4 Types of Supportive Clothing to Wear as a New Athlete
In sports, an injury can happen at any time. It’s inevitable. Although you can’t prevent pain or injury entirely, there are a few accessories that you can wear to decrease the likelihood of it happening. This list is compiled of the 4 best pieces of supportive gear that can be worn in almost every sport.
Mouthguard
One of the most important pieces of protective gear is the mouthguard. This is also something that every athlete should have before performing. Losing a tooth is a tragedy that nobody ever wants to experience. Therefore, wearing a mouthguard will provide you with the protection that you need. According toDental Works, the small device is designed to fit over your teeth and absorb the contact that it takes.
Jock or Jill: Athletic Supporter
Another vital piece of equipment that should be used by every athlete goes by many different names. You may recall it by a few different titles such as a jockstrap, jill, cup, or athletic supporter. This supportive undergarment has a high level of preventative care. If you’re an athlete of any kind, then you’re fully aware of how sensitive the genital area can be. However, with the athletic supporter, the pelvic area will remain protected throughout your physical activity.
Ankle Compression Sleeve/Strap
An ankle roll is probably one of the most common injuries that athletes face. Although the injury usually isn’t too serious, it still doesn’t feel pleasant. But with an ankle compressionsleeve or strap, you are far more unlikely to experience an ankle roll or sprain. Alongside the protective attributes that the ankle compression sleeves offer, they’re sleek and can slide into your shoes with ease.
Protective Girdle
Girdles are a multi-padded pair of leggings that's designed to protect the thighs, hips, and bottom. However, there are certain types of girdles that allow you to insert your own pads rather than provide you with them. Nevertheless, both types are proven to provide you with an immense amount of protection. And what’s special about this protective piece of equipment is that you’re allowed to wear it while playing a handful of different sports.Now things can happen and these accessories aren’t 100% effective, but if you’re an athlete, it’d be wise to invest in at least one of these protective accessories
New Results: Innovative program is improving lives of seniors with dementia in Newfoundland & Labrador and Prince Edward Island
ST JOHN'S, Nov. 13, 2019 /CNW/ - Today, the Canadian Foundation for Healthcare Improvement (CFHI), the Government of Newfoundland and Labrador, and Health PEI announced the results of a successful collaboration to appropriately reduce the use of antipsychotic medication among people with dementia who are living in long term care organizations in Newfoundland and Labrador and Prince Edward Island.
More than half of participating residents in Newfoundland and Labrador and Prince Edward Island prescribed antipsychotics without a diagnosis of psychosis had these medications safely reduced or discontinued. This improves their care experiences and lives while also reducing the risk of negative health outcomes.
The Appropriate Use of Antipsychotics (AUA) is a person-centred approach1 to care that engages people living with dementia, their families and staff to understand the causes of behaviours and underlying issues (such as pain), and respond to an individual's unmet needs based on their personal history. The approach involves reviewing the appropriateness of antipsychotic medication and creating individualized care plans with alternative activities that are meaningful and enjoyable, like exercise, pet or music therapy. This also provides an opportunity to create supportive environments that help the person to feel calm, safe, and comfortable.
The final results of the collaboration include:
In Newfoundland and Labrador, 52 percent of residents2 who were prescribed antipsychotic medication, but did not have a psychosis diagnosis, had their medication reduced or discontinued (30 percent discontinued, and 22 percent reduced dose)
In Prince Edward Island, 53 percent of residents² who were prescribed antipsychotic medication but did not have a psychosis diagnosis had their medication reduced or discontinued (25 percent discontinued, and 28 percent reduced dose)
No change in physical or verbal aggressive behaviours among these residents.
The results were announced at a workshop in St John's with the participating teams from the two provinces. The teams now have the opportunity to join the Momentum Challenge – an invitation-only CFHI program that assists teams to expand the reach of an innovation and sustain its impact.
The collaboration to expand person-centred dementia care and the appropriate use of antipsychotics began in January 2018 involving all 39 publicly-funded long term care homes in Newfoundland and Labrador, all nine publicly-funded homes in Prince Edward Island, and five from the Seniors Quality Leap Initiative – a North American network of long term care organizations focused on improving clinical care and safety for seniors.
There are more than 419,000 Canadians aged 65 and older diagnosed with dementia; and more than 78,000 new cases diagnosed every year among this age group.3 Antipsychotic medications are often used to help manage behaviours related to dementia in long-term care, for example agitation and aggression. However, there is a lack of evidence to support their effectiveness for people who do not have a diagnosis of psychosis and a risk of significant side effects such as confusion, dizziness and stroke or even death.
Through province-wide expansion in Quebec, New Brunswick, Newfoundland and Labrador and Prince Edward Island, CFHI has supported more than 300 teams to provide more person-centred dementia care and reduce potentially inappropriate antipsychotic use.
CFHI and partners have developed resources and tools to support people and organizations to better understand the use of antipsychotic medications, have conversations about their appropriate use, and support long term improvements in person-centred approaches to care. These free resources are available on the CFHI website and include resources from the Canadian Patient Safety Institute, Choosing Wisely Canada and Alzheimer's Society of Canada.
"We are very pleased with the progress to date, and would like to thank the families and staff of all our long term care homes throughout the province for their commitment to the appropriate use of antipsychotics collaborative. Their commitment, and the support from CFHI, has resulted in improvements in care and quality of life for people living in long term care. While this project has concluded, our commitment to improving outcomes in this area will continue," said the Honourable John Haggie, Minister of Health and Community Services, Government of Newfoundland and Labrador.
"We are very proud of how the long term care homes have fully embraced this approach to care and we congratulate them on their commitment and leadership," said Andrew MacDougall, Director of Long-Term Care, Health PEI. "We will be working with private long term care homes to expand the reach of the AUA approach."
David Clothier's wife, Madonna, is a resident at Bay St George in Newfoundland and Labrador. Through the AUA approach, Donna has had her antipsychotic medication successfully reduced. "Madonna was like someone living in a fog and after her medication was reduced, she came out of that fog" said Mr. Clothier. "Donna started putting out her hand for me to take, we now walk almost every day. She is more receptive to other people and interacts with staff and other residents."
"We're delighted to celebrate the leadership of Newfoundland and Labrador and Prince Edward Island in improving care for people living with dementia," said Jennifer Zelmer, President and CEO of CFHI. "Their efforts will help to accelerate national declines in potentially inappropriate antipsychotic use. In 2013-14, about one in three long term care residents who did not have a psychosis diagnosis were prescribed an antipsychotic. By 2017-18, that number had dropped to one in five."
About the Canadian Foundation for Healthcare Improvement The Canadian Foundation for Healthcare Improvement works shoulder-to-shoulder with partners to accelerate the identification, spread and scale of proven healthcare innovations. Together, we're delivering lasting improvement in patient experience, work life of healthcare providers, value for money and the health of everyone in Canada. CFHI is a not-for-profit organization funded by Health Canada. Visit cfhi-fcass.ca for more information.
_______________
1 In this context, person-centred approach refers to a way of thinking and improving care where the people using healthcare services are equal partners in planning, developing and monitoring care and ensures it meets their needs
2 Of those still participating in the program at the end of Phase 1 and Phase 2
The views expressed herein do not necessarily represent the views of Health Canada.
SOURCE Canadian Foundation for Healthcare Improvement
For further information:
or to arrange media interviews, please contact: Graeme Wilkes, Senior Director, Communications and Government Relations, Canadian Foundation for Healthcare Improvement, Mobile: 613-698-7538 | Graeme.Wilkes@cfhi-fcass.ca
Canadian icons come together: Canopy Growth and Drake launch new cannabis wellness company
TORONTO and LOS ANGELES, Nov. 7, 2019 /CNW/ - Canopy Growth Corporation ("Canopy Growth" or the "Company") (TSX: WEED) (NYSE: CGC) and Aubrey Drake Graham ("Drake") are pleased to announce that they have entered into agreements to launch the More Life Growth CompanyTM, a fully licensed producer of cannabis based in Drake's hometown of Toronto, Canada.
"When we first began talks with Drake we were extremely inspired by and aligned with his vision to bring best-in-class cannabis products to the world," said Mark Zekulin, CEO, Canopy Growth Corporation. "Drake's perspective as a culture leader and entrepreneur combined with Canopy Growth's breadth of cannabis knowledge will allow our new company to bring an unmatched cannabis experience to global markets."
Drake's eclectic career includes experience across a wide variety of industries including music, television, film, fashion, sports, brand development, content curation and social and digital media strategy. Having launched numerous successful brands over the past decade, he is uniquely positioned to bring his innovative eye to the recreational cannabis industry.
"The opportunity to partner with a world-class company like Canopy Growth on a global scale is really exciting," shared More Life Growth Company founder, Drake. "The idea of being able to build something special in an industry that is ever growing has been inspiring. More Life and More Blessing."
Proudly based in Drake's hometown of Toronto, More LifeTM is centred around wellness, discovery and overall personal growth with the hope of facilitating connections and shared experiences across the globe.
"All in all, we couldn't be more excited to partner with Drake to bring his vision for the More Life Growth Company to global cannabis markets," concluded Mr. Zekulin. "We anticipate a long, successful, and mutually beneficial working relationship."
The Company and Drake will share further details on the More LifeTM team and vision in the weeks to come.
Transaction Details
In connection with the launch of the More Life brand, a previously wholly-owned subsidiary (the "More Life Growth Company") of Canopy Growth, has issued shares to certain entities that are controlled by Drake ("Drake"). Following the issuance of the shares, Drake holds a 60% ownership interest in the More Life Growth Company, with Canopy Growth retaining a 40% ownership.
The More Life Growth Company is the beneficial owner of an entity licensed by Health Canada for the cultivation, processing and sale of cannabis at its production facility in Scarborough, Ontario (the "More Life Facility"). Canopy Growth will continue to provide all of the day-to-day operations and maintenance of the More Life Facility and will retain all of the rights to distribute the product that is cultivated at the More Life Facility.
As consideration for the issuance of the shares of the More Life Growth Company, Drake has granted More Life Growth Company the right to exclusively exploit certain intellectual property and brands in association with the growth, manufacture, production, marketing and sale of cannabis and cannabis-related products, accessories, merchandise and paraphernalia in Canada and internationally. The maintenance of the non-Canada rights after 18 months is contingent upon certain performance criteria of the More Life Growth Company being met. The More Life Growth Company has sublicensed such rights in Canada to Canopy Growth in exchange for payments to be made by the Company on the sale of More LifeTM products, providing Canopy Growth with the exclusive rights to distribute More LifeTM products in Canada. In addition, Canopy Growth has the option to extend the terms and conditions of the sublicense into all international jurisdictions.
Canopy Growth and Drake have entered into a shareholders agreement, investor rights agreements, and various other ancillary agreements to govern the operations of the More Life Growth Company. In connection with these arrangements, Canopy Growth has the right to nominate two directors to the board of the More Life Growth Company as well as a pre-emptive right to maintain its ownership interest in the More Life Growth Company.
Advisors
Cassels Brock & Blackwell LLP acted as legal counsel to Canopy Growth and Reed Smith LLP acted as legal counsel to Drake in connection with the transaction.
Here's to Future (More Life) Growth.
About Canopy Growth Corporation Canopy Growth (TSX:WEED, NYSE:CGC) is a world-leading diversified cannabis, hemp and cannabis device company, offering distinct brands and curated cannabis varieties in dried, oil and Softgel capsule forms, as well as medical devices through Canopy Growth's subsidiary, Storz & Bickel GMbH & Co. KG. From product and process innovation to market execution, Canopy Growth is driven by a passion for leadership and a commitment to building a world-class cannabis company one product, site and country at a time. Canopy Growth has operations in over a dozen countries across five continents.
Canopy Growth's medical division, Spectrum Therapeutics is proudly dedicated to educating healthcare practitioners, conducting robust clinical research, and furthering the public's understanding of cannabis, and has devoted millions of dollars toward cutting edge, commercializable research and IP development. Spectrum Therapeutics sells a range of full-spectrum products using its colour-coded classification Spectrum system as well as single cannabinoid Dronabinol under the brand Bionorica Ethics.
Canopy Growth operates retail stores across Canada under its award-winning Tweed and Tokyo Smoke banners. Tweed is a globally recognized cannabis brand which has built a large and loyal following by focusing on quality products and meaningful customer relationships.
From our historic public listing on the Toronto Stock Exchange and New York Stock Exchange to our continued international expansion, pride in advancing shareholder value through leadership is engrained in all we do at Canopy Growth. Canopy Growth has established partnerships with leading sector names including cannabis icons Snoop Dogg and Seth Rogen, breeding legends DNA Genetics and Green House Seeds, and Fortune 500 alcohol leader Constellation Brands, to name but a few. Canopy Growth operates eleven licensed cannabis production sites with over 10.5 million square feet of production capacity, including over one million square feet of GMP certified production space. For more information visit www.canopygrowth.com
Notice Regarding Forward Looking Statements This news release contains "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Canopy Growth or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Examples of such statements include, among others, statements with respect to the ability of the Company and the More Life Growth Company to bring cannabis products to global markets; and the products that the More Life Growth Company will be offering the adult use market in Canada. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including the Company's ability to bring cannabis products to global markets; the timing and availability of the Company's products in the adult-use market in Canada; the timing and completion of a go-public transaction for the More Life Growth Company; risks related to the production, processing and sale of cannabis; and such risks contained in the Company's annual information form dated June 25, 2019 and filed with Canadian securities regulators available on the Company's issuer profile on SEDAR at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information or forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information and forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise, unless required by applicable securities laws.
Harmony® Test: The first non-invasive prenatal test approved by Health Canada
Canadian women now have access to an approved non-invasive prenatal test
LAVAL, QC, Nov. 7, 2019 /CNW Telbec/ - Pregnant women can rely on the HARMONY test, the first non‑invasive prenatal test approved by Health Canada.
As early as the 10th week of pregnancy, the HARMONY test can analyze fetal cell-free DNA in a sample of the mother's blood and determine the probability of trisomy 21 (Down syndrome) and other common fetal aneuploidies.
The HARMONY test is the only test of its kind to be recognized by Health Canada as meeting its requirements of safety, effectiveness and quality. The HARMONY test is also CE-marked in Europe.
"With this first Health Canada license* granted for a non-invasive prenatal test, Roche is setting a new standard. Pregnant women and health care professionals can now rely on the only test having met the Medical Devices Bureau of Health Canada's rigorous requirements. This is an important recognition about the HARMONY test's consistent technical and clinical performance,'' says Tonino Antonetti, Executive Director, Regulatory Affairs & Quality Management, at Roche Diagnostics, Division of Hoffmann-La Roche Limited, in Canada.
Recognized and proven
With over 59 peer-reviewed publications, Harmony is the most proven non-invasive prenatal test. In clinical studies, it has been shown that Harmony can detect > 99% of trisomy 21 cases, 97.4% of trisomy 18 cases and 93.8% of trisomy 13 cases, with a false positive rate of less than 0.1%.i This non-invasive prenatal test is available in more than 100 countries worldwide to pregnant women of ages 18 years and older.
Screening programs across Canada
In the clinical practice guideline published in September 2017, the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian College of Medical Geneticists (CCMG) recommend that ''all pregnant women in Canada, regardless of age, should be offered, through an informed counselling process, the option of a prenatal screening test for the most common fetal aneuploidies''. ii
Non-invasive prenatal screening tests are currently reimbursed under certain conditions in Ontario (since 2015), British Columbia (since 2016) and Yukon (since 2017). In April 2018, the Quebec Government announced that it would, in the year to come, move forward with public funding for such a test in high-risk pregnancies.
About the Harmony Non-Invasive Prenatal Test
The Harmony non-invasive prenatal test is validated for pregnant women of 18 years and older with more than 1.4 million tests performed worldwide. Over 218,000 samples have been included in 59 peer-reviewed publications regarding the Harmony test iii, including the landmark NEXT study iv published in The New England Journal of Medicine. These studies show that the Harmony test was statistically superior to the existing first-trimester screening practice for the detection of trisomy 21.
The Harmony non-invasive prenatal test is based on cell-free DNA and is considered a prenatal screening test, not a diagnostic test. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document. All women should discuss their results with their healthcare provider who can recommend confirmatory, diagnostic testing where appropriate.
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 have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
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 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
® HARMONY is a trademark of Roche. All other product names and trademarks are the property of their respective owners.
Non-Invasive Prenatal Testing (NIPT) based on fetal cell-free DNA analysis is not a diagnostic test. No irrevocable obstetrical decision should be made on a positive result generated from a Non-Invasive Prenatal Testing (NIPT) based on fetal cell-free DNA analysis, without confirmation by other invasive diagnostic testing.
* Health Canada Class III license.
i Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686.
ii Audibert F et al. J J Obstet Gynaecol Can. 2017 Sep;39(9):805-817. doi: 10.1016/j.jogc.2017.01.032.
iii List of 59 peer-reviewed publications regarding the Harmony test and reference IV below :
1. Ashoor G et al. Fetal Diagn Ther. 2012;31(4):237-43.
2. Ashoor G et al. Am J Obstet Gynecol. 2012;206(4):322.e1-5.
3. Nicolaides KH et al. Am J Obstet Gynecol. 2012;207(5):374 e1-6.
4. Norton ME et al. Am J Obstet Gynecol. 2012;207(2):137.e1--8.
5. Sparks et al. Am J Obstet Gynecol. 2012;206(4):319e1-9.
6. Sparks et al. Prenat Diagn. 2012;32(1):3-9.
7. Ashoor G et al. Ultrasound Obstet Gynecol. 2013;41(1):21-25.
8. Ashoor et al. Ultrasound Obstet Gynecol. 2013;41(1):26-32.
9. Brar et al. J Matern Fetal Neonatal Med. 2013;26(2)-143-45.
10. Fairbrother et al. Prenat Diagn. 2013: March 1-5.
11. Gil MM et al. Ultrasound Obstet Gynecol. 2013;42(1):34-40.
12. Verweij et al. Prenat Diagn. 2013;33(10):996-1001.
13. Wang et al. Prenat Diagn. 2013;33(7):662-6.
14. Song et al J Matern Fet Neonatal Med 2013 Aug 26(12)
15. Gil MM et al. Fetal Diagn Ther. 2014;35(3):204-211.
16. Feenstra et al. Prenat Diagn. 2014;34(2):195-8.
17. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
18. Hooks et al. Prenat Diagn. 2014;34(5):496-499.
19. Nicolaides KH et al. Fetal Diagn Ther. 2014;35(1):1-6.
20. Struble et al. Fetal Diagn Ther. 2013;35(3):199-203.
21. Willems et al. Facts View Vis Obgyn. 2014;6(1):7-12.
22. Wallerstein et al. J Pregnancy 2014.
23. Bevilacqua et al. Ultrasound Obstet Gynecol. 2015;45(1):61-66.
24. Comas et al. J Matern Fetal Neonatal Med. 2015;28(10):1196-1201.
25. Gil MM et al. Ultrasound Obstet Gynecol. 2015;45(1):67-73.
26. Hernández-Gómez et al. Ginecol Obstet Mex. 2015;83(5):277-288.
27. Norton ME et al. N Engl J Med. 2015;372(17):1589-1597.
28. Quezada et al. Ultrasound Obstet Gynecol. 2015;45(1):101-105.
29. Quezada et al. Ultrasound Obstet Gynecol. 2015;45(1):36-41.
30. Stokowski et al. Prenat Diagn. 2015;35(12):1243-1246.
31. Chen et al. Prenat Diagn. 2016;36(13):1217-1224.
32. Gil MM et al. Ultrasound Obstet Gynecol. 2016;47(1):45-52.
33. Gil MM et al. J Matern Neontal Med. 2016:November 1-7.
34. Kagan et al. Arch Gynecol Obstet. 2016;294(2):219-224.
35. McLennan et al. Aust NZ J Obstet Gynaecol. 2016;56(1):22-28.
36. Revello et al. Ultrasound Obstet Gynecol. 2016;47(6):698-704.
37. Sarno et al. Ultrasound Obstet Gynecol. 2016;47(6):705-711.
38. Bevilacqua et al. Fetal Diagn Ther. 2017 Aug 23.
39. Bjerregaard et al. Dan Med J. 2017 Apr;64(4).pii: A5359.
40. Chan et al. BJOG An Int J Obstet Gynaecol 2017
41. Jones et al. Ultrasound Obstet Gynecol. 2018 51:274-277.*
42. Kagan et al. Ultrasound Obstet Gynecol. 2017 Sep 19.
43. Kornman et al. Fetal Diagn Ther. 2017 Sep 6.
44. Langlois et al. Prenat Diagn. 2017 37(12)1238-1244
45. Miltoft et al. Ultrasound Obstet Gynecol. 2017 Jun 22.
46. Richardson et al. Prenat Diagn. 2017 Dec 37(13) 1298-1304
47. Schmid et al. Fetal Diagn Ther. 2017 Nov 8.
48. Scott et al. J Matern Neonatal Med. June 8 2017:1-8.
49. Rolnik et al. Ultrasound Obstet Gynecol. 2018 Jan 10.
50. Schmid et al Obstet Gynecol 2018; 51: 813–817
51. Lee et a Hum Reprod. 2018 Feb 15.
52. Bevilacqua et al Fetal Diagn Ther. 2018 Jun 13:1-10
53. Kagan et al Fetal Diagn Ther 2018
54. Chen et al J Matern Fetal Neonatal Med. 2018 Jun 20:1-4
55. Rolnick et al Obstetrics & Gyn 2018;. 132:2,
56. Kostenko et al Fetal Diagn Ther. 2018 Aug 21:1-11
57. Bevilacqua et al Exp Rev Molec Diagn 2018; 18:7 591–599
58. Galeva et al Ultrasound Obstet Gynecol 2018
59. Kagan et al Arch Gynecol Obstet. 2018 Dec 5.
*Analytical & clinical validations, clinical utility studies. Cost analysis and registry publications are excluded from the samples-studied calculations
iv Norton M, et al. N Engl J Med. 2015 Apr 23;372(17):1589-97
SOURCE Roche Diagnostics
VUMI® Canada, in partnership with Humania Assurance, is proud to announce that this month will be launching a new product for the Canadian market.
Prestige VIP is an innovative health insurance plan specifically designed to expand the health care options for Canadians while offering them easy access to world renown doctors and hospitals worldwide.
Outside of Canada, the plan will work without a providers' network, allowing Canadians to seek treatment with the medical provider of their choice. While in Canada, the plan will complement the Provincial Health Insurance coverage and/or any other employer healthcare plan, allowing them to have more options and the peace of mind of being able to access the best treatment when they need it most.
Prestige VIP is underwritten by Humania Assurance and will be available for individuals, third party administrators (TPA) and corporations. The individual plan will offer deductible options starting at C$250 and a maximum coverage of up to C$5,000,000 per policy year, per person up to the age of 75. For third party administrators (TPAs), the plan will offer coverage up to C$1,000,000, and for corporate groups, coverage that ranges from C$1,000,000 up to C$5,000,000.
Humania Assurance is one the most prestigious and soundest insurance companies in Canada. Founded in 1874, it is a multiple award-winning company that provides insurance coverage to over 200,000 individual and corporate clients.
VUMI® Canada, Inc is a privately-owned Canadian company that is part of VUMI® Group, an international healthcare group that is headquartered in Dallas, Texas, USA and has more than 30 years of experience in the healthcare industry. The VUMI® Canada sales and operations will be under the leadership of Gino Stirpe CHS, a seasoned insurance executive with a proven career track and 30 years in the insurance industry.
"The wide range of benefits of this new plan and the VIP service commitment of VUMI® Canada, together with the award-winning expertise of Humania Assurance, make Prestige VIP a must-have for any Canadian," said David Rendall, CEO of VUMI®.
SOURCE VUMI Group
Xeomin Cosmetic® Licensed for Additional Indications In Canada
Expanded indications build on 10 years of proven efficacy and safety1
BURLINGTON, ON, Nov. 7, 2019 /CNW/ - Merz Pharma Canada Ltd., an affiliate of the global Merz Pharma Group, has announced that Health Canada has provided marketing authorization for additional indications for Xeomin Cosmetic® (botulinum toxin type A, free from complexing proteins), which include use in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines and lateral canthal lines (crow's feet).2
The additional indications build upon the previous indication for the temporary improvement in the appearance of moderate-to-severe glabellar lines, also known as frown lines, between the eyebrows, in adult patients.
The active ingredient in Xeomin Cosmetic® temporarily relaxes the muscle to give the treated area a smoother appearance. It is the first and only neuromodulator free from unnecessary proteins for treatment of frown lines, crow's feet, and forehead lines.2 This 'clean effect' means there is less likelihood of reduced treatment response with ongoing use. 3,4
"Secondary treatment failure and reduced response is being recognized more frequently in aesthetic practice.5 As patients are using neurotoxins more regularly and in multiple facial areas, it's important to consider longer-term use and the need for a treatment that does not contain impurities that are unnecessary and may impact future therapeutic effect," says Dr. Sam Hanna, MD, DABD, Medical Director at Dermatology On Bloor in Toronto, Ontario, Past President of the Toronto Dermatologic Society and a Diplomate of the American Board of Dermatology.
"Xeomin Cosmetic's expanded indications promote panfacial rejuvenation which is increasingly understood to be the standard of care in facial aesthetics. Treating panfacially promotes a more natural and robust aesthetic response which I believe results in better outcomes for patients," he continues.
Market research shows that the treatment of upper facial lines, such as frown lines, crow's feet, and forehead lines are the most requested of all facial indications, with demand growing.6 In its most recent report, the American Society for Aesthetic Plastic Surgery (ASAPS) noted treatment with botulinum toxin continues to grow exponentially, highlighting an increase of 35.8% in the procedure between 2014 and 2018.7
2019 marks 14 years of XEOMIN® availability globally and 10 years in Canada. Leading to its license and since, over 200 publications have supported XEOMIN®'s efficacy, the most notable demonstrating significant effect in the treatment of single indications and combined in the upper face; a favourable tolerability profile and maintenance of results over four months.1,3
Xeomin Cosmetic® requires no freezing or refrigeration so its packaging is simple and eco-friendly, meaning less waste in clinics, easy storage, and less environmental impact along the way as it's delivered to customers.
"We know that purity matters to physicians who inject with Xeomin Cosmetic® - and it matters to their patients.8 We're proud that Merz Canada can provide them with effective and innovative technology backed by science and precise manufacturing, in addition to a more environmentally-conscious option," says Bob Bennett, President and General Manager of Merz Pharma Canada.
About Merz Pharma Canada
Merz Pharma Canada Ltd. is a specialty healthcare company that develops and commercializes innovative, high-quality treatment solutions in aesthetics, skin care and neurosciences in Canada. Founded in 2009, Merz Pharma Canada Ltd. is located in Burlington, Ontario and is a wholly owned subsidiary of the Merz Pharma Group, a privately- owned company headquartered in Frankfurt, Germany. Our ambition is to become the most admired, trusted and innovative aesthetics and neurotoxin company. By developing products that improve patients' health and help them to live better, feel better and look better, we will continue to make significant contributions to the well-being of individuals around the world.
Safety Information
Xeomin Cosmetic® is indicated in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines, lateral canthal lines and glabellar lines. Xeomin Cosmetic is incobotulinumtoxinA (purified neurotoxin free from complexing proteins). Xeomin Cosmetic should only be given by a physician with the appropriate qualifications and experience in the treatment and the use of required equipment. Xeomin Cosmetic should not be used if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin Cosmetic; if an infection is present at the injection site; if you suffer from generalized disorders of muscle activity (e.g., myasthenia gravis, Eaton Lambert-Syndrome). Before you use Xeomin Cosmetic talk to your doctor or pharmacist if you suffer from any type of bleeding disorder; you receive substances that prevent the blood from clotting (anticoagulant therapy); you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection; you suffer from a disease called amyotrophic lateral sclerosis (ALS); you suffer from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction); you have swallowing difficulties; if you had problems with injections of Botulinum toxin type A in the past; if you are due to have surgery. Tell your doctor if you are taking other medicines, especially aminoglycoside antibiotics which may increase the effect of Xeomin Cosmetic. If you are pregnant or breast-feeding, Xeomin Cosmetic should not be used. Side effects following treatment with Xeomin Cosmetic are rare and are generally not serious. The most commonly reported side effects include headache, swelling around the eye, changes in the shape of the eyebrow, drooping of the eyelid and pain and bruising near the injection site. Seek immediate medical attention if swallowing, speech or respiratory problems arise. XEOMIN and Xeomin Cosmetic contain the same active ingredient in the same formulation. Therefore adverse events observed with the use of XEOMIN also have the potential to be associated with the use of Xeomin Cosmetic.
This is not a complete list of side effects. For any unexpected effects while taking Xeomin Cosmetic, contact your treating healthcare provider.
Kersher M, et al. Efficacy and safety of IncobotulinumtoxinA in the treatment of upper facial lines: results from a randomized, double- blind, placebo-controlled Phase III study. Dermatol. Surg 2015;41: 1149-1157.
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Kazerooni R, Decrease in Therapeutic Effect Among Botulinumtoxin Type A Agents: Analysis of the FDA Adverse Event Reporting System Database. AAD Presentation March, 2019.
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Stengel G and Bee E. Antibody-induced secondary treatment failure in a patient treated with botulinumtoxin type A for glabellar frown lines. Clin Interv Aging 2011;6:281-284.
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Kantar Health Survey, 2015.
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The American Society for Plastic Surgery, National Data Bank Report, 2018.
8.
GIM Company for Innovative Market Research. Boucouture Purity Insights; Results of a Quantitative Market Research in UK, Germany, Italy & Russia. September 2017.
SOURCE Merz Pharma Canada Ltd.
Digital Health Week 2019: Join the Celebration!
TORONTO, Nov. 7, 2019 /CNW/ - Canada Health Infoway (Infoway) is inviting Canadians to participate in Digital Health
Week 2019 (Nov. 11-17) to celebrate how digital health is transforming health care in Canada. This is the sixth year for this nationally recognized awareness week, which is once again being held in conjunction with the Infoway Partnership Conference (Nov. 12-13 in Ottawa).
"Digital Health Week is a time to recognize and celebrate our collective achievements in digital health and to raise awareness about the value and benefits that Canadians and our health system are realizing as a result of digital innovations," said Michael Green, President and CEO of Infoway. "In addition to the economic benefits of more than $30 billion from digital health, Canadians are also experiencing better health outcomes as a result of more accurate information, more informed patient/provider communications, timely prescription renewals, and better self-management of health conditions."
Digital Health Week is now part of ACCESS 2022, a social movement to unite people behind a vision of creating a modern, 21st century health system that will give Canadians access to their personal health information and to digitally enabled health tools and services anytime, anywhere, from the device of their choice.
"We invite all interested Canadians — including patients, caregivers, clinicians, industry, innovators and health organizations — to join the movement to help build the health system we would all like to see," Green said.
Once again, dozens of organizations are participating in Digital Health Week activities. Here are some of the events planned during the week:
#HCLDR Tweet Chat — Join the conversation on Tuesday, Nov. 12, 8:30 – 9:30 p.m. ET using #HCLDR and #ThinkDigitalHealth
Digital Health Week (Nov. 11-17, 2019) was created by leading health organizations to celebrate how digital health is transforming care across the country and to increase awareness about the value and benefits of digital health for all Canadians.
About Canada Health Infoway
Infoway helps to improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health across Canada. Through our investments, we help deliver better quality and access to care and more efficient delivery of health services for patients and clinicians. Infoway is an independent, not-for-profit organization funded by the federal government. Visit www.infoway.ca.
Participating Organizations
The following health organizations from across Canada are supporting ACCESS 2022 and Digital Health Week:
Join Us in November—Parkinson's Conferences start this weekend in Ontario
TORONTO, Nov. 7, 2019 /CNW/ - Parkinson Canada, the definitive voice for the Parkinson community in Canada, is pleased to offer the following educational events, in Toronto, Hamilton and London, Ontario this month. These informative sessions are created for people with Parkinson's, their caregivers and families; the healthcare community; students in healthcare studies and the media.
RSVP preferred—seating is limited so book early to avoid disappointment.
Saturday, November 9, 2019—Gaining Ground in Parkinson's Research
Features keynote speaker, Dr. Nicolas Dupré, a neurologist at the CHU de Québec-Laval University, an Associate Professor in the Department of Medicine of the School of Medicine (Laval University), and the Director of the Neuromuscular and Neurogenetic Disease Clinic of the CHU de Québec Université Laval. This full-day event includes an introduction to Canadian Open Parkinson Network (C-OPN) that will accelerate discoveries and the path to a cure. You will also hear from a Parkinson's patient advocate, Benjamin Stecher and more information on Clinical Trials with Dawn Richards of Clinical Trials Ontario. Registration preferred with some tickets available at the door. Free parking. Register Here (special rates below)
10:00 am-3:00 pm Toronto Botanical Gardens—Floral Hall 777 Lawrence Avenue East Toronto, Ontario M3C 1P2
For more information: Alison Li, Community Development Coordinator T: 1 (800) 565-3000 ext. 3373 E: alison.li@parkinson.ca
Saturday, November 9: Dance and Parkinson's: A Dance of Art and Science; with David Leventhal
Parkinson Canada and Hamilton City Ballet Dance for Parkinson's, both members of the Dance for Parkinson's Network, present Dance and Parkinson's: A Dance of Art and Science in Hamilton, Ontario. This free half-day event (9:00 AM—12:30 PM) features keynote speaker David Leventhal, founding teacher and Program Director for Dance for PD®, a complimentary continental breakfast and a dance class with live musicians. Registration is closed—some tickets available at the door—contact paul.scibetta@parkinson.ca or call 1-800-656-3000 x 3337
Venue: Michelangelo's Banquet Centre, 1555 Upper Ottawa St, Hamilton, ON L8W 3E2
Saturday, November 16 Advancing Parkinson Research, Advocacy & Awareness Conference—London, ON
Featuring keynote speaker Dr. A. Jon Stoessl, UBC, Neurologist Researcher, this full-day event (9:00 AM to 3:00 PM) will also include an introduction to the new Canadian Open Parkinson Network (C-OPN), presentations by Parkinson Canada funded researchers; sessions on advocacy and education; includes lunch and snacks. This is Dr. Stoessl's only speaking appearance in eastern Canada this year—do not miss out on hearing from this internationally sought expert on Parkinson's disease. Tickets must be reserved in advance. Student $10, Individual $15, Couples $20.
The audience will receive complimentary copies of the Canadian Guideline for Parkinson Disease, 2nd Edition, which provides practical guidance for physicians, allied health professionals, people with Parkinson's and families on Parkinson's disease management.
Venue: DoubleTree by Hilton, 300 King Street, London, ON N6B 1S2 Do not miss this opportunity to hear Dr. Stoessl in person!
For media inquiries, interviews and passes, contact: Anne Marie Gabriel, CAE, Manager, Communications, 416 227 3396, 1 800 565 3396
Proposed Changes to OHIP include Fundamentally Flawed Policies
TORONTO, Nov. 7, 2019 /CNW/ - Ontario's doctors have always supported a fair and transparent process regarding billing information. It is important for taxpayers to know where their hard-earned dollars are going.
Some changes proposed by the government of Ontario to the OHIP billing process include initiatives that will make the system more open and transparent. Others are fundamentally flawed and give the province sweeping powers that go far beyond what is needed to address any concerns the provincial government has.
These legislative changes ignore the fact that the vast majority of billing issues can be prevented by modernizing and providing education on the OHIP Schedule of Benefits (the Schedule), a confusing system with more than 7,000 billing codes that are written as guidelines–not a detailed document designed to be interpreted literally. Many of these codes are vague and open to interpretation. In a system this large and complex, especially one in which there is a shortage of doctors and where physicians deliver care to more than 340,000 patients every day, mistakes can be made.
For more than 10 years, the OMA has been advocating that the province update the Schedule to make it simpler and clearer. This is a foundational first step and only requires the will of the ministry to move forward.
"We understand that updating the Schedule will require a lot of time and effort. However, we see it as the only effective solution to this problem. A legislative approach such as the one the province is proposing has been tried in the past and was a dismal failure that was shown to have a negative impact on patients as well as physicians. We have repeatedly offered to sit down with the government to do the hard work needed to update the Schedule and to better educate physicians in using it to prevent mistakes," OMA President Dr. Sohail Gandhi said.
The OMA supports increased transparency and making physician billing information public as long as proper context is provided. The OMA supports the province's decision to modernize OHIP cards and eliminate the old red and white OHIP cards to help root out fraud in the system.
As well, the OMA also believes that no doctor should be billing inappropriately. In our experience, this happens rarely and when it does, it must be addressed. The OMA understands from the Ministry of Health it has concerns about deliberate over-billing by as few as 100 of the 31,577 practicing physicians in Ontario.
However, the legislation proposed by the provincial government adversely affects every physician in Ontario. It raises issues of fundamental fairness, puts the onus of proof on physicians, and increases red tape and administrative burdens on physicians. It also contains provisions that allow the government to introduce regulations to unilaterally amend and impose new terms on any existing agreement with physicians.
"The proposed legislation treats every doctor in Ontario as being guilty until proven innocent. Even people who receive a parking ticket have the right of appeal and more access to fair and due process than this legislation gives to physicians," Dr. Gandhi said.
The OMA believes the province already has all the powers it needs to identify issues around inappropriate billing.
As leaders in the medical community, the OMA is actively involved in the health system transformation now underway. We will continue to advocate to correct the fundamental flaws in this legislation and ensure that Ontario has an open and transparent OHIP billing process that is fair to everyone in the system.
About the OMA
The Ontario Medical Association represents Ontario's 43,000 plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.
SOURCE Ontario Medical Association
Janssen Announces Health Canada Approval of IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Patients experienced a 77 per cent reduction in risk of disease progression or death compared to chlorambucil plus obinutuzumab
IMBRUVICA® Product Monograph now includes additional monotherapy long-term follow-up data
TORONTO, Nov. 8, 2019 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announces the Health Canada approval of IMBRUVICA® (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults.1,2 This is the ninth indication for IMBRUVICA® in Canada since its first approval in November 2014, and the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL.
"In just five years, IMBRUVICA® has become an important option for CLL treatment," says Dr. Loree Larratt, Professor in the Division of Hematology in the Faculty of Medicine and Dentistry at the University of Alberta in Edmonton. "Whether as monotherapy, or now in combination with obinutuzumab, IMBRUVICA® is proven to be an effective alternative to chemoimmunotherapy."
Concurrently, the IMBRUVICA® Product Monograph has been updated to include additional long-term efficacy data for IMBRUVICA® use as a monotherapy in CLL, with five years of follow-up from the Phase 3 RESONATE (PCYC-1112) clinical trial and four years of follow-up from the Phase 3 RESONATE-2 (PCYC-1115) trial. This data demonstrates that more than seven in 10 treatment-naïve patients were still progression free after four years on IMBRUVICA®.3
"More effective treatments are needed for Canadians living with CLL," said Antonella Rizza, CEO of Lymphoma Canada. "This combination therapy represents an important new advancement for CLL patients. It is exciting to see that research is continuing to drive progress, providing patients with improved treatment options to consider, in consultation with their health care professionals, in the management of their disease."
About IMBRUVICA® in Combination with Obinutuzumab The latest approval is based on data from the Phase 3 iLLUMINATE study (PCYC-1130), a head-to-head clinical trial comparing IMBRUVICA® plus obinutuzumab to chlorambucil (a chemotherapy agent) plus obinutuzumab. At a median follow-up of 31 months, IMBRUVICA® plus obinutuzumab showed a significant improvement in Independent Review Committee (IRC)-evaluated progression free survival compared with chlorambucil plus obinutuzumab (median not evaluable [NE] vs. 19 months; hazard ratio [HR] 0.23; 95 per cent confidence interval [CI]: 0.15-0.37; P<0.0001), with a 77 per cent reduction in risk of progression or death.4 Patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV) treated with IMBRUVICA® plus obinutuzumab experienced an 85 per cent reduction in risk of progression or death (HR 0.15; 95 per cent CI: 0.09-0.27).5 The IRC-evaluated overall response rate was 89 per cent in the IMBRUVICA® plus obinutuzumab arm versus 73 per cent in the chlorambucil plus obinutuzumab arm.6 The data were presented in an oral session at the 2018 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The Lancet Oncology.
The most common adverse reactions (occurring in 20 per cent or more of patients) of all grades in patients treated with IMBRUVICA® plus obinutuzumab in the iLLUMINATE study were neutropenia (48 per cent), thrombocytopenia (36 per cent), rash (36 per cent), diarrhea (34 per cent), musculoskeletal pain (33 per cent), bruising (32 per cent), cough (27 per cent), infusion related reactions (25 per cent), hemorrhage (25 per cent), and arthralgia (22 per cent).7
About IMBRUVICA® Monotherapy Long-Term Follow-Up With a median follow-up of 48 months (up to 55 months of follow-up) in RESONATE-2 (PCYC-1115-CA) and its extension study among treatment-naïve CLL patients, the median investigator-assessed PFS was not reached in the IMBRUVICA® arm and was 15 months [95 per cent CI (10.22, 19.35)] in the chlorambucil arm; (HR = 0.14 [95 per cent CI (0.090, 0.21)]).8 The 4-year PFS estimates were 73.9 per cent and 15.5 per cent, respectively.9 The Kaplan-Meier landmark estimate for overall survival (OS) at 48 months was 85.5% in the IMBRUVICA® arm and 75.6 per cent in the chlorambucil arm, irrespective of 54.9 per cent of patients who crossed over from the chlorambucil arm to receive ibrutinib treatment.10
In the RESONATE (PCYC-1112) trial among relapsed/refractory CLL patients, at a median follow-up of 55.9 months (up to 63 months of follow-up), the median investigator-assessed PFS was 44.1 months [95 per cent CI (38.54, 56.87)] in the IMBRUVICA® arm and 8.1 months [95 per cent CI (7.79, 8.25)] in the ofatumumab arm (HR=0.14; 95 per cent CI: 0.11, 0.19).11 The Kaplan-Meier landmark estimate for OS at 60-months was 62.2 per cent in the IMBRUVICA® arm and 54.8 per cent in the ofatumumab arm, irrespective of 67.9 per cent of patients who crossed over from the ofatumumab arm to receive ibrutinib treatment.12 The ORR (per investigator) was 87 per cent in the IMBRUVICA® arm versus 22.4 per cent in the ofatumumab arm.13
About Chronic Lymphocytic Leukemia (CLL) CLL is a cancer that begins in blood stem cells, starting in abnormal lymphoid stem cells. It usually develops slowly over the course of months or years. In 95 per cent of cases, the abnormal lymphoid stem cells develop into cancerous, or malignant, B lymphocytes. CLL is one of the most common types of leukemia in adults.14 Over 2,200 people in Canada are diagnosed with CLL each year.15
About IMBRUVICA® IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK) and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.16
IMBRUVICA® was first approved in Canada in 2014. It is indicated for the treatment of patients with previously untreated active chronic lymphocytic leukemia (CLL), including those with 17p deletion; or patients with CLL who have received at least one prior therapy, including those with 17p deletion. It is indicated in combination with bendamustine and rituximab for the treatment of patients with CLL who have received at least one prior therapy. It is also now indicated in combination with obinutuzumab for treatment-naïve patients with CLL. For patients with Waldenström's macroglobulinemia (WM), IMBRUVICA® is indicated as a single agent or in combination with rituximab. Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).
IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA® in Canada.
About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*Dr. Larratt was not compensated for any media work. She has been compensated as a consultant.
*Antonella Rizza, Lymphoma Canada, was not compensated for any media work. Lymphoma Canada has received funds for patient engagement.
Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding IMBRUVICA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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1
IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. November 7, 2019.
