Drug Channels

NOVEMBER 23, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble Reconsidering Amazon P.S. Please join the nearly 13,000 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter. Happy Thanksgiving, everyone!

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

NOVEMBER 23, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon P.S. You can also find my daily posts on LinkedIn , where I have more than 21,000 followers.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

MAY 27, 2020

Before you venture outside for your lockdown barbeque, check out these noteworthy items off the Drug Channels grill: Payers predict how COVID-19 will affect formularies Our analysis of the 2020 retail-to-mail shift AmerisourceBergen profiles biosimilars Plus, CVS pharmacy offers a clever way to measure appropriate social distancing.

Biosimilars 52

Biosimilars Specialty Pharmacies Pharmacy Hospitals 52

Drug Channels

NOVEMBER 22, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon Plus, the FDA preps you for Thursday with a regulatory soup review. Happy Thanksgiving, everyone!

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy FDA Biosimilars 98

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals 49

Hospitals Pharmacy Compliance Government 49

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals 45

Hospitals Pharmacy Compliance Government 45

Drug Channels

NOVEMBER 9, 2022

Fein will share his latest thinking on a wide range of topics, including: Retail and specialty pharmacy trends Vertical integration and consolidation The Inflation Reduction Act of 2022 The Medicare Part D Redesign Biosimilars Discount cards and cash-pay pharmacies The growing impact of hospitals and health systems The 340B Drug Pricing Program Federal (..)

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

NOVEMBER 24, 2020

In this issue: Rebate rule redux Most Favored Nation and healthcare benchmarking Amazon’s pharmacy customer opportunity Drug spending realities updated GPO consolidation Plus, I congratulate Dirk Rodgers of RxTrace on his retirement. Before you stretch your stomach, stretch your mind with this extra-stuffed helping of food for thought.

Pharmacy 52

Pharmacy Specialty Pharmacies Biosimilars Doctors 52

Drug Channels

NOVEMBER 23, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon P.S. You can also find my daily posts on LinkedIn , where I have more than 21,000 followers.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Biosimilars Drugs 52

Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! contains new data on hospital acquisitions and consolidation activity. pharmaceutical distribution industry. Section 6.1.6.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! reviews the evolving specialty pharmacy industry and discusses emerging challenges from direct distribution models that bypass wholesale distribution.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

FDA Law Blog: Biosimilars

APRIL 8, 2024

To address the underlying causes of shortages, the White Paper suggests that the creation (by Congress) of two programs that link inpatient hospital purchasing and payment decisions to supply chain resilience practices would better incentivize investments in mature manufacturing practices. Section I.C

Drugs 59

Drugs FDA Hospitals Government 59

FDA Law Blog: Biosimilars

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. A number of drug companies sued to enjoin enforcement.

Pharmacy 59

Pharmacy Pharmaceuticals Government Hospitals 59

FDA Law Blog: Biosimilars

JULY 5, 2023

Specifically, the Agency recognizes that that an outsourcing facility may distribute a drug it compounded to a “state licensed pharmacy, federal facility, or licensed physician, which subsequently dispenses the drug pursuant to a prescription.” Draft Guidance III.B.2(e) More specifically, the prohibition includes when a “third party (e.g.,

FDA 52

FDA FDA Approval Licensing Licensing 52

Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. This year has demonstrated the underlying resilience of U.S.

Pharmacy 52

Pharmacy Vaccine Drugs Pharmaceuticals 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

physicians services or inpatient hospitals services) and for which Medicaid payment may be made as part of payment for the service “and not as direct reimbursement for the drug.” 1396r-8(k)(3). Under the final rule, “direct reimbursement for the drug” would not be limited to separate payment for the drug.

Regulations 59

Regulations Drugs International Pharmacy 59