Calibrate’s Post

FDA Consults Through Digital Health Technologies on Advancing Diabetes Detection with Industry Leaders Dexcom and Novo Nordisk have engaged with the FDA to promote the use of digital health technologies for early detection of prediabetes and undiagnosed Type 2 diabetes. The collaboration aligns with the FDA's agenda to utilize digital innovations in healthcare. The FDA initiated a call for public comments on the role of AI and machine learning in diabetes detection, gathering feedback from stakeholders. Novo Nordisk and Dexcom shared their recommendations, emphasizing the need for FDA guidance on incorporating digital health technologies in diabetes care. The FDA aims to harness the potential of technology to improve healthcare outcomes and is considering actions regarding digital health technologies for diabetes detection. The collaborative effort between regulatory bodies and industry leaders illustrates a commitment to innovation and patient-centered care. The FDA sought input on various areas, including community engagement and scientific innovation. Novo Nordisk advocated for collaboration between the FDA's drug and device units and clear guidelines on verification and validation processes. Dexcom emphasized the need for specific guidance on digital health technologies. Both companies expressed interest in utilizing continuous glucose monitors for data collection in clinical trials. The consultation provided valuable insights into subpopulations and the application of AI in analyzing datasets. While specific actions are still under consideration, the engagement of stakeholders paves the way for personalized and effective diabetes care solutions. For more details please click the link! https://lnkd.in/dx-d-xsY #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

💊 Anti-Malarial Chapter‼️‼️ 👉 The Most common drug "Artem Plus" With Generic of ‼️Artimether ➕ Lumeffantrine‼️ 1️⃣ Weight based Dosage. 2️⃣ Treatment in Non-immune Children. 3️⃣ Treatment in Multi-Resistant Areas. 4️⃣ Dosage in Hepatic & Renal Impairment. 5️⃣ Concomitant Use with food. #AntiMalarial #RoleOfPharmacists #SharingIsCaring

Pleased to share groundbreaking news from the diabetes care sector! The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for a once-weekly basal insulin treatment. This innovative approach promises to revolutionize the management of type 2 diabetes by simplifying treatment schedules and potentially enhancing adherence and outcomes for patients. The pivotal clinical trials have demonstrated not only superior blood sugar control compared to daily insulins but also a significantly lower risk of hypoglycemia, making it a game-changer for patients and healthcare providers alike. As we anticipate further approvals, including the FDA in the United States, the potential impact on diabetes care and patient quality of life cannot be overstated. This advancement underscores the importance of innovation in managing chronic conditions and offers hope for millions seeking simpler, more effective treatment options. Stay tuned for more updates on this exciting development in diabetes care. #DiabetesManagement #HealthcareInnovation #Type2Diabetes https://lnkd.in/eqsnuf7Q

In a recent and unprecedented decision, British Columbia's Health Minister announced immediate restrictions on the sale of the GLP-1 receptor agonist Ozempic (semaglutide). Non-Canadians can no longer procure the medication, marking a unique step in Canadian drug policy. The reason? Over-prescription by non-resident physicians, aiming at Ozempic's use for off-label purposes in neighboring countries, with a 37-fold increase compared with prescriptions typically filled for Americans in British Columbia for other medications. The debate about people with obesity "creating a shortage of the medication intended for diabetes" is an important one (and we have no business either promoting or participating in the belief that people with one disease have "more right" to access to medications than those with other conditions). The larger view, however can't be dismissed and it is the lack of effective therapy for management of a disease like obesity/overweight that over 60% of US adults are living with. This is the deep cause for unregulated use like the one detected, and now prevented in Canada. Until valid solutions are available for all, one can't be surprised that people with medical conditions are forced to source medications from any possible avenue, including other countries, or worse — unregulated markets including compounding pharmacies. #accesstocare #weightloss #glp1 #pharmaregulation

This article is a clear reminder of why the team at Inagene is so focused on getting the word out about pharmacogenetic testing. #Pharmacogenetics #PersonalizedMedicine #HealthCareInnovation #PatientSafety #Inagene

Not all drugs give us direct, objective data when treating patients. For example, with migraine prevention drug studies, we typically measure the total reduction in migraine days and percentage of people with 50% reduction in migraine days. Unlike cholesterol or blood sugar, determining migraine days isn't something we can get from a blood sample. Not only that but the margins are slim, fremanezumab (Ajovy) has shown to reduce migraine days by 1-2 days per month compared to placebo. It may not sound like a lot but ask any chronic migraine patient, it's meaningful. But with a list price of almost $800, at what point do we add this therapy on? Prior authorization criteria will often require the patient to have failed only one preventative therapy and only one rescue therapy before approval. Unfortunately, prior authorizations can only do so much to reduce drug spend. What if an alternative low cost preventative drug worked? What if the failed therapy was due to side effects that could have been adjusted for? What if we're not using the correct scoring measures to determine a drug's impact? What if the provider wants the patient to "fail" therapy to initiate something easier for them to manage? There is so much that happens before PBMs can have influence on drug spend. Apothicor Wellness #apothicorwellness #wellness #healthcare #healthbenefits #benefits #employeebenefits #pharmacists #pbm #priorauthorization

Recently, GLP-1 drugs like semaglutide (Ozempic and Wegovy) and tirzepatide (Mounjaro) have taken the healthcare world by storm, offering an almost miraculous solution to some of the most pressing medical issues affecting patients today. These glucagon-like peptide-1 receptor agonists work by enhancing the body’s natural insulin secretion and slowing gastric emptying, leading to improved blood sugar control and weight loss. With the rising prevalence of diabetes and obesity worldwide, the demand for this treatment is higher than ever, positioning GLP-1 drugs as a critical component in the modern healthcare arsenal. As a result, the healthcare market appears to be on the cusp of a significant transformation. Learn more about the rise of GLP1 medications in our latest article: https://lnkd.in/gaCr4ymu #healthtech #healthcare #innovation #investing #ETF #healthtechETF #thematicETF #healthcareinnovation #medicine #patientcare #healthcaretechnology #hospitals #hospitalcare #healthtechnology #digitalhealth #GLP1 #GLPagonists #weightloss #ozempic

Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. However, the drug is now being marketed as a heart drug. So will Medicare start covering the drug? Read on to find out. #wegovy #ozempic #medicare #obesity #heartdisease https://lnkd.in/dEnVRwRY

Preventing Medication Tragedies: How Inagene’s Pharmacogenetic Testing Can Save Lives Jim’s story, recently highlighted in the Toronto Star, is a stark reminder of the urgent need for pharmacogenetic testing. After experiencing severe side effects from a commonly prescribed antidepressant, Halliday suffered years of debilitating symptoms like chronic pain, muscle stiffness and brain damage which left him unable to run, golf or even cry. John’s doctor told him to take a pharmacogenetic test which revealed his body’s inability to metabolize the medication. Pharmacogenetic testing examines how genes affect drug responses, helping to prevent adverse reactions and reduce trial and error in prescriptions. Despite its benefits, access to this testing through public funding, is limited in Canada due to cost concerns. At Inagene, we offer direct-to-consumer pharmacogenetic tests with a simple at-home cheek swab that helps individuals avoid potential adverse drug reactions. If Halliday had taken our test before starting his medication, his ordeal could have been avoided. Our affordable and accessible testing can help patients receive the right medication the first time, improving health outcomes and enhancing quality of life. Join us in advocating for broader access to pharmacogenetic testing. Learn more about how Inagene is leading the way in personalized medicine at www.inagene.com. Link to full Toronto Star article in comments. #Pharmacogenetics #PersonalizedMedicine #HealthcareInnovation #PatientSafety #Inagene

Further evidence of a drug that is created to "block" a biological function to treat a symptom of a natural process only to create potentially life threatening affects to the liver. Working with a holistic nutritional professional or integrative medical doctor can address the whole HUMAN and not just symptomology. Hot flash pharmaceuticals are not worth your life! Menopause is not a disease to be treated, but a transition into a beautiful phase of life that can be managed within the whole body, through food, lifestyle, sleep, and social upgrades. Blocking receptors and autonomic functions within our physiology is not always the right answer. Advocate for your body...no matter what season it is in. https://lnkd.in/gzi5XTw3