Archive for February, 2020

Photo: Yulia Gorbachenko

BEST ACNE-REDUCING FACIALRejuran Healer+ Laser Peel$737 for 60 minutes, Priv ClinicAt the heart of this facial is polynucleotide, a biopolymer molecule highly compatible with the human body. Delivered into the skin via a series of micro injections, it reportedly helps repair damaged skin cells, boost collagen synthesis, reduce sebum production and even out the skins moisture-oil balance. The miniscule punctures in the skin also trigger its natural wound-healing response, boosting cellular turnover. Some light swelling may appear post-treatment, but it goes away within 24 hours. Meanwhile, skin is visibly suppler, and looks smoother and healthier.

BEST ANTI-AGEING FACIALInstant Youth ProgrammeFrom $260 for 75 minutes, EstheClinicBehold the ultimate helping hand to counter the signs of mature skin. Each treatment is uniquely tailored to your specific skin type and needs, with subsequent sessions building on and enhancing the effects of prior treatments to maximise collagen production for firmer skin. By using the latest in aesthetic technology alongside EstheClinics specially selected cosmeceutical products, the signs of ageing are thus tackled from the inside out, with effects continuing to last up to four months after completing the programme.

BEST ANTI-BLEMISH FACIALTetra+ $398 per session, The Aesthetics Medical ClinicThis four-in-one treatment features a symphony of lasers with varying wavelengths to tackle multiple issues in just one sitting. A pigment wavelength breaks down melanin clusters to improve discoloration; a custom fractional laser refines texture; a superficial wavelength zaps clogged pores clean; and a long-pulse wavelength stimulates collagen production. Expect minimal to no downtimeand a smoother complexion in no time at all.

BEST BRIGHTENING FACIALRejuvenation Laser and Stem Cell Infusion$1,888 for five sessions, The Aesthetics Medical ClinicCombining two laser machinesQ Switch and yellow laserthat work in tandem to give you radiant, glowy skin, this also removes dirt, dead skin cells, oil and superficial hair, so skin is not only brightened, but also clearer and cleaner. The laser also helps to regulate oil production and reduce pigmentation, while the potent 80percent stem cell-derived serum delivers proteins, growth factors and cytokines intoskin to help boost regeneration and repair.

BEST CLEANSING FACIALJet Set$129 for 30 minutes, EPIONIdeal as a maintenance facial for time-strapped individuals, this express purifying solution rejuvenates weary skin in 30 minutes. A highpressure aqua jet peel gently sweeps away any build-up of dry and dead skin, before an ultrasonic deep cleanse purges pores of dirt, sebum and impurities. Jet technology is then used to infuse skin with potent actives with intense hydrating and brightening benefits.

Related article:BAZAAR Spa Awards 2020: Best Face Therapies To Transform And Pamper Your Skin

BEST DETOXIFYING FACIALVitamin C Infusion$288 for 45 minutes, Simply AestheticsBid adieu to skin woes such as open pores, blemishes, pigmentation and dullness with a super-potent dose of medical-grade vitamin C, which smooths and revitalises the skin. Besides getting rid of pore-clogging impurities that can make the skin appear dull or lacklustre, the facial also stimulates the dermal cells to actively produce collagen in order to regain that plump, fresh-faced radiance.

BEST EXPRESS FACIALIDS Electro Infusion (IEI)$280 for 45 minutes, IDS AestheticsGreat as a lunchtime facial, this uses a combination of electronic-magnetic pulses and LED light to brighten and firm skin. Designed to tackle various skin conditionspigmentation, fine lines, wrinkles, dryness, dullnessthis quickie facial is deemed a universal beauty enhancer and works its magic in less than an hour.

BEST EYE LIFT TREATMENTSygmaLift Eyes$670 for 60 minutes, Clifford AestheticsWhether its eyebags or dark circles that no concealer can hide, the root causes of your undereye issues are sussed out with a consultation in order to tailor an effective treatment. SygmaLift therapy, which utilises high-intensity focused ultrasound technology, is then applied to the under-eye area to contract the connective tissues deep within to tighten and smooth skin. The end resulta marked improvement in the appearance of under-eye bags, sagginess, discoloration and linestakes years off your face!

BEST HYDRATING FACIALHydraFacial$250 for 35 minutes, Dr Kevin Chua Medical & AestheticsThis all-in-one treatment starts off with a deep cleanse, and an exfoliating cocktail of salicylic and glycolic acids to break up pore-clogging impurities, allowing the HydraPeel Tip to essentially vacuum out sebum, product build-up, blackheads and dirt, before infusing skin with intensive serums to replenish hydration levels and provide antioxidant protection.

BEST LIFTING & FIRMING FACIALThermage FLX$5,350 for 90 minutes, Priv ClinicWant to reduce the look of fine lines, wrinkles, sagging skin and other signs of ageing, or simply delay their dreaded appearance? Promising just that is the Thermage FLX, which uses radio frequency to stimulate cell regeneration and collagen production. This newgen treatment is optimised for improved comfort and more controlled delivery, and the results from one session is said to last for months.

BEST PORE-REFINING FACIAL3D Deep Pore Cleansing Facial$588 for 90 minutes, Aesthetics Central ClinicFlawless skin can now be had with this signature treatment that utilises a patented device called 50 Micron Jet Technology, where high-pressure micro-jets of water gently push out the sebum and impurities trapped in pores. As the pores are being cleaned out, the machine delivers a serum, designed to lift and tighten skin while encouraging microcirculation, deep into the skin.

BEST REJUVENATING FACIALPicoWay RESOLVE $650 for 30 minutes, Dr Kevin Chua Medical & AestheticsSo named for the technology where laser pulses are delivered in picosecondsa unit of measurement that refers to one trillionth of a seconda PicoWay facial sends small bursts of intense laser energy deep into the skin to stimulate its natural healing abilities. The short pulsations mean that less heat is emitted during the procedure, so you neednt worry about post-treatment burns. Benefits of the treatment, which is suitable for most skin types, include plumper, suppler skin with improved tone and texture.

Related article:Spa Awards 2020 Best Rejuvenating Facial: PicoWay RESOLVE

BEST RESURFACING FACIALPico Fractional Laser Treatment$300 for 60 minutes, Calvin Chan Aesthetic & Laser ClinicVia short but intense pulses of laser energy delivered deep into the dermis, the skin is transformed from the inside out as new collagen and elastin is produced to significantly improve the appearance of pitted acne scars, pigmentation and wrinkles. And if youre worried about downtime, dont. The surface of the skin is left intact while the deep tissue heals, which means theres no recovery time involved.

BEST SHAPING & TIGHTENING FACIALBiologique Recherche Remodeling Face $380 for 90 minutes, Freia AestheticsThis kicks off with a 60-minute booster customised to your skins needs, followed by a proprietary massage that promotes blood flow and stimulates the lymph nodes for a detoxifying effect. The Remodelling Face machine then uses a bespoke blend of electric, galvanic and high-frequency currents to enhance the benefits of the preceding steps, and deliver product actives deeper and more efficiently into skin for a supreme lifting, tightening and plumping effect.

BEST SOOTHING FACIALSeriously Soothing $209 for 90 minutes, EPIONLiving up to its name, this hydrates and calms thirsty skin with a side of sensitivity. Ultrasonic energy is first used to give skin a deep cleanse. This is followed by a dose of much-needed hyaluronic acid and the application of a soothing face mask. The final step: LED red light therapy to help stimulate collagen production and reduce redness or inflammation.

Related article:Cindy Crawford Shows How She Stays Fabulous At Every Age In Our February Issue

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Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern - Harper's Bazaar Singapore

Liposuction is a surgical procedure to remove extra fat from your body. It started in the 1980s and has become one of the most popular plastic surgeries in the US. An estimated 258,000 Americans got it in 2018.

Today, you can expect to pay around $3,500 for liposuction and most health insurance plans won't cover the cost. But if you're willing to pay the price, liposuction is a relatively safe and quick procedure that can help you shed fat that diet and exercise can't.

Here's what you need to know about how liposuction works and why it's not a weight-loss tool.

Liposuction is a 1-to2-hour-long procedure where fat cells are permanently removed from your body, usually for cosmetic reasons. People who get liposuction don't do it to lose large amounts of weight but rather to help sculpt the shape of their body.

Some of the most common places to have fat removed are the belly, thighs, buttocks, arms, back, the upper neck just under the chin, and jawline/jowls.

Depending on where you're getting the procedure, doctors will either provide a local anesthetic to numb the area of operation or they will give you a general anesthetic so you're unconscious during the procedure.

Then, surgeons will often inject into the area of operation a solution containing a mix of saline solution, a numbing medicine, and medicine the decreases bleeding. This is to help the skin and fat separate from important structures like muscles and blood vessels so they aren't damaged during the suctioning process.

After that, the surgeon inserts a long metal instrument called a cannula under your skin. The cannula then vacuums out your fat. During this process, surgeons may also use a smaller microcannula to remove fat in nearby areas to achieve a more natural, smoother contour.

Once the fat is removed through liposuction it can be discarded or it can be injected back into your body to enhance features like breasts, buttocks, or face. Or, more recently, in the last decade or so, liposuction has also been used to retrieve stem cells a type of cell that can form other specialized cells in the body for laboratory research.

After liposuction, your surgeon will likely recommend you wear a temporary band or brace over the area of operation to help the skin heal. The band or brace also helps prevent fluid from building up in the area of operation where the fat was removed, between the skin and deeper structures like muscles and blood vessels.

Whether you are awake or asleep during liposuction, you shouldn't feel any pain during the procedure, says Marco A. Pelosi II, MD, a cosmetic surgeon with experience performing liposuction procedures. The recovery, also, should be a relatively mild process.

After getting liposuction, you will feel soreness similar to a muscle ache. "The level of this soreness is typically a 2 or 3 out of 10 for a few weeks," says Pelosi, adding that you should be able to go back to work in 2 to 3 days.

Ongoing pain near the area where the cannula was inserted is a risk of liposuction, and if the pain grows or pain killers don't help, you should tell your surgeon.

According to the Cleveland Clinic, you should not use liposuction as a weight loss alternative. It recommends that if you want to lose weight, you should first try diet and exercise, then use liposuction to take care of more stubborn areas like the chin or belly fat.

Moreover, research shows that people who keep up other weight loss practices like a healthy diet and exercise will see better results after liposuction and keep fat from returning to a particular area.

This is because while liposuction permanently removes fat cells from your body, there is nothing to stop the remaining fat cells from getting bigger if you gain more weight.

There are some important safety tips to look for when choosing a liposuction provider.

First, look for a facility that meets national safety requirements. You can verify if a facility is accredited on the American Society of Plastic Surgeons' website here.

Pelosi says that doctors should also do blood work testing and medical clearances before a liposuction procedure to ensure your safety. These tests are to make sure you can safely undergo general anesthesia without complication. If, for example, you have an infection or are pregnant, you may not qualify for the surgery.

Last, but not least, is to look for a surgeon who is board-certified in performing these types of procedures and also has extensive experience with liposuction procedures so you know that they are well versed in the technique. To find out more about a practitioner's experience with liposuction, you can check the American Society of Plastic Surgeons' website.

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What is liposuction? How the procedure works and how painful it is - Insider - INSIDER

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Statistics, Trends, Size, Growth Opportunities, Share Demand and Forecast to 2025 - Jewish Life News

The market analysis and insights included in the Cosmetic Skin Care market report presents key statistics on the market status of global and regional manufacturers and is an essential source of guidance which provides right direction to the companies and individuals interested in the industry. To prosper in this competitive market place, businesses are highly benefited if they adopt innovative solutions such as this Cosmetic Skin Care market research report. This wide-ranging market research report acts as a backbone for the success of business in any sector. The market drivers and restraints have been explained in the report with the use of SWOT analysis.

Global cosmetic skin care marketis 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 ;

Complete report on Global Cosmetic Skin Care Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

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.

Key Questions Answered in Global Cosmetic Skin Care Market Report:-

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Customize report of Global Cosmetic Skin Care Market as per customers requirement also available.

Market Segmentations:

Global Cosmetic Skin Care Market is segmented on the basis of

Market Segmentations in Details:

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North America

Europe

Asia-Pacific

South America

Middle East & Africa

Competitive Analysis: Global Cosmetic Skin Care Market

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.

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COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 - Reporting 99

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] 10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in these patients. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

Triple-negative breast cancer is an aggressive malignancy. It is very encouraging that KEYTRUDA in combination with chemotherapy has now demonstrated positive results as both a first-line treatment in the metastatic setting with this trial, and as neoadjuvant therapy in the KEYNOTE-522 trial, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. We look forward to sharing these findings with the medical community at an upcoming congress and discussing them with the FDA and other regulatory authorities.

The KEYTRUDA breast cancer clinical development program encompasses several internal and external collaborative studies. In addition to KEYNOTE-355, in TNBC these include the ongoing registration-enabling studies KEYNOTE-242 and KEYNOTE-522.

About KEYNOTE-355

KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigators choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) compared with placebo plus one of the three chemotherapy regimens for the treatment of locally recurrent inoperable or mTNBC that has not been previously treated with chemotherapy in the metastatic setting. Part 1 of the study was open-label and evaluated the safety and tolerability of KEYTRUDA in combination with either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin in 30 patients. Part 2 of KEYNOTE-355 was double-blinded, with dual primary endpoints of OS and PFS in all participants and in participants whose tumors expressed PD-L1 (CPS 1 and CPS 10). The secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

Part 2 of KEYNOTE-355 enrolled 847 patients who were randomized to receive KEYTRUDA (200 mg intravenously [IV] on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and Area Under the Curve [AUC] 2 [carboplatin] on days 1 and 8 of each 21-day cycle); or placebo (normal saline on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and AUC 2 [carboplatin] on days 1 and 8 of each 21-day cycle).

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

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

Classical Hodgkin Lymphoma

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High (MSI-H) Cancer

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

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

Gastric Cancer

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

Esophageal Cancer

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

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Read more from the original source:
Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for...

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Maybe the winter blues have you feeling down, or youre wondering if your crappy month could actually be depression. So you pull out your phone, Google mood boosters, and cross your fingers that youll get better suggestions than bubble baths and homemade face masks.

The truth is, your happiness is influenced by a whole mess of factors. Brain chemicals and hormones make a big difference. Take serotonin, for instance. This tiny chemical is a whole mood.

Serotonin is a neurotransmitter found in your brain, blood, and digestive system. It ships messages feel-good, stabilizing ones between nerve cells. Thats why its been dubbed the happy hormone or happy chemical.

Serotonin helps you sleep, controls cravings, and keeps your digestion regular (which is a low-key mood booster on its own, amiright?). Studies are still unclear on whether serotonin is directly responsible for good vibes or if it simply plays a critical role in regulating your nervous system.

Since serotonin is basically your wellness ride-or-die, bad things happen when it gets too low. Some of this is theoretical its not like we can stick a needle in your brain to check the serotonin level, and there are no blood tests yet. But the theory has yet to be proven wrong.

Symptoms of a serotonin slump include:

Weve all heard the jokes about tryptophan, the mystical amino acid in turkey that puts you into a food coma. Research has also linked tryptophan-heavy diets with feeling happier and calmer.

Sure, tryptophan makes you sleepy, but your body also uses it to create serotonin. Some of the strongest evidence for the serotonin theory comes from studies that show low intake of tryptophan is linked to depression.

+ = =

More tryptophan equals more serotonin and more good vibes all around.

Upping your serotonin isnt as simple as smashing turkey legs on repeat. Your brain has an uber-protective covering called the blood-brain barrier, and good ol tryptophan has to wait in line to be admitted just like everyone else.

Good news: Research suggests that pairing tryptophan with carbs bypasses this issue.

Pro tip:

Since carbs tell your body to release insulin, and insulin speeds up amino acid absorption, eat your tryptophan-rich meals with 2530 grams of carbs.

Some people need supplements or even antidepressants to get their serotonin flowing. But there are a few natural ways to boost this brain chemical.

Your mission is to load up on tryptophan, which your body can convert into happy, healthy serotonin. But eating one trypto-laced turkey leg wont make much difference in your serotonin levels.

Instead, a steady diet of tryptophan-rich foods paired with carbs could raise your serotonin levels over time.

Here are some of the best tryptophan-heavy foods to fill up on.

Eggs specifically the yolks are packed with tryptophan. Theyre full of amino acids and antioxidants like tryptophan, tyrosine, choline, biotin (great for hair, skin, and nails!), and omega-3 fatty acids.

Pro tip: For all the benefits without extra cholesterol, go for hard-boiled instead of fried. Remember to pair it with a carb for maximum effect. Toast or oatmeal, anyone?

Pineapple is a triple threat when youre feeling drained or sick. It has tryptophan, a bit of serotonin, and lots of bromelain an enzyme proven to reduce inflammation.

Pro tip: Pack two tryptophan powerhouses into one meal with a Hawaiian-style chicken and pineapple dish served over rice (dont forget the carb!).

Heres one more reason to order the cheese board next time youre out for happy hour.

In a study of 25 healthy people, participants reported significantly better moods during a 4-day diet high in tryptophan than during their subsequent 4-day diet low in tryptophan. And which food made them so happy? Mozzarella, for starters.

Bananas are already famous for their potassium content. But wait theres more! The National Sleep Foundation recommends eating half a banana 1 hour before bedtime because of the fruits tryptophan content. Since fruit is already full of good carbs, its a perfect pairing.

You know where this is going. Yep, salmon is full of tryptophan too. Aside from fueling your serotonin reserves, salmon floods your body with omega-3 fatty acids, which have been found to reduce the risk of fatal heart disease.

Tofu is the best serotonin-boosting food for vegans and vegetarians. Its also one of the proteins Cleveland Clinic recommends dishing out to cure the winter blues.

Pro tip: Look for calcium-set tofu for a meal that will help you feel happier and stronger.

Remember the first time you heard the word tryptophan? It was probably on a long-ago Thanksgiving. We all know turkey has tryptophan. And now you know tryptophan is good for more than summoning Mr. Sandman it also unlocks your serotonin potential.

Good news for snackers: Every nut and seed you can think of contains tryptophan. Bonus points for nuts because studies show that a handful a day may help keep the oncologist and cardiologist away!

Pro tip: Round out your good vibes snack with dried fruit (good carbs!) instead of chocolate for healthier noshing.

Eating your feelings isnt always the best path to happiness. Keep your serotonin flowing with these lifestyle tweaks too:

H2O keeps your brain and the rest of your body running smoothly. Next time youre feeling low, try downing a big glass of water. Rinse and repeat.

Aerobic exercise releases tryptophan and endorphins into your bloodstream.

Research suggests serotonin levels dip in winter. Sunshine seems to jump-start your bodys serotonin production.

Theres more research to be done, but this serotonin-and-sunshine connection could explain seasonal affective disorder (SAD). On a related note, get your level of Vitamin D checked and take a supplement if indicated.

A happy, healthy diet goes beyond tryptophan-rich foods. Recent studies indicate that eating a balanced diet could help protect against depression.

Processed foods full of artificial sweeteners and food coloring can screw with your gut bacteria, which affects your mood and overall wellness.

Some research suggests that massage lowers cortisol, which is the ying to serotonins yang. In a 2012 study of pregnant women with depression, two 20-minute massages a week decreased anxiety and increased serotonin after about 4 months.

Sometimes eating all the turkey and getting all the sunshine still doesnt lift your spirits. If youre here for serotonin boosters because day-to-day life feels like a struggle, you might be depressed.

Talk to your doctor about antidepressants, supplements, and therapy options.

Some people have naturally lower levels of serotonin. This brain chemistry imbalance might feel like a permanent cloud over your head, a lack of motivation, or even intense irritability.

Doctors sometimes prescribe selective serotonin reuptake inhibitors (SSRIs) for people who have chronically low serotonin. SSRIs prevent your happy chemical from being reabsorbed too quickly, so serotonin sticks around longer, prolonging good vibes.

Here are some common SSRIs used to treat depression:

In the last few years, SSRIs have gotten some criticism. One article in 2015 even called them the marketing of a myth. Why? Because even though SSRIs have been in pharmacists rotation since the 1980s, research still hasnt totally backed up their effectiveness.

The pills do boost serotonin in the bloodstream, but the jurys still out on whether they do the same in the brain. A 2014 study of mice suggested serotonin might not factor into depression at all. In 2015, another study linked serotonin with vulnerability to stress.

Serotonin also has an anti-inflammatory effect, and research has shown that people with depression have higher indicators of inflammation in blood tests.

So whats the verdict? SSRIs seem to help people with depression, but the reasons are more complicated than a simple low serotonin = bad mood equation.

You could fill up on tryptophan with turkey, cheese, and nuts or you could pop a few tryptophan pills. Just remember to check with your doctor before downing any new supplement.

Its important to know if supplements will interact with your prescription meds, over-the-counter meds, vitamins, or even herbal remedies.

Be sure to research where your supplement was manufactured and buy it from a reputable source the FDA doesnt monitor the quality and safety of supplements.

Pro tip:

Never buy a supplement from a brand you cant easily research and verify. Its important to know whether the product youre buying is pure and high-quality.

These are the most tried-and-true supplements for bumping your mood into a happy place:

Tryptophan supplements are waaay more potent than turkey, salmon, or tofu. That means these high doses of tryptophan are more likely than food to cross the blood-brain barrier. You can buy tryptophan supplements online.

This funny-sounding supplement is actually a flowering plant. Its been touted as a mood booster for years, but research is mixed.

Proceed with caution:

St. Johns wort doesnt play nice with some prescription meds including birth control and cancer drugs. Also avoid taking it with antidepressants or other serotonin-boosting meds.

You can buy St. Johns wort supplements online.

Eating more probiotics could boost your tryptophan levels (and you know what that means: more serotonin!).

The beauty of probiotics is that theyre available in so many forms. Lets count the ways: kombucha, tempeh, yogurt, kimchi, sauerkraut, and oh yes, probiotic supplements.

In 2013, a small study suggested that 5-HTP could be just as effective as antidepressants for mild depression. Further research hasnt been as promising, but its still possible this supplement has the power to enter your brain and kick-start serotonin production.

You can buy 5-HTP supplements here.

PSA:

You can have too much of a good thing! Serotonin overdose is real. Dont mix supplements with SSRIs. Chat with your doctor before switching supplements or changing your SSRI dosage.

If you feel sad or sluggish all the time, it might be time to call a doctor or make an appointment with a therapist. Mood disorders are complex. It takes more than a supplement, a massage, or half a banana at night to treat depression.

After an appointment with a healthcare provider, you might start taking an SSRI or another antidepressant. Or you might be prescribed a different kind of therapy or treatment. Only a medical pro can give you a personalized plan for managing depression.

Serotonin is a neurotransmitter found in several parts of your body. Its best known for making you feel happy and healthy. There are natural ways to boost serotonin, but that doesnt mean you have to do it alone.

If you think you might have depression or another mood disorder, dont hesitate to call your healthcare provider and ask for help.

Visit link:
Serotonin FTW: How to Boost Your Happy Hormone - Greatist

FARMINGTON As a medical student at the University of Arizona, training to go into family medicine, Karren Seely watched as the curriculum circumnavigated or fully avoided topics relating to the health of lesbian, gay, bisexual, transgender and queer people.

There were no more than three classes over three years that covered LGBTQ issues and most focused on HIV/AIDS, she said. When she moved to Maine for the Maine Dartmouth Family Residency Program in 2011, it got worse.

The residency was actually more lacking than medical school, oddly enough, even though there were LGBTQ staff, Seely, 43, said. That was one of the disappointments. Any training that got done, I had to instigate. It just wasnt a priority and thats understandable because theyre trying to teach so much and the regulatory bodies that manage the education of students werent requiring residencies to teach that.

The knowledge she acquired was through conferences she sought out and her own lived experiences as a transgender woman.

Barriers like this, far from unique to the Maine Dartmouth program, illustrate one side of a problem many Mainers know well: Quality healthcare for members of the LGBTQ community is hard to come by. Not enough providers are informed enough to administer proper care, and even where there is good service, accessing it can be tough. Patients often face long waitlists or must travel far distances. Some avoid medical appointments altogether out of fear of mistreatment because of their orientation or identity.

About 67,000 LGBTQ people are living in Maine currently, roughly 6,000 to 12,000 of whom are transgender, according to Quinn Gormley, executive director of Maine Transgender Network.

Seely is one of just 22 medical practitioners in Maine and one of two in central Maine who are part of the only national network of providers dedicated to caring for the LGBTQ community, the GLMA: Health Professionals Advancing LGBTQ Equality Provider Directory. She works at Farmington Family Practice, under the Franklin Community Health Program of MaineHealth. The second is Maia Pinsky, of Gardiner Family Medicine, who was on maternity leave at press time but will be back in mid-February.

The directory can reveal some surprising statistics. Massachusetts, for instance, has five times the population of Maine, but 13 times the number of LGBTQ-friendly providers. In context, Maine is more rural and Boston is home to one of the countrys leading LGBTQ health care, education, research and advocacy groups, Fenway Health. Still, Maines most rural neighbor, Vermont, has less than half the population, but three quarters the number of providers on the directory. There is definitely a shortage of providers in Maine, Gormley said.

The LGBTQ community is one of the major underserved populations, Seely said. For example, lesbian women are more likely to have breast cancer, and were not sure why.

The suicide rate among lesbian, gay and bisexual youth is significantly higher; its nine times higher than the national average for transgender people. Nearly 50% of transgender adults have attempted suicide at least once in their life. Theres a higher rate of smoking and substance use, and this is all largely attributed to societal stigma and the chronic trauma that is associated with that.

While some LGBTQ health needs are specific to the community, like hormone therapy or sex reassignment surgery, health professionals familiar with the population, research institutes and advocates say that most care belongs in primary care or family medicine settings. Much of the required care is universal treating sore throats, allergies, infections, pains and sprains or other conditions like heart disease, diabetes and cancer. Other needs simply require awareness: knowing that just because a lesbian woman is not having penetrative sex with men, she still needs gynecological exams; that because estrogen is a risk factor for breast cancer, transgender women over 50 who have been taking estrogen for more than five years should receive mammograms; and so on, according to Gormley.

Treating (the LGBTQ community) is not particularly complicated, Seely said. You just need to be familiar with the standards of care and get to know the patients.

Gormley echoed that sentiment.

The view that LGBTQ care is a specialty is unfortunate, because something we hear a lot from doctors we train is that they dont think they have a lot of LGBTQ patients, which means they dont have the right data, said Gormley, who runs dozens of trainings a year in Maine and has educated thousands of medical providers. A lack of education and normalcy in LGBTQ health issues results in a lack of competent care.

A lot of doctors are nervous about being labeled as the queer or trans doctor because very quickly they end up having a practice thats only queer and trans and I dont know why. I think were great patients.

Gormley vividly recalls one of the low moments in her own healthcare history. Seven years ago, she went to an emergency room in Lincoln County after breaking her arm while working at a wood shop.

I sit down at the check-in desk with teary eyes because my arm was broken, and across from me is this girl who was in my homeroom in high school and who I had gone to school since kindergarten with, Gormley said.

She knew exactly who I was. I had just come out, and my ID and insurance card didnt match, and she told me that the emergency room wouldnt provide care for me because my identifications didnt match, and she told me to try another hospital. This was a person who knew who I was and knew why my information wouldnt match. It was a hospital where I had received all my care for 20 years.

Bureaucratic things like that happen a lot, and its incredibly embarrassing and often the excuse for providers and even more often front-end workers who dont want to deal with you because of your orientation or identity or they dont want to solve the problem of someone who doesnt fit through the system easily.

RURAL HEALTHCARE

Nowhere in Maine do the issues of accessible and quality LGBTQ healthcare intersect stronger than they do in its rural areas.

Census data shows that nationwide, people in rural communities are more likely to have low incomes and less likely to have health insurance. LGBTQ populations are also more likely to have low incomesand less likely to have health insurance.

LGBTQ healthcare is an area of inequity everywhere in the United States, Gormley said. I think what makes Maine unique is that the intersection of rural healthcare and poverty is particularly strong for us.

As of 2016, Maine was the most rural state in the country, with 61.6% of its population considered rural.

LGBTQ people living in rural areas are at a statistical disadvantage, Gormley said. Maines rural health system is lacking already these are the people already struggling to meet the basic needs of the communities they serve. Anyone else who isnt going to fit cleanly into expectations of what those needs are is going to struggle.

It is in this realm where providers like Seely are setting an example for the state. While she moved to Maine in part to escape the Arizona heat and in part because she was drawn to the Maine Dartmouth program, she said she decided to continue practicing in Farmington for a reason.

And thats because physicians are needed the most in the rural areas, and I knew that LGBTQ-friendly physicians would be needed even more than just any other physician in rural areas, she said.

Right now, she is the primary care provider for 1,700 patients, about 5% roughly 85 of whom are LGBTQ, she said. Some come to Farmington from smaller towns such as Rumford and others from bigger cities including Bangor, Lewiston-Auburn and Augusta.

Currently at capacity, the only new patients Seely will take on are LGBTQ.

I dont believe weve reached that point, Seely said about having to turn LGBTQ patients away. Were trying hard not to reach that point thats partly why Im only accepting LGBTQ patients at the moment.

Generally it isnt like a floodgate kind of situation. Its more here and there. People come in and then I accept them and get them the help they need. Sometimes I work as a consultant for local providers who just havent felt comfortable or experienced enough to help their LGBTQ patients.

SEELYS APPROACH

Hanging up in the four rooms where Seely sees patients at Farmington Family Practice are lists of resources from OUT Maine, an organization that empowers and educates rural LGBTQ youth in Maine; brightly colored flyers titled Gender 101 and rainbow-colored stickers indicating that the rooms are safe spaces for LGBTQ folks. Visible signs of support, she said, can help put patients at ease.

I know some of my patients have had bad experiences (with doctors) in the past, and theyve expressed that to me but I dont really ask for details, Seely said. Mostly I just apologize and tell them that this is a safe space.

I know sometimes its outright hostility from doctors and sometimes its just the ignorance side of things. On rare occasions, patients end up getting triggered and they hear what theyve heard in the past, and it may not necessarily be what the provider was trying to do.

Some of the best ways for doctors to avoid harming LGBTQ patients, Seely said, are to not misidentify their names, gender identities or sexualities and to use their preferred pronouns, such as she/her/hers, he/him/his, or the gender-neutral they/them/their.

The best way to do that is to ask the patients, Seely said. When in doubt, the biggest thing is: dont make assumptions. In our charts, we have the patients name that they go by, whether its legal or not, listed there, and what their preferred pronouns are.

When she sees her patients, Seely makes sure to ask if the names and pronouns on file are still accurate. She hopes that in the future, intake forms at Farmington Family Practice and elsewhere will ask patients to self-identify sexual orientation and gender identity to make the sharing of that information easier for people. It can be difficult to bring up without being prompted.

Understanding that coming out isnt a one-time experience is something that is important for doctors to keep in mind, Seely said.

Its a lifelong process, because for the most part, people dont know youre LGBTQ unless you tell them, so every time you encounter somebody youre thinking about who is safe to talk to about that versus not and that kind of thing. Its important to understand that thats a constant process, and even when theyre coming to see their doctor or their doctors staff, any negative experience can be significantly magnified.

She cautioned that doctors must especially value confidentiality with LGBTQ patients.

Outing patients, particularly minor patients, importantly, is right up there with the complications of, say, dealing with pregnant teenagers, Seely said. It can be outright dangerous. Teenagers can get thrown out of their home.

According to the Center for American Progress, while LGBTQ youth comprise between 5% and 10% of the youth population, about 40% of the homeless youth population is LGBTQ.

This reality is hard for Seely to forget: She was kicked out of her own home at age 20 when she came out as a transgender woman to her birth parents.

ROLE OF DIRECTORIES

Provider directories, like the one from GLMA: Health Professionals Advancing LGBTQ Equality, are a boon to accessible care for the LGBTQ community. They are an anonymous way to find reliable for the most part medical care. They are also a modern version of the whisper networks that allowed the LGBTQ, and especially trans, community to find good doctors during a time when, as Gormley said, it was considered best practice for providers who served us to actively prevent us from talking to each other.

With the policing of gender identities, doctors figured out pretty quickly that when we talk to each other, we tell each other the answers to things that get you through, she said.

There are no formal training requirements (or fees) for doctors to register for and appear in the GLMA: Health Professionals Advancing LGBTQ Equality directory, and because of that, the organization has struggled to vet every provider on its list. One Albion-based provider, for example, is still on the directory, despite having left the practice at least a year ago, according to an official at the Lovejoy Health Center. But seeking inclusion on the resource, despite its flaws, can indicate that a provider is at least interested in reaching out to the LGBTQ community.

Being a part of a list really shows its a huge first step for a lot of people, said Scott Nass, president of GLMA: Health Professionals Advancing LGBTQ Equality and a family physician in Palm Springs, California.

I know a lot of people welcome LGBTQ folks in their practice but hesitate to put (their) name on the list. But letting the LGBTQ community know youre there available, offering whatever support or expertise you can, is really important.

The organization asks providers to take steps to make their practice more inclusive and continue to educate themselves in the latest standards of care for the LGBTQ community, Nass said. An impending update to the database will include more avenues for patients to submit feedback about their experiences with particular doctors.

MaineTransNet has been building a Maine-specific provider directory for the LGBTQ community, called the Maine Queer Health Community Database. Currently in its beta form, there are already 30 provider listings and Gormley said she expects about 50 by the end of February.

Our thought in investing in a database was: aggregate and put the information in a central space so everyone can access it, Gormley said. We want it to be able to be more specific (than GLMA: Health Professionals Advancing LGBTQ Equality) and something thats really designed for Maine. Its not helpful for someone in Presque Isle that theres a really great doctor in Portland.

In the Maine Queer Health Community Database, there are options for community members to leave reviews, and there are also more specific search categories. For instance, people can look for providers based on region and whether or not someone accepts MaineCare.

You can also search using a broader definition of provider, Gormley said. In addition to medical and mental health providers, there are safe people on the database to go to to get your hair cut or for hair removal just a broader scope of wellness care.

Outside of the directories, many members of the LGBTQ community also share information about good or bad providers over Facebook groups and other social media.

HOPE

Despite challenges that persist, Maine has come a long way in recent years in terms of addressing health inequities in the LGBTQ community.

Penobscot Community Health Care has been recognized by the Human Rights Commission for the past eight years as an LGBTQ Healthcare Equality Leader. In 2015, the Barbara Bush Childrens Hospital at Maine Medical Center opened the states first-ever gender clinic though there is a waitlist for appointments. The Mabel Wadsworth Center in Bangor was awarded MaineTransNets first-ever accolade for outstanding transgender healthcare in 2019.

The Health Equity Alliance founded Maines first annual LGBTQ+ Healthcare Conference in 2015, held in Augusta, and in Lewiston, Bangor and Farmington in successive years.

The overall expansion of MaineCare and the addition of transgender medical care coverage have created a massive change in the conversation just in the last six months, Gormley said. MaineTransNet is currently working on defining the boundaries of that coverage, which Gormley said was left vague by the Department of Health and Human Services.

In the future, she hopes to see legislation that would increase MaineCare reimbursement rates so that more providers are willing to work with patients on MaineCare.

Another part of Gormleys vision for a better Maine circles back to what Seely noticed was lacking in her medical school and residency programs: universal education on the LGBTQ community at-large.

Other states have started requiring practitioners to include LGBTQ competency within their continuing education and within medical and social work education wed really like to see that become a requirement in Maine, Gormley said. Most practitioners are well-intentioned but nervous they dont want to hurt anybody and I think once theyve had the ability to have the things that make them anxious addressed, theyd become more enthusiastic about providing care to our community.

It boils down to this, Gormley said: If (doctors) were more familiar with our bodies, theyd know how to treat our bodies better; if they knew how to talk to us, wed be more comfortable talking to them. Health inequities in the LGBTQ community are a result of stigma and a lack of access, not because our bodies are different.

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Farmington doctor leads by example when it comes to LGBTQ care in rural Maine - Kennebec Journal & Morning Sentinel

Inhis last interview with a Los Angeles Timessports columnist, Kobe Bryant, of course, talked about basketball and the LA Lakers. But he also spoke about bein...

Inhis last interview with a Los Angeles Timessports columnist, Kobe Bryant, of course, talked about basketball and the LA Lakers.

But he also spoke about being a family man and how he wanted to elevate youth and womens sports, according to audio of the interview released by the LA Times Saturday.

When asked why he didnt attend many Lakers home games, Bryant said hed rather spend time at home.

I have gone through 20 years of the majority of my career with my kids Natalia and Gianna without being able to have that consistently, Bryant said.

So for me to make a trip up to the Staples Center, that means Im missing the opportunity to spend another night with my kids, and I know how fast it goes. Natalia is 16 and Gianna is 13. So that time came and went and so I want to make sure that the days Im away from them, are days that I absolutely have to, he said. Id rather just be hanging with them.

The interview is from October, just a few months before Bryant, his 13-year-old daughter Gianna and 7 others were killed in a helicopter crash. Columnist Arash Markazi decided to drive two hours to meet Bryant for a 17-minute interview.

It was one of the best decisions Ive ever made in my career, Markazi wrote.

He loved Giannas curiosity

Markazi asked Bryant abouthis relationship with Gianna, who went by Gigi, and coaching her youth basketball team.

Its a trip to see her move and the expressions that she makes, Bryant said. Its a trip, you know, the genetics. Genetics is a real thing, man.

He continued: What I love about Gigi is her curiosity about the game Even in a very heated situation in a game where its very competitive and back and forth, she can detach herself and come over and ask a very specific questions, which is not common.

All of our girls can do that, Bryant said, but the part that I think is most exciting is that its her curiosity and her ability to think critically in tight situations, (thats) pretty damn cool.

Bryant was asked about imagining his daughter moving away to play ball in college, and like many fathers he admitted, you never want to see your kids leave home, but eventually they have to.

He wanted to support girls and women in sports

Bryant also shared his thoughts about elevating female athletes, saying that hed always been abig supporter of the womens game. But having daughters who play sports his oldest, Natalia, plays volleyball was a big part of his desire to help push womens sports forward.

Just trying to enhance the womens game, not just in basketball but in volleyball and other sports, is extremely important. Anything I can do to help, Im gonna do.

He pointed to coaching his team at the Mamba Sports Academy, and telling the players and coaches that it was a group effort to win. Similarly, this is a joint effort to raise the womens game, he said.

Markazi also asked Bryant about his legacy, and whether he saw the Mamba Academy and youth sports playing a big role in how he was remembered.

Hopefully, he said, if we do it the right way, were known more for what we did after than what we did during.

I think you can have a lasting impact, he said. I mean winning championships, thats great. Building families, thats great. But when you can create stories and create moments and events and companies that can provide opportunities and inspire kids and create situations where people can be better, I think that has a lasting impact, more so than winning championships does.

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Kobe Bryant talked family and elevating female athletes in last interview with LA Times columnist - FOX 61

Appraiser earns highest professional status

Matt Hawk of Shackelford and Associates in Greenville has been awarded the Accredited Rural Appraiser (ARA) designation from the American Society of Farm Managers and Rural Appraisers.

Hawk earned the designation by meeting requirements in experience and education, in addition to passing written examination and abiding by the societys code of ethics.

Hawk joins a select 45 percent of the societys membership who have received the accredited status and currently maintain it through the societys continuing education program.

Accredited Rural Appraisers can ensure that an appraisal complies with regulations and requirements. They possess expertise exceeding nearly all state certification and licensing requirements.

In addition, an Accredited Rural Appraiser is connected to a national network of professional resource information.

The American Society of Farm Managers and Rural Appraisers is the largest professional society for rural property land experts, with more than 2,100 members in 31 chapters throughout the United States.

Dr. Craig Steffee joins Gastroenterology East

Gastroenterology East has announced the addition of its own in-house pathologist, Dr. Craig Steffee.

A North Carolina native, Steffee completed his undergraduate studies at Duke University as an Angier B. Duke Scholar with a B.S. in biology and genetics.

He obtained his M.D. at Wake Forest University Bowman Gray School of Medicine, where he was inducted into the Alpha Omega Alpha medical honor society.

He completed his internship and residency in Pathology at Bowman Gray School of Medicine/NC Baptist Hospital where he served as chief resident.

Steffee completed a fellowship in cytopathology at the ECU Brody School of Medicine and served on the faculty of the ECU Department of Pathology prior to entering private practice in 2000.

He is board certified in anatomic pathology, clinical pathology and cytopathology.

Steffee is skilled in surgical pathology and has been interpreting gastrointestinal biopsies in both hospital and outpatient gastroenterology endoscopy center settings in eastern North Carolina for more than 20 years.

Butler to focus on women investors at Milestone

Milestone Wealth has announced the expansion of its financial planning and wealth management services with an additional emphasis on women investors; especially those going through a life transition such as a job/career change, divorce, sale of a business, retirement or loss of a spouse or loved one. The firm long has specialized in providing financial services to medium and large-sized businesses, and is bringing its expertise to a vastly underserved market.

Belinda Butler, recently designated as a certified financial planner and moving into the role of associate wealth manager, will help lead this effort. A member of the Milestone Wealth team since 2016, Butler is suited to understand the needs of women investors and help them feel comfortable managing their financial lives, especially during and after times of significant change.

We want to help women make the best use of the resources you have to benefit your life, your family and the community, Butler said. Wealth is not just the money you have, it is your ability to use money to achieve the kind of life you want. The female portion of the market has always been underserved, and we are passionate about delivering sound financial guidance and advice in order to serve as an important catalyst and trusted partner that empowers them to take control of their financial lives.

Belinda is a tremendous asset to the Milestone Wealth team, said Dave Hunt, owner of Milestone Wealth. She will do an excellent job of connecting with women throughout our community and offering them the same high level of financial services that business owners and families have come to trust us with as we manage their wealth and investments.

Robinson recognized as 2020 Super Lawyer

Attorney Les Robinson of the Robinson Law Firm in Greenville has been recognized as a 2020 Super Lawyer.

This is the sixth consecutive year Robinson has received this honor. With more than 32 years of experience and having taken more than 3,500 cases to trial, Robinson has established himself as a seasoned trial-ready attorney representing his clients facing charges involving drugs and alcohol, violent crimes, wildlife offenses, domestic disputes and other criminal acts.

Each year, Super Lawyers rates lawyers from across the country to put together a list of the most elite attorneys in the United States. The criteria for the recognition includes 12 indicators of professional achievement and peer nominations. These indicators include verdicts/settlements, professional activity, honors/awards and experience. Through a rigorous process, the Super Lawyers recognition is only given to those attorneys with the most points earned during the evaluation.

The words Super Lawyers used to describe Robinson are experienced, skillful and relentless.

It is an honor to be recognized as one of the top attorneys in the country, Robinson said. I look forward to continuing to serve eastern North Carolina. Working diligently to prepare the best defense possible for my clients has always, and will always, remain my top priority.

Robinson was born and raised in Greenville. He graduated from East Carolina University and attended Campbell University School of Law where he received his Juris Doctorate degree in 1986.

After graduating from law school, he returned to Greenville where he entered into private practice in August 1986. Since that time, he has tried more than 3,500 bench and jury trials throughout eastern North Carolina.

Robinson repeatedly has been elected by his peers to leadership positions in local, district and state bar organizations. He served for nine years as the elected Bar Councilor representative to the North Carolina State Bar. As Bar Councilor, he served on numerous committees in the capacity as committee member, vice chairman and chairman. In addition, he is a frequent continuing legal education speaker for legal associations throughout the state. He has also given presentations for the North Carolina Advocates for Justice, North Carolina Bar Association, North Carolina Public Defenders and the North Carolina Institute of Government.

Keller Williams Realty hires new agents

Keller Williams Realty Points East has hired two new agents.

Tiki Jackson is a native of Boston, Mass., who has lived in the Greenville area for four months.

She is separated and has one child.

Jackson has been in real estate for the past 30 years.

Dan Jacobo is a native of Greenville and has lived in the area for 23 years.

He is single and in his spare time he enjoys soccer.

Jacobo has an associates degree in information technology.

He has been in real estate for one month.

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People in the News - Greenville Daily Reflector

The recent outbreak of the coronavirus has shown us that our global health system is only as strong as its weakest link.

The key to stemming the spread of such illnesses lies in bolstering connectivity and communication between health bodies and thats precisely the theme here at Arab Health 2020.

Artificial intelligence means medical bodies can link up their data and act quickly in a crisis.

"As emergency physicians and practitioners were often on the frontline. But Ill give you an example of how technology and AI may help outbreaks, not just Coronavirus, but for seasonal influenza," says Dr Jacques Kobersy, emergency medicine institute chair, Cleveland Hospital Abu Dhabi.

"When you have an organisation like WHO who are alerted to the fact that there is some new virus circulating, Artificial intelligence might give us the opportunity to flag that those unusual symptoms are occurring way before human clinicians and departments of health realize it. And help us get ahead of these sort of pandemics maybe a month or so ahead of time before they really fester."

55,000 attendees from 159 countries have touched down in Dubai to showcase and learn about the life-changing and groundbreaking technologies poised to transform healthcare as we know it.

Autonomous ambulances

Soon, AI could make autonomous ambulances that automatically arrive at a patients house as soon as somethings wrong.

"We call it a smart ambulance. The high-risk patient, they will start to wear wearable devices. Let's say something happened to that patient. These devices will start to send all the vital data to the system and the hospital. So the physician, he can monitor all the data and monitor the patient 24 hour," says Dr Rashid al Hashimi - youth council member, UAE ministry of health (mohap).

In the future, the ambulance will be auto-drive. So it will go directly to the patient. While they are moving all these signals will be green for them.

When the patient enters the ambulance, there will be some high-resolution cameras. They will detect the patient's face and will give all the data which is very important for the rescuers to help the patient.

While they are going to the hospital, there will be like a virtual doctor inside the ambulance.

AI implants

AI is already powering implants that can monitor patients vitals around the clock.

"We can put devices under the skin and telemonitor heart patients even at home. We have put this device on 30 patients," says Dr Noor al Muhairi, head of medical services, hospital dept (mohap).

"One of them was in London. And we saw that we have an abnormality in his heart. And we called them directly and told him, go to the nearest hospital and this saved him."

And unprecedented advancements in stem-cell research mean damaged heart cells can now be regrown.

"In treatment, we collaborated with Osaka University, where they have done a study on stem cells that have been generated to cardiac cells. You can bring stem cells to make the heart cells regenerate," says Dr Muhairi.

"So this is one of the latest technology in heart treatment and in collaboration with Japan, we are going to do a clinical study here in the Ministry of Health."

Analysing wounds

Meanwhile, image analysis of wounds using machine learning can now prevent amputations caused by diseases like diabetes.

"This machine is checking the healing process for the diabetic foot. It will give us the results within 30 seconds. We are just scanning for the wound.2

"There is information going back 15 years in this machine. So it will check with other types of wound and it will analyze for us exactly the problem. We can prevent amputations from the complication of diabetes," says Dr Halima el Shehhi, the emergency department unit manager at the ministry of health and prevention, UAE.

Whether it's artificial intelligence, new equipment, new abilities to analyze patients and treat them, things that we could only imagine a few years ago now have come to fruition.

Soon the days of treating illnesses after they occur will give way to an age of truly preventative healthcare.

Original post:
AI is transforming healthcare as we know it: Arab Health 2020 - Euronews

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ --Seattle Genetics, Inc.(Nasdaq: SGEN) and Astellas Pharma Inc.(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract #441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2

"Cisplatin-basedchemotherapy is the standard treatment for first-line advanced urothelial cancer; however, it isn't an option for many patients,"said Jonathan E. Rosenberg, M.D., Medical Oncologist and Chief, Genitourinary Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York."I'm encouraged by these interim results, including a median progression-free survival of a year for patients who received the platinum-free combination of PADCEV and pembrolizumab in the first-line setting."

In the study, 58 percent (26/45) of patients had a treatment-related adverse event greater than or equal to Grade 3: increase in lipase (18 percent; 8/45), rash (13 percent; 6/45), hyperglycemia (13 percent; 6/45) and peripheral neuropathy (4 percent; 2/45); these rates were similar to those observed with PADCEV monotherapy.3Eighteen percent (8/45) of patients had treatment-related immune-mediated adverse events of clinical interest greater than or equal to Grade 3 that required the use of systemic steroids (arthralgia, dermatitis bullous, pneumonitis, lipase increased, rash erythematous, rash maculo-papular, tubulointerstitial nephritis, myasthenia gravis). None of the adverse events of clinical interest were Grade 5 events. Six patients (13 percent) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. As previously reported, there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.

The data demonstrated the combination of PADCEV plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 73.3 percent (33/45; 95% Confidence Interval (CI): 58.1, 85.4) after a median follow-up of 11.5 months (range,0.7 to 19.2). Responses included 15.6 percent (7/45) of patients who had a complete response (CR)and 57.8 percent (26/45) of patients who had a partial response. Median duration of response has not yet been reached (range 1.2 to 12.9+ months). Eighteen (55%) of 33 responses were ongoing at the time of analysis, with 83.9% of responses lasting at least 6 months and 53.7% of responses lasting at least 12 months (Kaplan-Meier estimate).The median progression-free survival was 12.3 months (95% CI: 7.98, -) and the 12-month overall survival (OS) rate was 81.6 percent (95% CI: 62 to 91.8 percent); median OS has not been reached.

"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating PADCEV in this platinum-free combination in the first-line setting," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

"These additional results support continued evaluation of PADCEV in combination with other agents and at earlier stages of treatment for patients withurothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

About the EV-103 TrialEV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.

The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. Patients were dosed in a 21-day cycle, receiving an intravenous (IV) infusion of enfortumab vedotin on Days 1 and 8 and pembrolizumab on Day 1. At the time of this initial analysis, 45 patients (5 from the dose-escalation cohort and 40 from the dose-expansion cohort A) with locally advanced and/or metastatic urothelial cancer had been treated with enfortumab vedotin (1.25 mg/kg) plus pembrolizumab in the first-line setting.

The primary outcome measure of the cohorts included in this analysis is safety. Key secondary objectives related to efficacy include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). DoR,PFS and OS are not yet mature.

Additional cohorts in the EV-103 study will evaluate enfortumab vedotin:

More information about PADCEV clinical trials can be found at clinicaltrials.gov.

About Bladder and Urothelial CancerIt is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.5 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.6 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.7

The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are ineligible for cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.8

About PADCEV PADCEV (enfortumabvedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.9

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.2,9Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

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

About Seattle GeneticsSeattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people's lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.comand follow @SeattleGenetics on Twitter.

About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.

About the Astellas and Seattle Genetics CollaborationSeattle Genetics and Astellas are co-developing enfortumab vedotin-ejfv under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

Seattle Genetics Forward-Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the EV-103 and EV-302 clinical trials; clinical development plans relating to enfortumab vedotin; the therapeutic potential of enfortumab vedotin; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of enfortumab vedotin may fail to establish sufficient efficacy; that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.3 Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.4 ClinicalTrials.gov. A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103). https://clinicaltrials.gov/ct2/show/NCT03288545.5 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.6National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.7International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow. 8 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.9 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.

SOURCE Astellas

http://www.seattlegenetics.com

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Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy...

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

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Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe are Vericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc. A large number of players are anticipated to enter the global market throughout the forecast period.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Regenerative Medicine Market Analysis Trends, Growth Opportunities, Size, Type, Dynamic Demand and Drives with Forecast to 2025 - Jewish Life News

RESEARCH TRIANGLE PARK, N.C. , Feb. 04, 2020 (GLOBE NEWSWIRE) -- Asklepios BioPharmaceutical (AskBio), a clinical-stage adeno-associated virus (AAV) gene therapy company, and its NanoCor Therapeutics subsidiary today announced that the first patient has been dosed in a Phase 1 clinical trial of NAN-101. NAN-101 is a gene therapy that aims to activate protein phosphatase inhibitor 1 (I-1c) to inhibit the activity of protein phosphatase 1 (PP1), a substance that plays an important role in the development of heart failure.

Congestive heart failure (CHF) is a condition in which the heart is unable to supply sufficient blood and oxygen to the body and can result from conditions that weaken the heart muscle, cause stiffening of the heart muscles, or increase oxygen demand by the body tissues beyond the hearts capability.

"Dosing the first patient using gene therapy to target I-1c to improve heart function is a tremendous milestone not only for the AskBio and NanoCor teams but, more importantly, for patients whose quality of life is negatively affected by CHF, said Jude Samulski, PhD, Chief Scientific Officer and co-founder of AskBio. We initially developed this gene therapy as treatment for late-stage Duchenne muscular dystrophy patients who typically die from cardiomyopathy. Following preclinical studies, we observed that heart function improved, which led us to investigate treatment for all types of heart failure.

Were excited to be involved in this novel approach for patients with Class III heart failure, said Timothy Henry, MD, FACC, MSCAI, Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital in Cincinnati, Ohio, and principal investigator for the study. These patients currently have no other options besides transplant and left ventricular assist devices (LVAD). Today, we started to explore the potential of gene therapy to change their outcomes.

Heart disease is the leading cause of death worldwide, with CHF affecting an estimated 1% of the Western world, including over six million Americans. There is no cure, and medications and surgical treatments only seek to relieve symptoms and slow further damage.

Research by many investigators around the world has been trying to understand what exactly goes wrong in the heart and weakens its pumping activity until it finally fails, said Evangelia (Litsa) Kranias, PhD, FAHA, Hanna Professor, Distinguished University Research Professor and Director of Cardiovascular Biology at the University of Cincinnati College of Medicine. The aim has been to identify potential therapeutic targets to restore function or prevent further deterioration of the failing heart. Along these lines, research on the role of I-1c started over two decades ago, and it moved from the lab bench to small and large animal models of heart failure. The therapeutic benefits at all levels were impressive. It is thrilling to see I-1c moving into clinical trials with the hope that it also improves heart function in patients with CHF.

About the NAN-101 Clinical Trial NAN-CS101 is a Phase 1 open-label, dose-escalation trial of NAN-101 in subjects with NYHA Class III heart failure. NAN-101 is administered directly to the heart via an intracoronary infusion by cardiac catheterization in a process similar to coronary angioplasty, commonly used to deliver treatments such as stem cells to patients with heart disease. The primary objective of the study is to assess the safety of NAN-101 for the treatment of NYHA Class III heart failure, as well as assess the impact of this treatment on patient health as measured by changes in exercise capacity, heart function and other factors including quality of life.

AskBio is actively enrolling patients with NYHA Class III heart failure to assess three doses of NAN-101. Please refer to clinicaltrials.gov for additional clinical trial information.

Would you like to receive our AskFirst patient engagement program newsletter? Sign up at https://www.askbio.com/patient-advocacy.

About The Christ Hospital Health Network The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn with six ambulatory centers and dozens of offices conveniently located throughout the region. More than 1,200 talented physicians and 6,100 dedicated employees support the Network. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes, the finest experiences, all in an affordable way. The Network has been recognized by Forbes Magazine as the 24th best large employer in the nation in the magazines Americas 500 Best Large Employers listing and by National Consumer Research as the regions Most Preferred Hospital for more than 22 consecutive years. The Network is dedicated to transforming care by delivering integrated, personalized healthcare through its comprehensive, multi-specialty physician network. The Christ Hospital is among only eight percent of hospitals in the nation to be awarded Magnet recognition for nursing excellence and among the top five percent of hospitals in the country for patient satisfaction. For more than 125 years, The Christ Hospital has provided compassionate care to those it serves.

About AskBioFounded in 2001, Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company dedicated to improving the lives of children and adults with genetic disorders. AskBios gene therapy platform includes an industry-leading proprietary cell line manufacturing process called Pro10 and an extensive AAV capsid and promoter library. Based in Research Triangle Park, North Carolina, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. An early innovator in the space, the company holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids. AskBio maintains a portfolio of clinical programs across a range of neurodegenerative and neuromuscular indications with a current clinical pipeline that includes therapeutics for Pompe disease, limb-girdle muscular dystrophy type 2i/R9 and congestive heart failure, as well as out-licensed clinical indications for hemophilia (Chatham Therapeutics acquired by Takeda) and Duchenne muscular dystrophy (Bamboo Therapeutics acquired by Pfizer). For more information, visit https://www.askbio.com or follow us on LinkedIn.

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AskBio Announces First Patient Dosed in Phase 1 Trial Using AAV Gene Therapy for Congestive Heart Failure - BioSpace

Press Release

Gosselies, Belgium, 11February 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, announces that the Company will today present at the Annual Meeting of the Orthopaedic Research Society (ORS), in Phoenix (Arizona), USA.

The Annual ORS Meeting is the yearly summit organised by the international Orthopaedic Research Society, gathering scientists, clinicians and entrepreneurs to advance musculoskeletal research and orthopaedic care. In the oral presentation, Bone Therapeutics will highlight additional preclinical in vitro and in vivo results demonstrating the potent osteogenic properties of its allogeneic bone-forming cell therapy platform, ALLOB, to promote bone-formation and improve fracture healing in relevant models.

ALLOB is the Companys allogeneic product that consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors, and is manufactured through a proprietary, scalable production process. ALLOB successfully completed two Phase II studies in two indications and the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the PhaseIIb clinical trial in patients with difficult-to-heal tibial fractures.

Presentation Details:

Title: ALLOB, A Ready-to-use and Injectable Cryopreserved Allogenic Cell Therapy Product Derived from Bone Marrow Mesenchymal Stem Cells, Displays Potent Osteoinductive and Osteogenic Properties, Leading to Enhanced Bone Fracture HealingSpeaker: Sandra Pietri, PhD Associate Director R&D, Bone TherapeuticsSession: Podium Session 58 Bone Cell Signaling and TreatmentsDate: Tuesday, 11 February 2020Time: 8:00am 9:00am MST (4pm 5 pm CET)Location: Room West 301D, Phoenix Convention Center, Phoenix, Arizona, USA

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering Phase III development for the treatment of pain in knee osteoarthritis. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) to start the pivotal Phase III program has been submitted to the regulatory authorities in Europe and the trial is expected to start in Q1 2020.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the promising Phase IIa efficacy and safety results for ALLOB, the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

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Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics to present preclinical data on the osteogenic properties of ALLOB in bone repair at the Annual Meeting of the Orthopaedic Research...

'This is the beginning of my new life'

I thought my cancer diagnosis was a death sentence, said Lynnette Williams-Briggs, 60, of Seaford, Delaware, who was diagnosed with advanced B-cell lymphoma in 2018.

Briggs cancer is now in complete remission thanks to successful chimeric antigen receptor CAR-T cell therapy she received in August atChristianaCaresHelen F. Graham Cancer Center & Research InstitutesBone Marrow and Stem Cell Transplant Program.

I can breathe again. This is the beginning of my new life, Williams-Briggs said following the treatment that restored her hope for a second chance at life.

She was the first patient to receive CAR-T cell therapy in Delaware. A second patient was treated in December 2019, and doctors are preparing several more patients for CAR-T cell transplants in coming weeks.

The U.S. Food and Drug Administration has approved CAR-T cell therapy to treat patients like Williams-Briggs with highly resistant, B-cell blood cancers, for whom other available options have failed.

CAR-T cell therapy is only available at select cancer centers with specialized expertise in cellular therapies that are recognized for quality by the Foundation for the Accreditation of Cellular Therapy.

The Graham Cancer Centers Bone Marrow and Stem Cell Transplant Program is the only one in Delaware that is certified to treat adult patients with advanced B-cell lymphomas and children and young adults (to age 25) with acute lymphoblastic leukemia, using an FDA-approved drug.

CAR-T cell therapy is highly personalized medicine that attempts to use the bodys natural defenses to fight against cancer. The transplant team extracts millions of T cells, from the patients bloodstream, using a specialized blood filtration process called leukapheresis. The collected T cells are flash-frozen and sent to a lab for reprogramming, and then later infused back into the patient using a process similar to a blood transfusion.

The therapy is considered a living drug with potential benefits that could last for years.

When we first met Ms. Williams-Briggs, her cancer had progressed rapidly despite a third round of chemotherapy, so we knew we had to move quickly, said Graham Cancer Center Hematologist Peter Abdelmessieh, D.O. He worked closely with the bone marrow/stem cell transplant team and Graham Cancer Center leadership over the course of just eight months to develop the CAR-T cell therapy program.

It was truly a team effort to bring CAR-T cell therapy to our community so quickly, Dr. Abdelmessieh said.

CAR-T cell therapy has been extremely effective for many patients like Williams-Briggs, whose PET scan at 90 days confirmed her remission.

The supercharged T cells Williams-Briggs received were genetically modified in the lab to sprout new surface tools that improve their ability to recognize, latch onto and destroy other cells (including cancer cells) that express a specific antigen called CD19. These reprogrammed cells continue to multiply in the body after treatment, remaining on guard to seek and destroy any new cancers that might develop.

With continued success in increasing numbers of patients, it is conceivable that in the not too distant future, CAR-T cell therapy could become the new standard of care, replacing chemotherapy and stem cell transplants for many cancers, Dr. Abdelmessieh said.

The extended recovery period for CAR-T cell therapy is generally two to three months. After the infusion, patients may spend up to three weeks in the hospital to monitor treatment response and any side effects.

During the first 30 days after leaving the hospital, patients are required to remain close to the treatment center for regular follow-up care.

The ability to offer potentially life-saving CAR-T cell therapy is one more reason our patients need not travel further than the Graham Cancer Center for state-of-the-science cancer treatment, said Nicholas J. Petrelli, M.D., Bank of America medical director of the Helen F. Graham Cancer Center & Research Institute.

The Bone Marrow and Stem Cell Transplant Program is an outstanding example of how well our clinical teams work together to drive innovation in patient care.

Although patients normally do not experience the side effects associated with chemotherapy, such as nausea, vomiting or hair loss, CAR-T cell therapy is not without risks. A common side effect, which Williams-Briggs also experienced, is cytokine release syndrome. This is an inflammatory condition that causes flu-like symptoms that may be mild or severe.

The transplant team responded quickly to manage her symptoms while she received expert care on the Bone Marrow Transplant and Oncology unit at Christiana Hospital.

From the moment I first met with my transplant team, I felt like I was part of one big loving family that extended beyond my own loved ones, Williams-Briggs said.

Dr. Abdelmessieh and my ChristianaCare family gave me hope to keep fighting when I really didnt think I would make it. I would have driven anywhere to get life-saving treatment, but I am thankful that I did not have to. I found my miracle closer to home.

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First CAR-T cell cancer therapy patient in Delaware - Dover Post

A research team featuring an expert from City University of Hong Kong (CityU) has developed a novel dual approach for the first time for concurrently rejuvenating both the cardiac muscle and vasculature of the heart by utilising two types of stem cells. The results give hope for a new treatment for repairing myocardial infarction (MI) heart.

Dr Ban Ki-won, Assistant Professor of the Department of Biomedical Sciences and his research team, including researchers from Konkuk University, The Catholic University of Korea, Pohang University of Science and Technology and T&R Biofab in South Korea, have conducted the first study of two distinct stem cell effects for cardiac repair. The two major types of stem cells employed are human bone marrow derived mesenchymal stem cells (hMSCs) and cardiomyocytes derived from human induced pluripotent stem cells (hiPSC-CMs). The research findings have been published in Nature Communications in a paper titled Dual stem cell therapy synergistically improves cardiac function and vascular regeneration following myocardial infarction.

Both cardiac muscles and vasculatures are severely damaged following MI, and so the therapeutic strategies should focus on comprehensive repair of both at the same time. But the current strategies only focus on either one, Dr Ban said.

Dr Ban said that, with limited therapeutic options for severe MI and advanced heart failure, a heart transplant was the last resort. However, such an operation is very risky, costly and subject to limited supply of suitable donors. Therefore, stem cell-based therapy has emerged as a promising therapeutic option.

In the study, the hiPSC-CMs were injected directly into the border zone of the rats heart, while the hMSCs-loaded patch was implanted on top of the infarct area, like a bandage. The results showed that this dual approach led to a significant improvement of cardiac function and an enhancement of vessel formation on a MI heart.

We believe this novel dual approach can potentially provide translational and clinical benefit to the field of cardiac regeneration. Based on the same principle, the protocol may also be utilised for repairing other organs including the brain, liver and pancreas in which multiple types of stem cells co-exist, Dr Ban added.

The research team is working on follow-up studies in larger animal models such as pigs. The patent application for this research result has been submitted.

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First dual stem cell therapy jointly developed by City University of Hong Kong brings new hope for cardiac repair - QS WOW News

NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

This is a key turning point in ourworktowardprovidingALSpatientswith a potential new therapy,said ChaimLebovits, President and CEO ofBrainStorm. We commend the FDA foritscommitmentto the ALS communityandtofacilitating the development, and we ultimately hope, the approvalofNurOwn.The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.

Brian Wallach, Co-Founder of I AM ALS stated: There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

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 NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

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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 causeBrainStorm Cell Therapeutics Inc.'sactual 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, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms 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 BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms 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.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

Or

Katie Gallagher | Account Director, PR and MarketingLaVoieHealthScience Strategic CommunicationsO: 617-374-8800 x109M: 617-792-3937kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS - Yahoo Finance

Methionine is an amino acid found in meat, eggs, and dairy. Its absorbed by T-cells that are part of our immune system. Those cells are also believed to be the immune cells that attack our myelin, creating the nerve damage that results in multiple sclerosis.

In this study, mice eating less methionine had a reduced number of a certain type of T-cell, which led to a delay in disease onset and progression. The researchers believe reducing methionine intake can actually dampen the immune cells that cause disease, leading to better outcomes.

Changing a persons diet to reduce the amount of methionine (amino acid found in food) could delay the development and progression of inflammatory and autoimmune disorders, including multiple sclerosis (MS).

That finding was described in the study Methionine Metabolism Shapes T Helper Cell Responses through Regulation of Epigenetic Reprogramming, published recently in the journal Cell Metabolism.

Click here to read the full story.

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Unlike hematopoietic stem cell transplants, in which stem cells are removed from a patients bone marrow and later infused back into the bloodstream, mesenchymal stem cell transplants (MSCT) collect those stem cells from the patients spinal column and return them there. This study concludes that MSCT is safe and that cells delivered into the spinal cord produced a significantly slower disease progression rate than did cells delivered into the bloodstream.

Transplanting patients ownmesenchymal stem cellsis a safe therapeutic approach and can delay disease progression in people with MS, a meta-analysis review shows.

The study also showed that cells transplanted to the spinal cord (intrathecal injection) were associated with significantly slower disease progression rates, compared to cells delivered into the bloodstream.

Click here to read the full story.

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Why do neurologists often use spinal taps when determining whether someone has MS? This study provides one of the reasons.

People with MS have a more diverse set of immune cells in their cerebrospinal fluid (CSF), the fluid that bathes the central nervous system, but no such diversity is seen in their blood, a study reports. Instead, MS causes changes in the activation of immune cells in the blood.

The distinct set of immune cells in MS patients CSF shows enrichment of pro-inflammatory cells that promote disease severity in MS mouse models.

Click here to read the full story.

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Heres encouraging news about a possible treatment that can lower the number of brain lesions in someone with MS. Keep in mind this is only a Phase 2 trial. A Phase 3 trial isnt expected until later this year. However, a news release from research sponsor Sanofisays, This molecule may be the first B-cell-targeted MS therapy that not only inhibits the peripheral immune system, but also crosses the blood-brain barrier to suppress immune cells that have migrated into the brain.

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint a significant reduction in the number of new lesions visible on a brain imaging scan in a Phase 2 trial in people with MS, study results show.

SAR442168, formerly known as PRN2246, is an oral, small molecule being co-developed by Principia Biopharmaand Sanofi Genzyme. It works by inhibiting Brutons tyrosine kinase (BTK), a protein important for the proliferation of immune cells, particularly B-cells. By blocking BTK, it is expected that SAR442168 can reduce inflammation that damages the nervous system in people with MS.

Click here to read the full story.

Did you know that some of my columns from The MS Wire are now available as audio briefings? You can listen to them here.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

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MS News that Caught My Eye Last Week: Methionine, MSCT, Spinal... - Multiple Sclerosis News Today

When actor Danny Thomas opened St. Jude Children's Research Hospital in 1962, the survival rate for childhood cancer was just 20 percent. Today, that rate is 80 percent, thanks to medical advancements and research breakthroughs -- including those made by the doctors at St. Jude.

St. Jude's work treating children with cancer from across the world at no charge to their families is well-known, but doctors at the hospital are also conducting more clinical trials for cancer than any other children's hospital. The St. Jude Children's Research Hospital -- Washington University Pediatric Cancer Genome Project has resulted in groundbreaking discoveries about several childhood cancers, and in April, the St. Jude research team announced that they had developed a gene therapy that can cure infants born withX-linked severe combined immunodeficiency, commonly known as "bubble boy disease."

In addition, St. Jude leads the Childhood Cancer Survivor Study, which includes more than 30 institutions across North America and more than 20,000 childhood cancer survivors. All of the research that St. Jude's doctors do, and all of the discoveries they make, are shared freely with doctors and scientists worldwide -- an important contribution to not only the treatment of childhood cancers but, hopefully, the discovery of cures.

"The research facilities here are fantastic. Like, when you donate to St. Jude, you're not just donating to help the kids and their families, you're donating for this tremendous amount of research that's going into save more lives," shared King Calaway during the 2020 Country Cares for St. Jude Kids seminar in Memphis, Tenn., in mid-January. "It's fantastic ... And the fact that it's openly shared among other researches all around the world ... That's incredible."

When the rising country band and other artists visited St. Jude during the Country Cares seminar, they were offered a look inside the hospital's research lab. Johnny McGuire called the experience "really cool," and marveled at how the organization shares all of their discoveries, while Jackson Michelson recalled to The Boot his conversation with a doctor from the UK who had planned to work at St. Jude for one year but has now been at the hospital for a decade.

"I thought it was gonna be a cry-fest for me, but I left so inspired by what I saw, and the real, hard data of support, of success," admitted Brett Kissel. "It's an incredible facility ... This is an establishment that works ... and it's getting better with every year."

Independent artist Abbey Cone, too, was blown away by the doctors she met in the research lab, and the other St. Jude employees she met during her time at the hospital. "Every person I talked to today ... you could literally see the passion they have for their job and St. Jude as an organization," she reflected.

On Feb. 6-7, more than a dozen country radio stations owned by Townsquare Media, The Boot's parent company, will hold their 2020 Country Cares radiothons to raise money for St. Jude Children's Research Hospital. In the past six years, these stations have raised more than $9.2 million, and even more money has come from additional TSM stations that hold radiothons later in the year. To join the fight against childhood cancer and become a Partner in Hope, visit St. Jude's official website.

Country Cares Through the Years: See the Stars With St. Jude Patients

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In St. Jude's Research Labs, 'You Can Literally See the Passion' for Finding Cures - The Boot

One common theme was the importance of companies having their own launch protocols and fine-tuning them to suit individual therapy areas and markets. Although many companies have developed launch excellence codes, their diffusion and adoption across global organisations seem to be variable.

There are two key questions companies should ask themselves when theyre preparing to introduce a new product: do they have a launch framework, and is the company empowered to use it?, said Suzie Denton, Managing Director, Consulting at McCann Health.

The most successful organisations establish their own codes of practice to ensure theres a standardised approach to launching across the company. Then within that framework, theyll define clear launch archetypes; what type of launch is it? What level of investment does it require? What is the size and scale of expectation? Who needs to be involved? And what is the protocol for becoming launch ready from global to local? Secondly, empowering teams to use a framework is as important as establishing one.

"Everybody involved in the launch preparation phase must both understand and be able to implement the launch excellence approach the company believes in. It has to be cohesive, joined up and embedded across regions because, whatever the market nuances are, consistency in global and local delivery is essential.

Customer-focused

A second core component is the need to be customer-focused rather than brand-led. This philosophy underpins all successful launches throughout the brand life cycle. Launch excellence is about prioritising what matters for the launch brand. Every product is different, so you cant launch everything in the same way, said Denton.

The complexities of todays marketplace mean we really need to get beneath the surface of the brand and the opportunity, and take a bespoke approach to every launch. Running through all of this is the need to be customer-centric. Companies can sometimes become so focused on the data and the science that they forget to think about what matters to the doctor, the patient or the payer.

"What are the critical things that drive their behaviour now? What shift in behaviour is required to take them to where you want them to be? And how can you create meaningful engagement to help that transition? You wont change that belief state by focusing solely on the data you need to get closer to customers to help them along that journey. Customer-centricity is arguably the most important aspect of launch excellence. Without it, a brand cannot hope to succeed.

Sustainable healthcare: a key driver

Emma Gorton, Director, Hanover Communications, believes that advances in medicine are rewriting the rules of healthcare and changing the nature of pharmaceutical launches. The essence of what a launch is has changed, said Gorton.

Weve been through an era where we had incremental increases in innovation delivering blockbuster treatments for prevalent long-term conditions and headline diseases. However, were now moving into areas like immunotherapy and are on the edge of amazing innovations that will deliver great outcomes for patients.

"These advances are putting huge pressure on healthcare budgets. The debate has shifted; previously it was all around access to innovation but now theres a greater focus on the need for sustainability in healthcare systems.That has affected how launches work because people are looking for, and are now able to measure, different things from treatments cost- effectiveness, societal value, whole system costs.

There are huge implications for communications. Take gene editing, for example. Were going to get to the point where treatments like gene therapies will be ubiquitous so we need to set ourselves up for them now and embrace the ethical debate so that we bring the public along with us.

"We dont want to be in a situation where the public only understands the complex access challenges we will face for potentially curative medicines when people are being denied them due to cost. We need to get ahead of it. That means thinking about the things that might affect a launch as early as possible and shaping those communications proactively. As things get more complex, we need more time to explain them, to prepare the market.

Timing is everything

When it comes to launching a new medicine, timeliness is key. Essentially, a good launch is about getting breakthrough treatments to the people that need them as quickly as possible, said Gorton.

There are lots of stakeholders involved in that process right across the ecosystem and were all working towards that same goal. Progress is about developing relationships, creating collaborations and building long-term advocacy to ensure medicines get to the right people in the shortest possible time.

"Success requires being agile and responsive to fast-moving environments, and also being much more efficient. The rise of AI, along with better access to deep data, has the potential to reduce R&D time frames making it easier to develop launch plans closer to launch when the environment is much clearer.

Right customer, right time, right message

Stakeholder engagement is critical, but in an era characterised by significant pressure on costs both among customers and companies optimising resources is the name of the game. Companies are striving to be more innovative in how they go to market, said Sabine Dettwiler, Managing Director, Commercial Advisory Group, Syneos Health.

Its a huge ongoing challenge. How do you deploy your resources so you get to the right customer at the right time with the right messages but, at the same time, minimise costs? Theres a real focus on customer-centricity, yet we still see launches where companies go after the wrong stakeholder or dont tell the right story.

"Fundamentally, you need to develop a relevant, resonant story that differentiates your product and clearly conveys the value you bring to the patient and the healthcare system as a whole. Doing this means knowing your market and your stakeholders inside out, and understanding whether you can carve out a niche where youre likely to get more traction.

"The best launch plans define how theyre going to target that niche. Many companies have moved away from one-size-fits-all messaging.Theyre developing tight, customer-specific stories that align with an overarching message and theyre leveraging market insight to create sound strategies for how they target them. The key is to engage early.

Develop launch plans by purpose

One long-standing challenge in pharma launches is the engagement between R&D and commercial. In most pharma companies, the owner of an asset until phase 3 is typically development, said Dettwiler. However, development people rarely have commercial backgrounds or even if they have, they are incentivised by commercial metrics.Too often, companies are late in considering the market potential of a compound.

"Those that leave those commercial considerations until phase 3 are invariably getting there too late. Its improving, but its still an issue. The most progressive companies have shifted their approach; instead of developing launch plans by function, theyre designing them by purpose. Theyre looking at their strategic objectives and working backwards.

If pharma companies want to rewrite the headlines of launch excellence, they need to ensure that their planning, strategy and execution provide unambiguous answers and leave no lingering question marks at all

"What are we trying to achieve? What do we need to get there? Do we need a cross-functional approach that involves input from market access, HEOR, marketing etc and at what point do we get them on board? This approach is helping to tear down silos and develop a structured, cross- functional roadmap that helps get a product to market as efficiently as possible. Ultimately, all these functions have a shared purpose. Launch excellence is about understanding that purpose, as early as possible, and collaborating with the right people at the right time in order to deliver it.

Trial and error: the danger of isolating clinical and commercial

One of the most frequently voiced theories on launch excellence is the importance of starting with the end in mind. In pharmas case, this means configuring clinical development in line with identifiable customer needs. Its a common sense principle but its not yet become a default behaviour across the industry.

The traditional approaches to launching a product still tend to sit in the commercial function, said Chuck Stevens, Vice President and Global Head of Access, Commercialisation & Communications at ICON plc. However, those approaches need to migrate out and begin to align with HEOR, medical affairs and clinical teams. Companies need to look at how they design their clinical trials and what their target regulatory approaches are in different markets around the globe and start to overlay a commercial launch approach onto that regulatory sequencing.

Often, the way clinical and regulatory teams configure clinical trials to meet local regulatory requirements is misaligned with how a drug needs to be introduced commercially in those markets. Similarly, commercial teams need to drill down and understand HTA requirements within the disease category to ensure trials are designed to capture the necessary data for modelling.

"When drugs dont receive HTA regulatory support in major markets, its sometimes because companies havent modelled correctly so when HTA bodies reverse engineer those models, they find that either information is omitted or things are included that skew the way they would normally assess a drug. These costly errors underline why the early alignment of R&D and commercial is essential at launch.

Dont forget the patient

Another area where theres room for improvement is pharmas understanding of the end user the patient consumer. Although every company says and believes that theyre patient-centric, their understanding of what constitutes value to a patient is often suboptimal, said Stevens.

Definitions of value will obviously differ from customer to customer payers, patients, prescribers and providers will all have different views. In todays marketplace, with the level of innovation coming through in areas like rare disease and genetic disorders, its incredibly difficult to model cost-effectiveness to determine value for the patient or caregiver. Theres also lots to do before we can define societal value for expensive curative treatments.

So how does this translate into launch excellence? Very early in development as early as phase 1 and 2 patient insight is critical, said Stevens. Pharma must move beyond traditional market research and engage patients, one-to-one, to uncover their perspectives on everything from their disease experience and diagnostic pathways, to the things that prevent treatment and the real-world implications of taking a medicine.

"Understanding all these things is important it will shape trial design, identify unmet need and help articulate the patient value that will drive adoption at launch. True patient insight and engagement is critical.

The headline

Launching a new medicine is like crafting an article that captures attention: its how you start that matters. If pharma companies want to rewrite the headlines of launch excellence, they need to ensure that their planning, strategy and execution provide unambiguous answers and leave no lingering question marks at all.

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It started with a miss - PMLiVE

(CNN) Inhis last interview with a Los Angeles Timessports columnist, Kobe Bryant, of course, talked about basketball and the LA Lakers.

But he also spoke about being a family man and how he wanted to elevate youth and womens sports, according to audio of the interview released by the LA Times Saturday.

When asked why he didnt attend many Lakers home games, Bryant said hed rather spend time at home.

I have gone through 20 years of the majority of my career with my kids Natalia and Gianna without being able to have that consistently, Bryant said.

So for me to make a trip up to the Staples Center, that means Im missing the opportunity to spend another night with my kids, and I know how fast it goes. Natalia is 16 and Gianna is 13. So that time came and went and so I want to make sure that the days Im away from them, are days that I absolutely have to, he said. Id rather just be hanging with them.

The interview is from October, just a few months before Bryant, his 13-year-old daughter Gianna and 7 others were killed in a helicopter crash. Columnist Arash Markazi decided to drive two hours to meet Bryant for a 17-minute interview.

It was one of the best decisions Ive ever made in my career, Markazi wrote.

Markazi asked Bryant abouthis relationship with Gianna, who went by Gigi, and coaching her youth basketball team.

Its a trip to see her move and the expressions that she makes, Bryant said. Its a trip, you know, the genetics. Genetics is a real thing, man.

He continued: What I love about Gigi is her curiosity about the game Even in a very heated situation in a game where its very competitive and back and forth, she can detach herself and come over and ask a very specific questions, which is not common.

All of our girls can do that, Bryant said, but the part that I think is most exciting is that its her curiosity and her ability to think critically in tight situations, (thats) pretty damn cool.

Bryant was asked about imagining his daughter moving away to play ball in college, and like many fathers he admitted, you never want to see your kids leave home, but eventually they have to.

Bryant also shared his thoughts about elevating female athletes, saying that hed always been abig supporter of the womens game. But having daughters who play sports his oldest, Natalia, plays volleyball was a big part of his desire to help push womens sports forward.

Just trying to enhance the womens game, not just in basketball but in volleyball and other sports, is extremely important. Anything I can do to help, Im gonna do.

He pointed to coaching his team at the Mamba Sports Academy, and telling the players and coaches that it was a group effort to win. Similarly, this is a joint effort to raise the womens game, he said.

Markazi also asked Bryant about his legacy, and whether he saw the Mamba Academy and youth sports playing a big role in how he was remembered.

Hopefully, he said, if we do it the right way, were known more for what we did after than what we did during.

I think you can have a lasting impact, he said. I mean winning championships, thats great. Building families, thats great. But when you can create stories and create moments and events and companies that can provide opportunities and inspire kids and create situations where people can be better, I think that has a lasting impact, more so than winning championships does.

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Kobe Bryant talked family and elevating female athletes in last interview with LA Times columnist - KFOR Oklahoma City

NXIVMthe self-help organization lead by Keith Raniere that was actually a cult and possessed a secret wing that coerced women into sex through blackmailhas yet another damning accusation. Turns out, some of the sex abuse was also, allegedlyracist.

According to Times Union, a daily paper that services the NXIVM hub of Albany, Raniere created an empowerment group called One Asian to recruit East Asian women for sex. He also attempted to establish another group targeting women in sororities called Ten C, which stood for The Emperor Has No Clothes.

A newly filed federal lawsuit against Raniere alleges that he and his associates successfully lured over 100 women for One Asian, The Times Union reports. One Asian offered a special curriculum that Raniere tailored to what he characterized as women raised with more masculine values than Western women, the lawsuit reads. According to Raniere, this combination of female genetics and masculine attributes, such as discipline and self-denial, made the woman he recruited virtually perfect humans. Thus, he selected women who specifically met Ranieres criteria for potentially suitable sexual partners, the document states. One of the platniffs, a Canadian woman chosen to lead One Asian, said Ranieres right hand/Smallville actor Allison Mack told her sex was no big deal and just like playing tennis.

According to The New York Times, NXIVMs many programs became increasingly misogynistic over time, including indoctrination that instructed women that they did not deserve equal pay because they need to quit their jobs to have children, and that men are meant to be polyamorous while women are meant to be monogamous.

In June 2019, Keith Raniere was found guilty on seven counts, including racketeering, racketeering conspiracy, wire fraud conspiracy, forced labor conspiracy, sex trafficking, sex trafficking conspiracy and attempted sex trafficking. He is expected to be sentenced in Brooklyn on April 16.

Link:
NXIVM's Keith Raniere Allegedly Created an 'Empowerment Group' to Recruit Asian Women for Sex - Jezebel

A saleswoman takes meatloaf from a meat counter in a supermarket. Photo: Jan ... [+] Woitas/dpa-Zentralbild/ZB (Photo by Jan Woitas/picture alliance via Getty Images)

The notion that processed meat is not good for your health is not a new one. The high salt content, additives, and even just the red meat itself are all known to be linked to increased incidence of high blood pressure, heart disease, and obesity. But it is also known that studies assessing nutritional intake and health outcomes are notoriously difficult to carry out, and even more difficult to interpret. Even when such studies attempt to tease out other lifestyle variables such as exercise habits, tobacco use, alcohol intake, stress, and sleep quality, the data are always subject to debate, especially when a smattering of genetics and co-morbidities (other health issues) are thrown in.

A 2019 editorial in the Annals of Internal Medicine pointed out the reasons for these inconsistencies. In it, the authors describe several studies with vastly differing conclusions, ranging from processed meat is carcinogenic to processed meat is probably carcinogenic to the association between processed meat consumption and colon cancer and cardiovascular disease is weak. The editorial then reviews several meta-analyses which included hundreds of other studies, totaling over six million individuals. These studies found extremely small differences in overall health outcomes based on processed meat consumption, including all-cause mortality, cancer, and heart disease.

Three year old child eating salami

Because even the largest nutritional studies are observational, with so much of the data subject to confounding variables of other lifestyle habits and genetics, even those with high statistical significance for any link between sausage links and heart disease are not necessarily translatable in the real world of objective data. Better studies look at randomized controlled trials, which, even if performed over shorter duration, as short as six months as opposed to many years, may offer more accurate results than purely observational data. But even these studies have not determined with any certainty the health benefits or harms of meat consumption.

A more recent study, published in the February 3, 2020 issue of JAMA Internal Medicine, included not only processed meat consumption as a potential association with cardiovascular disease and death, but also unprocessed red meat, poultry, and fish consumption. But again, even this study looks at association, which is quite different from causation. As an analogy of association, a sunny day is associated with crowds at the beach, but the sunny skies did not cause the beach to be crowded. Association has been muddied into causation in countless debates on health data, including data on meat consumption, red wine consumption, vaccination schedules, and screen time, to name just a few. The authors of this months JAMA study sought to find an association (again, not causation) between various types of meats and fish with all-cause mortality and cardiovascular disease.

Young Woman Eating Chicken

The study collected data between 1985 and 2002, and participants were followed until 2016. The subjects included over 29,000 adults from six individual cohort studies. The average age was 53 years, and included roughly equal numbers of individuals who identified as male or female. Seventy percent of the subjects were white. Of the four types of consumed products, those with any of the three types of meat consumption, including poultry, had increased incidence of cardiovascular disease compared to those reporting only fish consumption. Both processed and unprocessed meat consumption were associated with increased all-cause mortality compared to those consuming just fish or poultry. All good news for you fish and fowl consumers? Perhaps. But even this study is one of association, despite the fact that they followed subjects for many years, in whats known as a prospective as opposed to a retrospective study.

In a prior Forbes article, I reported on clinical guidelines published in the October 2019 issues of the Annals of Internal Medicine, which found that there were no health benefits to reducing processed or unprocessed meat consumption. Digging a little into that study authors relationships quickly found that they had financial ties to the meat industry. Clearly an association that will bias any data, even when the data showed association, not causation.

Coming into play now is the health of our planet, not just our coronary arteries. Many environmental studies are pointing at meat (and dairy) consumption as major sources of greenhouse gases, and that if we humans all became vegetarians (or better, vegans), the impact on reducing climate change and improving air quality would save us all. Other data have found this not to be the case, showing that animal agriculture accounts for less than 4% of U.S. greenhouse gas emissions. Another way of looking at meat consumption data is by the energy needed to produce the energy meat gives. In other words, one study reported that livestock use 80% of farmland energy but produce only 18% of consumed calories. In addition, beef produce over 100 kilograms of greenhouse gases per 100 grams of protein they provide, whereas tofu, a plant-based soy protein, produces only 3.5 kilograms of greenhouse gas for that same 100 grams of protein.

Beef cattle standing in a field

We still do not have answers when it comes to meat consumption- neither for our own health nor for the health of our planet. While many human studies are leaning towards data showing poorer health outcomes with meat consumption, and environmental studies are also showing negative impacts on the climate due to beef agriculture, definitive data is still up for grabs. No matter how you slice it.

The rest is here:
The Heartbreak Of The Deli Counter: More Thinly Sliced Data - Forbes

A reporter examines a 23andMe DNA genetic testing kit in Oakland, California.

Cayce Clifford | Bloomberg | Getty Images

It has not been a good year for consumer DNA testing companies.

In January, Silicon Valley-based 23andMe laid off 100 employees, about 14% of its workforce. A month later, Ancestry, which has offices in Utah and San Francisco, also cut 100 jobs, representing about 6% of its staff.

The major reason for the downsizing? Simply put, consumers aren't buying as many at-home DNA tests as they used to.

The first sign came in the summer, when Illumina, maker of the DNA sequencing machines that are used by Ancestry and 23andMe, acknowledged in an earnings call to investors that the category had hit a lull. CEO Francis DeSouza didn't share an explanation for that, but noted that Illumina was taking a "cautious view" of the opportunity in the near term. Orasure, maker of the spit tubes used by consumer DNA testing companies, has also seen its stock take a hit.

At that time, some smaller companies were already feeling the impact. Helix, a start-up that spun out of Illumina to build an "app store" model for DNA tests, cut staff in May. The company revealed to Bloomberg that it was shifting its focus away from consumers to population health, meaning it would work with health industry partners. A few months later, Veritas Genetics another company focused on consumers that sold more expensive but more detailed whole genome sequencing tests shuttered its U.S. operations.

So what happened? There hasn't yet been a detailed study to understand the shift in consumer thinking around these tests. But CNBC spoke with some of the leading genetics experts and doctors, who shared a few theories.

Dawn Barry, a former Illumina executive with a start-up in the space called LunaDNA, blames a few factors, especially privacy concerns.

Consumers have seen a slew of reports in the past few years about how companies are using their personal data for targeted advertising, without their knowledge, and might be feeling particularly sensitive about their health information.

Anne Wojcicki, CEO of 23andMe, has previously referred to these concerns as the "Facebook effect." In her view, consumers are increasingly freaked out about stories they're reading in the media about privacy, mostly about Facebook and other technology companies, and are reacting by feeling anxious about getting DNA tests.

Companies like 23andMe do make money off this information. Her company does ask for consent from users and it has publicly explained its revenue model, but a big part of its business involves its relationships with pharmaceutical companies like GlaxoSmithKline. 23andMe also has a therapeutics arm, where it is hoping to leverage its database of millions of people's DNA to develop new drugs.

Making matters worse for these companies, suggests Barry, is the Golden State Killer case. Law enforcement honed in on a suspect after running DNA from a decades-old crime scene through a free online database, where anyone can upload their genetic information.

A suspect was found through a distant relative who might have paid for a test via Ancestry or 23andMe, and then uploaded it into the database.

The case raised all sorts of complicated questions about whether genetic information is fundamentally different than other types of data because it implicates family members and not just individuals.

Other experts suspect that consumer DNA testing companies might have run out of early adopters. The theory goes that there's about 20 million or 30 million consumers who are naturally interested in learning more about their family background, and it's not that challenging or expensive to sell tests to them. At this point, many of these people have already been sold to, and there's no reason for them to buy a second test. Ancestry has sold about 14 million tests, and 23andMe has sold some 9 million.

But many people are wary about learning information they might not want to know like the father who raised them isn't their biological father or that they have a risk for a genetic disease that they can't take a pill to prevent.

There's likely a larger consumer segment that's interested, but still wary about these tests. They might not believe that the information is valuable enough to warrant the price tag. The cheapest tests sell for $99, and they'll cover ancestry and some health risks but lack truly actionable health information, like whether an individual might respond poorly to a drug based on their genetic makeup.

"The ancestry market is a finite market," said David Mittelman, CEO of Othram, a genomics start-up and a molecular physicist. A decade or so in, "these companies are beginning to tap out the market."

Mittelman notes that customer acquisition costs, including ad dollars these companies need to spend on sites like Facebook, will increase over time.

"I think the companies know this," he said. "The investment in health shows that they are working to appeal to a broader market."

What's noteworthy about the recent round of layoffs is that Ancestry kept all of its employees at its Ancestry Health business. And 23andMe is still highly focused on its drug development business. That suggests that both companies are indeed hinging their future on developing powerful health applications.

In light of that, some geneticists are optimistic about their future.

"First of all, a slowdown isn't a stoppage," said Dr. Robert Green, a professor of genetics at Harvard Medical School. "Our research is finding that genetics is about to take its rightful place in medical care for the world."

As Green explains, it's been a challenge for doctors to understand how genetics can inform their patient care. Many haven't had the education about genetics to understand how to talk about it with their patients or recommend tests that might be beneficial. But that's starting to change.

For instance, 23andMe is starting to roll out new tests that can identify people's risk for chronic diseases like diabetes, called polygenic risk scores. These results could be used by doctors to help steer their patients toward making healthier lifestyle choices to help them avoid getting the disease.

And for these companies, which already have genetic databases of millions of people, they might not need to keep spending ample marketing dollars to acquire new customers. Instead, they could focus on developing new insights from their existing databases. if they succeed at that, they can forge partnerships to the medical industry.

As Mittelman puts it, there's no need to "force people down an ancestry funnel."

Green agrees, saying companies like 23andMe and Ancestry might double down on more expensive but more detailed sequencing tests that provide a lot more relevant health information. 23andMe has dabbled with those kinds of tests but has been reluctant to roll out higher-priced tests while its main focus has been growth.

"The direct-to-consumer phenomenon will give way to a more of a proper integration of genomics into the day-to-day care of patients," said Green. "What we're seeing is a course correction, and consumers are waking up to the potential limitations of a $99 test."

CNBC Evolve will return, this time to Los Angeles, on June 8. Visit cnbcevents.com/evolve to apply to attend.

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Consumer DNA testing is a bust: Here's how companies like Ancestry and 23andMe can survive - CNBC

Clinical vs. DTC Genetic Testing

When 23andMe laid off roughly 100 employees last month, it was another admission that direct-to-consumer, or at-home, genetic testing sales are down at some leading companies. The reasons, however, while varied, have nothing to do with the interest in genetic testing. People want the information but it seems many prefer to get it from their doctors.

Theres reason for the interest: The field of genetics is booming.

Since the 1990s when we started testing for BRCA1, BRCA2 [which most notably increase the risk of breastandovarian cancers]and TP53 [which regulates cell division and keeps tumors from forming], the number of indications, or signs for cancer and the number of genes we can identify has expanded. And it will only continue to grow, Dr. Banu Arun, co-medical director of the Clinical Cancer Genetics Program at MD Anderson Cancer Center, tells SurvivorNet.

She notes that clinical genetic tests can aid in making recommendations for surveillance, determine prognosis and assist in treatment decision-making for cancer patients. Direct-to-consumer genetic tests dont offer that proverbial microscope.

When trying to understand your hereditary cancer risk, saysDr. Arun, clinical testing is the way to go.

Comparing DTC to clinical testing for cancer is actually a bit like apples to oranges.

Direct-to-consumer tests, which are relatively inexpensive ($99 and up), can make predictions about peoples health and ancestry. But theyre limited when it comes to offering tests for cancer risk. Currently, theFood and Drug Administration (FDA) has allowed at least one direct-to-consumer genetic testing company, 23andMe, to offer a test for cancer risk; it looks for three specific variations in BRCA1andBRCA2.

With direct-to-consumer testing, its only a very small piece of the puzzle, Megan Frone, board certified genetic counselor in the Clinical Genetics Branch at the National Cancer Institute, tells SurvivorNet. I think about it like a typo somewhere in a novel, she says. Theyre only looking at three pages, she says. You could have a typo anywhere else in the novel thats breaking that gene and giving you a higher risk for cancer, and theyre just not looking.

Clinical-grade testing can analyze the risk of 50 different types of cancer, according to The National Cancer Institute.

A study last year from the National Center for Biotechnology Informationnotes some other drawbacks, including how DTC tests frequently do notprovide conclusive results.

Most genetic tests performed by DTC companies are limited to few major genetic variants related to the phenotypes of interest, which leads to poor discriminatory power, it notes.

This means DTC genetic testing does not guarantee that a consumer with a high genetic risk score will suffer from a certain disease, it only indicates a genetic propensity.

Plus, test results could reveal other, unexpected, health risks.

You have to ask, Are they going to tell me about specific results I might not want to know about?' Frone says. Some at-home tests will tell you your risk for carrying certain Alzheimer gene variants. We dont have any particular treatment for Alzheimers. Some people dont want to know about that stuff because theres nothing they can do about it. They dont necessarily realize that theyre going to get that back on a test report.

All of which points to that important ingredient: an expert who can interpret and make an action plan.

DTC tests are often conducted without the involvement of a healthcare provider and without an understanding of clinical validity and utility, notes theCenters for Disease Control.

A recent study based on anonline survey of 1,001 adultsrepresentative of the population, found that public awareness of genomics and personalized medicine was not increasing in line with advancements in the industry. Seventy-three percent of the survey respondents had not heard of genetic counseling which is conducted by certified health professionals to advise consumers/patients on how to interpret genetic test results.

The first step for someone interested in learning about their risk for developing cancer, according to Frone, is to speak with a health care provider or genetic counselor to learn about options. Then, a risk assessment can be conducted by a certified genetic counselor.

In this type of consult, theyll look at personal medical history and family medical history. And, if youre female, theyll look at your hormonal risk factors, Frone explains. There are computer models to identify risks and patterns within someones personal and family history.

The next step, she says, is to discuss what needs to be done to test for the potential hereditary cancer syndrome.

People need to go into it understanding that genetic testing is really complicated, Frone says. To achieve the full value of it, weve got to apply the genetic test results in the context of their family health history and their other risk factors to understand final risk. Direct-to-consumer testing is very different from that. Its more recreational.

For those identified during the consult as being higher risk, insurance typically covers clinical testing. For people at a lower risk, they may be advised to skip testing altogether, or, they can pay out-of-pocket (costs can vary from $250 or more depending on whether a single gene or the entire genome is being tested).

For example, the BRCA1 and BRCA2 test 23andMe runs has been given the green light from the FDA, meaning the agency has determined that the benefits of the product outweigh the known risks for the intended use.

This specific test looks at three variants to determine if a woman is at an increased risk for developing breast and ovarian cancer, or if a man is at a higher risk for developing breast and prostate cancer.

It really is most relevant for individuals with Ashkenazi Jewish background because it can only look at three variants that can occur in these genes, when there are thousands possible, Frone says.

The actual test has been put in the Medical Devices class II risk category by the FDA. Class I devices, such as dental floss, are lowest risk. Class II, which includes condoms and powered wheelchairs, are moderate risk. Class III devices, such as pacemakers, require FDA approval in order to be marketed, while class I and II do not.

These mutations are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population, the FDA cautions.

Researchers estimate that roughly 5-10 percent of all cancers have a known genetic element, so while DNA tells a story, it doesnt write the entire script. External factors, like environmental nutrients or toxins, and lifestyle choices also influence risk for developing cancer.

Learn more about SurvivorNet's rigorous medical review process.

Kim Constantinesco is a freelance writer who specializes in health and founder ofPurpose2Play, which reports on positive and inspiring stories in sports. Read More

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Genetic Testing Is on the Rise Heres Why to Get it Done Through a Health Care Provider - SurvivorNet