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.ONCOLOGY
Medical oncologists split on telehealth's clinical effectiveness
Healthcare IT News
A study published this week in the Journal of the American Medical Association Network Open found that although medical oncologists recognized the convenience and access to care presented by telehealth video visits, many raised doubts about its clinical effectiveness.
The qualitative study, which took place before COVID-19 swept the country, examined 29 medical oncology health professionals' perceived benefits and drawbacks of telehealth video visits.
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COVID-19 vaccines open door for cancer treatments, others
VOA News
The new tools scientists are deploying to fight the COVID-19 pandemic may soon go to work against cancer, autoimmune diseases and other illnesses.
The vaccines from drug companies Moderna and Pfizer-BioNTech use a new way to train the body's immune system to respond to infection.
They are testing the same techniques to recruit the immune system to attack tumors.
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Health officials: Don't let COVID-19 stop you from getting cancer screenings
WLNS-TV
Yes, there’s a global pandemic, but that doesn’t mean you should neglect your health, and stop going for check ups and screenings, especially if you think something might wrong.
According to health experts at McLaren Greater Lansing, when it comes to cancer, every second counts. Regular screenings are crucial to detection and treatment before cancer spreads and can make the difference between catastrophic consequences or a life as a survivor.
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.GENOMICS
Repeat DNA expands our understanding of autism spectrum disorder
Nature.com
Approximately half of the human genome, known as the repeatome, consists of repetitive DNA sequences. The repeatome includes more than one million tandem repeats — sections of DNA in which a sequence is replicated many times in tandem — whose biology remains largely unexplored. More than 50 diseases are known to be caused by expansion of a tandem-repeat sequence in a single gene; among them are Huntington’s disease and fragile X syndrome.
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Many identical twins actually have slightly different DNA
Smithsonian Magazine
Research published on Jan. 7 in the journal Nature Genetics shows that identical twins differ by an average of 5.2 genetic mutations. The authors argue that these small differences between twins’ genetic code could change how scientists study human development.
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.EMERGING MEDICAL TECHNOLOGIES
MRI AI tool could lead to more targeted prostate cancer treatment
Diagnostic Imaging
An artificial intelligence tool, developed using MRI data, could soon top the list of strategies used to determine which men are most likely to experience a prostate cancer recurrence.
Together with a small group of institutions, Case Western Reserve University has developed RadClip, an AI tool that is designed to make it easier for providers target patients with better treatment options.
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Remote monitoring, wearable companies look to capitalize on virtual care boom: JPM21
MedTech Dive
One business bright spot of the coronavirus pandemic has been skyrocketing use of telehealth as patients stayed home and out of doctor offices, benefiting virtual care firms like Teladoc.
The boom has rippled out to makers of remote patient monitoring and wearables like continuous glucose monitors and insulin pumps, where devices are utilized to either deliver basic care or monitor patients and collect data.
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.BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
Deep learning sharpens near-infrared images for cancer diagnostics
Physics World
Fluorescence imaging is a valuable method for examining biological systems. To achieve the maximum tissue penetration depth and minimum light scattering, detecting near-infrared fluorescence in the long-wavelength end of the second NIR window, known as NIR-IIb, provides the best results. Unfortunately, NIR-IIb imaging relies on nanoparticle fluorescent probes that often contain toxic elements, hindering its clinical translation.
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Study offers data related to physicians' potential liability to use AI in personalized medicine
News-Medical.net
Physicians who follow artificial intelligence advice may be considered less liable for medical malpractice than is commonly thought, according to a new study of potential jury candidates in the U.S. Published in the January issue of The Journal of Nuclear Medicine. The study provides the first data related to physicians' potential liability for using AI in personalized medicine, which can often deviate from standard care.
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.REGENERATIVE MEDICINE
Hope for children with rare heart condition: novel stem cell therapy to save the day
Okayama University via ScienceDaily
In a new study, scientists at Okayama University isolated cardiac stem cells and assessed their potential use as regenerative therapy in young patients with cardiac defects. They confirmed the safety and effectiveness of their proposed treatment in early-phase trials and even identified the mechanism through which the stem cells improved cardiac function. Based on these preliminary findings, they hope to proceed to larger clinical trials and move towards pharmaceutical approval in the future.
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Study: Formula predicts ideal dose of stem cells to cure HIV
Pharmacy Times
A study published in eLife found optimal conditions following a stem cell transplant that could control HIV without the need of an everyday pill.
To date, there are only 2 cases of a cure to HIV — dubbed the Berlin patient and the London patient — who both received transplants with stem cells from donors who lack a molecule called CCR5, which HIV is attracted to. The right balance of stem cell dose, cell type, and timing of antiretroviral therapy could potentially lead to a spontaneous cure of HIV, according to the study authors.
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.MANAGED HEALTHCARE NEWS
New directions for healthcare consumerism
Managed Healthcare Executive
From declining brand loyalty, increased care deferment, the fast adoption of telehealth, a rise in wearable tech and a broader focus on social media marketing, NRC Health, the leading provider of in-depth customer intelligence in healthcare, shared millions of healthcare consumers' current preferences for care in the recent 2021 Healthcare Consumer Trends Report.
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COVID-19 utilization declines: The top red flags for payers and providers
Managed Healthcare Executive
The COVID-19 pandemic in the U.S. has led to a significant drop in medical procedures as a result of individual and organizational precautions. This decrease, particularly during the first months of the pandemic, has and will continue to have severe implications for plans, providers and patients.
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.FDA: NEW TREATMENTS AND TECHNOLOGY
FDA approves Enhertu for gastric cancer subset
Healio
The FDA approved fam-trastuzumab deruxtecan-nxki for treatment of certain patients with gastric or gastroesophageal adenocarcinoma.
The approval applies to use of the agent by adults with locally advanced or metastatic HER2-positive disease who received a prior trastuzumab-based regimen.
Fam-trastuzumab deruxtecan-nxki is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab; a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.
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FDA approves Crizotinib for pediatric ALK+ ALCL indication
Cancer Network
The FDA approved the multikinase inhibitor crizotinib as therapy for young adult or pediatric patients who are at least one year of age with relapsed or refractory, systemic anaplastic large cell lymphoma that is harboring an ALK aberration, according to the agent’s developer Pfizer.
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.ACCOUNTABLE CARE ORGANIZATIONS
Next generation ACOs saved Medicare $558M in 2019
RevCycleIntelligence
Accountable care organizations taking on the greatest financial risk in Medicare through the Next Generation ACO Model saved the public payer over $558 million in 2019, according to partial data from CMS.
CMS released the data on 37 of the 41 Next Generation ACOs participating in 2019. The data excluded savings and quality data from four ACOs that deferred financial settlement for last year’s performance period.
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Telehealth flexibilities continue and ACOs are held harmless under public health emergency extension
Healthcare Finance
With the public health emergency extended to April, providers get additional time to use waivers for telehealth and other flexibilities.
Aside from these flexibilities, the public health emergency holds accountable care organizations harmless from financial losses for the months in which the PHE is in effect. For example, if the PHE is in effect for six months in 2021, then ACOs will only be liable for half of the shared losses they may experience this year.
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.NAMCP UPDATES
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| Verrica Pharmaceuticals Inc., a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). The NDA for VP-102 was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in July 2020. Click here to view the full press release.
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| Biodesix, Inc., a leading data-driven diagnostic solutions company with a focus in lung disease, today announced publication of an analysis of the company’s Nodify XL2® lung nodule test. The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules. Please click here to view the full press release.
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| LivaNova PLC, a market-leading medical technology and innovation company, today announced the publication of a new study in the International Journal of Bipolar Disorders that showed adding Vagus Nerve Stimulation Therapy (VNS Therapy®) to treatment as usual (TAU) significantly improves outcomes in patients with treatment-resistant bipolar depression (TRBD). The study examined patients from a five-year prospective registry and found 63% of TRBD patients treated with adjunctive VNS Therapy in addition to TAU had a significant reduction in depressive symptoms, as measured by a 50% or greater reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS), compared with 39% of patients in the TAU alone group. Click here to view the entire press release. Click here to view the entire press release.
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| Additionally, LivaNova PLC announced a publication in Contemporary Clinical Trials, which details the design for “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression” or the RECOVER clinical study. RECOVER is currently under way as part of a Coverage with Evidence Development framework of the U.S. Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination process. Click here to view the entire press release.
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| In late 2018, the National Association of Managed Care Physicians (NAMCP) decided to create the Value Based Care Council (VBCC). The VBCC mission supports empowering medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. The goal is to improve the integration of cost, quality, and access in the clinical decision making process so as to enhance the effectiveness and efficiency of extracting value from the associated spend in order to optimize outcomes.
Pursuant to the above, and in response to an unmet need in the marketplace, the VBCC developed a short form in order to enhance the effectiveness and efficiency with which value propositions can be shared between industry and the medical leadership of various payers throughout the country. This same short form provides a concise and consistent manner with which value propositions can be shared and provides the ability to align expectations prior to actually conducting conversations or having a meeting regarding a product or service.
The Product Value Proposition Customer Engagement Short Form can be found on the NAMCP website (www.namcp.org) in the Value Based Care Council subsection of the Councils tab, under tools and resources. Please contact Will Williams at wwilliams@namcp.org with questions or for additional information.
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| Jazz Pharmaceuticals is excited to announce the approval of ZEPZELCA™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ZEPZELCA is a second-line therapy that has been studied in both platinum-sensitive and -resistant SCLC patients. Please click here for more information.
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| Takeda Pharmaceuticals is part of, "The Fight Is In Us", an initiative to maximize the individual and societal benefit of COVID-19 plasma. The campaign will focus on recruiting COVID-19 survivors to donate their plasma at licensed blood and plasma donor centers.- If you’ve recovered from #COVID19, your immune system has antibodies that could be used as a treatment. See if you can help others by donating plasma www.TheFightIsInUs.org. #TheFightIsInUS
- The antibodies that helped you or someone you know fight off COVID-19 may be able to help others. Visit www.TheFightIsInUs.org to see if you qualify to donate plasma. #TheFightIsInUs
You are a survivor, now you could be a hero. Plasma from recovered #COVID19 patients could play a key role in creating a potential therapy for coronavirus. Learn how you can donate at www.TheFightIsInUs.org #TheFightIsInUs
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| Biodesix, Inc., a leading diagnostic company in lung disease, recently announced a partnership with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Two studies published this month, ahead of peer review, reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR. Biodesix currently has a focus on lung disease and offers other diagnostic testing for lung cancer utilizing the ddPCR platform.Click here for more information.
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| "Modeling Cost-Effectiveness of On-Demand Treatment for Hereditary Angioedema Attack" was recently published in the Journal of Managed Care Pharmacy's February 2020 issue. Hereditary angioedema (HAE) is a rare disease that causes painful and potentially fatal episodes of swelling (attacks). HAE attacks can be unpredictable and the need to treat sudden attacks promptly and effectively is critical to minimize risk of hospitalization, morbidity, and mortality. A cost-effectiveness model was evaluated that considers evaluation of on-demand medications, healthcare utilization and patient well-being. For access to the publication, please click here.
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| Biodesix, Inc. announced initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO®) (avelumab). Development efforts will now focus on transferring the test into Biodesix's CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex™ artificial intelligence (AI) platform. Click here to read the full press release.
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| The NAMCP Medical Directors Institute recently held the first meeting of its Executive Leadership Council (ELC) at the recent Fall Managed Care Forum. The NAMCP Medical Directors Institute decided in late 2018 to create the Value Based Care Council (VBCC) with a mission to empower medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. Click here to view an overview of the genesis, formation, and work of NAMCP's Value Based Care Council. Please click here to view the press release.
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| LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced the first patient enrolled in "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression" (RECOVER). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. The first patient was enrolled by Dr. Azfar Malik in St. Louis. Click here to read the full press release.
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| Biodesix, Inc. this week highlighted findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat® blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer. Click here to see the full press release. | |
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