Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018.[1] Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).[2] Continue reading “Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU”

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

The recent first global approval of bictegravir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

Bictegravir (Biktarvy®), developed by Gilead Sciences, received its first global approval in February 2018 in the USA as a fixed-dose combination, with emtricitabine and tenofovir alafenamide. Continue reading “Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen”

Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia

Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia

The recent first global approval of elsulfavirine has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia”

Niraparib (Zejula™): First Global Approval – Oral maintenance therapy for recurrent ovarian-related cancer

Niraparib (Zejula™): First Global Approval –  Oral maintenance therapy for recurrent ovarian-related cancer

The recent first global approval of niraparib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Niraparib (Zejula™): First Global Approval – Oral maintenance therapy for recurrent ovarian-related cancer”