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.ONCOLOGY
Assessing the link between sugary drinks and cancer
Pharmacy Times
Over the past two decades, there has been an increase in the consumption of sugar worldwide, partly because of beverage marketing and growing urbanization. This lifestyle is deeply rooted in western countries. Data from the U.S. National Health and Nutrition Examination Survey showed that the intake of sugar in the U.S. population surpassed the recommended calorie intake, with the average intake of men and women aged 18 years and older being 1.5 and 2.8 greater, respectively.
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Child's cancer has different effects on fathers' and mothers' earnings
News-Medical.Net
Mothers and fathers of children diagnosed with cancer are affected financially in different ways. While mothers' incomes fall in the short term and then rise, the adverse financial repercussions on fathers occur later. Researchers at Uppsala University have investigated the socioeconomic impact on parents of having a child diagnosed with cancer. The study is published in the International Journal of Cancer.
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.GENOMICS
Switching DNA functions on and off with light
Phys.org
DNA is the basis of life on earth. The function of DNA is to store all the genetic information an organism needs to develop, function and reproduce. It is essentially a biological instruction manual found in every cell. Biochemists at the University of Münster have now developed a strategy for controlling the biological functions of DNA with the aid of light.
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Scientists develop high-throughput mitochondria transfer device
University of California - Los Angeles Health Sciences via ScienceDaily
Scientists from the UCLA Jonsson Comprehensive Cancer Center have developed a simple, high-throughput method for transferring isolated mitochondria and their associated mitochondrial DNA into mammalian cells. This approach enables researchers to tailor a key genetic component of cells, to study and potentially treat debilitating diseases such as cancer, diabetes and metabolic disorders.
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.EMERGING MEDICAL TECHNOLOGIES
New therapeutic target discovered for chromosomally unstable tumors
Genetic Engineering & Biotechnology News
Scientists at Memorial Sloan Kettering Cancer Center, New York have discovered a critical mechanism that allows cancer cells to grow in an inflammatory environment. ENPP1, a highly accessible molecule on the surface of cancer cells, is a key player in this mechanism and can be leveraged to sensitize certain types of cancers to immunotherapeutic drugs, the study reports.
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Largest players in MedTech industry embrace artificial intelligence
Medical Device Network
According to GlobalData forecasts, the market for artificial intelligence/machine learning platforms will reach $52B in 2024, up from $29 billion in 2019. The COVID-19 pandemic has triggered a rapid implementation of new technologies in the medical technology industry. Consequently, the MedTech industry’s biggest players, such as GE Healthcare, Medtronic and Philips are some of the biggest investors in AI and ML.
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.BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
Utilizing companion diagnostics to drive clinical decisions
Pharmacy Times
Precision oncology originates from the discovery of relevant, unique molecular abnormalities associated with specific cancers. It focuses on the selection of a specific anticancer therapy based upon the presence of an actionable target and disrupting that target’s role in driving cancer growth, thereby optimizing clinical benefit to the patient.
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Prediabetes subtypes identified
AAAS via EurkAlert!
All prediabetes is not the same: in people in the preliminary stages of type 2 diabetes, there are six clearly distinguishable subtypes, which differ in the development of the disease, diabetes risk, and the development of secondary diseases. This is shown in a study by the Institute for Diabetes Research and Metabolic Diseases of Helmholtz Zentrum München at the University of Tübingen, Tübingen University Hospital and the German Center for Diabetes Research.
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.REGENERATIVE MEDICINE
B-cell transcription factor helps gut regenerate
BioWorld
A Chinese study has shown that the recently discovered transcription factor Bach2, which is important in B-cell development and progression of inflammatory disease, also regulates gastrointestinal regeneration by facilitating DNA repair after ionizing radiation exposure.
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.MANAGED HEALTHCARE NEWS
Medical insurance planning for a healthy practice in 2021
Managed Healthcare Executive
With the coronavirus pandemic accelerating a shift towards telemedicine, 2020 has been a year of tremendous change in the medical industry, and 2021 will be no different.
Movements such as the incoming Biden administration who promises to shift the regulatory landscape, insurers remain to play catch-up with these surprising developments.
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Ready or not, the new year brings Trump's price transparency rule
Managed Healthcare Executive
The Trump administration’s price transparency rule, which requires hospitals to disclose what they charge for basic items and services, will take effect Jan. 1 after getting the green light from a U.S. appellate court with just days to spare earlier this week.
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.FDA: NEW TREATMENTS AND TECHNOLOGY
FDA grants priority review to Lorbrena for lung cancer subset
Healio
The FDA granted priority review to lorlatinib for first-line treatment of anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, according to the agent’s manufacturer.
Lorlatinib is a third-generation anaplastic lymphoma kinase inhibitor designed to inhibit tumor mutations that most often contribute to treatment resistance.
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FDA approves 1st generic of drug used to treat severe hypoglycemia
U.S. Food & Drug Administration
On Dec. 28, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia, which may occur in patients with diabetes mellitus.
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.ACCOUNTABLE CARE ORGANIZATIONS
Congress testores Medicaid to Pacific Islanders in US
NPR
Congress has restored Medicaid to Pacific Islanders legally residing in the U.S. under a military and economic Compact. The original entitlement was nullified in the 1990s during welfare reform.
Buried in the $900 billion COVID relief package is Medicaid restoration for thousands of Pacific Islanders living in the U.S. People from the Federated States of Micronesia, Palau and the Marshall Islands qualify under a compact of free association.
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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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