FDA Approves Clinical Trial of a New approach to treat millions suffering from Enlarged Prostates
Urotronic, Inc. is maker of innovative Optilume BPH Catheter System
Plymouth, MN ( September 24, 2019 ) - Urotronic, Inc., a medical device company pioneering a new solution that could dramatically change the way millions of men around the world with enlarged prostates are treated, announced today it has received approval from the U.S. Food and Drug Administration (FDA) to begin its US pivotal study for the Optilume BPH Catheter System.
The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. More than 12 million American men are reported to suffer from enlarged prostates or Benign Prostatic Hyperplasia (BPH) and over 750,000 new cases are diagnosed each year.
“The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn’t surgically cut, burn, lase, steam or leave anything behind in the prostate like the other BPH technologies,” said Dr. Steven Kaplan, Professor, Icahn School of Medicine at Mount Sinai and Director of the Men’s Wellness Program, Mount Sinai Health System in New York and the principal investigator of PINNACLE “. This technology holds tremendous promise.”
Kaplan says the Optilume BPH balloon is also the first minimally invasive in-office therapy to provide symptom scores and flow rates similar to the more invasive gold standard known as TURP – (transurethral resection of the prostate).
Millions of men struggle to deal with the symptoms of BPH, including frequency, nocturia, intermittency, urgency, weak stream and straining to urinate as a result of being refractory or non-responsive, or unwilling to deal with the side effects of medical therapy, or reluctant to undergo an invasive surgical procedure requiring general anesthesia.
"We are excited about the accomplishments our team has made," said Urotronic CEO David Perry. “FDA approval is really a validation of our work to this point highlighting Urotronic’s potential to truly transform the urology market through an innovative approach and treatment for men suffering from BPH.”
The Optilume BPH procedure is a minimally invasive treatment that gives urologists the opportunity to offer an office-based or outpatient treatment option that may provide relief to men who are looking for an alternative to currently available BPH treatment offerings.
Dr. Kaplan and other investigators will monitor the progress of the PINNACLE clinical trial, which will get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
“This technology is very disruptive, and the end beneficiary is going to be the patients,” said investor and company board member Doug Kohrs. “Urotronic has embarked on an anatomy sparing approach to treating BPH that no one else has ever taken.”
The Optilume BPH Catheter System is an investigational device, not available for sale. CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
The prospective PINNACLE U.S. trial markets will include but will not be limited to; Advanced Urology Institute; Daytona Beach, Fla - Arkansas Urology; Little Rock, AR - Chesapeake Urology Associates; Baltimore, MD - Cornell University : New York, NY - Regional Urology, LLC; Shreveport ,LA - Sheldon Freedman Urology LTD: Las Vegas, NV - Western New York Urology Associates; Cheektowaga, New York- Associated Urologists of NC; Raleigh, NC -AUUA (Academic Urology & Urogynecology of Arizona); Phoenix, AZ- Carolina Urology Clinical Research (CUCR) ; Myrtle Beach, SC - Carolina Urology Partners; Charlotte, NC - Mount Sinai; New York, NY- Urology of Virginia; Norfolk, VA - Chesapeake 2; Baltimore, MD - Integrated Medical Professionals; Long Island, NY
About Urotronic, Inc. Urotronic, Inc., headquartered in Plymouth, Minnesota, is an early stage medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume™ drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary tract conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The drug-coated balloon technology under clinical investigation creates a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and our products, please visit us at http://urotronic.com/ or to schedule interviews with any of these stakeholders contact publicist Robb Leer 612.701.0608
CANNA BATH CO. LAUNCHES NATIONAL CBD WELLNESS LINE
Oakland-based entrepreneur Jessica Bernardo releases her line of handmade, all-natural bath salts, bombs, and lotions to stores across the U.S. for the wellness consumer who doesn’t want to visit a cannabis dispensary
OAKLAND, CALIFORNIA – SEPT. 24, 2019 Perfect for those who wish to enjoy the pain relieving medicinal effects of the cannabis plant without any of the psychoactive elements of THC, Canna Bath Co. announces that its new line of CBD-infused products is now at some 100 outlets across the U.S.
Founded in Jessica Bernardo’s Oakland kitchen (and bathtub!) in 2015, Canna Bath Co. originally paired its therapeutic grade essential oils and salts with THC extract for pain relief. Still federally illegal but permitted in many states, THC is the psychoactive ingredient found in cannabis and is a regulated product sold only in dispensaries. Bernardo soon found that her customers didn’t want to have to visit a cannabis dispensary to receive the relief her products offer.
Switching to hemp-derived CBD this year helped demand for Canna Bath Co.’s products to explode across the nation as stores try to keep up with consumer interest in CBD-infused products. A recent Acosta study found that 28% of all consumers use CBD in one form or another daily.
A unique line of bath bombs, salts, and lotions made of all-natural ingredients, scented with essential oils, and blended with intuition and grace, Canna Bath Co. products are for those seeking a luxurious bath experience, softer skin, and pain relief but who don’t want to use a THC product. CBD, a palliative derived from the hemp plant that has no psychoactive properties yet can offer pain and stress relief, is the perfect solution.
Infused with CBD derived from legally grown and tested North American hemp, Canna Bath Co. products include a blend of Epsom and Himalayan CBD Bath Salts to help you relax, breathe more clearly, and soothe sore muscles.
Scented with a variety of natural essences such as lavender, bergamot, jasmine, coconut, lime, ylang ylang, vanilla, rosemary, or peppermint, Canna Bath Co.’s CBD Bath Bombshelp you to sleep, reduce anxiety, energize, and soothe sore muscles.
The proprietary line of after-bath CBD Lotions offer muscle relief and smooth dry skin.
Canna Bath Co. works with Nardo’s Naturals and sources essential oils to produce clean, holistic bath and beauty products perfect for today’s wellness practitioner and those looking to enjoy self-care at home.
Trained as a massage therapist, founder Jessica Bernardo, 34, has always had an interest in health and natural remedies. Making her own CBD-infused bath products with natural holistic ingredients that offer pain relief and produce glowing skin was a logical step.
“When I was in massage school, my focus was on helping people feel better without harsh pain medicine,” she says. “I was already playing around with bath products and supplements using apple cider vinegar, lavender, rosemary, and other natural ingredients. This is the perfect combination of my two passions.”
Handmade with essential oils and therapeutic-grade CBD that has been third-party lab tested for quality and potency, Canna Bath Co. products are available at cannabathco.comand at select stores across the U.S.
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ABOUT CANNA BATH CO.
Canna Bath Co is a woman-owned business based in Oakland, CA, whose products are all sourced for sensitive skin. We believe in holistic healing approaches and offering the benefits of the hemp plant in a form everyone can enjoy. Learn more: cannabathco.com and @cannabathco #plantsoverpills #cbd #womanownedbusiness #bossbabe #cbdbathbomb #soakitup
Vaping crisis: Journalists encouraged to keep asking tough questions during vaping crisis
TORONTO, Sept. 24, 2019 /CNW/ - DashVapes Inc., Canada's largest independently owned e-cigarette company, is concerned about the recent spread of misinformation and the holding back of accurate and important information in regard to recent vaping-related illnesses and deaths, in Canada and the USA.
"We ask all stakeholders in the vaping industry to make sure they fully answer media questions," said DashVapes President Shai Bekman.
"Further, we ask all stakeholders and public health agencies to not mislead the media, similarly to what has been done by the Middlesex-London Health Unit; and through them, mislead the Canadian public, health and marketing regulators, government officials, people who vape, and importantly, the families and friends of vapers who worry, based on current negative news coverage," said Mr. Bekman.
Mr. Bekman went on to add "the recent media hysteria has driven droves of people back to combustible tobacco. It's made people believe that e-cigarettes are just as harmful as cigarettes, which is a public health disaster. Adult smokers should know that if they smoke, they could vape to reduce their harm by at least 95 percent according to Public Health England."
DashVapes asks the media to do three things:
Do not "scalp" the stories created by other journalists. Do your own reporting, ask your own questions, and do your own fact checking, especially with medical professionals.
Further, we urge you to go beyond "correctly attributed opinion" of designated spokespeople. Check what they tell you.
Do not roll over for stonewalling. DashVapes understands the need for some privacy, but that's no excuse for "sources and experts" making statements that damn our industry and refuse to back them up with facts and information. Patient confidentiality cannot outweigh what is in the public interest and public safety.
Be cynical and suspicious. Journalists regularly work with a mix of cynicism, suspicion and doubt in regard to businesses and business people involved in a controversy. You dig into what we say, and look for errors or exaggerations.
"Follow the money" is your favourite phrase.
DashVapes asks you to apply this same digging and reporters' research into your anti-vaping sources. Just because a person in a lab coat is sitting at a table in front of TV cameras does not mean the complete truth is being delivered.
DashVapes will help you avoid being called out for stories that mask openness or raise questions about accuracy, or let anti-vaping factions mislead journalists, and through them, Canadians.
The Canadian Vaping Association is establishing an official association-wide communications protocol. For official comments and information on vaping, please contact The Canadian Vaping Association. Darryl Tempest, Executive Director, (647) 274-1867. dtempest@thecva.org
You can expect to hear from DashVapes when we think we can help your stories, and we look forward to your calls, emails and messages, when you think we can help your understanding.
DashVapes' YouTube Channel
Our YouTube channel will post stories to keep the media and other stakeholders up to date.
About DashVapes Inc.
DashVapes Inc., Canada's largest independently owned e-cigarette company, operates 12 vape retail stores in Ontario and British Columbia. In addition, DashVapes operates an international website that serves customers in Canada, the U.S., the U.K., Europe, and Australia.
DashVapes operates two ISO-9001, cGMP, HACCP certified, purpose-built laboratories for the manufacturing of Nicotine E-Liquid, with manufacturing facilities in Markham, Ontario, and Burnaby, British Columbia.
DashVapes was founded in 2013 by President Shai Bekman, who smoked 40 cigarettes per day (1.5-2 packs) for 13 years. While he wanted to quit smoking, nothing worked for him until he tried vaping. He started DashVapes to give smokers the choice of a less harmful alternative to cigarettes.
SOURCE DashVapes, Inc
Avicanna (TSX: AVCN) Aras Azadian, CEO & Co-Founder to speak at the 12th Annual International Natural & Organic Cosmetics Conference About Organic CBD Skin Care and Pura Earth™ in Berlin, Germany
/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS/
TORONTO, Sept. 23, 2019 /CNW/ - Avicanna Inc. ("Avicanna" or the "Company")(TSX: AVCN), a biopharmaceutical company focused on the development, manufacturing and commercialization of organic and sustainable plant-derived cannabinoid-based products, is pleased to announce that its CEO and Co-Founder Aras Azadian will be a highlighted speaker on the global organic cosmetics industry and the use of CBD in cosmetic products and specifically Avicanna's organic CBD cosmetic line Pura Earth at a leading industry conference in Berlin, Germany. The 12th International Natural & Organic Cosmetics Conference is an industry leading event at which executives from global cosmetics companies will focus on essential topics and current industry trends in presentations, panels and discussion groups.
Panel Discussion Details:
Organic Cosmetics - Newcomers & Best Practices Tuesday, September 24th 3:15 – 3:45pm Ellington Hotel, Berlin Germany
As a result of Avicanna's upcoming global launch of its Pura Earth™ derma-cosmetics products, Mr. Azadian brings extensive knowledge related to this years' "What's Next" Key Topic: Cannabidiol as a Cosmetic Ingredient. Aras co-founded Avicanna with the vision of establishing a bio-pharmaceutical company focused on medical and pharmaceutical applications of cannabinoids.
"As a front runner in the development, and commercialization of plant-derived organic and sustainable cannabinoid-based products Avicanna has been instrumental in the evolution of the CBD cosmetics market through unprecedented quality standards and an evidence based approach, and I look forward to sharing our expertise with my global colleagues. This platform is an excellent forum to meet like-minded executives and discuss how we operate in this hypergrowth industry and the current gaps related to CBD consumer products" stated Aras Azadian, Chief Executive Officer.
The cosmetics industry is actively evaluating CBD products however, due to its infancy, regulatory limitations, lack of data to substantiate claims and the current low-quality products in the market certain regions have progressed with significant hesitancy. Avicanna's extensive knowledge generated through years of R&D work with cannabidiol and through the development and optimization of its Pura Earth™ line of derma-cosmetics will educate participants to understand how CBD is working on a molecular level in cosmetics, what to look out for when evaluating CBD products and how this ingredient will influence the cosmetics industry in the future.
About Pura Earth™
Pura Earth™ is Avicanna's derma-cosmetic line which utilizes a combination of purified cannabidiol (CBD) and other synergistic botanical ingredients designed to naturally regulate and nourish the skin. The Pura Earth™ products are formulated with CBD cultivated under organic and sustainable conditions by Avicanna's subsidiaryin Santa Marta, Colombia in the foothills of the Sierra Nevada Mountains. The Pura Earth™ product line was designed by Avicanna and optimized in partnership with the University of Toronto using Avicanna's proprietary formulations. The Pura Earth™ product line will be manufactured by Altea Farmaceutica S.A. ("Altea") under Good Manufacturing Practices standards. In addition, Centro de Atención e Investigación Médica CAIMED S.A.S. is currently completing clinical studies on selected Pura Earth™ products in order to demonstrate their effectiveness with specific cosmetic endpoints, such as reduction of fine lines associated with aging, efficacy as a moisturizer for eczema prone skin, and reduction of sebum and redness attributed to acne. Pura Earth is expected to be launched originally in Colombia in Q4 2019 followed by the European Union in early 2020.
About Avicanna Avicanna is an Ontario corporation focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products through its two main business segments, cultivation and research and development.
Avicanna's two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia are the base for Avicanna's cultivation activities. These two companies are licensed to cultivate and process cannabis for the production of cannabis extracts and purified cannabinoids including cannabidiol (CBD) and tetrahydrocannabinol (THC).
Avicanna's research and development business is primarily conducted out of Canada at its headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto. Avicanna's scientific team develops products, and Avicanna has also engaged the services of researchers at the Leslie Dan Faculty of Pharmacy at the University of Toronto for the purpose of optimizing and improving upon its products.
Avicanna's research and development and cultivation activities are focused on the development of its key products, including plant-derived cannabinoid pharmaceuticals, phyto-therapeutics, derma-cosmetics and Extracts (defined as plant-derived cannabinoid extracts and purified cannabinoids, including distillates and isolates), with a goal of eventually having these products manufactured and distributed through various markets.
Stay Connected For more information about Avicanna, visit www.avicanna.com, call 1-647-243-5283, or contact Setu Purohit, President by email info@avicanna.com.
Cautionary Note Regarding Forward-Looking Information and Statements Certain information in this press release contains forward-looking statements. Such statements include but are not limited to the completion of the speaking engagement and the expected timing of the launch of the Pura Earth products. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict, including the risk factors set out under the heading "Risk Factors" in the Company's long form final prospectus dated July 8, 2019. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements, unless and until required by securities laws applicable to the Company.
SOURCE Avicanna Inc.
WALMART ENDS SALES OF VAPING AND TOBACCO PRODUCTS
Walmart just banned the sale of all handguns and tobacco products including vaping products.
Discussing this topic is Joshua Mansour, M.D, board-certified hematologist/oncologist who is conducting a national educational tour on the dangers of vaping.
Q&A:
What do you think about Walmart’s decision to end sales of vaping and tobacco products?
Answer: I applaud their decision and hope other retailers voluntarily follow suit. There remains a façade that this isn’t as dangerous as smoking traditional tobacco cigarettes, however e-cigarettes have many other dangers as further discovered recently. To further elaborate, patients thus far have experienced shortness of breath, fatigue, weight loss, coughing and even severe lung disease leading to lung collapse. In addition, several of the symptoms of nicotine include, but are not limited to tremors, increase in heart rate, profuse sweating, nausea, vomiting, dizziness and even seizures
Tell us about the government’s recent deadline for e-cigarette makers to change their marketing practices.
Answer: The federal government has been lenient on these manufacturers in allowing them until 2022 to submit their plans for preventing underage access to their products. However now The FDA said it requested that JUUL provide a written response describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), including its plan to prevent the same or similar violations in saying that it is safer than cigarettes. Failure to do so, it warned, “may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.
The underage vaping problem has escalated in recent years as the providers of vaping products claimed vaping was safer than cigarettes, yet the whole vaping craze addicted millions of young people to nicotine who had not been cigarette smokers prior. Besides addiction, what other dangers are associated with vaping?
Answer: To further elaborate, patients thus far have experienced shortness of breath, fatigue, weight loss, coughing and even severe lung disease leading to lung collapse. In addition, several of the symptoms of nicotine include, but are not limited to tremors, increase in heart rate, profuse sweating, nausea, vomiting, dizziness and even seizures. Further cardiovascular strain can occur and as you mentioned addition. There are also several other dangers that we are unfortunately learning about from many impurities that are being found in cartridges.
4. How damage can frequent vaping do to underage people?
Answer: Recent studies and statistics have shown that approximately 20% of users are underage. As described above there are several detrimental effects that these electronic cigarettes can have at any age. By starting younger, people are exposing themselves to a
What are some ideas that you have for limiting the underage access to vaping products?
I think that Walmart has taken a big first step in eliminating the selling of these products from their stores all together. In order to limit much of the underage access, there will need to be further enforcement on the products and how they are obtained. I think that changing the marketing strategies as well as banning the flavors will also make the products less appealing to the younger population.
Why do people think that vaping is safer than smoking cigarettes?
Answer: Many of the possible side effects that we have seen with conventional cigarette smoking, which is now marketed and outwardly displayed to the public, is not done so with electronic cigarettes and devices. This of course can be because not enough time has passed to show a correlation or causal relationship. This doesn’t mean that the it doesn’t exist though. It took decades before doctors believed that there was a case against cigarettes. It is now known to be the deadliest artefact in the history of human civilization
What do you recommend that people should do if they are already addicted to nicotine through vaping—should they switch to paper cigarettes?
Answer: NO! If patients are addicted to nicotine through vaping at this time, they should discuss this with a healthcare provider. Several resources and steps to help patients with addiction can be discussed. Some of these include a nicotine gum program or a patch, similar to what is used with patients addicted to traditional tobacco cigarettes.
Dr. Joshua Mansour is a board-certified hematologist/oncologist working and in the field of hematopoietic stem cell transplantation and cellular immunotherapy in Los Angeles, California. In June 2019 he was a recipient of the ‘40 Under 40 in Cancer’ award. Abstracts, manuscripts and commentaries by Dr. Mansour have been published in U.S. News & World Report and more than 100 other esteemed journals and media outlets.
4 Ways to Maintain Healthy Skin While Exercising
Frequent exercise will help you to have a healthy body and to maintain the appropriate weight, but physical activity can detrimentally affect your skin. Fortunately, there are great ways to care for your skin to avoid having any problems that can lead to cancer, wrinkles or acne. Here are four ways for you to maintain healthy skin while you are exercising.
Protection from the Sun’s Ultraviolet Rays
If you are exercising outside, then you must protect your skin from the sun’s ultraviolet rays. Look for sunscreen lotions or creams that are water-resistant so that they will remain on your skin even after a day of hard exercise and sweat. Make sure to reapply the sunscreen products according to the package’s label to avoid having sunburned skin. Protecting your skin from sunlight can prevent skin cancer.
Proper Cleansing After Exercising
When you are exercising, you will perspire more, and your skin will also produce additional oils. This means that you must clean your skin frequently to avoid having blemishes that include pimples or blackheads. Look for facial and body skin cleansers that are appropriate for your skin’s type so that you won’t have greasy or dry skin. After physical activity, make sure to shower or bathe right away to avoid having a foul odor.
Professional Facial Services
At a medical spa, you can request professional facial services to have beautiful skin despite exercising intensely. There are several types of facials available, including exfoliating dry skin tissue or removing sebum from the skin’s pores. You can also undergo laser treatments to lighten skin discolorations. An aesthetician can also inject fillers to improve your facial appearance, or you might prefer an injection of a neurotoxin to reduce skin wrinkles.
Drinking Enough Water
Your skin needs hydrationto remain healthy and attractive. When you aren’t drinking enough water, you will feel terrible, and it will often affect your skin. The average adult requires a minimum of eight glasses of water each day, but if you are engaging in physical activity, then you will need much more than this. Begin your day by drinking a glass of water and make sure to carry bottles of water with you while you are exercising. If you can, find water bottles that you can clip onto a bicycle’s frame or that will attach to a belt around your waist.
Inspect Your Skin
After exercising, make sure to inspect your skin for any problems that can include having blisterson your feet or chafing around your waist. These are common skin problems that are caused by excessive skin rubbing when you are perspiring.Brooke Chaplan is a freelance writer and blogger. She lives and works out of her home in Los Lunas, New Mexico. She loves the outdoors and spends most of her time hiking, biking, and gardening. For more information, contact Brooke via Facebook at facebook.com/brooke.chaplan or Twitter @BrookeChapl
Addition of KISQALI® to drug plan in Quebec expands access to treatment for metastatic breast cancer
Provincial reimbursement provides public access to treatment that may delay the progression of advanced breast cancer
DORVAL, QUEBEC, September 19, 2019 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Quebec will now reimburse KISQALI® (ribociclib) for eligible patients in combination with an aromatase inhibitor (letrozole) under the province's public drug program for first-line treatment of postmenopausal women living with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.1
For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.2 It may happen before or after treatment, or it may develop from reoccurring breast cancer.3 Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.4 While overall 5-year survival rates for female breast cancer are relatively high, at 87%, women with advanced breast cancer face a 22% survival rate over 5 years.5
"The public reimbursement of KISQALI® for metastatic breast cancer in Quebec represents a promising milestone for women living with metastatic breast cancer," said Dr. Nathaniel Bouganim, Medical Oncologist, McGill University Health Centre. "Now, patients will have access to more options to potentially help slow disease progression."
"We are thrilled to see the province of Quebec grant access to therapeutic options that help improve the quality of life of women living with metastatic breast cancer," said Nathalie Tremblay, Chief Executive Officer, Quebec Breast Cancer Foundation.
KISQALI® belongs to a family of medications called protein kinase inhibitors. These medications work by stopping cancer cells from dividing and growing. KISQALI® received Health Canada approval for use with letrozole on March 2, 2018, for the treatment of postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer as first-line endocrine-based therapy based on findings from the pivotal MONALEESA-2 trial. When given together with letrozole, KISQALI® may help slow down the growth and spread of breast cancer cells.6
"Novartis is committed to bringing innovative therapies that can improve the quality of life for those impacted by breast cancer," said Daniel Hébert, Country Medical Head Oncology, Novartis Pharmaceuticals Canada Inc. "The reimbursement of KISQALI® is a testament to the ongoing need for public access to this treatment, and we continue to work collaboratively with the remaining provinces and territories to ensure patients from across Canada with metastatic breast cancer and their healthcare providers have public access to KISQALI®."
About KISQALI®(ribociclib) KISQALI® is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. KISQALI® was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About Novartis in Advanced Breast Cancer Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.
About Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2018, the company invested $52 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.
5 Canadian Cancer Society. Canadian Cancer Statistics, a 2018 special report on cancer incidence by stage. Available at: www.cancer.ca/Canadian-Cancer-Statistics-2018-EN. Accessed on July 15, 2019.
108 Tips, Tricks, and Ideas for When You’re Stressed Out,
Anxious, or Overwhelmed
By Liza Kindred
THE HANDS-ON MANUAL OF HEALING AND SELF CARE FOR BUSY PEOPLE AND SKEPTICS LIVING IN A STRESSFUL WORLD
You already know that you should meditate, and that meditation will make you happier and healthier. But you’re tired and irritated, and every time you try to meditate, your mind races and you can't stop thinking about your to-do list. You’re constantly told that if you stop, try to get balanced and refocus, everything will be OK. But that sounds even more stressful. Can you relate?
Turn to EFF This! Meditation: 108 Tips, Tricks, and Ideas for When You’re Stressed Out, Anxious, or Overwhelmed [Rock Point Press, October 22, 2019] by meditation teacher and sought-after global keynote speaker, Liza Kindred. This hands-on manual for living in a stressful world can be integrated into your daily life and features easy, quick – and often free – things we can do to alleviate our own stress. Half of the exercises can be done in five minutes or less. Learn to celebrate the small victories in life with a “to done” list. Release yourself from phone addiction with a digital detox plan. Get your body out of stress mode by practicing diaphragmatic breathing. Be transported, and open your heart with a pick-me-up playlist. These are just a few of the simple, practical strategies that will help you find your center.
“Something has happened out there in the world where even when we are trying to find wellness, we are being told we need to constantly fix or heal or improve ourselves—as if something inside of us is inherently broken; as if the problems live inside of us, and not out there in a world that has nearly lost its collective mind,” says Kindred. “If you feel crazy, or anxious, or sad, or depressed, or overwhelmed, that makes sense. It is not because you are broken or can’t cope—it’s because the world is in a state right now. But that state is not us. And just because we are stressed to the max and freaked out doesn’t mean that we have to live like that. You can find the place of beauty, calm, and equanimity that already exists inside of you.”
The book draws upon a Shamatha (mindfulness-awareness) practice rooted in radical compassion for self. The 108 tips, tricks, and ideas presented in Eff This! are all centered on the idea that, as humans, we might not be “finished,” but we are complete. Everything you need to attain enlightenment is already contained within you, and you can use meditation—and these practices—to connect with it.
“This, right here, is your permission to be gentle with yourself, no matter what,” adds Kindred. “This is your permission to make taking care of your physical, mental, emotional, and spiritual health a top priority.”
About the Author:
Liza Kindred is the creator of EFF THIS! Meditation, where she offers mindfulness practices to cynics, skeptics, and busy people. She is also the founder of Mindful Technology™ where she teaches companies how to build tech that values humans more than machines. Kindred is a licensed minister, a level two reiki practitioner, and a terrible but passionate surfer.
As a meditation teacher and sought-after global keynote speaker, Kindred has taught and spoken on five continents, from huge events like SxSW and Web Summit to intimate gatherings on living room floors. Her clients include companies like Vogue Magazine, Microsoft, Hearst, and FedEx. She has appeared in The New York Times, Wired Magazine, Well+Good, The Telegraph, and Entrepreneur Magazine.
EFF This! Meditation:108 Tips, Tricks, and Ideas for When You’re Stressed Out, Anxious, or Overwhelmed releases on October 22, 2019 and is available on Amazon and other retail outlets.
We are all subject to marketing and advertising on a daily basis. Nowadays it seems like even thinking about skin care will get you bombarded with countless ads and sponsored post on social media. But how trustworthy are some of the marketing buzzwords used to describe the effects of skincare merchandise? We reached out to an anti-aging expert and board-certified Denver Plastic Surgeon, Dr. Manish Shah. Shah advocates helping consumers understand what this frequently used language means. Dr. Shah is also an ethical patient safety advocate.
“There are many ways marketers attempt to pull the wool over the eyes of the consumer with empty phrases and jargon,” comments Dr. Shah. “A phrase such as ‘clinically tested’ and ‘doctor recommended’ is used to mislead consumers into thinking a certain product has more credibility than it actually does.” However, Dr. Shah explains, when these phrases are used it says nothing for the results of the clinical tests or what the products were tested for. In terms of products being “Doctor recommended,” Shah warns that “consumers don’t know what doctor recommended the product in most cases and if those doctors are getting some sort of incentive for endorsement.”
Dr. Shah shares common marketing jargon phrases used to mislead consumers.
A Product that claims “Patented Technology”
“Patents are not necessarily a foolproof sign that something is groundbreaking or effective,” explains Dr. Shah. “Marketers use this language to convey innovation and superiority that their product might not necessarily have over its competitors,” he says. Patents are sometimes authorized through technicality instead of breakthrough meaning any new combination of ingredients, methods or production process can be patented as long as it is new.
“Maximum strength”
This is a term used often by skin cleansers and moisturizers. “It’s a relative term and the consumer doesn’t really know what it is relevant to. It’s language that entices the shopper to make the purchase without really telling them how it accomplishes ‘maximum strength’ results,” says the Denver Plastic Surgeon.
“Clinical strength”
From painkillers to hydrating serums, companies love to bill their products as having “clinical strength.” Dr. Shah says consumers should practice healthy skepticism with such claims. “A product that claims it has clinical strength, in many cases, could have been tested by the doctors developing it. If you think about it you can’t really pinpoint what that phrase means because it is relative and we have no context as to what the company considers clinical strength,” says Shah. The perception, explains Dr. Shah, is that the product is better because the world clinical makes it sound more credible.
“For All Skin Types”
“This is a difficult promise to deliver on,” says Shah who has practiced his specialty for 14 years. “Not all skin is the same. If someone has an allergy to an ingredient or some form of dermatitis they really should speak to their doctor about what products are best to include in their regiment instead of blindly trusting a label,” he says.
“FDA Approved”
The FDA has different protocols for skincare products that make cosmetic claims as opposed to those that make more medical claims such as promising to increase production of collagen in the skin. Since that is a body function the FDA treats those differently than normal skincare products. However, the FDA just stipulates that the product being sold is safe to use in the manner in which it is directed to be used “FDA approval is not credential that shows the superiority of results,” says Dr. Shah. The plastic surgeon recommends that you not be sold on the sole factor of an FDA approval.
“Anti-Aging, Revitalizing, or Age Defying”
We’ve all seen these on the labels of some cream or serum or advertised in a commercial where beautiful models and actresses are displayed in all of their airbrushed and well-lit perfection. “These terms are somewhat misleading in that they give the perception of an unrealistic turning back of the clock,” says Dr. Shah. To many consumers viewing an advertisement, it might seem like buy and using that product will help them look like an ageless actress and that is not accurate.” Aging gracefully and maintaining a more youthful look has a lot to do with nutrition, exercise, genes, consistent skin care, stress levels, and cosmetic procedures when necessary. But according to Shah, people cannot cling onto just one aspect in order to look their best and no one product will reverse the clock.
Medical-Looking Packaging
Be wary of bottles that look like test tubes, labels or packages that include a medical or first aid cross, or feature type that looks like Rx suggesting that it’s a prescription-strength formula even though it’s sold over the counter.
Botanical
Dr. Shah explains that “An actual botanic is technically an ingredient that is derived from a plant. But, again, “botanical” may be used in advertising to refer to something that is synthetic but acts similar to a plant-based ingredient.”
Instant Results
Keep in mind that “instant results” aren’t the same as “long-term results.” Meaning, you may use a product that gives you instant moisture or has a quick-acting firming effect, but those results may fade after a few hours and require reapplication. Dr. Shah’s final advice: “Check a product to make sure it specifies whether its “instant” effects are long lasting or short term.”
Firming
What you think it means: Proven to make skin look tauter.
What it really means: Essentially nothing. “There is no objective way to measure firming,” says Dr. Shah “When a brand says their product has been shown to firm your skin, that claim can only be based on very subjective consumer perception.”
Natural
What you think it means- Make from the earth’s own ingredients with no chemicals
What is really means-
“Natural” doesn’t necessarily mean anything about the purity of a product. It’s a term that hasn’t been defined by the FDA. To determine what’s actually in a product, read the ingredients list. How many can you pronounce? If they sound like a list of chemicals, they are. There may be a benefit for some people to avoid parabens, usually absent from “natural” products, if their skin is sensitive.
Gluten-Free
What you think it means- That the product is not made with any gluten.
What it really means- Unlike foods, cosmetics labeled “gluten-free” aren’t regulated by the FDA. Do you need gluten-free beauty products? Maybe, if you’re gluten-sensitive and it’s a lipstick, gloss, or balm, which you could ingest in tiny amounts. Otherwise, it’s not necessary.
Dr. Manish Shah M.D., F.A.C.S. is board-certified by the American Board of Plastic Surgery and member of the American Society of Plastic Surgeons, the American Society of Aesthetic Plastic Surgery and the International Society of Aesthetic Plastic Surgery. Dr. Shah’s specialties include revision facial aesthetic surgery, rhinoplasty (“nose reshaping”), and aesthetic surgery of the breast (breast augmentation, breast lift, breast reduction). He is, however, well-trained in all areas of aesthetic surgery. Dr. Shah’s aim is to obtain a natural appearing transformation that complements the real you.
Five Simple Isometric Exercises for a Full Body Workout
There are five basic exercises that have been around since humans have been walking on two legs – the squat, lunge, push-up, pull-up and sit-up. But pull-ups and push-ups can be too difficult for many people and all five can cause muscle strains or other injuries if done improperly. We recommend doing these simple isometric exercises with the Activ5 fitness tracker and app so you can exercise safely and effectively, and also monitor your activity and progress.
Isometric Squat
The Activ5 version of the isometric squat is the Chair Pose. Often referred to as the “mother” exercise, a properly done squat works almost your entire body with one exercise.
Stand up straight and place Activ5 between both knees (if you don't have the Activ5, simply press your knees together)
Extend both arms in front of you.
Bend your knees and slowly squat down as if you’re about to sit in a chair, keeping your hips above your ankles. Stop when you’re a few inches above your “chair.”
Press Activ5 with your knees as you squeeze your thigh muscles. Your app will tell you how long to hold the pose. Trust us. You’ll feel the burn. (If performing without the Activ5, you can simply keep pressing your knees together for about a minute).
Isometric Lunge
The Activ5 version of the lunge is the Single Leg Deadlift, which is done on both the left and right leg individually. Let’s start with your left foot.
Step forward with your left foot.
Lower your hips until both knees are bent at about 90 degrees.
Place Activ5 on your left leg just above the knee and press Activ5 as you squeeze your leg muscles (If performing without the Activ5, simply place your hands in the same area and position as shown in the picture and press for 60 seconds or longer until you feel the work on your muscles).
Keep your left heel firmly on the ground. Again, use your app for guidance.
Repeat with your right leg.
Pull-Up
A pull-up requires a great deal of arm and shoulder strength. Activ5 has over a dozen exercises that work the same muscle groups. We’re using the Hook, which works your biceps, shoulders, and core. Do this one sitting down. As with the lunge, you do this for both your left and right arms individually.
Make a fist with your left hand.
Bend your left elbow and bring it up until your left arm is parallel to the ground.
Hold Activ5 in your right hand in front of your left fist.
Press Activ5 between your left fist and right palm.
Repeat with your right fist and left palm.
Push-Up
As with the pull-up, the push-up requires a variety of muscle groups, including your chest, and Activ5 has several exercises to develop these muscle groups. Let’s start with the Standing Chest Press.
Hold Activ5 between both hands in “prayer” position, with your elbows out.
Press both palms into Activ5 to squeeze your chest muscles.
Keep both feet firmly on the ground.
Sit-Up
Old fashioned sit-ups often result in back injuries. Activ5 gives you a safer sit-up with the Crunch.
Lay on your back with your knees bent, feet flat on the ground and knees about hip-width apart.
Place your hands on your chest, with Activ5 beneath your palms.
Contract your core to lift your head and shoulders off the ground.
Press Activ5 as you squeeze your core muscles.
That’s the Activ5 Full Body Simply Daily Workout. If you don’t have the Activ5, you should know just worked your arms, abs, shoulders, legs and butt. The Activ5 app can show you other exercises that replicate these 5 core exercises.
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