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Latest From Legal Issues

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

BioPharmaceutical Biosimilars

Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets

Court denies JHL motion to dismiss trade secret theft suit, bars development or sale of biosimilars that rely on information from Genentech documents; trial scheduled to begin in November 2020.

Intellectual Property Biosimilars

US Visa Concerns Led ICH To Choose Canadian Meeting Site

The US, one of ICH’s original three member authorities, was spurned in favor of Canada for the pharmaceutical regulatory harmonization initiative’s next meeting in the region because of some participants’ difficulties obtaining US visas.

Manufacturing Legal Issues

Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.


Generic Drugs Launches

Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity

US FDA would get an overall increase in funding under the president's fiscal year 2020 budget proposal, although the generic drug industry opposes reforms targeting the 180-day exclusivity clock for first filers.
Generic Drugs Legislation
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