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Drug Pricing Manufacturers Regulatory Requirements

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Robins Kaplan LLP

Generic Launches - Winter 2024

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

Hogan Lovells on

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

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