Biosimilars Council’s Post

📢 𝗜𝗻 𝗰𝗮𝘀𝗲 𝘆𝗼𝘂 𝗺𝗶𝘀𝘀𝗲𝗱 𝗶𝘁 📢 🚀 Hoodin 𝗥𝗔𝗤𝗔 𝗗𝗲𝗲𝗽 𝗗𝗶𝘃𝗲𝘀 🤿 with Veronika Valdova 👀𝗧𝗵𝗲 𝗳𝘂𝗹𝗹 𝗩𝗶𝗱𝗲𝗼 ⏯ ⏹⏮ ⏪ ⏩❗ 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 Veronika Valdova and Marcus Emne for an deep introduction to the complex world of classification dilemmas in the medical field. 💊💉 This presentation really sheds light on the challenges that sponsors of regulatory submissions often face, particularly when dealing with substance-based devices. These devices, notorious for their complexity, can be classified as a drug in one region and as a medical device in another. This dichotomy presents unique challenges and requires a deep understanding of the regulatory landscape across different regions. 🌍 Veronika and Marcus, you really helped bring invaluable clarity and guidance in navigating these challenges and probably saved some of the audience time and money moving forward. 𝙂𝙧𝙚𝙖𝙩𝙡𝙮 𝙖𝙥𝙥𝙧𝙚𝙘𝙞𝙖𝙩𝙚𝙙 👏 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 Hoodin 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for your time and please 𝗦𝗵𝗮𝗿𝗲, 𝗟𝗶𝗸𝗲 👍 and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs 

We need to reform access and transparency in prescription drugs and the few PBM intermediaries who, through consolidation, control much of American’s access. A friend unfortunately experienced a nightmare with CVS Caremark. Luckily they are sharpe minded and extremely diligent and were able to get the issue resolved after going through multiple channels. What are seniors supposed to do? Especially those who need to rely on caregivers as their intermediary advocates? Is there any other aspect of our lives where personal agency has been as structurally eroded as in healthcare? The good news is there is a growing collective consciousness and desire for something better, which will be the catalyst for change. #pbms #pharmacy #seniorhealth #advocacy #healthpolicy #healthplans

On the topic : Strengthen the fight against fake medicines. What stuck with me was the phrase...Guarantor of a safe and secure pharmaceutical supply... In Sweden, around a million transactions take place every day in the system at the more than 1,500 locations that are connected. More and more people buy their medicines and other pharmacy products via the internet from the established pharmacy operators. But today we know quite a bit about how extensive the illegal trade is when it comes to fake medicines. A survey conducted by the Swedish Medicines Agency showed that 1 percent of the 1,000 respondents had bought medicines via the internet, without a prescription, from an unapproved online pharmacy. Having said that the Swedish system for pharmaceutical supply is more protected than other nations due to e-verification systems. Sweden also does not have wholesalers, but a system with two large pharmaceutical distributors that are hired by the pharmaceutical companies. Read more in the article....

It's not easy navigating new IRA pricing.

*Pharma companies extracted USD 2 trillion from consumers in the name of cholesterol level treatment.* What a shame on medical research fraud and authorities. Their incompetency costed USD 2 trillion to people those who were fit and healthy. *Cholesterol* is finally officially removed from Naughty List. The US government has finally accepted that *cholesterol* is not a _nutrient of concern_. *doing a U-turn* on their warnings to us to stay away from high-cholesterol foods since the 1970s to avoid heart disease and clogged arteries. This means eggs, butter, full-fat dairy products, nuts, coconut oil and meat have now been classified as *safe* and have been officially removed from the _nutrients of concern_ list. The US Department of Agriculture, which is responsible for updating the guidelines every five years, stated in its findings for 2015: "Previously, the Dietary Guidelines for Americans recommended that cholesterol intake be limited to no more than 300 mg/day. "The 2015 DGAC will not bring forward this recommendation because available evidence shows no appreciable relationship between consumption of dietary cholesterol and serum (blood) cholesterol, consistent with the AHA/ACC (American Heart Association / American College of Cardiology) The Dietary Guidelines Advisory Committee will, in response, no longer warn people against eating high-cholesterol foods and will instead focus on *sugar as the main substance of dietary concern*. US cardiologist Dr Steven Nissen said: _It's the right decision_. _We got the dietary guidelines wrong. They've been wrong for decades_." When we eat more foods rich in this compound, our bodies make less. If we deprive ourselves of foods high in cholesterol - such as eggs, butter, and liver - our body revs up. The Real Truth about Cholesterol. The majority of the cholesterol in you is produced by your liver. Your brain is primarily made up from cholesterol. It is essential for nerve cells to function. Cholesterol is the basis for the creation of all the steroid hormones, including estrogen, testosterone, and corticosteroids. *High cholesterol in the body is a clear indication which shows the liver of the individual is in good health.* Dr. George V. Mann M.D. associate director of the Framingham study for the incidence and prevalence of cardiovascular disease (CVD) and its risk factors states: _Saturated fats and cholesterol in the diet are not the cause of coronary heart disease. *That myth is the greatest deception of the century, perhaps of any century*_ *Cholesterol is the biggest medical scam of all time* There is no such thing as *bad Cholesterol* *If the cholesterol level is high in our body, it shows the liver is working perfect.* Experts say that there is nothing like LDL or HDL. ………….. ….. *Cholesterol is not found to create block any where in human body*. Please share the recent facts about CHOLESTEROL

Excited for the #ACC24 Late Breaking Clinical Trials!! A few that address #innovation #digitalhealth #accesstocare #collaborativeintelligence: **Remote Acute Assessment of Patients With High #Cardiovascular Risk Post-acute Coronary Syndrome (TELE-ACS) **Effect of #Gamification, Financial Incentives or Both Combined to Increase Physical Activity Among Patients With Elevated Risk For Major Adverse Cardiovascular Events. The Be Active Randomized Clinical Trial **The #Diabetes Remote Intervention to Improve Use of Evidence-based Medications (DRIVE) Study: A Randomized Evaluation of a Team-based Remote Education and Medication Management Program to Reduce CV and Kidney Risk **Health 360x Registry: Scalable #Workforce For Equitable Access to Point of Care #decentralizedclinicaltrials **Hózhó (#HeartFailure Optimization at Home to Improve Outcomes): A Pragmatic Clinical Trial of Telephone-based Guideline-directed Medical Therapy Optimization in Navajo Nation **Advancing Acute MI Care in Densely Populated LMICs: Innovative Standalone #ChestPain Units For Expedited Triage and Timely Management – A Role Model For #Global Healthcare Systems American College of Cardiology Harlan Krumholz Christopher Cannon, MD Sachin H. Jain, MD, MBA Jennifer Goldsack Kendal K. Whitlock, MPH Helen Burstin Daniel Kraft, MD Jennifer N. Avari Silva David Cho Katie Berlacher James Januzzi Cathy Gates Cathie Biga Nicole Napoli Joyce Donnellan Shalen F.

The 2025 MA and Part D rule has been finalized. This is substantially what was proposed. Lots here on brokers and agents, D-SNPs, and more. Analysis to come. Dig in. https://lnkd.in/eYnCABhd #medicareadvantage

Excellent platform for pharmacovigilance

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