex Pharmaceuticals, Genelux Corporation, Cell Genesys, Advantagene, GenVec, BioCancell, Celgene, Epeius Biotechnologies, Introgen Therapeutics, Ziopharm Oncology
Gene Therapy Technologies Market Research Methodology
Research methodology is succeeded by combining special industry knowledge and in-country research encounters. We employ data interrogation methodologies to generate new and meaningful analyses and insights. The research method uses extencive use of secondary sources, paid database platforms to pinpoint and collect needed information, that is very useful to gain knowledge on technical, commercial and market-oriented aspects.
These collected data information are carefully filtered, analyzed, compared, and presented in a manner that are easy to understand and develope accurate research study. Furthermore, all collected data is subjected to encounter exhaustive review process at country level, regional level, and global level.
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What Challenges Gene Therapy Technologies May See in Next 5 Years: Bluebird bio, Adaptimmune, GlaxoSmithKline, Merck - Nyse Nasdaq Live
Krystal Biotech to Present at the Cowen 40th Annual Healthcare Conference – BioSpace
PITTSBURGH, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (Krystal) (NASDAQ: KRYS), a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from skin diseases, today announced that Krish S. Krishnan, chairman and chief executive officer, will present at the Cowen 40th Annual Healthcare Conference in Boston being held March 2-4, 2020 at the Boston Marriott Copley Place.
Details for the presentation are as follows:
A webcast of the presentation will be available for 90 days and can be found on the Krystal Biotech website at: http://ir.krystalbio.com/events-and-presentations/events.
AboutKrystal BiotechKrystal Biotech, Inc.(NASDAQ:KRYS) is a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from dermatological diseases. For more information, please visithttp://www.krystalbio.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Krystal, including but not limited to statements about the development of Krystals product candidates, such as plans for the design, conduct and timelines of ongoing clinical trials of bercolagene telserpavec (B-VEC) and KB105, the clinical utility of B-VEC and KB105 and Krystals plans for filing of regulatory approvals and efforts to bring B-VEC and KB105 to market, the market opportunity for and the potential market acceptance of B-VEC and KB105, plans to pursue research and development of other product candidates, the sufficiency of Krystals existing cash resources and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC and KB105, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption Risk Factors in Krystals annual and quarterly reports on file with theU.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystals views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystals views as of any date subsequent to the date of this release.
CONTACTS:
Investors:Ashley R. RobinsonLifeSci Advisorsarr@lifesciadvisors.com
Media:Darren Opland, PhDLifeSci Communicationsdarren@lifescicomms.com
Source: Krystal Biotech, Inc.
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Krystal Biotech to Present at the Cowen 40th Annual Healthcare Conference - BioSpace
Actinium Presents Positive Findings from Mid-Point Analysis of Pivotal SIERRA Trial of Iomab-B at 2020 Transplantation & Cellular Therapy Meetings…
NEW YORK, Feb. 21, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") announced today findings from the SIERRA trial that were presented at the 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (TCT) in Orlando, FL. Dr. Boglarka Gyurkocza, the principal investigator from Memorial Sloan Kettering Cancer Center, revealed that there were key differences in side effects reported in patients treated in the Iomab-B and control arms of the study with rates of febrile neutropenia, sepsis and mucositis being markedly lower in the Iomab-B arm.
The oral presentation also featured updated results from the fifty percent enrollment mid-point analysis including BMT access rates, engraftment and 100-day non-relapse transplant related mortality (TRM). After accounting for these factors, the results showed that, on an intent-to-treat or ITT basis, 78 percent of patients in the Iomab-B arm are potentially evaluable for the primary endpoint compared to 13 percent in the control arm. In addition, an important and recent protocol amendment was highlighted; the approximately 30 percent of patients who are expected to fail induction therapy with venetoclax plus hypomethylating agents1 are now eligible for enrollment in the SIERRA trial. The change is expected to increase the addressable patient population of the study given that this combination is now recommended as part of the NCCN or National Comprehensive Cancer Network guidelines, is widely used and expected to become the treatment of choice.
Key Interim Results:
The data tables that follow summarize key findings that were presented as part of the TCT proceedings. As highlighted in the table below, patients receiving Iomab-B showed lower rates of key adverse events relevant in the BMT setting in compared to patients randomized to receive physician's choice of salvage chemotherapy on the control arm. For example, patients receiving Iomab-B had a much lower incidence of sepsis of 3 percent compared to the 42 percent incidence in the control arm.
Adverse Event* N (%)
Randomized to Iomab-B andreceived BMT (N=31)
Randomized to Control Armand received BMT (N=7)
Febrile Neutropenia
8 (25.8)
3 (42.8)
Sepsis/Septic Shock
1 (3.2)
3 (42.8)
Stomatitis (mucositis)
3 (9.7)
2 (28.6)
Pneumonia/Lung Infection
4 (12.9)
1 (14.3)
Hypertension
61 (19.4)
1 (14.3)
Decreased Appetite
5 (16.1)
0 (0.0)
Device related infection
4 (12.9)
1 (14.3)
Hypophosphatemia
2 (6.5)
1 (14.3)
* All adverse events reported irrespective of attribution to protocol-directed procedures
1) 5 patients had hypertension considered unrelated to Iomab-B and 1 patient had hypertension possibly related to Iomab-B
"This detailed safety data from SIERRA is highly encouraging, particularly in this patient population, as neutropenia and sepsis are hallmark toxicities associated with chemotherapy-based conditioning regimens that next to relapse are leading causes of morbidity and mortality post-transplant," said Dr. Vijay Reddy, Vice President, Clinical Development and Head of BMT at Actinium. "Chemotherapy-based conditioning damages normal organs, such as the gastrointestinal tract, which allows gut bacteria to cause serious infections. The data showing less mucositis, febrile neutropenia, and sepsis are consistent with the targeted nature of Iomab-B, since a lack of damage to the gastrointestinal track would lead to a reduction in these adverse events. BMT is the only curable treatment option for older patients with active, relapsed or refractory AML. Yet these patients face restricted access and suboptimal outcomes due to reliance on chemotherapy-based conditioning regimens and perceptions in the hematologist community around safety and eligibility for BMT. With the SIERRA trial, our goals are to eliminate these barriers leading to more patients receiving BMT and with better patient outcomes. With this additional safety data in hand, we have even greater confidence in our ability to change the perceptions around BMT and are excited to update the transplant and hematology communities on Iomab-B's potential to positively impact patients through improved access to BMT and better outcomes."
The presentation highlighted that 100 percent (31/31) of patients receiving a therapeutic dose of Iomab-B achieved successful BMT engraftment with only a 6 percent (2/31) TRM rate compared to the control arm where 18 percent (7/38) achieved engraftment with a 29 percent (2/7) TRM rate. At the 100-day post BMT time point, on an ITT basis, there were 29 patients from the Iomab-B study arm potentially evaluable for the primary endpoint of durable Complete Remission (dCR) at 180 days compared to 5 patients in the control arm. By this measure, 78 percent of patients in the Iomab-B arm are potentially eligible for the dCR primary endpoint compared to 13 percent of patients in the control arm. The mid-point analysis and data presented at TCT can be viewed here.
Detailed engraftment data is presented in the table below:
BMT Feasibility andOutcome Data
Randomized toStudy Arm (N=37)
Randomized to Control Arm (N=38)
ReceivedTherapeutic Doseof Iomab-B andreceived BMT(N=31)1
Achieve CR andreceived standardBMT (N=7)
Did not Achieve CR(N=31/38)2
Crossed over from toIomab-B and receivedBMT (N=20)
BMT Engraftment Rate (%, N)
100% (31/31)
18% (7/38)
100% (20/20)
Median Bone Marrow Blasts% at randomization
(%, range)
29% (5-88)
26% (5-97)
At crossover: 31%
(6-87)
At randomization: 35%(5-75)
Median Days to BMT postrandomization (days, range)
30 (23-50)
67 (51-86)
64 (44-161)
Median Days to AbsoluteNeutrophil Count Engraftment(days, range)
15 (9-22)3
18 (13-82)4
14 (10-37)5
Median Day to PlateletEngraftment (days, range)
20 (4-39)3
22 (9-35)4
19 (13-38)5
100-day non-relapsetransplant related mortality(%, N)
6% (2/31)
29% (2/7)
10% (2/20)6
1) No therapeutic dose (6) due to: declining Karnofsky Performance Scale (PFS) (3), Infusion reaction (1), unfavorablebiodistribution (1), post-randomization eligibility (1)
2) Ineligible for crossover (9) due to: hospice care/progression (4), declined/ineligible for BMT (2), died pre-crossover (3),eligible for crossover (2) did not receive Iomab-B due to declining status
3) Absolute Neutrophil Count engraftment data not available (1), platelet engraftment data not available (4)
4) ANC and platelet engraftment data not available (1), engraftment failure (1)
5) ANC engraftment data not available (1) out of 20, platelet engraftment data not available (3)
6) 1 patient at 161 days had delayed transplant due to infection and respiratory failure, received Iomab-B and BMT when stable
Dr. Mark Berger, Actinium's Chief Medical Officer, stated, "As we approach critical enrollment milestones in the SIERRA trial, our focus turns to bringing Iomab-B to as many patients as possible that can benefit from this product candidate and as expeditiously as possible. Consequently, we made an important amendment to the SIERRA protocol to expand the potential patient pool by including in the eligibility criteria patients who fail induction therapy with venetoclax plus hypomethylating agents. As targeted agents such as venetoclax and others have gained approval, the acute myeloid leukemia treatment landscape has evolved with a significant percentage of patients being treated with these agents in frontline and relapsed settings. In fact, as of mid-2019, venetoclax plus hypomethylating agents have been included as part of the AML National Comprehensive Cancer Network guidelines and medical practice is embracing these regimens widely. However, these regimens are not curative, nor do they eliminate the need for BMT. Indeed, approximately thirty percent of patients fail to achieve a remission after two cycles of induction therapy with venetoclax and most patients ultimately relapse with a median duration of response of less than one year. This amendment has already had a positive impact on the trial that we expect to continue through the remaining portion of enrollment. Most importantly, if Iomab-B gains approval, this amendment will support its use for the significant and growing number of patients receiving and failing venetoclax as induction therapy instead of traditional 7+3 induction chemotherapy. We look forward to continuing to provide key updates as SIERRA reaches key milestones and completes enrollment in 2020."
Sources: 1) DiNardo et al. Venetoclax combined with decitabine or azacitidine in treatment-nave, elderly patients with acute myeloid leukemia. Blood 2019 133(1): 7-17 https://doi.org/10.1182/blood-2018-08-868752
About the SIERRA TrialThe SIERRA trial (Study ofIomab-B inElderlyRelapse/RefractoryAcute Myeloid Leukemia) is the only randomized Phase 3 trial that offers BMT (Bone Marrow Transplant) as an option for older patients with active, relapsed or refractory AML or acute myeloid leukemia. BMT is the only potentially curative treatment option for older patients with active relapsed or refractory AML and there is no standard of care for this indication other than salvage therapies. The SIERRA trial is a 150-patient, multicenter randomized trial that studying Iomab-B compared to physician's choice of salvage chemotherapy. The primary endpoint of the SIERRA trial is durable Complete Remission of 180 days and the secondary endpoint is 1-year overall survival. Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the anti-CD45 antibody apamistamab and the radioisotope I-131 (Iodine-131). The 20 active SIERRA trial sites in the U.S. and Canada represent many of the leading bone marrow transplant centers by volume. For more information, visit http://www.sierratrial.com.
About Transplantation & Cellular Therapy Meetings (TCT)
TCT, formerly known as the BMT Tandem Meetings, are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).Each year the conference brings together several thousand investigators, clinicians, researchers, nurses and other allied health professionals from over 500 transplant centers from over 50 countries around a full scientific program focused on bone marrow transplant and cellular therapies.
About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3Study ofIomab-B inElderlyRelapsed orRefractoryAcute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over fifty percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1/2 anti-HIV stem cell gene therapy with UC Davis and is expected to be studied with a CAR-T therapy in 2020. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contacts:
Investors:Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 535-7743
Media:Alisa Steinberg, Director, IR & Corp Commsasteinberg@actiniumpharma.com(646) 237-4087
View original content to download multimedia:http://www.prnewswire.com/news-releases/actinium-presents-positive-findings-from-mid-point-analysis-of-pivotal-sierra-trial-of-iomab-b-at-2020-transplantation--cellular-therapy-meetings-of-astct-and-cibmtr-tct-301009012.html
SOURCE Actinium Pharmaceuticals, Inc.
Merck loses its chief digital officer, spotlighting talent hunt for the hottest title in Big Pharma – Endpoints News
TARRYTOWN, NY In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascals roommates sat her down on their couch and staged an intervention.
Are you sure this is what you want to be doing with your life? she recalls them asking her.
Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didnt see her roommate for a week. For months, that was life in Christos Kyratsous lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.
Im ok, I dont have Ebola, Pascal told them. I see that death toll rising and I cant not do something about it.
Last August, Regeneron learned they had succeeded: In a large trial across West Africa, their drug, REGN-EB3, was vastly more effective than the standard treatments. It was surprise news for the company, coming just 10 months into a trial they thought would take several years and a major victory in the global fight against a deadly virus that killed over 2,000 in 2019 and can carry a mortality rate of up to 90%.
For Kyratsous and Pascal, though, it brought only fleeting reprieve. Just four months after the NIH informed them REGN-EB3 worked, Kyratsous was back in his office reading the New York Times for updates on a new outbreak on another continent, and wondering alongside Pascal and senior management whether it was time to pull the trigger again.
In late January, as the death toll swelled and the first confirmed cases outside China broke double digits, they made a decision. Soon they were back on the phone with the multiple government agencies and their coronavirus partners at the University of Marylands Level 3 bio lab. The question was simple: Can Kyratsous and his team use a process honed over two previous outbreaks, and create a treatment before the newest epidemic ends? Or worse, if, as world health experts fear, it doesnt vanish but becomes a recurrent virus like the flu?
Christos likes things immediately, Matt Frieman, Regenerons coronavirus collaborator at the University of Maryland, told Endpoints. Thats what makes us good collaborators: We push each other to develop things faster and faster.
Click on the image to see the full-sized version
The first time Regeneron tried to respond to a global outbreak, it was something of a systems test, Kyratsous explains from his office at Regenerons Tarrytown headquarters. Kyratsous, newly promoted, has crammed it with photos of his family, sketches of viral vectors and a shark he drew for his 3-year-old son. He speaks rapidly an idiosyncrasy his press person says has only been aggravated this afternoon by the contents of his Regeneron Infectious Diseases-minted espresso glass and he gesticulates with similar fluidity, tumbling through antibodies, MERS, the novel coronavirus, Ebola-infected monkeys.
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Merck loses its chief digital officer, spotlighting talent hunt for the hottest title in Big Pharma - Endpoints News
Intellia Therapeutics to Hold Conference Call to Discuss Fourth Quarter and Full-Year 2019 Earnings and Company Update – Yahoo Finance
CAMBRIDGE, Mass., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, will present fourth quarter and full-year 2019 financial results and operational highlights in a conference call on February 27, 2020 at 8 a.m. ET.
To join the call:
U.S. callers should dial 1-877-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the companys website at http://www.intelliatx.com, beginning on February 27, 2020 at 12 p.m. ET.
About Intellia Therapeutics
Intellia Therapeutics is a leading genome editing company focused on developing proprietary, curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course, and through improved cell therapies that can treat cancer and immunological diseases, or can replace patients diseased cells. The combination of deep scientific, technical and clinical development experience, along with its leading intellectual property portfolio, puts Intellia in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Learn more about Intellia Therapeutics and CRISPR/Cas9 at intelliatx.com and follow us on Twitter @intelliatweets.
Intellia Contacts:
Investor Contact: Lina LiAssociate Director, Investor Relations+1 857-706-1612lina.li@intelliatx.com
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Media Contact:Jennifer Mound SmoterSenior Vice President, External Affairs & Communications+1 857-706-1071jenn.smoter@intelliatx.com
Stocks to Follow: Mastercard Incorporated (MA) and CRISPR Therapeutics AG (CRSP) – BOV News
MORGAN STANLEY ASIA LTD. bought a fresh place in Mastercard Incorporated (NYSE:MA). The institutional investor bought 2.3 million shares of the stock in a transaction took place on 12/31/2019. In another most recent transaction, which held on 12/31/2019, SWEDBANK ROBUR FONDER AB bought approximately 1.6 million shares of Mastercard Incorporated. In a separate transaction which took place on 12/31/2019, the institutional investor, GOLDMAN SACHS & CO. LLC (PRIVATE bought 1.3 million shares of the companys stock. The total Institutional investors and hedge funds own 77.30% of the companys stock.
In the most recent purchasing and selling session, Mastercard Incorporated (MA)s share price increased by 0.97 percent to ratify at $344.56. A sum of 3010854 shares traded at recent session and its average exchanging volume remained at 3.31M shares. The 52-week price high and low points are important variables to concentrate on when assessing the current and prospective worth of a stock. Mastercard Incorporated (MA) shares are taking a pay cut of 0.43% from the high point of 52 weeks and flying high of 59.57% from the low figure of 52 weeks.
Mastercard Incorporated (MA) shares reached a high of $347.24 and dropped to a low of $342.6349 until finishing in the latest session at $343.99. Traders and investors may also choose to study the ATR or Average True Range when concentrating on technical inventory assessment. Currently at 5.68 is the 14-day ATR for Mastercard Incorporated (MA). The highest level of 52-weeks price has $343.10 and $215.93 for 52 weeks lowest level. After the recent changes in the price, the firm captured the enterprise value of $344.4B, with the price to earnings ratio of 43.37 and price to earnings growth ratio of 2.44. The liquidity ratios which the firm has won as a quick ratio of 1.40, a current ratio of 1.40 and a debt-to-equity ratio of 1.56.
Having a look at past record, were going to look at various forwards or backwards shifting developments regarding MA. The firms shares rose 4.12 percent in the past five business days and grew 6.46 percent in the past thirty business days. In the previous quarter, the stock rose 22.72 percent at some point. The output of the stock increased 23.91 percent within the six-month closing period, while general annual output gained 56.20 percent. The companys performance is now positive at 15.40% from the beginning of the calendar year.
According to WSJ, Mastercard Incorporated (MA) obtained an estimated Buy proposal from the 36 brokerage firms currently keeping a deep eye on the stock performance as compares to its rivals. 0 equity research analysts rated the shares with a selling strategy, 2 gave a hold approach, 29 gave a purchase tip, 4 gave the firm a overweight advice and 1 put the stock under the underweight category. The average price goal of one year between several banks and credit unions that last year discussed the stock is $359.44.
CRISPR Therapeutics AG (CRSP) shares on Wednesdays trading session, jumped 4.35 percent to see the stock exchange hands at $58.11 per unit. Lets a quick look at companys past reported and future predictions of growth using the EPS Growth. EPS growth is a percentage change in standardized earnings per share over the trailing-twelve-month period to the current year-end. The company posted a value of $0.97 as earning-per-share over the last full year, while a chance, will post -$5.03 for the coming year. The current EPS Growth rate for the company during the year is 134.10% and predicted to reach at -13.40% for the coming year. In-depth, if we analyze for the long-term EPS Growth, the out-come was 54.00% for the past five years.
The last trading period has seen CRISPR Therapeutics AG (CRSP) move -21.47% and 88.98% from the stocks 52-week high and 52-week low prices respectively. The daily trading volume for CRISPR Therapeutics AG (NASDAQ:CRSP) over the last session is 1.35 million shares. CRSP has attracted considerable attention from traders and investors, a scenario that has seen its volume jump 4.33% compared to the previous one.
Investors focus on the profitability proportions of the company that how the company performs at profitability side. Return on equity ratio or ROE is a significant indicator for prospective investors as they would like to see just how effectively a business is using their cash to produce net earnings. As a return on equity, CRISPR Therapeutics AG (NASDAQ:CRSP) produces 11.70%. Because it would be easy and highly flexible, ROI measurement is among the most popular investment ratios. Executives could use it to evaluate the levels of performance on acquisitions of capital equipment whereas investors can determine that how the stock investment is better. The ROI entry for CRSPs scenario is at 4.90%. Another main metric of a profitability ratio is the return on assets ratio or ROA that analyses how effectively a business can handle its assets to generate earnings over a duration of time. CRISPR Therapeutics AG (CRSP) generated 9.60% ROA for the trading twelve-month.
Volatility is just a proportion of the anticipated day by day value extendthe range where an informal investor works. Greater instability implies more noteworthy benefit or misfortune. After an ongoing check, CRISPR Therapeutics AG (CRSP) stock is found to be 5.65% volatile for the week, while 4.66% volatility is recorded for the month. The outstanding shares have been calculated 63.38M. Based on a recent bid, its distance from 20 days simple moving average is 5.27%, and its distance from 50 days simple moving average is -3.80% while it has a distance of 16.08% from the 200 days simple moving average.
The Williams Percent Range or Williams %R is a well-known specialized pointer made by Larry Williams to help recognize overbought and oversold circumstances. CRISPR Therapeutics AG (NASDAQ:CRSP)s Williams Percent Range or Williams %R at the time of writing to be seated at 32.64% for 9-Day. It is also calculated for different time spans. Currently for this organization, Williams %R is stood at 28.28% for 14-Day, 28.28% for 20-Day, 66.19% for 50-Day and to be seated 41.23% for 100-Day. Relative Strength Index, or RSI(14), which is a technical analysis gauge, also used to measure momentum on a scale of zero to 100 for overbought and oversold. In the case of CRISPR Therapeutics AG, the RSI reading has hit 52.87 for 14-Day.
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Stocks to Follow: Mastercard Incorporated (MA) and CRISPR Therapeutics AG (CRSP) - BOV News
Gene Editing Tools Market- increasing demand with Industry Professionals: Thermofisher Scientific, CRISPR Therapeutics – Instant Tech News
A new Profession Intelligence Report released by Stats and Reports with the title Global Gene Editing Tools Market can grow into the most important market in the world that has played an important role in making progressive impacts on the global economy. Global Gene Editing Tools Market Report presents a dynamic vision to conclude and research market size, market hope and competitive environment. The study is derived from primary and secondary statistical data and consists of qualitative and numerical analysis. The main company in this survey is Thermofisher Scientific, CRISPR Therapeutics, Editas Medicine, NHGRI, Intellia Therapeutics, Merck KGaA, Horizon.
Gene editing or Genome editingis a way of making specific changes to the DNA of a cell or organism. An enzyme cuts the DNA at a specific sequence, and when this is repaired by the cell a change or edit is made to the sequence.
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This report clearly shows that the Gene Editing Tools industry has achieved significant growth since 2018. It is based on an in-depth assessment of the industry. The analysis provided in this report shows the leading segments to gain a strong presence in the industry and the insights that help determine new strategies. In conclusion, analysts who value unbiased information about stakeholders, investors, product managers, marketing executives, and supply, demand, and future predictions value the report.
Preliminary Data:Get raw market data and contrast from wide front. Data is constantly filtered so that only validated and authenticated sources are considered. The data is also collected from many reputable paid databases and many reports in our repository. A comprehensive understanding of the market is essential to understanding and facilitating the complete value chain. We collect data from raw material suppliers, distributors, and buyers.
Furthermore, the years considered for the study are as follows:Historical year 2014-2018Base year 2019Forecast period** 2019 to 2025[** unless otherwise stated]
Research Methodology:The market engineering process uses a top-down and bottom-up approach and several data triangulation methods to evaluate and validate the size of the entire market and other dependent sub-markets listed in this report. Numerous qualitative and quantitative analyzes have been conducted in the market engineering process to list key information / insights. The major players in the market were identified through the second survey and the market rankings were determined through the first and second surveys.
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Crucial Research:During the first survey, we interviewed various key sources of supply and demand to obtain qualitative and quantitative information related to this report. Key supply sources include key industry participants, subject matter specialists from key companies, and consultants from several major companies and organizations active in the digital signage market.
Minor Research:The second study was conducted to obtain key information on the supply chain of the industry, the markets currency chain, pools of major companies, and market segmentation, with the lowest level, geographical market, and technology-oriented perspectives. Secondary data was collected and analyzed to reach the total market size, which was verified by the first survey.
This research many focuses on future market segments or regions or countries to channel efforts and investments to maximize growth and profitability. The report presents an in-depth analysis of key vendors or key players in the market competitive landscape and market.The research provides answers to the following key questions:
What are the Major applications of the Gene Editing Tools Market?Applications cover in these Reports Is:Sickle Cell Disease, Heart Disease, Diabetes, Alzheimers Disease, Obesity and Others
what are the Types of the Gene Editing Tools Market?Types Cover in this Research :Zinc finger nucleases (ZFNs), Transcription Activator-Like Effector-based Nucleases (TALENs), CRISPR-Cas system
Who are the main competitors in the market and what are their priorities, strategies, and developments?Lists of Competitors in Research Is:Thermofisher Scientific, CRISPR Therapeutics, Editas Medicine, NHGRI, Intellia Therapeutics, Merck KGaA, Horizo n
Read Full TOC of Gene Editing Tools Research Study at @www.statsandreports.com/report/340551-global-gene-editing-tools-market-size-status-and-forecast-2019-2025
All percent shares, breaks, and classifications were determined using the secondary sources and confirmed through the primary sources. All parameters that may affect the market covered in this study have been extensively reviewed, researched through basic investigations, and analyzed to obtain final quantitative and qualitative data. This has been the study of key quantitative and qualitative insights through interviews with industry experts, including CEOs, vice presidents, directors and marketing executives, as well as annual and financial reports from top market participants.
Years considered for the study are:Historical year 2014-2018Disreputable year 2019Estimate period** 2019 to 2025 [** unless otherwise stated]
Essentials of Table of Content:
1 Report Overview1.1 Research Scope1.2 Key Market Segments1.3 Target Player1.4 Market Analysis by Type1.5 Market by Application1.6 Learning Objectives1.7 years considered
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2 Global Growth Trends2.1 Global Gene Editing Tools Market Size2.2 Trends of Gene Editing Tools Growth by Region2.3 Corporate trends
3 Gene Editing Tools Market shares by key players3.1 Global Gene Editing Tools Market Size by Manufacturer3.2 Global Gene Editing Tools Key players Provide headquarters and local3.3 Major Players Products / Solutions / Services3.4 Enter the Barriers in the Gene Editing Tools Market3.5 Mergers, acquisitions and expansion plans
4 Market By-products4.1 Global Gene Editing Tools Sales by Product4.2 Global Gene Editing Tools by Product Revenue4.3 Global Gene Editing Tools
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Gene Editing Tools Market- increasing demand with Industry Professionals: Thermofisher Scientific, CRISPR Therapeutics - Instant Tech News
How The Monkeyflower Gets Its Spots | Berkeley – Patch.com
From the University of California, Berkeley:
The yellow monkeyflower's distinctive red spots serve as 'landing pads' for bees and other pollinators, helping them access the sweet nectar inside. A new study reveals the genetic programming that creates these attractive patterns.
The intricate spotted patterns dappling the bright blooms of the monkeyflower plant may be a delight to humans, but they also serve a key function for the plant. These patterns act as "bee landing pads," attracting nearby pollinators to the flower and signaling the best approach to access the sweet nectar inside.
"They are like runway landing lights, helping the bees orient so they come in right side up instead of upside down," said Benjamin Blackman, assistant professor of plant and molecular biology at the University of California, Berkeley.
In a new paper, Blackman and his group at UC Berkeley, in collaboration with Yaowu Yuan and his group at the University of Connecticut, reveal for the first time the genetic programming that helps the monkeyflower and likely other patterned flowers achieve their spotted glory. The study was published online today (Thursday, Feb. 20) in the journal Current Biology.
"While we know a good deal about how hue is specified in flower petals whether it is red or orange or blue, for instance we don't know a lot about how those pigments are then painted into patterns on petals during development to give rise to these spots and stripes that are often critical for interacting with pollinators," Blackman said. "Our lab, in collaboration with others, has developed the genetic tools to be able to identify the genes related to these patterns and perturb them so that we can confirm what's actually going on."
In the study, the research team used CRISPR-Cas9 gene editing to recreate the yellow monkeyflower patterns found in nature. On the left, a wild-type monkeyflower exhibits the typical spotted pattern. In the middle, a heterozygote with one normal RTO gene and one damaged RTO gene exhibits blotchier spots. And on the right, homozygote with two copies of the damaged RTO gene is all red, with no spots.
The positions of petals' spots aren't mapped out ahead of time, like submarines in a game of battleship, Blackman said. Instead, scientists have long theorized that they could come about through the workings of an activator-repressor system, following what is known as a reaction-diffusion model, in which an activator molecule stimulates a cell to produce the red-colored pigment that produces a spot. At the same time, a repressor molecule is expressed and sent to neighboring cells to instruct them not to produce the red pigment.
The results are small, dispersed bunches of red cells surrounded by cells that keep the background yellow color.
"By tweaking the parameters how strongly a cell turns on an inhibitor, how strongly the inhibitor can inhibit the activator, how quickly it moves between cells it can lead to big spots, small spots, striped patterns, really interesting periodic patterns," Blackman said.
In the study, UC Berkeley postdoctoral researcher Srinidhi Holalu and research associate Erin Patterson identified two natural varieties of the yellow monkeyflower one type with the typical red spots in the throat of the flower and a second type with an all-red throat appearing in multiple natural populations in California and Oregon, including at the UC Davis McLaughlin Reserve. In parallel, UConn postdoctoral researcher Baoqing Ding worked with a very similar plant with fully red-throated flowers found when surveying a population of Lewis's monkeyflower that had induced DNA mutations.
Monkeyflower plants with the RTO gene knocked out by CRISPR-Cas9 gene editing produce one big patch where all flowers exhibit a fully red throat, in contrast to wild fields where red-tongued flowers appear in small dispersed spots.
In a previous study, the Yuan lab had found that a gene called NEGAN (nectar guide anthocyanin) acts as an activator in the monkeyflower petals, signaling the cells to produce the red pigment. Through detailed genomic analysis in both monkeyflower species, the two groups were able to pinpoint that a gene called RTO, short for red tongue, acts as the inhibitor.
The red-throated forms of the monkeyflower have defective RTO inhibitor genes, resulting in a characteristic all-red throat, rather than red spots. To confirm their findings, Holalu used the CRISPR-Cas9 gene editing system to knock out the RTO gene in spotted variants of the flower. The result was flowers with a flashy red throat. Further experiments revealed how the functional form of the RTO protein moves to neighboring cells and represses NEGAN to prevent the spread of pigmentation beyond the local spots. This study is the first reported use of CRISPR-Cas9 editing to research the biology of monkeyflowers.
The team also collaborated with Michael Blinov at the UConn School of Medicine to develop a mathematical model to explain how different self-organized patterns might arise from this genetic system.
"This work is the simplest demonstration of the reaction-diffusion theory of how patterns arise in biological systems," said Yaowu Yuan, associate professor of ecology and evolutionary biology at UConn. "We are closer to understanding how these patterns arise throughout nature."
This press release was produced by the University of California, Berkeley. The views expressed here are the author's own.
Link:
How The Monkeyflower Gets Its Spots | Berkeley - Patch.com
Edited Transcript of RGEN earnings conference call or presentation 20-Feb-20 1:30pm GMT – Yahoo Finance
WALTHAM Feb 21, 2020 (Thomson StreetEvents) -- Edited Transcript of Repligen Corp earnings conference call or presentation Thursday, February 20, 2020 at 1:30:00pm GMT
* Anthony J. Hunt
Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board
* Jon K. Snodgres
* Sondra S. Newman
Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst
H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate
* Jacob K. Johnson
William Blair & Company L.L.C., Research Division - Partner & Healthcare Services Analyst
* Joseph P. Munda
Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst
SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst
Good day, ladies and gentlemen, and welcome to the Repligen Corporation's Year-End and Fourth Quarter of 2019 Earnings Conference Call. My name is Rocco, and I will be your coordinator. (Operator Instructions) Please note, today's event is being recorded.
I would now like to turn the call over to your host for today's call, Sondra Newman, Global Head of Investor Relations for Repligen. Please go ahead.
Sondra S. Newman, Repligen Corporation - Senior Director of IR [2]
Great. Good morning, everyone. Thanks for joining our call today. On this call, we'll cover our financial results and business highlights for Repligen's fourth fiscal quarter and full year 2019, and we'll provide financial guidance for the year 2020. Our President and CEO, Tony Hunt, will cover business updates and our CFO, Jon Snodgres, will cover our financial results and guidance.
As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for financial performance of the company are subject to risks and uncertainties that may cause actual events or results to differ.
Additional information concerning risk factors is included in our annual report on Form 10-K, the current report on Form 8-K, which we filed today and other filings that we make with the Securities and Exchange Commission. Today's comments reflect our current views, which could change as a result of new information, future events or otherwise. And the company does not obligate or commit itself to update forward-looking statements, except as required by law.
During this call, we are providing non-GAAP results and guidance. Reconciliations of GAAP to non-GAAP financial measures are included in the press release that we issued this morning, which is posted to Repligen's website and on sec.gov. The non-GAAP figures in today's report include revenue growth at constant currency, gross profit and gross margin, operating expenses, including R&D and SG&A, operating income and operating margin, income tax expense, net income and earnings per share as well as EBITDA and adjusted EBITDA. These adjusted financial measures should not be viewed as an alternative to GAAP measures, but are intended to better enable investors to benchmark Repligen's current results against historical performance and the performance of peers.
Now I'll turn the call over to Tony Hunt.
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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [3]
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Thank you, Sondra. Good morning, everyone, and welcome to our 2019 year-end update. We are delighted with the way we finished off the year with 21% organic growth in the fourth quarter, 33% organic growth for the full year and overall 2019 growth for the company, coming in at 39%. All 3 franchises accelerated in 2019 as we benefited from customers scaling up on mAb processes and new customers implementing our technologies, especially in the area of gene therapy, where we now have greater than 50 significant customers today and just as many smaller customers.
Throughout the year, our team continued to execute on our long-term growth strategy with M&A and R&D remaining at the core of our success.
In 2019, we completed our acquisition of C Technologies, establishing an important new vertical for the company in process analytics.
Our R&D team delivered TFDF filtration technology, a game-changing technology and harvest clarification, an area that has seen little innovation over the last 10 to 20 years. Supporting our growth strategy and operational investments in 2019, we completed a series of financings that leave us with over $500 million in cash at year-end and positions us well for the future.
Looking back at the year, there were 5 key drivers of growth. First, as I mentioned, we saw strong adoption of gene therapy accounts where we help to deliver yield and efficiency improvements in viral vector manufacturing. Gene therapy represented approximately 15% of our overall 2019 revenue with filtration products accounting for 60% and chromatography products accounting for 35% of sales into these accounts. We saw a fairly even split between CDMO and gene therapy developers at 52% and 48% of revenue, respectively. And with the strong base of core customers and differentiated technology, we are really well positioned for growth in gene therapy. Second, we saw increased adoption of our XCell ATF products in both N-1 seed train, a traditional perfusion applications. The expansion of ATF applications into fed-batch processes is a key growth driver for us as it is the catalyst for sustained long-term growth north of 20%.
Third, we saw significant uptick of our TFF systems portfolio where we put more focus on tying systems and consumables into targeted upstream and downstream applications. We made the decision 12 months ago to focus on building out systems for our TFF portfolio. And not only has this team delivered on more traditional UF/DF applications, but they've also delivered on the development and launch of TFDF technology and fed-batch harvest clarification.
Fourth, we saw accelerated adoption of our OPUS prepacked columns as CDMOs and pharma customers continue to scale and expand. Combined with new demand for OPUS and gene therapy, we delivered approximately 1,400 comps to our customer base in 2019, up from 700 comps in 2018.
To ensure our ability to stay ahead of demand, we made significant investments in 2019 and here again in 2020 to expand our capacity and resources at OPUS production. And finally, just the overall strength of the biologics market, where in the U.S. alone, 10 new mAbs and 2 gene therapy drugs were approved in 2019. With a rich pipeline of over 1,000 biological drug candidates, the expectations are high for strong growth in the years ahead.
Before jumping into the quarter, I also wanted to highlight some of our key accomplishments in 2019. Starting with C Technologies, which was our first acquisition in process analytics. During our 7 months of C Tech ownership in 2019, we focused our efforts on commercial expansion, R&D acceleration and building out the financial team and implementing public company processes at C Tech.
We successfully built our commercial team with 10 dedicated reps, we focused R&D efforts on accelerating next-gen FlowVPE, and we completed the build-out of the finance team. For the year, C Tech products contributed close to $16.4 million in revenue, right in line with our $16 million to $17 million projection. We look forward to seeing the impact of our new commercial team in 2020, where we expect C Technologies to generate approximately $32 million in revenue.
Moving now to R&D. 2019 was a year where we made significant progress. A key goal for us entering the year was to develop and launch TFDF technology. We did a very successful technical launch of the product in September, and then our systems team followed up with the development of benched-up and production scale systems, which will be launched here in Q1. We also made progress with our next-gen ATF controller, which is scheduled to launch in late Q1, early Q2. In addition, key products like SIUS gamma and next-gen ligands are reaching their final stages of product development and will soon be available in the marketplace. From a capacity and infrastructure standpoint, 2019 was a huge year for us. We increased our office capacity fivefold and have dedicated programs in place to expand again in 2020. Our operations team also expanded and centralized manufacturing of XCell ATF in Marlborough and completed the Phase I implementation of SAP. Financially, we were able to raise close to $500 million net through a series of equity and convertible debt financings, again, putting us in a strong position for future M&A.
So moving now to our Q4 results and full year 2019 performance. As reported today, we had a great quarter with $69.5 million in sales. The story of the quarter was our organic growth performance against difficult comps. Each of our proteins, filtration and chromatography franchises performed well and together delivered 20% plus organic growth in the quarter and 20%, 30% and 40% organic growth, respectively, for the year.
In filtration, our XCell ATF product line had a record year. Our customers scaled up into late stage trials, and we saw increased use of ATF and N-1 seed train applications, reflecting a broader application of the technology into fed-batch processes. Single-use ATF continued to perform well in 2019, with revenue growth of 45%. Our SIUS flat sheet TFF cassette business also had a very strong quarter and year, up over 25%. The story continues to be around new accounts and key wins in gene therapy applications. Our hollow fiber portfolio also had a good quarter in Europe, 30% with the robust demand for single-use flow paths, hollow fiber modules and KrosFlo systems. We expect that our hollow fiber business will have another strong year in 2020. And our overall filtration franchise will grow approximately 25%.
Moving to chromatography for our OPUS business finished up over 30% for the quarter and 50% for the year. The story in the quarter was the continued adoption of our prepacked column technology in CDMOs and gene therapy accounts, which now account for 20% of our OPUS revenue. In parallel, we were able to improve our lead times significantly by bringing 5 new production suites online in December. We also saw accelerating adoption to focus ATF columns, as customers put our technology into late-stage and commercial processes.
We expect continued momentum for OPUS in 2020 as our customers scale and expand. We expect our OPUS franchise to grow at or above 20%, with overall chromatography at 15% in 2020.
Our OEM proteins business performed well in Q4 and was up 20% for the full year, led by strengthened growth factors with 50% growth from ligands. As mentioned, throughout 2019, we expect GE to transition to in-house ligand manufacturing here in 2020, creating a $12 million to $13 million or 4% to 5% headwind for the company. We expect that NGL-Impact A ligand will continue to gain traction in the marketplace as customers implement this technology in early-stage clinical trials. So overall, we expect the company to grow at 14% to 18% in 2020, with organic growth in the 10% to 14% range.
We expect H2 to be stronger than H1 as some of the larger scale-up projects is in the second half of 2020. Unlike other companies, it will take a few more months to understand what the long-term impact might be on overall company performance from the coronavirus in China in fiscal year 2020. For quarter 1, there may be some shift in revenue into Q2 based on customer timing.
As we move into 2020, our strategic priorities will center on the following: new product launches with a focus on TFDF and ATF controllers, expanding our market presence in harvest clarification applications with TFDF technology, further expanding our market presence in gene therapy through our filtration and chromatography franchises; broadening the customer base and applications for C Technologies; implementing capacity expansion and operating margin improvement programs; and finally, evaluating M&A opportunities to supplement our organic growth.
In summary, we believe we are well positioned to gain further share by processing. We believe that the blueprint we've put in place over the last 5 years around building out a world-class commercial team, bringing disruptive technologies to market and supplementing our technology base with select M&As will be the catalyst for growth over the coming years. Also, based on the investments we've made in R&D over the last 3 years, we expect 2020 to be a milestone year for us in terms of product launches.
Before concluding, I wish to recognize our employees around the globe for their commitment and leadership in 2019. I also want to thank our loyal shareholders and customers for their parts in Repligen's success and we look forward to another strong year for the company and bioprocessing.
With that, I'll turn the call over to Jon for a more detailed financial report.
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Jon K. Snodgres, Repligen Corporation - CFO & Secretary [4]
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Thank you, Tony, and good morning, everyone. Today, we are reporting our financial results for the fourth quarter and full year 2019, as well as providing our financial guidance for the year 2020. Unless otherwise mentioned, all financial measures discussed reflect non-GAAP measures. As you've seen in our press release this morning, we delivered strong financial performance for both the fourth quarter and full year 2019. We had another strong quarter with revenues of $69.5 million, representing 34% reported growth and 21% organic growth. For full year 2019, we reported record revenue of $270.2 million. The year-over-year increase of $76 million represents 39% overall growth, including 2 points of foreign currency headwind and 33% organic growth, $16 million or 8% of our revenue growth was attributed to our June 2019 acquisition of C Technologies.
Operationally, we continue to prioritize key areas of investments in the company. In 2019, 7% of revenue supported R&D programs that continue to produce disruptive technologies, like our new TFDF platform that we launched in the second half of the year. We also made important capital investments in our manufacturing sites, with a significant portion of our spend dedicated to increasing overall production capacity and expanding and upgrading our IT systems and infrastructure.
Now to provide more insights into our overall financial performance. As Tony mentioned earlier, our direct-to-customer franchises continue to perform well. Our direct products represented 79% of the company's total revenue in the fourth quarter and 76% for the full year compared to 72% for full year 2018. On a regional basis, for the full year, pro forma direct product revenue growth was fairly consistent across regions, with approximately 30% growth in North America, Europe and Asia. For the full year 2019, Asia represented 16% of direct revenue, while Europe and North America accounted for 28% and 56%, respectively.
Now moving to our income statement. Fourth quarter adjusted gross profit was $39.8 million, representing an increase of $11.3 million or 40% over the fourth quarter of 2018. Our adjusted gross margin was 57.2% for the fourth quarter of 2019 compared to 54.8% for the same period in 2018. The 240 basis point improvement was driven by favorable OPUS column to resin mix in our chromatography franchise and by increased demand for growth factor products in our proteins franchise. Full year 2019 adjusted gross profit of $154.1 million reflects an increase of $45.9 million or 42% compared to the full year of 2018. Adjusted gross margin was 57% for the full year 2019 compared to 55.8% for 2018, with the 120 basis point increase, driven by overall sales volume leverage in our factories, our new C Technologies product line and favorable product mix, partially offset by investments in capacity and operations.
With respect to operating expenses. Adjusted research and development costs for the fourth quarter of 2019 were $4.9 million compared to $3 million for the fourth quarter of 2018. For the full year 2019, adjusted R&D expenses were $18.8 million compared to $15.7 million in 2018. Key drivers of the year-over-year increase were the timing of our C Technologies acquisition, investments in our next-generation filtration technologies, as well as continued investments in our ligand programs.
Overall, R&D expenses finished the year at 7% of revenue.
Adjusted SG&A for the fourth quarter of 2019 was $22.2 million compared to $14.4 million for the fourth quarter of 2018. Full year adjusted SG&A was $71.8 million in 2019 compared to $53.1 million in 2018. The year-over-year increase in adjusted SG&A was related to the timing of our C Technologies acquisition and the build-out of our process analytics commercial team, as well as expansions and enhancements of our facilities, IT systems and commercial team.
Now moving to adjusted earnings and EPS. In the fourth quarter of 2019, our adjusted operating income was $12.7 million, a 15% increase compared to $11.1 million reported in the fourth quarter of 2018. Our adjusted operating margin was 18.3% compared to 21.3% for the fourth quarter of 2018. Our operating costs during the fourth quarter of 2019 included approximately $1 million of nonrecurring expenses, mostly in IT and recruiting. For the full year of 2019, our adjusted operating income was $63.5 million, a 61% increase compared to $39.4 million for the full year of 2018.
Our 2019 full year adjusted operating margin was 23.5%, a 320 basis point improvement compared to 20.3% for the 2018 period, reflecting a strong year of growth and operational execution in our business.
Adjusted net income for the fourth quarter of 2019 was $10.8 million, an increase of 21% compared to $8.9 million in the same period in 2018. Full year 2019 adjusted net income was $52.5 million, an increase of 74% compared to $30.1 million for the full year 2018.
Adjusted EPS for the fourth quarter of 2019 increased to $0.20 per fully diluted share from $0.19 for the fourth quarter of 2018.
For the full year of 2019, adjusted EPS increased to $1.07, up 62% from $0.66 in 2018.
Our cash and cash equivalents, which are GAAP metrics, totaled $528.4 million at December 31, 2019. For full year 2019, we generated free cash flow of $44.1 million, inclusive of $67.2 million of operating cash flow, less $23.2 million of capital investments primarily related to our facility and capacity expansion projects and IT systems investments.
Now moving to 2020 full year guidance. Our GAAP to non-GAAP reconciliations for our 2020 financial guidance are included in the reconciliation tables in today's earnings press release. As previously mentioned, unless otherwise noted, all 2020 financial guidance discussed will be non-GAAP. Please also keep in mind that our 2020 guidance may be impacted by fluctuations in foreign exchange rates beyond our current projection of a net 0 impact on full year sales and does not include the potential impact of any new acquisitions that the company may pursue.
Today, we are setting our 2020 full year revenue guidance, a GAAP metric at $309 million to $319 million, reflecting growth in the range of 14% to 18% as reported and 10% to 14% on an organic basis. Our adjusted gross margin guidance for 2020 is 55% to 56%, which reflects the impacts of expected headwinds from lighter GE volumes and investments in our facilities, capacity, IT systems and staffing to support expected strength and long-term market demand and overall growth. Adjusted operating income is expected to be in the range of $70 million to $74 million, with adjusted operating margins in the range of 22% to 23% of revenue for the year.
We are expecting 2020 adjusted income tax expense of approximately 23% of adjusted pretax income, which anticipates impacts from strong international revenue growth in higher tax rate countries in Europe and Asia.
We are expecting full year 2020 adjusted net income in the range of $57 million to $60 million for the year, and adjusted EPS in the range of $1.07 to $1.12 per fully diluted share. Please note that our 2020 adjusted EPS guidance reflects a $0.09 dilution impact due to share count increases, primarily related to our 2019 financing activities.
Our guidance reflects an estimated 53.4 million fully diluted shares outstanding for the full year, an increase of approximately 4 million. Adjusted EBITDA is now expected to be in the range of $80 million to $84 million for the full year 2020, with depreciation and intangible amortization expense is expected to be approximately $10.5 million and $15.5 million, respectively.
The company again expects to invest an estimated $20 million to $22 million in 2020 for capital expenditures as we proceed with our build-out of our OPUS manufacturing facility in Breda, planned capacity expansions in our Massachusetts and California facilities and with continued investments in SAP.
We expect 2020 year-end cash and cash equivalents, a GAAP metric to be in the range of $580 million to $590 million, with our CapEx investments being fully funded by cash generation from our operations. As you can see, we've executed on another strong year of performance in 2019, including making substantial investments in the company as part of our 2-year plan to prepare us for continued long-term growth.
This completes our financial report, and I will now turn the call back to the operator to open the lines for questions.
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Questions and Answers
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Operator [1]
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(Operator Instructions) Today's first question comes from Dan Arias of Stifel.
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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [2]
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Maybe just to start on guidance. 32% organic is a pretty big year. So obviously, you have a tough comp there. When you look at the momentum that you're exiting 2019 with though, can you just talk about the approach to the 2020 outlook in terms of being conservative or not conservative? And then how you feel about just the shape of the business and the drivers that you have relative to this time last year when you guided to, I believe, 13% to 17% organic growth. So less than half of what you ended up doing?
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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [3]
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Yes. Thanks, Dan. Yes, I think in general, we finished off the year. We had good momentum through the second half of the year. I think as we looked at 2020 guidance, I think it was important for us to really gauge what was going on in each of the businesses, right, in each of the divisions. So within chromatography and filtration, we feel pretty good about it. Our OPUS business came off a massive year last year, up over 50%. And our filtration product line also had a really, really big year. So we've got really difficult comps in 2020. We expect that our filtration franchise will grow 25%. We think that our OPUS franchise will grow 20% plus. Our proteins business is probably the main headwind that we have and so we know we have a 4% to 5% headwind going into 2020. So if you take our 10% to 14% guidance. And we didn't have that headwind, we would really be doing 14 -- 15% to 19%. So we think, actually, the guidance we're putting out there right now is very realistic. While we feel really good about our businesses, really good about our products, we think this is the right guidance for us.
To your second part of your question about last year where we guided mid-teens, and we came in at 30%. I think the piece that really surprised us last year was the proteins business, right? And we had guided down 5%, and it came in really, really strong. So if you take that out of the equation, it would really drop down the overall organic growth pretty significantly. So I think that was a big factor. I think the other factor last year is that no one really in the industry predicted how fast the gene therapy market was going to grow. And I think we all kind of missed that a little bit. And so that's kind of the explanation for last year.
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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [4]
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Yes. Okay. That's actually my second question. Just on gene therapy, is there some color you can give on just how you feel about the expansion and the evolution of that market in terms of new activity and the scale of our project work. And then I guess, along those lines, I mean, one of the things that it sounded like you were trying to stay grounded on last year was this idea that a lot of things went right in 2019 in that field. And that, that always doesn't happen, Phase I don't always go to Phase II, et cetera. So I guess the question is that sitting 2 months into the new year, how are you looking at things relative to the way that you would have hoped they would have been 6 to 12 months ago?
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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [5]
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Yes. I think when you look at how we finished in Q4, the gene therapy customer base was again strong for us in terms of shipments, in terms of orders as we -- it's difficult for us to see much beyond the first half of the year. We know, as I said earlier in my prepared remarks that we know there are some significant scale-up programs that are happening in the second half of the year. But in general, we haven't seen any slowdown in gene therapy, and we're expecting gene therapy will drive -- will grow about 30% for us in 2020.
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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [6]
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Okay. It sounds like you've given the 3 questions here, so I'll take the opportunity. Maybe just on TFDF, that sounds like it's one of the more meaningful products in the portfolio these days. So what is the thought on just the industry coming around to the dual filtration benefit that you get there. My sense is that, that might take 1 year or 2 for that to ramp and be a material contributor. Is that the way that you're thinking about it? And then what does the runway look like if you wanted to look beyond just this year and into 2021 and 2022?
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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [7]
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Yes, I think you have it spot on. The -- it's going to take a couple of years for TFDF to take off, but we've got a significant number of trials lined up here in Q1. We expect it will generate $1 million, $2 million in revenue for us this year. But every year, going forward, we expect that revenue will double. And so it's not one of those product lines that we expect to grow at 20%, 25%, 30%. We expect that over the next few years, this is a technology that's going to scale quickly. But obviously, we've to get through the trials, we've got to prove the technology. We've done that so far, but on a limited basis, and I think we're very confident that the technology is going to be a key technology for us. That said, I wouldn't underestimate the rest of the product launches that we're bringing to market this year. So we really are bringing innovation in ATF. We're bringing out the next-generation FlowVPE technology in the second half of the year. We've got new ligands coming through. We've got next-generation, SIUS gamma. Really feel this year is a key year for us in terms of product launches that will set us up really well for 2021 and beyond.
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Continued here:
Edited Transcript of RGEN earnings conference call or presentation 20-Feb-20 1:30pm GMT - Yahoo Finance
Catalyst Biosciences Reports Fourth Quarter and Full-Year 2019 Operating & Financial Results and Provides a Corporate Update – Yahoo Finance
Presented positive clinical and pre-clinical data from its MarzAA and DalcA hemophilia programs
Announced a global license and collaboration agreement with Biogen to develop and commercialize pegylated CB 2782 for Dry AMD
SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO), today announced its operating and financial results for the fourth quarter and full-year ending December 31, 2019 and provided a corporate update.
We made exceptional progress in both our subcutaneously-dosed (SQ) MarzAA (FVIIa) and SQ DalcA (FIX) programs this past year. Earlier this month at EAHAD, positive data was presented in an oral presentation from the Companys Phase 2b SQ DalcA trial in subjects with hemophilia B clearly demonstrating efficacy and safety. We also presented data from MarzAA and Factor IX gene therapy programs in three posters, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. Catalysts therapies have demonstrated the potential to effectively treat hemophilia subcutaneously in a $3.4 billion market.
Dr. Usman continued, "Additionally, our February 2020 financing combined with our current cash provides funding through several major milestones for our lead Phase 3 ready MarzAA and Phase 2b DalcA product candidates, as well as our FIX gene therapy and complement inhibitor programs."
Recent Milestones:
Expected Milestones
Fourth Quarter and Full-year 2019 Results and Financial Highlights
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on addressing unmet needs in rare diseases and systemic complement mediated disorders. Our protease engineering platform includes development programs in hemophilia and a research program on subcutaneous (SQ) systemic complement inhibitors. Our engineered coagulation factors are designed to overcome the significant limitations of current IV treatment options, facilitate prophylaxis, and ultimately deliver substantially better outcomes for patients using SQ dosing. Our lead asset, MarzAA has completed Phase 2 development having met its primary endpoint of significantly reducing the annualized bleed rate (ABR) in individuals with hemophilia A or B with inhibitors. Our second hemophilia asset, DalcA is completing a Phase 2b clinical trial and is being developed for the treatment of hemophilia B. We also have a global license and collaboration agreement with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy associated dry age-related macular degeneration.
For more information, please visit http://www.catalystbiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about the potential uses and benefits of MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the potential market opportunity for MarzAA and DalcA, plans to start a Phase 3 trial of MarzAA in second half of 2020 and report final data in the second quarter of 2020 from a MarzAA Phase 1 pharmacokinetic and pharmacodynamic study to support future SQ treatment of bleed studies, to announce final Phase 2b trial data for DalcA in the second quarter of 2020, plans to announce primate data for Factor IX gene therapy in the second quarter of 2020, and potential future milestone and royalty payments from Biogen. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed and may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA, or MarzAA, including the generation of antibodies, which has been observed in patients previously treated with DalcA, the risk that costs required to develop or manufacture the Companys products will be higher than anticipated, the risk that Biogen will terminate our agreement with them, competition and other risks described in the Risk Factors section of the Companys quarterly report filed with the Securities and Exchange Commission on November 7, 2019, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.
Story continues
Contact:
Ana KaporCatalyst Biosciences, Inc.investors@catbio.com
Catalyst Biosciences, Inc.Consolidated Balance Sheets(In thousands, except shares and per share amounts)
Catalyst Biosciences, Inc.Consolidated Statements of Operations(In thousands, except share and per share amounts)
Cell and Gene Therapy Consumables Market 2019-2026 by Top Key Players, Industry Size, Share, Demand, Revenue Overview Report – Instant Tech News
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Furthermore, the report provides the explored data by categorizing the Cell and Gene Therapy Consumables market based on type and form of service or product, applications, the technology involved, end-users, and others. It also entails comprehensive data relating to particular financial and business terms, anticipated market growth, market strategies, and much more. Using graphs, flowcharts, and figures in the report, the professional presented the examined information in a better comprehensible manner.
Additionally, the report also encompasses an explanation of key factors that are likely to considerably stimulate or hamper Cell and Gene Therapy Consumablesmarket growth. It also elucidates on the future impact of enforcing regulations and policies on Cell and Gene Therapy Consumablesmarket growth. The computed expected CAGR of the Cell and Gene Therapy Consumables market based on earlier records about the Cell and Gene Therapy Consumables market and existing market trends together with future developments are also mentioned in the report. The report also comprises the geographical bifurcation of the Cell and Gene Therapy Consumables market.
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Some of Major Market Player ProfilesIncluded in this Report Are:
Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook, Dendreon Pharmaceuticals, LLC, Fibrocell Science, Inc., General Electric, Kolon TissueGene, Inc., Orchard Therapeutics plc., Pfizer, Inc., PromoCell GmbH, RENOVA THERAPEUTICS, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Vericel, Helixmith Co., Ltd., and Vitrolife
The Cell and Gene Therapy Consumables Market report provides objective, evenhanded evaluation, and assessment of opportunities in the Cell and Gene Therapy Consumables market with a methodical market research report including numerous other market-associated fundamental factors. Our experienced industry analysts estimate the growth opportunities, cost, market sizing, technologies, applications, supply chains, companies, import & export, market share, and so on, with the exclusive endeavor of helping our customers to make well-informed business decisions.
The market beat is reveled in this report which can allow the consumer in using key strategies to gain competitive advantage. Such a far-reaching and thorough research survey gives the essential expansion with key suggestions and unbiased measurable analysis, which can be used to enhance the current position and develop future extensions in a specific area in the Cell and Gene Therapy Consumablesmarket.
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Imperative regions all over the world are secured and the advancements, patterns, restrictions, drivers, and difficulties impacting the growth of the Cell and Gene Therapy Consumablesmarket over these essential areas are covered. An examination of the impact of holistic and government policies on the market is likewise comprised to offer an all-encompassing summary of the future viewpoint of the Cell and Gene Therapy Consumables market.
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The major region covered in this report:
The Middle East and Africa
Some of the major objectives of this report:
1) To provide a detailed analysis of the market structure along with the forecast of the various segments and sub-segments of the global Cell and Gene Therapy Consumables market.
2. To provide insights about factors affecting market growth. To analyze the Cell and Gene Therapy Consumables market based on various factors- price analysis, supply chain analysis, porter five force analyses, etc.
3. To provide historically and forecast revenue of the Cell and Gene Therapy Consumables market segments and sub-segments with respect to four main geographies and their countries- North America, Europe, Asia, and the Rest of the World.
4. Country-level analysis of the market with respect to the current market size and future prospective.
5. To provide country-level analysis of the market for segment by application, product type and sub-segments.
6. To provide strategic profiling of key players in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market.
7. Track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the global Cell and Gene Therapy Consumables market.
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Cell and Gene Therapy Consumables Market 2019-2026 by Top Key Players, Industry Size, Share, Demand, Revenue Overview Report - Instant Tech News
Gene Therapy Market Growth, Trends and Demands Research Report and Forecast 2027 – Instant Tech News
An exclusive Gene Therapy Market research report has been fabricated through the in depth analysis of the market dynamics across five regions including North America, Europe, South America, Asia-Pacific, Middle East and Africa. The segmentation of the market by components, end users, and region was done based on the thorough market analysis and validation through extensive primary inputs from industry experts (key opinion leaders of companies, and stakeholders) and secondary research (global/regional associations, trade journals, technical white papers, companys website, annual report SEC filing, and paid databases). Further, the market has been estimated by utilizing various research methodologies and internal statistical model.
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The key players influencing the market are:
This report contains:
Gene Therapy Market report also provide a in-depth understanding of the cutting-edge competitive analysis of the emerging market trends along with the drivers, restraints, and opportunities in the market to offer worthwhile insights and current scenario for making right decision. The report covers the prominent players in the market with detailed SWOT analysis, financial overview, and key developments of last three years. Moreover, the report also offers a 360 outlook of the market through the competitive landscape of the global industry player and helps the companies to garner Gene Therapy Market revenue by understanding the strategic growth approaches.
Gene Therapy Market is a combination of qualitative as well as quantitative analysis which can be broken down into 40% and 60% respectively. Market estimation and forecasts are presented in the report for the overall global market from 2020 2027, considering 2020 as the base year and 2020 2027 forecast period. Global estimation is further broken down by segments and geographies such as North America, Europe, Asia-Pacific, Middle East & Africa and South America covering major 16 countries across the mentioned regions. The qualitative contents for geographical analysis will cover market trends in each region and country which includes highlights of the key players operating in the respective region/country, PEST analysis of each region which includes political, economic, social and technological factors influencing the growth of the market.
Report Spotlights
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Gene Therapy Market Growth, Trends and Demands Research Report and Forecast 2027 - Instant Tech News
Viral Vector and Plasmid DNA Manufacturing Market 2020 Regional and Growth Opportunity by Top Players: Merck, uniQure, The Cell and Gene Therapy…
Viral Vector and Plasmid DNA Manufacturing Market with Insights and Key Business Factors
Reports Monitor offers its latest report on the [Global Viral Vector and Plasmid DNA Manufacturing Market size and CAGR between 2020 and 2025.] report that includes comprehensive analysis on a range of subjects such as segmentation, competition, market dynamics and regional expansion. The report offers highly detailed competitive analysis of theGlobal Viral Vector and Plasmid DNA Manufacturing Market, where the business and industry growth of leading companies are thoroughly evaluated on the basis of production, recent developments, technology, geographical footprint, and various other factors. This will help players to prepare themselves well for any unforeseen situations in the industry competition and give a tough competition to other players in the global Viral Vector and Plasmid DNA Manufacturing Market.
TheMajor Manufacturers Covered in this Report:Merck, uniQure, The Cell and Gene Therapy Catapult, Waisman Biomanufacturing, Addgene, Creative Biogene, Novasep, Cobra Biologics, Aldevron, , and more.
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Scope of the ReportThe research report provides key information on the supply chain of the industry, the markets currency chain, pools of major companies, and market segmentation, geographical market, and technology-oriented perspectives.The authors of the report have also provided qualitative and quantitative analyses of several microeconomic and macroeconomic factors impacting the global Viral Vector and Plasmid DNA Manufacturing market. In addition, the research study helps to understand the changes in the industry supply chain, manufacturing process and cost, sales scenarios, and dynamics of the global Viral Vector and Plasmid DNA Manufacturing market.
Market segment by Type, the product can be split intoAdenovirusRetrovirusPlasmid DNAOthers
Market segment by Application, the product can be split intoBiopharmaceutical CompaniesResearch Institutes
On the basis of geography, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.
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The report covers major aspects:
1. The report evaluates the key factors of drivers, restraints, and opportunities enabling strategic decision making with perceptive to identify the potential market.2. Various economic factors that are significant in determining the Viral Vector and Plasmid DNA Manufacturing market trend, buying decisions and market attractiveness are being analyzed for market estimation and forecasting.3. The analysis will support stakeholders such as manufacturers and distributors in identifying and capturing markets with high potential.4. The study also discusses various environmental and regulatory factors critical for the Viral Vector and Plasmid DNA Manufacturing market growth.
Key Benefits for Viral Vector and Plasmid DNA Manufacturing Market:A.In-depth analysis of the market is conducted by constructing market estimations for the key market segments between 2020 and 2025. The report provides an extensive analysis of the current and emerging Viral Vector and Plasmid DNA Manufacturing market trends and dynamics.B. Key market players within the market are profiled in this report and their strategies are analyzed thoroughly, which helps to understand the competitive outlook of the industry.D.Extensive analysis of the market is conducted by following key product positioning and monitoring of the top manufacturers within the market framework.E. A comprehensive analysis of all the regions (North America, Europe, Asia-Pacific, South America, The Middle East and Africa)
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Further, the Viral Vector and Plasmid DNA Manufacturing industry research report determines the Marketing Analysis, Regional Market Analysis, International Trade Analysis. The market Traders or Distributors with Contact Information by Region and Supply Chain Analysis. That is followed by various business strategies, the report contains essential outcome help could boost the interest level of the individuals in the market.