June 11, 2018
A D.C. federal judge came down on the side of Eagle Pharmaceuticals Inc. on Friday, ordering the U.S. Food and Drug Administration to grant orphan drug exclusivity to the company's chemotherapy drug Bendeka.
May 04, 2018
Eagle Pharmaceuticals Inc. urged a D.C. federal judge in oral arguments Friday to upend an FDA rejection of orphan drug exclusivity on a chemotherapy drug, arguing the agency is bound by a prior court ruling to grant the company's request and can't justify the denial by claiming the orphan drug law is ambiguous.
August 30, 2017
Apotex Inc. has the right to intervene in a suit Eagle Pharmaceuticals Inc. is bringing against the FDA regarding a cancer treatment Eagle claims should have been given orphan drug exclusivity, as the fate of Apotex's in-process generic is directly affected by the litigation, a D.C. federal judge said Wednesday.
August 18, 2017
Apotex Inc. waited until litigation over the U.S. Food and Drug Administration's denial of orphan drug exclusivity for Eagle Pharmaceuticals Inc.'s chemotherapy injection Bendeka was nearly over before saying it needed to be involved to protect its in-process generic, Eagle said Thursday, urging the D.C. federal court to keep its competitor out of the suit.
August 08, 2017
Apotex Inc. on Monday asked a D.C. federal court for permission to intervene in Eagle Pharmaceutical Inc.'s suit accusing the FDA of wrongly denying it orphan drug exclusivity for the chemotherapy injection Bendeka, saying the release date of its in-process generic is at risk.
July 13, 2016
The second half of 2016 will produce industry-shaping court decisions regarding off-label marketing of medical devices, sales of biosimilars, drug exclusivity and anti-smoking regulations. Here are key cases to watch.
April 28, 2016
The U.S. Food and Drug Administration is flouting a recent court ruling and federal law by refusing to grant orphan drug exclusivity for chemotherapy infusion Bendeka, according to a complaint filed Wednesday in D.C. federal court.