article thumbnail

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

article thumbnail

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means – The Drug Price Negotiation Program and Pending Legal Challenges

Big Molecule Watch

Congress left Medicare drug pricing to the drug manufacturers, pharmacies, and insurance plan sponsors to determine, and expressly prohibited the government from “interfering” in those private price negotiations under the so-called “Non-Interference Clause” of the Medicare Modernization Act of 2003.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

NHC Comments on the Federal Evidence Agenda on Disability Equity

Putting Patients First Blog

Too often the formal notice and comment process does not reach these marginalized communities and federal agencies must actively work to seek their input in non-traditional ways. This process respects their autonomy by involving them in decision-making to the extent that they are able.

article thumbnail

Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Efforts are underway to work with the FDA to resolve them.

article thumbnail

JCR Pharma and Alexion partner on JUST-AAV gene therapy platform

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. JCR has also developed a proprietary blood-brain barrier-penetrating technology, J-Brain Cargo, to deliver biotherapeutics into the central nervous system. Topic sponsors are not involved in the creation of editorial content.

article thumbnail

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. MAXSHOT.PL via Shutterstock. Give your business an edge with our leading industry insights.

article thumbnail

DoH and Children’s National Hospital link for cell and gene therapy

Pharmaceutical Technology

This alliance seeks to bolster clinical trial capabilities through improved regulatory processes and data governance. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. They aim to develop patient-specific treatment protocols while ensuring adherence to rigorous international standards.