Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima™ SC, for the treatment of people with rheumatoid arthritis

• Remsima™ SC is the innovative subcutaneous (SC) version of Celltrion Healthcare's Remsima^® 
• This novel formulation provides an alternative administration option for Canadian physicians and their patients
• Celltrion Healthcare Canada Limited will continue to work to ensure access to innovative, high-quality biologics in Canada and around the world for patients with inflammatory conditions

TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima™ SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA). 

Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.¹ 

Remsima™ SC is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Remsima™ SC should be used as maintenance therapy after the completion of an induction period with intravenous infliximab.² The Health Canada NOC issued for Remsima™ SC is based on clinical evidence that showed the clinical response to Remsima™ subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to Remsima^TM SC at Week 30 was comparable to maintaining Remsima^TM SC up to Week 54 (up to Week 64 for safety profile).^2,3

"Remsima™ SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima™ SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima™ SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment." 

With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima™ SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment. 

As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima™ SC.

"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada. We are proud that Remsima™ SC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company's growth," said Jovan Antunovic, Senior Vice President and Commercial Director at Celltrion Healthcare Canada.

Celltrion has applied for patent protection, until 2038, for Remsima™ SC in approximately 100 countries throughout North America, Europe and Asia. 

Notes to Editors:

About CT-P13 (biosimilar infliximab)^4-6

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima^® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra^®. CT-P13 is approved in more than 94 countries (as of January 2021) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options: via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received EU marketing authorization for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima^® SC will be reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) with the outcome expected by 2022.

About Celltrion Healthcare 

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us 

SOURCE Celltrion Healthcare

Amgen Presents Results From Phase 2 Cohort of CodeBreaK 100 Clinical Study Evaluating Investigational Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC)

The results are the first from a completed pivotal Phase 2 study in NSCLC 
with a median follow-up of more than one year

MISSISSAUGA, ON, Feb. 1, 2021 /CNW/ - Amgen has announced results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) and are the first from a completed pivotal Phase 2 study in NSCLC with a median follow-up of more than one year. Please note the safety and efficacy of sotorasib is still under investigation and market authorization has not been obtained.

Sotorasib demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) in previously treated patients with KRAS G12C-mutated advanced NSCLC. The results were also consistent with earlier Phase 1 results. Patients were treated with sotorasib 960 mg once daily orally, Prior to the trial, 81 % of patients had progressed on platinum-based chemotherapy and PD1/L1 inhibitors, with the remainder progressing after having received one of these therapies.

"There remains a significant unmet need for new therapeutic options to help support patients with advanced non-small cell lung cancer who have failed first-line treatment," said Suna Avcil, executive medical director, Amgen Canada. "Scientists and researchers around the world have invested four decades of research into trying to find these answers. We are encouraged by the results of this Phase 2 study and believe they offer important clinical insights."  

"I am pleased to see continued progress in the development of potential therapies for patients with advanced NSCLC harbouring a KRAS G12-C mutation," said Dr. Adrian G. Sacher, M.D., M.M.Sc., F.R.C.P.C., Division of Medical Oncology & Hematology Princess Margaret Cancer Centre.  "This research is critical to better understanding the disease and, more importantly, moving toward better patient care."

Most treatment-related adverse events (TRAEs) associated with sotorasib were mild to moderate (grade 1 or 2) and no treatment-related deaths. Grade 3 TRAEs were reported in 25 (19.8%) patients and 1 patient (0.8%) reported a Grade 4 TRAE. The most frequently reported TRAEs (any grade) were diarrhea (31.0%), nausea (19.0%), increased alanine aminotransferase (15.1%) and increased aspartate aminotransferase (15.1%). TRAEs led to treatment discontinuation in 7.1% of patients. 

NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.^1,2 KRAS G12C is one of the most common driver mutations in NSCLC³ and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.⁴ Approximately 13 per cent of patients with NSCLC harbour the KRAS G12C mutation.^5,6

Following recent regulatory submissions in the U.S., European Union, Australia, Brazil, Canada and UK, Amgen is working with regulatory agencies across the globe to bring sotorasib to NSCLC patients as quickly as possible. Amgen's request for sotorasib to be considered for accelerated review under the Notice of Compliance with conditions (NOC/c) pathway in Canada was recently determined to be acceptable.

About Sotorasib

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRAS^G12C inhibitor.⁷ Sotorasib was the first KRAS^G12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents. In just over two years, the sotorasib clinical program has established the largest clinical data set with more than 700 patients studied across 13 tumour types to date.

About CodeBreaK

The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to study patients with an advanced solid tumour with the KRAS G12C mutation. 

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumours. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumours (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Canada

As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. 

To learn more about Amgen Canada, visit www.amgen.ca and follow us on www.twitter.com/amgencanadagm.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by Health Canada, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by Health Canada for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

References

SOURCE Amgen Canada

Wellcome grants €1.3 million to RCSI to further develop prognostic blood test for psychotic disorders

DUBLIN, Feb. 1, 2021 -- RCSI University of Medicine and Health Sciences has received a €1.3 million grant from Wellcome to further develop a blood test that can predict whether a person is likely to develop a psychotic disorder years later.

The researchers had previously analysed blood samples taken from people at clinical high risk of psychosis. These individuals were followed up for several years to see who did and did not develop a psychotic disorder.

After assessing the proteins in blood samples and using machine learning to analyse this data, the scientists were able to find patterns of proteins in the early blood samples that could predict who did and did not develop a psychotic disorder at follow-up. 

The most accurate test was based on the 10 most predictive proteins. It correctly identified those who would go on to develop a psychotic disorder in 93% of high-risk cases, and it correctly identified those who would not in 80% of cases.

The grant will now enable the researchers to determine if this test is similarly accurate at predicting who will develop a psychotic disorder from other international groups of clinical high risk individuals. The ultimate goal is to develop a commercially-available test for use in clinical practice so people can be treated earlier and more effectively. 

“Wellcome’s support will enable us to further expand our research and directly benefit patients,” said Professor David Cotter, a professor of molecular psychiatry at RCSI, consultant psychiatrist in Beaumont Hospital, Dublin and investigator at FutureNeuro, the SFI research centre for chronic and rare neurological diseases.

“Ideally, we would like to prevent psychotic disorders, but that requires being able to accurately identify who is most at risk. This grant will allow us to study these markers in other people at high risk of psychosis to confirm our previous findings.”

The work builds on a patent previously filed by the researchers, and this grant marks a key step in commercialising the test. 

“I would like to congratulate Professor Cotter and his team as well as thank Wellcome for awarding RCSI this grant,” said Professor Fergal O’Brien, Director of Research and Innovation at RCSI.

“The funding will be instrumental in carrying out a core mission of RCSI research – translating research from the laboratory directly to the patient. I look forward to seeing this research forge new paths in psychiatric care.”

The grant comes from Wellcome’s Psychosis Flagship, which aims to reduce the global burden of psychosis by improving diagnosis, maximising the impact of early treatment and by developing novel, targeted interventions. 

On this project, RCSI will collaborate with researchers from the UCD Conway Institute and from Cardiff University. Other collaborators include those from the University of Melbourne, Yale University, University of North Carolina at Chapel Hill, University of Bristol, Trinity College Dublin and Kings College London.

“Identifying individuals who are most at risk of developing psychosis is a key challenge in the field. Overcoming this could enable early interventions that will help improve outcomes for patients, which is the vision of Wellcome’s Psychosis Flagship,” said Dr Lynsey Bilsland, Deputy Head of Programme, Translation & Portfolio Integration at Wellcome.

ENDS

About RCSI University of Medicine and Health Sciences

Ranked number one globally for Good Health and Well-being in the Times Higher Education (THE) University Impact Rankings 2020, RCSI University of Medicine and Health Sciences is an international not-for-profit university, with its headquarters in Dublin. 

RCSI is exclusively focused on education and research to drive improvements in human health worldwide. It is among the top 250 universities worldwide in the THE World University Rankings (2020) and its research is ranked first in Ireland for citations. RCSI has been awarded Athena Swan Bronze accreditation for positive gender practice in higher education.

Visit the RCSI MyHealth Expert Directory to find the details of our experts across a range of healthcare issues and concerns. Recognising their responsibility to share their knowledge and discoveries to empower people with information that leads them to better health, these clinicians and researchers are willing to engage with the media in their area of expertise.

About Wellcome 

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, global heating and infectious diseases. 

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New Brain Science Approach to Mental Health

New 8-week Masterclass harnesses power of cannabis to resolve trauma and difficult emotions

January 28, 2021, Tampa, FL— Everyone struggles with past trauma and resulting difficult emotions. For many, the past year has exacerbated these feelings.

The problem with sadness, anger, fear, guilt and shame is that unless you find the root cause, you never do more than slap a band-aid on the issue. Becca Williams, a board member of the American Academy of Cannabinoid Medicine, one of the only certified Emotional Liberation™ teachers in the world, offers a unique cannabis assisted emotional recovery program designed to find the cause and release all of the associated negative emotions and feelings.

Cannabis' ability to facilitate brain and nervous system reorganization and healing aligns closely with the established benefits of meditation – and for many amplifies and accelerates the process. William’s program is a synthesis of cutting edge brain science and ancient Eastern practices. 

“The cannabis isn’t the solution, it’s more like a mental lubricant,” said Williams. “It’s like a truth serum.”

Williams advises patients on what is the best CBD or cannabis for their individual needs. The cannabis is integrated with the meditation portion of a session.

In addition to the eight-week masterclass, private session packages are available. All programs are virtual to allow clients to join from anywhere from the privacy and safety of their own home.

To learn more about cannabis-assisted emotional recovery or to interview Becca Williams, please contact dena@provenmediaservices.com

About Becca Williams

Becca Williams is a yoga therapist and educator who specializes in cannabis-assisted emotional & trauma recovery. Her practice integrates ancient healing modalities that utilize expressive movement and breathwork techniques with the judicious use of cannabis. Becca is a registered dietitian/nutritionist, a certified Emotional Liberation® facilitator and a long-time cannabis advocate and activist. She holds certificates from healer.com in Cannabis Core Curriculum, Dosage Protocols & Methodologies, CBD Essentials and Clinical Application. Becca has worked as a group facilitator, speaker, and mentor for personal and collective transformation for more than two decades. She was the founder of MJ Straight Talk, which aired on the Free Speech Network. Becca is on the board of the American Academy of Cannabinoid Medicine and a member of the Society of Cannabis Clinicians and NORMAL.

January is Glaucoma Awareness Month: Don’t Go Blind from Glaucoma

New York, NY, January 29, 2021 — It’s the new year and one of your resolutions should be to get your eyes checked, advises Dr. Daniel Laroche, Director of Glaucoma Services and President of Advanced Eyecare of New York. Despite the busyness of the new year, he says it’s still important to stay on top of regular doctor visits, including visits with your eye doctor.  

What is Glaucoma? Glaucoma is a disease of the eye characterized by three components:

1. Damage and loss of the retinal ganglions cells and optic nerve described as cupping

2. Loss of visual field

3. Usually increased eye pressure (the mean normal eye pressure is 15mmHG)

People at risk for glaucoma include the elderly, Blacks, people with elevated eye pressure, primary relatives with glaucoma, persons with high myopia, high hyperopia, history of eye trauma and diabetes. Blindness from glaucoma is insidious. In most cases, there is no pain, and the loss of vision occurs slowly from peripheral to central. The central reading vision is not affected until the end, thus most people do not realize it until they have lost a substantial amount of their peripheral vision. In low or normal pressure glaucoma, the central vision may be affected first.

The elevated intraocular pressure damages the optic nerve both mechanically and creates decreased blood flow to the eye. The most identifiable cause of glaucoma is the enlarged lens or cataract in the eye. Early cataract surgery and trabecular bypass has become the best option to stop vision loss in patients with glaucoma. The current use of eyedrops and laser help to lower intraocular pressure but do not address the causative mechanism of the glaucoma being the enlarged lens. Incisional cataract surgery and glaucoma surgery is often needed to truly stabilize glaucoma. 

All people should be screened regularly for glaucoma as part of a medical eye exam. Screening should consist of an eye examination consisting of gonioscopy (examination of the drainage angle), intraocular pressure measurement with Goldmann applanation tonometry and a dilated optic nerve examination. If there appears to be any damage to the optic nerve or abnormal pressure, then a visual field test should be performed, and optic nerve photos taken. Persons with thin corneas should be more aggressively monitored and treated for glaucoma as the disease tends to be worse in these patients.

If you have eye pressure or glaucoma and feel that you may be losing vision, Dr. Laroche recommends that you seek the care of a glaucoma specialist for a second opinion. DON’T GO BLIND FROM GLAUCOMA! People with conditions such as glaucoma and diabetic retinopathy that could lead to blindness if left unchecked need to stay particularly vigilant with their checkups. The pandemic shouldn’t keep you from visiting your doctor, but for patients over 60, Dr. Laroche advises it's better to stay home and do telehealth visits or video consultations until the pandemic flattens. He also encourages people to wear face masks on visits and maintain social distancing, even if they are in a health clinic, and if you’re high-risk, consider adding eye protection when in public spaces.

“Eyesight or human vision is one of the most important senses. As much as 80 percent of what we feel comes through our sense of sight. By protecting the eyes, people will reduce the chance of blindness and vision loss while also staying on top of any developing eye diseases, such as glaucoma and cataracts. 

“A healthy brain function requires a healthy vision. The brain is our most essential organ, and it allows us to control other organs. Normal and healthy vision contributes to improved learning and comprehension for a better quality of life,” says Dr. Laroche.

About Dr. Daniel Laroche

Dr. Laroche is an exceptional glaucoma specialist in New York. He studied and received his bachelor's degree from New York University and a medical doctorate with honors in research from Weil Cornell University Medical College. He underwent a medical internship at Montefiore Hospital and finished his ophthalmology residency at Howard University Hospital in Washington D.C., where he was the chief resident in his third year. He later completed his glaucoma fellowship at New York Eye and Ear. 

For more information about Dr. Laroche, please call (212) 663-0473 or visit: www.advancedeyecareny.com. To learn what causes glaucoma, please watch https://www.youtube.com/watch?v=iEKOj-KJ0oo. To watch a glaucoma procedure, please visit https://www.youtube.com/watch?v=u7gS-7fGXGE&list=UUXVc2YbXJZGBSgtoknvid8w&index=4&t=2s. 

Cutback Coach is creating a new wellness category in proactive alcohol health

Stepping into the newest frontier of wellness, mindful drinking, Cutback Coach is creating a new category in wellness, proactive alcohol health. With their recent infusion of 3.1 million in seed funding, Cutback Coach is already helping thousands of people build better habits around their alcohol consumption. Backed by some of the biggest names in health and wellness including Mike Lee of MyFitnessPal and James Park of FitBit, Cutback Coach hopes to make counting drinks as common as counting steps or counting calories. Co-Founders Nick Allen and Ian Andersen announced the nationwide launch of their proactive alcohol health platform, with the goal of helping anyone who regularly drinks alcohol build more mindful drinking habits.

Cutback Coach is poised to help millions build a healthier relationship with alcohol in 202. Just as you don’t need to be extremely out of shape to get benefits from tracking calories and steps, you don’t need to be an extremely heavy drinker to improve your overall health by tracking your alcohol consumption. Our goal is to help people be more mindful about their drinking, especially after the challenges 2020 presented for many of us,” says CEO and Co-Founder Nick Allen. With 3 in 4 US adults drinking more in 2020 vs. 2019, the founders see now as the perfect time to re-examine our collective relationship with alcohol. 

Unlike the vast majority of alcohol health apps and programs in the market today, Cutback Coach is focused on mindful drinking rather than an all-or-nothing approach. The program is designed for people who enjoy drinking and have no desire to quit, but who occasionally feel the impact of overconsumption. Cutback Coach provides a personalized plan for each participant, incorporating their lifestyle characteristics, baseline habits, and individual goals. After a 6 month beta program, in which thousands tested the product and experienced an average of 29% reduction in weekly alcohol consumption after 4 weeks,

Cutback Coach leverages proven behavioral psychology strategies to support users in balancing their drinking to achieve health benefits including better sleep, weight loss, increased productivity and more energy. The program takes a novel approach in that it’s delivered entirely via 2-way text message, providing an easy, effective and high- touch method for daily participation. Some tips that Cutback Coach provides to help build mindful drinking habits include;

• Implementing “dry days” throughout the week
• Taking 5-10 minutes between drinks
• Cutting out the last drink of the night that you don’t really want, and that makes you feel worse the next morning

With February looking like “New New Year” and many people taking personal inventory around their personal habits, we wanted to put Cutback Coach on your radar.

Doctors demand action to prevent more COVID-19 outbreaks and deaths in long-term care

TORONTO, Jan. 28, 2021 /CNW/ - Premier Doug Ford must act immediately to end the humanitarian crisis ravaging Ontario's long-term care homes before more of the province's elderly and vulnerable residents get sick and die from COVID-19, Ontario's doctors said today.

"We cannot allow this deplorable situation to continue one minute longer," said Dr. Samantha Hill, president of the Ontario Medical Association. "The vaccine supply is beyond our control, but there are many other effective initiatives we must take immediately to safeguard our most vulnerable." 

The Ontario Medical Association called on the government to implement the following measures immediately:

• Provide paid sick days to all employees, including those in long-term care, so no one has to make the difficult decision whether to stay home if they have or suspect they have COVID-19 or feel obliged to go to work to earn money for food or rent. 
• Hire and train more people to work in long-term care, and work with doctors to aggressively shift societal attitudes so that caring for older adults is considered to be one of the most important jobs in the world. 
• Require long-term care homes to immediately implement a staff and visitor screening program that includes the rapid antigen test that detects people who are not yet showing symptoms of COVID-19. 
• Give priority for COVID-19 vaccines to long-term care residents and health-care providers. 
• Provide funding to ensure all long-term care staff receive adequate training in infection prevention and control, including the proper use of personal protective equipment, and that they have adequate supplies of PPE.

"Societies are judged by how they treat their elders and most vulnerable members," said OMA CEO Allan O'Dette. "History will judge us poorly unless we all move quickly, within our areas of authority and expertise, to improve conditions in long-term care homes."

These recommendations build on others the OMA has made to the government and Ontario's Long-Term Care COVID-19 Commission.

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

Bariatric Surgery Associated with Diabetes Remission, Reduced COVID-19 Risk

Surgery in progress, photo credits ©Nordclinic

In addition to enhanced cosmetic appearance, bariatric surgeries lower the chance of hospitalization and death from COVID-19 and have an impact on reducing and preventing other severe obesity-related diseases

January 29, 2021. Worldwide obesity rates have nearly tripled in the last 45 years, leading to the rise of weight-loss surgeries. While commonly obesity is related to such diseases as type 2 diabetes and hormonal imbalances, recent studies have found a link between disproportionate fat distribution and severity of COVID-19, which doubles the risk of hospitalization and death from the coronavirus. When the traditional weight-loss strategies like physical activity or diets are insufficient, doctors may recommend bariatric surgery.

Bariatric surgeries make changes to the patients' digestive system, helping them to lose weight when the other options have proved unsuccessful. Gastric bypass, one of the most common bariatric procedures, involves creating a small pouch from the upper part of the stomach and connecting it to the small intestine. As a result, the swallowed food bypasses most of the patient‘s stomach and part of the small intestine, and they will feel full with less food. Other variations, such as gastric sleeve, decrease the size of the stomach to reduce food intake, resulting in long-term weight loss.

"For severely obese patients with BMI of 40 or higher, bariatric surgery can have a critical impact on the quality of life. In addition to an enhanced cosmetic appearance, bariatric procedures also prevent future health problems and often lead to remission of severe diseases, such as type 2 diabetes. In the long run, this helps tremendously when it comes to contracting and fighting the coronavirus," said prof. Almantas Maleckas, a leading surgeon at Nordbariatric Clinic, a forefront medical institution for bariatric weight-loss surgeries in Kaunas, Lithuania.

A recent study found that those patients who have had weight-loss surgery are less likely to be hospitalized for the coronavirus. As for diabetes, 80-85% of the risk of developing type 2 diabetes is accounted to obesity, while weight loss is associated with a reduced risk of the disease. Within five years of the procedure, most people with type 2 diabetes have achieved remission. Gastric bypass surgery produces the best results with the lowest rebound rates even for patients who have complex medication regimens or poor control of blood sugar. 

“More than half of our clinic’s patients have obesity-related diseases. Some of these can lead to fatal conditions, such as heart attacks or strokes, and are extremely problematic when it comes to catching and treating the coronavirus. In these cases, bariatric surgery can be a life-saving procedure, and some of our patients have already expressed gratitude for becoming more resilient in the face of the virus,” said prof. Maleckas. “Unfortunately, patients often face prolonged waiting times or delays in most of the countries worldwide. Each month, Nordbariatric Clinic performs over 50 bariatric surgeries, ensuring short waiting periods and safety. Each patient is tested for COVID-19 and receives the necessary post-surgery care.”

Bariatric surgery can also benefit people who suffer from various gastrointestinal disorders. One of the most common conditions is acid reflux or gastroesophageal reflux (GERD), closely associated with obesity. Gastric bypass can provide a substantial long-term improvement in GERD symptoms, such as heartburn and reflux. A study that followed morbidly obese patients with GERD before and after receiving a gastric bypass operation shows that the procedure can successfully alleviate the GERD symptoms for the majority of patients.

When starting a family, obesity can also affect couples’ ability to get pregnant. By reducing the excess weight, bariatric surgery helps to restore hormonal balance for men. This increases sperm count and its concentration, increasing the chances of conception. For reproductive-age women, bariatric procedure mediates the regression of polycystic ovarian syndrome, the most common cause of infertility. After the surgery, the size of the ovaries is restored, and the period cycle returns to normal, promoting successful pregnancy.

"Unfortunately, obesity is becoming more common around the globe and affects every aspect of one’s life. It is a delicate subject matter that requires a sensitive approach, especially when considering the raging pandemic. If every other method of weight-loss fails, surgical weight-loss procedure may be a solution that will improve the overall quality of life and prevent serious complications," concluded prof. Maleckas. 

Patients choose Nordbariatric Clinic mostly because of the high-quality services offered by the team of prof. Almantas Maleckas. A surgeon with 15 years of working experience in Sweden, Gothenburg University hospital, treats patients both in Sweden, UAE and Lithuania and has already carried out more than 6,000 bariatric surgeries working in this highly specialized and complicated field where a specialist's competence and experience are essential.

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ABOUT NORDBARIATRIC 

Nordbariatric is a private bariatric surgery clinic in Kaunas, Lithuania, part of Nordclinic, offering high-quality services and focusing on foreign patients. It is equipped with modern diagnostic and surgical facilities. Medical professionals at the clinic speak fluent English and show personal attention to every patient. www.nordbariatric.com/en/