Cosmetic Skin Care Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 – PRnews…
By daniellenierenberg
Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Increasing self-consciousness among population and rising demand for anti- aging skin care products are the factor for the market growth.
Global Cosmetic Skin Care Market By Product (Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products), Application (Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others), Gender (Men, Women), Distribution Channel (Online, Departmental Stores and Convenience Stores, Pharmacies, Supermarket, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026
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Market Definition: Global Cosmetic Skin Care Market
Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.
Market Drivers:
Market Restraints:
Key Benefits:
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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of industry in these regions, from 2020 to 2027, covering
Global cosmetic skin care market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cosmetic skin care market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.
Few of the major competitors currently working in the global cosmetic skin care market are LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics Ltd among others.
Cosmetic Skin Care Market: Key Questions Answered in Report
The research study on the Cosmetic Skin Care market offers inclusive insights about the growth of the market in the most comprehensible manner for a better understanding of users. Insights offered in the Cosmetic Skin Care market report answer some of the most prominent questions that assist the stakeholders in measuring all the emerging possibilities.
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How to get a beautiful skin without surgery – Times of India
By daniellenierenberg
Real beauty is reflected in your skin. If you want a clearer, younger looking skin, non-surgical cosmetic treatments and some maintenance after that can let you achieve immediately visible and long-lasting results. You dont have to always undergo cosmetic surgery to improve appearance and reduce the signs of ageing. In fact, you can choose non-surgical cosmetic treatments to reduce wrinkles, plump up your lips, smoothen the surface of your skin. We spoke with Dr. Anup Dhir Senior Consultant, Cosmetic Surgeon, Apollo Hospital, Delhi to know more about non-cosmetic procedures that can bring a drastic change in your appearance and here's what the doctor had to say.Non-surgical cosmetic treatments: Broadly, these treatments are of three types. We can use laser and other energy based devices like radiofrequency and ultrasound, we can do injectables like botox, fillers microfat and PRP, or we can do time tested older procedures like chemical peels, dermabrasion and microneedling to rejuvenate the skin.Laser skin resurfacing for wrinkles is very commonly done with carbon dioxide or erbium fractional laser and helps by removing the top layer of the skin and making it look younger. Laser hair reduction is done with lasers for facial and body hair and normally six sittings are needed at monthly intervals.Radiofrequency energy devices like thermage, exilis, e matrix etc. and ultrasound devices like HIFU help in formation of new collagen under the skin by directing energy at a particular level under the skin.
Botox injection for wrinkles -This injection is very commonly used for treatment of facial wrinkles and weakens the muscles which cause wrinkles. It has to be repeated after 4-6 months.
Anti-wrinkle treatment by fillers is again a very popular procedure in which hyaluronic acid fillers are injected into scars and wrinkles. The resulting improvement lasts for 9-15 months.
Fat injection for scars and wrinkles are the gold standard for rejuvenation and in this, your own body fat is sucked, processed and injected in the facial wrinkles. Microfat and nanofat are the types of fat which can be used. The fat has its own stem cells and they help to rejuvenate the skin and improve texture and; help in face lift and rejuvenation of hands also.
PRP skin rejuvenation is done by taking your blood and making platelet rich plasma from it and this is injected in the facial skin and it can also be used in the scalp to reduce the hair fall and help in regrowth.
Dermabrasion involves taking the outer layer of skin with a diamond roller under a local anesthetic and the new skin on healing has less scars. The purpose of surgical dermabrasion is to help diminish the appearance of deeper scars and skin imperfections and smoothen the skin.
Chemical peels use a chemical solution to smoothen the texture of your skin by removing the damaged outer layers. It is one of the least invasive ways to improve the appearance of your skin. Superficial peels with fruit acids like glycolic acid etc. are also called lunchtime peels as they have hardly any down time and can give quick results. As sun exposure, acne, or just getting older can leave your skin tone uneven, wrinkled, spotted or scarred, these peels can help these conditions. They also helps to whiten the skin.
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How to get a beautiful skin without surgery - Times of India
The Amniotic Fluid Stem Cell Therapy market to invigorate from 2018 to 2026 – TechnoWeekly
By daniellenierenberg
Stem cells are biological cells which have the ability to distinguish into specialized cells, which are capable of cell division through mitosis. Amniotic fluid stem cells are a collective mixture of stem cells obtained from amniotic tissues and fluid. Amniotic fluid is clear, slightly yellowish liquid which surrounds the fetus during pregnancy and is discarded as medical waste during caesarean section deliveries. Amniotic fluid is a source of valuable biological material which includes stem cells which can be potentially used in cell therapy and regenerative therapies. Amniotic fluid stem cells can be developed into a different type of tissues such as cartilage, skin, cardiac nerves, bone, and muscles. Amniotic fluid stem cells are able to find the damaged joint caused by rheumatoid arthritis and differentiate tissues which are damaged.
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Medical conditions where no drug is able to lessen the symptoms and begin the healing process are the major target for amniotic fluid stem cell therapy. Amniotic fluid stem cells therapy is a solution to those patients who do not want to undergo surgery. Amniotic fluid has a high concentration of stem cells, cytokines, proteins and other important components. Amniotic fluid stem cell therapy is safe and effective treatment which contain growth factor helps to stimulate tissue growth, naturally reduce inflammation. Amniotic fluid also contains hyaluronic acid which acts as a lubricant and promotes cartilage growth.
With increasing technological advancement in the healthcare, amniotic fluid stem cell therapy has more advantage over the other therapy. Amniotic fluid stem cell therapy eliminates the chances of surgery and organs are regenerated, without causing any damage. These are some of the factors driving the growth of amniotic fluid stem cell therapy market over the forecast period. Increasing prevalence of chronic diseases which can be treated with the amniotic fluid stem cell therapy propel the market growth for amniotic fluid stem cell therapy, globally. Increasing funding by the government in research and development of stem cell therapy may drive the amniotic fluid stem cell therapy market growth. But, high procedure cost, difficulties in collecting the amniotic fluid and lack of reimbursement policies hinder the growth of amniotic fluid stem cell therapy market.
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The global amniotic fluid stem cell therapy market is segmented on basis of treatment, application, end user and geography:
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Rapid technological advancement in healthcare, and favorable results of the amniotic fluid stem cells therapy will increase the market for amniotic fluid stem cell therapy over the forecast period. Increasing public-private investment for stem cells in managing disease and improving healthcare infrastructure are expected to propel the growth of the amniotic fluid stem cell therapy market.
However, on the basis of geography, global Amniotic Fluid Stem Cell Therapy Market is segmented into six key regionsviz. North America, Latin America, Europe, Asia Pacific Excluding China, China and Middle East & Africa. North America captured the largest shares in global Amniotic Fluid Stem Cell Therapy Market and is projected to continue over the forecast period owing to technological advancement in the healthcare and growing awareness among the population towards the new research and development in the stem cell therapy. Europe is expected to account for the second largest revenue share in the amniotic fluid stem cell therapy market. The Asia Pacific is anticipated to have rapid growth in near future owing to increasing healthcare set up and improving healthcare expenditure. Latin America and the Middle East and Africa account for slow growth in the market of amniotic fluid stem cell therapy due to lack of medical facilities and technical knowledge.
Some of the key players operating in global amniotic fluid stem cell therapy market are Stem Shot, Provia Laboratories LLC, Thermo Fisher Scientific Inc. Mesoblast Ltd., Roslin Cells, Regeneus Ltd. etc. among others.
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The Amniotic Fluid Stem Cell Therapy market to invigorate from 2018 to 2026 - TechnoWeekly
Harnessing regeneration of retinal tissues: An option almost within reach – Ophthalmology Times
By daniellenierenberg
This article was reviewed by Russell N. Van Gelder, MD, PhD
Neuronal cell replacement therapies remain a challenge in retinal diseases. Some fish and salamanders have the innate ability to regenerate retinal tissue after injuries and, as Russell N. Van Gelder, MD, PhD, pointed out, if researchers could harness this ability in humans, the possibilities would be great for repairing or replacing damaged tissue in a wide variety of retinal diseases. Stem cells are the key to cell replacement therapies.
Stem cells are cells that have not terminally differentiated and still have the potential to become many types of terminal cells, said Van Gelder, from the Department of Ophthalmology at the University of Washington in Seattle. We all started as embryonic stem cells in the earliest phases of development.
Related: Retinal pathologies challenging to image with current technologies
Van Gelder went on to explain that there are now methods to create equivalently totipotent stem cells from individual induced progenitor stem cells derived from an individuals blood or epithelial cells.
The overarching goal is to create a cell type that needs replacement from a stem cell precursor, he said.
A major achievement in this quest for regenerative ability occurred in 2014 when an entire eye cup was grown from progenitor stem cells.
Van Gelder also described a study1 in which green fluorescent proteinlabeled retinal precursors derived from embryonic stem cells were transplanted into the subretinal space of macaques. Three months after the procedure, the researchers demonstrated that the bolus of cells persisted and had outgrowth of axons that were seen going to the optic nerve and on to the brain.
This result establishes the validity of a stem cell-based approach for doing regenerative medicine in primates, he said.
Related: Persistent retinal detachment associated with retinoblastoma
Replacement therapy hurdlesAs of now, however, no stem cell-based replacement treatment has received FDA approval. The problems preventing establishment of a treatment have been technical in nature and include correct cellular differentiation as well as generating adequate numbers of cells for large transplantation experiments, establishing correct cell polarity and connectivity, and ensuring the safety of these approaches regarding tumor or hamartoma formation, Van Gelder explained.
Managing inflammatory responses is a problem after cell transplantation. He cited a Japanese study2 of individual progenitor cell-derived retinal progenitor cells transplanted subretinally in monkey models.
Even with an immune HLA-matched donor, there was still a marked inflammatory response at the site of the transplantation, Van Gelder said. This and other inflammatory responses will have to be managed for cell transplantation to be successful.Related: Intravitreally injected hRPCs improve vision in retinitis pigmentosa cases
There are regulatory hurdles to clear. The FDA Center for Biologics Evaluation and Research regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.
Van Gelder recalled the well-publicized case of transplantation of fat-derived mesenchymal cells into patients eyes, resulting in loss of vision bilaterally. He pointed out that it is important to temper patient expectations regarding these therapies and to ensure that the work is being done with the highest degree of ethical integrity.
While great progress has been made in this field, significant barriers remain to the successful adoption in the clinical setting in the coming years, Van Gelder concluded. The barriers to cell replacement should be overcome.
Read more by Lynda Charters
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Russell N. Van Gelder, MD, PhDe: russvg@uw.edu Van Gelder has no financial interests in this subject matter. He serves on the advisory committee for the National Eye Institute Audacious Goals Initiative.
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References
1. Chao JR, Lamba DA, Kiesert TR, et al. Transl Vis Sci Technol. 2017;6:4; doi:10.1167/tvst/6/3/4
2. Fujii S, Sugita S, Futatsugi Y, et al. A strategy for personalized treatment of iPS-retinal immune rejections assessed in cynomolgus monkey models. Int J Mol Sci. 2020;21(9):3077. doi:10.3390/ijms21093077
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Harnessing regeneration of retinal tissues: An option almost within reach - Ophthalmology Times
8 Skin-Boosting, Anti-Aging Treatments for Generation Xers and Beyond – NewBeauty Magazine
By daniellenierenberg
Getting up there in years comes with its drawbacks and benefits, and the onset of facial lines and volume loss that comes tends to be at the top of the list as one of its main disadvantages. You can count facial aging right up there with the onslaught of back pain and the occasional grey hair turning into a full head of silver. To soften those where did they come from facial lines and give skin a more youthful glow, these anti-agers target the main offenders: wrinkles and uneven skin tone and texture.
2/8
Glycolipids in Dr. Loretta Intense Replenishing Serum ($70) trash moisture on the skin surface to help hydrate skin while the antioxidant lipochroman combats free radicals and protects from harmful UV light, leaving skin looking plump, smooth and rejuvenated.
3/8
Apply a layer of Augustinus Bader The Face Oil ($230) morning and night. Utilizing Professor Baders TFC8 technology, the oil promotes cellular renewal, which helps smooth skin texture and reduce the look of fine lines and wrinkles.
4/8
The name says it all with Zo Skin Healths Firming Serum ($235). Lightweight and tolerable for even sensitive skin types, this anti-ager includes the brands ZCORE complex which consists of a synthetic tetrapeptideand sweet yellow clover to help strengthen skin laxity. Plant stem cells provide plant stem cell complex provides powerful antioxidant protection while sodium DNA helps stimulate cell repair and reduce inflammation.
5/8
Harnessing the brands signature ingredient, La Prairies Skin Caviar Liquid Lift ($690) blends two types of caviar, Premiere and Absolute, into a milky emulsion to deliver the perfect dose of serum that promises firmer skin and enhanced elasticity.
6/8
Bioeffect Limited Edition EGF Serum ($495) is said to have twice the original EGF formulas anti-aging benefits due to its inclusion of a rare black barley that is grown at the brands state-of-the-art greenhouse in Iceland. The EGF stands for Epidermal Growth Factor, which in this serum is totally plant derived and signals skin cells to prompt collagen and elastin production. The unique bottle was designed by Icelandic artist Shoplifter and is made from black obsidian.
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8 Skin-Boosting, Anti-Aging Treatments for Generation Xers and Beyond - NewBeauty Magazine
Augustinus Bader on his revolutionary approach to skincare – Wallpaper*
By daniellenierenberg
Augustinus Bader on his revolutionary approach to skincare
The mind behind the most coveted products in beauty discusses thescience behind the brand
When Augustinus Bader first launched The Cream in 2018, it was hailed as a miracle. In a matter of weeks, it could transform any skin type within any age range, dispelling wrinkles, redness, dryness, scaring, visible pores, sagginess, and practically every other skin concern it would usually take a shelf load of serums to combat. While miraculous, magical, and other mystical attributions caneasily, and quite fairly, be applied to Augustinus Bader products, the real genius of the brand comes down to pure science.
The Augustinus Bader skincarebrand was the by-product of its namesakes development of medical-grade cream, which could heal severe burn injuries to an extent that was previously only possible through skin grafts. Professor Bader, a stem cell and biomedical scientist at Leipzig University, was hoping to get the cream backed by a pharmaceutical company but, in the words of his business partner Charles Rosier, clinical trials cost tens of tens of millions of dollarsand the majority of accidents around burns happen to children, often in third-world countries. For a pharmaceutical company, when the outcome is not necessarily the most profitable outcome, theres less interest.
Inspired to make Baders cream widely available, Rosier encouraged the Professor to translate the principles of his burn cream into skincare. In my mind, I thought, if we create a cream thats superior to whats on the market and its a big success, then he can focus on is research and we can finance the clinical trial.
Baders cream centred around one, revolutionary hypothesisthat the body already possesses all of the stem cells it needs to regenerate itself. The problem, when it comes to the skins inability to heal from severe injuries or just the everyday effects of ageing, is that the bodys ability to trigger those regenerative cells has been impeded.
Bader developed this hypothesis based on two observations. First, that the size of the wound affects the bodys ability to heal. Asmall paper cut heals quickly, while a large scale burn takes time to heal and often leaves scar tissue. Secondly, the body automatically knows where the site of an injury is. When you cut your left hand, your body immediately starts sending cells to the area of the cut so that the skin can rebuild. Yet,the same tissue would never rebuild on your right hand because it rebuilt on your left. Only where there is a wound is the body rebuilding.
In Baders words, If the cut is super small, you would have a small distance between the edges of the cut skin and the cells can still communicate over this small distances through the hand, and would close the wound. But if you burn your hand, the cells would be dying and the signal response cannot arrive at this injury. The response is totally different, the small cut heals perfectly, while on the other side the big injury kills this confirmation.
So the basis of [my] hypothesis is that this is probably just the absence of specific molecules that cannot arrive to the site of the injury because cells are dying or are blocked. So many, many years ago I started trying to find solutions to this problem because genetically speaking were the same human being, why would we have these limitations, why would we have these problems? It doesnt make any sense.
I thought, why not try to replace what the cells would be doing if they were present? That triggering complex, which singles the cells to respond to the injury, or, when it comes to skincarewrinkles, is the secret, miracle likeelement of Baders cream.
Unlike most skincare, which just changes the outside surface of the skin, Baders skincare works from the inside out, transforming the bodys internal, cellular communication for exterior changes. I think ageing is just a lack of repair, a lack of regeneration. Skin is a living organism, which has to be remodelled, meaning repaired a little bit everyday. But you can accelerate this repair lead.
Theres something super, super sensitive inside of you, which are these cells that sense the microenvironment and respond to the need. So the cream, in a way, is only a toolbox, which helps your stem cells when they sense this need to interact more appropriately.
This new approach to the effects of ageing is a revolution in skincare that, no doubt, heralds the beginning of a new science-driven, cellular-focused trend in the industry.
This year, Bader has launched a number of additional products to his line beyond The Cream and its companion The Rich Cream. The new additions include a Cleansing Gel, Face Oil, Body Cream and, as of today, Cleansing Balm with more releases set for the next year.
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Augustinus Bader on his revolutionary approach to skincare - Wallpaper*
22 Best Night Creams 2020 for All Skin Types and Concerns – Greatist
By daniellenierenberg
Top notch ingredients are vital when it comes to creams. We chatted with skin care pros to see which ingredients are the best . This helped us pick out the products with the most oomph.
We also factored in:
Pricing guide
Night creams def have a rep for being expensive and some totally are. You should expect to pay more for extra bells and whistles (e.g. designer brands, fancy packaging, etc.). But thats definitely not the case percent of the time. You can find awesome, dermatologist-recommended products for around $10.
This guide will help you pick the best cream for your skin and budget:
$ = $10$20$$ = $25$50$$$ = $51$75$$$$ = over $76
Whether youre looking for a simple cream that gives your skin a glowy boost or a powerful cream for more mature skin to help reduce fine lines, theres a cream for you. Here are the top 22 night creams for every need.
Price: $$$$
Designed for all skin types, this lightweight cream uses retinol to reduce the appearance of lines. Hyaluronic acid delivers hydration and improves skins tone and texture. It also has niacinamides and picolinamides that support your skins natural barrier and lock in moisture.
Cons: Some peeps with sensitive skin said it caused irritation.
Buy Murad Retinol Youth Renewal Night Cream online.
Price: $
Unlike some heavy duty hydrators, this cream is oil-free and wont clog pores. You can use it day and night without worrying about pesky pimples.
It has the benefits of anti-aging while being lightweight enough to not trigger acne, says dermatologist Erum Ilyas, MD, MBE, FAAD. If youre looking for a cream but dont want to risk breakouts, this is a nice one to try.
Cons: It might not be hydrating enough for dry skin.
Buy OLAY Total Effects 7-in-1 Anti-Aging Moisturizer online.
Price: $$
Found: An overnighter that fights the signs of aging and keeps breakouts at bay. Retinol helps plump skin to reduce the appearance of lines and wrinkles. Salicylic and lactic acids keep bacteria from clogging pores and causing breakouts.
Cons: Salicylic acid can be drying.
Buy Arcona PM Blemish Lotion online.
Price: $$
This concentrated balm harnesses the power of colloidal oatmeal and sweet almond oil to soothe itchy, inflamed skin. It promotes a smoother and more even skin texture and can help reduce redness. Its even safe to use around your eyes and on your lids.
Cons: Some users found the rich texture to be a bit greasy.
Buy Skinfix Eczema Dermatitis Face Balm online.
Price: $$
This cream delivers heavy duty hydration to fight ashiness (thanks, avocado and shea butter). The vitamin C can help combat hyperpigmentation from exposure to UV rays (which is more likely in darker skin).
Cons: It might trigger breakouts in oily or acne-prone skin.
Buy Eve Hansen Vitamin C Night Cream online.
Price: $$
This super hydrating treatment straddles the line between cream and mask. Ingredients like squalene, glycerin, and fountain plant quench parched skin. It also helps protect the skins natural barrier to keep moisture in.
Cons: Some users complain that the texture is too thick to the point of being straight up sticky.
Buy Kiehls Ultra Facial Overnight Hydrating Masque online.
Price: $$$$
Dermatologist Deborah Longwill, DO, FAOCD, counts this potent potion as a current fave.
It combines the anti-aging ingredient resveratrol with antioxidant-rich ingredients like glycoin and ectoin, she explains.
These ingredients help shield your skin from environmental stresses. They also work to enhance elasticity, improve texture, and hydrate cells.
Cons: Its on the spendy side.
Buy Doctors Daughter Extremolyte Stem Cell Serum online.
Price: $$$
This hydrating-but-not-overly-heavy cream nourishes and plumps skin with ingredients like ceramides and hyaluronic acid. Oh, and its been clinically tested to reduce fine lines, dryness, and loss of firmness in just 7 nights.
Cons: Steer clear if youre not a lavender fan.
Buy IT Cosmetics Confidence in Your Beauty Sleep Night Cream online.
Price: $$
Does added fragrance irritate your skin? Same. Thankfully, this non-irritating cream that gets the job done. Its also loaded with vitamin E which fights redness and inflammation.
Cons: This cream is definitely on the thick side. It might feel heavy on oily skin.
Buy Olay Regenerist Night Recovery Anti-Aging Face Moisturizer online.
Price: $
Retinols a go-to ingredient for minimizing the appearance of fine lines thanks to its ability to protect the skin-plumping protein collagen.
It also has hyaluronic acid, a moisturizer to help prevent irritation and dryness that may be a better option for those with dry or sensitive skin, says dermatologist Susan A. Bard, MD.
Cons: Some users report experiencing redness or rashes.
Buy Neutrogena Rapid Wrinkle Repair Night Moisturizer online.
Price: $$$
This cream uses bakuchiol, a natural retinol alternative. Thats good news if you have sensitive skin.
Its a functional analog of retinol meaning it has the same effect, with one huge advantage: Its less irritating because its also an anti-inflammatory agent, Ilyas says.
Cons: Its got a strong peachy scent that you might love or hate.
Buy OLEHENRIKSEN Goodnight Glow Retin-Alt Sleeping Crme online.
Price: $
Ahhh. Heres a cooling gel cream made with licochalcone, a licorice-based skin soother. It fights redness and irritation in folks with sensitive, rosacea-prone skin. The creams noncomedogenic so it wont clog your pores either.
Cons: This stuffs very gentle. But it still might be too strong on super sensitive skin. Def do a patch test before slathering it all over your face.
Buy Eucerin Redness Relief Night Cream online.
Price: $
Bard loves recommending this simple, no-frills wrinkle fighter to patients. Its inexpensive, easy to find at most drugstores, and it works.
It contains retinol which helps improve fine lines and wrinkles, stimulate collagen production and decrease pigmented spots, she says.
Cons: The retinol in this formula is designed for daily use. But its still worth starting off gradually and work your way up. This gives your skin time to adjust.
Buy RoC Retinol Correxion Deep Wrinkle Night Cream online.
Price: $$
Lotus and peach extract fight oxidative stress and keep your skin looking glowy. But what really sets this lightweight cream apart is the floral peach aroma that comes wafting out the second you open the jar. Another perk: Its good for all skin types.
Cons: Its not formulated to fight fine lines or wrinkles.
Buy Lotus Youth Preserve Dream Face Cream online.
Price: $$$
Grease is not the word here. The gel formula delivers hydration but its still light and cooling. Its got niacinamide, viniferine, and natural pearlizers to fight the appearance of dark spots even out skin tone.
Cons: Some peeps said it didnt brighten their skin.
Buy Caudalie Vinoperfect Instant Brightening Moisturizer online.
Price: $$$
TBH the whole women vs. men products thing is silly. Right? But this cream feels a bit more manly thanks to the neutral packaging and woodsy scent. It fights fine lines and wrinkles with retinol and uses the antioxidant ferulic acid to combat dark spots and sun damage.
Cons: The heavy-duty retinol can be a little harsh especially if your skins not used to it.
Buy Dr. Dennis Gross Ferulic + Retinol Moisturizer online.
Price: $$
Glycolic acid is great at reducing the appearance of dark spots because it can suppress the production of melanin. The acid improves skins elasticity and boosts firmness too. So its an all-around awesome fountain of youth-kinda option.
Cons: Its a serum. If youre looking for hydration, youll still want to layer a moisturizer over top.
Buy Bolden Nighttime Repair Serum with 10% Glycolic Acid online.
Price: $$
Vitamin C and collagen are your eyes BFF. They brighten and plump the delicate skin around your peepers. This ones got both and a little goes a long way.
Cons: Its thick and rich. So it might clog your pores if it ends up on your T-zone.
Buy OLEHENRIKSEN Banana Bright Eye Cream online.
Price: $$$
This certified-organic cream boasts vitamin C, fruit stem cells, grape-seed oil, and squalene. It will brighten and hydrate without the use of parabens, petroleum, sulfates, pesticides, or phthalates.
Cons: The grape-seed oil might be too much for oily or acne-prone skin.
Buy Juice Beauty Stem Cellular Anti-Wrinkle Overnight Cream online.
Price: $
You can legit get amazing results from a night cream without spending megabucks. This dermatologist-developed moisturizer plumps and renews skis with a peptide complex. It also restores the skins natural barrier with essential ceramides. Plus its not greasy!
Cons: This is definitely a utilitarian option. If you love extras like scents or pretty packaging, skip it.
Buy CeraVe Skin Renewing Night Cream online.
Price: $
The suns UV rays can seriously stress your skin. This can cause dark spots, discoloration, and fine lines. But ingredients like green tea and vitamin C help fight sun-induced stress. This hydrating cream delivers both.
Cons: The packaging looks like it came from 1995, which, depending on what youre going for might ruin your #shelfie. (Or maybe not.)
Buy LILY SADO TEA+C Green Tea + Vitamin C Moisturizer online.
Price: $
Snow mushroom and sodium hyaluronate deliver mega moisture, while soothing lavender oil and chamomile extract help you chill and unwind. After anointing yourself with this vegan lotion, you might just wanna close your eyes and doze off.
Cons: You wont get as much anti-aging action here.
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22 Best Night Creams 2020 for All Skin Types and Concerns - Greatist
World Cord Blood Day 2020 Speakers to Present Revolutionary CAR-NK Cell Therapy, Potential Treatments for Covid-19 Related MIS-C and Advantages of…
By daniellenierenberg
TUCSON, Ariz., Oct. 21, 2020 /PRNewswire/ --Registration is now open for the World Cord Blood Day 2020 virtual conference (register free on Eventbrite) featuring world renown cord blood transplant doctors and cellular therapy researchers. To be held on November 17th, the virtual conference will provide an opportunity for healthcare professionals, expectant parents, and students to learn about life-saving cord blood stem cells via a mix of livestream and on-demand sessions. The public is also invited to participate in a wide variety of free educational events being held around the globe by WCBD Official Participants (see listings on http://www.WorldCordBloodDay.org).
Attendees of the virtual conference will learn how cord blood has been used in more than 40,000 stem cell transplants since 1988 to treat over 80 life-threatening diseases including leukemia, sickle cell anemia, thalassemia, and lymphoma. Ground-breaking research will also be presented by scientists who are discovering cord blood's full potential in CAR-NK immunotherapy, the emerging field of regenerative medicine to potentially treat autism, cerebral palsy, Covid-19 related MIS-C and more. Keynote presentations will be made by Dr. Joanne Kurtzberg (Duke Department of Pediatrics, Duke Center for Autism and Brain Development), Dr. Katy Rezvani (MD Anderson Cancer Center), Dr. Jonathan Gutman (University of Colorado), Dr. Leland Metheny (Case Western Reserve University), and Monroe Burgess (Quick Specialized Healthcare Logistics). Dr. Moshe Israeli (Rabin Medical Center) will lead the opening session on HLA matching and cord blood.
In addition, a panel of industry experts will discuss how cord blood has come to the forefront during the Covid-19 pandemic. Increasingly, stem cells transplant doctors are using cord blood units collected well before the pandemic and now available for immediate use. Attendees will also hear from Dr. David Hall and Vanessa Yenson, who both beat cancer thanks to cord blood transplants.
To view the full agenda, please visit: https://www.worldcordbloodday.org/online-medical-conference-agenda-wcbd-2020.html
Organized and hosted by Save the Cord Foundation (501c3 non-profit), this year's event is officially sponsored by Quick Specialized Healthcare Logistics. "We're proud to be a sponsor of World Cord Blood Day for the fourth year in a row. This year is sure to be very informative and exciting, providing the latest information from some of the industry's top doctors and researchers. We're humbled to play a role in the research and development of cord blood derivative therapies by providing logistics supply chain solutions to cord blood, biotech and pharmaceutical companies worldwide," said David Murphy, Executive VP of Quick's Life Science Division.
Inspiring Partners this year include the Cord Blood Association (CBA), Be the Match (NMDP), World Marrow Donor Association (WMDA-Netcord), AABB Center for Cellular Therapy and Foundation for the Accreditation of Cellular Therapy (FACT).
Visit http://www.WorldCordBloodDay.org to learn how you can participate and/or host an event. Join us on social media using the hashtags: #WCBD20 and #WorldCordBloodDay.
About Save the Cord Foundation
Save the Cord Foundation (a 501c3 non-profit) was established to advance cord blood education. The Foundation provides non-commercial information to parents, health professionals and the public regarding methods for saving cord blood, as well as current applications using cord blood and the latest research. Learn more at http://www.SaveTheCordFoundation.org.
About Quick Specialized Healthcare Logistics
Quick is the trusted logistics leader serving the Healthcare and Life Science community for almost 40 years. Quick safely transports human organs and tissue for transplant or research, blood, blood products, cord blood, bone marrow, medical devices, and personalized medicine, 24/7/365. Quick's specially trained experts work with hospitals, laboratories, blood banks and medical processing canters, and utilize the safest routes to ensure integrity, temperature control and chain of custody throughout the transportation process. Learn more at http://www.quickhealthcare.aero.
Media Contact:Charis Ober[emailprotected]520-419-0269
SOURCE Save the Cord Foundation
http://www.SaveTheCordFoundation.org
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World Cord Blood Day 2020 Speakers to Present Revolutionary CAR-NK Cell Therapy, Potential Treatments for Covid-19 Related MIS-C and Advantages of...
Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn – GlobeNewswire
By daniellenierenberg
SOMERSET, N.J. and NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Catalent (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced an agreement for the manufacture of NurOwn, BrainStorms autologous cellular therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or motor neuron disease.
NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons and neuroprotection. The therapy has received Fast Track status from the U.S. FDA for ALS and has also been granted Orphan Drug Status for ALS by both the FDA and the European Medicines Agency. BrainStorm is currently completing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Phase 3 study in the U.S.
As part of its commitment, Catalent will undertake the transfer of the manufacturing process to, and provide future CGMP clinical supply of NurOwn from, its new, 32,000 square-foot cell therapy manufacturing facility in Houston, Texas. On completion of the clinical trials and in anticipation of potential approval of NurOwn, the companies will look to extend the partnership to include commercial supply from the Houston facility.
We are proud to have a partner in Catalent whose excellence in manufacturing quality therapies will support commercial supply of NurOwn, said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. We know that ALS patients are in urgent need of a new treatment option. If NurOwn is successful in the current clinical trials, this agreement will be integral to ensuring rapid access for patients.
Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, Our experience in cell therapy development, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston offers, position us to best support BrainStorm, with its leading therapeutic candidate for ALS treatment. We look forward to partnering with BrainStorm and providing our stem cell manufacturing expertise as we work to optimize production and streamline the products path towards commercial launch.
About Catalent Cell & Gene Therapy
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.
About NurOwn
NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment inAugust 2020. For more information, visit the company's website at http://www.brainstorm-cell.com.
Safe-Harbor Statement
Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
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Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn - GlobeNewswire
Randomized Controlled Study Using Direct Injection of Remestemcel-L Into Inflamed Gut of Patients With Crohn’s Disease and Ulcerative Colitis -…
By daniellenierenberg
NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis has commenced at Cleveland Clinic.
Mesoblast Chief Medical Officer Dr Fred Grossman said: Inflammation of the gut in Crohns disease and ulcerative colitis closely resembles the most severe manifestation of advanced-stage, life-threatening acute graft versus host disease (aGVHD). Mesoblasts objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to steroid-refractory aGVHD.
Mesenchymal stem cells (MSCs) promote healing of inflamed gut tissue by downregulating gut mucosal effector T-cell activity and promoting regulatory T-cell formation.1 MSCs have been tested in clinical trials of Crohns disease using two different modalities: intravenous infusions of MSCs to treat the primary inflammation of Crohns disease and local injections of MSCs to treat fistulae complicating Crohns disease.
A third modality, endoscopic delivery of MSCs, has been successful in preclinical experimental models of colitis, reducing the excessive cytokine storm in the inflamed gut and resulting in tissue healing.2-3 The study at Cleveland Clinic will be the first in humans using local delivery of MSCs in the gut, and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.
The studys lead investigator Dr Amy L. Lightner, Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic, stated: We are aiming to establish a new treatment paradigm by administering remestemcel-L at one of two escalating doses, or placebo, directly to inflamed gut tissue in patients with medically refractory Crohns disease and ulcerative colitis, both highly debilitating conditions with significant, unmet medical needs.
According to recent estimates, more than three million people (1.3%) in the US alone have inflammatory bowel disease, with more than 33,000 new cases of Crohns disease and 38,000 new cases of ulcerative colitis diagnosed every year.4-6 Despite recent advances, approximately 30% of patients are primarily unresponsive to anti-TNF agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically-refractory Crohns disease eventually require surgical treatment of their disease,7 which can have a devastating impact on quality of life.
References1.Mayne C and Williams C. Induced and natural regulatory T cells in the development of inflammatory bowel disease. Inflamm Bowel Dis 2013; 19: 17721788.2.Molendijk I et al. Intraluminal Injection of Mesenchymal Stromal Cells in Spheroids Attenuates Experimental Colitis. Journal of Crohn's and Colitis, 2016, 9539643.Pak S eta al. Endoscopic Transplantation of Mesenchymal Stem Cell Sheets in Experimental Colitis in Rats. Scientific Reports | (2018) 8:11314 | DOI:10.1038/s41598-018-296174.CDC Facts and Figures 20155.Globaldata Pharmapoint 20186.Dahlhamer JM, MMWR Morb Mortal Wkly Rep. 2016;65(42):11661169.7.Crohns and Colitis Foundation
About Remestemcel-LMesoblasts lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. Remestemcel-L is thought to have immunomodulatory properties to counteract severe inflammatory processes by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, likely, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: statements about the initiation, timing, progress and results of Mesoblast and its collaborators clinical studies; Mesoblast and its collaborators ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblasts ability to maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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Randomized Controlled Study Using Direct Injection of Remestemcel-L Into Inflamed Gut of Patients With Crohn's Disease and Ulcerative Colitis -...
British Society for Haematology Guideline Update for the Diagnosis and Management of Chronic Myeloid Leukemia – Cancer Therapy Advisor
By daniellenierenberg
The development of tyrosine kinase inhibitors (TKIs) has revolutionized the treatment of chronic myeloid leukemia (CML).1,2 However, despite effectively inducing remission and prolonging survival in patients with CML, TKI therapy does not eradicate leukemia stem cells (LSCs), which are responsible for drug resistance, relapse, and disease progression.2 Given recent changes to the treatment paradigm, updated clinical practice guidelines are essential to ensure optimal clinical care is provided.2
The British Society for Haematology (BSH) published a guideline update for the investigation and management of CML in adults and children in the British Journal of Haematology.1 Lead author of the guidelines, Graeme Smith, MD, of St Jamess University Hospital in the United Kingdom, and coauthors, developed the evidence-based recommendations to provide clinical practitioners with clear guidance on the diagnosis and treatment of adults and children with CML (Tables 1 and 2).
Diagnosis and Key Investigations
The diagnosis of CML is established based on findings from a peripheral blood smear and bone marrow aspirate showing positivity for BCR-ABL1, and the presence of the Philadelphia (Ph) chromosome. The Ph chromosome, or a variant, is present in approximately 95% of CML cases. Other cases include a cryptic BCR-ABL1 fusion, commonly detected by reverse transcriptase polymerase chain reaction (RT-PCR), or fluorescence in situ hybridization (FISH). Additional findings from bone marrow aspirate include the presence of other cytogenetic abnormalities, including isochromosome 17q or trisomy 19, and trisomy 8, suggesting a higher risk of progression to accelerated phase or blast crisis in adults.
Table 1. Selected Recommendations by the BSH Guideline Panel on the Diagnosis of CML1
Table 2. ELTS Score Calculation1
This article originally appeared on Hematology Advisor
Some Patients With AML Secondary to MPN May Benefit From Venetoclax in Combination With a Hypomethylating Agent – Oncology Nurse Advisor
By daniellenierenberg
The combination of the BCL2 inhibitor venetoclax with a hypomethylating agent (HMA) may be a treatment option for patients who develop acute myeloid leukemia (AML) secondary to a myeloproliferative neoplasm (MPN), according to results of a small, retrospective cohort study published in Leukemia Research.1
The Philadelphia chromosome-negative MPNs, which include polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are clonal disorders resulting in the proliferation of myeloid cells in the bone marrow. Both PV and ET can progress to secondary myelofibrosis which, along with PMF, can progress to secondary AML, also known as MPN-blast phase (MPN-BP).
Furthermore, MPN-BP, defined in this study as being associated with peripheral or bone marrow blasts of at least 20%, is not sensitive to intensive chemotherapy, and clinical outcomes for patients with this disease are very poor. Median overall survival is only approximately 3 to 5 months, and allogeneic hematopoietic stem cell transplantation (HSCT) is considered the only curative option for these patients.
Venetoclax in combination with an HMA, azacitidine, decitabine, or low-dose cytarabine recently received regular US Food and Drug Administration (FDA) approval for the treatment of adults with newly diagnosed AML who are at least 75 years old or unable to tolerate intensive chemotherapy.2 However, patients with MPN-BP were excluded from the VIALE-A (ClinicalTrial.gov Identifier: NCT02993523) and VIALE-C (ClinicalTrial.gov Identifier: NCT03069352) phase 3 studies evaluating venetoclax in combination with azacitadine and low-dose cytarabine, respectively, in newly diagnosed AML.
This study included 8 patients with MPN-BP and 1 with MPN-accelerated phase (MPN-AP), defined as peripheral or bone marrow blasts of 10% to 19%, which was associated with very high-risk cytogenetics, who were treated at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai in New York, New York. Most of the patients in this cohort had relapsed/refractory disease, and had been treated with prior therapies.
A key study finding included the achievement of either a complete response (CR) or a CR associated with incomplete hematologic recovery (CRi) in 3 patients treated with the combination of venetoclax plus decitabine or azacitidine. In addition, stable disease as best response was achieved by 2 additional patients who received this treatment.
Of note, 2 of the 3 patients who achieved a CR/CRi had experienced disease relapse on prior HMA therapy.
This suggests a synergy with the combination that is not precluded by prior HMA exposure, the study authors remarked.
Perhaps more striking was the finding that when this therapeutic approach was used as a bridge to HSCT in 3 patients who achieved CR, CRi, or stable disease, all of them were alive at a median follow-up of 8.5 months compared with 4.2 months for the overall cohort.
However, high rates of grade 3 or higher bleeding and infection were observed in this patient cohort, and occurred in 5 and 7 patients, respectively.
Given the propensity for prolonged cytopenias with resultant complications, caution should be used in patients with baseline cytopenias, study authors noted.
In closing, the study authors stated, This is the largest report of venetoclax use in patients with MPN-AP/BP and suggests that this therapeutic strategy is a viable treatment option in this adverse risk group eligible for HSCT.
They further added that prospective clinical trial evaluation of combination HMA and venetoclax in MPN-BP is warranted.
Disclosures: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
References
1. Tremblay D, Feld J, Dougherty M, et al. Venetoclax and hypomethylating agent combination therapy in acute myeloid leukemia secondary to a myeloproliferative neoplasm. Leuk Res. Published online September 22, 2020. doi:10.1016/j.leukres.2020.106456
2. U.S. Food and Drug Administration. FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia [news release]. U.S. Food and Drug Administration; October 16, 2020. Accessed October 19, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-regular-approval-venetoclax-combination-untreated-acute-myeloid-leukemia
Be Biopharma debuts with $52M to advance engineered B-cell therapies – FierceBiotech
By daniellenierenberg
You may have heard of T cells, but Aleks Radovic-Moreno, Ph.D., Be Biopharmas co-founder, president and director, is betting on B cells as the future of cell therapies.
Our mission is to develop what we see as a new class of cell medicines that have a broad new pharmacology, he said of B cells potential. We think it's a big new white space that's enabled by the rich biology of these cells.
The Cambridge, Massachusetts-based company is capitalizingearly on research by scientists at the University of Washington School of Medicine. With a $52 million series A round in the bank, it'smaking a beeline for the clinic.
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Why the enthusiasm around B cells? The wayRadovic-Moreno sees it, they'rethe cellular gadget, if you will, that's really good at making large amounts of protein, and they also traffic to where you want them to go."
When we think about it from a drug development standpoint, now you have a system that can make a protein that you want in high quantities in places where you want it to be made, he added.
B cells may also be useful for targeting specific tissues and modulating microenvironments, or [talking] to the cells that are nearby, he said.
One of the biggest challenges to bringing Be Bio to fruition was making the products themselves. Theyre harder to engineer than other cell types thanksto their intrinsic biology, Radovic-Moreno said. Theyre also hard to make correctly and in large quantities, challenges the company only recently overcame.
Those two are the final two bottlenecks that were preventing B cells from being a viable stem cell therapy modality, he said.
RELATED: Q32 debuts with $46M to 'rebalance' innate and adaptive immunity
The applications of B cells include everything from autoimmune diseases to cancer and monogenic disorders, which are caused by variation in a single gene. B-cell therapy could eliminate the need for patients with monogenic disorders who are missing proteins to get biweekly four-hour infusions.
And that's not all. It couldalso eliminate the need for bone marrow transplants in these patients, as well asthe need for a pre-therapy round of chemotherapy, otherwise known as conditioning. For cancer patients who need conditioningahead of a stem cell treatment, the regimencan be deadly up to 10% of the time.
That's extraordinary if you think about a therapy killing patients 10% of the time, Radovic-Moreno said.
Beyond pushing Be'spipeline toward the clinic, the new fundingfrom Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund and other investorswill bankroll potential partnerships and build out the company's team.
The most important thing is to build a great company, hire the best people. We want to be the best B-cell engineers in the world and in history, Radovic-Moreno said. We want to fully capitalize on the timing of this, given that it's a very kind of unusual place to be in this time and age of biotech, where you're sitting right in front of this massive blue wave, big blue ocean of possibilities so big.
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Be Biopharma debuts with $52M to advance engineered B-cell therapies - FierceBiotech
Potential impact of Covid-19 on Rheumatoid Arthritis Stem Cell Therapy Market Growth and Demand, Concludes Fact.MR – The Cloud Tribune
By daniellenierenberg
The globalRheumatoid Arthritis Stem Cell Therapy marketstudy presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Rheumatoid Arthritis Stem Cell Therapy market player in a comprehensive way. Further, the Rheumatoid Arthritis Stem Cell Therapy market report emphasizes the adoption pattern of the Rheumatoid Arthritis Stem Cell Therapy across various industries.Request Sample Reporthttps://www.factmr.com/connectus/sample?flag=S&rep_id=1001The Rheumatoid Arthritis Stem Cell Therapy market report highlights the following players:The global market for rheumatoid arthritis stem cell therapy is highly fragmented. Examples of some of the key players operating in the global rheumatoid arthritis stem cell therapy market include Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others.
The Rheumatoid Arthritis Stem Cell Therapy market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.Important regions covered in the Rheumatoid Arthritis Stem Cell Therapy market report include:
North America (U.S., Canada)Latin America (Mexico, Brazil)Western Europe (Germany, Italy, U.K., Spain, France, Nordic countries, BENELUX)Eastern Europe (Russia, Poland, Rest Of Eastern Europe)Asia Pacific Excluding Japan (China, India, Australia & New Zealand)JapanMiddle East and Africa (GCC, S. Africa, Rest Of MEA)
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Allogeneic Mesenchymal stem cellsBone marrow TransplantAdipose Tissue Stem Cells
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HospitalsAmbulatory Surgical CentersSpecialty ClinicsHave Any Query? Ask our Industry Experts-https://www.factmr.com/connectus/sample?flag=AE&rep_id=1001
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Which regulatory authorities have granted approval to the application of Rheumatoid Arthritis Stem Cell Therapy in Health industry?How will the global Rheumatoid Arthritis Stem Cell Therapy market grow over the forecast period?Which end use industry is set to become the leading consumer of Rheumatoid Arthritis Stem Cell Therapy by 2028?What manufacturing techniques are involved in the production of the Rheumatoid Arthritis Stem Cell Therapy?Which regions are the Rheumatoid Arthritis Stem Cell Therapy market players targeting to channelize their production portfolio?Get Full Access of the Report @https://www.factmr.com/report/1001/rheumatoid-arthritis-stem-cell-therapy-market
Pertinent aspects this study on the Rheumatoid Arthritis Stem Cell Therapy market tries to answer exhaustively are:
What is the forecast size (revenue/volumes) of the most lucrative regional market? What is the share of the dominant product/technology segment in the Rheumatoid Arthritis Stem Cell Therapy market? What regions are likely to witness sizable investments in research and development funding? What are Covid 19 implication on Rheumatoid Arthritis Stem Cell Therapy market and learn how businesses can respond, manage and mitigate the risks? Which countries will be the next destination for industry leaders in order to tap new revenue streams? Which new regulations might cause disruption in industry sentiments in near future? Which is the share of the dominant end user? Which region is expected to rise at the most dominant growth rate? Which technologies will have massive impact of new avenues in the Rheumatoid Arthritis Stem Cell Therapy market? Which key end-use industry trends are expected to shape the growth prospects of the Rheumatoid Arthritis Stem Cell Therapy market? What factors will promote new entrants in the Rheumatoid Arthritis Stem Cell Therapy market? What is the degree of fragmentation in the Rheumatoid Arthritis Stem Cell Therapy market, and will it increase in coming years?Why Choose Fact.MR?
Fact.MR follows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.
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Potential impact of Covid-19 on Rheumatoid Arthritis Stem Cell Therapy Market Growth and Demand, Concludes Fact.MR - The Cloud Tribune
Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Mesoblast, Loop Industries, Turquoise Hill…
By daniellenierenberg
NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Mesoblast Limited (NASDAQ: MESO), Loop Industries, Inc. (NASDAQ: LOOP), Turquoise Hill Resources Ltd. (NYSE: TRQ), and Reata Pharmaceuticals, Inc. (NASDAQ: RETA). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.
Mesoblast Limited (NASDAQ: MESO)
Class Period: April 16, 2019 to October 1, 2020
Lead Plaintiff Deadline: December 7, 2020
Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).
In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.
On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.
On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.
On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.
On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.
The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
For more information on the Mesoblast class action go to: https://bespc.com/MESO
Loop Industries, Inc. (NASDAQ: LOOP)
Class Period: September 24, 2018 to October 12, 2020
Lead Plaintiff Deadline: December 14, 2020
On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.
On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.
The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
For more information on the Loop class action go to: https://bespc.com/Loop
Turquoise Hill Resources Ltd. (NYSE: TRQ)
Class Period: July 17, 2018 to July 31, 2019
Lead Plaintiff Deadline: December 14, 2020
Turquoise Hill is an international mining company focused on the operation and development of the Oyu Tolgoi copper-gold mine in Southern Mongolia (Oyu Tolgoi), which is the Companys principal and only material resource property. Turquoise Hills subsidiary, Oyu Tolgoi LLC, holds a 66% interest in Oyu Tolgoi, and the remainder is held by the Government of Mongolia.
Rio Tinto plc and Rio Tinto Limited are operated and managed together as single economic unit and engage in mining and metals operations in approximately 35 countries. Through their subsidiaries, Rio Tinto owns 50.8% of Turquoise Hill. A Rio Tinto subsidiary, Rio Tinto International Holdings, Inc. (Rio Tinto International or RTIH; and collectively with Rio Tinto plc and Rio Tinto Limited, Rio Tinto), is also the manager of the Oyu Tolgoi project, including having responsibility for its development and construction.
On July 31, 2019, Turquoise Hill issued a press release and Management Discussion & Analysis (MD&A) making further disclosures about the status of the project, including that Turquoise Hill took a $600 million impairment charge and a substantial deferred income tax recognition adjustment tied to the Oyu Tolgoi project, and that it suffered a loss in the second quarter. The next day, before the market open, Rio Tinto issued a release concerning in part the project status, including that it had also taken an impairment charge related to the Oyu Tolgoi project, of $800 million.
Following this news, on August 1, 2019, Turquoise Hills common stock price closed at $0.53 per share, down 8.62% from the prior days closing price of $0.58 per share.
The complaint, filed on October 15, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements and omitted to disclose material facts regarding the Companys business and operations. Specifically, defendants made false and or misleading statements and/or failed to disclose that: (i) the progress of underground development of Oyu Tolgoi was not proceeding as planned; (ii) there were significant undisclosed underground stability issues that called into question the design of the mine, the projected cost and timing of production; (iii) the Companys publicly disclosed estimates of the cost, date of completion and dates for production from the underground mine were not achievable; (iv) the development capital required for the underground development of Oyu Tolgoi would cost substantially more than a billion dollars over what the Company had represented; and (v) Turquoise Hill would require additional financing and/or equity to complete the project.
For more information on the Turquoise Hill class action go to: https://bespc.com/TRQ
Reata Pharmaceuticals, Inc. (NASDAQ: RETA)
Class Period: October 15, 2019 to August 7, 2020
Lead Plaintiff Deadline: December 14, 2020
Reata is a clinical stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways that regulate cellular metabolism and inflammation.
Among Reatas drug candidates under development is omaveloxolone, which is in Phase 2 clinical development to treat Friedreich's ataxia (FA). Following the announcement of positive data from the MOXIe Part 2 study of omaveloxolone for FA inOctober 2019, the Company represented that it would seek submission for marketing approval of omaveloxolone for the treatment of FA in the U.S. with the U.S. Food and Drug Administration (FDA).
OnAugust 10, 2020, Reata issued a press release announcing its second quarter 2020 financial results, wherein it disclosed that the FDA is not convinced that the MOXIe Part 2 results of the Company's study assessing omaveloxolone for the treatment of FA will support a single study approval without additional evidence that lends persuasiveness to the results, and that, [i]n preliminary comments for [a] meeting, the FDA stated that [Defendants] will need to conduct a second pivotal trial that confirms the mFARS [modified Friedreich's Ataxia Rating Scale] results of the MOXIe Part 2 study with a similar magnitude of effect.
On this news, Reatas stock price fell$51.79per share, or 33.16%, to close at$104.41per share onAugust 10, 2020.
The Complaint, filed on October 15, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Companys business. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) the MOXIe Part 2 study results were insufficient to support a single study marketing approval of omaveloxolone for the treatment of FA in the U.S. without additional evidence; (ii) as a result, it was foreseeable that the FDA would not accept marketing approval of omaveloxolone for the treatment of FA in the U.S. based on the MOXIe Part 2 study results; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
For more information on the Reata class action go to: https://bespc.com/REATA
About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com
Genmab Announces IFM, HOVON and Janssen Achieve Positive Topline Results in Second Part of Phase 3 CASSIOPEIA Study of Daratumumab in Multiple Myeloma…
By daniellenierenberg
Company Announcement
Copenhagen, Denmark; October 21, 2020 Genmab A/S (Nasdaq: GMAB) announced today positive topline results from the second part of the Phase 3 CASSIOPEIA (MMY3006) study of daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT). The second part of the study, which is being conducted by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, LLC (Janssen), met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.53 (95% CI 0.42 0.68), p < 0.0001) resulting in a 47% reduction in the risk of progression or death in patients treated with daratumumab. The safety profile observed in this study was consistent with the known safety profile of daratumumab and no new safety signals were observed.
Based on the results at the pre-planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC), it was recommended to unblind the study results. Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, plans to discuss the potential for a regulatory submission for this indication with health authorities, and plans to submit the data to an upcoming medical conference and for publication in a peer-reviewed journal.
Following the positive data from the first part of the CASSIOPEIA study, we are very pleased to see this benefit. We are appreciative of the efforts of the IFM, of HOVON and of Janssen for their work on this study, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the CASSIOPEIA (MMY3006) StudyThis Phase 3 study is a randomized, open-label, multicenter study, conducted by the IFM in collaboration with the HOVON and Janssen, which includes 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who were eligible for high dose chemotherapy and ASCT. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide and dexamethasone (VTd) or VTd alone. The primary endpoint was the number of patients that achieved a stringent complete response (sCR). In the second part of the study, patients that achieved a response underwent a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival.
About Multiple MyelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5
About DARZALEX (daratumumab)DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.
DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.
In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase 3 studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.
About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.
1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, August 2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf Last accessed August 20207 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.
Company Announcement no. 45CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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Genmab Announces IFM, HOVON and Janssen Achieve Positive Topline Results in Second Part of Phase 3 CASSIOPEIA Study of Daratumumab in Multiple Myeloma...
COVID-19 can affect the heart – Science Magazine
By daniellenierenberg
The family of seven known human coronaviruses are known for their impact on the respiratory tract, not the heart. However, the most recent coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has marked tropism for the heart and can lead to myocarditis (inflammation of the heart), necrosis of its cells, mimicking of a heart attack, arrhythmias, and acute or protracted heart failure (muscle dysfunction). These complications, which at times are the only features of coronavirus disease 2019 (COVID-19) clinical presentation, have occurred even in cases with mild symptoms and in people who did not experience any symptoms. Recent findings of heart involvement in young athletes, including sudden death, have raised concerns about the current limits of our knowledge and potentially high risk and occult prevalence of COVID-19 heart manifestations.
The four common cold human coronavirusesHCoV-229E, HCoV-NL63, HCoV-OC43, and HCoV-HKU1have not been associated with heart abnormalities. There were isolated reports of patients with Middle East respiratory syndrome (MERS; caused by MERS-CoV) with myocarditis and a limited number of case series of cardiac disease in patients with SARS (caused by SARS-CoV) (1). Therefore, a distinct feature of SARS-CoV-2 is its more extensive cardiac involvement, which may also be a consequence of the pandemic and the exposure of tens of millions of people to the virus.
What appears to structurally differentiate SARS-CoV-2 from SARS is a furin polybasic site that, when cleaved, broadens the types of cells (tropism) that the virus can infect (2). The virus targets the angiotensin-converting enzyme 2 (ACE2) receptor throughout the body, facilitating cell entry by way of its spike protein, along with the cooperation of the cellular serine protease transmembrane protease serine 2 (TMPRSS2), heparan sulfate, and other proteases (3). The heart is one of the many organs with high expression of ACE2. Moreover, the affinity of SARS-CoV-2 to ACE2 is significantly greater than that of SARS (4). The tropism to other organs beyond the lungs has been studied from autopsy specimens: SARS-CoV-2 genomic RNA was highest in the lungs, but the heart, kidney, and liver also showed substantial amounts, and copies of the virus were detected in the heart from 16 of 22 patients who died (5). In an autopsy series of 39 patients dying from COVID-19, the virus was not detectable in the myocardium in 38% of patients, whereas 31% had a high viral load above 1000 copies in the heart (6).
Accordingly, SARS-CoV-2 infection can damage the heart both directly and indirectly (see the figure). SARS-CoV-2 exhibited a striking ability to infect cardiomyocytes derived from induced pluripotent stem cells (iPSCs) in vitro, leading to a distinctive pattern of heart muscle cell fragmentation, with complete dissolution of the contractile machinery (7). Some of these findings were verified from patient autopsy specimens. In another iPSC study, SARS-CoV-2 infection led to apoptosis and cessation of beating within 72 hours of exposure (8). Besides directly infecting heart muscle cells, viral entry has been documented in the endothelial cells that line the blood vessels to the heart and multiple vascular beds. A secondary immune response to the infected heart and endothelial cells (endothelitis) is just one dimension of many potential indirect effects. These include dysregulation of the renin-angiotensin-aldosterone system that modulates blood pressure, and activation of a proinflammatory response involving platelets, neutrophils, macrophages, and lymphocytes, with release of cytokines and a prothrombotic state. A propensity for clotting, both in the microvasculature and large vessels, has been reported in multiple autopsy series and in young COVID-19 patients with strokes.
There is a diverse spectrum of cardiovascular manifestations, ranging from limited necrosis of heart cells (causing injury), to myocarditis, to cardiogenic shock (an often fatal inability to pump sufficient blood). Cardiac injury, as reflected by concentrations of troponin (a cardiac musclespecific enzyme) in the blood, is common with COVID-19, occurring in at least one in five hospitalized patients and more than half of those with preexisting heart conditions. Such myocardial injury is a risk factor for in-hospital mortality, and troponin concentration correlates with risk of mortality. Furthermore, patients with higher troponin amounts have markers of increased inflammation [including C-reactive protein, interleukin-6 (IL-6), ferritin, lactate dehydrogenase (LDH), and high neutrophil count] and heart dysfunction (amino-terminal pro-Btype natriuretic peptide) (9).
More worrisome than the pattern of limited injury is myocarditis: diffuse inflammation of the heart, usually representing a variable admixture of injury and the inflammatory response to the injury that can extend throughout the three layers of the human heart to the pericardium (which surrounds the heart). Unlike SARS-associated myocarditis, which did not exhibit lymphocyte infiltration, this immune and inflammatory response is a typical finding at autopsy after SARS-CoV-2 infections. Involvement of myocytes, which orchestrate electrical conduction, can result in conduction block and malignant ventricular arrhythmias, both of which can lead to cardiac arrest.
Along with such in-hospital arrythmias, there have been reports of increased out-of-hospital cardiac arrest and sudden death in multiple geographic regions of high COVID-19 spread, such as the 77% increase in Lombardy, Italy, compared with the prior year (10). There have been many reports of myocarditis simulating a heart attack, owing to the cluster of chest pain symptoms, an abnormal electrocardiogram, and increased cardiac-specific enzymes in the blood, even in patients as young as a 16-year-old boy. When there is extensive and diffuse heart muscle damage, heart failure, acute cor pulmonale (right heart failure and possible pulmonary emboli), and cardiogenic shock can occur.
COVID-19associated heart dysfunction can also be attributed to other pathways, including Takotsubo syndrome (also called stress cardiomyopathy), ischemia from endothelitis and related atherosclerotic plaque rupture with thrombosis, and the multisystem inflammatory syndrome of children (MIS-C). The underlying mechanism of stress cardiomyopathy is poorly understood but has markedly increased during the pandemic. MIS-C is thought to be immune-mediated and manifests with a spectrum of cardiovascular features, including vasculitis, coronary artery aneurysms, and cardiogenic shock. This syndrome is not exclusive to children because the same clinical features have been the subject of case reports in adults, such as in a 45-year-old man (11).
Recent series of COVID-19 patients undergoing magnetic resonance imaging (MRI) or echocardiography of the heart have provided some new insights about cardiac involvement (1214). In a cohort of 100 patients recovered from COVID-19, 78 had cardiac abnormalities, including 12 of 18 patients without any symptoms, and 60 had ongoing myocardial inflammation, which is consistent with myocarditis (12). The majority of more than 1200 patients in a large prospective cohort with COVID-19 had echocardiographic abnormalities (13). This raises concerns about whether there is far more prevalent heart involvement than has been anticipated, especially because at least 30 to 40% of SARS-CoV-2 infections occur without symptoms. Such individuals may have underlying cardiac pathology.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has the potential to directly and indirectly induce cardiac damage.
To date, there have been four small series of asymptomatic individuals with bona fide infections who underwent chest computed tomography (CT) scans to determine whether there were lung abnormalities consistent with COVID-19. Indeed, half of the asymptomatic people showed lung CT features that were seen in patients with symptoms. But so far, there have been minimal cardiac imaging studies in people who test positive for SARS-CoV-2 or are seropositive but without symptoms. Furthermore, the time course of resolution or persistence of any organ abnormalities after SARS-CoV-2 infection has not yet been reported. With a high proportion of silent infections despite concurrent evidence of internal organ damage, there is a fundamental and large hole in our knowledge base.
In contrast to people without symptoms, there is a substantial proportion of people who suffer a long-standing, often debilitating illness, called long-COVID. Typical symptoms include fatigue, difficulty in breathing, chest pain, and abnormal heart rhythm. An immunologic basis is likely but has yet to be determined. Nor have such patients undergone systematic cardiovascular assessment for possible myocarditis or other heart abnormalities, such as fibrosis, which could account for some of the enduring symptoms. It would not be surprising in the future for patients to present with cardiomyopathy of unknown etiology and test positive for SARS-CoV-2 antibodies. However, attributing such cardiomyopathy to the virus may be difficult given the high prevalence of infections, and ultimately a biopsy might be necessary to identify virus particles to support causality.
Cardiac involvement in athletes has further elevated the concerns. A 27-year-old professional basketball player, recovered from COVID-19, experienced sudden death during training. Several college athletes have been found to have myocarditis (14), including 4 of 26 (15%) in a prospective study from Ohio State University (15), along with one of major league baseball's top pitchers. Collectively, these young, healthy individuals had mild COVID-19 but were subsequently found to have unsuspected cardiac pathology. This same demographic groupyoung and healthyare the most common to lack symptoms after SARS-CoV-2 infections, which raises the question of how many athletes have occult cardiac disease? Systematic assessment of athletes who test positive for SARS-CoV-2, irrespective of symptoms, with suitable controls through some form of cardiac imaging and arrhythmia screening seems prudent until more is understood.
The most intriguing question that arises is why do certain individuals have a propensity for heart involvement after SARS-CoV-2 infection? Once recognized a few months into the pandemic, the expectation was that cardiac involvement would chiefly occur in patients with severe COVID-19. Clearly, it is more common than anticipated, but the true incidence is unknown. It is vital to determine what drives this pathogenesis. Whether it represents an individual's inflammatory response, an autoimmune phenomenon, or some other explanation needs to be clarified. Beyond preventing SARS-CoV-2 infections, the goal of averting cardiovascular involvement is paramount. The marked heterogeneity of COVID-19, ranging from lack of symptoms to fatality, is poorly understood. A newly emerged virus, widely circulating throughout the human population, with a panoply of disease manifestations, all too often occult, has made this especially daunting to unravel.
Acknowledgments: E.J.T. is supported by National Institutes of Health grant UL1 TR001114.
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COVID-19 can affect the heart - Science Magazine
The role of induction therapy before autologous stem cell transplantation in low disease burden AL amyloidosis patients – DocWire News
By daniellenierenberg
This article was originally published here
Amyloid. 2020 Oct 21:1-9. doi: 10.1080/13506129.2020.1835635. Online ahead of print.
ABSTRACT
BACKGROUND: Induction therapy is recommended before autologous stem cell transplantation (ASCT) for AL amyloidosis patients with high disease burden [bone marrow plasma cells (BMPCs) > 10%], but the role of induction therapy before ASCT in patients with low disease burden (BMPCs 10%) is still unknown.
METHODS: A total of 227 patients with AL amyloidosis were included in this study. Among 227 patients, 124 patients received bortezomib-based induction prior to ASCT and were defined as group A, 35 patients received other chemotherapeutic induction and were defined as group B, and the other 68 patients without induction were defined as group C. We compared the differences of efficacy and prognosis between the three groups.
RESULTS: The haematological overall response rates (ORR) of groups A, B and C were 91%, 67% and 75%, respectively. The complete response rates (CR) of groups A, B and C were 50%, 25% and 20%, respectively. Both the ORR and CR rates of group A were significantly higher than those of groups B and C. The renal response rates of groups A, B and C were 64%, 46% and 47%, respectively. The cardiac response rates of groups A, B and C were 74%, 45% and 40%, respectively. The renal and cardiac responses rates of group A were also significantly higher than those of the other two groups. After a median follow-up of 44 months, the median OS was not reached. The 5-year estimated overall survival (OS) rates of groups A, B and C were 81%, 57% and 67%, respectively. The median progression-free survival (PFS) was 83 months for all patients. The 5-year estimated PFS rates of groups A, B and C were 61%, 38% and 49%, respectively. Both the OS and PFS of group A were higher than those of both group B and group C. On multivariate analysis, baseline dFLC > 50 mg/L was associated with worse survival, but induction with bortezomib was associated with better survival.
CONCLUSION: Our study demonstrated that low disease burden AL patients who are eligible for ASCT may benefit from bortezomib-based induction therapy.
PMID:33084412 | DOI:10.1080/13506129.2020.1835635
Exosome Therapeutic Market 2020-2026 Demand Analysis and Projected Huge Growth by Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH,…
By daniellenierenberg
To better structure this Exosome Therapeutic Market report, a nice blend of advanced industry insights, practical solutions, talent solutions and latest technology is utilized which gives an excellent experience to the readers or end users. The report is a valuable resource which provides current as well as upcoming technical and financial details of the industry to 2026. CAGR values for the market for an estimated forecast period of 2020 to 2026 are mentioned in the report which helps determine costing and investment For better understanding of the market and leading business growth, Exosome Therapeutic Market research report is the ideal solution.
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Market Analysis and Insights:Global Exosome Therapeutic Market
Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.
The major players covered in theExosome Therapeutic Marketreport areevox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global.Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.
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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.
Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.
Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.
This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.
Global Exosome Therapeutic Market Scope and Market Size
Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.
Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.
Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.
Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.
Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.
Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.
Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.
Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.
Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.
The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.
Exosome therapeutic Market Country Level Analysis
The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.
The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.
Country Level Analysis, By Type
North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.
Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration
Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.
Competitive Landscape and Exosome Therapeutic Market Share Analysis
Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.
Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.
For instance,
Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.
Customization Available:Global Exosome Therapeutic Market
Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.
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Stem Cell Assay Market expected to Witness a Sustainable Growth over 2025 – TechnoWeekly
By daniellenierenberg
Stem Cell Assay Market: Snapshot
Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues andtumors, wherein their toxicity, impurity, and other aspects are studied.
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With the growing number of successfulstem cell therapytreatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.
Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.
Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.
Global Stem Cell Assay Market: Overview
The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.
The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.
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Global Stem Cell Assay Market: Key Market Segments
For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.
In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.
The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.
Global Stem Cell Assay Market: Regional Analysis
Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.
Global Stem Cell Assay Market: Vendor Landscape
A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.
Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).
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Stem Cell Assay Market expected to Witness a Sustainable Growth over 2025 - TechnoWeekly