Drug Channels

MARCH 31, 2022

Along with sunshine and fine weather, this vernal equinox has ushered in a crop of new and noteworthy stories: Health inequities in utilization management Insurers compute big white bagging savings The biosimilar boom accelerates The patient upside of manufacturers’ copay support Whoa. CVS Health takes the red pill. to 1:30 p.m.

Biosimilars 98

Biosimilars Pharmacy Drugs 98

Drug Channels

APRIL 20, 2022

Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. d/b/a Drug Channels Institute.

Biosimilars 98

Biosimilars Pharmacy Production Drugs 98

Drug Channels

JANUARY 19, 2022

For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Each exclusion list contains 400 to 500 products.

Biosimilars 98

Biosimilars Pharmacy Production Drugs 98

Drug Channels

APRIL 29, 2024

April is over, so it's time to hop into this month’s selection of noteworthy news: CVS Health’s formulary boosts a Humira biosimilar An insurer ditches buy-and-bill to save money for plans—but maybe not for patients?

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

JULY 11, 2022

Informa Connect's Hub and Specialty Pharmacy Models West. September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Copyright © 2006-2022 Pembroke Consulting, Inc. Delivered as a Hybrid Event. Attorney’s Office District of NJ Gustav W.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Compliance 98

Drug Channels

AUGUST 25, 2021

Time to pack away the bathing suit and get serious again—with these curated curiosities combed from the now-barren Drug Channels beach: OptumRx joins the PBM GPO game Pharmacy DIR fees hit $11 billion A terrific resource on state biosimilar laws Patient views on utilization management Plus, my social media success…from a (print) newspaper ad!

Biosimilars 83

Biosimilars Pharmacy Drugs Research 83

Drug Channels

MARCH 14, 2023

Pharmacies and Pharmacy Benefit Managers , available for purchase and immediate download. Pharmacies and Pharmacy Benefit Managers , our 14th edition, provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. I am pleased to announce our new 2023 Economic Report on U.S.

Pharmacy 98

Pharmacy Drugs Marketing Biosimilars 98

Drug Channels

OCTOBER 25, 2022

Sink your fangs into Amgen’s fantastic new report on the biosimilar boom Wicked! Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Mark Cuban tells ghost stories about PBMs. Walgreens terrifies Wall Street with its 340B losses. Physicians think payers cast evil utilization management spells. d/b/a Drug Channels Institute.

Biosimilars 98

Biosimilars Drugs Pharmacy 98

Drug Channels

MARCH 5, 2024

WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies. Pharmacies and Pharmacy Benefit Managers.

Pharmacy 98

Pharmacy Biosimilars Drugs Marketing 98

Drug Channels

NOVEMBER 29, 2022

In this issue: Mark Cuban schools Elon Musk on PBMs Market access lessons from Semglee Gen Z rejects the pharmacy career path A potent call for 340B transparency Plus, get ready to love the ‘90s again! Please join me for my upcoming live video webinar, Drug Channels Outlook 2023 , on December 16, 2022, from 12:00 p.m. to 1:30 p.m.

Pharmacy 97

Pharmacy Drugs Marketing Biosimilars 97

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). Decision at 8-9.

Pharmacy 59

Pharmacy Regulations Compliance Government 59

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. 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!

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

NOVEMBER 15, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. The Outlook 2022 marks our third annual outlook webinar. Broadcast live on December 17, 2021. to 1:30 p.m.

Specialty Pharmacies 94

Specialty Pharmacies Biosimilars Pharmacy Drugs 94

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ). 2, 2020 ( DOJ Press Release ).

Pharmacy 52

Pharmacy Regulations Production Laboratories 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 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

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Happy Thanksgiving, everyone! Before you stretch your stomach, stretch your mind with our extra-stuffed helping of food for thought. to 1:30 p.m.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

NOVEMBER 9, 2022

Friday, December 16, 2022 12:00 p.m. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2023. to 1:30 p.m. Read on for full details on pricing and registration.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

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! to 1:30 p.m.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy FDA Biosimilars 98

Drug Channels

OCTOBER 17, 2022

December 12-14, 2022 in Philadelphia, PA www.informaconnect.com/trade. Don’t miss Informa Connect's Trade & Channel Strategies Summit , coming up December 12-14, 2022 in Philadelphia! Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to November 11, 2022.*. Other restrictions may apply.

Biosimilars 75

Biosimilars Pharmacy Therapies Production 75

Drug Channels

NOVEMBER 23, 2021

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Happy Thanksgiving, everyone! Before you stretch your stomach, stretch your mind with our extra-stuffed helping of food for thought. to 1:30 p.m.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Biosimilars Drugs 52

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

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. By Larry K.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

FDA Law Blog: Biosimilars

MAY 16, 2024

Press Release – Sovah Health (“Sovah”), a hospital system in Virginia, agreed to pay $4,360,000 and entered into a Non-Prosecution Agreement in June 2022 after a pharmacy tech diverted more than 11,000 schedule II doses and another 1,900 schedule III-V doses. The nurse who allegedly stole the drugs died in March 2022.

Hospitals 59

Hospitals Nurses Compliance Pharmacy 59

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

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

Drug Channels

JUNE 25, 2024

Happy 248th birthday, America!

Biosimilars 52

Biosimilars Drugs Pharmacy 52

FDA Law Blog: Biosimilars

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

Pharmacy 105

Pharmacy FDA FDA Approval Production 105

FDA Law Blog: Biosimilars

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

FDA 111

FDA Production Trials Pharmacy 111

FDA Law Blog: Biosimilars

APRIL 8, 2024

pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. Section I.C of the White Paper states, accurately, that “factors that cause drug shortages are multi-faceted and involve many market participants.”

Drugs 59

Drugs FDA Hospitals Government 59

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. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Production 40

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).

FDA Approval 45

FDA Approval FDA Production Pharmacy 45

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. Allergan Sales , which affirmed a lower court decision in a Federal False Claims case involving best price stacking.

Drugs 59

Drugs Regulations Government Vaccine 59

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.

FDA 40

FDA Science Regulations Production 40