Try our Advanced Search for more refined results
- Law360
- Law360 UK
- Law360 Pulse
- Law360 Employment Authority
- Law360 Tax Authority
- Law360 Insurance Authority
- Law360 Real Estate Authority
- Law360 Healthcare Authority
- Law360 Bankruptcy Authority
- Products
- Lexis®
- Law360 In-Depth
- Law360 Podcasts
- Rankings
- Regional Powerhouses
- Law360's MVPs
- Women in Law Report
- Law360 400
- Diversity Snapshot
- Practice Groups of the Year
- Rising Stars
- Titans of the Plaintiffs Bar
- Sections
- Adv. Search & Platform Tools
- About all sections
- Browse all sections
- Banking
- Bankruptcy
- Class Action
- Competition
- Employment
- Energy
- Expert Analysis
- Insurance
- Intellectual Property
- Product Liability
- Securities
- Beta Tools
- Track docs
- Track attorneys
- Track judges
EAGLE PHARMACEUTICALS, INC. v. BURWELL et al
Case Number:
1:16-cv-00790
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
-
June 11, 2018
Eagle Wins Orphan Drug Status In Row With FDA
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
FDA Can't Evade Prior Orphan Drug Ruling, Eagle Says
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 Cleared To Intervene In Eagle's Orphan Drug Suit
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 Can't Join Nearly Done Orphan Drug Suit, Eagle Says
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 Wants In On Orphan Drug Suit To Protect Generic
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
Life Sciences Cases To Watch In The 2nd Half Of 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
FDA Flouting Court On Orphan Drug Exclusivity, Suit Says
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.