HIV Archives - Page 10 of 11

European Commission Approves Gilead’s Biktarvy

Approvals, European Commission, FDA/Regulatory, HIV, Nucleoside Reverse Transcriptase Inhibitors

The European Commission granted Marketing Authorization for Gilead Sciences Inc.’s Biktarvy as a once-daily single tablet regimen for the treatment of HIV-1 infection.

June 25, 2018/by Business Wire

Teva Announces Exclusive U.S. Launch of Generic Version of Reyataz

Generics, Hepatitis, HIV, Product Launches, Therapeutics

Teva Pharmaceutical Industries Ltd. announced the exclusive launch of a generic version of Reyataz (atazanavir) capsules in the U.S.

December 27, 2017/by Business Wire

U.S. FDA Approves Expanded Labeling for Epclusa

Approvals, Black Box Warning, FDA, FDA/Regulatory, Hepatitis C, HIV, Labeling Update

The FDA approved updated labeling for Gilead Sciences’ chronic hepatitis C virus drug Epclusa to include use in patients co-infected with HIV.

August 1, 2017/by Business Wire

FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

Biologics License Application (BLA), FDA, FDA/Regulatory, HIV, PDUFA, Priority Review

The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

June 30, 2017/by Marketwired

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

HIV

Gilead Sciences Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.

June 12, 2017/by Business Wire

Merck Receives FDA Approval of Isentress HD

Approvals, FDA, FDA/Regulatory, HIV

Merck announced that the U.S. FDA approved Isentress HD, a new 1,200 mg once-daily dose of the company’s integrase inhibitor Isentress (raltegravir).

May 30, 2017/by Business Wire

Kowa Pharmaceuticals America Announces INTREPID Trial Results in The Lancet HIV Showing Superior LDL Cholesterol Reduction with LIVALO Compared with Pravastatin in Adults with HIV and Dyslipidemia

"Bad" LDL Cholesterol, Dyslipidemia, HIV

Kowa Pharmaceuticals America Inc. today announced publication of results of the INTREPID Trial (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) in The Lancet HIV. Results of the Phase 4 trial showed that LIVALO (pitavastatin) 4 mg was superior to pravastatin 40 mg in reducing LDL cholesterol (LDL-C) in adults with HIV and dyslipidemia and had a comparable safety profile.

April 19, 2017/by Business Wire

U.S. FDA Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey for the Treatment of HIV-1 Infection

Approvals, FDA, FDA/Regulatory, Health, HIV

– Odefsey is the Smallest Single Tablet HIV Regimen – FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (GILD) today announced that the U.S. Food and Drug Administration (FDA) has […]

March 1, 2016/by Business Wire

With presidential primaries right around the corner, the cost of prescription drugs is at the top of the public’s healthcare priority list for the President and Congress, according to polling data from the Kaiser Family Foundation.

December 10, 2015/by Joshua Slatko

European Commission Approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults

Approvals, EU, FDA/Regulatory, HIV, R&D, Studies, Therapeutics

The European Commission approval is based upon Phase III clinical trial – Reyataz®(atazanavir) and cobicistat combination demonstrated virologic failure rates as low as 6% at 48 weeks and 8% at […]

July 17, 2015/by Business Wire