Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate
Similar antibody response in adults and in the elderly after two doses Neutralizing antibody responses were 10 times higher than people recovering from COVID-19 No related severe adverse events reported
QUEBEC CITY and LONDON, May 18, 2021 /CNW/ - Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to report positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago's plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK's pandemic adjuvant. These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing. Immunogenicity, as measured by the neutralizing antibody titer, was high - about 10 times higher than those in a panel of sera from patients recovering from COVID-19. No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.
"We are very excited to see such positive results from the Phase 2 data. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age," said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago. "These results give us confidence as we continue to move forward with our Phase 3 clinical trial. We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide."
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, "We are delighted to see that the results suggest a very strong immune response. Medicago's COVID-19 vaccine candidate, combined with GSK's pandemic adjuvant, was also well tolerated, reinforcing its potential benefits. We now look forward to the outcome of the ongoing Phase 3 trial of the refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic."
The Phase 3 trial of the vaccine candidate launched on March 16, 2021. Trial sites are currently enrolling subjects in Canada, the United States, the United Kingdom, and Brazil, with additional sites expected to be added in the coming weeks. The vaccine candidate has received Fast Track designation by the FDA in the United States, and Health Canada has initiated a review of Medicago's COVID-19 rolling submission under the Interim Order.
About Phase 2: Results Summary
The interim data from Phase 2 trial in adults and in the elderly have been published on an online preprint server at MedRxiv.
This publication focuses on presenting safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-γ and IL-4 ELISpot) responses, in Adults aged 18-64 (Adults) and Older Adults aged 65+ (Older Adults).
Medicago's vaccine candidate with GSK's pandemic adjuvant exhibited an acceptable safety profile and adverse events (AE) were primarily mild or moderate and of transient duration.
AEs in Older Adults were more limited than those observed in the Adult population.
Medicago's vaccine candidate with GSK's pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses.
The vaccine candidate induced a greater humoral response in Adults than Older Adults after a single dose but after the second dose both age cohorts responded with NAb titers that were about 10 times higher than those in a panel of sera from patients recovering from COVID-19.
About the Phase 2/3 study
The Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK's pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities.
The Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It was conducted in multiples sites in Canada and the United States on a population composed of healthy adults (18-64y), elderly adults (over 65y) and adults with comorbidities. Each age group enrolled up to 306 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate which will be the final analysis.
The Phase 3 portion is an event-driven, randomized, observer-blinded, crossover placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in up to 30,000 subjects in North America, Latin America and Europe and within the same population.
About Medicago
Medicago is on a mission to improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-derived therapeutics. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.
SOURCE Medicago
Preliminary results suggest nearly 6% of Montreal children tested from October to April had antibodies to SARS-CoV-2
MONTREAL, May 18, 2021 (GLOBE NEWSWIRE) -- Preliminary results from a study underway in Montreal shed important light on the extent to which 2 to 17 years-old have had COVID-19 between last October 2020 and this April 2021. As an overall average, 5.8% of participating children were found to have antibodies to SARS-CoV-2, the virus that causes COVID-19. However, the seroprevalence (proportion of children with antibodies in their blood) increased sharply over time. In October and November of 2020, only 3.3% of children had antibodies. By April 2021, in the third wave, 8.9% of the students tested had antibodies. The results of this study are preliminary and have not yet been peer-reviewed.
The study which was announced October 20, 2020, named EnCORE, collected finger prick (dried blood spot) samples from 1,632 children and adolescents attending schools and daycares in four neighbourhoods of Montreal: the West Island, Plateau Mont-Royal, Montreal North, and Mercier-Hochelaga Maisonneuve (HOMA).
“Our preliminary results show infections in children and adolescents grew faster in the February-April 2021 period,” says project lead Dr. Kate Zinszer, Assistant Professor at l’École de santé publique, Université de Montréal, and researcher at the Centre de recherche en santé publique. “The results also suggest that seroprevalence is higher in neighbourhoods with lower socio-economic indexes and at a greater percentage for racialized residents. That said, our results could also simply reflect the later timing of recruitment this winter and spring in the Hochelaga-Maisonneuve (HOMA) and Montreal-North areas, corresponding to increased transmission via variants during our third wave.”
Seroprevalence estimates by neighbourhood suggest that 4.8% of children and teens on the West Island had antibodies to SARS-CoV-2, 5.4% in the Plateau, 6.2% in HOMA, and 7.3% in Montreal-North. The blood samples were taken from 354 children in daycare, 725 children in elementary schools, and 553 students in high schools. Looking at the geographical split, 33% were from Plateau-Mont-Royal, 31% from the West Island, 22% from HOMA, and 15% from Montreal-North.
“Interestingly, of the 95 children who tested positive for antibodies with our serology test, 82% had previously tested negative for SARS-CoV-2 or had never been tested for the virus. This means most of the participating children's infections would have gone undetected without this study,” adds Dr. Zinszer.
The survey portion of the study also gives insight into vaccine confidence and the mental health repercussions of the pandemic on Montreal children, teens and their parents.
“Most of the parents surveyed, 86%, said that they were likely to have their child vaccinated against COVID-19, but the percent is lower among visible minorities,” states Dr. Zinszer. “About a third (33%) of parents who were from visible minorities indicated they would be reticent to vaccinate their children.”
When it comes to behaviour and emotional health, surveys filled out by parents suggest 33% of children have had difficulties with emotions, concentration, behaviour, or relationships with other people. In addition, 55% of children have been less physically active, 54% have been spending more time on screens for non-educational purposes, 81% have been spending less in-person time with friends, and 54% are less socially connected. Interestingly, 14% of parents reported their child was more socially connected during the pandemic than she or he had been before COVID hit.
“These preliminary results correspond with growing evidence that COVID-19 is affecting poorer neighbourhoods and racialized communities more than others,” says CITF Leadership Group member Dr. Jim Kellner, a pediatric infectious disease consultant and leader of the CITF’s Pediatric Network. “This means that efforts to protect these communities through public health surveillance, safer workplaces, and tailored vaccine distribution need to be scaled up urgently. As well, vaccinating adolescents is the right thing to do, now that we have vaccines that are Health Canada approved for age 12 and up. Although seroprevalence may have reached 9.6% in some neighbourhoods recently, herd immunity is far off. We need to include younger children in vaccination strategies, offering them safe and effective protection from this very serious illness.”
Recruitment continues
The EnCORE research study is starting its second phase and is calling on all parents and legal guardians with children attending selected schools and daycares to have their children take part. Participation requires a consent form, an online questionnaire, and a home finger prick test. Researchers will inform parents if their child does have antibodies to SARS-CoV-2, although that still does not guarantee immunity against the virus that causes COVID-19. Vaccination is recommended in any case for people who have antibodies to SARS-CoV-2. To participate in the study or see if your child’s school or daycare is participating, please visit the EnCORE website: encorestudy.ca.
About the COVID-19 Immunity Task Force
The Government of Canada established the COVID-19 Immunity Task Force in late April 2020. The Task Force is overseen by a Leadership Group of volunteers that includes leading Canadian scientists and experts from universities and healthcare homes across Canada who are focused on understanding the nature of immunity arising from the novel coronavirus that causes COVID-19. To that end, the CITF is supporting numerous studies to determine the extent of SARS-CoV-2 infection in Canada (in the general population as well as in specific communities and priority populations), understand the nature of immunity following infection, develop improved antibody testing methods, and help monitor the effectiveness and safety of vaccines as they are rolled out across Canada. The Task Force and its Secretariat accordingly work closely with a range of partners, including governments, public health agencies, institutions, health organizations, research teams, other task forces, and engages communities and stakeholders. Most recently, the Task Force has been asked to support vaccine surveillance, effectiveness and safety as part of its overall objective to generate data and ideas that inform interventions aimed at slowing—and ultimately stopping—the spread of SARS-CoV-2 in Canada. For more information visit: www.covid19immunitytaskforce.ca
Canadians Are Not OK, 83% of Canadians Report One Or More Symptoms of Depression With Many Turning To Substances To Cope With Negative Emotions During COVID-19 Pandemic, According to Field Trip Health's First Annual "State of Mind" Survey
New, annual survey commissioned by Field Trip Health reveals that 1 in 4 Canadians self rate their current mental health as fair or poor, with women bearing the brunt of the fallout
More than Eight in 10 Canadians report showing symptoms of depression
TORONTO, May 18, 2021 /CNW/ - Today, Field Trip Health Ltd. (CSE: FTRP) (CSE: FTRP.WT) (OTCQX: FTRPF) ("Field Trip"), a leader in the development and delivery of psychedelic therapies, released the findings of a survey that revealed how Canadians are feeling, how they are coping, and what they are doing to feel better amidst the COVID-19 pandemic. After nearly 15 months of rolling global lock-downs due to the COVID-19 pandemic, it is to no one's surprise that the survey results show a nation in the depths of a mental health crisis.
Key Findings On Current Mental Health: Depressed and Unaware
So depressing in fact, in the last two weeks (prior to the survey), more than half of Canadians felt down, depressed, or hopeless (56%) and felt little interest or pleasure in doing things (59%), while nearly three-quarters felt tired or had little energy (72%).
The survey also found that:
The impact of the pandemic fallout is not being borne equally:
Women are more likely than men to indicate less than ideal mental states (with 30% describing their current mental health as either fair or poor, compared to 20% of men).
Younger Canadians are also more likely to be experiencing the most negative feelings:
34% of 18-24 year olds
26% of 25-34 year olds
32% of 35-49 year olds
25% of 50-64 year olds
12% of 65+ year olds
These negative feelings are so severe that in the two weeks prior to this survey alone, nearly one in four Canadians (23%) have felt that they would be better off dead or thought of injuring themselves.
Canadians Coping Mechanisms
Unsurprisingly, the survey also revealed that Canadians have turned to a number of different coping mechanisms to deal with the negative thoughts or emotions, with drugs and vices being a key source of respite for many.
In particular, of those using the following to cope:
Alcohol and Cannabis. Half have increased their cannabis usage (50%) and alcohol consumption (44%).
Screen Time. Almost three quarters have increased their social media usage (72%) and two thirds have increased their television consumption (67%).
Pornography. More than one in three (40%) have increased their pornography consumption.
Gambling. More than half (53%) have increased their gambling.
Overeating. Almost three-quarters (70%) have increased their excess consumption of food.
Prescription Medication. One in four (25%) respondents reported an increase in the use of prescription medicine since the start of the pandemic. Younger Canadians were also more likely to report an increase in use of prescription medications:
41% of 18-34 year olds
25% 35-49 year olds
25% of 50-64 year olds
17% of 65+ year olds
What Canadians Are Willing to Do To Feel Better
Despite much of the doom and gloom reflected in the survey, there was one silver lining: nearly four in ten Canadians said they are likely to seek professional help in the future to help support their mental health with 39% of Canadians likely to seek a therapist to support their mental health.
And even though 76% of Canadians reported never having tried psychedelics, one in three Canadians (34%) would support the use of psychedelic-assisted therapies after a description of the process, and 20% would be open to trying psychedelic therapies with professional support, with an additional 25% curious to learn more about it.
Those that expressed hesitancy in trying psychedelic-assisted therapies, did so because they do not know enough about it with one in three (34%) stating that they didn't know enough about it or were afraid of the possible side effects (34%).
"Canada is recognized as one of the most forward-thinking, equitable countries in the world", said Ronan Levy, Co-founder and Executive Chairman of Field Trip. "However, the strain COVID-19 is causing on our mental and emotional well-being is shining a light on areas where we can improve, specifically options for mental health care. My hope is that all Canadians, including politicians and regulators, will continue to educate themselves, and their peers on all of the options available to them, including the incredible promise of psychedelic-assisted therapies".
Recent studies published in the New England Journal of Medicine and Nature Medicine suggest that psychedelic-assisted therapies using psychedelic molecules such as psilocybin and MDMA are as good, and very likely orders of magnitude better, than conventional treatments for depression and post-traumatic stress disorder. Other studies are investigating the use of psychedelics and psychedelic assisted therapies for treatment of eating disorders such as anorexia, substance use disorders, migraines, cluster headaches and even Alzheimer's disease.
"This data revealed in this survey isn't shocking to me", said Dr. Mike Dow, a certified Psychedelic Assisted Therapy Expert. "Canada's mental health system has been under strain for years and the COVID-19 pandemic only exacerbated its issues. Psychedelic-assisted therapy using ketamine, which is a legal, Health Canada approved drug, is a way in which we can help those who are bearing the brunt, or simply just not able to cope, with fallout of the pandemic, with a powerful, safe and immediately available treatment option.
With 6 locations operating (Toronto, New York, LA, Chicago, Atlanta and Houston), and 6 more under construction (Amsterdam, San Diego, San Carlos, Seattle, Washington DC and Fredericton), Field Trip has become one of the largest providers of psychedelic therapies in the world with clinics.
Survey Methodology
All figures, unless otherwise stated, are from YouGov Plc. Total sample size was 2015 adults. Fieldwork was undertaken between 20th - 29th April 2021. The survey was carried out online. The figures have been weighted and are representative of all US adults (aged 18+).
About Field Trip Health Ltd.
Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people from those in need, with a simple, evidence-based way to heal and heighten engagement with the world.
This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business, which may include, but are not limited to, statements relating to Field Trip's intended use of proceeds from the Offering. Often but not always, forward-looking information can be identified by the use of words such as "expect", "intends", "anticipated", "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would" or "will" be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management's ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Neither the Canadian Securities Exchange, nor its Regulation Services Provider, nor the OTC Markets have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.
SOURCE Field Trip Health Ltd.
Shocking Increase in Opioid-Related Overdoses Sparks Public Health Crisis & a Call to Action
Baltimore, MD, May 18, 2021 — Tens of thousands of American lives end prematurely every year due to opioid overdoses, leaving families shattered. Dr. Paul Christo, anAssociate Professor in the Division of Pain Medicine at the Johns Hopkins University School of Medicine, wants to remind those battling addiction to make use of telemedicine and tele-mental health services that emerged as valuable resources during the pandemic, and he adds, clinicians need to advocate to their patients that online treatment options are available.
Dr. Christo, who is on the frontlines working to curb the impact of the opioid crisis, also wants patients to know that critical medications for maintaining sobriety can now be prescribed by telehealth or telephone.
"The number of fatalities from opioid-related overdoses could be nearly 30 percent higher than reported due to missing information or incomplete death records,” he says. “The worst fear is that because of social isolation, people are not being found or treated immediately."
The opioid epidemic today progressed in three phases, according to the Centers for Disease Control and Prevention. The first involves deaths caused by prescription opioids, the second, an increase in heroin use, and the third, a surge in the use of synthetic opioids or fentanyl. Experts say the U.S. is right in the middle of the third phase of the epidemic, due to the increasing availability of fentanyl and increasing rates of overdose deaths involving synthetic opioids.
According to a recent study there were 632,331 drug overdoses between 1999 and 2016. Most of these deaths (78.2 percent) were drug overdoses with known drug classification. Moreover, 21.8 percent were unclassified drug overdoses. A further investigation revealed that for unclassified drug overdoses, 71.8 percent involved opioids, translating to 99,160 additional opioid-related deaths.
There were over 70,000 drug overdose deaths in 2017, according to an estimate from the CDC. Based on findings from the new study, over half of those deaths — about 47,000 — are suspected of having involved opioids.
Another study on opioid overdoses found that the number of drug overdose deaths decreased by 4 percent from 2017 to 2018. In 2018, more than 67,000 people died from drug overdoses, making it a leading cause of injury-related death in the United States. Almost 70 percent involved a prescription or illicit opioid of those deaths.
“COVID 19 impacted the drug supply chain by closing borders on some regions, and it led to the higher death rate,” Dr. Christo explained. He added that drugs become more challenging to get, and the potency of overdose goes up. It also impacts the price, everything goes up, and in that sense, it becomes more deadly each day, according to Dr. Christo.
About Dr. Paul Christo
Dr. Paul Christo serves as Director of the Multidisciplinary Pain Fellowship Program at Johns Hopkins Hospital. He is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain. Dr. Paul Christo also hosts an award-winning, nationally syndicated SIRIUS XM radio talk show on overcoming pain called, Aches and Gains®. For more information about Dr. Paul Christo. Please visit www.paulchristomd.com.
Supermax HealthCare Canada announces the appointment of a new Executive Vice President
LONGUEUIL, QC, May 18, 2021 /CNW Telbec/ - Mr. Sylvain Bergeron, owner of Supermax HealthCare Canada is pleased to announce the appointment of Mr. Nicolas Bergeron as Executive Vice-President. This change is effective immediately.
We are confident that this appointment will have a positive impact on Supermax HealthCare Canada. The expertise that Mr. Bergeron has acquired over the past seven (7) years within the company will allow us to achieve new objectives and continue to grow Supermax HealthCare Canada to an enviable level internationally.
This appointment comes as a result of the company's rapid growth over the past five (5) years. Mr. Nicolas Bergeron was one of the main actors of this growth through his interventions at several levels.
We would like to take this opportunity to announce that the manufacturing division of Supermax Medical, created in February 2021, currently has a capacity of 210 million 3-ply disposable medical masks.
Founded in 2004, Supermax Healthcare Canada is a division of the Supermax Group based in Berhad, Malaysia. Supermax Corp in the second biggest disposable glove manufacturer worldwide. Supermax's brand is a synonym of quality.
SOURCE Supermax Healthcare Canada Inc.
Shock and Denial Consume Parents of Addicts
“About Natalie is groundbreaking. It doesn’t preach or pretend to offer a panacea. Instead, it offers a refreshing, authentic look at one family’s struggle with addiction, easily the most powerful book published on the subject in the 21st century.”— Dr. Maryel McKinley PhD, Addictions Expert, Former Co-Host, “All Talk Recovery Radio,” Los Angeles, Arbitron rated No. 1 in Southern California
Pittsburgh, PA, May 18, 2021 — Like the band that played on as the Titanic sank, Christine Naman unpacked the groceries and made a meatloaf — the simple act of normalcy distracting her from an unthinkable reality: addiction was pulling her daughter under.
“Even with the picture of the situation coming more clearly into focus, I clung to denial like a kayaker who has been thrown from his boat would cling to a branch lying across the water,”Christine says. “It is amazing how deep into denial a person can go and how strongly they can hang onto it before reality smacks them around enough so that they let go.”
Christinetraces her daughter's years-long battle with addiction in About Natalie, a gripping, cautionary tale of how, in spite of a loving family and a comfortable life, a child can end up on the wrong path, meet the wrong people and get lost in the unthinkable.
About Natalie takes readers deep inside Christine’s emotional and mental turmoil as she grows into her new, unfortunate role as the parent of an addict. She steps on syringes left on the floor and wrestles one from the family dog’s mouth. She lives the nightmare of finding an unresponsive child on the floor and uses Narcan to revive her. She chases away a drug dealer and stays up all night waiting for her missing child to come home. She rejoices during periods of recovery and hope and is devastated during relapses. When her daughter suffers, Christine suffers right along with her.
Interwoven with Christine’s reflections are Natalie’s compelling poems that share her personal pain and the unvarnished truth of her struggle.
At its core, About Natalie is a story of fighting for — and right alongside — the ones we love, no matter how difficult the circumstances. It is a story of keeping the faith, battling hard and never giving up.
Bestselling author Christine Pisera Naman is a wife to a beautiful man named Peter and a mother to three fantastic kids named Jason, Natalie and Trevor. In her free time, she enjoys crocheting, which she does poorly; painting, again poorly; and volunteering at her local hospital, which she hopes she does well. She is the author of the Faces of Hope series of books that are now housed in the 9/11 Memorial Museum in New York City. Her other works include Caterpillar Kisses, Christmas Lights, The Novena and The Believers.About Natalie is her heart poured onto paper.
She hopes that by sharing her family’s difficult story she can bring understanding and knowledge to those who do not know the problem firsthand as well as provide comfort to those who know the nightmare of addiction all too well.
Sandoz Canada congratulates the Quebec government on implementing a shift towards biosimilars
The shift announced by Quebec will follow a similar approach to policies introduced in British Columbia, Alberta and recently in New Brunswick to transition patients who use a reference biologic to a biosimilar. This will contribute to substantial annual savings that can be reinvested in healthcare and innovative new drugs.
The transition will take place under the supervision of the attending physicians and patients will continue receiving safe and effective treatment. Sandoz Canada has a portfolio of six biosimilars (Omnitrope, Rixymio, Erelzi, Hyrimoz, Ziextenzo and Inclunox).
Sandoz Canada is committed to supporting patients, their healthcare professionals and the Quebec government throughout the transition period with quality biosimilar medicines, medical teams, physician and pharmacist advocacy teams, as well as proven patient support programs.
BOUCHERVILLE, Quebec, May 18, 2021 (GLOBE NEWSWIRE) -- Sandoz Canada, a leader in generic pharmaceuticals and biosimilars, welcomes the Quebec Government’s shift towards biosimilars. According to the government’s announcement, this transition will generate annual savings of more than $100 for the public drug insurance plan and its insured parties. These savings will be reinvested in the healthcare system to improve access to innovative drug therapies, in particular.
Quebec is following the biosimilar transition policies implemented by British Columbia and Alberta in 2019 and, more recently, New Brunswick in 2021. With this announcement, the provinces that have adopted and implemented such a policy now make it possible for almost half of the Canadian population to benefit from it1. Under the Quebec initiative, the province will eventually cover only biosimilar drugs on formularies, with some exceptions, and will transition patients who use the reference biologic medicine to the listed biosimilar by April 12, 2022, under the supervision of their attending physicians.
“At Sandoz Canada, we are pleased to see that Quebec is adopting a switch policy already initiated by other provinces and is moving towards biosimilars. We are ready to support the government, physicians, pharmacists and all healthcare professionals with our six quality biosimilars, while helping to generate significant savings for the healthcare system,” said Michel Robidoux, President and General Manager, Sandoz Canada. “With COVID-19 placing our healthcare system under major budget constraints, biosimilar transition policies are an opportunity to contribute to the sustainability of health system financing and provide funding for new innovations,” he added.
“The government has stated its intention to engage in discussions with key healthcare partners, and Sandoz intends to actively cooperate in these discussions. We want to share our experience with the Ministry in order to provide patients with the highest quality of care. It will also be an opportunity to clarify certain details of the shift towards biosimilars, in particular with the new regulation (section 80.2) coming into effect as part of the Act respecting prescription drug insurance,” said Karine Matteau, Vice President, Bio-Generic Hospital/Physician channel and Head of Biosimilars at Sandoz Canada. “Sandoz is fully committed to supporting patients and their healthcare team during this transition period and beyond through our education initiatives and our patient support programs. We have set up a website for Canadians, BiosimilarsGeneration.ca, which contains a wealth of information and resources related to biosimilars,” she added.
About Biosimilars
A biosimilar is a biologic medicine that has demonstrated it is highly similar and has no clinically meaningful differences in efficacy and safety compared to the reference biologic already authorized for sale.2 Biosimilars may become commercially available following the expiry of patents and data protection periods of the reference biologic medicine.
The Patented Medicines Pricing Review Board has estimated that private and public drug plans across Canada could save from CA$294 million to CA$1.136 billion by 2021 for established biosimilars3 available in Canada for at least two years, and from CA$222 million to CA$447 million by 20234 for new biosimilars that recently entered the Canadian market.
For further information on biosimilars in Canada, visit BiosimilarsGeneration.ca, which aims to support and educate patients, healthcare professionals and Canadians by providing policy updates from public drug plans, as well as evidence-based information and resources from Canadian, international research and clinical communities, and patient organizations representing Canadians living with chronic diseases who take biologic medicines. In addition, the site also presents the positions of organizations that represent Canadian patients with chronic diseases who take biologic drugs.
Since 2009, Health Canada has authorized 36 biosimilars of reference biologics present on the Canadian market5 and Sandoz Canada has six of them marketed in the country (Omnitrope, Erelzi, Ziextenzo, Riximyo, Hyrimoz and Inclunox).
About transitioning
In the context of biosimilar use, Health Canada “considers switching between authorized products to refer to a change from routine use of one specific product to routine use of another specific product. Patients and healthcare providers can have confidence that biosimilars are effective and safe for each of their authorized indications. No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.”6
About Sandoz Canada
Sandoz International GmbH is a world leader in generics and biosimilars and a division of the Swiss multinational Novartis.
Sandoz Canada is a pioneer, a leader and trusted supplier of quality generics and biosimilars with over 65 million prescriptions per year, based on decades of global experience and capabilities in the development, manufacturing and commercialization of its products. Sandoz launched the first biosimilar in Europe in 2006 and in the Canadian market in 2009.
4 Alternative Therapies That Help With Your Energy Levels
If you feel as if your energy levels are just not as high as you would like, you may think the only way to see improvements is to visit a doctor and be prescribed medication. However, there are actually many other types of alternative therapies that can boost your energy levels and make you feel years younger. If you're tired of being tired all the time and want to be filled with plenty of energy day in and day out, try the following alternative therapies.
Tai Chi
An ancient Chinese form of exercise, tai chi is often credited with helping people relieve stress, become pain-free, and have increased energy levels. A low-impact exercise consisting of slow, controlled movements of your body, you can do tai chi on your own or join a local class. Easy to do and learn, it's a great alternative to other forms of exercise.
Light Therapy
If you suffer low energy levels during the winter months, it could be related to seasonal affective disorder, also known as SAD. Should this be the case, light therapy using things like the Visum Light can often be very helpful in getting your energy levels recharged. Since light therapy only takes a few minutes each day, it is an easy and convenient way to start feeling better.
Meditation
While you may think simply sitting still for a few minutes in your favorite chair will accomplish the same thing as meditation, you are wrong. Once you embrace meditation, you will start to reap immediate benefits regarding increased energy levels and focus. Whether you choose to meditate first thing each morning or at the end of your day, a few minutes of deep thought alone will be very beneficial.
Exercise
When you first think about exercising to increase your energy levels, you probably think this will only make you more tired than you already are each day. However, even moderate exercise, such as walking, can help to release endorphins that reduce fatigue and low energy. Best of all, experts agree that you only need about two or three hours of moderate activity each week to see great results. Thus, whether you start walking or decide to work in your yard, exercise is a great therapy to solve your low energy problems.
Once you decide to be proactive about increasing your energy levels, trying any of these alternative therapies should help start to notice improvements in your physical as well as mental energy.
Cutting Edge Foot and Ankle Clinic Treats All Problems of the Foot & Ankle
Cutting Edge Foot and Ankle Clinic in Nashville treats all problems of the foot and ankle and accepts same-day appointments.
Cutting Edge Foot and Ankle Clinic, located at 343 Dickerson Pike, Ste 740, Nashville, TN, uses the latest surgical and non-surgical techniques and procedures to improve their patients’ quality of life and make their feet happy and keep you moving.
Cutting Edge Foot and Ankle treats all conditions of the foot and ankle which include: dermatological skin diseases, such as plantar warts, ingrown toenails, and nail fungus. To deformities such as bunions, hammertoes and flatfeet. They are patient-oriented and pride themselves on same-day appointments, no matter the reason.
Dr. David Farnen, DPM is originally from Southern California but has been a Nashville native for several years. Dr. Farnen completed his B.S. in Biological Sciences from the University of California, Irvine, and obtained his doctorate from Rosalind Franklin University of Medicine and Science / Chicago Medical School in Chicago, Illinois. He then completed his surgical residency training at Eastern Virginia Medical School and the Sentara Hospital healthcare system. Dr. Farnen has a strong enthusiasm and commitment to research. During his medical training, he was awarded an NIH grant to research diabetes and peripheral neuropathy effects on the foot and ankle.
Dr. Farnen is a board-qualified foot-and-ankle surgeon by the American Board of Foot and Ankle Surgery, board-certified by the American Board of Podiatric Medicine with a subspecialty in limb salvage, wound care, and hyperbaric oxygen therapies. He specializes in all aspects, both surgical and non-surgical foot and ankle care. He has a passion for dermatological pathologies, diabetic foot care, wound care, and cutting-edge technologies (no pun intended) in foot and ankle care. Dr. Farnen is a member of the American Podiatric Medical Association and the American College of Foot and Ankle Surgeons.
Dr. Farnen says, "We strive to provide the best care and educate our staff, colleagues, and patients to put their best 'feet forward'. We treat our patients and their family members like our family, because they are a part of our family."
Cutting Edge Foot and Ankle Clinic
Cutting Edge Foot and Ankle Clinic offers the highest quality podiatric care in a comfortable, convenient, and compassionate setting. Our team of licensed professionals specializes in addressing global podiatric concerns in infants, children, teens, and adults. We take pride in diagnosing and treating a variety of foot problems and educating our patients on preventative techniques.
4 Ways You Can Help Yourself Through a Repetitive Strain Injury
When you have suffered a repetitive strain injury involving your hands, wrists, shoulder, neck, or other parts of your body, you suddenly realize just how hard it can be to accomplish even the simplest of tasks without being in pain. However, the good news is that repetitive strain injuries do eventually go away, provided you know what to do regarding proper treatment. If you want to help yourself get through a repetitive strain injury, here are four things you can do to get your body healed up and back on track.
Acupuncture
When you are in pain from a repetitive strain injury, acupuncture has been shown to be a very effective treatment. An ancient Chinese medical technique that has existed for thousands of years, more and more people now use this to get surprisingly effective results. By working with a skilled acupuncturist who can place needles into various pressure points of your body, your injury may heal much faster than you expected.
Physiotherapy
With its goal of restoring normal movement to injured body tissue, physiotherapy can be customized for your particular needs. Combining elements of electrotherapy, joint mobilization, and ergonomics, a physiotherapist from River Oaks Wellness and similar centers can work with you to develop a program emphasizing injury-specific exercises, ergonomics, and more to decrease the chances of the injury reoccurring later on.
Stretching Exercises
If you tend to lead a sedentary lifestyle and perhaps have a job where you sit at a desk working at a computer for hours at a time, the result can be muscles, tendons, and ligaments that over time become shortened and far less flexible, making it easier to sustain a repetitive strain injury. To help with this, stretching exercises are often used on patients with these injuries. Simple and easy to do, they may include stretching your fingers on both hands for 15-20 seconds for up to three times per day.
Massage
If you have an injury to your neck or shoulders, having regular massage therapy can be of tremendous benefit in your effort to heal. From deep-tissue massages to milder forms of massage therapy, visiting a certified massage therapist once a week or more if needed can help your muscles heal and relieve stress.
While it can be frustrating waiting for a repetitive strain injury to heal, using some of these treatment methods can help speed up the healing process. From acupuncture to physiotherapy and more, sticking to a treatment program will soon have you feeling as good as new.
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