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Gross-to-Net Bubble Update: 2023 Pricing Realities at 10 Top Drugmakers

Drug Channels

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. These data remain inconvenient for drug pricing flat earthers (#DPFE): When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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CMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate Program; HPM Issues Detailed Summary

FDA Law Blog: Biosimilars

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

Dosage 59
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Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases

FDA Law Blog: Biosimilars

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.

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January 2025 Newsletter

Safe Biologics

This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. Read the full statement here.