Drug Channels

SEPTEMBER 6, 2023

CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz.

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Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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Drug Channels

MARCH 30, 2023

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version.

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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. Delivered as a Hybrid Event. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *.

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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.

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Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. Read on for Saket’s insights.

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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. The notable new material in this 2023-24 edition includes: New data about commercial pricing and reimbursement for provider-administered biosimilars appears in Section 3.2.2.

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Drug Channels

NOVEMBER 14, 2023

Fein, CEO 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 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. This event is part of The Drug Channels 2023 Video Webinar Series. to 1:30 p.m.

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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 ). 21 U.S.C. §

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023-24 edition at special discounted prices. pharmaceutical distribution industry.

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Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Trade and Channel Strategies is back and we have a lot to talk about! Why should you attend this pivotal event?

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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.

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Drug Channels

JUNE 5, 2023

thINc’s Specialty Networks and Patient Support Services Summit In-Person Event | August 29-30, 2023 Lowes Philadelphia, Philadelphia, PA www.thinc360.com/specialty Copyright © 2006-2023 Pembroke Consulting, Inc. com/specialty Early rates are in effect. Use promo code DC5123 to save an additional $100 off the early rates.

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Drug Channels

JUNE 26, 2023

Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to July 28, 2023.* Join your colleagues on August 14-16, 2023 at the Westin Copley Place for the Health Systems & Pharma Partnering Summit to optimize strategic partnerships and improve quality, manage costs and enhance patient outcomes.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.”

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FDA Law Blog: Biosimilars

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. of the White Paper states, accurately, that “factors that cause drug shortages are multi-faceted and involve many market participants.”

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. Priority A List. New on CDRH’s guidance agenda.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. before such manufacturer signs a Discount Program agreement) and non-binding of their phase-in eligibility if they provide CMS all ownership information by December 8, 2023.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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