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Recent Articles

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Gilead resubmits application to FDA for approval of long-acting injectable HIV drug lenacapavir after FDA refused authorization in February due to drug’s compatibility with borosilicate glass vial; Gilead now using aluminosilicate glass vial for drug

FDA lifts clinical hold on Gilead’s injectable lenacapavir HIV treatment, pre-exposure prophylaxis as Gilead changes borosilicate glass vials to aluminosilicate glass vials; hold was from concerns about drug’s compatibility with borosilicate vials

FDA approves Hologic’s Aptima CMV Quant assay for use with Hologic’s automated Panther system for solid organ, stem cell transplant patients; test is firm's first post-transplant pathogen detection test in US, joins tests for HIV-1, hepatitis C and B

J&J’s Janssen unit stops development of HPV, hepatitis B vaccines with Bavarian Nordic but keeps Ebola and HIV vaccine programs; J&J to focus on hepatitis B treatments currently under development, including two combination therapies in Phase 2 studies

Commentary: mRNA technology used by Pfizer, Moderna for COVID vaccines could end up unlocking much more for future of health care; numerous mRNA vaccine candidates are being researched, undergoing clinical trials for treating cancer, HIV, flu, ebola, more

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