Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. the drug and device) of the combination product.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority A List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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Drug Channels

NOVEMBER 13, 2024

As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing. For 2025, DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that the number of PDPs will drop to a historic low. What else should you expect for 2025? Legislate in haste. Repent in leisure.

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Drug Channels

NOVEMBER 19, 2024

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025.

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Drug Channels

MARCH 31, 2025

Threes still company in the world of pharmacy benefit managers. Below, we break down the latest market share data from Drug Channels Institute (DCI), explore the developments driving these changes, and examine what they signal for the future of the PBM landscape. P.S. Special launch pricing on our new 2025 Economic Report on U.S.

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Drug Channels

MARCH 11, 2025

Next week, Drug Channels Institute (DCI) will release our 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. For 2024, DCI estimates that total prescription dispensing revenues at retail, mail, long-term care, and specialty pharmacies reached $683 billion, up 9% from the 2023 figure. to 1:30 p.m.

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Drug Channels

JANUARY 22, 2025

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. In fact, nearly all marketed Humira biosimilars are excluded from the larger PBMs 2025 formularies.

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Drug Channels

MARCH 18, 2025

I am pleased to announce that Drug Channels Institutes new 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is now available for purchase and immediate download. Pharmacies and Pharmacy Benefit Managers. 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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Drug Channels

FEBRUARY 18, 2025

Small pharmacies have ghosted Medicare Part Ds preferred networksno farewell party, no breakup text, just a quiet exit. A few months ago , DCI highlighted how the largest pharmacy chains are participating as preferred cost sharing pharmacies in the 2025 stand-alone prescription drug plan (PDP) networks. Abracadabra!

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Drug Channels

APRIL 1, 2025

Click here to see the original post from January 2025. For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. What do you think? All rights reserved.

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Drug Channels

JANUARY 14, 2025

During my recent Drug Channels Outlook 2025 video webinar, I tackled a wide range of crucial topicsincluding the controversial 340B Drug Pricing Program. As I explain in this video excerpt, we may finally see reform of this rapidly expanding program.

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Drug Channels

DECEMBER 11, 2024

This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. In the video excerpt below, I walk through a brief history of 340B contract pharmacies. I conclude with a follow the dollar example of 340B prescription economics with contract pharmacies. All rights reserved.

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Fierce BioTech

MARCH 28, 2025

From catch-all to calibrated: A more targeted approach to pharma DTC marketing Explore how pharma marketers can optimize impact by leveraging pharmacy retail media to reach high-intent audiences. Discover ways to boost first-fill and refills while maximizing marketing spend.

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FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Comments on the proposed order are due May 25, 2025. Nor does it allow for full consideration of the implications of removing PE from the monograph and leaving pseudoephedrine as the only oral decongestant active ingredient that can be used in an OTC drug marketed under the monograph.

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Drug Channels

FEBRUARY 3, 2025

Informa Connect's Access USA March 18-20, 2025, Pre-Event Workshops on March 17 Drug Channels readers save 10%* on their registration with code 25AUSA10 Three events. 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. The future of patient access. Which event is for you? All rights reserved.

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Drug Target Review

MARCH 13, 2025

The operational impact of xAI is substantial, especially given that 37 percent of the market views the explanation of results from GenAI algorithms as a strategic priority that goes beyond regulatory compliance. He holds a masters degree from University of Salerno in political sciences and marketing. 2024 [cited 2025 Feb 7].

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Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m. Or, just click here to order.)

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