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Pharmaceutical Industry › Negotiations

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

Mintz - Health Care Viewpoints on

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

Ankura on

On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

McDermott+

Drug Payment Reform and Transparency: It’s What’s on the Menu for Policymakers

McDermott+ on

August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more

Epstein Becker & Green

CMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process

Epstein Becker & Green on

The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more

Mintz - Health Care Viewpoints

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Mintz - Health Care Viewpoints on

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more

Knobbe Martens

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Knobbe Martens on

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

Dechert LLP

SEC and Drugmaker Allergan Reach Settlement over M&A Disclosure Violations

Dechert LLP on

The U.S. Securities and Exchange Commission and drugmaker Allergan settled claims that Allergan failed to disclose negotiations with third parties following the announcement of a hostile tender offer by Valeant and co-bidder...more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Disclosure Failures During Merger Talks

Stinson - Corporate & Securities Law Blog on

The SEC announced that Allergan Inc. had agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. The SEC’s order finds that Allergan failed...more

Mintz - Health Care Viewpoints

The Challenge of Non-Interference

Mintz - Health Care Viewpoints on

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator. Essentially, they are without...more

King & Spalding

In the Wake of Trade Agenda Momentum, TPP Negotiations Continue

King & Spalding on

The United States made significant headway with the Administration's trade agenda in the summer of 2015. With the passage of Trade Promotion Authority, Congress has agreed to ensure trade agreements negotiated by the...more

Foley & Lardner LLP

Trans-Pacific Partnership Negotiations Face Tighter Timeline as Talks Continue

Foley & Lardner LLP on

Trade ministers announced that they will continue negotiations over several unresolved provisions of the Trans-Pacific Partnership (TPP) during a four-day meeting in Maui, Hawaii that concluded July 31. Trade ministers...more

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