Amarin Vascepa News Today

Law aims to encourage competition in the pharmaceutical industry, making it easier for generics to enter market.

After the generic infringement debacle, Amarin transitioned from a growth stock to a turnaround play. See it can turn around with pressure from Sarissa Capital?

As we enter the second month of 2022, the old saying, "If at first you don't succeed, try, try again" and the famous line, "I'm not dead," from Monty Python and the Holy Grail, come to mind to describe two issues...

Generic drug makers often use "skinny labels" to carve out approved indications that are covered by an innovator's patents, and thus to avoid liability for inducing infringement.

The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but...

The Bloc

The opportunity to shut out competitors after a 30-day investigation would be a powerful tool for businesses, but potentially a very dangerous one too

To embed, copy and paste the code into your website or blog: On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs. The Ensuring Innovation Act supports generic drugs by clarifying the technical qualifications for earning exclusivity as a "new chemical entity." The Advancing Education on Biosimilars Act provides for increased federal efforts to educate patients, doctor...

To embed, copy and paste the code into your website or blog: On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring Innovation Act replaces the term “active ingredient” with “active moiety” in parts of the Federal Food, Drug, and Cosmetic Act (FDCA), effectively endorsing the U.S. Food and Drug Administration’s (FDA) ability to refine the meaning of the term in ...