Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. The notable new material in this 2022-23 edition includes three new sections: Section 3.4.1. Section 6.1.6.

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Drug Channels

MAY 24, 2023

In recent years, each of these companies has launched new group purchasing organizations (GPOs) to further consolidate the number of covered lives in rebate negotiations with pharmaceutical manufacturers. Today, I examine these PBM-owned GPOs and then speculate on five plausible explanations for their existence.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). McClain , No.

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Drug Channels

APRIL 12, 2022

As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. Thus, the government actuaries expect that pharmaceuticals will not be the key driver of U.S. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. healthcare spending.

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Drug Channels

JULY 29, 2022

Note that the forecasts below did not account for policy changes that could further reduce pharmaceuticals' share of U.S. Click here to see the original post from April 2022. As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S.

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Drug Channels

APRIL 8, 2022

Michael discusses patient support challenges that are unique to specialty-lite pharmaceuticals. He goes on to describe four new categories of patient solutions and pharmacy models specific to this growing market segment. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Read on for Michael’s insights.

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Drug Channels

OCTOBER 2, 2024

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. The 340B contract pharmacy market shows little sign of slowing down. For an updated look at what’s next for the 340B contract pharmacy market, join Adam J.

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Drug Channels

OCTOBER 2, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on DCI's new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post from May 2023. Today, I examine these PBM-owned GPOs and then speculate on five plausible explanations for their existence.

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Drug Patent Watch

DECEMBER 10, 2024

India has long been recognized as a significant player in the global pharmaceutical industry, particularly in the production of generic drugs. The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines.

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Drug Channels

APRIL 21, 2022

Pharmacy Distribution and Reimbursement System for Patient-Administered, Outpatient Brand-name Drugs. This post is adapted from Chapter 3 of our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. addresses the Inflation Reduction Act of 2022. Group purchasing organizations for small pharmacies (Section 2.2.5.)

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The Pharma Data

OCTOBER 27, 2021

GSK Consumer Healthcare today unveils a three-year programme to support the pharmacy profession with additional practical resources, mental health provisions and proposed policy changes as part of its new report Standing with Pharmacists in the Age of Self-Care.

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Drug Channels

MAY 21, 2024

WHAT YOU WILL LEARN The federal 340B Drug Pricing Program continues to grow much more quickly than the overall pharmaceutical market. DCI estimates that 340B discounts equated to more than 17% of total value of gross-to-net reductions for brand-name pharmaceuticals. Pharmacies and Pharmacy Benefit Managers.

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Drug Channels

DECEMBER 16, 2021

This week, I’m rerunning some popular posts while I prepare for tomorrow's live video webinar: Drug Channels Outlook 2022. In Cardinal’s 2021 fiscal year, CVS purchased more than $42 billion in pharmaceuticals from the wholesaler—about double the figure from 10 years ago. Hope you can join me! See the links below. drug purchaser.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. state pharmaceutical assistance programs). 1395w-114c(b)(4)(B)(i).

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DrugBank

SEPTEMBER 26, 2024

The EMA's stringent requirements aim to ensure that biosimilars are as safe and effective as their reference products, thus safeguarding patient health and maintaining the integrity of the pharmaceutical market. For instance, introducing biosimilars in Europe has been estimated to have saved over €30 billion as of 2022. 

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The Pharma Data

MARCH 21, 2022

Nat Chem Biol, 2022. Salisporamide has a long history at Scripps and UC San Diego. Microbiologist Paul Jensen and marine chemist Bill Fenical of Scripps Oceanography discovered both salinosporamide A and the marine organism that produces the molecule after collecting the microbe from sediments of the tropical Atlantic Ocean in 1990.

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The Pharma Data

AUGUST 10, 2021

By the end of 2022, Bristol Myers Squibb aims to double executive representation of Black and Hispanic/Latino employees in the U.S. This alliance with Bristol Myers Squibb is a natural area of collaboration for FAMU, given our College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health,” said Larry Robinson, Ph.D.

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Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” However, this is not an agency-initiated effort.

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Agency IQ

JANUARY 4, 2024

To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.” The company submitted four separate citizen petitions to the FDA from March 2021 through October 2022 regarding benzene impurities.

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The rule, will also, if finalized, address communication with State boards of pharmacy. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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The Pharma Data

OCTOBER 27, 2020

We commenced launch activities for the Remunity Pump for Remodulin, including shipping training devices to specialty pharmacies and certain health care practitioners, and entering into agreements with specialty pharmacies to purchase Remunity Pumps and accessories and to pre-fill the Remunity cartridges exclusively with Remodulin.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). The sales data evaluated was from 2022, which.

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

This occurred in January 2022 when the Departments issued additional guidance , which discussed reports of denial of coverage in violation of the ACA requirement and provided a reminder to plans and issuers of their responsibilities under the statute and 2019 HRSA Guideline (FAQ Part 51, Q9).

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

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Agency IQ

AUGUST 25, 2023

For example, the Natural Products Association (NPA) asked the FDA in February 2022 to determine either that CBD is not excluded from the definition of a dietary supplement under 21 CFR Part 190.6, The potential for Congress to overturn this dynamic could have major and negative effects on the drug’s current owner, Jazz Pharmaceuticals.

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. pharmacies and personal imports from India can be safe as well.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Forest Pharmaceuticals, Inc. 4th 851 (6th Cir.

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Drug & Device Law

OCTOBER 25, 2023

Wilson applied Nexus Pharmaceuticals, Inc. Central Admixture Pharmacy Services, Inc. , 2022), which we identified as our third best case of last year , precisely because it enforced preemption against CA claims of this sort that sought to usurp FDA authority. 4th 1040 (9th Cir.

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Drug & Device Law

OCTOBER 10, 2023

Similarly, the court in Nexus Pharmaceuticals, Inc. Central Admixture Pharmacy Services, Inc., A claim based on non-disclosure of registry status with the FDA, however, would require the court to adjudicate whether registry was required—an issue solely within the discretion of the FDA. 48 F4th 1040, 1049 (9 th Cir.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 2022) (many other cases recognize this problem with class actions). 3d 1243 (9th Cir.

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Drug & Device Law

MARCH 31, 2023

Condemning attempts to sue those who set certification standards, here , in 2022. Rejecting anti-vaxxers attempting to sue the Center for Disease Control, here , also in 2022. 2022 WL 336585 (D. 4, 2022), which rejected a pharmaceutical trade libel claim against a peer-reviewed medical article and the journal that published it.

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Drug & Device Law

MARCH 30, 2023

Throwing that aside for non-funny political theater, Missouri enacted a law in 2022 that limited the ability of pharmacists to react to prescriptions for human use of either of these drugs. IMS Health, Inc. , Reagan Nat’l Adver. of Austin , 142 S.

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Drug & Device Law

FEBRUARY 20, 2023

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 3d , 2022 WL 6225596 (S.D. 2022 WL 6225661, at *5 (S.D.

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