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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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NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

Putting Patients First Blog

The NHC appreciates CMS’ efforts to gather patient-centered data as part of this ICR and its commitment to making the process more relevant for patients and patient organizations. While we acknowledge these improvements, it is important to note that some aspects of the data collection process may remain challenging.

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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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Difference between Prescription vs Non-prescription drugs

FADIC

FDA approval process The FDA regulates both OTC and prescription drugs, but in different ways. Prescription drugs have to go through the New Drug Application (NDA) process. The application includes submitting clinical drug trial data and information about the manufacturing process.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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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NHC Submits Comments to CMS RE CY 2026 Policy & Technical Changes to MA and Part D Proposed Rule

Putting Patients First Blog

Coverage of Anti-Obesity Medications (AOMs) The NHC applauds CMS for aligning with the medical community and proposing to recognize obesity as a chronic disease and allow Medicare Part D coverage for AOMs. Below, we provide detailed comments and recommendations on key provisions of the proposed rule.

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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.