Melinta Therapeutics, LLC, et al v. FDA, et al
| Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc. |
| United States Food and Drug Administration, United States Department of Health and Human Services, Xavier Becerra, In his official capacity as Secretary of Health and Human Services and Robert McKinnon Califf, M.D., In his official capacity as Commissioner of Food and Drugs, United States Food and Drug Administration |
| Nexus Pharmaceuticals, Inc. |
| 22-5288 |
| November 2, 2022 |
| U.S. Court of Appeals, D.C. Circuit |
| Other Statutory Actions |
Docket Report
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| PER CURIAM ORDER [1975720] filed granting motion to dismiss case for lack of jurisdiction [ # 1972212-2 ]; dismissing as moot motion to expedite case [ # 1972314-2 ]. See order for details. The Clerk is directed to withhold issuance of the mandate herein until seven days after resolution of any timely petition for rehearing or petition for rehearing en banc. Before Judges: Katsas, Walker and Childs. [22-5288] [Entered: 12/01/2022 11:53 AM] |
| REPLY [1974625] filed by Nexus Pharmaceuticals, Inc. to response [ # 1973607-2 ], [ # 1973599-2 ] [Service Date: 11/21/2022 by CM/ECF NDA] Length Certification: 2,580 words. [22-5288] (Nichols, Andrew) [Entered: 11/21/2022 10:03 PM] |
| REPLY [1974609] filed by Xavier Becerra, Robert McKinnon Califf, M.D., FDA and HHS to response [ # 1973631-2 ] [Service Date: 11/21/2022 by CM/ECF NDA] Length Certification: 2026 words. [22-5288] (Carroll, Sarah) [Entered: 11/21/2022 05:19 PM] |
| RESPONSE IN OPPOSITION [1973599] to motion to expedite case [ # 1972314-2 ], motion to dismiss case for lack of jurisdiction [ # 1972212-2 ] filed by Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc. [Service Date: 11/14/2022 by CM/ECF NDA] Length Certification: 4315 words. [22-5288] (Bucholtz, Jeffrey) [Entered: 11/14/2022 05:34 PM] |
| RESPONSE IN OPPOSITION [1973607] to motion [ # 1972314-2 ] filed by Xavier Becerra, Robert McKinnon Califf, M.D., FDA and HHS [Service Date: 11/14/2022 by CM/ECF NDA] Length Certification: 1116 words. [22-5288] (Carroll, Sarah) [Entered: 11/14/2022 05:50 PM] |
| RESPONSE IN OPPOSITION [1973631] to motion to dismiss case for lack of jurisdiction [ # 1972212-2 ] filed by Nexus Pharmaceuticals, Inc. [Service Date: 11/14/2022 by CM/ECF NDA] Length Certification: 5,178. [22-5288] (Nichols, Andrew) [Entered: 11/14/2022 10:49 PM] |
| PER CURIAM ORDER [1972504] filed that the request for expedited briefing on the motion to expedite be denied. directing responses to motion to expedite case [ # 1972314-2 ] and motion to dismiss case for lack of jurisdiction [ # 1972212-2 ]. Responses due on 11/14/2022 - - replies to responses due 11/21/2022. Before Judges: Katsas, Walker and Childs. [22-5288] [Entered: 11/07/2022 04:09 PM] |
| MOTION [1972314] to expedite case filed by Nexus Pharmaceuticals, Inc. (Service Date: 11/04/2022 by CM/ECF NDA) Length Certification: 4,363 words. [22-5288] (Nichols, Andrew) [Entered: 11/04/2022 09:57 PM] |
| ENTRY OF APPEARANCE [1972139] filed by Jeffrey S. Bucholtz and co-counsel Paul Alessio Mezzina; Amy R. Upshaw on behalf of Appellees Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc.. [22-5288] (Bucholtz, Jeffrey) [Entered: 11/04/2022 09:46 AM] |
| MOTION [1972212] to dismiss case for lack of jurisdiction filed by Xavier Becerra, Robert McKinnon Califf, M.D., FDA and HHS (Service Date: 11/04/2022 by CM/ECF NDA) Length Certification: 1890 words. [22-5288] (Carroll, Sarah) [Entered: 11/04/2022 12:56 PM] |
| ENTRY OF APPEARANCE [1972309] filed by Andrew C. Nichols on behalf of Appellant Nexus Pharmaceuticals, Inc.. [22-5288] (Nichols, Andrew) [Entered: 11/04/2022 06:55 PM] |
| ENTRY OF APPEARANCE [1972053] filed by Sarah Carroll and co-counsel Daniel Tenny on behalf of Appellees Xavier Becerra, Robert McKinnon Califf, M.D., FDA and HHS. [22-5288] (Carroll, Sarah) [Entered: 11/03/2022 02:42 PM] |
| NOTICE OF APPEAL [1971830] seeking review of a decision by the U.S. District Court in 1:22-cv-02190-RC filed by Nexus Pharmaceuticals, Inc.. Appeal assigned USCA Case Number: 22-5288. [22-5288] [Entered: 11/02/2022 03:15 PM] |
| US CIVIL CASE docketed. [22-5288] [Entered: 11/02/2022 03:14 PM] |
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| Plaintiff / appellee: Melinta Therapeutics, LLC | |
| Represented By: | Amy R. Upshaw |
| Represented By: | Jeffrey S. Bucholtz |
| Represented By: | Paul Alessio Mezzina |
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| Plaintiff / appellee: Rempex Pharmaceuticals, Inc. | |
| Represented By: | Jeffrey S. Bucholtz |
| Represented By: | Amy R. Upshaw |
| Represented By: | Paul Alessio Mezzina |
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| Defendant / appellee: United States Food and Drug Administration | |
| Represented By: | Sarah Carroll |
| Represented By: | Daniel Tenny |
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| Defendant / appellee: United States Department of Health and Human Services | |
| Represented By: | Sarah Carroll |
| Represented By: | Daniel Tenny |
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| Defendant / appellee: Xavier Becerra, In his official capacity as Secretary of Health and Human Services | |
| Represented By: | Sarah Carroll |
| Represented By: | Daniel Tenny |
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| Defendant / appellee: Robert McKinnon Califf, M.D., In his official capacity as Commissioner of Food and Drugs, United States Food and Drug Administration | |
| Represented By: | Sarah Carroll |
| Represented By: | Daniel Tenny |
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| Intervenor defendant / appellant: Nexus Pharmaceuticals, Inc. | |
| Represented By: | Janine Carlan |
| Represented By: | Andrew Curtis Nichols Esquire |
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