Roche’s antibody cocktail for COVID-19 may face affordability issues in India, says GlobalData
Following the news that Roche has received emergency use authorization (EUA) for a COVID-19 antibody cocktail casirivimab and imdevimab;
Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:
“Roche’s antibody cocktail casirivimab and imdevimab are among the only two drugs to be exclusively developed and approved for COVID-19 treatment. Bamlanivimab and etesevimab being the other antibody cocktail from Eli Lilly. Most of the approved therapies for COVID-19 are repurposed, where they showed benefits in COVID-19 patients, but the original drug was in development or approved for other indications.
"According to GlobalData’s Pharma Intelligence Center, India is the second country to approve Roche’s COVID-19 antibody-drug cocktail casirivimab and imdevimab. In November 2020, the US was the first country to approve it. Moreover, Roche’s partner Regeneron has applied for the US approval as a preventative treatment.
“The Central Drugs Standards Control Organisation (CDSCO) of India has fast-tracked Roche’s antibody-drug cocktail approval based on the data with the US FDA and the scientific opinion of a European regulatory panel. The drug has shown to reduce hospitalizations in COVID-19 patients at a high risk of developing severe COVID-19.
“India is currently struggling with the severe second wave of COVID-19 with more than 350,000 cases daily and with drug shortages as well. To improve the overall situation concerning a lack of available treatments, the CDSCO has recently approved Natco’s baricitinib to be used with remdesivir, Zydus Cadila’s Virafin (pegylated interferon alpha-2b) whereas Merck’s partner Natco has applied for emergency approval for molnupiravir in India.
“Roche’s antibody cocktail will be distributed by its partner Cipla in India. Considering that it is a combination of two recombinant human immunoglobulin G-1 (IgG1) monoclonal antibodies, it is expected to be highly expensive compared to other treatment options available for mild to moderate patients and will not be an affordable treatment for many patients. Therefore, the drug will be primarily available for patients in metro and top-tier cities in India, where the number of patients who can afford this drug are high. Moreover, it needs to be seen how the cocktail antibody works against the new variants in India like the ‘double mutant’ variant and other variants being reported in India.”
Pomelo Health launches a revamped healthcare platform to the Quebec market
MONTREAL, May 6, 2021 /CNW Telbec/ - Pomelo Health is announcing the Quebec launch of the newest version of their patient engagement software, the Pomelo Platform.
Over the last decade, Pomelo Health (formerly known as Chronometriq) has made a name for itself in the health tech space by helping millions of patients get better access to care via an EMR-integrated software for clinics featuring online appointment booking, automated reminders, as well as a registration kiosk.
The latest release offers an array of new tools, such as secure communication, remote check-in, mass communications, video consultations, and a patient portal, where patients can get access to their health journey and engage in secure communications with their clinic. Available as a standalone software, or as an integrated add-on to EMRs, the Pomelo Platform leverages additional touchpoints with patients and enables healthcare providers to focus on offering optimal care.
CEO & co-founder Yan Raymond-Lalande explains:
"We're really excited to offer a fully revamped platform to the Québec market, where it all started for us 10 years ago. We worked with doctors, clinic staff and governments to design a versatile piece of software that meets the growing needs of the healthcare industry, while still remaining focused on the patient. The Pomelo Platform was built to enhance the patient experience and be adaptable enough to become the clinic's core communication solution - both now and after the pandemic."
The last year has prompted significant acceleration in the adoption of new technology within the healthcare industry, resulting in an increase in clinic capabilities and a shift in patient expectations. The release of the Pomelo Platform comes in at the perfect time to fuel this new dynamic.
This new addition also paves the way for Pomelo Health in new verticals such as hospitals and pharmacies, namely for COVID-19 testing and vaccination. The Pomelo Platform is already implemented in hundreds of pharmacies across North America and is trusted by thousands of healthcare professionals.
About Pomelo Health Pomelo Health, formerly Chronometriq, was founded in 2012 with the sole purpose of improving access to healthcare. The company acquired competitor Health Myself in 2020 and is one of the fastest growing companies in healthcare software, with offices in Montreal, Toronto and Boston. It offers a full platform of products to improve clinics' productivity, efficiency and communications with patients.
SOURCE Pomelo Health
Should a Person with Autism Be Allowed to Become a Professional Boxer and Put His Life at Risk?
Forest, VA, May 6, 2021― It’s a struggle that parents of children with special needs face every day and well into that child’s adulthood: how much decision-making latitude is safe?
NOKI is an empowering story from Douglas Farrago, MD, about a young man with autism who wants to become a professional boxer. Life’s circumstances have dictated the reason for him choosing this path. The lawless world of boxing has its reasons for embracing Noki and his abilities. And they are not good ones. So, the debate wages on: Should Noki be allowed to make the life-altering decision to enter the ring and put his life on the line?
Meanwhile, what few know is that Noki is actually a savant and can imitate and transform himself into any legendary boxer he wants — a plot twist that allows NOKI to pay homage to some of the greatest boxers of all time.
Dr. Farrago draws upon his experiences as an All-American collegiate boxer, a sports medicine trainer for professional boxers in Houston and his decades-long career in medicine during which he worked with autism patients to lend authenticity to his characters and narrative.
“Noki becomes somewhat of a hero to those with special needs in this story, which I think is pretty cool,” he said. “I felt it would be nice if a story showed that those with autism don’t need to be anything but themselves, and maybe it is the rest of us who need to change.”
Ultimately, NOKI is a heartwarming story that will spark real conversations about the limits that society places on people with special needs. Knowingly or not.
Author Douglas Farrago, MD, is board certified in the specialty of Family Practice. Recently retired, he had a large following of autistic and special needs patients in his career. Dr. Farrago is the inventor of the Knee Saver, which is currently in the Baseball Hall of Fame. The Knee Saver and its knock-offs are worn by many major league baseball catchers. He also invented the CryoHelmet, used by athletes for head injuries as well as migraine sufferers.
Dr. Farrago received his Bachelor of Science from the University of Virginia in 1987, his Master of Education degree in Exercise Science from the University of Houston in 1990 and his Medical Degree from the University of Texas at Houston in 1994. His residency training occurred way up north at the Eastern Maine Medical Center in Bangor. Dr. Farrago still blogs every day on his website Authenticmedicine.com and lectures worldwide about the present crisis in our healthcare system and the effect it has on the doctor-patient relationship. Dr. Farrago has written six books to date, his latest one being NOKI.
Absolutely! Gluten-Free Launches New Look and Varieties
of the Delicious Grain-Free Snacks You Will ABSOLUTELY Love!
Bayonne, NJ (May 2021) – The top innovator in gluten-free snacks, Absolutely! Gluten Free, is showcasing their delicious new line of sweet and savory products with a fresh new look & feel to their packaging, just in time to Celebrate Celiac Awareness Month this May!Absolutely! Gluten Free’s new packaging and varieties showcase the innovative high-quality products offered and the brand’s commitment to flavorful, gourmet gluten-free snacks with a modern twist. The delicious new line includes an assortment of sweet and savory snacks are made with clean and wholesome ingredients that are absolutely, positively free of not only gluten, but grain, rice, corn, soy and dairy.
No matter the reason you choose to eat gluten-free, Absolutely! Gluten Free line of real, wholesome snacks and treats are the perfect choice for any occasion. Stock up for school or work snacks, family dinners or small celebrations, or to make your mom something extra special for Mother’s Day, Absolutely! Gluten Free is so good that everybody will want to eat them! The delicious product line includes:
Absolutely! Gluten Free’s popular crackers and flatbreads are crisp, crunchy, and delicious, with a wide range of flavors including Original Variety, Toasted Onion, Everything, and Cracked Pepper. The crackers and flatbreads are perfect for that amazing cheese and charcuterie board, for dipping, topping, to accompany with soups or salads, or straight out of the box.
New Absolutely! Gluten Free’s Coconut Chews answer your calling for something sweet and decadent. The chocolate drizzled Coconut Chews are moist, soft coconutty sweets that now come in two new flavors – Key lime and Blueberry.
The wildly popular Absolutely! Gluten Free Macaroons are available in Chocolate, Coconut, and Cranberry. These mouthwatering chewy bites of goodness are sure to satisfy everyone’s sweet tooth.
“Absolutely! Gluten-Free, is the must have product line not only for people who are seeking to eliminate gluten from their diets, but for people who are looking to discover delicious snacks and treats that are also healthy and free of allergens.” Says Laura Morris, Associate Marketing Director for the brand. “Absolutely! Gluten Free is ‘proof of the pudding’ that gluten-free can also mean delicious.”
All Absolutely! Gluten Free products are all-natural, certified gluten-free, and OU certified kosher. AGF is a division of Kayco Foods based in Bayonne, NJ. To learn more about Absolutely! Gluten Free visit the website https://www.absolutelygf.com
20 Tenets to Help Women Lead Purposeful, Successful Lives Revealed in The Woman Code
Morning Joe Host & Author of Know Your Value, Mika Brzezinski, Pens Foreword
Washington, D.C., May 6, 2021 — The pandemic forced everyone to pivot and re-prioritize, and for many women, that meant putting themselves last. Now, more than ever, women need to know their value, recognize their worth and fill their own cups first.
“Women are the soul of what keeps the world going. We keep our families, our companies, our communities and our nations intact,” explains Sophia A. Nelson, acclaimed journalist and author of The Woman Code: 20 Powerful Keys to Unlock Your Life (April 2021, Health Communications).
Named one of the most inspirational books by Woman’s Day in 2015-2017, this transformative book is updated with new insights about the profound economic and societal shifts that have changed our world since the pandemic. Nelson guides women through living out a powerful life Code that will lead them to purposeful, meaningful and authentically successful lives.
Every woman lives by a Code, whether she realizes it or not. It informs how she treats herself and others and how far she is willing to go in order to find success. Nelson calls on women to examine whether the Code they’re living by is truly helping them create the lives they desire. A senior columnist for USA Today and a frequent commentator on CNN, Nelson reveals 20 powerful Codes including:
Know Your Value
Be Resilient
Choose Your Thoughts and Words Wisely
Lift Other Women as You Climb
Practice Love, Laughter, Loyalty
With life quotes from philosophers and poets, mystics and her maternal grandmother, plus her experience as a Black woman rising through the ranks of a male-dominated news industry, The Woman Code is an essential tool of transformation for women to enjoy in reading groups, retreats and Bible study groups. It will help women honor themselves while navigating the demands of work, home, family and friendship no matter what their age or stage in life.
About the Author
Sophia A. Nelson is an award-winning American author and journalist who appears regularly on CNN’s Inside Politics and Newsroom as a legal and political analyst. She is an adjunct professor in the Department of Philosophy and Religion at Christopher Newport University in Newport News, Virginia.
Nelson covered former First Lady Michelle Obama at the White House from 2010–2012. The author appears frequently on CNN and has been a contributor to MSNBC, NBC, Fox News, the BBC, ABC World News with Diane Sawyer and the Today show. She writes for The Huffington Post Healthy Living and The Daily Beast. She has also contributed to USA Today, Essence, The Wall Street Journal, The New York Times and The Washington Post. She is the author of The Woman Code, Black Woman Redefined, and E Pluribus ONE.
ADELAIDE, AUS, May 7, 2021 - (ACN Newswire) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.
Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).
This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).
In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.
The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.
Avance Clinical CEO Yvonne Lungershausen said OGTR accreditation is important for our international clients. "Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector," she said.
Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.
Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include: 1. The Government R&D grant means up to 43.5% rebate on clinical trial spend 2. Telehealth pivot during COVID-19 pandemic - speed and continuity 3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks 4. No IND required for clinical trials 5. Full GMP material is not mandated for Phase I clinical trials 6. Established clinical trial environment with world-class Investigators and sites 7. Established healthy subject databases and specialized patient populations 8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care 9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research 10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
Common Joint Problems Athletes Face and How to Overcome Them
Part of being an athlete is pushing yourself, but pushing too hard may result in joint injuries which aren't always something you can overcome on your own. Joint problems can be severe and lead to long-lasting consequences. You must focus on recovery, allow yourself to heal, and get the right treatment to overcome these and other common joint problems for athletes.
Dislocations
A dislocated joint happens when bones are pushed from their sockets and can involve shoulder, hip, knee, elbow, finger, or toe joints. This type of injury is common in contact sports like football and is an emergency that requires immediate joint realignment by a medical professional. Immediate care helps prevent soft tissue damage and lingering pain. Even if you know how to pop your dislocated joint back in place, you may have already sustained damage that will cause long-term discomfort.
Knee Injuries
Complete knee replacement procedures are common among athletes because there are so many ways a knee can be injured. Knee injuries can happen in contact sports as well as from kicking, jumping, and running. Symptoms can range from slight tenderness to an inability to walk. The joint as well as surrounding ligaments and tissues can be damaged, and injuries can have a cumulative effect, creating pain that gets worse over time. For severe injuries, knee replacement is often the only solution, especially if conservative treatments have failed.
Elbow Problems
Problems with the elbow are almost as common as knee issues. Often lumped together under the general term tennis elbow, arm issues can involve joint damage, tendonitis, and other problems from overuse and abuse that lead to pain, nerve damage, and functional impairment. Specific stretches can help relieve some elbow symptoms. When your doctor focuses only on pain relief and not correcting the underlying issues, though, the problem only gets worse. Insist on a diagnosis and treatment for the underlying injury or disease.
Back Pain
A wide range of problems can cause back pain and numbness, tingling, and weakness in the back. Back pain can also travel down the leg or arm and aggravate other medical conditions. Untreated back pain can lead to permanent back problems, such as neck pain or spinal stenosis which is a narrowing of the spinal canal. The first step in treatment is symptom relief through hot or cold compresses, medication, or chiropractic treatment. However, exercises and perhaps even surgery may be necessary to help reduce pain and improve function.
Additionally, problems with the shoulders and hips are common for athletes, especially as you age. While the most common joint problems for athletes vary by sport, every joint concern has a treatment. From compresses to stretching, exercise, and surgery, getting treatment can help you get on with your passion for athletics and maintain top-level performance for as long as possible.
Memoir Details Author’s Journey with Mental Illness and Disability Long Island, NY, May 6, 2021 – As we enter Mental Health Awareness month, one author and artist is sharing her coming-of-age story through the lenses of mental illness, disability and steadfast determination. Long Island native Ruth Poniarski’s first book, Journey of the Self: Memoir of an Artist, published by Charlotte, North Carolina-based Warren Publishing, is a stunning and unflinchingly-honest memoir that challenges the stigmas placed on mental illness. The book has received glowing reviews, including a Kirkus Star review.
It started as a college prank; a friend offered Ruth Poniarski a brownie that, unbeknownst to her, was laced with angel dust. What resulted was a debilitating accident, and the first of many mental breakdowns that spiraled into diagnoses of psychosis, schizophrenia, severe anxiety and bipolar disorder.
For years, Poniarski struggled to cope with her new reality as she undertook a rigorous architectural program, sought out new friends (and the perfect mate) and battled through the depths of mental illness. Her journey led her in all directions as she sought comfort, solace, stability and love.
Now an accomplished artist, Poniarski considers her memoir to be a portrait of sorts.
“This book, like many of my paintings, is about introspection,” she says. “So many of us, particularly when we’re young, seek definition through labels or through what others think of us. It’s so easy to say, ‘I have bipolar disorder, therefore, X,’ or, ‘So and so doesn’t love me the way I love him, therefore, Y.’ But none of that is who we truly are.”
The release of Poniarski’s memoir is particularly timely in light of the coronavirus pandemic and social distancing orders.
“A lot of people are stuck at home right now. This kind of isolation forces a person to examine themselves; what makes them unique beyond who they are to society,” says Poniarski. “That kind of self-reflection allows us to become more available to others. You have to know yourself first.
“So, who am I?” Poniarski laughs. “Well … you’ll just have to read the book!”
For more information about Ruth Poniarski or her book, please visit: ruthponiarski.com.
UK pilots a new program, providing free vaping starter kits to smokers in emergency rooms
BEAMSVILLE, Ontario, May 06, 2021 (GLOBE NEWSWIRE) -- National Health Services (NHS) is now trialing a program that will provide some smokers admitted to emergency departments free vaping starter kits and instruction on how to use them, in combination with ongoing stop smoking support. The other group of smokers will be provided only a leaflet with information on local stop smoking services. Both groups will be asked one, three and six months later if they still smoke. The Canadian Vaping Association (CVA) commends the UK for continuing to make evidence based decisions, while ensuring the lives of smokers remain a priority.
Public Health England (PHE) has been a global leader in vaping research and support for vaping as a harm reduction tool. Despite the global denial of vaping’s efficacy, PHE has never waivered in its guidance to smokers that vaping is a less harmful alternative to smoking. The misperceptions about vaping have prompted PHE to release several statements to reassure the public and smokers. Most notably stating, “There are over 6 million smokers in England and smoking is still the leading cause of premature death and disease particularly among the most disadvantaged in our society. Helping more smokers quit is vital if we’re to achieve the government’s vision of a smoke free society by 2030, and vaping has a role to play. Vaping has helped many thousands of smokers quit to date. But many thousands more could benefit if they were not put off by the persistent, worsening and inaccurate beliefs the public hold about vaping. Smokers should be reassured by today’s authoritative and detailed report which shows that the UK’s e-cigarette regulations are effective, and vaping remains a safer alternative to smoking. I urge smokers to have confidence in our regulatory system and not be put off by alarmist headlines about the risk of vaping which are not backed up by the evidence.”
“The CVA is encouraged by the UK’s progressive policy and initiatives. The science coming out of the UK has been consistent in finding vaping to be far less harmful and effective for quitting smoking. We implore the Government of Canada to follow the UK’s lead and ensure the lives of smokers are the primary consideration when implementing policy,” said Darryl Tempest, Executive Director of the CVA.
FEELING YOUNGER BUFFERS OLDER ADULTS FROM STRESS, PROTECTS AGAINST HEALTH DECLINE
Younger ‘subjective age’ can have functional health benefits, study finds
WASHINGTON — People who feel younger have a greater sense of well-being, better cognitive functioning, less inflammation, lower risk of hospitalization and even live longer than their older-feeling peers. A study published by the American Psychological Association suggests one potential reason for the link between subjective age and health: Feeling younger could help buffer middle-aged and older adults against the damaging effects of stress.
In the study, published in Psychology and Aging, researchers from the German Centre of Gerontology analyzed three years of data from 5,039 participants in the German Ageing Survey, a longitudinal survey of residents of Germany age 40 and older. The survey included questions about the amount of perceived stress in peoples’ lives and their functional health – how much they were limited in daily activities such as walking, dressing and bathing. Participants also indicated their subjective age by answering the question, “How old do you feel?”
The researchers found, on average, participants who reported more stress in their lives experienced a steeper decline in functional health over three years, and that link between stress and functional health decline was stronger for chronologically older participants.
However, subjective age seemed to provide a protective buffer. Among people who felt younger than their chronological age, the link between stress and declines in functional health was weaker. That protective effect was strongest among the oldest participants.
“Generally, we know that functional health declines with advancing age, but we also know that these age-related functional health trajectories are remarkably varied. As a result, some individuals enter old age and very old age with quite good and intact health resources, whereas others experience a pronounced decline in functional health, which might even result in need for long-term care,” said study lead author Markus Wettstein, PhD, who is now at University of Heidelberg. “Our findings support the role of stress as a risk factor for functional health decline, particularly among older individuals, as well as the health-supporting and stress-buffering role of a younger subjective age.”
The results suggest that interventions that aim to help people feel younger could reduce the harm caused by stress and improve health among older adults, according to the researchers – though further study is needed to help determine what kind of interventions would work best. For example, Wettstein said, messaging campaigns to counteract ageism and negative age stereotypes and to promote positive views on aging could help people feel younger. In addition, more general stress-reduction interventions and stress management training could prevent functional health loss among older adults, according to Wettstein.
Finally, more research is needed to figure out the ideal gap between subjective and chronological age, according to Wettstein, as previous research has suggested that it’s helpful to feel younger up to a point but that benefits decrease as the gap between subjective and chronological age increases. “Feeling younger to some extent might be adaptive for functional health outcomes, whereas ‘feeling too young’ might be less adaptive or even maladaptive,” he said.
