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Centers for Medicare & Medicaid Services (CMS) BPCIA

Mintz - Health Care Viewpoints

Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress

It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more

Goodwin

White Paper Investigates Biosimilar Competition and Price Reduction

Goodwin on

In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and...more

Holland & Knight LLP

Healthcare Law Update: February 2018

Holland & Knight LLP on

Antitrust - FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses - The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more

Mintz - ML Strategies

Health Care Update - February 2016 #2

Mintz - ML Strategies on

Martin Shkreli Not the Big Story on the Hill Last Week - Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more

McGuireWoods LLP

Sandoz’s Zarxio® Launches with 15% Wholesale Discount

McGuireWoods LLP on

On September 3, 2015, Sandoz Inc. (“Sandoz”) announced that it launched the first biosimilar in the United States, Zarxio® (filgrastim-sndz). Sandoz began marketing Zarxio® following a Federal Circuit Order to permit it to...more

Mintz - Health Care Viewpoints

FDA Finalizes Key Guidance Documents on Biosimilars

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more

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