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PBM Industry Update: Trends, Challenges, and What's Ahead (NEW Live Video Webinar)

Drug Channels

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. Drawing from the brand-new 2025 Economic Report on U.S.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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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

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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Year in Review: Top Regulatory Developments of 2023

Big Molecule Watch

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program. According to a reported statement from Amgen, its settlement agreement with Janssen allows Amgen to sell WEZLANA “no later than January 1, 2025.”

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Year in Review: Top Regulatory Developments of 2024

Big Molecule Watch

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Here are some of the top regulatory developments from 2024.

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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

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Issue Brief: Improving Prescription Drug Price and Cost Transparency. Accessed January 2, 2025. ” Accessed January 9, 2025.

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India is rising from a CDMO perspective when it comes to biologics

Express Pharma

A lot of the work we’ve done in many years leading up to this and would be a big driver of 2025, is how do we really start seeing and feeling the impact of new technologies in the business? It will continue to be a trend in 2025. There’s two ways. A lot of that innovation is driven right here from our offices in India.