Nabriva Therapeutics plc.
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Latest From Nabriva Therapeutics plc.
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
Public/Private Partnerships Keep Gonorrhea Drug Development Alive
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.
Nabriva Hopes To Relaunch Xenleta In Community Setting As Pandemic Subsides
Moving away from its earlier hospital-based focus with the novel antibiotic, Nabriva also thinks selling Merck & Co.’s Sivextro will provide complementary business.
2020 Sees Sharp Rise In EU New Drug Approvals
The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.
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