Fluconazole should not be standard fungus prophylaxis for people with HIV -- new PHS/IDSA guidelines.
• By The Pink Sheet
FLUCONAZOLE SHOULD NOT BE USED FOR ROUTINE HIV PROPHYLAXIS of the fungal infections candidiasis and cryptococcosis, the Public Health Service and the Infectious Diseases Society of America recommend in new guidelines for prevention of opportunistic infections. Pfizer's Diflucan (fluconazole) is approved for treatment of oropharyngeal and esophageal candidiasis and cryptococcal meningitis often related to HIV/AIDS; as prophylaxis for candidiasis in patients who undergo bone marrow transplantation who receive chemotherapy; and, most recently, for treatment of vaginal candidiasis ("The Pink Sheet" July 11, p. 8).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.