Experts Look for Solutions as Fentanyl Overdose Deaths Surge
Baltimore, MD, November 8, 2021 — There’s no question that the pandemic caused a troubling upward trend in addiction disorders, with many people turning to substances like opioids to help them cope with the loss of a loved one, feelings of isolation or job stress. But amid the darkness came a sliver of light: the dawn of telehealth and tele-mental health services, which provide convenient ways for folks to seek help.
“We’ve also seen the rollout of naloxone … the opioid reversal agent that can save lives,” said Dr. Paul Christo in a recent interview. “It doesn’t have to be prescribed by a physician. It can be, but in certain states, pharmacists can dispense it without a prescription. … And … drugs like methadone, buprenorphine and suboxone … these drugs help prevent relapse, reduce craving and are really important.”
Dr. Christo, Associate 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 these valuable telemedicine and tele-mental health services, and adds that it’s important for clinicians to advocate to their patients that online treatment options — including telehealth prescriptions for critical medications — are available.
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.
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Knee Replacements vs ACL Reconstruction Recovery
Joint pain and dysfunction are common problems that affect many adults. Damage may be due to accidents, sports injuries, or natural aging processes. The patient may experience joint pain, stiffness, swelling, and instability. Procedures such as total knee replacement and ACL reconstruction are available to restore normal weight-bearing and movement to the knee. There are significant differences between these two surgical procedures and why they are performed.
When Is An ACL Reconstruction Procedure Needed?
An ACL reconstruction is normally done when the anterior cruciate ligament is so torn or damaged and can’t be successfully repaired. The reconstruction procedure removes the ligament and replaces it with tissue from another part of the body or from donor tissue that is reserved for grafting purposes. ACL injuries most commonly occur when a person stops or changes direction abruptly, which is a common occurrence in soccer, basketball, and even downhill skiing. Typically, athletes report that they recognized as soon as it happened that something was wrong with their ACL and they anticipated reconstruction would be needed.
When Is A Total Knee Replacement Needed?
While ACL reconstruction involves damage to ligaments in the knee, total knee replacement involves damage to the bones that make up the joint. This problem usually occurs from arthritis, in which cartilage that cushions the bones of the knee during movement becomes worn away. The most common arthritis for this procedure is osteoarthritis and other knee diseases such as rheumatoid arthritis and psoriatic arthritis. Typically, patients with severe pain or severely limited range of motion are considered for this procedure. Knee replacement replaces the damaged joint with a new one made of artificial materials. Typically, due to the invasive nature of a total knee replacement, it is typically recommended that patients use physiotherapy and steroid injections first before considering surgery.
Differences in Surgical Technique
Asian senior or elderly old lady woman patient show her scars surgical total knee joint replacement Suture wound surgery arthroplasty on bed in nursing hospital ward : healthy strong medical concept.
An ACL reconstruction is performed as a minimally-invasion procedure. This means that only small incisions are made in the knee. Instruments are inserted into the incision to remove the damaged ligament and replace it with tissue from the patient’s body or donor tissue. With ACL tears, simply sewing up the ligament doesn’t usually lend to a full recovery or use of the ligament, which means that grafting is required. Grafting enables your body to recover with full motion instead of stinted growth when sewing the tendon. The procedure typically takes between two and three hours long. Once the procedure is complete, patients tend to go home on the same day. In most cases, there is between an 80-90% success rate for ACL surgeries.
In a total knee replacement, a large incision must be made in the knee joint. Damaged areas of bone are removed and replaced with durable materials that create an artificial knee joint. Implants are typically made of metal alloys, ceramic material, or strong plastic parts. This is typically addressed prior to the surgery and each type of material has pros and cons. However, patients typically don’t have much say in this option as it is usually based on the surgeon’s preferred material and training. The entire procedure typically takes between one to three hours. Once the procedure is complete, patients tend to stay in the hospital for two to three days. During this time, you’ll recover from the anesthesia and surgery. In most cases, there is around an 82% success rate for knee replacement surgeries.
Differences in Recovery Time
Generally, an ACL reconstruction procedure requires an extended period of six months of rehabilitation. A patient who has had ACL reconstruction may not return to normal, rigorous activity for up to a year and it typically takes 12 weeks before being able to be weight bearing on the knee. Additionally, the physical therapy that follows after an ACL reconstruction is typically very strict to ensure that you get as much use out of your knew tendon as possible. Not to mention the nutrition needed to help your body recover.
A knee replacement requires physical therapy for 4 to 8 weeks. A patient who has had a knee replacement can return to normal activities after 12 weeks. However, some strenuous activities that put too much stress on the replaced joint should be avoided. Additionally, it typically takes 6-8 months before patients reach full recovery maximal strength and endurance.
Your orthopedic physician will determine the right surgical procedure for your individual case. Both surgeries have been performed millions of times, with good rates of success for the patient. The most critical point is to follow your doctor’s instructions and your physical therapist’s workout plan precisely to enjoy the best outcomes for your surgery.
Feeling Healthy? What to Talk to Your Doctor About During Your Annual Check-Up
An annual physical is an important measure for staying healthy. It allows your physician to get to know you and your current condition, anticipate potential problem areas and develop a rapport in talking about health matters. Healthy individuals often wonder what they should talk about during these visits when they don’t have any medical problems to report. Here are a few topics to talk about to make the most of your annual physical.
Discuss Your Weight Goals
Obesity is a known factor for a number of health problems, such as high blood pressure, diabetes, heart disease, and even some types of cancer. If you are carrying a few extra pounds, you can discuss ways to lose weight with your doctor. If you are underweight, your physician can offer ways to help you add a few pounds for optimum health.
Ask About Exercise Options
Regular exercise is a critical part of your health maintenance strategy and can help you avoid many illnesses. Various types of exercise are available. These programs often recommend individuals to “check with their doctors" to prevent any injury from the exercise. Your doctor can advise on whether you are able to participate in an exercise program and will allow the physician to note for the records that exercise is part of your lifestyle.
Mention the Supplements You Take
Female nurse holding a clipboard folder, giving prescription drug orange pill jar to adult senior man. Doctor's appointment hospital healthcare case
If you are healthy enough, you will want to continue to do all you can to stay healthy and avoid serious illness. You may take supplements on a regular basis to strengthen your immune system, support joint health or increase your energy. It’s important to discuss these supplements with your doctor to ensure they don’t interfere with other medications you may be taking or pose a danger of overuse.
Discuss Current Medications
If you are taking medication, you may wish to discuss whether you should keep taking it or whether you continue to need it. You can also discuss the need for vaccinations, such as a flu shot, to prevent serious complications from contagious illnesses. If you’re worried about the cost of these medications, most insurance policies, even non-Obamacare health insurance policies have coverage for certain medications, supplements, and vaccines.
Ask About Test Results
You may have done a number of medical tests in advance of your appointment for the annual physical. Your doctor can provide information about the results of the tests and if there are any concerns. Understanding what these tests reveal can help you to adjust your diet, exercise levels, or other health measures to ensure that you maintain good health in the future.
Even when you are completely healthy, an annual physical is an opportunity to check in with your doctor and learn the best ways to protect your health going forward. Take this opportunity to ask questions, so you can participate fully in maintaining your health.
PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch
Focusing on partnership model for MicroDose-MN™ and MacroDose-MN™ patches to deliver psychedelics.
Creating value and intellectual property protection for psychedelic programs.
Providing pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022 with psychedelics.
TORONTO, Nov. 03, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce it has entered into a research collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.
PharmaTher is currently conducting IND-enabling research studies with MicoDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinical studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021.
The Company is also conducting research studies with its MicoDose-MN™ and MacroDose-MN™ patch as a next generation delivery system for psychedelics with ketamine, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”). Also, the Company has decided to expand research to include ibogaine and mescaline.
Partnership opportunities currently exist with MDMA, LSD, DMT, ibogaine and mescaline for specialty pharmaceutical companies seeking a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards FDA Phase 1 and 2 clinical studies in 2022.
The Company’s MicroDose-MN™ and MacroDose-MN™ patches have the potential to efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
“We are pleased to collaborate with Revive in achieving their product portfolio objectives with psilocybin. Our microneedle patch technologies aim to become a next generation delivery system for psychedelics for various indications and healthcare environments. Although our focus remains on building our ketamine-based product pipeline, we will continue to partner with specialty pharmaceutical companies seeking a delivery solution for psychedelics and proprietary drugs to unlock significant value and return on investment for PharmaTher,” said Fabio Chianelli, CEO of PharmaTher.
Michael Frank, CEO of the Company, commented, "Our focus is developing and commercializing a specialty psilocybin-based product portfolio, and the research collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one-fits-all product profile solution with psilocybin. For psilocybin to be a next-generation therapeutic, different use and delivery forms will be required to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies, such as PharamTher.”
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
Osteoporosis is a manageable chronic disease and the risk of osteoporotic fractures can be reduced with treatment.iHowever, osteoporosis remains largely undiagnosed and untreated.ii,iii The CPGs provide recommendations for the assessment, prevention, and management of osteoporosis and specify that osteoporosis management should be guided by assessing a patient's absolute risk of fractures. Yet, as highlighted in a recent report by the Public Health Agency of Canada, fewer than 20% of Canadians experiencing an osteoporotic fracture receive therapies to prevent further fractures.i
"We know that fractures, including those of the spine, wrist, and hip, after the age of 50, increase the chance of having another fracture within five years," says Dr. Alexandra Papaioannou, one of the study's lead authors. "This study reinforces the importance of appropriate medical intervention in helping prevent subsequent fractures, and the role education and technology can play in helping improve health outcomes for patients."
STUDY RESULTS
Using an electronic medical record (EMR)-based dashboard called the "ADVANTAGE OP EMR" tool, 84 physicians located across Canada shared their practice activities related to bone mineral density (BMD) testing, 10-year fracture risk calculation and treatment for those at high risk for osteoporosis.
Key results of the study included the following:
Across all practices, there were 171,310 adult patients, 40 years of age and older, of whom 17,214 (10%) were at elevated risk for fracture.
Sixty-two percent of patients potentially at elevated risk for fractures did not have BMD testing completed.
For patients with BMD completed, fracture risk was calculated in only 29%.
Of those with fracture risk calculated, 19% were at high risk, of whom 37% were not treated with osteoporosis medications as recommended by CPG.
Seventy-seven per cent of Ontario family physicians identified the lack of EMR tools as a significant barrier to implementing the osteoporosis clinical practice guidelines.
"Family physicians themselves have identified a need for clinical support tools that identify potential risk factors, calculate fracture risk, and offer advice on treatment options," adds Dr. Papaioannou.
ABOUT ADVANTAGE OP
The authors of the study developed the Dashboard Initiative for Quality Improvement in the Management of Patients with Osteoporosis (ADVANTAGE OP). The ADVANTAGE OP dashboard serves as a mechanism for alerting physicians of patients' potential fracture risk to improve screening and management.
The ADVANTAGE OP EMR tool consists of an interactive algorithm to facilitate assessment and management of fracture risk using CPG. The FRAX® and Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tools were embedded to facilitate 10-year fracture risk calculation. Physicians managed patients as clinically indicated but with EMR reminders of guideline recommendations; participants shared practice level data on management activities after 18-month use of the tool.
"As a result of this program we have a better understanding of how physicians can be helped with EMR-based decision support tools to enable and facilitate optimal decision-making in patient management. At the same time, gathered data can help to inform the development of real-world strategies and tools that will better support the implementation of osteoporosis CPGs within primary care," says Dr Anatoly Langer, another of the study's lead authors.
This study was financially supported by Amgen Canada as an investigator-initiated study.
About Osteoporosis
Osteoporosis is a condition that causes bones to become thin and porous, decreasing bone strength and leading to increased risk of breaking a bone.iv The most common sites of broken bones from osteoporosis are the wrist, spine, shoulder and hip.iv Osteoporosis can strike at any age, however it mainly affects women after menopause as their ability to form new bone cannot keep up with the rate at which bone is being lost.iv,v This bone loss leads to weakened bones over time, increasing the potential for a break.iv
At least one in three women and one in five men will suffer a broken bone from osteoporosis during their lifetime.iv Broken bones from osteoporosis are more common than heart attack, stroke and breast cancer combined.iv One in three people who break a hip will re-break it at one year, and over one in two will suffer another bone break within five years.iv
The World Health Organization has officially declared osteoporosis a public health crisisvi, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.vii Recently, the Public Health Agency of Canada has also recognized osteoporosis as a major public health concern in Canada due to the significant morbidity, mortality and costs associated with osteoporotic fractures, combined with a large osteoporosis care gap.i
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 uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
iiPapaioannou A, Giangregorio L, Kvern B, Boulos P, Ioannidis G, Adachi JD (2004) The osteoporosis care gap in Canada. BMC Musculoskelet Disord 5:11
iiiPapaioannou A, Kennedy CC, Ioannidis G, Gao Y, Sawka AM, Goltzman D, Tenenhouse A, Pickard L, Olszynski WP, Davison KS, Kaiser S, Josse RG, Kreiger N, Hanley DA, Prior JC, Brown JP, Anastassiades T, Adachi JD (2008) The osteoporosis care gap in men with fragility fractures: the Canadian Multicentre Osteoporosis Study. Osteoporos Int 19:581–587.
viThe World Health Organization. Bulletin of the World Health Organization. Exercise interventions: defusing the world's osteoporosis time bomb. Available at: http://www.who.int/bulletin/volumes/81/11/mingchanwa1103.pdf. Accessed August 30, 2021
AstraZeneca Canada Files for Health Canada Authorization of AZD7442 for Prevention Of COVID-19
MISSISSAUGA, ON, Nov. 3, 2021 /CNW/ - AstraZeneca Canada has initiated a rolling review New Drug Submission with Health Canada for authorization of AZD7442, its long-acting antibody (LAAB) combination, for prevention of symptomatic COVID-19.
If granted, AZD7442 would be the first LAAB to receive Health Canada authorization for COVID-19 prevention.
Preliminary 'in vitro' findings demonstrate that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.5,6
"AZD7442 is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo. This is an important option, especially for vulnerable populations like those who are immune-compromised and often aren't able to mount a protective response following vaccination," said Dr. Alex Romanovschi, Vice President, Scientific Affairs, AstraZeneca Canada. "With this Health Canada filing, we are one step closer to providing an additional long-lasting option to help protect against COVID-19 alongside vaccines."
In August 2021, AstraZeneca announced high-level results from the PROVENT pre-exposure prophylaxis trial, which showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. Importantly, the trial population included people with co-morbidities and who may be in need of additional protection from SARS-CoV-2 infection. Greater than 75% of participants in PROVENT presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. AZD7442 was well-tolerated.
AZD7442 was optimized using AstraZeneca's proprietary YTE half-life extension technology which more than triples the durability of its action compared to conventional antibodies.1-4
About AZD7442 AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein7 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration;1-4 data from the Phase I trial show high neutralizing antibody titres for at least nine months.8 The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.9
AZD7442 is being studied in a comprehensive clinical trial program for both prevention and treatment of COVID-19 in over 9,000 participants. In the Phase III PROVENT trial, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. The trial included 5,197 participants in a 2:1 randomization AZD7442 to placebo. The primary analysis was based on 5,172 participants who did not have SARS-CoV-2 infection at baseline. The LAAB was well tolerated, and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups.
In TACKLE,10 a Phase III mild-to-moderate COVID-19 outpatient treatment trial, AZD7442 met its primary endpoint demonstrating a 50% reduction in the risk of developing severe COVID-19 or death compared to placebo in outpatients who had been symptomatic for seven days or less.
Other ongoing trials include collaborator treatment trials in outpatient and hospitalized settings.
Data published in Nature in July 2020 showed that in preclinical experiments, the LAABs were able to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.11
About AstraZeneca Canada AstraZeneca is a global, innovation-driven biopharmaceutical business with a focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on four important areas of healthcare: Cardiovascular, Renal and Metabolic disease; Oncology; Respiratory & Immunology; and Rare Diseases. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ roughly 1,090 employees across the country and our headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.
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Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrobial Agents and Chemotherapy. 2013; 57 (12): 6147-53.
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Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Antimicrobial Agents and Chemotherapy. 2017; 61(3): e01714-16.
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Yu XQ, et al. Safety, tolerability, and pharmacokinetics of MEDI4893, an investigational, extended-half-life, anti-staphylococcus aureus alpha-toxin human monoclonal antibody, in healthy adults. Antimicrobial Agents and Chemotherapy. 2016; 61 (1): e01020-16.
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Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants. ThePediatric Infectious Disease Journal. 2018; 37(9): 886-892.
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Wang L et al. Ultrapotent antibodies against diverse and highly transmissible SARS-CoV-2 variants. Science. 2021 Jul 1. doi: 10.1126/science.abh1766.
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ACTIV. National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https://opendata.ncats.nih.gov/variant/activity [Last accessed: September 2021].
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Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101/2021.01.27.428529.
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Loo Y-M, et al. AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans. medRxiv. Cold Spring Harbor Laboratory Press; 2021 [preprint] Available from: https://www.medrxiv.org/content/10.1101/2021.08.30.21262666v1.
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van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548.
Each year brings with it fashion trends, decorating trends, and beauty trends. The latter covers everything from nails, haircare, makeup and skincare. With the ubiquity of social media, and TikTok, beauty users now can pick up popular trends from anywhere across the world and follow them. Skincare is the biggest segment in the beauty industry with global sales that hover around $130 billion in 2019. There is so much for consumers to digest and decide on. We turned to Dr. Michael Somenek, a Washington, D.C. Board Certified Facial Plastic Surgeon and skin care expert. He takes a microscope to some of the hottest trends in 2021 to give you insight into what’s worth your hard- earned dollars.
CBD In Skincare
CBD (short for cannabidiol) has no plans of easing up its reign on the skin-care world in 2021 and beyond. As a case in point, there are at least two major skin care brands that now include CBD in their skincare, not to mention the indie companies that have created CBD skincare. Dr. Somenek’s take: “As far as it being good for skin, it acts as both an anti-inflammatory agent and an oil reduction agent. Theoretically, its addition to skin care products, especially those tasked to fight acne and other inflammatory skin conditions, is probably legitimate. It is also a good antioxidant that can help protect against free radical damage to skin cells. CBD can be made from hemp which helps skincare companies get around the federal ban on marijuana. Side effects of unregulated use include: Nausea, fatigue and irritability. CBD can increase the level in your blood of the blood thinner coumadin, and it can raise levels of certain other medications in your blood by the exact same mechanism that grapefruit juice does.”
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Microneedle Patches
Some beauty editors and bloggers swear by pimple patches. According to experts, those patches are about to get even more advanced by way of a ton of tiny microneedles (or "microstructures"). The logic is that you can out put a smaller amount of acne-fighting ingredients into these tiny little cones and apply it to the skin, it's a better, more effective delivery system.
Here's how they are purported to work: The small band-aid-like sticker has spikes coated with hyaluronic acid that are thinner than a hair follicle. Through these teeny painless pricks in the skin, the patch drives the active ingredients deep into the skin.
Dr. Somenek’s take:
“There is plenty of good medical literature on the validity of these small patches that are impregnated with various chemicals. The patch gets worn and the needles (either metallic or made out of absorbable polymer) penetrate the skin delivering the chemical treatment. Their design takes advantage of the concept of transcutaneous delivery of drugs. Patches can be custom made to fit various areas of the face and deliver anti-aging or other chemicals while a patient sleeps. The efficiency of delivery is better through the tiny skin punctures than if you only put the chemical directly on the intact skin. In theory, aesthetic practitioners can make custom topical treatments and place them on the patches to deliver customized at-home skin treatments for their patients.”
Is a Cryotherapy Facial Is the Best Way to Brighter, Tighter Skin?
Cryotherapy has gained popularity in recent years with spa treatments exposing clients to sub-zero temperatures to help relieve pain and improve their health. This wellness treatment has recently undergone another adaptation with the cryotherapy facial treatment. The Cryo Facial is a cryogenic treatment that is performed by what is considered a "cryo probe," which beams vaporized liquid nitrogen across the forehead, cheeks, nose and chin. Different from the cryotherapy chambers that can be used for pain relief, the facial targets helping the face look younger.
Dr. Somenek’s take: “This may be more suspect. There isn't a great deal of study-based evidence that cryotherapy facials actually do what they claim. Typically, cryotherapy uses extremely cold liquid nitrogen to freeze exposed skin cells to kill them, like a wart. The facials use the same liquid nitrogen as a spray, but the aesthetician doesn't stay in one area too long to avoid frostbite to the skin. Some level of cold injury occurs, probably to a very superficial level of the skin, so there may be some exfoliation. But there are safer ways to get exfoliation without risking frostbite or hyperpigmentation.”
ANTI-POLLUTION SKIN CARE
Your skin is exposed to environmental aggressors on a regular basis. Although unseen, these pollutants can wreak havoc on your skin by breaking down collagen and elastin, the fibers that give skin its bounce. To help reduce these unwanted side effects, anti-pollution skin care products are continuing to gain favorability among consumers. Just as SPF is now de rigor in skin care, this seems to be the case with anti-pollution ingredient.
Dr. Somenek’s take: “I think that this is a new name for old tech. In brief, our skin is exposed to environmental contaminants that create inflammatory conditions. These conditions lead to build-up of free radicals in the skin. The ingredients in antipollution skin care are basically strong antioxidants that protect against free radicals. But the skin is assaulted by more than chemicals. It experiences dehydration, UV exposure, temperature changes, etc. True antipollution skincare should guard against all this. Typical protective and reparative ingredients include vitamin E, vitamin C, retinoids, hyaluronic acid, zinc oxide, vitamin B3, and bisabolol.”
Dr. Somenek’s final verdict: Just as one can become a slave to fashion, the same can happen with skin care trends. My best advice is to consult with your skincare physician. Discuss what you are exposed to during the day. Is it sun, pollution, humid air, wind, etc.? Talk to your doctor about what type of skin you have. Skin type changes as you age, and as hormonal factors come into play. Someone who had oily skin in their 20’s and 30’s can have combination skin in their 40’s and 50’s. Speak with your aesthetic provider about what your specific goals are for your skin. Is it reduced acne? Fewer wrinkles? Reduced brown spots? Broken capillaries? Just because something is a trend, does not mean it’s right for your skincare type or your goals. If you have a regimen that works for you, stick with it. Don’t be tempted by designer brands if drugstore brands are effective for you. There is nothing wrong with giving your skincare routine a modern “kick,” but good skincare does not mean one must try everything available on the market or in a med/spa or doctor’s office.
Understand the 7 Archetypes and Finally Meet Your Match
“Commitment can’t be forced, scheduled, or altered. It either comes from the heart or it doesn’t.” —Dr. Carmen Harra
Miami, FL, Nov. 2, 2021 — What does your dream relationship look like? Perhaps you’re looking for a fairy tale, or a lifetime of financial stability, or just the “perfect” partner to grow old with. You may have already created a “type” in your mind, and you’re looking for the person who checks all the boxes. But what if this approach to love is wrong?
Preconceived standards and expectations about relationships can be misleading at best and flat-out harmful at worst, explains world-renowned psychologist Carmen Harra.
Whether you’re entering the dating scene for the first time, starting over or hoping to strengthen a current relationship, Harra’s new book, Committed: Finding Love and Loyalty Through the Seven Archetypes, will prompt you to reevaluate the way you think about love — and ultimately make better choices.
“Before you can find a devoted partner, you have to unlearn other people’s versions of love and relearn your own,” she said.
In Committed, Harra and co-author anddaughter Alexandra Harra, who is a certified relationship coach, explain the seven main archetypes we all encounter, the promises they hold and the challenges they pose to relationships.
The first part of Committed is devoted to the work we need to do on the inside, and readers will learn how to reexamine core beliefs they hold, clear karmic patterns, heal any emotional trauma, liberate themselves from people who no longer serve them and develop an unshakable sense of self-worth.
The second half of the book teaches readers how to identify archetypes in others and themselves, navigate the world of online dating, build emotional intimacy, mediate external influences and apply real-world solutions to resolve relationship problems.
Ultimately, Committed aims to help you find and keep the love you deserve: an authentic, impassioned relationship that fills you with excitement each morning and puts your mind at ease every night.
Carmen Harra is an intuitive psychologist, best-selling author, radio show host and relationship expert. In the past 25 years, she has helped over 40,000 people rediscover peace of mind, reclaim personal power and regain joy. Her clients come from all walks of life, from the lady next door to Hollywood celebrities and eminent politicians. She’s the author of international best-sellers like Everyday Karma, Decoding Your Destiny, The Eleven Eternal Principles, and Wholeliness, among others. Carmen has been featured in such publications as The New York Times, New York Post, and New York Daily News, and on shows like Good Morning America, The View, Good Day New York, the Today show, and Fox News. She currently hosts Miracle Guidance for Everyday Life every Tuesday on OMTimes Radio.
Alexandra Harra is a certified life and relationship coach and author, while also boasting commendable career accomplishments as a writer. She writes regularly for renowned publications such as TheHuffington Post and proactively aids her mother's mission to bring joy and love into people's relationships.
For more information, visit www.CarmenHarra.com, or follow the author on Instagram (carmenharra) or Facebook (DrCarmenHarra).
Committed: Finding Love and Loyalty Through the Seven Archetypes
Publisher: Newman Springs Publishing Inc.
ISBN-10: 1638812586
ISBN-13: 978-1638812586
Available everywhere books are sold, including Amazon.com and BN.com
Mother of Young Heroin Addict Opens Up and Says, ‘This is Us’
Pittsburgh, PA, Nov. 2, 2021 — Christine Naman understands all too well that those who struggle with mental illness and addiction are not faceless numbers. They are real people who are valued and cherished by their families, and she wants the world to know and understand her daughter, Natalie.
“People are silent in their shame,” Christine said in a recent interview. “They’re quiet about it. And when you reach out and say, ‘this is us,’ people are anxious to unload and say, ‘that’s us too.’”
Christinetraces her daughter's years-long battle with mental illness and addiction — and opens up about her own struggles with denial and the shame she carries for not recognizing the signs — in About Natalie, a gripping, cautionary tale of how a child can suddenly end up on the wrong path, meet the wrong people and get lost in the unthinkable.
“I did not know the signs or symptoms,” Christine said. “I didn’t know the looks of things or the smells of things. Often times, it was right in front of me. I just didn’t know what I was seeing.”
Natalie was just 15 years old when she became addicted to heroin. They were everyday people, living everyday lives, and then the floor dropped out.
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. 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 brilliant poems that share her personal pain and the unvarnished truth of her struggle.
Full of compassion, understanding and hope for those struggling with mental illness and addiction, 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 these problems firsthand as well as provide comfort to those who know the struggles of mental illness and addiction all too well.
Award-Winning Parma! Vegan Parmesan Offers Cheese Lovers A Delectably Nutritious Range of Dairy-Free, Protein-Rich Condiments Ideal For Main Dishes, Salads, Pizza & More!
MEDFORD, OREGON - With just the right condiment, a plain salad becomes a festival of flavors, a plate of vegetables transforms into a delectable stroll through a country garden, and an ordinary bowl of pasta becomes a savory work of art. And perhaps no condiment covers as many different foods and as many different cultures as classic Italian Parmesan cheese.
Unfortunately, for vegans or anyone following a dairy-free and/or calorie-conscious diet, parmesan cheese has always been not only off limits but one of the most difficult of life’s little indulgences to forego. If only someone, somewhere, could create a non-dairy parmesan cheese alternative so authentically delectable that even the most discerning cheese lovers would never miss its conventional counterpart ever again!
Well, luckily for countless millions of us, someone has. Welcome to the next revolution within the booming vegan cheese category – Parma!
Created in Oregon just over 15 years ago by Sister River Foods’ founder Shannon Schnibbe (Tofurky founder Seth Tibbott is an ongoing Advisor), Parma! was established in response to a rapidly-growing need within the vegetarian marketplace for a breakthrough allergen-free parmesan alternative.
Comprised of four deliciously distinct varieties – including Better Than Bacon Parma! –voted Favorite Bacon-Flavored Product in 2017 by VegNews magazine – Parma! is a plant-based umami superfood line of convenient and affordable products that are Paleo and Keto-friendly, a complete protein, dairy-free, soy-free, gluten-free, non-GMO and Certified Kosher.
In addition, all four raw nut and seed-based Parma! flavors contain whole raw ingredients, are low in sodium, heart-healthy, packed with essential B vitamins and trace minerals, replete with beneficial animo acids and an excellent source of healthy oils.
A World Of Flavor
Available in health stores nationwide as well as on the www.eatparma.com site, Amazon, VitaCost and other online retailers, Parma! is ideal for environmentally conscious consumers, vegans, vegetarians, flexitarians and all health conscious eaters. Unlike some other vegan cheese alternatives, Parma! has also proven highly appealing to mainstream cheese aficionados who are ready to eschew traditional cheese so long as a healthier option boasting authentic flavor, aroma and texture is available.
Sold in 3.5 and 7-ounce bottles, Parma! can be savored on pasta, lightly steamed vegetables, pizza, salads, potatoes, avocado toast, popcorn and countless other hor d'oeuvres, main dishes and desserts. For suggested recipes, please visit https://eatparma.com/category/recipes/.
·Better Than Bacon Parma! – Voted Favorite Bacon FlavoredProduct by VegNews and featuring a smokey cheesey umami bacon flavor. Ingredients: Nutritional Yeast, Organic Sunflower Seeds, Walnuts, Ground Paprika, Organic Dried Onion, Natural Flavor, Organic Brown Sugar, Himalayan Crystal Salt, Smoked Salt, Organic Hemp Seeds.
·Chipotle Cayenne Parma! – Blessed with a smokey umami flavor akin to the most popular barbeque potato chips, with a slight cayenne kick at the end. Ingredients: Nutritional Yeast, Organic SunflowerSeeds, Walnuts, Organic Ground Chipotle Pepper, Himalayan Crystal Salt, Organic Hemp Seeds, Organic Onion Powder, Organic Ground Cayenne Pepper.
·Garlicky Green Parma! – Distinguished by acheesey umami Italian herb flavour complemented by nutritiously delicious kelp, pumpkin and sesame seeds. Ingredients: Nutritional Yeast, Organic SunflowerSeeds, Walnuts, Organic Pumpkin Seeds, OrganicDried Garlic, Himalayan Crystal Salt, Organic Hemp Seeds, Organic Sesame Seeds, Organic Kelp Powder, Organic Dried Basil, Organic Dried Oregano.
For parmesan lovers in Europe (in other words – just about everyone!), Parma! also offers a specially branded line called Shake! Original featuring a mouth-wateringly cheesey umami flavor and such ingredients as nutritional yeast, raw organic sunflower seeds, raw walnuts, raw organic pumpkin seeds, raw organic hemp seeds, and Himalayan crystal salt.
Parma! is expected to introduce a bold new line of products to the U.S. marketplace later this year.
Only The Beginning
Founded in 2004, Parma! has steadily grown to its current status as a leader in the dairy-free cheese alternative arena and a key player in the multi-billion-dollar global vegan food category.
Looking back on the origins of the Parma! brand, Sister River Foods’ co-founder and CEO Shannon Schnibbe recalls that it all started as the result of her severe allergies and effort to find foods that might give her relief. Introduced to raw foods, she was soon inspired to begin making what is now Parma! for herself, friends and family. After moving to Oregon and becoming pregnant with her first baby, she decided to combine her passion for healthy eating with her corporate experience and turn her hobby into an actual business. The vegan parmesan revolution had begun!
Today, Shannon takes special pride not only in the rave reviews, industry honors, new distribution channels and increased sales Parma! has enjoyed in recent years, but in her brand’s ability to provide a more nutritious yet equally delicious alternative for those who have been missing out on one of life’s true culinary pleasures – parmesan cheese.
According to Tofurky founder Seth Tibbott, "Like Tofurky, Parma is an authentic, trailblazing brand with deep roots that took hold when the plant-based world was very young. I love that it is a family owned business run by kind, passionate people producing a wholesome vegan food with exceptional flavor."
Adds Shannon, “Parma! gives you that cheesey flavor without all the dairy baggage. It provides an excellent food source of high-quality vitamins and minerals, including B vitamins, omega 3’s and trace minerals, along with the natural goodness of hemp, and it tastes great! We’re deeply grateful for the exceptionally warm reception our brand has received from consumers and industry leaders since our very first days on the market and look forward to continuing to shake up the dairy-free industry for many, many years to come.”
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