Don’t Let Your Vet Pay the Ultimate Price: Happy Vet Happy Pet Delivers Life-Saving Insights
Atlanta, GA, April 20, 2021 — If you have a pet, then you have a vet. And if you know a vet, you know someone statistically at a higher risk of anxiety, depression and even suicide. But you have the power to positively impact — and even save — that veterinarian’s life, asserts Sandy Weaver, author and Program Director of the Center for Workplace Happiness.
Her groundbreaking new book, Happy Vet Happy Pet: Caring for Your Pet’s Caregiver, outlines three simple rules that all pet owners should follow when interacting with their pet’s veterinarian.
“I’ve known for years, as have those in the veterinary field, that there was an issue with suicide and veterinarians,” Sandy says. “Then in early 2019, the CDC report on veterinary suicide was published in the Journal of the American Veterinary Medical Association, and what had been anecdotal became data: male veterinarians are 2.1 times more likely, and female veterinarians are 3.5 times more likely, to complete suicide than their non-veterinarian peers.”
Happy Vet Happy Pet is a distillation of Sandy’s research into neuroscience, neuroplasticity and positive psychology mixed with data from the CDC report. The result is an impactful approach that weaves easy-to-understand science with stories that touch the minds and the hearts of pet owners — empowering them to be part of the solution.
Chapters dive deep into topics all pet owners should understand, including:
1. The heart, mind and life of a person who decides to become a veterinarian; 2. The very human, very vulnerable person behind the scrubs; 3. The ways clients unknowingly mistreat their pets’ caregivers; 4. Three simple rules to follow to help your veterinary team; and 5. What to do if you feel that someone near you is facing suicidal desperation.
Happy Vet Happy Pet will change your relationship with your veterinarian and their team forever. And what you learn in this book could save your veterinarian's life.
Author Sandy Weaver is an expert speaker, trainer, mastermind facilitator and lover of all things dog.
As the Program Director of the Center for Workplace Happiness, Sandy creates the training programs, workshops, mastermind groups and keynotes that help people lead happier, more successful lives. She is also a citizen-scientist in the fields of neuroscience, neuroplasticity and positive psychology. In 2019, she took the resilience tools and strategies she’d been teaching to general audiences and crafted programs specifically for veterinary teams. Her goal is to touch the life of every veterinarian and technician in a way that helps them avoid the pain and despair that comes with an inability to manage stress.
Now in her 40th year of Siberian Husky ownership, Sandy is a passionate advocate for veterinarians and their teams and an ongoing donor to Not One More Vet.
Author Featured in Netflix series Surviving Death Shares Story of Hope and Evidence of Afterlife
New York, NY, April 20, 2021 — Imagine being a bartender at a busy Broadway show when just before intermission, you get the call – your too young dad has suddenly died. As your family’s screams of despair pierce your ear and instantly shatter your world, hundreds of patrons abuzz with energy from the comedic first act descend on you. They hastily begin ordering drinks, and somehow a shell that looks like you makes them, while your inside crumbles away. How do we move forward when such a devastating loss befalls us?
Love, Dad intimately shares one family’s darkest hours and their road to healing, a road that has been long ignored or scoffed at by the scientific community. Mike Anthony, a healthy skeptic, goes to great lengths to uncover the paradigm-shifting research into the nature of consciousness that exists, and shows us why it must be put back in the forefront with no shame attached.
Love, Dad details Anthony’s true story as he pulls himself out of despair, and alongside his family, finds true connection and communication with his dad once again. Given the transformative nature of the experience, he couldn’t help but share what happened, hoping to bring others the peace he’d discovered. So compelling is his story that Netflix chose to feature it in three episodes of their series Surviving Death.
This eye-opening book pushes the boundaries of what we think we know, unlocking the door to new and exhilarating possibilities. What might it be like to know that death is truly not the end? In Love, Dad we get one family’s answer.
When a stranger’s unpredictable phone call delivers a message that Anthony’s dad had contacted her from “the other side,” it kicks off a chain of events that would entirely change his family’s perspective on life, death and the transcendent nature of love. Join him on his remarkable quest, as his skeptical mindset gets challenged and eventually overruled through an extraordinary journey, leading to an event that would forever change his understanding of reality.
“Though I’ve always wondered, since I was a child,” Anthony remarks, “about what we are and how and why we’re here, and what happens to us when we die, I did not imagine I’d ever have such direct evidence to suggest that something, something ‘other worldly’ does, indeed, happen to us.”
Everyone needs this book. Our largest looming fear is death, and our greatest pain is the grief we feel when someone we love dies. But what if we knew that death is just a doorway, and loss is really just an alteration of relationship? Could we all live with a greater sense of peace if we knew our “lost” loved ones are actually very close by, and our own “passing” is simply that — a passage through? Anthony now knows the answer and you can, too!
Most importantly, Love, Dad gives us the hope that is so desperately needed during these times and does so with honesty, grace and evidence.
“The Netflix series Surviving Death, in which a part of my story is told, explores evidence that impacts every human being on the planet. Evidence of things that science says are impossible. And yet, they happen. I know they do. Because I have seen them. In Love, Dad: How My Father Died ...Then Told Me He Didn’t, I tell the story of how I came to know, without doubt, that our science has much yet to uncover.”
About Mike Anthony Mike Anthony has been a professional actor and (not-professional) bartender since he graduated from Wayne State University with a Master of Arts degree in Theater. His first book, Life At Hamilton, chronicles the extraordinary time he spent as a theater bartender with an up-close perspective of Hamilton: An American Musical as it rocketed into Broadway history.
Beyond his life in theater, Anthony’s journey took an unexpected turn when his dad passed, leading him down a remarkable path of discovery. He now spends a good portion of his time exploring evidence suggestive of the survival of consciousness beyond the demise of the physical body.
He uses his acting abilities, often during the Christmas season, at the Theatre at Monmouth in Maine. He is still the bar manager at Hamilton, though on hiatus due to Covid. He currently lives in Milford, CT.
Love, Dad: How My Father Died... Then Told Me He Didn't Publisher: Waterside Productions ISBN-10: 1951805666 ISBN-13: 978-1951805661 Available from Amazon.com
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Broken and Beautiful: Let God Turn Your Mess into a Masterpiece
Seattle, WA, April 20, 2021 — If you have a past of brokenness—abuse, dysfunction, addiction or other trauma—it doesn’t have to define your future. There is hope for a brighter path forward if we let God lead the way.
“We’re going to fail. The truth is, that’s exactly where God wants us to be so that He can grow us,” writes Christine Soule in her inspirational story, Broken and Beautiful. “The key is discovering who you are in Christ — your true identify. And that’s especially significant if you, like me, have a past of brokenness.”
Soule’s life was a jumbled pile of broken pieces. Her father was married seven times; her mother four times. Between her parents’ divorce when she was 5 years old and the day she allowed the power and presence of God into her heart, she watched her sister have an affair with her adoptive father; met 15 siblings she never knew at her biological father’s funeral; turned to drugs and alcohol; got pregnant at 17; had twins less than two years later; and became a victim of human trafficking. She had to break the cycle for the sake of her children. With nowhere else to turn, she dropped to her knees and prayed. And that’s when everything changed.
Broken and Beautiful is Soule’s remarkable story of how God took the pieces of her broken, astonishingly dysfunctional life and transformed it all into a breathtaking mosaic of joy and purpose.
“The places where you feel hopeless are exactly what He wants to redeem and fill with beauty, dignity and strength. He has a plan for your pain. A wonderful intention for your failures. A purpose for your hardest, darkest stories,” Soule writes.
Told with honesty and surprising touches of humor, Soule shares her journey from drug-addicted stripper to exuberant Jesus lover with a passion for helping others embrace God’s love. Broken and Beautiful is a raw, authentic story of hope, from a place of experience.
Author Christine Soule lives with the love of her life, Mitch Soule, in Seattle. They have five kids and three wonderful grandchildren. She is the founder and CEO of Providence Heights (www.providenceheights.org), a nonprofit created to house women and children in need and to provide counseling, education and jobs.
CGPA Welcomes Life Sciences Investments in Federal Budget 2021, But A More Comprehensive Approach Is Needed
TORONTO, April 20, 2021 /CNW/ - The following is a statement by Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA), in response to Federal Budget 2021.
"The Canadian Generic Pharmaceutical Association (CGPA) welcomes the federal government's recognition that a stronger life sciences sector and vaccine production can contribute to a more resilient Canada and healthier Canadians. CGPA member companies and the 11,000 Canadians that work in our industry play a vital role in Canada's economy and the sustainability of our health-care system by providing safe and effective cost-saving medicines.
While CGPA is supportive of the proposed financial investments intended to strengthen Canada's life sciences sector, this is only one element of what is needed to attract and sustain long-term investments. A comprehensive life sciences strategy that reflects the regulatory, market and other needs of the sector is needed to make Canada a more attractive and globally competitive place for investment to ensure a more robust and resilient domestic industry.
More attention and support must also be given to the challenges facing the generic medicines sector, which provides the vast majority of the medicines used every day to treat Canadians suffering from COVID-19 and so many other critical ailments.
In June 2020 CGPA released its Blueprint for a Sustainable Supply of Prescription Medicines for Canadians, which identifies measures to enhance Canada's existing pharmaceutical manufacturing capacity and domestic capabilities, create a more resilient pharmaceutical supply chain, ensure Canada's role within a well-functioning global supply chain, and encourage the establishment of a more coordinated approach to equipping Canada for future health emergencies.
The COVID-19 pandemic has served as a wake-up call for governments, health-care professionals and the broader public on the importance of having a robust and resilient domestic pharmaceutical industry. Ensuring a sustainable supply of prescription medicines for Canadians must be a priority for federal and provincial governments as they consider the economic and health policies that will guide Canada into the future.
CGPA and its member companies are committed to working with governments and other stakeholders to apply the lessons that we have learned from the pandemic to make the domestic industry and prescription drug supply chain even stronger and more secure for Canadians.
Generic prescription medicines are dispensed to fill more than 73 percent of all prescriptions in Canada but account for less than 20 percent of the $32-billion Canadians spend annually on prescription medicines. Compared with many countries that rely solely on importing their prescription medicines, Canada is fortunate to have extensive domestic generic pharmaceutical manufacturing capacity and capabilities. This is particularly important in times of health crises such as the COVID-19 pandemic."
About the Canadian Generic Pharmaceutical Association The Canadian Generic Pharmaceutical Association (CGPA) represents Canada's generic pharmaceutical industry. The industry plays an important role in controlling health-care costs in Canada. Generic drugs are dispensed to fill more than 73 percent of all prescriptions but account for account for less than 20 percent of the $32-billion Canadians spend annually on prescription medicines.
SOURCE Canadian Generic Pharmaceutical Association
TORONTO, April 20, 2021 /CNW/ - Ontario's doctors strongly endorse the six recommendations made by the COVID-19 Science Advisory Table today to reduce transmission of the virus, protect our health-care system and reopen the province safely as soon as possible.
The Ontario Medical Association supports the advisory table's focus on targeted solutions to stop the worst spread of COVID-19 since the pandemic began a year ago — and spelling out what will not work.
"People are dying and being hospitalized at staggering rates, but those rates are not equal among all Ontarians," said OMA President Dr. Samantha Hill. "We call on the government to implement immediately all of the solutions proposed by the Science Advisory Table to stop the virus from transmitting in our workplaces and hotspot neighbourhoods. Failure to do so allows the virus to continue to spread. Failure to do so allows more Ontarians to fall ill, need hospitalization and die. Failure to do so risks doctors' ability to care for any of us."
Here's "what will work," according to the advisory table:
Permitting only truly essential workplaces to stay open with stronger safety enforcement. The OMA also supports giving workers effective personal protective equipment and access to on-site COVID testing.
Paying essential workers to stay home when they are sick, have been exposed to the virus or need time to get vaccinated. The OMA has advocated throughout the pandemic for paid sick days so that no one has to decide whether to stay home or go to work to keep their job or earn income.
Vaccinating residents of hotspots and essential workers quickly, which means allocating as many doses as possible to those neighbourhoods and speeding up the overall vaccination process. The OMA also calls on the federal government to give more vaccines to hotspot provinces such as Ontario rather than distribute them through the current per capita allocation.
Restricting movement into the province and between regions in the province.
Focusing on public health measures that work such as physical distancing, wearing masks and no indoor gatherings with people from outside your household.
Keeping people safely connected by maintaining social connections and outdoor activity. This means allowing small groups of people from different households to meet outside with masking and two-metre distancing, keeping playgrounds open, allowing outdoor team sports with masks, and clearly encouraging safe outdoor activities.
The OMA agrees with the advisory table that the following "won't work:"
Policies that harm or neglect racialized, marginalized and other vulnerable populations.
Inconsistent policies with no clear link to scientific evidence.
Policies that discourage safe outdoor activity.
About the OMA
The Ontario Medical Association represents Ontario's 43,000 plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.
SOURCE Ontario Medical Association
Post-Lockdown Classrooms: Auspicious Settings for Fresh Approaches
Brooklyn, NY, April 20, 2021 — The pandemic proved that schools can pivot away from “how it’s always been done” and create new paths toward learning. With returning pupils widely believed to have lost ground in their learning, now is a promising time to consider approaches to classroom management and lesson delivery that have enjoyed sustained success abroad.
In A Mirror for Americans: What the East Asian Experience Tells Us about Teaching Students Who Excel, author Cornelius Grove approachably describes the thinking and practices of K–5 educators in East Asia, contrasting them with typical classroom approaches here in the U.S.
“People who’ve had experience in unfamiliar cultures often remark that they now see their own culture with fresh eyes,” Dr. Grove explains. “It’s as though they’ve looked into a mirror and seen alternative possibilities for themselves. They realize that they have ways of doing things that aren’t etched in stone but actually are choices. Different choices could be made.”
A Mirror for Americans is the sister volume for Dr. Grove’s 2017 book, The Drive to Learn: What the East Asian Experience Tells Us about Raising Students Who Excel, which reveals the impactful role of East Asian parenting in accelerating children’s classroom learning.
A Mirror for Americans, grounded in 50 years of research,is a concise, easy-to-understand read that concerns itself with preschool through grade 5, and dives deep into how teachers instruct and interact with their pupils. Among the findings reported by Dr. Grove are:
In preschool and grade 1, East Asian children practice individual and group behaviors that promote both their own learning and their teacher’s efficient lesson delivery.
Teachers design lessons based on the internal logic of the content, not on factors such as a need to motivate, to have fun learning, or to draw out pupil creativity. But they do present content so that all their pupils – slower and more advanced – will benefit.
Whether a lesson is student-centered or teacher-centered doesn’t concern East Asians. East Asian lessons are knowledge-centered. Dr. Grove details what that means.
Among the nine chapter titles are:
How Children’s Learning Is Regarded
How Classroom Teaching Is Regarded
How Classroom Lessons Are Delivered
How Mathematics Lessons Are Delivered
Other Performance-Related Topics
Author Cornelius N. Grove holds a Master of Arts in Teaching degree from Johns Hopkins and a Doctor of Education from Columbia. He has had a decades-long fascination with the cultural factors that affect children’s ability to learn in school. At a 2005 conference in Singapore, he spoke about the two instructional styles found around the world. In 2013 he wrote The Aptitude Myth: How an Ancient Belief Came to Undermine Children's Learning Today, a historical study of why most Americans believe that inborn ability determines school performance. For two recently published encyclopedias (2015 and 2017), he wrote entries on “pedagogy across cultures.” And now with A Mirror for Americans and The Drive to Learn, he is revealing the complementary roles played by home and school in building children’s academic prowess.
Health and Fitness Travel Designs 30 Day Wellness Workcations
Health and Fitness Travel, the wellness holiday specialists has seen a big increase in clients enquiring and booking long wellness workcations in the last 6 months with stays ranging anywhere from 30 to 60 nights. As a result of the pandemic, travellers will take fewer trips but will extend the duration of these trips for maximum benefit to combine business with wellness – this is a trend that is here for the foreseeable as the travel industry seeks to recover following the second year of restrictions.
Health and Fitness Travel has catered for this emerging trend by offering the perfect solution - 30-day wellness workcations that allow clients to incorporate wellness around their work schedules. Here are the top 5 wellness workcations to cater for remote workers in need of a change of scenery and to reserve their mental health during these uncertain times.
Located in the quiet vibrancy of the French Riviera, between Toulon and Nice, the five-star resort of Lily of the Valley offers a comprehensive wellness retreat to reset your diet, mind and perhaps even your very wellbeing with a focus on alternative therapies to combat the toxifying elements of modern living. With complimentary yoga classes and a relaxing atmosphere, guests can strike the balance between wellness and work with one of four wellness programmes; discover, reboot , reset or reborn.
Health and Fitness Travel (0203 397 8891 healthandfitnesstravel.com) offers 21 nights at Lily of the Valley for £11,770pp. Price includes full board, a wellness programme and optional return private transfers.
Nestled at the foothills of the mystical Mount Taygetos, Euphoria Retreat in Greece exudes tranquillity and natural charm to keep you motivated throughout your healthy break. This weight loss retreat is carefully designed around the individual's physical and mental needs to help guests achieve their optimal weight. 3GL test results are analysed to determine the best treatments for you which include Chinese medicine, private fitness training sessions, lymphatic drainage massages as well as complimentary access to the retreat's spa facilities.
Health and Fitness Travel (0203 397 8891 healthandfitnesstravel.com) offers 21 nights at Euphoria Retreat from £12,360pp. Price includes full board, a wellness programme and optional return private transfers.
Situated on the beautiful island of Koh Samui in Thailand, Absolute Sanctuary offers the perfect long stay retreat to transform your physical, spiritual, and emotional realms in a structured 3-phase process. Your journey beings with an initial in-depth wellness consultation followed by an array of rejuvenating treatments, from manual lymphatic draining to a Swedish or aroma oil massage. Pilates and yoga sessions are complimented by detoxifying nutrition and life coaching sessions will equip you with a more positive outlook upon your return home.
Health and Fitness Travel (0203 397 8891 healthandfitnesstravel.com) offers 30 nights at Absolute Sanctuary from £7,875pp. Price includes full board, a wellness programme and return private transfers.
The pioneering SHA Wellness Clinic in Spain prides itself on offering uniquely tailored programmes for its clients and focuses on creating and maintaining healthy habits. SHA's Rebalance and Immune System allows guests to rejuvenate with tailored treatments while individual consultations will help you learn healthy habits which can be implemented in daily life. Incorporating the best of holistic and scientific medicine, this programme targets the recovery and stimulation of the body’s natural defence system, ensuring you stay strong and healthy.
Health and Fitness Travel (0203 397 8891 healthandfitnesstravel.com) offers 21 nights at SHA Wellness Clinic from £13,270pp. Price includes full board, a wellness programme and return private transfers.
Situated on Cariblue's crescent shaped beach and surrounded by acres of unspoilt rainforests and natural waterfalls you'll find the luxurious spa resort that is BodyHoliday. Offering comprehensive body analysis and a tailor-made wellness plan, the BodyScience medical retreat uses your unique genetic information to achieve optimum health in both body and spirit. Experience a life-changing wellness holiday that will boost your energy, cleanse your body, and centre your mind, setting you well on the path to optimal wellness.
Health and Fitness Travel (0203 397 8891 healthandfitnesstravel.com) offers 21 nights at BodyHoliday from £9,860pp all-inclusive with a wellness programme and return transfers.
Health and Fitness Travel is a global luxury wellness travel company that originated in the UK in 2010 and is committed to providing healthy holidays that enhance and change lives. Created by Paul Joseph as a result of his passion for health and fitness travel and offering bespoke holidays to improve people’s well-being to lead happier and healthier lives.
Health and Fitness Travel offers clients a tailor-made seamless service with the very best health and fitness holidays, handpicked by its expert team, together with exclusive and added value packages with the best deals. As leading specialists, Health and Fitness Travel has also created their own collection of trademark healthy holidays in various destinations which include Fusion Fitness™, Mindful Triathlon™, BodyBreaks™ and Discover Recover™, offering clients the best value and holiday experience. For more information visit: www.healthandfitnesstravel.com /www.healthandfitnesstravel.com/wellness-holidays
Diet and fitness go hand in hand for anyone looking to remain healthy. The foods you eat determine your health, which determines the success of your exercises. You cannot have a poor diet with an above-average exercise plan and be optimally healthy. It all depends on how well you match your diet to your fitness routine.
Consume Protein
Consume protein to improve the results of any physically demanding workout. Protein repairs the muscles that are damaged due to physical strain. Its consumption is similar to applying polish on a table to protect it from scratching. The protein builds and rebuilds muscles that wear down over time. It provides needed boosts of energy when carbohydrates are not available. While you recover from an injury, a protein-rich diet reduces the symptoms of chronic hunger and fatigue.
Drink Water
Everyone is advised to drink at least eight glasses of water a day. Combine your drinking water needs with those of your fitness needs. Bring a water bottle along to the gym or park, and drink before, during and after exercises. Water helps to replenish the fluids and nutrients that you lose while working out and sweating.
Consume Simple Carbohydrates
During exercise, your levels of energy are burned away quickly. Simple carbohydrates, such as sugary snacks and sports drinks, provide quick boosts of the energy that are needed to remain quick and alert. With regular exercise, you're allowed to add more simple carbohydrates to your diet. An example is the eat anything dietthat provides no concerns about gaining weight or storing excess sugar in your body.
Consume Workout Meals
Consume meals before or after a major workout. You want to prepare a meal that is not too small or not too large. Some people advise that you refrain from eating a meal before exercise. Food converts into energy, so if you don't have food in your system, you get tired more easily while working out. Some people get lightheaded and may faint during a rigorous exercise. You need workout meals to restore the energy supply in your body.Few people can perform vigorous workouts, go home, eat piles of unhealthy foods and expect to be successful. To receive the best results from your fitness routine, it's important that you choose the types and amounts of food carefully. Your diet is directly linked to your fitness and vice versa. Consider both of these systems as you create the best plan to be healthy
Vision Loss Rehabilitation Canada (VLRC) Announces New President and CEO
TORONTO, April 19, 2021 /CNW/ - Vision Loss Rehabilitation Canada (VLRC), a leading provider of rehabilitation services for Canadians with vision loss, announces today that Patrick Levesque has been appointed as the organization's new President and CEO.
Vision Loss Rehabilitation Canada announces that Patrick Levesque has been appointed as the new President and CEO.
"I am tremendously excited to be joining the team at Vision Loss Rehabilitation Canada," said Levesque. "This organization is a crucial part of the health care continuum in Canada, and the services it provides are integral to quality of life for thousands of Canadians from coast to coast to coast. I am honoured to be able to lead this organization into its next chapter."
Levesque joins the VLRC team with considerable experience in the fields of rehabilitation and health care; he has spent much of his career working with and for individuals with disabilities, particularly vision and hearing loss.
As an executive leader, Levesque worked in a Integrated University Health and Social Services Center in Montreal and facilitated the merger of a new enhanced rehabilitation centre. He led multiple community outpatient programs for all ages, including a unique joint partnership deafblind program with low vision services, and a specialized cochlear implant clinic, serving Quebec residents and francophones in Canada.
After moving to Toronto, Patrick continued to drive organizational growth, strategic transformation, and system change. He has helped shape mental health services for vulnerable people with proactive advocacy, system redesign, and quality improvement actions. Under his leadership, organizations have improved client satisfaction and outcomes, reduced wait times, and managed important cost savings while implementing complex system transformation.
"I am very pleased to see VLRC enter its next phase of growth as a key health care provider in all provinces," said CNIB President and CEO, John M. Rafferty. "Patrick is joining the team at a critical juncture in the organization's history, and I look forward to working with him and the entire VLRC team on our shared goal of creating a more inclusive world for people with sight loss."
VLRC thanks Rafferty for his transformational and dedicated leadership in founding the organization.
Until 2018, the health services now provided by VLRC were delivered through CNIB (Canadian National Institute for the Blind), a longstanding Canadian charity for which Rafferty is the President and CEO. However, Rafferty always believed that the rehabilitation services the charity provided, such as training in mobility and daily living skills, were fundamental to the health and wellness of Canadians with vision loss - and therefore, these services needed to be funded by provincial health systems, not charitable donations.
After years of working with provincial governments to make that case, CNIB eventually achieved full government funding for its rehabilitation services. Shortly after that, Vision Loss Rehabilitation Canada was established as an independent non-profit organization to deliver these services.
VLRC now serves approximately 102,000 Canadians with vision loss and has 44 locations in communities across Canada.
About Vision Loss Rehabilitation Canada Vision Loss Rehabilitation Canada is a provincially funded, accredited health care organization staffed by a passionate team of certified professionals. The organization provides professional, high-quality and sustainable rehabilitation to Canadians with vision loss now and into the future. Learn more at visionlossrehab.ca.
SOURCE Vision Loss Rehabilitation Canada
DARZALEX® SC Becomes the First and Only Health Canada-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis, A Rare Disease
DARZALEX® SC combination regimen is supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder
TORONTO, April 19, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today Health Canada approved DARZALEX® SC (daratumumab injection), a subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd, also known as DCyBorD) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 The DARZALEX® SC combination regimen is the first and only Health Canada approved treatment for patients with AL amyloidosis,2 a rare blood cell disorder with no cure.3 AL amyloidosis occurs when an abnormal protein produced in the bone marrow is deposited and builds up in vital organs like the heart and kidneys, impacting their ability to function.4
"AL amyloidosis is rare and can present differently from person to person, yet many patients experience organ deterioration or failure by the time they are diagnosed. I hope this approval can lead to greater awareness of this disease and the importance of early diagnosis and treatment," says Dr. Victor Zepeda, Assistant Professor of Medicine at University of Calgary and Clinician Scientist at the Arnie Charbonneau Cancer Institute.** "Patients with this disease have extremely limited options, and today's approval of this subcutaneous formulation of daratumumab offers new hope for those with AL amyloidosis and their caregivers."
The Health Canada approval is based on positive results from the Phase 3 ANDROMEDA (AMY3001) study, which were presented at the European Hematology Association (EHA) 2020 Annual Congress. The study evaluated DARZALEX® SC in combination with VCd, compared with VCd alone, a common treatment regimen used in adult patients with newly diagnosed AL amyloidosis.5 Patients receiving treatment with D-VCd experienced a hematologic complete response rate (hemCR) nearly triple that of patients receiving VCd alone (53 per cent for D-VCd and 18 per cent for VCd; P<0.0001).6
AL amyloidosis is a life-threatening blood cell disorder that occurs when blood plasma cells in the bone marrow produce amyloid deposits, which build up in vital organs and eventually cause organ deterioration.7 The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, gastrointestinal tract and nervous system.8,9
About one-third of patients with AL amyloidosis visit five or more doctors before receiving a diagnosis, and 72 per cent are diagnosed more than one year after experiencing first symptoms.10,11 Patients often have a poor prognosis due to the delay in diagnosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions.12 As many as 30 per cent of patients with AL amyloidosis die within the first year after diagnosis.13
"We look forward to the potential of helping patients with AL amyloidosis who, until now, had no approved therapies for the treatment of their disease," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "This approval underscores our continued commitment to deliver innovative therapies, which improve the outcomes for patients diagnosed with plasma cell diseases such as AL amyloidosis."
The Health Canada review was conducted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies, including Health Canada.
Janssen looks forward to working with insurers to determine how the DARZALEX® SC combination regimen can be made accessible for newly diagnosed patients with AL amyloidosis through both private and public insurance plans.
About the ANDROMEDA StudyANDROMEDA (AMY3001) is an ongoing Phase 3, randomized, open-label study investigating the safety and efficacy of DARZALEX® SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd), compared to VCd alone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.14 The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.15 The primary endpoint is overall complete hematologic response rate by intent-to-treat (ITT).16 Patients received DARZALEX® SC 1,800 mg administered subcutaneously once weekly from weeks 1 to 8, once every 2 weeks from weeks 9 to 24 and once every 4 weeks starting with week 25 until disease progression or unacceptable toxicity or a maximum of 2 years.17 Among patients who received D-VCd, 74 per cent were exposed for 6 months or longer and 32 per cent were exposed for greater than one year.18
The most common treatment-emergent adverse events (≥20 per cent) in the D-VCd arm were peripheral edema, fatigue, diarrhea, constipation, nausea, upper respiratory tract infection, peripheral sensory neuropathy, dyspnea, cough, insomnia, and anemia. 19 Serious treatment-emergent adverse events occurred in 43 per cent of patients in the D-VCd arm. Serious treatment-emergent adverse events that occurred in at least 5 per cent of patients in the D–VCd arm were pneumonia (7 per cent) and cardiac failure (7 per cent). 20 Fatal adverse reactions occurred in 11 per cent of patients in the D-VCd arm. 21 Fatal adverse reactions that occurred in more than one patient included cardiac arrest, sudden death, and cardiac failure (3 per cent respectively), and sepsis (1 per cent).22
About DARZALEX® SC
DARZALEX® is the first CD38-directed monoclonal antibody (mAb) approved to treat multiple myeloma.23 In 2020, DARZALEX® SC became the only subcutaneously administered CD38-directed antibody approved to treat patients with multiple myeloma.24 And now, DARZALEX® SC in combination with bortezomib, cyclophosphamide and dexamethasone is the first and only Health Canada approved treatment for patients with AL amyloidosis. 25 The safety and efficacy of DARZALEX® SC have not been established in AL amyloidosis patients with advanced cardiac disease (Mayo Stage IIIB or NYHA Class IIIB or IV).26
Daratumumab binds to CD38, a surface protein highly expressed across clonal plasma cells that cause serious conditions such as multiple myeloma and AL amyloidosis.27 Daratumumab induces tumor cell death through cell lysis via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).28 Daratumumab has also demonstrated immunomodulatory effects such as increasing CD4+ and CD8+ T-cells counts, which may contribute to clinical response.29
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX®. Janssen Inc. commercializes DARZALEX® and DARZALEX® SC in Canada. For full Prescribing Information and more information about DARZALEX® SC, please visit www.janssen.com/canada.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*All trademark rights used under license. **Dr. Zepeda was not compensated for any media work. He has been compensated as a consultant.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX® SC. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References:
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1 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
2 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
6 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
7 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928
9 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928
10 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928
11 McCausland KL, et al. Patient. 2018;11(2):207-216
13 Merlini G, et al. Light chain amyloidosis: the heart of the problemHaematologica. 2013;98(10):1492-1495
14 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
15 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
16 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
17 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
18 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
19 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
20 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
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23 Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565
24 Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565
25 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
26 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
27 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
28 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
29 [DARZALEX® SC Product Monograph, Janssen Inc., April 12, 2021]
SOURCE Janssen Inc.
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