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Biogen admits slow Aduhelm launch, as scientists question label again

pharmaphorum

.” He blamed the poor performance on ” confusion, misinformation and controversy surrounding our data and the approval process.” “Our findings are concerning given the broad FDA labelling for aducanumab,” said corresponding author Timothy Anderson.

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External control arms and debunking real-world data myths

pharmaphorum

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. This can require new processes, technologies and an organisation mind shift.”. In both situations, ECAs provide the foundation of comparison between an active treatment population and a control cohort.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

We believe that patient-centric engagement is essential to ensure that the negotiation process leads to outcomes that genuinely benefit patients. Patient Engagement The NHC recognizes and commends CMS’ willingness to improve the listening sessions and the data submission processes. Improving the Data Collection (ICR) Process.

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How Pharmacists Can Use Artificial Intelligence To Advance Their Practice: Insights From ChatGPT

ID Stewardship

We’ll dive into the many ways AI can assist pharmacists, from streamlining medication dispensing processes to enhancing patient education. Personalized Medication Recommendations : AI algorithms can process patient data, such as age, gender, medical conditions, and allergies, to generate tailored medication recommendations.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. Luckily, even without insurance coverage, this medication is available in generic form and is very affordable, usually costing between $15 to $40 per month. It’s a process and a journey, but it’s definitely worth it.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.