5 Eco-friendly swaps that are better for you and the planet
This year, make the switch to a plastic-free lifestyle while supporting these sustainable brands.SAN DIEGO, CALIF- FEBRUARY 01, 2021 -- Goodbye 2020 hello 2021! After an arduous year, it’s nice to see brands that are creating a positive impact on the planet. With plastic being recycled only 9% of the time, these companies are making a commitment to change. Switching to a plastic-free lifestyle has never been easier. We’ve compiled a list of 5 stand-out brands for our eco-friendly New year Resolutions.
1. NonikoClean up your bathroom while cleaning up the planet! Noniko, the first-ever plastic-free, all natural refillable deodorant is creating a new industry standard for personal care products. This sleek stainless steel deodorant case is yours for life and the stainless steel refills are meant to be sent back to the company to be sanitized and refilled. Hello circular economy! To add on to that, Noniko offers a seamless conscious subscription that delivers your new refill to your door, and a prepaid shipping label to send your old refill back. This company is making deodorant fun and eco-friendly. The perfect countertop eye candy.
2. Dropps Dropps offers non-toxic, plastic-free laundry and kitchen cleaning products that harness the power of nature to make your household squeaky clean. These non-toxic products are helping to turn the tide against pollution, plastic waste, and animal cruelty. To make things better? When you subscribe you get 30% off your order! 3. Boyish This eco-friendly clothing brand will for sure make your wardrobe more sustainable this year. Boyish is a sustainable denim line focused on quality, fit and authentic washes. Their collections are centered on vintage silhouettes with a modern twist. Boyish commitment to the planet is seen throughout their whole product development cycle from the factories they work with to the dyes they use and the amount of water produced to make denim. All jeans are produced with sustainable fabrics through a completely environmentally-friendly and cruelty-free process. Sustainable and affordable? Sign us up!
4. Bite Bite is determined to eliminate plastic waste one toothpaste tablet at a time. This brand reinvented toothpaste for the better. Not only are they plastic-free, but there are no cheap fillers, harsh chemicals, and artificial dyes in their ingredients- only the good stuff. Committed to sustainability from start to finish, this brand covers everything. Bite offers a subscription program in which you receive your refills straight to your doorstep in 100% compostable mailers. Say goodbye to your old toothpaste tube, and say hello to the future!5. Blueland Blueland is changing the way we clean. Buy your bottle once and refill forever. From cleaning tablets, to powder detergent, there is 20 oz of powerful cleaning spray all in the size of a nickel. Blueland emphasizes the reuse model. After all, plastic is meant to last forever and is unfontunately only used once. This brand wants to change that by offering refill tablets and laundry detergent powder to pop into the bottles that you have already purchased from Blueland.
HeartLife Foundation Puts Heart Failure at the Centre of Heart Month with Launch of New Tools to Support Canadians
First and only heart failure Charter addresses importance of establishing a national standard of care for Canadian patients and their caregivers
VANCOUVER, BC, Feb. 1, 2021 /CNW/ - Today, HeartLife Foundation (HLF), Canada's first – and only – national patient-led Heart Failure (HF) organization, is calling attention to the realities of living with HF by releasing the first-of-its-kind Canadian Heart Failure Patient & Caregiver Charter. Coinciding with February's Heart Month, the Charter outlines a set of rights and responsibilities to support the creation and implementation of a much-needed national standard of care for Canadians living with HF and their caregivers.
HF is a common, chronic heart disease on the rise in Canada, with more than 600,000 Canadians living with HF.[i] Each year, 92,900 Canadians are newly diagnosed – a diagnosis that changes a person's life forever.[ii] People living with HF experience an emotional and physical burden with the disease. Common symptoms include shortness of breath, chest pain, fatigue, and swelling of the ankles and feet. People living with HF experience changes to their lifestyle, may be unable to do all the things they used to and may need to rely more on others. Patients and their caregivers are overwhelmed with medical information, medications, appointments, and in some cases device therapy. It is important to note, heart failure does not have a cure. New feelings of fear, uncertainty and loneliness are common, but there is hope. By diagnosing and treating the potentially debilitating effects of HF at its early stages, people can live longer, fuller and more active lives.
When it comes to HF, diagnosis, access to care, medical therapies and support services varies widely from one region to the next. That's why HLF has been working to bring support to Canadians living with HF through awareness with patients, families, and caregivers and tools like the Charter.
"We're thrilled to launch the Charter. It's more important than ever to ensure a national standard of high-quality care for all Canadians living with heart failure," said Marc Bains, Co-Founder, VP, HLF and heart transplant recipient who was diagnosed at age 23. "The Charter is a step forward to ensuring the patient voice is heard, and that all Canadians have access to consistent high-quality care that can improve their quality of life."
In the era of a pandemic, people living with HF are highly vulnerable and at greater risk of contracting COVID-19 and experiencing further complications with their disease.[iii] The effects of the pandemic on healthcare resources means many patients are waiting longer for care, and the longer they wait, the higher the chances of further, irreversible damage to the heart.
"As someone living with heart failure, I know first-hand the impact of the diagnosis and how it changes your life. That's why it's our goal at HLF to provide hope by improving health outcomes and the lives of Canadians with heart failure no matter where they live," said Bains. "It's crucial to not leave heart failure patients and their caregivers behind. Together, we can establish better access to the resources, support and standardized care needed to live the quality of life we deserve during the pandemic and beyond. HeartLife's vision is to create a better everyday life for people living with HF. It's about life, not failure."
The Charter intends to improve the understanding of what HF and HF care is, facilitate discussions with stakeholders to drive change, establish a national standard of care consistent across Canada and develop real-world solutions for patients. To create the Charter, HLF worked with patients and family caregivers from across Canada to gain insight into the challenges facing Canadians directly affected by the disease.
Alongside the Charter, through the support of HF patients, caregivers and health care practitioners, HLF is also launching the HF Patient Journey Map. The tool captures real patient experiences: life before diagnosis, the diagnosis and living with HF. It illustrates the many unique stories to help visualize the impact of the disease and show how with the right supports, patients can live well with HF.
HF is a condition where the heart cannot pump enough blood through the body to meet its needs. The heart is unable to fill with enough blood, or its pumping action isn't strong enough, or both.
Survival is improved through education, awareness, and access to specialist health care and therapy. A timely and accurate HF diagnosis is essential in receiving treatment, improving quality of life and reducing hospitalizations.
About HeartLife Foundation
HeartLife Foundation is Canada's first – and only – national patient-led Heart Failure organization. We are a Federal Charity aimed at raising public awareness of Heart Failure, engaging patients, families, and caregivers to provide education and support, facilitate access to the latest research, innovations, and treatments, and advocate better care for all.
HLF is available for "heart-to-heart" media interviews.
Make ‘Go on a Diet’ Resolutions Obsolete with the Whole Person Integrative Eating Program
San Francisco, CA, February 1, 2021 — What if you never again need to make a New Year’s resolution to lose weight or “go on a diet” because your most-of-the-time way of eating empowers you to eat and weigh less? Original, pioneering research by holistic nutrition researcher Deborah Kesten, M.P.H., and behavioral scientist Larry Scherwitz, Ph.D.—authors of the award-winning Whole Person Integrative Eating: A Breakthrough Dietary Lifestyle to Treat the Root Causes of Overeating, Overweight, and Obesity—reveals that replacing the complex reasons you overeat— called “overeating styles”—with the scientifically sound Whole Person Integrative Eating (WPIE) dietary lifestyle (meaning, WPIE is a way of life; it’s not a traditional diet) may make weight-loss resolutions obsolete.
“Now is the time to ‘reset’ and rethink what and how we eat; to replace traditional dieting with a scientifically sound way of eating that lessens overeating and that leads naturally to weight loss, health and healing,” says Kesten.
Kesten and Scherwitz share a simple yet powerful premise: Identify the reasons you overeat (your overeating styles) and gain weight—with the illuminating self-assessment quiz—then overcome overeating and lose weight by replacing your overeating styles with the antidotes: the elements of the Whole Person Integrative Eating program.
By shedding light on the root causes of overeating, Kesten and Scherwitz present a program that empowers readers with a personalized plan, and in turn new hope and new choices to help them reduce overeating, lose weight and keep it off.
WPIE is not a diet that a person goes on … then off. It 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., Ph.D., clinical professor of medicine at University of California School of Medicine, San Francisco.
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, M.P.H.,is an international nutrition researcher, award-winning author and health journalist, with a specialty in preventing and reversing obesity and heart disease. She is also an experienced, expert speaker and presenter—from TV and podcast interviews to large conferences and small-group workshops.
Kesten 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 was Director of Nutrition at cardiovascular clinics in Europe and on the Board of Directors of the American Heart Association, San Francisco.
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 No.1 gold, best-book award in the Health category by Book Excellence Awards and is a No. 1 Amazon best seller. Kesten 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.
For many, Valentine’s Day is a day to give and receive love from loved ones. And while it’s important to show other’s how much you admire and appreciate them, it is important to remember that you are also your own Valentine!
Bestselling author, former immunologist, and leading mind-body wellness expert, Jaya Jaya Myra, states that finding ways to support your own mind, body and soul is the perfect Valentine treat to help you feel refreshed, rejuvenated and happy.
“We spend so much time focusing on others that many people forget to take care of themselves on or around Valentine’s Day. Well, focusing on you is the most important thing you can do. One, it’ll make you more attractive in the eyes of others when you have a healthy self-respect and two, whenever you feel better, you give other people permission to feel better about themselves too. You can spread love just by being a source of it to yourself.” says Jaya Jaya Myra.
Here are Jaya Jaya Myra’s top 4 ways you can practice self-care this Valentine’s Day:
Tip #1: Go for the Dark Chocolate - dark chocolate is not only an aphrodisiac, it also stimulates dopamine production in the body which helps elevate mood and wellbeing naturally. Win-win!
Tip #2: Make a Gratitude Jar - Get an empty jar and a notepad. Start making small notes each time you truly feel happy or grateful for something. Write it down, then add these notes to your jar. Come the end of the year or next year on Valentine’s Day, you’ll have hundreds of messages to yourself showing you just how awesome life can be!
Tip #3: Do Something Extra Special Today! - Maybe that means get a mani/pedi, get your hair done, get a massage, or even hire a maid to come clean your house! Splurge a little to show yourself some self love. After all, you are worth it.
Tip #4: Boost Libido Naturally (or decrease it, if you want) - Yes, there are many foods that can boost or decrease your libido naturally. If you want to get your sexy time on, you can go for some staples including celery or celery juice, ginger or ginger juice (note, those two combined are heavenly), pomegranates, saffron, apples, or fenugreek. If you want to slow it down and decrease libido, grab a salad, mint, licorice, or red meat. These can help keep you cool and out of a funk if you’re single or spending the day alone.
Powerful True Story Inspires Others to Seek Adventure, Turn Each Day into a Gift
Fort Wayne, IN, February 1, 2021 — Brittany Moser’s short life was not defined by how she died, but rather, by how she lived each day to the fullest and the profound impact she had on those around her. Brittany died from a rare condition, Addison’s disease, in 2017 at the age of 32. She had been a happy-go-lucky flight attendant, soaring high above reality, when her diagnosis suddenly brought her down to earth.
Rather than buckle under the weight of fear, she chose to be fearless and embarked upon the adventure of a lifetime with her best friend — her father. Free and Fearless: The Amazing Impact of One Precious Lifeis Brittany’s unforgettable story as told by her father, Philip Moser.
“This book is not about the grief of losing a child, but about making the most out of what we are given and living our lives positively and not out of fear,” Moser writes. “Brittany inspired me, an ordinary farm boy, to explore life, to climb mountains and to write a book.”
Free and Fearless is an honest, poignant account of Brittany’s legacy and the ripple effect that her outlook on life had on everyone who knew her. Philip hopes that by hearing her story, readers will be inspired by Brittany’s contagious spirit and unwavering desire for new adventures and experiences — even in the shadow of an incurable illness.
Among Brittany’s valuable life lessons that Philip shares with readers are:
1. How precious life is and how we can affect the people around us; 2. How an open mind and a positive attitude can inspire us to do things we never thought possible; 3. How to move out of our comfort zones and into a challenging existence that can turn each day into an exciting gift to be explored; 4. How to not let fear control us, and to use our abilities to seek unique, positive and inspiring adventures; 5. To embrace change as a natural part of life; 6. And finally, that we won’t be remembered by our things or our savings accounts, but by how we made other people feel.
“I want to share the same inspiration that I received for 32 years,” Philip added. “In the end, love truly does conquer all, and Brittany wanted us to know that.”
Author Philip Moser grew up on a farm in Angola, Indiana. After high school, he began working in different aspects of the grocery business, a career that continues to this day. He and his wife, Marilyn Wells, raised two incredible daughters, Camille and Brittany.
Atlanta, GA, February 1, 2021 — Your veterinarian chose to dedicate his or her life to the altruistic pursuit of tending to the health and lives of pets. What you may not have considered is that the health and life of your veterinarian also needs protecting: he or she is nearly four times more likely to die by suicide than someone among the general population. But there are ways you can help.
Sandy Weaver, author of the groundbreaking new book Happy Vet Happy Pet: Caring for Your Pet’s Caregiver, is on a mission to ease the lives of veterinarians, one client’s heart at a time.
“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 shares Sandy’s unique point of view that it takes a village to save a veterinarian. “Making pet owners mindful of how their behavior impacts their veterinarian mobilizes the village to help solve the problem,” she adds.
This book 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.
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima™ SC, for the treatment of people with rheumatoid arthritis
Remsima™ SC is the innovative subcutaneous (SC) version of Celltrion Healthcare's Remsima®
This novel formulation provides an alternative administration option for Canadian physicians and their patients
Celltrion Healthcare Canada Limited will continue to work to ensure access to innovative, high-quality biologics in Canada and around the world for patients with inflammatory conditions
TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima™ SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA).
Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.1
Remsima™ SC is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Remsima™ SC should be used as maintenance therapy after the completion of an induction period with intravenous infliximab.2 The Health Canada NOC issued for Remsima™ SC is based on clinical evidence that showed the clinical response to Remsima™ subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to RemsimaTM SC at Week 30 was comparable to maintaining RemsimaTM SC up to Week 54 (up to Week 64 for safety profile).2,3
"Remsima™ SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima™ SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima™ SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."
With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima™ SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.
As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima™ SC.
"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada. We are proud that Remsima™ SC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company's growth," said Jovan Antunovic, Senior Vice President and Commercial Director at Celltrion Healthcare Canada.
Celltrion has applied for patent protection, until 2038, for Remsima™ SC in approximately 100 countries throughout North America, Europe and Asia.
Notes to Editors:
About CT-P13 (biosimilar infliximab)4-6
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of January 2021) including the US, Canada, Japan and throughout Europe.
CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options: via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.
CT-P13 SC has received EU marketing authorization for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima® SC will be reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) with the outcome expected by 2022.
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us
Westhovens R et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford) 2020 Nov 23;keaa580: doi: 10.1093/rheumatology/keaa580.
Yoo DH, Jaworski J, Matyska-Piekarska E et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.
6.
Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.
SOURCE Celltrion Healthcare
Amgen Presents Results From Phase 2 Cohort of CodeBreaK 100 Clinical Study Evaluating Investigational Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC)
The results are the first from a completed pivotal Phase 2 study in NSCLC with a median follow-up of more than one year
MISSISSAUGA, ON, Feb. 1, 2021 /CNW/ - Amgen has announced results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) and are the first from a completed pivotal Phase 2 study in NSCLC with a median follow-up of more than one year. Please note the safety and efficacy of sotorasib is still under investigation and market authorization has not been obtained.
Sotorasib demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) in previously treated patients with KRAS G12C-mutated advanced NSCLC. The results were also consistent with earlier Phase 1 results. Patients were treated with sotorasib 960 mg once daily orally, Prior to the trial, 81 % of patients had progressed on platinum-based chemotherapy and PD1/L1 inhibitors, with the remainder progressing after having received one of these therapies.
"There remains a significant unmet need for new therapeutic options to help support patients with advanced non-small cell lung cancer who have failed first-line treatment," said Suna Avcil, executive medical director, Amgen Canada. "Scientists and researchers around the world have invested four decades of research into trying to find these answers. We are encouraged by the results of this Phase 2 study and believe they offer important clinical insights."
"I am pleased to see continued progress in the development of potential therapies for patients with advanced NSCLC harbouring a KRAS G12-C mutation," said Dr. Adrian G. Sacher, M.D., M.M.Sc., F.R.C.P.C., Division of Medical Oncology & Hematology Princess Margaret Cancer Centre. "This research is critical to better understanding the disease and, more importantly, moving toward better patient care."
Most treatment-related adverse events (TRAEs) associated with sotorasib were mild to moderate (grade 1 or 2) and no treatment-related deaths. Grade 3 TRAEs were reported in 25 (19.8%) patients and 1 patient (0.8%) reported a Grade 4 TRAE. The most frequently reported TRAEs (any grade) were diarrhea (31.0%), nausea (19.0%), increased alanine aminotransferase (15.1%) and increased aspartate aminotransferase (15.1%). TRAEs led to treatment discontinuation in 7.1% of patients.
NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.1,2KRAS G12C is one of the most common driver mutations in NSCLC3 and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.4 Approximately 13 per cent of patients with NSCLC harbour the KRAS G12C mutation.5,6
Following recent regulatory submissions in the U.S., European Union, Australia, Brazil, Canada and UK, Amgen is working with regulatory agencies across the globe to bring sotorasib to NSCLC patients as quickly as possible. Amgen's request for sotorasib to be considered for accelerated review under the Notice of Compliance with conditions (NOC/c) pathway in Canada was recently determined to be acceptable.
About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.7 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents. In just over two years, the sotorasib clinical program has established the largest clinical data set with more than 700 patients studied across 13 tumour types to date.
About CodeBreaK
The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to study patients with an advanced solid tumour with the KRAS G12C mutation.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumours. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.
A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumours (CodeBreaK 101) open for enrollment.
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations.
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
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3 Liu P, et al. Acta Pharmaceutica Sinica B. 2019;9(5):871–879.
4 Pakkala S, et al. JCI Insights. 2018;3:3120858
5 Biernacka A, et al. Cancer Genet. 2016;209:195-198.
6 Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.
7 Canon J, et al. Nature. 2019;575:217-223.
SOURCE Amgen Canada
Wellcome grants €1.3 million to RCSI to further develop prognostic blood test for psychotic disorders
DUBLIN, Feb. 1, 2021 -- RCSI University of Medicine and Health Sciences has received a €1.3 million grant from Wellcome to further develop a blood test that can predict whether a person is likely to develop a psychotic disorder years later.
The researchers had previously analysed blood samples taken from people at clinical high risk of psychosis. These individuals were followed up for several years to see who did and did not develop a psychotic disorder.
After assessing the proteins in blood samples and using machine learning to analyse this data, the scientists were able to find patterns of proteins in the early blood samples that could predict who did and did not develop a psychotic disorder at follow-up.
The most accurate test was based on the 10 most predictive proteins. It correctly identified those who would go on to develop a psychotic disorder in 93% of high-risk cases, and it correctly identified those who would not in 80% of cases.
The grant will now enable the researchers to determine if this test is similarly accurate at predicting who will develop a psychotic disorder from other international groups of clinical high risk individuals. The ultimate goal is to develop a commercially-available test for use in clinical practice so people can be treated earlier and more effectively.
“Wellcome’s support will enable us to further expand our research and directly benefit patients,” said Professor David Cotter, a professor of molecular psychiatry at RCSI, consultant psychiatrist in Beaumont Hospital, Dublin and investigator at FutureNeuro, the SFI research centre for chronic and rare neurological diseases.
“Ideally, we would like to prevent psychotic disorders, but that requires being able to accurately identify who is most at risk. This grant will allow us to study these markers in other people at high risk of psychosis to confirm our previous findings.”
The work builds on a patent previously filed by the researchers, and this grant marks a key step in commercialising the test.
“I would like to congratulate Professor Cotter and his team as well as thank Wellcome for awarding RCSI this grant,” said Professor Fergal O’Brien, Director of Research and Innovation at RCSI.
“The funding will be instrumental in carrying out a core mission of RCSI research – translating research from the laboratory directly to the patient. I look forward to seeing this research forge new paths in psychiatric care.”
The grant comes from Wellcome’s Psychosis Flagship, which aims to reduce the global burden of psychosis by improving diagnosis, maximising the impact of early treatment and by developing novel, targeted interventions.
On this project, RCSI will collaborate with researchers from the UCD Conway Institute and from Cardiff University. Other collaborators include those from the University of Melbourne, Yale University, University of North Carolina at Chapel Hill, University of Bristol, Trinity College Dublin and Kings College London.
“Identifying individuals who are most at risk of developing psychosis is a key challenge in the field. Overcoming this could enable early interventions that will help improve outcomes for patients, which is the vision of Wellcome’s Psychosis Flagship,” said Dr Lynsey Bilsland, Deputy Head of Programme, Translation & Portfolio Integration at Wellcome.
ENDS
About RCSI University of Medicine and Health Sciences
Ranked number one globally for Good Health and Well-being in the Times Higher Education (THE) University Impact Rankings 2020, RCSI University of Medicine and Health Sciences is an international not-for-profit university, with its headquarters in Dublin.
RCSI is exclusively focused on education and research to drive improvements in human health worldwide. It is among the top 250 universities worldwide in the THE World University Rankings (2020) and its research is ranked first in Ireland for citations. RCSI has been awarded Athena Swan Bronze accreditation for positive gender practice in higher education.
Visit the RCSI MyHealth Expert Directory to find the details of our experts across a range of healthcare issues and concerns. Recognising their responsibility to share their knowledge and discoveries to empower people with information that leads them to better health, these clinicians and researchers are willing to engage with the media in their area of expertise.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, global heating and infectious diseases.
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