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Approvals for Eli Lilly, Novartis; designations for Mereo, Matinas BioPharma


According to Market Intelligence, December 2022


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Approvals for Eli Lilly, Novartis; designations for Mereo, Matinas BioPharma

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 11.


* Eli Lilly and Co.'s Reyvow as an acute therapy for migraine with or without aura in adults.

* Novartis AG's Beovu for wet age-related macular degeneration.

* Pfenex Inc.'s PF708, a biosimilar of Eli Lilly's drug Forteo, for osteoporosis in certain patients at high risk of fracture.

* Clinuvel Pharmaceuticals Ltd.'s Scenesse to increase pain-free light exposure in adults who have a history of damage to skin resulting from erythropoietic protoporphyria.

* OraSure Technologies Inc.'s OraQuick Ebola Rapid Antigen as the first rapid diagnostic test for Ebola virus disease.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

Fast track

* Mereo BioPharma Group PLC's navicixizumab for high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or before Roche Holding AG's Avastin.

Other designations: orphan drug

* Matinas BioPharma Holdings Inc.'s MAT2203 for cryptococcosis.

* Neuren Pharmaceuticals Ltd.'s NNZ-2591 for Angelman syndrome.