FDA Law Blog: Biosimilars

DECEMBER 3, 2023

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. Non-applicable drugs (e.g.,

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Drug Channels

DECEMBER 10, 2024

This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. As you reread the article below, note that some manufacturers have already announced wholesale acquisition cost (WAC) list price declines for 2025. Pharmacies and Pharmacy Benefit Managers.

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Drug Channels

SEPTEMBER 10, 2024

I am pleased to announce the full agenda for the inaugural Drug Channels Leadership Forum , which will be held from March 17 to 19, 2025, at the Turnberry Resort and Spa in Miami. Everyone here at Drug Channels Institute (DCI) is excited to bring this novel event to the drug channels community. I hope you can join us!

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Drug Target Review

APRIL 11, 2025

Drug development is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. This promises to significantly improve the probability of success for new drugs, accelerating their development and ultimately delivering life-saving treatments to patients faster.

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Drug Channels

JUNE 25, 2024

Join my nearly 57,000 LinkedIn followers for daily links to neat stuff along with commentary from the Drug Channels community. Note that we will soon migrate our social media activity to the Drug Channels Institute LinkedIn page. Attendance will be limited, so click here to request an invite for our March 2025 event.

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Agency IQ

JANUARY 4, 2024

Pharmacopeia (USP) defines impurities as “any component of the drug substance that is not the chemical entity that is defined as the drug substance” or, “any component of a drug product that is not the drug substance or an excipient in the drug product.” Read AgencyIQ’s analysis of the ICH guideline here ].

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Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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National Institute on Drug Abuse: Nora's Blog

JANUARY 6, 2025

Yet the challenges we face around drug use and addiction have never been greater, with annual deaths from overdose that have vastly exceeded anything seen in previous eras and the proliferation of increasingly more potent addictive drugs. 6 & Improving access to addiction treatment In 2023, only 14.6

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Agency IQ

FEBRUARY 15, 2024

Priority A List.

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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

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

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 11, 2025

Next week, Drug Channels Institute (DCI) will release our 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. drug pricing, reimbursement, and dispensing system. Were offering special discounted pricing if you order before March 31, 2025. to 1:30 p.m. Click here to learn more and sign up.

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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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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The most common drug Californians may be looking for this winter is Paxlovid.

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Drug Channels

APRIL 9, 2025

It's time for Drug Channels annual update of vertical integration among insurers, PBMs, specialty pharmacies, and healthcare services within U.S. drug channels. Click here to share your thoughts with the Drug Channels LinkedIn community. What do you think? All rights reserved.

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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. drug pricing, reimbursement, and dispensing system. prescription drug channels. Pharmacies and Pharmacy Benefit Managers.

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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.

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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. You can find our updated counting below.

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Drug Channels

FEBRUARY 25, 2025

Celebrate the imminent return of spring with our selection of noteworthy news from around the drug channel. Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

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Drug Channels

FEBRUARY 7, 2025

Todays guest post comes from Richard Faris, Chief Strategy & Growth Officer at PANTHERx Rare Pharmacy. He explains the key considerations for choosing a specialty pharmacy network design, selecting the right pharmacy partners, and establishing patient services HUBs. Read on for Richards insights. All rights reserved.

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Drug Channels

JANUARY 7, 2025

It's time for Drug Channels annual examination of U.S. brand-name drug pricing. For 2024, average brand-name drugs list prices grew by only 2.3%. Whats more, after adjusting for overall inflation, brand-name drug net prices dropped for an unprecedented seventh consecutive year. The bubble wont vanish overnight.

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Drug Channels

MARCH 21, 2025

Greg discusses some of the challenges manufacturers face with product commercialization, patient access and adherence, and negotiating partnerships with pharmacy benefit managers (PBMs). Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Read on for Greg's insights.

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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. All rights reserved. This Feed is for personal non-commercial use only.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. In Neumanns Pharmacy, LLC , 90 Fed. By Andrew J.

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Drug Channels

MARCH 26, 2025

Spring has officially arrived in sunny downtown Philadelphiathe proud home base of Drug Channels. As you can see on the right, we celebrated in Miami at the Drug Channels Leadership Forum. on April 4, 2025, from 12:00 p.m. Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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Drug Channels

JANUARY 28, 2025

Before you overturn any cars, please enjoy this months playbook of articles, intercepted for you from the Drug Channels gridiron: Touchdown! Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. ( No, that's not a typo. How Mark Cuban would quarterback the U.S. All rights reserved.

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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.

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Drug Channels

APRIL 4, 2025

Click here to see the original post from January 2025. It's time for Drug Channels annual examination of U.S. brand-name drug pricing. For 2024, average brand-name drugs list prices grew by only 2.3%. But for the first time in years, I can foresee a time when SpongeBob SquarePants will move on from Drug Channels.

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Drug Channels

DECEMBER 17, 2024

Its been a huge year for Drug Channels Institute (DCI). Thanks to our new friends at HMP, we will hold the Drug Channels Leadership Forum. This landmark event will take place in March 2025 in Miami. (If Once again, I thank you, dear readers, for welcoming Drug Channels into your inboxes, browsers, and apps. No worries!

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Drug Channels

APRIL 2, 2025

Minnesota just released the industrys first ever mandated financial report on the 340B Drug Pricing Program. Below, I do a wicked deep dive into the data and highlight crucial implications about spending, profits, pharmacies, plans, patients, program integrity, and more. Its time to pay attention to the money behind the 340B curtain.

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Drug Channels

JANUARY 13, 2025

The inaugural Drug Channels Leadership Forum (DCLF) is coming soon! This exclusive event will be held from March 17 to 19, 2025, at the Turnberry Resort and Spa in Miami. drug channels. Speakers and panelists include top industry executives and subject matter experts from throughout the drug channel.

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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

DECEMBER 3, 2024

Minnesota just released the industry‘s first ever mandated financial report on the 340B Drug Pricing Program. Below, I do a wicked deep dive into the data and highlight crucial implications about spending, profits, pharmacies, plans, patients, program integrity, and more. It’s time to pay attention to the money behind the 340B curtain.

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Drug Channels

DECEMBER 12, 2024

This week, Im rerunning some popular posts while I prepare for tomorrows Drug Channels Outlook 2025 live video webinar. Time for DCIs annual update on the channels for provider-administered drugs. drug channels. Read more 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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