Roderic Pettigrew, Innovator in Biomedicine and Technology, Is the 2020 Winner of the Vannevar Bush AwardBRYAN-COLLEGE STATION, Texas — Gov. Greg Abbott on Monday congratulated the head of Texas A&M University’s Engineering Medicine, or EnMed, program, who will receive a prestigious lifetime achievement award from the National Science Board. The board announced Monday Roderic Pettigrew will be presented with the Vannevar Bush Award, which is considered one of the nation’s highest science awards. It honors lifelong science and technology leaders who have made exceptional contributions to the welfare of the nation through public service in science and technology and in shaping public policy. “Roderic Pettigrew’s passion and creativity have spurred innovation in biomedicine,” said Victor McCrary, Vice Chair of the National Science Board and Chair of the 2020 NSB Honorary Awards Subcommittee. “His reimagining of healthcare solutions is helping converge science fields, narrowing gaps between disciplines in a way that really impacts society. Pettigrew is helping us to see what might be, what could be, and what is possible.” Pettigrew’s contributions are wide-ranging. They include:
His advanced treatment for spinal injuries that enabled some chronically paralyzed men to regain voluntary muscle movement and sensory function.
His use of radiation in cancer treatments.
His work to use MRI to image the beating heart and quantify blood flow.
His establishment of a partnership with the Indian government to develop cuff-less blood pressure measurement, along with other low cost diagnostic and therapeutic technologies.
Pettigrew’s work also involved bringing out the best in others. While at NIH created the Quantum Grants Program to encourage researchers to undertake “medical moon shots” to solve major challenges through technological innovation. Pettigrew continues to help others archive greatness at Texas A&M, where he helped found EnMed in Houston. The program blends engineering and medicine in a 4-year curriculum to develop problem-solving “physicianeers;” graduates who earn a medical degree and a master’s degree in education. Plus, they must invent a solution to a healthcare problem that is ready for a patent. “It is an incredible honor to receive the Vannevar Bush Award, which is so steeped in science history,” Pettigrew said. “My only regret is that my parents are not alive to share this honor. They were my first role models.” Pettigrew was raised in rural Georgia and attended segregated public schools before attending Morehouse College in Atlanta through a Merrill Scholarship. After graduating with a B.S. in physics in 1972, he earned a M.S. in nuclear science and engineering at Rensselaer Polytechnic Institute and a Ph.D. in Applied Radiation Physics at Massachusetts Institute of Technology, where his work resulted in a new type of neutron activation radiation treatment of malignant brain tumors being pioneered at MIT-Harvard. In 1979 he received an M.D. from the University of Miami. In recent years, he has been elected to the National Academy of Medicine, the National Academy of Engineering, the American Academy of Arts and Sciences and the National Academy of Sciences India. He has received the Pierre Galletti Award from the American Institute for Medical and Biological Engineering, the Distinguished Service Award of both the International Society of Magnetic Resonance in Medicine and National Medical Association, the Pritzker Achievement Award of the Biomedical Engineering Society, and was the first winner of the Gold Medal of the Academy of Radiology Research. He also was awarded a Gold Medal from the Radiological Society of North America and received the Arthur M. Bueche Award from the National Academy of EngineeringThe NSB created the award in 1980 in memory of Vannevar Bush, who served as a science advisor to President Franklin Roosevelt during World War II, helped to establish federal funding for science and engineering as a national priority during peacetime and was behind the creation of the National Science Foundation. Past award recipients include: Leon Lederman (Fermilab), Nobel Laureate Harold Varmus (former NIH Director), Nobel Laureate Charles Townes (UC Berkeley -Laser Inventor), David Packard (Hewlett-Packard Company), Rita Colwell (former NSF Director), Charles Vest (former MIT President), and last year, Walter Massey (University of Chicago – oversaw Giant Magellan Telescope). About the National Science Board The National Science Board and the National Science Foundation's Director jointly head NSF. NSB identifies issues critical to NSF's future and establishes the agency’s policies. The NSB also provides the President and Congress with Science and Engineering Indicators, a biennial report on the state of science and engineering in the United States. Members are appointed by the President for six-year terms and selected for their eminence in research, education and records of distinguished service. About The Texas A&M University System The Texas A&M University System is one of the largest systems of higher education in the nation with a budget of $6.3 billion. The System is a statewide network of 11 universities; a comprehensive health science center; eight state agencies, including the Texas Division of Emergency Management; and the RELLIS Campus. The Texas A&M System educates more than 151,000 students and makes more than 22 million additional educational contacts through service and outreach programs each year. System-wide, research and development expenditures exceeded $1 billion in FY 2019 and helped drive the state’s economy.
Adventure-Filled Story Woven with Faith and Family Values
Shreveport, LA, September 28, 2020 —Matt Loman has already saved his family and his village from famine, finding his life’s true purpose in the process. But the journey toward his ultimate destiny is far from over, and just two days into his much-anticipated honeymoon, a compelling voice in his dreams pleads with him to “come home.”
Following the voice, Matt embarks on an adventure that few could imagine, as he spars with a band of crazed warriors, gets stuck in an enormous web and is nearly torn to shreds by giant beasts. How will he explain his latest escapades to his beautiful young wife, Patience?
With the Kingdom of Truevine and all that is good threatened by evil forces, it’s up to Matt and Patience to push beyond their own strengths, draw upon their faith and find the answer to saving the kingdom and their lives. Will they find it in time?
Coming Home takes readers on a family-friendly journey filled with faith, suspense and sweet romance. Written by father-daughter authors Bruce and Vernae Ewing, Coming Home unfolds one adventure at a time, with colorful characters and clever challenges for Matt and Patience that subtly reinforce family values and inspire readers to seek out their own true purposes. Suitable for all ages, Coming Home is an immensely enjoyable read that makes the perfect choice for family story time.
Dr. Bruce Ewing has been a pastor for 48 years, with 28 of those spent as a military chaplain. He has been married to the love of his life, Valerie, for 47 years and is the father of two precious daughters, Brecia and Vernae. Dr. Bruce is a Marriage and Family Relationship Consultant, teacher of biblical principles and teller of stories. His love for God and family is the catalyst for his writing. Love healed his own heart, so he tells stories to inspire others to discover the same grace he has received.
Co-author and Dr. Bruce’s daughter Vernae Ewing Thompson holds a BS in marketing and an MBA. She is married to singer/songwriter Lance Thompson. Vernae is an actor, model, producer, director and business owner. She acquired her love for books and writing through her childhood experiences while listening to her father’s wild bedtime adventure stories and stories from the Bible.
Coming Home is the second installment in the popular Treasure Tree series. Watch for the next book, The Reign of War. For more information, please visit www.thetreasuretreebook.com,or connect with the authors on Instagram: @thetreasuretreebook; or on Facebook: thetreasuretreebook.
Holistic, Science-Backed Program Helps Build a Healthier Relationship with Food, Eating and Weight
San Francisco, CA, Sept. 28, 2020 — Could a dietary lifestyle that nourishes us physically, emotionally, spiritually and socially be the answer to stemming America’s rising tide of overeating and obesity?
Original research points to yes, and in Whole Person Integrative Eating: A Breakthrough Dietary Lifestyle to Treat the Root Causes of Overeating, Overweight, and Obesity, nutrition researcher Deborah Kesten, M.P.H., and behavioral scientist Larry Scherwitz, Ph.D., offer documented proof that by nourishing ourselves multi-dimensionally each time we eat, we can develop deeper, healthier relationships with food and eating that leads to attaining and maintaining weight loss. The authors’ Whole Person Integrative Eating (WPIE) program is not a diet that a person goes on … then off. WPIE is a scientifically sound, dietary lifestyle designed to be practiced for a lifetime.
"If people follow the revolutionary program outlined in this game-changing, insightful book, it may be the most helpful step they can take toward losing weight and keeping it off," says bestselling author Kenneth Pelletier, M.D., clinical professor of medicine at University of California School of Medicine, San Francisco.
Divided into three parts, Whole Person Integrative Eating begins by describing seven root causes of overeating: Emotional Eating, Food Fretting, Fast Foodism, Sensory Disregard, Task Snacking, Unappetizing Atmosphere and Solo Dining. A Self-Assessment Quiz follows, with 76 questions to help readers identify their unique food choices and eating behaviors that lead to overeating and weight gain. Part Two provides a step-by-step guide to WPIE antidotes for each overeating style. It also explains why the elements of WPIE work and how they can be incorporated into daily life. And Part Three offers over 30 recipes based on the three main criteria of WPIE: fresh, whole and "inverse,” meaning mostly plant-based foods with small or no servings of animal-based foods.
An excerpt from the Foreword of Whole Person Integrative Eating by New York Times best-selling author Dean Ornish, M.D., Clinical Professor of Medicine, University of California:
“[The book] offers an evidence-based alternative to the conventional wisdom about attaining and maintaining weight loss. What’s groundbreaking about Kesten and Scherwitz’s research is twofold: They have created a scientifically sound, comprehensive, and integrative program for treating overeating, overweight, and obesity based on these principles. And in addition to what (food choices) and how(eating behaviors) we eat, they have identified seven statistically significant root reasons to explain why we overeat: what they call “new normal overeating styles” and eating behaviors that also have a profound influence on how much we eat and weigh.”
The authors’ paradigm-shifting message is that food influences not only the physical dimensions of health, but also our emotional, spiritual and social well-being. Their dietary lifestyle can build bridges between the millions who struggle with overeating and weight issues and the medical community. And it can inspire us all to re-envision our relationships with food, eating and weight, so that each time we eat, we are nourished … for life.
Deborah Kesten, MPH,is an international nutrition researcher, award-winning author, and medical/health writer, with a specialty in preventing and reversing obesity and heart disease. She served as Nutritionist on Dean Ornish, M.D.’s first clinical trial for reversing heart disease through lifestyle changes, the results of which were published in the Journal of the American Medical Association. She has served as Director of Nutrition at cardiovascular clinics in Europe and on the Board of Directors of the American Heart Association, San Francisco, for 10 years.
Kesten has published more than 400 nutrition and health articles. Her first book, Feeding the Body, Nourishing the Soul, received the first-place gold award in the Spirituality category from the Independent Publisher Book Awards. Whole Person Integrative Eating has been honored with the #1 gold, best-book award in the Health category by Book Excellence Awards. She is a VIP Contributor at Arianna Huffington’s Thrive Global, and is married to behavioral scientist and co-author of Whole Person Integrative Eating, Larry Scherwitz, Ph.D.
Holistic, Science-Backed Program Helps Build a Healthier Relationship with Food, Eating and Weight
San Francisco, CA, Sept. 28, 2020 — Could a dietary lifestyle that nourishes us physically, emotionally, spiritually and socially be the answer to stemming America’s rising tide of overeating and obesity?
Original research points to yes, and in Whole Person Integrative Eating: A Breakthrough Dietary Lifestyle to Treat the Root Causes of Overeating, Overweight, and Obesity, nutrition researcher Deborah Kesten, M.P.H., and behavioral scientist Larry Scherwitz, Ph.D., offer documented proof that by nourishing ourselves multi-dimensionally each time we eat, we can develop deeper, healthier relationships with food and eating that leads to attaining and maintaining weight loss. The authors’ Whole Person Integrative Eating (WPIE) program is not a diet that a person goes on … then off. WPIE is a scientifically sound, dietary lifestyle designed to be practiced for a lifetime.
"If people follow the revolutionary program outlined in this game-changing, insightful book, it may be the most helpful step they can take toward losing weight and keeping it off," says bestselling author Kenneth Pelletier, M.D., clinical professor of medicine at University of California School of Medicine, San Francisco.
Divided into three parts, Whole Person Integrative Eating begins by describing seven root causes of overeating: Emotional Eating, Food Fretting, Fast Foodism, Sensory Disregard, Task Snacking, Unappetizing Atmosphere and Solo Dining. A Self-Assessment Quiz follows, with 76 questions to help readers identify their unique food choices and eating behaviors that lead to overeating and weight gain. Part Two provides a step-by-step guide to WPIE antidotes for each overeating style. It also explains why the elements of WPIE work and how they can be incorporated into daily life. And Part Three offers over 30 recipes based on the three main criteria of WPIE: fresh, whole and "inverse,” meaning mostly plant-based foods with small or no servings of animal-based foods.
An excerpt from the Foreword of Whole Person Integrative Eating by New York Times best-selling author Dean Ornish, M.D., Clinical Professor of Medicine, University of California:
“[The book] offers an evidence-based alternative to the conventional wisdom about attaining and maintaining weight loss. What’s groundbreaking about Kesten and Scherwitz’s research is twofold: They have created a scientifically sound, comprehensive, and integrative program for treating overeating, overweight, and obesity based on these principles. And in addition to what (food choices) and how(eating behaviors) we eat, they have identified seven statistically significant root reasons to explain why we overeat: what they call “new normal overeating styles” and eating behaviors that also have a profound influence on how much we eat and weigh.”
The authors’ paradigm-shifting message is that food influences not only the physical dimensions of health, but also our emotional, spiritual and social well-being. Their dietary lifestyle can build bridges between the millions who struggle with overeating and weight issues and the medical community. And it can inspire us all to re-envision our relationships with food, eating and weight, so that each time we eat, we are nourished … for life.
Deborah Kesten, MPH,is an international nutrition researcher, award-winning author, and medical/health writer, with a specialty in preventing and reversing obesity and heart disease. She served as Nutritionist on Dean Ornish, M.D.’s first clinical trial for reversing heart disease through lifestyle changes, the results of which were published in the Journal of the American Medical Association. She has served as Director of Nutrition at cardiovascular clinics in Europe and on the Board of Directors of the American Heart Association, San Francisco, for 10 years.
Kesten has published more than 400 nutrition and health articles. Her first book, Feeding the Body, Nourishing the Soul, received the first-place gold award in the Spirituality category from the Independent Publisher Book Awards. Whole Person Integrative Eating has been honored with the #1 gold, best-book award in the Health category by Book Excellence Awards. She is a VIP Contributor at Arianna Huffington’s Thrive Global, and is married to behavioral scientist and co-author of Whole Person Integrative Eating, Larry Scherwitz, Ph.D.
Award-Winning Parma! Introduces Safe & Convenient Touchless Labels On Bottles Of Flagship Original Flavor
Popular Vegan Parmesan Brand Offers Cheese Lovers A Delectably Nutritious Range of Dairy-Free, Protein-Rich Condiments Ideal For Main Dishes, Salads, Pizza & More!
MEDFORD, OREGON, SEPTEMBER 24, 2020 – Responding to a rapidly-growing desire among both consumers and retailers for products that are hygienically safer and technologically more sophisticated, Sister River Foods’ popular Parma! plant-based parmesan “cheese” brand has just introduced touchless labels on its flagship “Original” flavor.
The new labels began shipping at the beginning of September and are now available to health food and mainstream grocery consumers nationwide as well as to those purchasing Parma! Original online at www.eatparma.com or via numerous other web retailers.
The announcement was made today by Shannon Schnibbe, Founder and CEO of Parma! parent company Sister River Foods.
Parma! Original touchless labels offer the ideal blend of consumer protection and convenience. Simply point a smartphone camera at the label and a link will appear. Touch the link and it will take you to a landing page where you can read all the label information for Parma! Original and also check out the label information for the brand’s three other flavors: Better Than Bacon, Chipotle Cayenne and Garlicky Green. All four flavors can also be purchased on the landing page.
In addition to enabling easy access to important product information, the new touchless labels reduce the need for shoppers to physically handle Parma! Original bottles in store – a welcome feature for consumers and retailers alike during the ongoing pandemic crisis.
Commenting on the new label, Ms. Schnibbe said, “As a company that cares deeply about the health and safety of the public as well as members of the grocery retail industry, we recognized the importance of converting to touchless labels at the earliest possible opportunity. I’m confident consumers will appreciate not only the added hygienic benefits of these touchless labels, but the ability to access all of the product details they want in the safest and most convenient manner possible.”
Plant-Based Parmesan Takes A Bold Step Forward With Parma!
With just the right condiment, a plain salad becomes a festival of flavors, a plate of vegetables transforms into a delectable stroll through a country garden, and an ordinary bowl of pasta becomes a savory work of art. And perhaps no condiment covers as many different foods and as many different cultures as classic Parmesan cheese.
Unfortunately, for vegans or anyone following a dairy-free and/or calorie-conscious diet, parmesan cheese has always been not only off limits but one of the most difficult of life’s little indulgences to forego. If only someone, somewhere, could create a non-dairy parmesan cheese alternative so authentically delectable that even the most discerning cheese lovers would never miss its conventional counterpart ever again!
Well, luckily for countless millions of us, someone did. Welcome to a true revolution within the booming vegan cheese category – Parma!
Comprised of four deliciously distinct varieties – including Better Than Bacon Parma! which was voted Favorite Bacon-Flavored Product in 2017 by VegNews magazine – Parma! is a plant-based umami superfood line of convenient and affordable products that are Paleo and Keto-friendly. In addition, all Parma! products are a complete protein, dairy-free, soy-free, gluten-free, non-GMO and Certified Kosher.
Moreover, all four raw nut and seed-based Parma! flavors contain whole raw ingredients, are low in sodium, heart-healthy, packed with essential B vitamins and trace minerals, replete with beneficial animo acids and an excellent source of healthy oils.
A World Of Flavor
Available in health stores nationwide as well as on the recently-revamped www.eatparma.com site, Amazon, VitaCost and other online retailers, Parma! is ideal for environmentally conscious consumers, vegans, vegetarians, flexitarians and all health conscious eaters. Unlike some other vegan cheese alternatives, Parma! has also proven highly appealing to mainstream cheese aficionados who are ready to eschew traditional cheese so long as a healthier option boasting authentic flavor, aroma and texture is available.
Sold in 3.5 and 7-ounce bottles, Parma! can be savored on pasta, lightly steamed vegetables, pizza, salads, potatoes, avocado toast, popcorn and countless other hor d'oeuvres, main dishes and desserts. For suggested recipes, please visit https://eatparma.com/category/recipes/.
Parma! varieties include:
Original Parma! – Featuring an irresistiblycheesey umami flavor. Ingredients: Nutritional Yeast, Organic SunflowerSeeds, Walnuts, Himalayan Crystal Salt, Organic Hemp Seeds.
Better Than Bacon Parma! – Voted Favorite Bacon FlavoredProduct by VegNews and featuring a smokey cheesey umami bacon flavor. Ingredients: Nutritional Yeast, Organic Sunflower Seeds, Walnuts, Ground Paprika, Organic Dried Onion, Natural Flavor, Organic Brown Sugar, Himalayan Crystal Salt, Smoked Salt, Organic Hemp Seeds.
Chipotle Cayenne Parma! – Blessed with a smokey umami flavor akin to the most popular barbeque potato chips, with a slight cayenne kick at the end. Ingredients: Nutritional Yeast, Organic SunflowerSeeds, Walnuts, Organic Ground Chipotle Pepper, Himalayan Crystal Salt, Organic Hemp Seeds, Organic Onion Powder, Organic Ground Cayenne Pepper.
Garlicky Green Parma! – Distinguished by acheesey umami Italian herb flavour complemented by nutritiously delicious kelp, pumpkin and sesame seeds. Ingredients: Nutritional Yeast, Organic SunflowerSeeds, Walnuts, Organic Pumpkin Seeds, OrganicDried Garlic, Himalayan Crystal Salt, Organic Hemp Seeds, Organic Sesame Seeds, Organic Kelp Powder, Organic Dried Basil, Organic Dried Oregano.
Only The Beginning
Founded in 2004, Parma! has steadily grown to its current status as a leader in the dairy-free cheese alternative arena and a key player in the multi-billion-dollar global vegan food category.
According to Tofurky founder Seth Tibbott, an advisor to Parma! since the company’s inception, "Like Tofurky, Parma is an authentic, trailblazing brand with deep roots that took hold when the plant-based world was very young. I love that it is a family owned business run by kind, passionate people producing a wholesome vegan food with exceptional flavor."
Adds Ms. Schnibbe, “Parma! gives you that cheesey flavor without all the dairy baggage. It provides an excellent food source of high-quality vitamins and minerals, including B vitamins, omega 3’s and trace minerals, along with the natural goodness of hemp, and it tastes great! We’re deeply grateful for the exceptionally warm reception our brand has received from consumers and industry leaders since our very first days on the market and look forward to continuing to shake up the dairy-free industry for many, many years to come.”
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Two Types Of People that exist. One sees the world with bright eyes and one with closed eyes. Is your glass half empty or half full? Honestly this podcast is all over the place but I hope you take something from it! Give it a review, stars and always feel free to reach out! Enjoy!
Get “Screen Overloaded” Kids Outside – with the Help of TurfMutt!
Alexandria, Va. - School is back in session for students around the country – and many kids, if attending school from home, are spending lots of time online and in front of screens.
Mutt Mulligan (“Mo-Mo”), a rescue dog who is “pawing it forward,” reminds us that enjoying time in the parks and yards nearby is good for us and for the planet. As the official spokesdog of the TurfMutt Foundation, Mo-Mo knows a thing or two about yards – and the boundless energy that many children need to expend outdoors.
Right now the safest place to spend time may be your personal green space – your yard. It can help your children de-stress, widen their play area, and build up knowledge in science and math. Mutt Mulligan offers tips to help make the most of your yard as an outdoor classroom.
Tip #1: Get outside throughout the day. Take a 20-minute break between classes at home, head out to the backyard and breathe some fresh air. During a lunch break, take a quick visit to the park. After spending a long day indoors, encourage children to get outside to enjoy the family yard.
Tip #2: Notice the different kinds of plants in your yard. Take kids around the outside of your home. Encourage them to take notes and sketch what they see. How is the landscape changing this time of year? What animals or birds might be nesting in or feeding on plants in the yard as the season progresses? What makes your yard unique from the others in the area? Draw the living (plants, trees, grass) and the non-living (patios, grills) parts of your landscape.
Tip #3: Learn about the world beneath little feet. Explain that one of the benefits of plant-filled green spaces is that they provide habitats, or natural homes, for many different creatures. Look for birds, bees and other creatures that have made both urban and suburban neighborhoods their home. Use a magnifying glass to help your child explore what lives in the grass or is resting on shrubs and trees.
Tip #4: Map out the living landscapes in your neighborhood. Go on a living landscape hunt. Walk around your neighborhood with your child and sketch the living landscapes, creating a map with symbols for trees, bushes, flowers and grass. You can also add markers for animal or insect habitats, or water sources.
Tip #5: Make a nature journal. Get some paper or a notebook and keep a record of when your family is outside and what you do when you are there. It can be as simple as jotting down the date and the activity you did outside, or as detailed as adding sketches of plants or animals observed, and more. Review the journal at dinnertime or weekly to see how much time you spent outside.
Tip #6: Put the right plant in the right place. If you’ve decided to add some new plants to your yard as a family activity, check the USDA Plant Hardiness Zone Map to find out what plants are best for where you live. Use a mix of native and adaptive plants and place them where they will thrive – a teachable moment for children!
Tip #7: Visit TurfMutt.com to play games and read digital storybooks for free to learn more. The website for the TurfMutt environmental education and stewardship program for grades K-8 offers home-based activities, digital storybooks, lesson plans for families and teachers, and more.
About TurfMutt
TurfMutt was created by the Outdoor Power Equipment Institute’s (OPEI) TurfMutt Foundation and has reached more than 70 million children, educators and families since 2009. Through classroom materials developed with Scholastic, TurfMutt teaches students and teachers how to “save the planet, one yard at a time.” TurfMutt is an official USGBC® Education Partner and part of their global LEARNING LAB. TurfMutt is an education resource at the U.S. Department of Education’s Green Ribbon Schools, the U.S. Department of Energy, the U.S. Environmental Protection Agency, Green Apple, the Center for Green Schools, the Outdoors Alliance for Kids, the National Energy Education Development (NEED) project, Climate Change Live, Petfinder and the U.S. Fish and Wildlife Service. In 2017, the TurfMutt animated video series won the coveted Cynopsis Kids Imagination Award for Best Interstitial Series. TurfMutt’s personal, home habitat is featured in the 2017-2019 Wildlife Habitat Council calendars. More information at www.TurfMutt.com.
Health Canada Grants Market Authorization to Polivy™ (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma[i]
First-in-class antibody-drug conjugate that specifically targets CD79b and destroys B cells through the delivery of an anti-cancer agent ii,iii
MISSISSAUGA, ON, Sept. 24, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on July 9, 2020, Health Canada, under the Notice of Compliance with Conditions (NOC/c) policy, has granted market authorization to Polivy™(polatuzumab vedotin), in combination with bendamustine and rituximab (BR) for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy.i
DLBCL is an aggressive and fast-growing form of non-Hodgkin's lymphoma (NHL). While it is generally responsive to treatment in the frontline, as many as 40 per cent of patients do not respond to initial treatment or relapse, at which time therapy options are limited and survival is short.iv
Health Canada's Notice of Compliance with Conditions policy provides conditional authorization for new drugs with promising evidence of clinical effectiveness, for patients suffering from serious, life- threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or for which a significant increase in efficacy or a significant decrease in risk is demonstrated in relation to an existing drug marketed in Canada.v Prior to authorization, the sponsor must undertake to design, carry out and report on confirmatory trials to verify the clinical benefit of the drug.v
"Despite the significant advances made over the last few years in the treatment of lymphoma, people with relapsed or refractory diffuse large B-cell lymphoma, particularly those who are not eligible for stem cell transplantation, continue to have limited options," said Dr. Laurie Sehn, Chair, Lymphoma Tumour Group, BC Cancer Agency, and a clinical investigator on the GO29365 study. "I am pleased a much needed new and effective option is available in Canada to combat this aggressive form of lymphoid cancer."
This new authorization is based on the results from the phase I/II GO29365 study, an international, multicenter, open-label, Phase Ib/II trial.i Results showed that 40 per cent of people treated with Polivy plus BR achieved a complete or partial response, meaning no cancer could be detected at the time of assessment (n=16/40; 95% CI: 25-57), compared to 18 per cent with BR alone (n=7/40; 95% CI: 7-33).viThe study also showed the median duration of responsiveness to treatment was 12.6 months for patients in the Polivy plus BR arm (n=12/25) versus 7.7 months for patients in the BR arm (n=2/10).vi
"Many DLBCL patients who have relapsed following first line or subsequent lines of therapy are ineligible for stem cell transplant, and there is a need for new treatment options for this patient group," said Kaitlyn Beyfuss-Laski, Manager of Patient Programs, Research and Advocacy at Lymphoma Canada. "The combination of polatuzumab vedotin (Polivy) with bendamustine and rituximab provides a new tool for this group of patients. We are so pleased that new treatment options are available to relapsed DLBCL patients in Canada."
About the GO29365 study
GO29365 is an international, multicenter, open-label, Phase Ib/II trial which included a randomized cohort of 80 patients, including four Canadians with previously treated DLBCL. Eligible patients were not candidates for autologous hematopoietic stem cell transplant (HSCT) at study entry, had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen, and had an ECOG PS ≤2. In this study, patients were randomized to receive Polivy plus BR (n=40) or BR alone (n=40) for six 21-day cycles. The median age was 69 years (range 30 to 86 years) and 71 per cent of patients were white and 66 per cent were male. The primary endpoint of the study was complete response (CR) rate at end of treatment (6 to 8 weeks after day 1 of cycle 6 or last study treatment) as assessed by independent review committee (IRC). Efficacy was based on the primary endpoint, complete response (CR) rate at the end of treatment as assessed by IRC. Key supportive efficacy endpoints were objective response rate at the end of treatment and best overall response rate. Duration of response was also assessed in the study.i
The most frequently-reported adverse drug reactions (ADRs) in patients with DLBCL treated with Polivy in combination with BR were anemia, thrombocytopenia, neutropenia, decreased appetite, neuropathy peripheral, fatigue, diarrhea, nausea, and pyrexia. Serious adverse events were reported in 64.4 per cent of Polivy plus BR treated patients which included febrile neutropenia (11.1%), pyrexia (8.9%), pneumonia (8.9%), anemia (4.4%), duodenal ulcer hemorrhage (4.4%), sepsis (4.4%), and thrombocytopenia (4.4%).i
About Polivy (polatuzumab vedotin)
Polivy is an antibody-drug conjugate (ADC) that combines the targeting ability of antibodies with chemotherapies to destroy cancer cells.ii,iii It specifically targets CD79b, a protein expressed in the majority of B cells and destroys the B cells through the delivery of an anti-cancer agent, while minimizing the effects on normal cells.ii,iii,vii Polivy offers a fixed-duration of treatment of six cycles through IV infusion, with each cycle lasting 21 days.i
About diffuse large B-cell lymphoma
DLBCL is the most common form of NHL that develops when the body makes abnormal B cells.viii It accounts for up to 30 to 40 percent of cases of NHL in Canada each year, with an estimated 150,000 diagnosed worldwide each year.ix,x It can occur at any age, however most people are diagnosed when they are in their mid-60s.viiiIt is also slightly more common in men than in women.viii Despite meaningful progress in the treatment of DLBCL, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens.xi This makes DLBCL increasingly harder to treat after each relapse, resulting in poor prognosis with median overall survival of around six months.xi
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof, combined with a focus on innovation, have made Roche the leader in personalized healthcare – a strategy that aims to provide patients with timely access to their best possible healthcare solution.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.
Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.
All trade-marks mentioned are the property of their respective owners.
i Polivy (polatuzumab vedotin) Canadian Product Monograph July 2020.
ii Dornan D, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114:2721–2729.
iii Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29:1578-1586.
x GLOBOCAN 2018. Estimated cancer incidence, mortality and prevalence worldwide in 2018. Available from: http://globocan.iarc.fr. Accessed May 2020.
xi Gisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018;182:633–643.
SOURCE Roche Canada
NEXPLANON® Contraceptive Arm Implant Now Available for Use in Canada
NEXPLANON® is the first single-rod arm implant to be approved by Health Canada for the prevention of pregnancy.1
The implant provides Canadians with a new birth control option that can be removed at any point during the three-year period by a healthcare professional.1
KIRKLAND, QC, Sept. 24, 2020 /CNW/ - Merck Canada Inc., an affiliate of Merck & Co., Inc., known as MSD outside the United States and Canada, announced today that NEXPLANON® (etonogestrel implant) 68 mg, a hormonal contraceptive implant, is now available in Canada.1 The implant, approved by Health Canada for the prevention of pregnancy for up to three years, provides Canadians with a progestin-only contraceptive option that is long-acting.1
"Health Canada's approval of NEXPLANON® is an important contribution to the Canadian contraceptive landscape," says Dr. Ashley Waddington, Family Planning specialist in the Department of Obstetrics and Gynecology, Queen's University. "Access to this reversible contraceptive method is good news for those who cannot take contraceptives containing estrogen due to medical conditions or patient preference, or for whom intrauterine devices are contraindicated or not desired. More contraceptive options allow for more patient choice and ensures Canadians can achieve their family planning goals."
The arm implant contains etonogestrel, a hormone that is continuously released in small amounts into the blood.1 It prevents pregnancy in two ways: by stopping the release of egg cells from the ovaries and by causing changes in the cervical mucus to make it difficult for sperm to enter the uterus.1
"Merck Canada is excited to provide a new birth control option," says AnnA Van Acker, President, Merck Canada. "This arm implant is an example of Merck's commitment to offer a range of birth control options in our growing Women's Health portfolio."
Approximately the size of a matchstick, the implant is a small, soft and flexible plastic rod that is inserted by a healthcare professional just below the skin on the inner side of a patient's upper arm.1 When inserted correctly, NEXPLANON was shown to be effective, with less than one pregnancy per 100 patients who used the birth control implant for one year.1
About NEXPLANON®
NEXPLANON is approved for pregnancy prevention for up to three years.1 By the end of the third year, the implant must be removed and may be replaced with a new implant, if continued contraceptive protection is desired.1 It will not protect patients against sexually transmitted infections (STIs), including HIV/AIDS.1 To prevent STIs, patients should use latex or polyurethane condoms while using the implant.1
The arm implant is radiopaque, meaning physicians can verify presence of the implant after insertion and can locate it prior to removal using two-dimensional X-ray, computed tomography (CT scan) and ultrasound scanning (USS), or magnetic resonance imaging (MRI).1 After insertion and prior to removal, physicians should be able to verify the presence of the implant in the patient's arm by palpation.1 If the implant cannot be palpated, the physician can use one of the four available methods to verify presence of the implant.1 Until the presence of the implant can be verified, patients should be advised to use a non-hormonal contraceptive method, such as condoms.1
The approval of the implant is based on results from a multicenter, randomized, double-blind, parallel group bioequivalence study comparing the radiopaque implant to the non-radiopaque etonogestrel subdermal implant (IMPLANON®).1NEXPLANON and the non-radiopaque etonogestrel subdermal implant met comparative bioavailability standards with respect to rate and extent of absorption of etonogestrel.1 The safety and efficacy of the non-radiopaque implant as a birth control option was demonstrated in adults who were between the ages of 18 and 40 years at the beginning of the clinical trial.1
The clinical trials, which were up to three years in duration, involved 923 subjects, with 1756 woman-years of use with the non-radiopaque etonogestrel implant (IMPLANON). In a subgroup of patients aged 18-35, six pregnancies were reported, resulting in a Pearl Index of 0.38.1 Each conception was likely to have occurred shortly before or within two weeks following removal of the non-radiopaque etonogestrel implant.1 Pregnancies were observed to occur as early as seven to 14 days after removal of the arm implant.1 If pregnancy is not desired after removal of the implant, another method of birth control must be started immediately.1
About Merck
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube and Twitter@MerckCanada
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2017 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Please see the product monograph for NEXPLANON® (etonogestrel implant) at:
1 NEXPLANON® Product Monograph. Merck & Co. Inc. Updated May 25, 2020.
SOURCE Merck
Emergent BioSolutions Applauds Pharmacy Leaders on Consensus Guidelines for Naloxone
First-ever Canadian national consensus guidelines which recommend all patients receiving an opioid should be dispensed take-home naloxone and counselled by a pharmacist.
MISSISSAUGA, ON, Sept. 24, 2020 /CNW/ - Emergent BioSolutions today announced its strong support for the new Canadian national consensus guidelines for naloxone prescribing by pharmacists published in the Canadian Pharmacists Journal for aiming to bring clarity and consistency to naloxone prescribing, which may ultimately help reverse more opioid poisonings until medical help arrives.
"Pharmacists are a critical part of a community and are truly on the frontlines of the opioid crisis," said David Renwick, Vice President & General Manager, Emergent BioSolutions Canada. "These consensus guidelines set a new standard of care in ensuring naloxone gets into the hands of those who need it – especially those who don't recognize the risk their opioid prescription may pose. Having naloxone on hand can make a real difference when an accidental opioid poisoning occurs."
Recent reports indicate disturbing numbers of opioid-related deaths across Canada: in 2019, there were 3,823 opioid-related deaths, with the highest rates in British Columbia, Alberta, and Ontario.i A 2016 report found a significant number of opioid poisoning deaths involve individuals who had an active or recent prescription for an opioid at time of death.iv Naloxone can help reverse the effects of an opioid overdose until medical help arrives. Despite the availability of take-home naloxone kits, naloxone dispensing by pharmacies is highly variable.ii
A steering committee of eight pharmacists from relevant practice and professional settings across Canada was convened to develop the consensus guidelines. The guidelines recommend all patients receiving an opioid should also be dispensed a naloxone kit and be counselled by a pharmacist. They also recommend pharmacists follow up with patients after three months and again at one year after dispensing naloxone, as well as conducting ongoing yearly follow ups.
These new consensus guidelines recommend that naloxone be dispensed proactively to all patients receiving opioids as it can be difficult for pharmacists to accurately assess the potential risk of opioid overdose. Approximately 1 in 8 (~4.7 million) people in Canada were prescribed opioids in 2018, representing a large number of people at risk for potential opioid-related toxicities and overdose.iii The data show prescription opioids can be involved in deaths due to opioid poisonings – as an example, around one-quarter to one-third of opioid-related deaths in Ontario involved individuals who had active prescription opioids at the time of their death.iv, v
Expanding access to naloxone and informing patients with prescription opioids on its use is also a priority issue in the United States. The U.S. Food and Drug Administration (FDA) now requires that labelling on opioid medications be updated to recommend health care professionals discuss the availability of naloxone, both when beginning and renewing treatment.vi It also recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder, and consider prescribing naloxone to those at increased risk of opioid overdose.vii
About Emergent BioSolutions Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.
Funding support provided by Emergent BioSolutions as acknowledged in the consensus guidelines.
iv Choremis B, Campbell T, Tadrous M, Martins D, Antoniou T, Gomes T. The uptake of the pharmacy-dispensed naloxone kit program in Ontario: A population-based study. PloS one. 2019;14(10):e0223589-e.
v Gomes T, Khuu W, Martins D, Tadrous M, Mamdani MM, Paterson JM, et al. Contributions of prescribed and non-prescribed opioids to opioid related deaths: population-based cohort study in Ontario, Canada. BMJ. 2018;362:k3207.
