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Pharmaceutical Industry › Pharmaceutical Patents › Department of Health and Human Services (HHS)

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Goodwin

President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American...

Goodwin on

On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Patent Thickets and Regulatory Challenges Cited as Major Factors Limiting Price Reductions in the Biologic Drug Space

Rothwell, Figg, Ernst & Manbeck, P.C. on

The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more

Mintz - Intellectual Property Viewpoints

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

Mintz - Intellectual Property Viewpoints on

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma under fire over quality, safety, and patents on costly brand drugs

Patrick Malone & Associates P.C. | DC Injury... on

When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more

McDonnell Boehnen Hulbert & Berghoff LLP

House Bill Would Allow HHS Secretary to Authorize Competitive Licenses for Drug Patents

McDonnell Boehnen Hulbert & Berghoff LLP on

A bill introduced in the House last July by Rep. Lloyd Doggett (D-TX) (at right), which could adversely impact pharmaceutical manufacturers holding drug patents, is starting to draw the attention of those outside the patent...more

Mintz - Health Care Viewpoints

Biosimilars in the Limelight – A Lot Has Happened Since January 2018

Mintz - Health Care Viewpoints on

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

Polsinelli

Recent 340B Orphan Drug Decision May Have Widespread Implications

Polsinelli on

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the “Mega-Reg” ...more

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