CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today announced the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie. Voyager retains full rights to the vectorization technology and certain novel vectorized antibodies developed as part of the collaborations.

Our efforts to harness AAV-based gene therapy to produce antibodies directly in the brain and overcome major limitations with delivery of current biologics across the blood-brain barrier have been highly productive, said Omar Khwaja, M.D., Ph.D., Chief Medical Officer and Head of R&D at Voyager. Through the tau and alpha-synuclein collaborations, we believe we have made considerable progress against targets for neurodegenerative diseases with this novel approach, reinforcing our enthusiasm for its potential to deliver therapeutically efficacious levels of biologics to the brain and central nervous system. We believe our continued work on discovery and design of novel AAV capsids with substantially improved blood-brain barrier penetrance will also considerably broaden the potential of AAV-based gene therapy, including vectorized antibodies or other biologics, for the treatment of severe neurological diseases.

The tau and alpha-synuclein research collaborations were formed in 2018 and 2019, respectively. Under the terms of the collaboration agreements, Voyager received upfront payments to perform research and preclinical development of vectorized antibodies directed against tau and alpha-synuclein. With the conclusion of the collaborations, Voyager has regained full clinical development and commercialization rights to certain product candidates developed within the context of the collaboration for the tau program. Voyager is free to pursue vectorized antibody programs for tau and alpha-synuclein alone or in collaboration with another partner.

Voyager does not anticipate any changes to its cash runway guidance due to the termination of the agreements. As of March 31, 2020, the Company had cash, cash equivalents and marketable debt securities of $250.9 million, which, along with amounts expected to be received for reimbursement of development costs from Neurocrine Biosciences, is expected to be sufficient to meet Voyagers projected operating expenses and capital expenditure requirements into mid-2022.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyagers wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinsons disease, Huntingtons disease, Friedreichs ataxia, and other severe neurological diseases. For more information, please visit http://www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, might, will, would, should, expect, plan, anticipate, believe, estimate, undoubtedly, project, intend, future, potential, or continue, and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the ability of Voyager to maintain research and development activities currently included within the collaboration agreements with AbbVie; Voyagers ability to advance its AAV-based gene therapies and its ability to continue to develop its gene therapy platform; the scope of the intellectual property rights and other rights that will be available to Voyager following the termination of the AbbVie collaboration agreements; the anticipated effects of the termination of the AbbVie collaboration agreements on Voyagers anticipated financial results, including Voyagers available cash, cash equivalents and marketable debt securities; and Voyagers ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period are forward looking. All forward-looking statements are based on estimates and assumptions by Voyagers management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the continued cooperation of AbbVie in activities arising from the termination of the AbbVie collaboration agreements, the development of the gene therapy platform; Voyagers scientific approach and general development progress; Voyagers ability to create and protect its intellectual property; and the sufficiency of Voyagers cash resources. These statements are also subject to a number of material risks and uncertainties that are described in Voyagers most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investors:Paul CoxVP, Investor Relations857-201-3463pcox@vygr.com

Media:Sheryl SeapyW2Opure949-903-4750sseapy@purecommunications.com

Read more from the original source:
Voyager Therapeutics Provides Update on AbbVie Vectorized Antibody Collaborations - GlobeNewswire

Recommendation and review posted by Bethany Smith

Twenty women participated in five focus groups held during December 2017 to February 2018 in two health care locations in Edmonton. Groups ranged in size from two to six women.

Characteristics of the participants are presented in Table1. The majority of women were aged in their 50s, had attended higher education, worked full time and were married or living with a partner. The women were in menopause transition or post-menopausal. The group reported a wide range of physical activity, from high to low (including 2 self-proclaimed couch potatoes).

All participants suffered from severe, often multiple, symptoms of menopause that had significantly impacted their QOL over an extended period of time. Insomnia, night sweats/hot flashes and fatigue were the most prevalent symptoms discussed. In addition, lack of sex drive and vaginal dryness, memory loss, depression, and lack of motivation were described as troubling symptoms. Participants stated that the severity of the symptoms and their impact on the QOL were undermined by their primary care physicians. Most participants also reported feeling socially isolated, without connection to women with similar menopause problems.

In this context, participants discussed the features of a walking program that would be suitable for women in menopause. Four distinct characteristics emerged: (A) sensitivity to health related realities of women in menopause; (B) inclusivity of various expectations and levels of readiness (fitness) among participating women; (C) attentiveness to the need for social support, and (D) flexibility in planning locations and scheduling of the program.

The current health status and ability to be physically active varied among participating women. Participants who reported being able to exercise, described a positive impact on their wellbeing, such as improved sleep and better mental stability. Others, who were more active in the past, but developed co-morbidities or injuries, felt regret that they had to reduce the intensity and/or type of exercise. Participants who reported currently being less active, highlighted symptoms of fatigue and lack of energy as the de-motivating factor to exercise, stating Tired women will not walk (P2, FG5) and Youre too tired to do it (P1, FG5).

Walking was perceived by the participants across all five focus groups as a type of exercise that could be easy, accessible, relaxing, less risky for the body, and open to any level (P1, FG5). Still, many worried that the incapacitating nature of their menopause symptoms described by one participant as struggling to get out of bed in the morning (P4, FG2) as well as other health issues would be a potential barrier to joining a walking program. Therefore, the participants suggested that the walking program should be sensitive to different health realities among menopausal women, such as fatigue, the worry about injury (P1, FG3) (especially during the winter), and possible overheating/hot flushes while walking.

I get so hot and then I get really irritated when you get that hot and you're irritated and when you can only take off so much clothes, right (P2, FG1).

Several suggestions were put forward to overcome these challenges such as indoor walking as a safer winter solution, cooling aids to manage overheating and hot flashes and basic coaching to prevent injury.

but Im thinking for people who have not been active, the worry about injury and just having somebody who can maybe coach them through that a little bit and what to expect or how to stretch out or what to watch for because even though we talk about walking and it seems like a simple thing, I wonder if its possible to have walking injuries (P1, FG3).

In addition, as some of the participants stated, the program should incorporate a right kind of encouragement to keep women motivated, included, and overcoming their concerns.

In the context of these health realities, the focus groups further discussed the programs goals and expectations. While there was a range of opinions how specific the goals of the walking program should be, the participants believed that the sense of clear expectations and purpose should be transparent, [] something that keeps us in check as to what the purpose of the walk is (P6, FG2).

Some participants stressed the need for disciplined commitment to the programs schedule, emphasizing the importance of predetermined health outcomes, something to achieve, you know, to look forward to (P2, FG2) to ensure that the program will make a difference (P3, FG1).

I also think being out and getting out giving you a sense of accomplishment that you know that I'm you know I'm doing this for me and I'm committed to it and I'm actually getting it done. I want some real rewards (P4, FG2).

A more flexible approach was suggested by others. Some participants believed that establishing high-achieving goals may be attractive to some women, but these could also deter less active and less competitive women. The program therefore should respect womens different initial fitness, offering different levels of walking intensity and leave room for individual goals.

As somebody who like I said is just starting to be a functioning human being again [] the expectations [should not be] too great []so that they can start out small but grow as it can like expand as they feel like they can take on more (P4, FG2).

I like to be able to keep track of my steps, thats my own personal goal so I think if people had individual goals thats great too (P1, FG3).

While developing specific goals would be important for some participants, others would be comfortable with a more general purpose of wellness, envisioning a less competitive program that will improve health (P2, FG4) or contribute to feeling better (P1, FG5). Openness to and inclusion of women with various expectations and levels of fitness surfaced as consequential characteristics of the walking program.

In discussion about the appropriate nature of the program, the importance of the social support to women, described by one participant as connecting with someone who is walking the same steps as I am (P2, FG5), was emphasized across all focus groups.

The participants envisioned an organized, regularly scheduled walking group that would be fun, with an optional coffee time at the end. Such a program would simultaneously provide an opportunity for physical activity and mutual emotional and social support to women who often do not have a place to share their menopause experience. This was discussed for example in FG3:

[] and its not necessarily about the walk [] its about the socialization. (P3) Yeah thats a big part (P4). Because that helps, its not the exercise that helps, its the socialization and realizing that they're not alone (P3). [] I think if the main focus is socialization, just all in the same boat, but were going to walk down the block and talk about our menopausal symptoms, [] the walking is the secondary piece (P2).

The concept of a buddy system was also broadly discussed across the focus groups in the context of the lack of motivation to be physically active that women often experience. One exchange, which occurred in FG1, suggested that peer encouragement and mutually developed accountability to one another would be an incentive to continued participation:

I would need a buddy because I wouldn't want to do it on my own (P3). Walking partners are great (P1). Thats true too (P2). I would need a buddy. I think definitely the, you know like, group or buddy I think it would, like for me that would be great. []and yeah to be accountable to go, yeah theres an accountability piece, theres a social piece, there is just that Yeah theres a lot of features to the buddy thing (P3).

An additional suggestion, made in two focus groups described a virtual community that would use a Facebook and/or a mobile application accessible to all its members. This was described as multipurpose tools that could increase motivation, keep the social network engaged, and keep track of individual achievements.

And if you set it up something like you know on one of the social aspects on Facebook whenever you set a group up and say ok this is the plan for the day, this is where everybody is going, love to see you there, you know and kind of just whoever shows, shows. You know its not a hardcore that you have to be there, its you know feel free when you feel up to it or when you're having a day or when you just need to talk (P3, FG3).

While most participants anticipated a face-to-face walking program that provides social group activity, some participants mentioned the possibility for a combination of group and individual activities. In FG4, this was suggested as an additional opportunity to clock our own walking (P2, FG4). In FG2, two participants (one who lives out of town, and one self-described loner), proposed a virtual community where participants would exercise on their own, but could connect periodically in person with the rest of the walkers:

they should make a menopause walking app or something so you check in or something like that (P3, referring to MyFitnessPal). if we did something like that and there was an app that could be adapted to be used then you're doing it alone but you're not alone (P2). I would want to see how everyone else is doing you know like P1 did 10,000 steps or she walked 10 miles this week. [] so if theres an app [] and if were all willing to provide that information [] to motivate us (P6).

By developing in- person and virtual community, as well as individual and group activities, the walking program would demonstrate adaptability and flexibility to suit different lifestyles, while simultaneously creating a space for social interaction.

The weather and seasonal changes were emphasized as a key aspect of developing a walking program. The severity of winters with low temperatures and icy sidewalks on one hand, and hot summer days on the other, call for flexibility in identifying appropriate locations and venues for walking. All focus groups discussed summertime walking along the many city walking trails, except when the temperature is too high and walking would be more comfortable in air-conditioned spaces.

During the winter, walking inside was preferred as a safer option by the majority of participants, for example walking in recreation centers or shopping malls; though some participants felt inside walking was a less attractive option.

Discussions about geographical locations for the walking program provided less consistent suggestions. While some of the participants were willing to drive and meet the group wherever it is located, the majority would prefer the program being closer to home, to save time and avoid unnecessary driving. The following exchange in FG4 exemplifies this point:

Well I guess it depends on where the women are all located right? You want to make it feasible, like you want to make it, you know, easily accessible; if somebody has to travel a half an hour plus to get there, its best to sort of have it in three to four different areas in the city (P2). I totally agree with that [] because if there was a walking group that just met downtown I wouldnt join it because I live [in the part of the city] thats a half an hour drive to get there (P1). I agree, I wouldn't drive far to go for a walk because I would just go for a walk out of my house (P5). Im a driver so that wouldn't bother me; that would be fine for me (P2). Its just the time I think for myself anyways you know its just, its making the time (P4).

Possible solutions included providing the program simultaneously in different neighborhoods or parts of the city, or be mobile and move around the city on a weekly basis, with the various time schedule options, such as evening walking (during the week) and mid-days or afternoons (on weekends).

As participants discussed a number of factors related to the logistics of the planning (weather, location, time), the need for accommodation and flexibility has emerged across all focus groups, to ensure the access and commitment to and feasibility and sustainability of the program. Most important for all women was the commonality of menopause for the walking group; as one woman sums it up: There is always the one constant, its the menopause group, so that constant there (P1, FG1).

Link:
Walking together: women with the severe symptoms of menopause propose a platform for a walking program; outcome from focus groups - BMC Blogs Network

Recommendation and review posted by Bethany Smith

In this study, 16 women with POI, aged between 28 and 47years, and a POI duration of 215years were interviewed. The demographic characteristics of the participants are summarized in Table1.

After content analysis of the interviews with a focus on the factors influencing the QOL of women with POI, three themes emerged (disease effect, distorted self-concept, and hormone replacement therapy effect), explained as follows (see Table2).

Consisting of two main categories i.e. physical and psychological, the theme is defined here as the direct negative influences POI exerts on the various aspects of a womans health, taking a toll on her QOL.

The very first complaints of POI in these women were menstrual disorders including menstrual irregularities, oligomenorrhea, and in some cases, metrorrhagia, occurring 6months to 6years prior to the final diagnosis. Two of them had primary amenorrhea. Many of the women with POI complained about vasomotor disorders such as hot flushes, night sweats, and heat intolerance.

I cant bear heat or thirst. Its been more intense in the last six months. When I begin to fall asleep at night, suddenly the hot flushes come about. Its as if I am burning from the inside. I cant go to sleep anymore when this happens, you know, because of the rapid heartbeat and all the sweating (20's-30's, disease duration: 2 years).

Fertility disorders were also caused by POI. The women inclined to have a baby complained about infertility. Those resorting to assisted reproductive technology (ART) mentioned donor egg pregnancy, abortion, and in-vitro-fertilization (IVF) as factors reducing their QOL and putting a long-lasting strain on them.

As for bone complications, two of the most commonly experienced issues were joint pain and osteoporosis. Also, a few of the women complained about post-menopausal tooth pain and sensitivity.

I have osteoporosis and severe joint pain. I feel pain deep in my bones. I cant take long walks (40's-50's, disease duration: 13 years).

The mucocutaneous complications were reported by almost all participants as occurring in the form of vaginal or skin dryness; vaginal itchiness and tightness; and reported by a few, there were falling hair and wrinkled skin.

Dryness and itchiness drive me crazy. Sometimes I scratch myself to bleeding. You wouldnt want to know how awful it is when at work, it hurts so much that I like to chop it off. (40's-50's, disease duration: 3 years)

The afflicted women would mainly experience sexual function disorders due to ovarian hypofunction. They experienced dyspareunia, reduced sex drive, and anorgasmia.

The disease has affected my sex life. I dont feel like having sex at all. Last time I had sex, it was so, so painful and hurt a lot. I just tried to cope up with it and make as if it wasnt there but I could never have an orgasm. (30's-40's, disease duration: 6 years)

Despite these disorders, most women expressed that their frequency of having sex remained unchanged.

Now that I am disabled and not a perfect woman anymore, I want to manage it and have a kind of normal sex life. I dont want my husband to feel deprived. I would like him to have a normal sex life. (30's-40's, disease duration: 3 years).

Many women were in good health, however, some of them reported conditions like weariness, loss of physical strength, and sleep disorders.

I feel as if I had become heavier when you dont get period, youre down youre not that agile anymore. Youre bored and not fresh. (30's-40's, disease duration: 4 years).

According to a majority of the participants, being diagnosed with the disease was shocking and unbelievable:

It came to me like a blow. I felt awful. I was shocked and frustrated. I was in shock for some time. (30's-40's, disease duration: 3 years).

The women experienced grief for quite a long time after being diagnosed with the disease. They were concerned about the complications of the disease (e.g. infertility, sexual problems, and osteoporosis), and couldnt easily talk or even think about it:

I am so disappointed. Everyone dreams of having a baby. I cry when Im alone and think of it , that I cannot experience it naturally. When others are talking about children or I see a little child, I get even more disappointed (30's-40's, primary amenorrhea).

There were many cases of becoming aggressive, agitated and losing control over anger associated with POI, reported by the interviewees. The conditions associated with fits of moodiness in these women included rage, mood swings, impatience, and, as reported by some of them, introversion.

Before receiving the treatments, I experienced all those changes of temperaments, you know, you suddenly get happy and then, for no reason you start to cry. I was beginning to feel helpless because it hurt so much. (30's-40's, disease duration: 5 years)

Also, there was a large number of these women complaining about stress-related problems such as anxiety, tension, and lack of concentration while before having POI, they never had such an experience at this level.

I am anxious; I very much like to read a book but I just cant seem to be able to finish it because of all the anxiety I have. I am trying to tell you that I lack concentration. (30's-40's, disease duration: 4 years)

The leading causes of POI womens anxiety were as follows: losing health, having children, and getting married. Other causes had roots in physical effects of the disease, its economic burden, fear of future incidence of the possible related complications, and its turning into a chronic disease:

Im worried about getting married. Im afraid there will be no Mr. Right accepting me as a girl getting to menopause at an early age who cannot give him a baby. (30's-40's, disease duration: 4 years)

Subsequent to POI-induced infertility as well as menopausal complications, many women experienced negative feelings including hopelessness, emptiness, being cursed, and unhappiness:

I feel empty for being infertile. I cant enjoy real happiness why should I be that unlucky? My peers get periods and are healthier than me. (40's-50's, disease duration: 10 years)

The analysis of the experiences of women with POI yielded factors such as threatened identity and disease stigma, distorting their self-concept and adversely affecting their QOL.

Femininity was threatened by amenorrhea and followingly, infertility; as a consequence, women would experience feelings like deficiency, losing self-confidence, femininity defect, being different from other women, and embarrassment. Some women even resisted entering a relationship with the opposite sex:

I feel disabled; I am not an all-around woman anymore. Compared to normal women, I lack something. Its as if Im weaker than other women. I feel I am sterilized. (30's-40's, disease duration: 3 years)

The identity, and as a result, the maternal role of POI women who wanted to have children were threatened since they couldnt have the natural experience of a genetic mother. Their main concerns turned out to be: forced acceptance of a donor egg, the donor egg childs lack of resemblance to them, not being accepted as a mother by the child, and the egg donor claiming the baby.

I accepted the donor egg to save my marriage, but there are some things to worry about. What if the child leaves me because I am not his/her genetic mother? What if the egg donor shows up and claims the baby one day or another? (30's-40's, initial amenorrhea)

POI had caused an undesirable self-image in women making them feel aged, withered, disabled during intercourse, and with deteriorated self-confidence as a result of breast sagging and poor fitness. One of the women explains:

A woman with POI is like a flower withered before blooming. I feel so old; it is as if I am too old for my age. Im not youthful anymore, Im withered. (30's-40's, disease duration: 4 years).

Another interviewee states that:

I feel like old women when I have to take calcium pills at this age to maintain strong bones. (30's-40's, disease duration: 5 years)

Most of the participants resorted to concealment due to the disease stigma. The afflicted women and the donor egg receivers intended to hide the disease and the donor egg from others. Also, some women reported feelings of isolation after having POI.

One of the problems I have with the diseases is that I have to hide it because I dont like anyone to find out about it. You need to make believe that you are fine while having it with you. (20's-30's, disease duration: 2 years)

The interviewees reported that they suffered consequences of the disease stigma such as being judged, being labeled, being blamed, looking pathetic, peoples scornful look, and the bad reputation of the disease.

I kind of feel like its becoming a drawback for me and my husband is using it against me. The moment something comes up, he brings it up and then its me with egg on my face. (30's-40's, disease duration: 6 years)

As a symptomatic therapy influencing the QOL, hormone replacement therapy (HRT) was administered to POI women. Two main categories emerged out of the participants experiences, i.e. positive or desirable effects, and negative or undesirable ones.

I take medicine to regulate my menstruation. My period is regular now and I have no hot flushes. I dont think of how it affects my health (40's-50's, disease duration: 3 years)

I have gained lots of weight since I took the medicines. Now, I have stopped using them by myself. I couldnt swallow the pills. I was fed up with them. (30's-40's, disease duration: 5 years)

See the original post here:
An exploration of factors affecting the quality of life of women with primary ovarian insufficiency: a qualitative study - BMC Blogs Network

Recommendation and review posted by Bethany Smith

Type 2 diabetes can mean one of two things: the body doesn't produce enough insulin, or the body's cells don't react to insulin - this is known as insulin resistance.

Insulin is a hormone that regulates the amount of blood sugar - the main type of sugar you obtain through eating food.

This sugar is an important source of energy and provides nutrients to the body's organs, muscles and nervous system.

However, consistently high blood sugar levels can inflict permanent damage to parts of the body such as the eyes, nerves, kidneys and blood vessels.

READ MORE:Type 2 diabetes: The cooking oil shown to lower blood sugar and reduce heart disease risk

Specific nerve damage can lead to a paralysis on one side of your face, otherwise known as Bell's palsy, it says.

Other telltale signs associated with Bell's palsy include:

You can stabilise your blood sugar levels by making healthy lifestyle decisions.

Diet forms an essential component of blood sugar control, and, while there's nothing you cannot eat if you have type 2 diabetes, you'll have to limit certain foods.

That's because certain food groups send your blood levels soaring.

One of the worst offenders are foods with a high carbohydrate content such as rice, pasta and flour (therefore including pastry, bread and other dough based foods).

Carbohydrate is broken down into glucose relatively quickly and therefore has a more pronounced effect on blood sugar levels than either fat or protein.

To help identify high and low carb items, you should refer to the Glycemic Index (GI).

The GI index is a relative ranking of carbohydrates in foods according to how they affect blood glucose levels.

Physical exercise also helps lower your blood sugar level.

According to the NHS, you should aim for 2.5 hours of activity a week.

"You can be active anywhere as long as what you're doing gets you out of breath," says the health body.

See more here:
Type 2 diabetes symptoms: Have you noticed this happen to one side of your face? Sign - Express

Recommendation and review posted by Bethany Smith

The mention of diabetes usually refers to type 2 diabetes (T2D) a worryingly common chronic illness among Malaysians.

Type 1 diabetes (T1D) is lesser known, but its impact on life is equally serious.

T1D (previously known as juvenile or insulin-dependent diabetes) is a chronic condition that comes about because the pancreas stops or only produces a little insulin.

Insulin is a hormone that helps control sugar (glucose) levels in the blood and allows our cells to use sugar from food for energy.

The lack of insulin causes sugar to accumulate in the bloodstream, leading to the many symptoms and complications of diabetes.

One possible cause of T1D is an autoimmune reaction that mistakenly destroys the insulin-producing beta cells in the pancreas.

Exposure to certain triggers in the environment, such as a virus, is also linked to T1D.

A major point that differentiates T1D from T2D is that T1D is not caused by lifestyle factors such as unhealthy eating habits or lack of physical activity.

It commonly occurs during childhood and adolescence, and is relatively rare, affecting around 5% of all diabetes patients.

Symptoms and complications

Unlike T2D, the symptoms of T1D may appear suddenly.

Early diagnosis is important to avoid serious complications such as diabetic ketoacidosis (DKA), but misdiagnosis as acute gastroenteritis or urinary tract infection can happen and should be avoided.

Common symptoms include:

Acute complications include:

> Hypoglycaemia

This is when blood sugar levels become too low due to high insulin levels when a T1D child delays a meal/snack, does not eat enough or exercises too much after her insulin has been administered.

It happens quickly and needs immediate treatment.

Symptoms include shaking, nausea, sweating and fatigue.

> DKA

The body breaks down fat cells when it cannot get enough glucose for fuel, resulting in chemicals called ketones.

This happens when the child misses his insulin injections or during inappropriate management of sick days.

The combination of high glucose, dehydration and ketone build-up leads to ketoacidosis, which can be fatal.

If it occurs, DKA must be treated as an emergency.

In Malaysia, about 70% of T1D patients are diagnosed with the condition after first going to the clinic or hospital with DKA symptoms, which includes vomiting, abdominal pain, rapid breathing and loss of consciousness.

Meanwhile, chronic complications of T1D include:

> Cardiovascular disease

The risk of cardiovascular problems, such as heart attack, stroke, atherosclerosis, high blood pressure and coronary artery disease, increases with diabetes.

> Organ damage

Blood vessels in organs like the eyes and kidneys can be damaged due to diabetes, causing kidney failure and serious eye conditions like cataract, glaucoma or blindness.

> Nerve damage

It starts with tingling, numbness or a burning sensation in the feet, and gradually spreads upward.

Over time, it can lead to total loss of sensation, and even loss of limbs.

Nerve damage also affects the gastrointestinal tract.

If a diabetic child starts a new physical activity, e.g. badminton or another sport, his or her insulin dose and meal plan needs to be adjusted to take into account their new energy expenditure. Filepic

Management

While there is no cure for T1D, there are ways to manage it so that the patient can live a regular life.

These include:

> Insulin administration

A child with T1D needs lifelong insulin therapy to control her blood sugar levels.

It can be administered via multiple daily injections or an insulin pump.

There are short-acting, rapid-acting and long-acting insulin.

Following a proper schedule for daily insulin administration is key to managing T1D.

> Blood sugar monitoring

Careful and regular monitoring of the patients blood sugar level is important to ensure that it remains within the target range.

Blood sugar levels need to be checked before and after eating, sleeping, exercising, driving, or when low blood sugar is suspected.

Self-monitoring with a chemically-treated paper strip is the standard way of measuring blood sugar, while intermittent and real-time continuous glucose monitoring systems are more advanced.

> Healthy eating

The child and his family needs to understand how different foods affect his blood sugar.

A dietician can propose a suitable diet plan focusing on whole grains, veggies and fruits.

Insulin doses should be tailored to the amount of carbohydrates taken, so the child and his caretakers need to learn to count the carbohydrate content in his food and drinks.

There is no specific diet restriction for T1D patients, but healthy eating is mandatory!

> Physical activity

Regular exercise is still necessary, but the child needs to know it can lower her blood sugar level.

Thus, her blood sugar needs to be monitored more frequently when starting a new activity to observe any effects.

Her meal plan or insulin doses may need to be modified to suit the new activity.

Being diagnosed with T1D can be a huge challenge for a child and his family.

Apart from the need for cautious management, T1D is also a costly disease while insulin is free at government hospitals, other medications, equipment and overhead costs can strain a familys finances as diabetes is a long-term condition.

However, T1D can be managed successfully.

With the right help and support, especially from parents, family members and a good healthcare team, a T1D child can cope with his condition and live a regular, healthy life.

Associate Professor Dr Muhammad Yazid Jalaludin is a consultant paediatrician and paediatric endocrinologist. This article is courtesy of the Malaysian Paediatric Associations Positive Parenting programme in collaboration with expert partners. For further information, please email starhealth@thestar.com.my. The information provided is for educational and communication purposes only and it should not be construed as personal medical advice. Information published in this article is not intended to replace, supplant or augment a consultation with a health professional regarding the readers own medical care. The Star does not give any warranty on accuracy, completeness, functionality, usefulness or other assurances as to the content appearing in this column. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.

The rest is here:
Dealing with type 1 diabetes in children - The Star Online

Recommendation and review posted by Bethany Smith

While advocacy groups say that bringing intersex people to the table is a start, interACT argued in a statement posted to its website that at least two intersex people with backgrounds in intersex human rights advocacy should participate in the dialogue. Hans Lindahl, the organizations communications director, also wants to see institutions like Lurie commit to reparations for generations of adults who have been irreparably harmed by these surgeries; that includes working to provide them with free or low-cost care that meets their particular needs.

The massive amount of focus is on infants, which I think clouds the issue for people, Lindahl told BuzzFeed LGBTQ. There's a population of decades worth of damaged intersex adults who have nowhere to go. Theres no adult intersex care specialty. Endocrinology or hormone doctors who can offer us knowledge and safety are truly rare. It often feels like theres nothing. Were left out to dry completely."

While activists say the ultimate goal is to encourage all medical centers to take proactive, comprehensive steps in support of their intersex patients, resources to staff a large-scale advocacy effort remain limited. Organizations like Intersex Justice Project and interACT are extremely small and predominantly volunteer-led, and Pagonis said the majority of donations that their group takes in go toward art supplies. To help fill that gap, Intersex Justice Project has provided toolkits, how-to guides, and even YouTube tutorials for activists who wish to start their own campaigns. That callout has led to protests in cities like London and Berlin in recent years.

Wall believes that empowering the next generation of intersex activists is critical for the movement to continue and hopes the recent victory against Lurie proves to them that change is possible. During a recent trip to the National Museum of African American History and Culture in Washington, DC, he was inspired by an exhibit on the Black Panther Party, the revolutionary political group that, like the Intersex Justice Project, was founded by just two people: Bobby Seale and Huey P. Newton.

They inspired a generation of young Black people and really pushed an idea, an ethos, and a cultural stance of Black liberation, Wall said. Their movement defined a generation. I think this is a lesson that we should never doubt the power of a few people making a difference.

The rest is here:
Activists Got A Chicago Childrens Hospital To End Intersex Surgeries. For Them, It's Just The Beginning. - BuzzFeed

Recommendation and review posted by Bethany Smith

As the Covid-19 pandemic progresses, researchers are reporting many unpleasant and downright weird side effects of this disease from neurological ailments such as confusion, to "Covid-toes"and rashes.

But it seems some Covid-19 patients are experiencing yet another side-effect hair loss. According to a report byScience Alert, 56-year oldPeggy Goroly, a Covid-19 patient from Long Island, New York, experienced severe fatigue, brain fog and heart palpitations. One perplexing symptom, however, was "traumatic" hair loss.

She asked members of a Facebook Covid-19 support group if she was the only one losing hair in clumps, and it turned out many patients were experiencing the same effect.

But how can Covid-19 affect your hair?

Hair loss and illness

Although hair loss is not listed as an official symptom, and the reports from Facebook support groups are anecdotal, Dr Shilpi Khetarpal, a dermatologist from Cleveland Clinic, confirms they have seen Covid-19 patients with severe hair loss.

According to Dr Khetarpal, the phenomenon is known as telogen effluvium, a form of temporary hair loss that occurs after a stressful, traumatic event. This condition is not the same as alopecia areata, a hair loss disorder resulting from an autoimmune disorder.

Harvard Health explains that 85% to 90% of the hair on the average person's head is in a so-called active stage of growing (anagen phase) while the rest of the hair is in a "resting" phase (telogen phase).

Shedding hair is normal, as hairs remain in the anagen phase for two to four years, then move into the telogen phase, where they "rest" for a couple of months, and then fall out to be replaced by new hairs.

But with telogen effluvium, more hairs are pushed into the "resting" phase, which results in more hair falling out, mostly from the top of your scalp.

There are many factors that can trigger telogen effluvium:

In the case of Covid-19 infection, patients may spot hair loss two to four months after the most severe symptoms, as hair will first enter the "resting phase" before falling out.

According to Dr Khetarpal, hair loss is therefore not listed as a symptom, but rather a side effect of Covid-19.

"This is why we're seeing these patients now, several weeks after Covid-19 symptoms resolve. Telogen effluvium isn't a symptom of Covid-19 as much as it is a consequence of the infection."

Hair loss can occur for six to nine months and will usually resolve on its own.

How can you manage Covid-19-related hair loss?

While the hair loss is mostly temporary, it can still be traumatic. But Dr Khetarpal states some people have a greater genetic predisposition for hair loss than others, and proper nutrition is a key factor in restoring hair growth, especially iron and vitamin D.

If you experience any other symptoms such as itching, burning or a rash on the scalp, you should preferably see a dermatologist, but if it's only hair loss, you can continue your normal washing and styling routine without worrying.

Consult your doctor about your iron and vitamin D levels and ask if it's necessary for a supplement. Dr Khetarpal also states that a biotin supplement should help restore hair growth.

'I don't have Covid-19, but I'm experiencing major stress during the pandemic could I lose my hair?'

While Covid-19 can be a devastating disease, you don't have to be physically ill to experience major psychological stress during this period. Therefore, hair loss can occur if you've had any increase in stress levels.

"There are so many pandemic-related stresses. There's financial stress, concern for ill family members, anxiety about contracting the virus, social isolation and changes related to working and schooling from home. We are absolutely seeing hair loss in non-Covid patients that seems related to pandemic stress."

READ:More symptoms of coronavirus: Covid toes and skin rashes

READ:Is Covid-19 now linked with strokes in young patients?

READ:Coronavirus hangs around even after symptoms subside

Image credit: Getty Images

Marelize Wilke

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Could hair loss be another Covid-19-related side effect? - Health24

Recommendation and review posted by Bethany Smith

Its always sad when somebody passes away, but things can get contentious for the deceaseds family when it comes to figuring out what happens with the estate when the person dies. That is especially true in the case of businessmen who own successful businesses and NFL teams are often among the most successful businesses around.

When longtime Denver Broncos owner Pat Bowlen passed away 2019, it kicked off a family feud that saw his survivors fighting over who would get control of the football franchise. And the leadership struggle turned ugly, tearing the family apart.

Bowlen bought the Denver Broncos in 1984, and he served as the teams CEO until stepping down in 2014, when his mental capacity became compromised with the onset and progression of Alzheimers disease.

The team won three Super Bowls under his ownership and found much success with having long runs of consistency, with the likes of QB John Elway and head coach Mike Shanahan sticking with the team for long tenures, and then signing QB Peyton Manning as a free agent late in his career to get the franchises third Lombardi Trophy.

RELATED: Art Rooney II and the 8 Other NFL Team Owners Who Arent Multi-Billionaires

Bowlen fathered many children, as reported by The Athletic. He had two daughters with his first wife, Sally, and with his second wife and widow, Annabelle, he had five more children.

When he stepped down from the Broncos, Bowlens ownership stake in the team about 77% was put into a trust overseen by three non-family members. When Anabelle passes away, Bowlens interest in the Broncos will be passed down to his seven children by marriage, with each receiving an equal share.

But Bowlen also has an eighth child, daughter Alexandra, who was born out of wedlock in 1988. Some older members of Bowlens knew he had an eighth child, but his younger children found out about her two months after his funeral. That led to questions about whether she was looking to join the battle for control of the team.

RELATED: Jerry Jones Is Surprisingly 1 of the Few NFL Owners to Play Football

Bowlens trust doesnt detail a clear line of succession for control of the Denver Broncos, which has led to hostility and multiple lawsuits in the battle over control. Bowlen hoped one of his children would emerge as the best candidate to take over principal ownership, but seven years into the search for a successor no one has been named yet and it doesnt seem like the trustees are close to picking the new controlling owner.

That has caused some people to speculate the trustees are intentionally dragging out the process to keep themselves in charge; they deny that claim. Team president and CEO, Joe Ellis, who is also one of the trustees and controlling owner delegee, has admitted that the situation looks messy. He says that the trustees are going to follow Pats plan, no one elses, saying that he knows exactly what Bowlen told him.

One of Bowlens sons, former college defensive back Johnny, worked in marketing for the team until being put on indefinite leave in 2015 after being arrested for domestic violence. He has said in the past that his father told him hed be the one to take over the team when the time came.

Johnny said that made a ton of sense because hes the most qualified and the most well-trained to take over. He claims to have all of the credentials other (than) this silly senior management job, and he expressed frustration with not getting to do what his dad wanted him to.

Johnny also says he hopes someone will at least let him try, which does not appear to be on the verge of happening.

Continued here:
The Denver Broncos Are in the Middle of a Nasty Family Argument Over Ownership - Sportscasting

Recommendation and review posted by Bethany Smith

Getting aching legs even though youre on your feet less? There are a couple of likely culprits both related to your circulatory system. Varicose veins affect about 30pcof the population roughly half of patients can see them on the surface, but the rest will only know they have them when they get aching legs, swollen ankles, red or brown stains around the ankles, phlebitis or leg ulcers,"explains Mark Whiteley, consultant venous surgeon and founder of The Whiteley Clinic. "During lockdown, many people have been less active and so we have seen more people coming in who have deteriorated quicker than we would expect.

Theres also another concern. Deep vein thrombosis, or clotting in the deep veins of the legs, can form in patients who are unwell or dehydrated, or less mobile than usual. DVT is also associated with underlying cancers in 10pcof people and because many people have not gone to doctors during lockdown because they are worried about Covid, then there may be a proportion of patients who have had undiagnosed cancers continue to grow, causing DVTs.

How to fix it: If you suspect you have either of this issues, then the only permanent fix is a diagnosis and treatment but if youre still isolating, then mobility and good health are a sensible stopgap. Keep well hydrated and walk as much as possible, says Whiteley.For varicose veins in particular, you can elevate the leg when youre resting, and wear graduated compression stockings if your circulation is good. However, none of these will give a good long-term outcome without finding the underlying problem and treating it.

More here:
What lockdown has done to our bodies and how to fix it - The Telegraph

Recommendation and review posted by Bethany Smith

As Americas force-in-readiness, theMarine Corpsis expected to do it all. They thrive in austere environments and can leave at a moments notice. The Corps has always operated in close coordination with the Navy and the two branches enjoy a very close relationship.

Despite their long history working together, the today the Corp is perhaps best known for their bloody island-hopping campaign of World War II renown. During that conflict, the venerable Higgens boata light-weighttroop transport of mostly wooden constructionferried Marines into beaches throughout the Pacific.

Though military technology has significantly progressed since the mid-1940s, the Marines current ship-to-shore vehicle is actually in some ways inferior to the distantly-related Higgins boat.

Assault Amphibious Vehicle (AAV)

The AAV entered service with the United States Marine Corps in the early 1970s. It was intended to provide Marines with a shorter ship to shore time and to give Marines a degree of protection while on land.It was therefore equipped with a .50 caliber heavy machine gun and a 40-millimeter automatic grenade launcher.

AAVs launch from the well decks of Navy amphibious ships, literally driving off the ships edge and into the sea toward land. They are normally operated by a three-man crew and can carry twenty-one full-armed Marines.Though decently well-armed, the Assault Amphibious Vehicles arent very fastand in some cases may have even been slower than the Higgins boat! As a result, several attempts have been made to replace them.

TheAmphibious Combat Vehicle, or ACV, is a USMC initiative that supersedes the now-cancelledExpeditionary Fighting Vehicleprogram in developing an AAV replacement. This multi-phase effort uses several various wheeled prototypes to explore different platforms and their capabilities, with the goal of eventually giving the USMC a faster, more survivable platform for ship-to-shore operations. It is a long-overdue project, as the AAV is gaining notoriety for the dangerous incidents it has been involved in.

Repeat Offender

Most recently, an AAV sunk during a training exercise off the coast of California near Camp Pendleton, causing the deaths of seven Marines and one Sailor. Though the investigation into what exactly caused the AAV to sink is ongoing, the aged vehicles have been previously criticized for being leaky. In 2017, fifteen Marines and one Navy corpsman were injured when their AAV caught fire during another training exercise, also at Camp Pendleton.

Speaking to reporters at a news conference, Lieutenant General Joseph Osterman explained that the Corps has squeezed out all the useful life they can out of this platform, saying that the AAVs were originally procured in 1972 but theyve gone through many service life extension programs. They bring it in, they literally bring it down to just the hull and rebuild everything inside of it. Weve done that multiple times through the years.

Postscript

It is time to mothball the Assault Amphibious Vehicle. After nearly fifty years of continuous service, the Corps deserves a replacement.

Caleb Larson holds a Master of Public Policy degree from the Willy Brandt School of Public Policy. He lives in Berlin and writes on U.S. and Russian foreign and defense policy, German politics, and culture.

Image: Reuters

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The Marine Corps' Assault Amphibious Vehicle Should Have Been Replaced Years Ago - The National Interest

Recommendation and review posted by Bethany Smith

Genes and Ovarian Cancer

Diagnosing ovarian cancer can involve a number of tests, including a physical exam, ultrasound, and blood tests. Genetic testing is also an important part of the diagnostic process, helping to not only detect ovarian cancers, but also find the right treatment for them.

About 15% of ovarian cancers are linked to gene changes called mutations that can be passed down through families. The most common genetic cause of ovarian cancer is a mutation in the BRCA1 or BRCA2 gene. These genes help to repair damaged DNA, and ensure the stability of the cells genetic material. If either of these genes is mutated, DNA damage continues to the point where it can eventually cause the cells to turn cancerous.

Most people who carry a BRCA gene mutation dont realize they have it until someone in their family is diagnosed with cancer. This is why its important for any new diagnosis of ovarian cancer to undergo genetic testing, to see if they are, in fact, a carrier, says Dr. Adam ElNaggar, a gynecologic oncologist at West Cancer Center in Memphis, Tennessee.

Certain groups of people, like Ashkenazi Jews or those whose families originated in Mediterranean countries, are especially susceptible to these mutations. Anyone with a family history of breast or ovarian cancer should ask their doctor about getting tested. Carrying one of the BRCA genes puts you at increased risk not only for ovarian cancer, but also for breast cancer and for other, less common cancers, Dr. ElNaggar says. Knowing your status could help you and your family stay on top of screenings for these other cancers, too.

Although guidelines recommend that all women with ovarian cancer have genetic testing when theyre diagnosed, only a small percentageof women actually do get tested, research finds. Regardless of your age or the type of ovarian cancer you have, testing should be part of your diagnosis.Besides providing valuable information to help your doctor decide on the best treatment for your cancer, knowing that you carry a genetic mutation is valuable for other family members, too. Your immediate family may also benefit from genetic testing. If they find they carry a BRCA1 or BRCA2 mutation it may be recommended that they begin undergoing more frequent screening tests for breast and ovarian cancer, and possibly even consider prophylactic surgery to avoid developing advanced cancer.

Gene mutations not only increase the risk of developing ovarian cancer, but they also can make certain types of treatments, like PARP inhibitor drugsmore effective. PARP is an enzyme that cells normally use to repair their damaged DNA. PARP inhibitors block this enzyme to prevent ovarian cancers with BRCA mutations from fixing DNA damage.

Three PARP inhibitors are approved to treat ovarian cancer:

Some women with ovarian cancer have another genetic marker called homologous recombination deficiency (HRD) that makes them particularly good candidates for PARP inhibitors. Ovarian cancers with HRD are already less able to repair their DNA damage, making them easier for the drugs to fight.

If you picture your DNA like a railroad track, there are two beams, as well as the cross lattice of woodwork, Dr. El Naggar says. When a section of that is taken out, your HRD genes would have come in and put that track back together, repairing both tracks. However, when theyre deficient, the body is unable to do that.

When only one track is broken in other words, one strand of DNA PARP enzymes come in and fix the damage so the cancer cell can keep growing. PARP inhibitors block that repair process which prevents the cancer cells from replicating spreading.

Data shows that PARP inhibitors can have the best results in women with a BRCA mutation or HRD, but new studies show that one PARP inhibitor, niraparib (brand name ZEJULA) may provide some benefit for women without these mutations, as well. These drugs can be used initially with chemotherapy and surgery in what is called first-line treatment, or as maintenance therapy to prevent the cancer from returning after treatment.

Genetic testing can benefit you if youve been diagnosed with ovarian cancer, by helping your doctor determine whether a treatment like a PARP inhibitor is likely to be effective against your cancer. It can also inform your family members, enabling them to be more diligent about getting genetic testing and cancer screening.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Adam ElNaggar is an assistant professor of gynecologic oncology at the University of Tennessee Health Science Center (UTHSC), and director of gynecologic cancer research at the West Cancer Center.Hisclinical interests include personalized medicine, advanced surgical techniques, and targeted therapies. Read More

About 15% of ovarian cancers are linked to gene changes called mutations that can be passed down through families. The most common genetic cause of ovarian cancer is a mutation in the BRCA1 or BRCA2 gene. These genes help to repair damaged DNA, and ensure the stability of the cells genetic material. If either of these genes is mutated, DNA damage continues to the point where it can eventually cause the cells to turn cancerous.

Certain groups of people, like Ashkenazi Jews or those whose families originated in Mediterranean countries, are especially susceptible to these mutations. Anyone with a family history of breast or ovarian cancer should ask their doctor about getting tested. Carrying one of the BRCA genes puts you at increased risk not only for ovarian cancer, but also for breast cancer and for other, less common cancers, Dr. ElNaggar says. Knowing your status could help you and your family stay on top of screenings for these other cancers, too.

Although guidelines recommend that all women with ovarian cancer have genetic testing when theyre diagnosed, only a small percentageof women actually do get tested, research finds. Regardless of your age or the type of ovarian cancer you have, testing should be part of your diagnosis.Besides providing valuable information to help your doctor decide on the best treatment for your cancer, knowing that you carry a genetic mutation is valuable for other family members, too. Your immediate family may also benefit from genetic testing. If they find they carry a BRCA1 or BRCA2 mutation it may be recommended that they begin undergoing more frequent screening tests for breast and ovarian cancer, and possibly even consider prophylactic surgery to avoid developing advanced cancer.

Gene mutations not only increase the risk of developing ovarian cancer, but they also can make certain types of treatments, like PARP inhibitor drugsmore effective. PARP is an enzyme that cells normally use to repair their damaged DNA. PARP inhibitors block this enzyme to prevent ovarian cancers with BRCA mutations from fixing DNA damage.

Three PARP inhibitors are approved to treat ovarian cancer:

Some women with ovarian cancer have another genetic marker called homologous recombination deficiency (HRD) that makes them particularly good candidates for PARP inhibitors. Ovarian cancers with HRD are already less able to repair their DNA damage, making them easier for the drugs to fight.

If you picture your DNA like a railroad track, there are two beams, as well as the cross lattice of woodwork, Dr. El Naggar says. When a section of that is taken out, your HRD genes would have come in and put that track back together, repairing both tracks. However, when theyre deficient, the body is unable to do that.

When only one track is broken in other words, one strand of DNA PARP enzymes come in and fix the damage so the cancer cell can keep growing. PARP inhibitors block that repair process which prevents the cancer cells from replicating spreading.

Data shows that PARP inhibitors can have the best results in women with a BRCA mutation or HRD, but new studies show that one PARP inhibitor, niraparib (brand name ZEJULA) may provide some benefit for women without these mutations, as well. These drugs can be used initially with chemotherapy and surgery in what is called first-line treatment, or as maintenance therapy to prevent the cancer from returning after treatment.

Genetic testing can benefit you if youve been diagnosed with ovarian cancer, by helping your doctor determine whether a treatment like a PARP inhibitor is likely to be effective against your cancer. It can also inform your family members, enabling them to be more diligent about getting genetic testing and cancer screening.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Adam ElNaggar is an assistant professor of gynecologic oncology at the University of Tennessee Health Science Center (UTHSC), and director of gynecologic cancer research at the West Cancer Center.Hisclinical interests include personalized medicine, advanced surgical techniques, and targeted therapies. Read More

Originally posted here:
The Important Role of Genetics in Ovarian Cancer Treatment - SurvivorNet

Recommendation and review posted by Bethany Smith

Overview for Breast Cancer Predictive Genetic Testing Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Various Dynamics.

The Breast Cancer Predictive Genetic Testing market is expected to grow from USD X.X million in 2020 to USD X.X million by 2026, at a CAGR of X.X% during the forecast period. The global Breast Cancer Predictive Genetic Testing market report is a comprehensive research that focuses on the overall consumption structure, development trends, sales models and sales of top countries in the global Breast Cancer Predictive Genetic Testing market. The report focuses on well-known providers in the global Breast Cancer Predictive Genetic Testing industry, market segments, competition, and the macro environment.

Under COVID-19 Outbreak, how the Breast Cancer Predictive Genetic Testing Industry will develop is also analyzed in detail in Chapter 1.7 of the report.In Chapter 2.4, we analyzed industry trends in the context of COVID-19.In Chapter 3.5, we analyzed the impact of COVID-19 on the product industry chain based on the upstream and downstream markets.In Chapters 6 to 10 of the report, we analyze the impact of COVID-19 on various regions and major countries.In chapter 13.5, the impact of COVID-19 on the future development of the industry is pointed out.

A holistic study of the market is made by considering a variety of factors, from demographics conditions and business cycles in a particular country to market-specific microeconomic impacts. The study found the shift in market paradigms in terms of regional competitive advantage and the competitive landscape of major players.

Download PDF Sample of Breast Cancer Predictive Genetic Testing Market report @ https://www.arcognizance.com/enquiry-sample/1196631

Key players in the global Breast Cancer Predictive Genetic Testing market covered in Chapter 4:OncoCyte CorporationMyriad GeneticsThermo Fisher ScientificQuest DiagnosticsCancer GeneticsInvitaePerkinElmerNeoGenomicsRocheIverson Genetics

In Chapter 11 and 13.3, on the basis of types, the Breast Cancer Predictive Genetic Testing market from 2015 to 2026 is primarily split into:High Penetrant GenesIntermediate Penetrant GenesLow Penetrant Genes

In Chapter 12 and 13.4, on the basis of applications, the Breast Cancer Predictive Genetic Testing market from 2015 to 2026 covers:HospitalsClinicsOther

Brief about Breast Cancer Predictive Genetic Testing Market Report with [emailprotected] https://www.arcognizance.com/report/global-breast-cancer-predictive-genetic-testing-market-report-2020-by-key-players-types-applications-countries-market-size-forecast-to-2026-based-on-2020-covid-19-worldwide-spread

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:North America (Covered in Chapter 6 and 13)United StatesCanadaMexicoEurope (Covered in Chapter 7 and 13)GermanyUKFranceItalySpainRussiaOthersAsia-Pacific (Covered in Chapter 8 and 13)ChinaJapanSouth KoreaAustraliaIndiaSoutheast AsiaOthersMiddle East and Africa (Covered in Chapter 9 and 13)Saudi ArabiaUAEEgyptNigeriaSouth AfricaOthersSouth America (Covered in Chapter 10 and 13)BrazilArgentinaColumbiaChileOthers

Years considered for this report:Historical Years: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Period: 2020-2026

Single User License Copy and Other Purchase [emailprotected] https://www.arcognizance.com/purchase/1196631

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Breast Cancer Predictive Genetic Testing Market

Chapter Four: Players Profiles

Chapter Five: Global Breast Cancer Predictive Genetic Testing Market Analysis by Regions

Chapter Six: North America Breast Cancer Predictive Genetic Testing Market Analysis by Countries

Chapter Seven: Europe Breast Cancer Predictive Genetic Testing Market Analysis by Countries

Chapter Eight: Asia-Pacific Breast Cancer Predictive Genetic Testing Market Analysis by Countries

Chapter Nine: Middle East and Africa Breast Cancer Predictive Genetic Testing Market Analysis by Countries

Chapter Ten: South America Breast Cancer Predictive Genetic Testing Market Analysis by Countries

Chapter Eleven: Global Breast Cancer Predictive Genetic Testing Market Segment by Types

Chapter Twelve: Global Breast Cancer Predictive Genetic Testing Market Segment by Applications12.1 Global Breast Cancer Predictive Genetic Testing Sales, Revenue and Market Share by Applications (2015-2020)12.1.1 Global Breast Cancer Predictive Genetic Testing Sales and Market Share by Applications (2015-2020)12.1.2 Global Breast Cancer Predictive Genetic Testing Revenue and Market Share by Applications (2015-2020)12.2 Hospitals Sales, Revenue and Growth Rate (2015-2020)12.3 Clinics Sales, Revenue and Growth Rate (2015-2020)12.4 Other Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Breast Cancer Predictive Genetic Testing Market Forecast by Regions (2020-2026)continued

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List of tablesList of Tables and FiguresTable Global Breast Cancer Predictive Genetic Testing Market Size Growth Rate by Type (2020-2026)Figure Global Breast Cancer Predictive Genetic Testing Market Share by Type in 2019 & 2026Figure High Penetrant Genes FeaturesFigure Intermediate Penetrant Genes FeaturesFigure Low Penetrant Genes FeaturesTable Global Breast Cancer Predictive Genetic Testing Market Size Growth by Application (2020-2026)Figure Global Breast Cancer Predictive Genetic Testing Market Share by Application in 2019 & 2026Figure Hospitals DescriptionFigure Clinics DescriptionFigure Other DescriptionFigure Global COVID-19 Status OverviewTable Influence of COVID-19 Outbreak on Breast Cancer Predictive Genetic Testing Industry DevelopmentTable SWOT AnalysisFigure Porters Five Forces AnalysisFigure Global Breast Cancer Predictive Genetic Testing Market Size and Growth Rate 2015-2026Table Industry NewsTable Industry PoliciesFigure Value Chain Status of Breast Cancer Predictive Genetic TestingFigure Production Process of Breast Cancer Predictive Genetic TestingFigure Manufacturing Cost Structure of Breast Cancer Predictive Genetic TestingFigure Major Company Analysis (by Business Distribution Base, by Product Type)Table Downstream Major Customer Analysis (by Region)Table OncoCyte Corporation ProfileTable OncoCyte Corporation Production, Value, Price, Gross Margin 2015-2020Table Myriad Genetics ProfileTable Myriad Genetics Production, Value, Price, Gross Margin 2015-2020Table Thermo Fisher Scientific ProfileTable Thermo Fisher Scientific Production, Value, Price, Gross Margin 2015-2020Table Quest Diagnostics ProfileTable Quest Diagnostics Production, Value, Price, Gross Margin 2015-2020Table Cancer Genetics ProfileTable Cancer Genetics Production, Value, Price, Gross Margin 2015-2020Table Invitae ProfileTable Invitae Production, Value, Price, Gross Margin 2015-2020Table PerkinElmer ProfileTable PerkinElmer Production, Value, Price, Gross Margin 2015-2020Table NeoGenomics ProfileTable NeoGenomics Production, Value, Price, Gross Margin 2015-2020Table Roche ProfileTable Roche Production, Value, Price, Gross Margin 2015-2020Table Iverson Genetics ProfileTable Iverson Genetics Production, Value, Price, Gross Margin 2015-2020Figure Global Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Global Breast Cancer Predictive Genetic Testing Revenue ($) and Growth (2015-2020)Table Global Breast Cancer Predictive Genetic Testing Sales by Regions (2015-2020)Table Global Breast Cancer Predictive Genetic Testing Sales Market Share by Regions (2015-2020)Table Global Breast Cancer Predictive Genetic Testing Revenue ($) by Regions (2015-2020)Table Global Breast Cancer Predictive Genetic Testing Revenue Market Share by Regions (2015-2020)Table Global Breast Cancer Predictive Genetic Testing Revenue Market Share by Regions in 2015Table Global Breast Cancer Predictive Genetic Testing Revenue Market Share by Regions in 2019Figure North America Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Europe Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure South America Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure North America Breast Cancer Predictive Genetic Testing Revenue ($) and Growth (2015-2020)Table North America Breast Cancer Predictive Genetic Testing Sales by Countries (2015-2020)Table North America Breast Cancer Predictive Genetic Testing Sales Market Share by Countries (2015-2020)Figure North America Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2015Figure North America Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2019Table North America Breast Cancer Predictive Genetic Testing Revenue ($) by Countries (2015-2020)Table North America Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries (2015-2020)Figure North America Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2015Figure North America Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2019Figure United States Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Canada Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Mexico Breast Cancer Predictive Genetic Testing Sales and Growth (2015-2020)Figure Europe Breast Cancer Predictive Genetic Testing Revenue ($) Growth (2015-2020)Table Europe Breast Cancer Predictive Genetic Testing Sales by Countries (2015-2020)Table Europe Breast Cancer Predictive Genetic Testing Sales Market Share by Countries (2015-2020)Figure Europe Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2015Figure Europe Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2019Table Europe Breast Cancer Predictive Genetic Testing Revenue ($) by Countries (2015-2020)Table Europe Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Europe Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2015Figure Europe Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2019Figure Germany Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure UK Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure France Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Italy Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Spain Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Russia Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Revenue ($) and Growth (2015-2020)Table Asia-Pacific Breast Cancer Predictive Genetic Testing Sales by Countries (2015-2020)Table Asia-Pacific Breast Cancer Predictive Genetic Testing Sales Market Share by Countries (2015-2020)Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2015Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Sales Market Share by Countries in 2019Table Asia-Pacific Breast Cancer Predictive Genetic Testing Revenue ($) by Countries (2015-2020)Table Asia-Pacific Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2015Figure Asia-Pacific Breast Cancer Predictive Genetic Testing Revenue Market Share by Countries in 2019Figure China Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Japan Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure South Korea Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Australia Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure India Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Southeast Asia Breast Cancer Predictive Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Breast Cancer Predictive Genetic Testing Revenue ($) and Growth (2015-2020)continued

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Impact Of Covid-19 on Breast Cancer Predictive Genetic Testing Market 2020 Industry Challenges, Business Overview and Forecast Research Study 2026 -...

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Princeton Aug 6, 2020 (Thomson StreetEvents) -- Edited Transcript of Iveric Bio Inc earnings conference call or presentation Wednesday, August 5, 2020 at 12:00:00pm GMT

* David F. Carroll

IVERIC bio, Inc. - Senior VP, CFO & Treasurer

* Glenn P. Sblendorio

IVERIC bio, Inc. - CEO, President & Director

IVERIC bio, Inc. - VP of IR & Corporate Communications

* Kourous A. Rezaei

IVERIC bio, Inc. - Senior VP & Chief Medical Officer

* Pravin U. Dugel

IVERIC bio, Inc. - Executive VP and Chief Strategy & Business Officer

Wedbush Securities Inc., Research Division - MD & Head of Healthcare of Equity Research

Good day, and welcome to the IVERIC bio Second Quarter 2020 Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Kathy Galante. Please go ahead.

Kathy Galante, IVERIC bio, Inc. - VP of IR & Corporate Communications [2]

Good morning, and welcome to IVERIC bio's conference call. Representing IVERIC bio today are Mr. Glenn Sblendorio, Chief Executive Officer and President; Dr. David Guyer, Executive Chairman; Mr. Dave Carroll, Chief Financial Officer; Dr. Pravin Dugel, Chief Strategy and Business Officer; Dr. Kourous Rezaei, Chief Medical Officer; Dr. Abraham Scaria, Chief Scientific Officer; and Mr. Keith Westby, Chief Operating Officer.

I would like to remind you that today, we will be making statements relating to IVERIC bio's future expectations regarding operational, financial and research and development matters, including statements regarding the impact of the COVID-19 pandemic on our research and development programs, operations and financial position and on the practices of retinal physicians and the conduct of clinical trials, our expectations to use GATHER1, our previously announced clinical trial for Zimura for the treatment of geographic atrophy as a Phase III clinical trial, our development and regulatory strategy for Zimura and our other product candidates, including our expectations for a second Phase III clinical trial, GATHER2, evaluating Zimura for the treatment of geographic atrophy and our expectations of our Phase IIb screening trial evaluating Zimura for the treatment of autosomal recessive Stargardt disease, our hypothesis regarding complement and the HtrA1 inhibition as a mechanism of action for the treatment of geographic atrophy and potentially other retinal diseases.

Our projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, the potentiality and development potential of our product candidates, the size of the potential market for indications our product candidates are intended to treat and the potential of our business development strategy.

These statements constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward-looking statements, including risks relating to the future progression of the COVID-19 pandemic and its impact on our research and development program, operations and financial position, initiation of the progress of research and development programs and clinical trials; availability of data from these programs; reliance on contract development and manufacturing organization, university collaborators and other third parties; establishment of manufacturing capabilities; expectations for regulatory matters; need for additional financing and negotiation and consummation of business development transactions and other risks.

I refer you to our SEC filings and in particular to the risk factors included in our current report on Form 8-K filed on June 17, 2020, for a detailed description of the risk factors affecting our business. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we disclaim any obligation to do so, except as required by law.

I will now turn the call over to Glenn.

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Glenn P. Sblendorio, IVERIC bio, Inc. - CEO, President & Director [3]

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Thanks, Kathy, and good morning, everyone. We appreciate and thank you for joining our call this morning. First, I hope you and your families are safe and healthy as we continue to navigate through these very challenging times. Here at IVERIC, we are very pleased with the level of execution we have achieved during the second quarter. We are thrilled to have reached another major milestone with Zimura.

In June, we announced positive 18-month results from GATHER1. Our first Phase III clinical trial for Zimura, a novel complement C5 inhibitor for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration or AMD. The GATHER acronym for Zimura Phase III clinical trials represents GA therapy. The 18-month results from GATHER1 indicated continuous Zimura treatment benefit with a favorable safety profile in patients with GA secondary to AMD. We think this is an impressive achievement since we believe GATHER1 is currently the only Phase III clinical trial showing suppression of GA growth with continuous treatment for 18 months.

Shortly following the positive results from GATHER1, we initiated patient enrollment in GATHER2, our second Phase III clinical trial for Zimura for the treatment of GA secondary to AMD. Our main priority is to aggressively drive patient recruitment and retention in the GATHER2 clinical trial. If the primary endpoint is achieved at month 12, we intend to file for approval of Zimura with the U.S. Food and Drug Administration and the European Medicines Agency.

The initiation of patient enrollment in GATHER2 brings us another step closer to potentially delivering a clinical meaningful therapy safely to patients with GA, where there is currently no treatment. We continue to work closely with the FDA, and we are pleased to receive FDA fast-track designation for Zimura for the treatment of GA secondary to AMD. In addition to the complement systems' potential role in GA and Stargardt disease, we believe, based on scientific data, that Zimura may have potentially -- may have a potentially impactful role in treating intermediate AMD as well as wet AMD. We believe there is strong scientific rationale to support the development of Zimura in multiple forms of AMD early and advanced, dry and wet.

We believe HtrA1, or high-temperature requirement A serine peptidase protein 1, could be another important target in the treatment of AMD. We called this program IC-500. HtrA1 is a small molecule inhibitor that is a promising compound in our pipeline. HtrA1 up-regulation has been implicated as a strong risk factor in the development of dry AMD. We are particularly encouraged by IC-500's ability to engage the target, both extra and intracellularly in early preclinical work.

Based on current time lines, we are planning to submit an IND to the U.S. FDA for IC-500 in GA secondary to AMD in 2021. Although bringing to more, to patients is our top priority, we continue to focus on our gene therapy program in orphan inherited retinal diseases. Kourous will review the details of our gene therapy pipeline in a few moments.

Following the positive GATHER1 18-month data, we strengthened our balance sheet with an underwritten public offering and a concurrent private placement with Vivo Capital and Samsara BioCapital, raising approximately $160 million in gross proceeds. Dave will cover our cash runway later in this call. We believe this fundraising enables us to further execute on our strategy to develop and deliver retinal treatments through our Zimura -- through Zimura, our gene therapy programs and IC-500 with potential to create long-term shareholder value.

At the beginning of the second quarter, we welcomed Dr. Pravin Dugel, who many of you know, to IVERIC bio. Pravin is a globally recognized retinal specialist, who has an extensive network and long-standing relationships with the bio and pharma ophthalmic industry. As our Executive Vice President and Chief Strategy and Business Officer, Pravin's experience and network will be instrumental in helping us build alliances with potential future collaborators, investors and other stakeholders. Pravin is helping to lead the company's strategy as we advance our portfolio of therapeutics and gene therapy R&D programs targeting multiple retinal diseases.

In July, we had the privilege of announcing the addition of Dr. Mark Blumenkranz to our Board of Directors. Mark is a biotech industry leader and internationally known vitreoretinal specialist, with a notable expertise in pharmaceuticals for age-related macular degeneration and ocular gene therapy. Mark has cofounded multiple biotech and medical technology companies. His experience and expertise in leading and building biotech companies, this further strengthens our Board. I'd now like to turn the call over to Pravin.

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Pravin U. Dugel, IVERIC bio, Inc. - Executive VP and Chief Strategy & Business Officer [4]

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Good morning, everyone. I hope you're all well. Thank you, Glenn, for the kind introduction. And this is an exciting time at the company. And it is my great pleasure to work closely with Glenn, David, Kourous and all my new colleagues. We are very excited by these 18-month GATHER1 results. This is a significant milestone for Zimura and potentially a significant advancement for patients with GA secondary to AMD.

We believe the 18-month data that we reported this past June further validates our 12-month results regarding Zimura's continuous positive treatment effect with a favorable safety profile in GA secondary to AMD and highlights the potential role of complement C5 inhibition in this disease. In the GATHER1 clinical trial, Zimura met its prespecified primary efficacy endpoint at 12 months and reached statistical significance in the international multicenter randomized, double-masked, sham-controlled Phase III clinical trial in GA secondary to AMD.

The reduction in the mean rate of GA growth over 12 months was 27.38% with a p-value of 0.0072 for the Zimura 2-milligram group as compared to the corresponding sham control group and 27.81% with a p-value of 0.0051 for the Zimura 4-milligram group as compared to the corresponding sham control group. These data for both dose groups were statistically significant. These positive 12-month data are further supported by the 18-month results, which we reported in June.

Over 18 months, the reduction in the mean rate of GA growth was 28.11% for the Zimura 2-milligram group as compared to its corresponding sham group and 29.97% for the Zimura 4-milligram group as compared to its corresponding sham control group. The primary efficacy endpoint was prespecified at 12 months using all of the power to detect a statistically significant difference. Therefore, the p-values at the 12-month statistical analyses are descriptive in nature. The descriptive p-value for the treatment effects at month 12 were a p-value of 0.0014 for the Zimura 2-milligram group and a p-value of 0.0021 for the Zimura 4-milligram group.

We believe having 18-month positive data with continuous treatment is a key differentiating factor for us when compared to other product candidates being developed for GA. Another key differentiating factor for this trial is that the treatment effect was observed in the very first measurement at 6 months with an increasing absolute difference between the treated group and the sham at each subsequent measurement time point. In other words, if these results are replicated in GATHER2 trials, we believe a doctor would be able to tell his or her patient that this drug has been -- has shown an effect as early as 6 months and then may have an increasing effect with every subsequent injection thereafter.

We do not believe this impactful efficacy profile has been observed in any other GA clinical trial to date. Zimura's favorable safety profile, another potential differentiating factor was maintained throughout the 18-month trial with no investigator-reported Zimura-related adverse events, no cases of endophthalmitis and no Zimura-related inflammation. The reported incidence of CNV in the untreated fellow eye was 11 patients, 3.8%; and in the study eye was 3 patients, 2.7% in the sham control group; 2 patients, 7.7% in the Zimura 1 milligram group; 8 patients, 11.9% in the Zimura 2-milligram group; and 13 patients, 15.7% in the Zimura 4-milligram group.

Note, we believe these rates of CNV were lower than what has been published for C3 inhibition, despite the fact that there were more Zimura injections administered over a longer period of time in a patient population with faster progressing disease. This is particularly the case when you look at the ratios of the incidents in the treated arms versus sham. The most frequently reported ocular adverse events in GATHER1 were related to the injection procedure and not the drug.

These GATHER1 reports are from the pre-COVID era, making the trial what we believe is the only pure pre-COVID positive Phase III clinical trial in GA. We believe there is a new environment for clinical trial execution and that the robust data from GATHER1 may help drive recruitment and retention of patients in GATHER2 and any future trials we may conduct for Zimura.

In the challenging COVID-19 pandemic era, we believe that investigators will be more enthusiastic and comfortable recruiting and retaining patients in a clinical trial with a drug that already has high-quality positive Phase III data. We recognize the challenges that retinal physicians face with their practices and conducting clinical trials in the COVID era, and we're working closely to support collaborating physicians. Kourous will discuss how we plan to leverage the quality of the GATHER1 results to maximize patient recruitment and retention for GATHER2 Phase III clinical trial.

Turning to our business development. We plan to continue our aggressive, but selective efforts as we continue to explore our options for future development and potential commercialization of Zimura, including potential out-license and collaboration opportunities.

Thank you for your time. I will now turn the call over to Kourous.

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Kourous A. Rezaei, IVERIC bio, Inc. - Senior VP & Chief Medical Officer [5]

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Thank you, Pravin, and good morning, everyone. We are excited to have the robust Zimura GATHER1 results presented at the association for Research in Vision and Ophthalmology, Arvo Annual Meeting by Dr. Karl Csaky, T. Boone Pickens' Senior Scientist and Director of the Molecular Ophthalmology Laboratory at the Retina Foundation of the Southwest and also presented at the American Society of Retina Specialists, ASRS Annual Meeting run 2 weeks ago by Dr. Baruch Kuppermann, Chairman of the Department of Ophthalmology at the University of California Irvine.

In the coming months, we are planning for our data to be presented by key opinion leaders at the major retina meeting in the U.S. and around the world. The positive GATHER1 clinical trial data has ignited a significant enthusiasm in our investigators to participate and enroll patients in the GATHER2 clinical trial. Further, we believe that the early onset and continuous treatment effect demonstrated in the GATHER1 clinical trial will be a key motivator for retention in the GATHER2 trial.

Our experienced clinical trial team has worked tirelessly in the past few months to support the smooth and expeditious initiation of the GATHER2 clinical trial. Some of these efforts include hosting multiple virtual websites with investigators and study coordinators in the U.S. and around the world. Frequent communications with the clinical trial site coordinators to assess and support their preparedness for COVID-19 and minimizing any potential disruption.

Making arrangements for patients to remotely perform certain trial-related tasks to minimize the time spent by the patients at the clinical trial sites and to reduce their exposure risk and ensure a safe environment for our patients. We thank all our principal investigators and their staff for their enthusiasm and support for the GATHER2 clinical trial.

Now I would like to provide some details regarding the design of the GATHER2 trial. GATHER2 is an international randomized, double-masked, sham-controlled, multicenter Phase III clinical trial, evaluating the safety and efficacy of Zimura 2-milligram in patients with geographic atrophy secondary to age-related macular degeneration. We are planning to enroll approximately 400 patients in this clinical trial.

Patients will be randomized 1:1 into 2 cohorts. The first cohort receiving monthly administration of Zimura 2-milligram for 12 months and the second cohort receiving monthly administration of sham. The prespecified primary efficacy endpoint is the mean rate of change in geographic atrophy growth over 12 months, measured by fundus autofluorescence at 3 time points; baseline, month 6 and month 12, very similar to the GATHER1 clinical trial.

If the primary efficacy endpoint is met at month 12, we are planning to file for marketing approval of Zimura for the treatment of geographic atrophy, secondary to age-related macular degeneration with the FDA and EMA. At month 12, we plan to re-randomize patients in the Zimura 2-milligram arm to receive either monthly or every-other-month administrations of Zimura 2-milligram. The final safety evaluation will be performed at month 24 for all patients.

Turning now to Stargardt disease. We currently have an ongoing Phase IIb screening clinical trial assessing the safety and efficacy of Zimura in patients with autosomal recessive Stargardt disease. Initially, we enrolled 95 patients in this trial. We have reopened the enrollment in this trial to add approximately 25 patients with the goal of enrolling a total of 120 patients as was initially intended in the protocol for this trial. We remain masked for this trial and plan to perform data analysis when all the patients have reached the month-18 time points.

Regarding our gene therapy programs, we continue with our IND-enabling activities and natural history studies for IC-100, our product candidate for rhodopsin-mediated autosomal-dominant retinitis pigmentosa and are planning to initiate the Phase I/II clinical trial for the first half of 2021. We also continue with the IND-enabling activity and natural history studies for IC-200, our product candidate for BEST1-related retinal diseases and are planning to initiate the Phase I/II clinical trial next year in 2021.

Our minigene programs continue to move forward. We are currently optimizing the minigene construct for our miniCEP290 program and plan to select the leads construct later this year. Thank you for your time. And please stay safe. I will now turn the call over to Dave. Dave?

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David F. Carroll, IVERIC bio, Inc. - Senior VP, CFO & Treasurer [6]

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Thank you, Kourous, and good morning, everyone. I'd like to highlight a few items from our press release this morning and also update our year-end cash guidance and our expected cash runway.

For the quarter, our net loss totaled $18.6 million or $0.32 per share compared to a net loss of $14.4 million or $0.35 per share for Q2 2019. This increase in net loss was driven primarily by an increase in R&D expenses, offset by a favorable settlement of a state income tax audit. Year-to-date, our net loss totaled $33.7 million or $0.61 per share compared to a net loss of $26.9 million or $0.65 per share for the same period in 2019, again, due to an increase in R&D expenses offset by a favorable settlement of the state tax audits.

Turning to our expected year-end cash balance and cash runway. We raised approximately $150 million in our June 2020 public offering and concurrent private placement. We now expect our year-end cash balance will range between $215 million and $220 million. We estimate that our cash will be sufficient to fund our capital expenditures and operating expenses as currently planned for at least mid-2024, excluding any potential approval or sales milestones payable to the Archimex Corp. or any potential commercialization expenses towards Zimura.

These estimates are based on our current business plan, which includes the continuation of our clinical development programs for Zimura, the progression of IC-100 and 200 gene therapy programs into the clinic and the advancement of our IC-500 development program. Our estimates assume that we will enroll approximately 400 patients for the GATHER2 trial. If facts and circumstances change, we'll adjust our guidance accordingly. Of course, these estimates do not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or any associated development that the company may pursue.

I'll now turn the call back over to Glenn. Thank you for your time.

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Glenn P. Sblendorio, IVERIC bio, Inc. - CEO, President & Director [7]

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Thanks, Dave, and I appreciate that. So just to recap the second quarter, despite these very challenging times, it was a good quarter for IVERIC bio.

There's a number of key takeaways: we completed our 18-month results for GATHER1. And as you've seen and we discussed today, with continuous effect and a good safety profile; second, we raised $160 million in gross proceeds, further strengthening our balance sheet and adding to our cash run normally; and third, although it was a difficult discussion back in March when we decided to pause the GATHER2 trial, we have now begun that trial and are recruiting patients.

So a good quarter for us. So I'd like to thank all of you for listening today to our call and for your continued support. And now I'll turn the call over to the operator so that we can open up the line for any questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

We will now take our first question from Stacy Ku of Cowen.

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Stacy Ku, Cowen and Company, LLC, Research Division - Equity Research Associate [2]

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Congratulations on the progress. So first question, given the time spent for sites in GATHER2 for Phase III and the recent trial initiation, how should we be thinking about the pace of enrollment? Would you be willing to give us some guidance on timing?

And my second question is around something that was briefly touched upon during your prepared remarks, but curious if you could elaborate what the team is thinking in terms of potential ex-U. S. partnerships. When would you ramp up these conversations?

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Glenn P. Sblendorio, IVERIC bio, Inc. - CEO, President & Director [3]

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Thank you, Stacy. It's Glenn, and thanks for the questions. First, on the timing for GATHER2, I mentioned a couple of things. It's early days and this is also a very competitive environment. And I think you've seen our execution in the past. So while we are dealing with a unique situation here with COVID, and I think as we've updated you through the second quarter, we've kept a very active and continuous dialogue with the investigators.

So at the current time, we're not going to provide any guidance as to when we finish the trial. So -- but we will continue to move at a pace that's as quick as we can. The key to that success will be the number of sites, the quality of the sites and obviously, the patient enrollment. So I am going to provide you detailed guidance at this point and the fact that we've got a pretty experienced team doing this.

As for the second question as it relates to collaborations. I think Pravin and his prepared statements did talk about that. Again, priority one for us today is the recruitment and retention of patients in GATHER2, but we are going to continue to explore our options for potential commercialization of Zimura, including a potential our-license. As you know, we do not have operations overseas even with the successful capital raise in a small company. So partnership at the right time will be an important part of our efforts to commercialize Zimura. Thanks for the calls -- thanks for the questions, Stacy.

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Operator [4]

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And we will now take our next question from David Nierengarten of Wedbush.

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David Matthew Nierengarten, Wedbush Securities Inc., Research Division - MD & Head of Healthcare of Equity Research [5]

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I'm sorry. I was on mute. Apologies. A couple of questions from me. First off, the...

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Glenn P. Sblendorio, IVERIC bio, Inc. - CEO, President & Director [6]

Originally posted here:
Edited Transcript of ISEE.OQ earnings conference call or presentation 5-Aug-20 12:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Physical pain is unpleasant, yet its vital for survival because its a warning that your body is in danger. It tells you to take your hand off a hot burner or to see a doctor about discomfort in your chest. Pain reminds us all that we need to take care of ourselves.

Feeling lonely is the social equivalent to feeling physical pain. It even triggers the same pathways in the brain that are involved in processing emotional responses to physical pain.

Just like feeling physical pain, feeling lonely and disconnected from others is also a signal that we need to take care of ourselves by seeking the safety and comfort of companionship. But what happens when we are unable to find companionship and the loneliness persists?

As scholars at the Center for Healthy Aging at Penn State, we study the impact of stress on the aging body and brain, including how it can worsen cognitive decline and risk for dementia. The social isolation older adults are experiencing now amid the coronavirus pandemic is raising new mental health risks, but there are things people can do to protect themselves.

The health consequences of loneliness

The COVID-19 pandemic has put many older adults social lives on hold, leaving them at greater risk for loneliness. They know they face a higher risk of developing severe symptoms from COVID-19, so many are staying home. Restaurant closures and limits on visitors to assisted living centers have made it harder to see family and friends.

But even prior to the pandemic, public health experts were concerned about the prevalence and health impacts of loneliness in the U.S. Loneliness affects between 19% and 43% of adults ages 60 and older, and many adults ages 50 and over are at risk of poor health from prolonged loneliness.

Research has shown that prolonged loneliness is associated with increased risk for premature death, similar to smoking, alcohol consumption and obesity. Other health consequences are also associated with loneliness, including elevated risk for heart disease and stroke, and it is associated with increased physician visits and emergency room visits.

Loneliness can affect brain health and mental sharpness

Older adults who are socially isolated or feel lonely also tend to perform worse on tests of thinking abilities, especially when required to process information rapidly. And those who feel lonely show more rapid decline in performance on these same tests over several years of follow-up testing.

It is thought that loneliness may contribute to cognitive decline through multiple pathways, including physical inactivity, symptoms of depression, poor sleep and increased blood pressure and inflammation.

Loneliness has also been found to increase the risk of developing dementia by as much as 20%. In fact, loneliness has an influence similar to other more well-established dementia risk factors such as diabetes, hypertension, physical inactivity and hearing loss.

Although the underlying neural mechanisms are not fully understood, loneliness has been linked with the two key brain changes that occur in Alzheimers disease: the buildup of beta-amyloid and tau proteins in the brain. Other indicators of psychological distress, such as repetitive negative thinking, have also be linked with the buildup of beta-amyloid and tau in the brain. Theories suggest that loneliness and other psychological stressors act to chronically trigger the biological stress response, which in turn appears to increase beta-amyloid and tau accumulation in the brain.

How loneliness can contribute to disease

The evidence suggests that prolonged feelings of loneliness are detrimental to health. So, how do those feelings get converted into disease?

Feeling lonely and socially isolated can contribute to unhealthy behaviors such as getting too little exercise, drinking too much alcohol and smoking.

Loneliness is also an important social stressor that can activate the bodys stress responses. When prolonged, that response can lead to increased inflammation and reduced immunity, particularly in older adults. Inflammation is the bodys response to fight off infection or heal an injury, but when it continues unchecked it can have a harmful impact on health. Stress hormones play an important role in making sure that inflammation doesnt get out of control. But, under chronic stress, the body becomes less sensitive to the effects of the stress hormones, leading to increased inflammation and eventually disease.

In healthy older people, loneliness is related to a stress hormone pattern similar to that of people who are under chronic stress. This altered pattern in the stress response explained why people who were lonelier had poorer attention, reasoning and memory ability.

Social activity can buffer against the decline

Maintaining high quality relationships may be a key for protecting brain health from the negative impacts of loneliness.

Older adults who feel more satisfied in their relationships have a 23% lower risk of dementia, while those who feel their relationships are supportive have a 55% lower risk of dementia, compared to those who feel dissatisfied or unsupported in their relationships.

Maintaining social activity also buffers against decline in thinking abilities, even for those who live alone or who have signs of beta-amyloid accumulation in their brain. One reason for these benefits to brain health is that maintaining strong social ties and cultivating satisfying relationships may help people to cope better with stress; people who feel better able to cope with difficulties or bounce back after a stressful event show less buildup of tau protein in their brains.

This is good news because, with the importance of social distancing for controlling the COVID-19 pandemic, how people manage their feelings and relationships is likely more important for brain health than the fact that they are spending time physically apart.

[Get our best science, health and technology stories. Sign up for The Conversations science newsletter.]

Strategies for coping with loneliness

Loneliness is a common and normal human experience. An important first step is to recognize this and accept that what you are feeling is part of being human.

Rather than focusing on whats not possible at the moment, try to refocus your attention on what you can do to stay connected and make a plan to take action. This could include planning to reach out to friends or family, or trying new activities at home that you normally wouldnt have time for, such as online classes or book clubs.

During times of high stress, self-care is essential. Following recommendations to maintain regular exercise and sleep routines, healthy eating and continuing to engage in enjoyable activities will help to manage stress and maintain mental and physical health.

Karra Harrington, Postdoctoral Research Fellow, Clinical Psychologist, Pennsylvania State University

Martin J. Sliwinski, Professor of Human Development and Family Studies, Director of the Center for Healthy Aging, Pennsylvania State University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Image: Reuters

Read more:
Social Isolation is Raising New Mental Health Risks in Older Adults - The National Interest

Recommendation and review posted by Bethany Smith

There are many different reasons why you may experience nausea. Sometimes it is due to an underlying medical condition. Other times, nausea may occur as a result of motion sickness or eating too much.

In many of these cases, taking anti-nausea medication can help relieve your symptoms quickly. But which medicine you should take depends on what's causing your nausea.

The most common causes of nausea include:

If you know you're going to be nauseous in advance, you can prevent it by taking medication beforehand. So, for example, if you know you're prone to get nausea on airplanes, you should take medication approximately half an hour before your flight takes off.

Here are the most common types of anti-nausea medicine for motion sickness:

Motion sickness medications work best when taken before the activity that may cause motion sickness, Devine says, so it won't help as much to take it after you feel nauseous.

Nausea caused by acid reflux is best resolved by treating the acid reflux itself, Devine says. The two major classes of medication to treat acid reflux are:

These are prescription medications, but some of them are available over-the-counter at lower strength doses. You should contact your doctor if you experience symptoms of acid reflux, like heartburn and nausea, that persist for seven days even with over-the-counter treatment.

Nausea during pregnancy typically subsides in the second trimester, though there are some people who experience it for longer, or who may have an extreme version, known as hyperemesis gravidarum.

Pyridoxine (Vitamin B6) is a common over-the-counter anti-nausea medication deemed safe during pregnancy, Devine says. However, the kind of anti-nausea medication or treatment best suited for a pregnant person depends on the severity of their nausea and other individual factors.

Some anti-nausea medications may impact fetal development, so if you think you may need anti-nausea medication, it's important to discuss options with your obstetrician first.

If you experience severe, recurrent episodes of nausea without a clear underlying cause your doctor may prescribe medications that act on histamine, dopamine, or serotonin receptors in the brain.

These prescription medications can help treat acute episodes of nausea or prevent future episodes. Examples include:

Common side effects of anti-nausea medication include:

Most medications to treat nausea are safe, Devine says, but there are cases where anti-nausea medication may not be a good idea. Some common anti-nausea medications, like those acting on dopamine and serotonin receptors, can affect electrical rhythms of the heart.

These medications are typically not recommended for people with a history of heart conditions or those on other medications with potential side effects of heart rhythm abnormalities.

Talk with your doctor about the best anti-nausea medication for your symptoms. Together, you can develop a treatment plan to prevent and treat your nausea.

"No one should have to suffer with frequent nausea and vomiting," Devine says. "In the overwhelming majority of cases, nausea can be well managed with a combination of lifestyle, dietary, and medication therapies."

For more information, learn about the best home remedies for nausea.

Go here to read the rest:
The best types of medicine for nausea and which is right for you - Insider - INSIDER

Recommendation and review posted by Bethany Smith

When looking into the connection between vitamin D and weight loss, researchers often use supplements in their studies, rather than tracking a subjects sun exposure or food.

Thats because pills are standardized and can be given in high doses to quickly up a study participants vitamin D level. For example, a study published in July 2018 in the International Journal of Preventive Medicine gave subjects who were overweight or had obesity 50,000 IU of vitamin D (an amount well above the recommended limit of 4,000 IU per day, or 28,000 IU per week, per the NIH) each week for six weeks. Researchers found in this small study that the subjects weight, BMI, waist circumference, and hip circumference all decreased significantly, and their vitamin D levels increased significantly, after taking this high vitamin D supplement regime. However, thats not a safe amount of vitamin D to take for weight loss (or any other reason) in the real world.

Although scientists havent done much research on eating vitamin D-rich foods and weight loss, theyre definitely still worth consuming. What we know is that foods high in D tend to be healthy anyways salmon, mackerel, mushrooms, vitamin D-fortified milk, which are part of a healthier diet, versus processed foods so consuming these would likely help with weight loss, says Agarwal.

And while researchers dont typically track sun exposure, getting a little sun the old-fashioned way isnt a bad idea, but its important to not overdose on sun, which can up your risk of skin cancer, according to Harvard Health Publishing.

More:
Can Taking a Vitamin D Supplement Help You Lose Weight? - Everyday Health

Recommendation and review posted by Bethany Smith

Nausea refers to feelings of queasiness often with the urge to vomit. Symptoms of nausea include sweating, a rush of saliva in the mouth, fatigue, and loss of appetite.

While it's often associated with acid reflux and over-eating, nausea can also occur during pregnancy, with motion sickness, or as a side effect of other medical disorders or common illnesses.

There are many anti-nausea medications that can help with severe or persistent nausea. But if your nausea is mild or occasional, there are also a number of effective home remedies that can help relieve your symptoms naturally.

Ginger is an effective remedy for nausea, says Daniel Devine, MD, internal medicine doctor and geriatrician at Devine Concierge Medicine, a primary care practice in Philadelphia.

That's because ginger has anti-inflammatory properties, which can support digestion, and its compounds are also thought to speed up the process of stomach contents moving into the small intestine, which can reduce symptoms of nausea.

A 2014 analysis of six different studies published in the Journal of the American Board of Family Medicine examining the use of ginger in pregnancy found that taking about one gram of ginger once a day for at least five days decreased symptoms of nausea and vomiting in early pregnancy. Studies have also found that ginger can be effective in managing nausea and vomiting symptoms for chemotherapy patients.

Ginger can be taken as a supplement, sold as capsules. You can also add pieces of whole, fresh ginger to your tea, or include it as a spice or seasoning in your food.

Peppermint has long been regarded as a traditional remedy for nausea, though the scientific evidence on its efficacy is not as robust as it is for ginger, Devine says. Still, many people swear by its calming properties.

The main ingredient in peppermint, menthol, is thought to relax the stomach, which can alleviate cramping and nausea.

One small study from 2014 published in the Journal of Perianesthesia Nursing suggested that even the scent of peppermint oil can alleviate nausea, but more research is needed to determine whether it is an effective remedy.

However, if you experience both nausea and vomiting, peppermint may not be very effective, since it is primarily used to treat nausea and not episodes of vomiting.

If you want to give peppermint a try, you can buy it as a tea or diffuse peppermint essential oil for aromatherapy by adding two to three drops of peppermint oil to a diffuser filled with water.

Eating too much can cause nausea, Devine says. That's because when you eat too much, it stretches the stomach, resulting in bloating, heartburn, and excessive digestive movement all of which can lead to nausea.

Eating small, frequent meals and consuming a bland diet without strong flavors can be helpful in reducing episodes of nausea, Devine says. Bland foods are easy to digest and can help settle your stomach.

Bland foods that can help with nausea include:

If you're feeling queasy, you should avoid spicy food and acidic beverages like soda, juice, or alcohol all of which can exacerbate nausea symptoms. You may even want to consider trying the BRAT diet when you feel nauseous.

It may be hard to eat or drink anything when you have nausea including water. But according to Devine, dehydration will only make your nausea worse.

This can be especially important if you're experiencing nausea as a result of extreme heat or humidity. In fact, nausea and vomiting are some of the main symptoms of heat exhaustion and heatstroke.

Overheating causes your blood vessels to dilate as your body tries to cool itself down and this change in blood pressure can manifest as nausea or dizziness. But if you drink lots of water and stay hydrated, it will help you cool down and return to a normal body temperature.

If drinking water is a challenge for you with nausea, you should take small sips throughout the day or try a soothing beverage like warm peppermint tea.

For more information, read about how much water you should be drinking each day to stay hydrated.

When you feel queasy, you might be tempted to lay down, but this actually isn't the best idea. Lying flat while nauseous could lead to vomiting, Devine says.

"It is important to use gravity to your advantage and keep your head inclined above your stomach," Devine says.

By staying upright, gravity helps keep your stomach contents down. Sitting down in an upright position or lying down with your head propped up on a couple pillows is the best choice if you're hoping to relieve nausea.

Acupressure is an alternative medicine practice of applying pressure to certain points on the body, known as meridians. The idea is that by putting pressure on these places, you send a message to the body to turn on its self-healing mechanisms, which may alleviate pain or nausea.

A 2006 review of more than 40 trials published in the journal Autonomic Neuroscience found that acupressure can reduce some symptoms of nausea.

One of the main pressure points for nausea is called the Pericardium 6, or Neiguan, located near your wrist. This pressure point is thought to alleviate nausea because the meridian pathway of this point travels up the arm, into the chest and upper abdomen, near the stomach.

Here's how to locate P6 and use this pressure point:

If nausea is associated with frequent episodes of vomiting, chest pain, or comes with dark stools or dark vomit, you should reach out to your doctor, Devine says. And if nausea persists for more than a couple days, or if the symptoms are quickly worsening, that could also be a sign that something more serious is going on.

For example, conditions like pancreatitis, bowel obstructions, or even a heart attack can cause nausea and will require medical attention.

Some people are also more prone to nausea due to certain conditions. These include:

Nausea can feel uncomfortable, but it is generally very manageable with the right approach. If you can't get rid of nausea with these natural home remedies, check in with your doctor, who can work with you to develop a treatment plan.

More here:
6 natural home remedies to get rid of nausea - Insider - INSIDER

Recommendation and review posted by Bethany Smith

New Jersey, United States Direct-To-Consumer (DTC) Genetic Testing Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2026Presented byVerified Market Researchpresents a broad and elementary study of the market giving point by point coverage of the industry with its major market trends. The report contains the most important industry information while highlighting essential and valuable data. The report highlights inside and out research on market size, the development condition, advancement pattern, activity situation, and future advancement trends of the Direct-To-Consumer (DTC) Genetic Testing Market. It offers learning of various factors like Direct-To-Consumer (DTC) Genetic Testing Market growth, consumption volume, and business price structures throughout the forecast amount from 2020 to 2026. This research will also help makers and venture associations to higher handle the occasion course of the market.

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Recommendation and review posted by Bethany Smith

LONDON--(BUSINESS WIRE)--Aug 5, 2020--

GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world. i

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease. BLENREP is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.

BLENREP is GSKs fifth major medicine approval in 2020 across areas of significant unmet medical need such as cancer, HIV and chronic kidney disease. This approval marks the second FDA approval for GSKs oncology portfolio in four months.

BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells. ii The approval of BLENREP was based on six-month primary results from the pivotal DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current standard of care.

Dr. Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University in Atlanta, Georgia, Chair of Emory Department of Hematology and Medical Oncology and Principal Investigator for DREAMM-2, said: While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care. Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of BLENREP, the first anti-BCMA therapy, is significant for both patients and physicians alike.

In the DREAMM-2 study, treatment with single-agent BLENREP 2.5 mg/kg every three weeks demonstrated a clinically meaningful overall response rate (ORR) of 31% (97.5% CI; 21-43) in patients who had received a median of seven prior lines of treatment (n=97). The median duration of response (DoR) had not been reached at the six-month analysis, but 73% of responders had a DoR equal to or greater than six months. The most commonly reported adverse events (20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Keratopathy is characterized as changes in the corneal epithelium as seen on eye examination, which can manifest with or without symptoms.

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Corneal adverse events were monitored with eye exams prior to each dose, allowing for dose reductions or interruptions as appropriate. Patients also used preservative-free eye drops. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the 2.5 mg/kg cohort. iii

BLENREP is available through participation in the BLENREP Risk Evaluation and Mitigation Strategy (REMS), which was developed to ensure appropriate use of the medicine. The program requires education for all physicians prescribing BLENREP and their patients regarding the ocular risks associated with treatment as well as monitoring. Additional information about the BLENREP REMS can be found at http://www.blenreprems.com or 1-855-209-9188.

Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF), said: The approval of BLENREP is an important advancement for patients with relapsed or refractory multiple myeloma, as it brings a much-needed new treatment to patients who face limited options due to their progressing disease. We are grateful for GSKs continued commitment to myeloma patients and their families.

In 2017, BLENREP was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

Making Our Products Affordable and Accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals can access more information about our oncology specific resources on insurance coverage and financial support at: http://www.TogetherwithGSKOncology.com or call: 1-844-4GSK-ONC (1-844-447-5662).

About Multiple Myeloma

Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable. iv In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease. v Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. vi

AboutBLENREP(belantamab mafodotin-blmf)

BLENREP is an antibody drug conjugate comprising a humanized anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

IMPORTANT SAFETY INFORMATION FOR BLENREP

WARNING: OCULAR TOXICITY

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.

Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.

Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).

Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).

Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.

BLENREP REMS:BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity. Notable requirements of the BLENREP REMS include the following:

Further information is available at http://www.BLENREPREMS.com and 1-855-209-9188.

Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.

Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8% . Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.

ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder. Among the 218 patients, 24% were exposed for 6 months or longer.

The safety of BLENREP as a single agent was evaluated in DREAMM-2. Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Among these patients, 22% were exposed for 6 months or longer.

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).

Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation.

Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).

Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%). The most common adverse reactions (20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

USE IN SPECIFIC POPULATIONS

Lactation: There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.

Females and Males of Reproductive Potential: BLENREP can cause fetal harm when administered to pregnant women. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk. No animal reproduction studies were conducted with BLENREP.

Pregnancy Testing: Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.

Infertility: Based on findings in animal studies, BLENREP may impair fertility in females and males. The effects were not reversible in male rats but were reversible in female rats.

Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the patients who received BLENREP at the 2.5-mg/kg dose in DREAMM-2 (n = 95), keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73m 2 as estimated by the Modification of Diet in Renal Disease [MDRD] equation). The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m 2 not on dialysis or requiring dialysis.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin upper limit of normal [ULN] and aspartate aminotransferase (AST) >ULN or total bilirubin 1 to 1.5 ULN and any AST). The recommended dosage of BLENREP has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN and any AST) .

INDICATION

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The full Prescribing Information, including BOXED WARNING and Medication Guide, will be available here.

GSK in Oncology

GSK is focused on maximizing patient survival through transformational medicines. GSKs pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com/about-us.

Editors Note: In addition to the FDAs approval of BLENREP, GSK has received four major medicine approvals to date in 2020 for CABENUVA (cabotegravir and rilpivirine) in Canada, DUVROQ (daprodustat) in Japan and ZEJULA (niraparib) and RUKOBIA (fostemsavir) in the US.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSKs Principal risks and uncertainties section of the Q2 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

References

i NCI Drug Dictionary - Anti-BCMA Antibody-Drug Conjugate GSK2857916. National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916.

Accessed May 2020.

ii Trudel S, Lendvai N, Popat R, et al. Antibodydrug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer Journal. 2019;9(4).

doi:10.1038/s41408-019-0196-6.

iii Lonial, S, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020; 21(2):20721.

iv Estimated number of incident cases worldwide, both sexes, all ages. World Health Organization. https://gco.iarc.fr/ Published 2020. Accessed May 2020.

v SEER Cancer Facts & Figures 2019. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed December 19, 2019.

vi Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20)

View source version on businesswire.com:https://www.businesswire.com/news/home/20200805006105/en/

CONTACT: GSK Inquiries:

Media Inquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)Tim Foley

+44 (0) 20 8047 5502

(London)Kristen Neese

+1 804 217 8147

(Philadelphia)Kathleen Quinn

+1 202 603 5003

(Washington DC)Analyst/Investor Inquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)Sonya Ghobrial

+44 (0) 7392 784784

(Consumer)Danielle Smith

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(London)James Dodwell

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(London)Jeff McLaughlin

+1 215 751 7002

(Philadelphia)Frannie DeFranco

+1 215 751 4855

Original post:
FDA Approves GSK's BLENREP (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma - The Baytown Sun

Recommendation and review posted by Bethany Smith

The latest report published by Regal Intelligence on Hematopoietic Stem Cell Transplantation (HSCT) market provides crucial market insights along with detailed segmentation analysis. The report examines key driving factors that are expected to drive the growth of the market.

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Report on Global Hematopoietic Stem Cell Transplantation (HSCT) Market 2020 comprises of 10 Sections in Table as follows:

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Hematopoietic Stem Cell Transplantation (HSCT) Market 2020: Regen Biopharma Inc, China Cord Blood Corp, CBR Systems Inc, Escape Therapeutics Inc,...

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Detailed Analysis & SWOT analysis, Stem Cell Therapy Market Trends 2020, Stem Cell Therapy Market Growth 2020, Stem Cell Therapy Industry Share 2020, Stem Cell Therapy Industry Size, Stem Cell Therapy Market Research, Stem Cell Therapy Market Analysis, Stem Cell Therapy market Report speaks about the manufacturing process. The process is analyzed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labor cost, etc.) and the actual process of whole Enterprise Stem Cell Therapy Market.

Stem Cell Therapy market 2020 is a professional and in-intensity look at on the modern state of the key-word industry. The document provides a simple review of the key-word marketplace together with definitions, classifications, programs and chain shape. The key-word enterprise evaluation is supplied for the worldwide marketplace which include improvement records, competitive landscape evaluation, and principal local development popularity.

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The Stem Cell Therapy marketplace file elaborates Stem Cell Therapy industry evaluation with various definitions and category, Product kinds & its packages and chain shape. Stem Cell Therapy market document presentations the manufacturing, sales, charge, and market proportion and boom rate of every type as following.

2020 Short Detail of this Stem Cell Therapy market report:

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Market Analysis and Insights: Global Stem Cell Therapy Market

In 2019, the global Stem Cell Therapy market size was USD 403.6 million and it is expected to reach USD 1439.9 million by the end of 2026, with a CAGR of 19.7% during 2021-2026.

Global Stem Cell Therapy Scope and Market Size

Stem Cell Therapy market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Stem Cell Therapy market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.

Segment by Type, the Stem Cell Therapy market is segmented into Autologous, Allogeneic, etc.

Segment by Application, the Stem Cell Therapy market is segmented into Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others, etc.

Regional and Country-level Analysis

The Stem Cell Therapy market is analysed and market size information is provided by regions (countries).

The key regions covered in the Stem Cell Therapy market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape and Stem Cell Therapy Market Share Analysis

Stem Cell Therapy market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Stem Cell Therapy business, the date to enter into the Stem Cell Therapy market, Stem Cell Therapy product introduction, recent developments, etc.

The major vendors include Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix), etc.

This report focuses on the global Stem Cell Therapy status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Stem Cell Therapy development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

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Stem Cell Therapy Market by Product Type:

Stem Cell Therapy Market by Applications:

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Next part of the Stem Cell Therapy Market analysis report speaks about the manufacturing process. The process is analysed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labour cost, etc.) and the actual process. Stem Cell Therapy market competition by top manufacturers, with production, price, and revenue (value) and market share for each manufacturer as per following;

Top Manufacturer Included in Stem Cell Therapy Market:

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After the basic information, the Stem Cell Therapy report sheds light on the production, production plants, their capacities, global production and revenue are studied. Also, the Stem Cell Therapy Market growth in various regions and R&D status are also covered.

Stem Cell Therapy Market Report by Key Region:

The global Stem Cell Therapy market is anticipated to rise at a considerable rate during the forecast period, between 2020 and 2026. In 2020, the market was growing at a mild rate and with the rising adoption of strategies by key players, the market is predicted to rise over the projected horizon. The report also tracks the most recent market dynamics, like driving factors, restraining factors, and industry news like mergers, acquisitions, and investments.

The report can help to know the market and strategize for business expansion accordingly. Within the strategy analysis, it gives insights from market positioning and marketing channel to potential growth strategies, providing in-depth analysis for brand fresh entrants or exists competitors within the Stem Cell Therapy industry. Global Stem Cell Therapy Market Report 2020 provides exclusive statistics, data, information, trends and competitive landscape details during this niche sector.

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Further in the report, Stem Cell Therapy Market is examined for price, cost and gross revenue. These three points are analysed for types, companies and regions. In prolongation with this data sale price for various types, applications and region is also included. The Stem Cell Therapy Industry consumption for major regions is given. Additionally, type wise and application wise consumption figures are also given.

To provide information on competitive landscape, this report includes detailed profiles of Stem Cell Therapy Market key players. For each player, product details, capacity, price, cost, gross and revenue numbers are given. Their contact information is provided for better understanding.

Other Major Topics Covered in Stem Cell Therapy market research report are as follows:

And another component .

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Stem Cell Therapy Market Report Aims To Outline and Forecast , Organization Sizes, Top Vendors, Industry Research and End User Analysis By 2026 -...

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Q: What's the connection between the novel coronavirus and the thymus gland? A friend of ours who is a doctor says it's probably what keeps young kids from getting so sick. I've never even heard of the thymus. What does it have to do with coronavirus?

A: From the earliest days of the novel coronavirus pandemic, the data revealed a puzzling disparity. Older adults were at increased risk of grave illness when infected with the virus, but children seemed to have a certain level of protection. And while it has since become clear that children can indeed become seriously ill if they become infected, they do so at far lower rates than adults. The reasons for this are still being investigated, but some researchers have recently suggested the role of the thymus gland as a possible factor.

If you place your finger at the notch at the top of your breast bone and draw a vertical line downward a few inches, you've traced the location of your thymus. It's made up of two roughly triangular lobes, which sit behind the breastbone and between the lungs. The thymus has several functions, but perhaps its most important role is to help produce the cells that will become T-lymphocytes, or T-cells. (The "T" stands for thymus-derived.) These are white blood cells that protect the body from bacteria, fungi, viruses and other pathogens.

T-cells, which are the ninjas of the immune system, start out in the bone marrow as stem cells. The immature stem cells exit the marrow, move through the blood and enter a specific region of the thymus. There, they undergo a complex process that teaches them how to recognize a wide range of potentially dangerous and deadly invaders. As T-cells, their job is to circulate throughout the body and, when they encounter the molecular signature of the pathogen they've been trained to recognize, to attack. T-cells also activate other immune cells, produce proteins known as cytokines and have a role in regulating immune response.

The thymus is unique in that it reaches maturity in utero and is at its largest and most active in children. Starting at puberty, it gradually becomes less active, and the glandular tissue begins to shrink. This continues throughout a person's life. By the time someone has reached their mid-60s, the thymus is largely inactive. By their mid-70s, the gland has been mostly replaced with fat. This decrease in thymus function is believed to be one of the reasons that, in their later years, older adults become more susceptible to disease and infection.

Emerging research into COVID-19 has shown a marked decrease in the number of T-cells in some gravely ill patients. Scientists are now asking whether age-related thymus decline, which means T-cells aren't quickly replaced, may play a role in the severity of illness seen in older adults. The flip side of this is whether, due to their robust production of T-cells, children's immune systems are able to stay one step ahead of the novel coronavirus. It's only a working theory, but it shows promise, and research into how this may affect and inform treatment continues.

Dr. Eve Glazier is an internist and associate professor of medicine at UCLA Health. Dr. Elizabeth Ko is an internist and assistant professor of medicine at UCLA Health. Send your questions to askthedoctors@mednet.ucla.edu.

More:
Theory suggests thymus plays role in severity of COVID - Chicago Daily Herald

Recommendation and review posted by Bethany Smith

The recent report on GlobalHormone Replacement Therapy Market Report 2020 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026 offered by Credible Markets, comprises of a comprehensive investigation into the geographical landscape, industry size along with the revenue estimation of the business. Additionally, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Hormone Replacement Therapy Market.

Impact of Covid-19 in Hormone Replacement Therapy Market: Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Hormone Replacement Therapy market in 2020. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor/outdoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

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Key players in the global Hormone Replacement Therapy market covered in Chapter 4:

Mithra PharmaceuticalsMerck KGaANovo Nordisk A/SAllerganAbbVie Inc.Endo Pharmaceuticals Solutions Inc.AmgenPfixer Inc.Eli Lilly and Company

In Chapter 11 and 13.3, on the basis of types, the Hormone Replacement Therapy market from 2015 to 2026 is primarily split into:

MenopauseHypothyroidismMale HypogonadismGrowth Hormone Deficiency

In Chapter 12 and 13.4, on the basis of applications, the Hormone Replacement Therapy market from 2015 to 2026 covers:

Estrogen and combinations ReplacementThyroid ReplacementGrowth ReplacementTestosterone

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:

United States, Canada, Germany, UK, France, Italy, Spain, Russia, Netherlands, Turkey, Switzerland, Sweden, Poland, Belgium, China, Japan, South Korea, Australia, India, Taiwan, Indonesia, Thailand, Philippines, Malaysia, Brazil, Mexico, Argentina, Columbia, Chile, Saudi Arabia, UAE, Egypt, Nigeria, South Africa and Rest of the World

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Some Points from Table of Content

Global Hormone Replacement Therapy Market Report 2020 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026

Chapter 1 Report Overview

Chapter 2 Global Market Growth Trends

Chapter 3 Value Chain of Hormone Replacement Therapy Market

Chapter 4 Players Profiles

Chapter 5 Global Hormone Replacement Therapy Market Analysis by Regions

Chapter 6 North America Hormone Replacement Therapy Market Analysis by Countries

Chapter 7 Europe Hormone Replacement Therapy Market Analysis by Countries

Chapter 8 Asia-Pacific Hormone Replacement Therapy Market Analysis by Countries

Chapter 9 Middle East and Africa Hormone Replacement Therapy Market Analysis by Countries

Chapter 10 South America Hormone Replacement Therapy Market Analysis by Countries

Chapter 11 Global Hormone Replacement Therapy Market Segment by Types

Chapter 12 Global Hormone Replacement Therapy Market Segment by Applications

Chapter 13 Hormone Replacement Therapy Market Forecast by Regions (2020-2026)

Chapter 14 Appendix

The research provides answers to the following key questions:

What is the expected growth rate of the Hormone Replacement Therapy market? What will be the market size for the forecast period, 2020 2026?

What are the major driving forces responsible for transforming the trajectory of the industry?

Who are major vendors dominating the Hormone Replacement Therapy industry across different regions? What are their winning strategies to stay ahead in the competition?

What are the market trends business owners can rely upon in the coming years?

What are the threats and challenges expected to restrict the progress of the industry across different countries?

What are the key opportunities that business owners can bank on for the forecast period, 2020 2026?

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Hormone Replacement Therapy Market Report 2020 (COVID-19 Impact Analysis) By Segmentations, Key Company Profiles & Demand Forecasts to 2020 2026...

Recommendation and review posted by Bethany Smith

The findings from a recent study by a UB researcher and others could prove to be a game-changer for men with Type 2 diabetes.

The single-site study, conducted over 11 years in Bremerhaven, Germany, found that testosterone therapy reversed Type 2 diabetes in one-third of the study participants.

The occurrence of this syndrome is common, and with appropriate testosterone replacement, obesity insulin resistance and diabetes may be reversible, says Paresh Dandona, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He co-authored the study, titled Remission of type 2 diabetes following long-term treatment with injectable testosterone undecanoate in patients with hypogonadism and type 2 diabetes: 11-year data from a real-world registry study.

The prospective, registry-based study was published in June in the online journal Diabetes, Obesity and Metabolism. Dandona also presented the data at the Annual Mohan Diabetes Foundation Symposium in Chennai, India, on July 25, where he was given the organizations Lifetime Achievement Award.

Type 2 diabetes, also known as Type 2 diabetes mellitus, results from a combination of insulin resistance and insufficient production of insulin, causing high blood sugar. The condition is common, with more than 3 million new cases per year in the United States. Reduced testosterone concentrations are found in 33% of men with Type 2 diabetes.

The discovery of this syndrome of hypogonadism in Type 2 diabetes was made by Dandonas group at UB in 2004. This group then extended the prevalence of this syndrome to include 25% of non-diabetic obese men in 2010. Thus, diabetes and obesity became the main cause of male hypogonadism. The group went on to demonstrate that such patients have additional insulin resistance that reverses with testosterone treatment in 2016.

Testosterone deficiency, which is also called male hypogonadism, contributes to reduced response of insulin to glucose, increased insulin resistance and eventually the onset of Type 2 diabetes.

The objective of the researchers study was to determine if men with Type 2 diabetes who also exhibit hypogonadism, when treated with testosterone in addition to their regular diabetes treatment, would demonstrate improved glycemic control and insulin sensitivity, and possibly eventually experience remission of Type 2 diabetes.

The investigators observed 356 men in a single urology practice clinic over 11 years. All patients received standard diabetes treatment, which included mandatory educational courses and materials. In addition, 178 men with a mean age of 62 years received 1,000 milligrams of subcutaneously injected, slow-release testosterone every 12 weeks after an initial six-week interval. The 178 subjects, mean age 64 years, who opted out of the testosterone therapy served as the control group.

The researchers took numerous measurements, including height, weight, waist circumference, blood pressure, hemoglobin, fasting glucose, HbA1c (the average amount of glucose in blood over a six- or 12-week period), insulin, heart rate, lipids, highly sensitive C-reactive protein and total testosterone, among others. They also assessed quality of life using the Aging Males Symptoms scale. Erectile function was also assessed, using the International Index of Erectile Function. Assessment of these clinical metrics was performed at least twice a year, and data over 11 years were analyzed.

The results showed that the men treated with testosterone had significant progressive and sustained reductions in their body weight, fasting glucose, HbA1c and fasting insulin over the treatment period, the authors wrote. In the control group, fasting glucose, HbA1c and fasting insulin increased.

One-third (34.3%) of men treated with testosterone saw remission of their diabetes; almost half (46.6%) achieved normal glucose regulation with antidiabetic treatment and a vast majority (83.1%) reached their target level of HbA1c.

Patients in the control group saw no remission of diabetes or reduction in glucose or HbA1c levels.

In addition, there were fewer deaths, myocardial infarctions, strokes and diabetic complications in the group treated with testosterone.

The research indicates that long-term treatment with testosterone is potentially a novel additional therapy for men with Type 2 diabetes and hypogonadism, the authors wrote.

The clinical significance of these results is further enhanced by the fact that one-third of men with Type 2 diabetes have hypogonadism. Hence, physicians encounter men with hypogonadism and diabetes very frequently. It is remarkable that while Type 2 diabetes mellitus leads to hypogonadism, treatment of hypogonadism results in remission of diabetes itself, the authors wrote.

Going forward, prospective randomized controlled trials are needed to confirm the data. One such trial is currently in progress.

Dandona is one of the worlds leading experts in the treatment of diabetes and vascular disease. He is also the ex-chief of endocrinology at UB and founder of the Diabetes and Endocrinology Center of Western New York, which is sponsored by the Jacobs School and Kaleida Heath. He sees patients at UBMD Internal Medicine.

Dandonas co-authors on the study include Karim Sultan Haider and Ahmad Haider, urologists in Bremerhaven, Germany; Farid Saad, a consultant to Medical Affairs Andrology at Bayer AG in Berlin; Gheorghe Doros from the Department of Epidemiology and Biostatistics at the Boston University School of Public Health; Markolf Hanefeld from GWT-TU Dresden GmbH and Medizinische Klinik, Universittsklinikum Carl Gustav Carus, in Dresden; Sandeep Dhindsa from the Division of Endocrinology, Diabetes and Metabolism at Saint Louis University; and Abdulmaged Traish from the Department of Urology at the Boston University School of Medicine.

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UB study finds testosterone therapy can lead to remission in men with Type 2 diabetes - UB Now: News and views for UB faculty and staff - University...

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author: Binwei Wang

I-Mab (Nasdaq: IMAB) announced Tuesday that the China National Medical Products Administration has accepted its pivotal trial application for eftansomatropin (also known as TJ101) as a weekly treatment for growth hormone deficiency in pediatric patients (PGHD), sending its shares up 3%, trading at $31.25 today in New York.

The clinical-stage biopharmaceutical company said eftansomatropin is an innovative long-acting recombinant human growth hormone (rhGH) with a novel molecular format utilizing Genexine's patented half-life extension hyFc fusion technology, which stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, alongside growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth.

Joan Shen, the chief executive officer of I-Mab stated, "The China NMPA's acceptance of this pivotal IND for eftansomatropin represents an important step towards bringing this innovative product to the Chinese market as planned."

She added, "With eftansomatropin, we will be able to potentially address a substantial unmet medical need with a safer, highly differentiated, and convenient therapy for pediatric patients suffering from the growth hormone deficiency."

According to Frost & Sullivan, PGHD affected approximately 3.4 million patients in Greater China, but only 3.7% of all PGHD patients were receiving growth hormone replacement therapy, which primarily consists of daily injections of rhGH. Recombinant human growth hormone therapy has been included in the National Reimbursement Drug List in China.

I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States.

The company raised $103.7 million in its IPO on January 17.

I-Mab has over 10 drug candidates in the pipeline in the therapeutic areas of immuno-oncology and autoimmune diseases.

Shares in I-Mab are up over 148% since the close of its first trading day on Jan. 17 as of midday Tuesday.

Read more:
I-Mab's IND Application Accepted By China NMPA; Shares Up - CapitalWatch

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