Topic
Pharmaceuticals
1,003 published works
Government Contracts Navigator
Court of Federal Claims Reaffirms Agency Discretion in TAA Country-of-Origin Determinations for Pharmaceuticals
Merle M. DeLancey, Jr. and Shane M. Hannon ● On July 28, 2026, the U.S. Court of Federal Claims issued its decision in AvKare, LLC v. United States[1], upholding the Department of…
Big Molecule Watch
FDA Issues Its First Freeze-Dried Plasma License
On July 29, 2026, the FDA announced that it had licensed EZPLAZ FDP, the first freeze-dried (lyophilized) plasma product to be licensed in the United States. The license was issued…
Jotwell
Gaming the Standard
The professional standard for medical malpractice, traditionally set by custom, has come under scrutiny. The most common concern is that custom may not reflect actual best practices,1 and health care…
SDNY Blog
Judge Carter Dismisses Novo Nordisk’s False Advertising Claims, Finding Statements About Compounded GLP-1s Were Susceptible To An Accurate Reading
On Friday, Judge Carter granted defendant Zealthy Inc.’s motion to dismiss claims brought by Novo Nordisk under the Lanham Act and New York General Business Law. Novo Nordisk alleged that…
International Trade Insights
Tariffs for UK Origin Patented Pharmaceuticals Reduced from 10% to Zero
By Robert Stang, Moushami Joshi
The Trump Administration has officially reduced tariffs on patented pharmaceuticals and associated pharmaceutical ingredients imported from the United Kingdom (UK) from 10% to 0%. This change, effective July 31, 2026,…
Spicy IP
Bearing the Burdens of Bolar
By SpicyIP
The Madras High Court’s decision in Novartis AG v. Venkata Narayana Active Ingredients offers the first post-trial examination of the evidence required to invoke Section 107A for exports to get…
Drug & Device Law
No Duty to Innovate: California Supreme Court Rejects New Negligence Theory
The California Supreme Court handed down its long-awaited decision in Gilead Tenofovir Cases yesterday, and as we hoped, the Court held that a drug manufacturer owes no duty of care…
Inside Class Actions
Third Circuit Raises the Bar for Proving Causation Through Statistical Evidence in RICO Pharmaceutical Fraud Class Actions
The Third Circuit recently vacated and remanded a district court’s decision granting class certification for a class of third-party payors (“TPPs”) pursuing Racketeer Influenced and Corrupt Organizations Act (“RICO”) claims…
JURIST
US appeals court reverses dismissal of Tylenol cases
A US federal appeals court on Monday reversed a trial judge’s decision to dismiss lawsuits against Kenvue, the maker of Tylenol. This judgment effectively revived hundreds of cases that were…
Botinha & Cabral - International Business
How to Expedite Medicine Factory Inspection by Brazil
By Bootie
A delayed site inspection can hold up an entire market entry plan. If your company needs to expedite medicine factory inspection by Brazil, the key issue is usually not speed…