Novartis' KISQALI® (ribociclib) product monograph in Canada now includes MONALEESA-3 data demonstrating statistically significant improvement in overall survival in postmenopausal women with HR+/HER2- advanced breast cancer

  • KISQALI® is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival (key secondary endpoint) with various endocrine treatment partners and the broadest spectrum of patients in two Phase III trials in advanced breast cancer.1
  • At the time of the second interim overall survival analysis, the MONALEESA-3 study met its key secondary endpoint demonstrating a statistically significant improvement in overall survival for the overall population.1
  • In Canada, 88% of all new breast cancer cases are diagnosed in individuals over the age of 50, and approximately 10% of women diagnosed will have an initial diagnosis of metastatic breast cancer.2,3

DORVAL, QC, March 18, 2021 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that statistically significant overall survival (OS) results for KISQALI® (ribociclib) in combination therapy have been approved within the KISQALI® Product Monograph. This is the second Phase III trial in which KISQALI®combination therapy met the secondary endpoint of OS at the pre-planned interim analysis.1

The pivotal Phase III MONALEESA-3 was a randomized double-blind, placebo-controlled study of KISQALI® in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer who had received no or only one line of prior endocrine treatment. These OS results have now been approved within the KISQALI® Product Monograph.

At the time of the second interim OS analysis, the study met its key secondary endpoint demonstrating a statistically significant improvement in OS for the overall population and was consistent for the prior endocrine therapy subgroups and across all other subgroups.1

"It is compelling to see consistently significant overall survival findings among pre-, peri-, and postmenopausal women," said Dr. Christine Brezden-Masley, Medical Oncologist, Mount Sinai Hospital. "These results lend an added level of confidence to help oncologists make more informed treatment decisions for their advanced or metastatic breast cancer patients."

For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body. Cancerous cells can spread anywhere in the body, but they most commonly spread to the bones or other common sites such as, the liver, brain, lungs and skin. This may happen before or after treatment, or it may develop from reoccurring breast cancer.4Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.5

"The element of time is front-and-centre for all women living with advanced or metastatic breast cancer, but for women diagnosed at an older age, navigating their disease may require different considerations which can impose an additional layer of concern and worry," said Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. "Increased overall survival benefit in postmenopausal women offers new hope to many." 

KISQALI® is indicated in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy. In pre/perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. KISQALI®is also indicated in combination with fulvestrant for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.1

"At Novartis, we are proud of the previously shared MONALEESA-7 and the recently added MONALEESA-3 overall survival data," said Daniel Hébert, Vice-President, Medical Affairs, Oncology, Novartis Pharmaceuticals Canada Inc. "In a world where 5-year survival rates in metastatic breast cancer remain persistently low, these data sets represent additional steps toward a future in which we hope to envision advanced or metastatic breast cancer as a chronic disease."

KISQALI® is now reimbursed in OntarioAlberta and British Columbia under the respective provincial drug programs, in addition to QuebecNew BrunswickNova ScotiaManitoba and Saskatchewan. Novartis continues to work towards securing coverage across the country. 

About KISQALI® (ribociclib)
KISQALI® is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. KISQALI® was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.  

KISQALI® first received Health Canada approval for use with letrozole on March 2, 2018, for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer as first-line endocrine-based therapy based on findings from the pivotal MONALEESA-2 trial. 

About Novartis in Advanced Breast Cancer
Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

About Novartis Pharmaceuticals Canada Inc. 
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2020, the company invested $45 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.    

About Novartis 
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com

KISQALI is a registered trademark. 

References 


1 KISQALI® Product Monograph, December 22, 2020. Available at: www.novartis.ca/kisqalimonograph. Accessed on March 9, 2021.
2 Canadian Breast Cancer Network. Living with Breast Cancer: Senior Women. Available at: https://www.cbcn.ca/en/senior_women. Accessed on March 9, 2021. 
3 Canadian Breast Cancer Network. Metastatic Breast Cancer in Canada Infographic. Available at: https://www.cbcn.ca/en/metastatic_infographic. Accessed on March 9, 2021.  
4 Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: https://www.cbcn.ca/en/what_is_mbc. Accessed on March 9, 2021.
5 Canadian Breast Cancer Network and Rethink Breast Cancer. Living with Metastatic Breast Cancer in Canada. Available at: https://www.cbcn.ca/web/default/files/public/Reports/Metastatic%20Breast%20Cancer%20In%20Canada%20Report%20June%202013%20-%20English.pdf. Accessed on March 9, 2021. 

SOURCE Novartis Pharmaceuticals Canada Inc.

National Poison Prevention Week campaign calls on Canadian residents to #CheckForPoisons among ordinary household items

Launching March 21 to 27, Parachute will be calling on Canadian households to #CheckForPoisons and ensure they are stored safety to prevent harm.

TORONTO, March 18, 2021 /CNW/ - With many potential poisons in Canadian homes and families spending more time there, it's more important than ever to know how to safely use and store items such as household cleaners, medications and cannabis products. Parachute is joining forces with our partners across the country to show all Canadians they have the power to #CheckForPoisons and prevent unintentional poisoning at home. 

"Each year, more than 4,000 people in Canada lose their lives and more than 20,000 are hospitalized due to poisoning," says Pamela Fuselli, President and CEO for Parachute, Canada's national charity dedicated to injury prevention. "To prevent poisonings from unintended exposures to household items, prevention is in your hands: we recommend storing products in their original, child-resistant packaging and keep items tempting to young children, such as pills that look like candy, both out of reach and locked away."

While cleaning products are not new to Canadian homes, the COVID-19 pandemic has increased focus on handwashing, cleaning and disinfecting. "The number of calls to poison centres regarding hand sanitizers, bleaches and disinfectants grew significantly in 2020, compared to 2019," says Dr. Margaret Thompson, President of the Canadian Association of Poison Control Centres." She recommends people review the labels on such products and don't mix together cleaning products, which can cause chemical reactions that produce dangerous gases.

Every household should have the number of their local poison centre readily available, whether stored in your cellphone or in a visible location, such as on the fridge. "A recent survey conducted by Parachute found that only 40 per cent of Canadian parents know about local poison centres, and the advice they can provide if a child is exposed to a potential posion," says Fuselli. Go to parachute.ca/poisoning for a complete list of poison centre numbers across Canada.

Other new poison issues to emerge in recent years that impact children include:

  • Cannabis edibles, which often resemble common snacks (e.g., cookies, brownies, gummy candies). A young child may be unable to tell the difference and unknowingly consume a large amount. 
  • Liquid nicotine refills for e-cigarettes, which are sold in flavours that may be appealing to children. Nicotine can be harmful to a child if they put it in their mouth, swallow it or spill it on their skin
  • Colourful, transparent laundry detergent pods may look like candies or toys to children. These can harm a child if ingested, or if the liquid squirts into their eyes. 

All these should be stored securely out of children's reach.

Check out our Poison Prevention Week resources:Parachute.ca/PoisonPreventionWeek and join in our awareness campaign on social media using the hashtags #CheckForPoisons and #NPPW2021.

This program is made possible through a financial contribution from Health Canada; the views expressed herein do not necessarily represent the views of Health Canada.

About Parachute
Parachute is Canada's national charity dedicated to reducing the devastating impact of preventable injuries. Injury is the No. 1 killer of Canadians aged 1 to 34, where on average one child dies every day due to injury. Through education and advocacy, Parachute is working to save lives and create a Canada free of serious injuries. For more information, visit us at parachute.ca and follow us on TwitterFacebookInstagram and LinkedIn.

SOURCE Parachute

Improve Your Life and Career by Making the Most of Happy Accidents

San Diego, CA, March 18, 2021 — Perhaps you were meant to read this article and it was meant to change your life. Serendipity is all around us, and it’s up to us to be aware of it, to explore its potential impact on our lives and to follow its gentle nudge toward positive outcomes whenever possible.  

“Most people go through life believing that unexpected, fortuitous events that often bring fame and fortune happen to only a lucky few individuals,” says Neil J. Farber, MD. “The truth is that unexpected events frequently happen to all of us. They may not bring tremendous fame or fortune, but they can be recognized and utilized to significantly improve one’s professional and personal life.” 

Dr. Farber’s new book, Serendipity: Utilizing Common Unexpected Events to Improve Your Life and Career, thoroughly explores the role that serendipity could play in our lives and explains that recognizing serendipitous events is better achieved with a certain set of skills.

“You have to have a mind-set that allows you to think that such events canhappen,” he explains, adding that by practicing self-awareness and cultivating keen visual and auditory observational skills, we are more likely to spot even the most subtle of serendipitous happenings.

Serendipity describes how to understand the different types of serendipitous events and how they are common to all of us; how to recognize these events when they do occur; how to acquire the skills necessary to become more aware of serendipity; how to “connect the dots” to bring the serendipitous event to a fortuitous conclusion (that is, what skills, assistance and resources may be necessary); and what to do with the end product or idea if it is profitable, or as sometimes happens, when it is not.

Dr. Farber uses events recorded in literature and the history books, as well as events that have occurred in his own personal and professional life to create a helpful guide for recognizing and turning common events into meaningful moments.  

Author Neil J. Farber is a Professor Emeritus of Clinical Medicine at University of California, San Diego, and a docent at the San Diego Air & Space Museum. He has been an academic internal medicine physician for 40 years, teaching, researching and providing patient care in medical schools initially on the East Coast. For the past 12 years, he was Professor of Clinical Medicine at University of California, San Diego, retiring at the end of April 2019. He has received numerous awards, including Top Doctor of San Diego five times, and is a member of the FDA Non-Prescription Drug Advisory Committee. He has published over 60 research papers and has had a multitude of serendipitous events occur, which have significantly (and positively) influenced his career and his personal life.

Serendipity: Utilizing Common Unexpected Events to Improve Your Life and Career

Publisher: Boyle & Dalton

Release Date: December 15, 2020

ISBN: 978-1-63337-456-0 (paperback)

ISBN: 978-1-63337-457-7 (e-book)

LCCN: 2020922389

Available from Amazon.com and BN.com

###

A New Study by Novateur Ventures Provides Global Analysis of COVID-19 Vaccines 

March 18, 2021: A new study by Novateur Ventures provides a comparative analysis of twelve COVID-19 Vaccines that had initiated or announced the Phase III clinical trial stage by early November 2020. The study highlights the early successes, as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic.

COVID-19 vaccines analyzed for the study 

  • messenger RNA - Moderna and Pfizer/BioNtech
  • Viral Vector-based (non-replicating) Vaccines - Astra Zeneca/University of Oxford, CanSino Biologics, Gamaleya Research Institute, Johnson & Johnson/Janssen (J&J)
  • Recombinant Protein-based Vaccines - Novavax and Medicago
  • Inactivated Virus - Three Chinese conglomerates and one Indian company

The study ‘Target Product Profile Analysis of COVID-19 Vaccines in Phase III Clinical Trials and Beyond: An Early 2021 Perspective’ appears in the Special Issue “Vaccines and Therapeutics against Coronaviruses” of the journal Viruses, an international peer-reviewed, open-access journal published monthly by the Multidisciplinary Publishing Institute (MDPI). 

“The global concerted effort to develop vaccines to fight COVID-19 and deliver it to millions of citizens around the world in less than a year is an unprecedented feat in the history of medicine and a triumph for vaccine research and development said study co-author Ali Ardakani, Founder & Managing Director at Novateur Ventures. “Vaccination-mediated herd immunity will play a key role in helping us in returning to a world unhampered by restrictions and to global prosperity.”

COVID-19 Vaccines belonging to four different platforms were analyzed in five different categories using a “harmonized” target product profile (TPP) version of guidance from the World Health Organization, Coalition for Epidemic Preparedness Innovations (CEPI) and Center for Biologics Evaluation and Research (CBER). Key analysis from the study -

  • Vaccine Efficacy - mRNA vaccines were a clear winner with efficacy in the 95% range and across a spectrum of ages, followed by the protein subunit platform with an efficacy of just under 90% in the UK. The inactivated virus platform ranks lowest based on currently available variable data. 
  • Dosing regimen - All but two (CanSino and Johnson & Johnson/Janssen) of the 12 vaccines in the various platforms analyzed in this study use a two-dose regimen.
  • Logistics - mRNA vaccines rank lowest with their burdensome cold-chain requirements.
  • Safety/reactogenicity – The inactivated virus platform was the top performer. The viral vector platform scores below the other three platforms due to some lingering concerns related to paused trials and adverse events.
  • Target price/accessibility - The production of mRNA vaccines can be scaled-up at a reasonable pace, but they are currently among the most expensive COVID-19 vaccines; the viral vector vaccines are the cheapest to prepare. The inactivated virus vaccines are relatively easy to produce and are cheap if one considers Bharat Biotech’s COVAXIN. However, there are some indications that the pricing of the vaccines made in China are very high.

The below ranking chart compares how well the vaccines match with the harmonized TPP using a scoring system of 1-5 and a weighting parameter for each category to provide a value out of 100 – 

VACCINES_RANKING_TABLE_FEB_2021_V2.jpg

“Ten out of twelve vaccines we analyzed have already received some form of authorization for use in different countries in a period of less than a year. This is a remarkable achievement,” said study co-author Colin D. Funk, Scientific Lead at Novateur Ventures. “We hope that SARS-CoV-2 viral variants, emerging at an alarming rate in various countries, will not derail the successful vaccine efforts to date.”

The study has also identified three main barriers/hurdles for ending the global COVID-19 pandemic -

  • While we know that antibody levels induced by natural infection with SARS-CoV-2 last several months, we do not know if there will be a requirement for repeat vaccine dosing on an annual (or other timeframe) basis. If repeat booster doses are required, especially related to the viral vector platform, will antibodies be directed to the vector and will this diminish vaccine efficacy?
  • Determining an immunological correlate of protection against SARS-CoV-2 is an important objective that still has not been achieved and will be crucial in facilitating future COVID-19 vaccine development and licensing.
  • Public perception and compliance in vaccine administration are also very large hurdles to surmount in order to achieve herd immunity in some countries/populations. While not discussed in this review, this is a key point that cannot be overlooked.

“The process of developing a vaccine from scratch normally takes place over several years but it’s truly amazing that we already have approved vaccines to fight the spread of COVID-19. This speaks volumes about the efforts various countries have put into pandemic preparedness and response,” said co-author Craig Laferrière, Head Vaccine Development at Novateur Ventures. This was made possible through concurrent pre-clinical and early Phase I studies, strategic risk measures and adaptive trial designs.”

About Novateur Ventures

Novateur is an established global life sciences advisory with extensive experience related to business development and product development of therapeutics, medical devices and digital health products. For more information, visit: http://www.novateur.ca

Post-Traumatic Thriving Shares Essential Elements for Authentic Healing

Los Angeles, CA, March 18, 2021 — Trauma has a way of showing up when we least expect it, and society sends many signals telling us that it’s admirable to put on a brave face and soldier on. But our grief is normal — even healthy, says world-renowned expert on disasters and trauma Dr. Randall Bell.

“The hallmark error is to continually dodge the pain. There is a time and place for avoidance. However, to heal and grow, we cannot doge the pain forever …,” he writes in his new book, Post-Traumatic Thriving: The Art, Science, & Stories of Resilience. “Suffering is our opportunity to stare our moral compass in the eye and deal with the problem in a dignified way.”

Dr. Bell undertook unprecedented research, and juxtaposes outcomes of scientific studies with stories of real people (many of them familiar) who have used their trauma as their fuel to thrive to reveal common denominators. He divides his remarkable insights into three sections: The Dive Stage, The Survive Stage and The Thrive Stage, and outlines a step-by-step process toward authentic healing.

To inspire and connect with readers who’ve experienced trauma, he shares stories of remarkable resilience, including the following:

• A deaf man with a glass eye invented the electric guitar and became a household name, remarkably wealthy and most importantly, happy. 

• A convicted murderer took responsibility for the damage he caused, graduated with honors from college, became a minister and turned around the hearts of the most hardened criminals.

• A girl born with cerebral palsy landed the world’s first starring role on national television and spoke at the White House three times.

• A woman hid in a basement for years and lost her entire family in the Holocaust. She eventually found true love and paints stunning artwork.

• The sister of a murder victim helped millions of women in toxic domestic relationships.

• A woman’s car crash resulted in an addiction to prescription drugs, a divorce, a loss of her children and a cot in a homeless shelter. She has rebuilt it all back and more.

• A man set to go to the Olympics had his hopes dashed by Jimmy Carter and went on to build a worldwide business empire.

Ultimately, Dr. Bell documents the science of happiness, as well as the individual styles and common thread that all post-traumatic thrivers have to emerge with a fulfilling life. When trauma hits, your most significant decision will be to dive, survive or thrive. If you choose to thrive, this book is for you.

As an economist, Dr. Randall Bell has consulted on more disasters on earth than anyone in history and is widely considered the world’s top authority in the field of post-traumatic thriving. His clients include the Federal Government, State Governments, International Tribunals, major corporations and homeowners. Dr. Bell believes that “the problem is not the problem — the problem is how we react to the problem.” 

Often called the “Master of Disaster,” Dr. Bell is squarely focused on authentic recovery and resilience. His research has been profiled on major television shows and featured in numerous magazines and the international media. More information can be found at www.posttraumaticthriving.com

Post-Traumatic Thriving: The Art, Science, & Stories of Resilience

Publisher: Core IQ Press

ISBN 978-0-9967931-7-9

Available from Amazon.com and all bookstores

###

Russell Alexander Law Firm Sees Dramatic Changes 
in Divorce on Pandemic Anniversary

LINDSAY, Ontario—Russell Alexander Collaborative Family Lawyers has seen dramatic changes in family law since the coronavirus pandemic began one year ago.

The Lindsay-based firm has seen family courts move to virtual hearings, fights among divorced couples over child custody and in-person schooling during quarantine, and an increase in separations and divorces from couples struggling during lockdown.

“The coronavirus pandemic has caused some of the biggest changes in family law that we’ve ever seen in a single year,” said founder Russell Alexander. “We’ll be seeing the long-term effects of this for years to come.”

The firm’s lawyers saw the changes almost immediately, as quarantine rules shut down courtrooms and forced lawyers to begin meeting with clients virtually using videoconferencing software like Zoom.Lockdowns also began to complicate existing custody arrangements, as divorced parents fought over visitation, traveling and managing home school. 

Alexander said that the tension among spouses who were forced to spend most of the last year together at home, with few opportunities for going out or seeing friends and family also took a toll on marriages. 

“We’ve gotten a lot more inquiries than usual from couples who are considering divorce after the pandemic,” he said. “The intensity of the last year has pushed some already-troubled marriages to the brink.”

Looking ahead, Alexander said that he expects family courts to continue holding some hearings virtually because they are convenient, while custody arrangements may even include some provisions for how to respond to future pandemics.

                                                                          
                                                                                                                                                      ***

Russell Alexander Collaborative Family Lawyers 
Russell Alexander Collaborative Family Lawyers is committed to practicing exclusively in the area of family law in Ontario dealing with all aspects, including separation and divorce, child custody and access, spousal support, child support, and division of family property. A team of lawyers provide guidance from start to finish, helping clients identify and understand the legal issues as well as the options and opportunities available through the transition. The firm has offices in Lindsay, Whitby, Oshawa, Markham, Peterborough and Toronto, Ontario. 

For more information, visit: 
http://www.russellalexander.com.

Stix Brands International Launches Frontline Protection Kits in Support of Brain Injury Canada

TORONTO, March 17, 2021 /CNW/ - Stix Brands International has officially launched their "Tools for the Rules" Campaign in support of Brain Injury Canada (BIC).

This initiative introduces personal Frontline Protection Kits available for purchase to protect you, your family and others from COVID-19. Each Kit contains: 

  • 5 PPE Health Canada-Approved masks; 
  • 2 personal SoapStix hand wash sprays;  
  • 1 personal SoapStix hand sanitizer spray. 

Each Kit costs $19.99 plus applicable taxes; your purchase helps support the services and treatment of the 165,000 Canadians who suffer from traumatic Brain Injuries every year.

For every Kit sold, Stix Brands will donate $4 to Brain Injury Canada.

To purchase your Frontline Protection Kit, visit www.protectionkits.ca

About Stix Brands International:

Stix Brands International was founded following the SARS and H1N1 outbreak to provide portable and practical solutions to help prevent the spread of germs and to increase access to personal hygiene. Our products use 100% natural ingredients that protect and soothe skin while eliminating germs. Our goal is to provide individuals with access to skin care protection everywhere they go. www.stixbrandsinternational.com

About Brain Injury Canada (BIC):

Brain Injury Canada is a national charitable organization focused on  education; advocacy and awareness of acquired brain injury. The stats around brain injury are pretty staggering and demonstrate the prevalence of brain injury across the nation. Traumatic brain injury (TBI) can impact every part of a person's life - cognitively, physically, emotionally and behaviourally. TBI's are caused by something that comes from outside the body. This includes blows, bumps, and jolts to the head.

Traumatic brain injury (TBI) is a leading cause of disability globally. TBI occurs at an annual rate of 500 out of 100,000 individuals. That is approximately one person injured every 3 minutes in Canada. 

 Please visit our brain injury resource website www.braininjurycanada.ca 

SOURCE Stix Brands International Inc.

Health Canada approves new indication for lung cancer treatment option ALUNBRIG®

First-line indication offers Canadians with advanced lung cancer new treatment options

TORONTO, March 17, 2021 /CNW/ - Takeda Canada Inc. is pleased to announce that Health Canada has issued ALUNBRIG® (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1 The approval is based on results from the phase 3 ALTA-1L trial which evaluated 275 patients and showed that once-daily ALUNBRIG® was superior to crizotinib on measures of efficacy and tolerability making it a promising first-line treatment option.2

"This is important news for Canadians living with ALK+ locally advanced or metastatic non-small cell lung cancer. New treatment options are essential to support patients on their journey. Having access to clinically evaluated therapies provides choices to stay ahead of cancer," said Dr. Geoffrey Liu, Senior Scientist, Princess Margaret Cancer Care Centre, University Health Network. "This new indication will be crucial to improving the health of Canadians impacted by ALK+ locally advanced or metastatic NSCLC. I look forward to sharing this positive announcement with patients."

Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 80 to 85 per cent of lung cancers diagnosed in Canada each year.There are many different subtypes of NSCLC that start in the different types of cells and tissues of the lung. ALK+ is a subset of NSCLC, often striking people at a younger age, many of whom have never smoked.4 Studies indicate that chromosomal rearrangements in the ALK gene is a key driver in this subset of NSCLC patients. Between three to five per cent of patients diagnosed with locally advanced or metastatic NSCLC test positive for the ALK gene rearrangement.5

"The approval of ALUNBRIG® is a significant step forward for Canadians battling advanced forms of lung cancer, who now have a new treatment option available in their fight against a devastating disease," says David Fyshe, Oncology Country Head, Takeda Canada. "We are proud of ALUNBRIG® clinical results demonstrating first-line treatment benefits. This new oncology indication directly supports Takeda's on-going commitments to uncover solutions for people living with cancer." 

In 2018, ALUNBRIG® (brigatinib) was issued marketing authorization with conditions, pending the results of trials, as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib). 

About the Phase 3 ALTA 1L Trial

The safety and efficacy of brigatinib was evaluated in a, Phase 3 open-label, multicenter trial (ALTA 1L) in 275 adult patients with advanced ALK+ NSCLC who had not previously received an ALK-targeted therapy with a documented ALK rearrangement based on a validated ALK testing. Patients could have up to 1 prior regimen of systemic anticancer therapy in the locally advanced or metastatic setting and had an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. The major efficacy outcome measure was progression-free survival as evaluated by a Blinded Independent Review Committee (BIRC). 

About ALUNBRIG® (brigatinib) 

ALUNBRIG® is a targeted medicine that blocks the action of the altered ALK gene to help shrink or slow cancer growth. ALUNBRIG® is administered orally, beginning with seven days of 90 mg once daily, followed by 180 mg once daily thereafter. ALUNBRIG® is now indicated as a monotherapy for the first-line treatment of adult patients with ALK+ locally advanced (not amenable to curative therapy) or metastatic NSCLC and as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).1

ALUNBRIG® and the ALUNBRIG Logo® are registered trademarks of ARIAD Pharmaceuticals, Inc.

About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. 

Additional information about Takeda Canada is available at www.takeda.com/en-ca.  

References 

1 ALUNBRIG® Product Monograph. Date of Revision March 2, 2021. Available at https://www.takeda.com/4a4cc3/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/alunbrig/alunbrig-pm-en.pdf. Accessed March 2021. 
2 Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, García Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11. PMID: 32780660; PMCID: PMC7605398. Accessed March 2021.
3 Canadian Cancer Society. Malignant tumours of the lung. Available at http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on. Accessed February 2021. 
4 Gridelli, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treat Rev 2014;40(2): 300–306.
5 Gainor JF, Varghese AM, Ou SH, et al. ALK rearrangements are mutually exclusive with mutations in EGFR or KRAS: an analysis of 1,683 patients with non-small cell lung cancer. Clin Cancer Res. 2013; 19(15):4273-81.

SOURCE Takeda Canada Inc

With a Two-Year Revenue Growth of 433%, Eosera®, Inc. Ranks No. 25 on Inc. Magazine’s List of the Fastest-Growing Private Companies in Texas

Companies on the 2021 Inc. 5000 Regionals: Texas list employed more than 44,000 people.
Fort Worth, TX, March 17th, 2021 - Inc. magazine today revealed that Eosera®, Inc. is No. 25 in Texas and No. 1 in Fort Worth on its second annual Inc. 5000 Regionals: Texas list, the most prestigious ranking of the fastest-growing Texas-based private companies. Born of the annual Inc. 5000 franchise, this regional list represents a unique look at the most successful companies within the Texas economy’s most dynamic segment—its independent small businesses.“It’s an honor to be included on the list, and we’re proud of Eosera’s growth and success over the past years. With a mix of hard work, luck, and opportunity, Joe and I founded a successful, amazing company with a wonderful culture and great team members,” says Elyse Dickerson, CEO.Elyse Dickerson and Joe Griffin, cofounders of Eosera, Inc., which ranks No. 25 on Inc. magazine’s list of the fastest-growing private companies in Texas.Complete results of the Inc. 5000 Regionals: Texas, including company profiles and an interactive database that can be sorted by industry, metro area, and other criteria, can be found at https://www.inc.com/inc5000/regionals/texas.“This list proves the power of companies in Texas no matter the industry,” says Inc.editor-in-chief Scott Omelianuk. “The impressive revenues and growth rates prove the insight and diligence of CEOs and that these businesses are here to stay.”Eosera’s comprehensive line of ear care products are available in over 13K retail stores.About EoseraEosera®, Inc. is a female-led biotech company that addresses underserved healthcare needs. Focused on ear care, Eosera was founded in 2015 by cofounders Elyse Dickerson and Joe Griffin. Eosera manufactures their products in Fort Worth, Texas, practices conscious capitalism, and sticks to their core values as a company. With products in over 13K stores, Eosera always puts people before profits and creates quality products for consumers addressing earwax blockage, ear hygiene, ear itch, and ear irrigation. The company’s fastest-growing products are EARWAX MD® and WAX BLASTER MD®. Eosera is proud to be everything ear care and proud to be creating the latest ear care innovations in decades. For more information, visit http://www.eosera.com/inc5000.More about Inc. and the Inc. 5000 RegionalsMethodologyThe 2021 Inc. 5000 Regionals are ranked according to percentage revenue growth when comparing 2017 and 2019. To qualify, companies must have been founded and generating revenue by March 31, 2017. They had to be U.S.-based, privately held, for profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2019. (Since then, a number of companies on the list have gone public or been acquired.) The minimum revenue required for 2017 is $100,000; the minimum for 2019 is $1 million. As always, Inc. reserves the right to decline applicants for subjective reasons.

Learn How to Unlock Your Inner Creative Genius 

Philadelphia, PA, March 17, 2021 — What is creative genius, where does it come from and, perhaps more importantly, how can we cultivate it in ourselves? 

In his groundbreaking new book, Higher Self Expression: How to Become an Artist of Possibility, meditation teacher and mystical philosopher Jeff Carreira explores the answers to these questions and more through a sweeping exploration of the nature of spiritual genius and the profound state of inner freedom that unleashes it.

“In this book, you will discover that genius is not only a talent that you are born with, but also a human capacity that can be trained and cultivated by anyone,” Carreira says. 

He examines the unusual lives of luminaries such as Gertrude Stein, Ralph Waldo Emerson, William James, Anaïs Nin, Philip K. Dick and Captain Marvel, and compares the genius of Eastern mysticism with the brilliance of Christianity and Islam. 

“You will explore great works of poetry, literature, science fiction, comic books and even extreme sports,” Carreira adds. “You will learn how to develop your own capacity for genius by discovering a mysterious inner state of mind that is intimately connected to life and simultaneously free of limitations and boundaries.” 

With a foreword by Jeffrey J. Kripal, J. Newton Rayzor Chair in Philosophy and Religious Thought at Rice University, Higher Self Expression will illuminate your own potential for genius through open-minded sensitivity, which Carreira says can be learned, practiced and mastered.

Jeff Carreira is a meditation teacher, mystical philosopher and author of 14 previous titles, who works with a growing number of people throughout the world. He offers retreats and courses guiding individuals in a form of meditation he refers to as The Art of Conscious Contentment. He creates courses and programs that encourage people to question their most foundational experience of reality until previously held assumptions fall away, leaving space for a dramatically new understanding to emerge. 

In his books and lectures, he explores revolutionary ideas in the domains of spirituality, consciousness and human development. He is passionate about the potential ideas have to shape how we perceive reality and how we live together. His enthusiasm for learning is infectious, and he has taught at colleges and universities throughout the world. His other books include American AwakeningPhilosophy Is Not a Luxury, The Soul of a New Self, Paradigm Shifting and The Art of Conscious Contentment. 

For more information, please visit www.jeffcarreira.com, or connect with him on social media at https://www.facebook.com/authorjeffcarreira.

Higher Self Expression: How to Become an Artist of Possibility

Publisher: Emergence Education Press

Release Date: April 1, 2021

ISBN-10: 1735265004

ISBN-13: 978- 1735265001

Available from Amazon.com and https://emergenceeducation.com/books/higher-self-expression/

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