search tools

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (EMA - European Medicines Agency)

Edit Public Technologies 16 Sep 2016
(Source. EMA - European Medicines Agency). 16/09/2016 ... For more information, please see the press release in the grid below ... Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine / Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil) to treat HIV infection and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension....

Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA - Therapeutic Goods Administration)

Edit Public Technologies 15 Sep 2016
(Source. TGA - Therapeutic Goods Administration). Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change. Changes commonly include 'new uses' and 'extended uses' ... SIMPONI ... GAZYVA ... emtricitabine and tenofovir alafenamide fumarate ... tenofovir disoproxil fumarate / emtricitabine ... tenofovir disoproxil fumarate / emtricitabine / rilpivirine [as hydrochloride]....

Prescription medicines: registration of new chemical entities in Australia (TGA - Therapeutic Goods Administration)

Edit Public Technologies 14 Sep 2016
(Source. TGA - Therapeutic Goods Administration). Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the TGA ... Orphan drug. 2016.SepAugJulJunMayAprMarFebJan. Previous years.20152014 ... TALTZ. ixekizumab. Sponsor ... emtricitabine / rilpivirine / tenofovir alafenamide ... tenofovir alafenamide (as fumarate)/elvitegravir / cobicistat /emtricitabine....

Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency (Johnson & Johnson)

Edit Public Technologies 12 Sep 2016
This new treatment would combine the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg) and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) and tenofovir alafenamide (TAF 10 mg), in one single tablet ... cobicistat, emtricitabine and tenofovir alafenamide....

European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually ...

Edit Business Wire 22 Aug 2016
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq. GILD) today announced that the European Commission has granted marketing authorization for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP ... ....

European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1 (Gilead Sciences Inc)

Edit Public Technologies 22 Aug 2016
(Source. Gilead Sciences Inc) ... FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug ... (Nasdaq. GILD) today announced that the European Commission has granted marketing authorization for once-daily Truvada(emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP....

Emtricitabine/tenofovir alafenamide in HIV infection: Added benefit not proven

Edit Science Daily 19 Aug 2016
When investigators reviewed Emtricitabine/tenofovir alafenamide in HIV infection, they found that partly no data were available, and partly the appropriate comparator therapy was not adhered to. The risk of nervous system disorders was increased for one patient group, they conclude ... ....

ViiV Healthcare launches phase III programme evaluating a two-drug regimen combining dolutegravir and lamivudine for HIV-1 treatment (GlaxoSmithKline Holdings (Americas) Inc)

Edit Public Technologies 16 Aug 2016
The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada) ... Each study will include approximately 700 subjects who will be randomised 1.1 to receive dolutegravir plus lamivudine or dolutegravir plus tenofovir/emtricitabine fixed-dose combination....

ViiV starts PhIII Programme for dolutegravir & 3TC (GSK - GlaxoSmithKline plc)

Edit Public Technologies 16 Aug 2016
The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada®) ... Each study will include approximately 700 subjects who will be randomised 1.1 to receive dolutegravir plus lamivudine or dolutegravir plus tenofovir/emtricitabine fixed-dose combination....

ViiV Healthcare launches phase III programme evaluating a two-drug regimen combining dolutegravir and lamivudine for HIV-1 treatment (GSK - GlaxoSmithKline plc)

Edit Public Technologies 16 Aug 2016
The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada®) ... Each study will include approximately 700 subjects who will be randomised 1.1 to receive dolutegravir plus lamivudine or dolutegravir plus tenofovir/emtricitabine fixed-dose combination....

JT files New Drug Application for second tenofovir alafenamide (TAF)-based anti-HIV drug in Japan PDF:79kb (Japan Tobacco Inc)

Edit Public Technologies 15 Aug 2016
(Source. Japan Tobacco Inc) FOR IMMEDIATE RELEASE ... Japan Tobacco Inc. (JT) (TSE. 2914) announced today that the Company filed a New Drug Application for a fixed-dose combination for the treatment of HIV-1 infection (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF) to the Japanese Ministry of Health, Labour and Welfare on 12th August. Under the terms of the agreement on March 2015, Torii Pharmaceutical Co., Ltd ... ###....

Comprehensive Care is Key in HIV Management, Pharmacists Say (ASHP - American Society of Health-System Pharmacists)

Edit Public Technologies 15 Aug 2016
(Source. ASHP - American Society of Health-System Pharmacists) ... 'We do not just take care of HIV ... 'HIV is typically not their biggest problem,' Smith said of her patients ... Most of them do not have this.' ... The U.S ... ... FDA in 2012 approved emtricitabine-tenofovir disoproxil fumarate combination therapy for preexposure prophylaxis (PrEP) to prevent HIV transmission to uninfected people who are at high risk for infection ... (noodl. 34950929) ....

Data for MSD’s Investigational Once-Daily Formulation of ISENTRESS® (Merck Canada Inc)

Edit Public Technologies 29 Jul 2016
The study found that after 48 weeks of treatment, 1200 mg raltegravir (given as 2 x 600 mg once-daily) was statistically non-inferior (88.9 percent, 472/531) to the marketed formulation approved dose of ISENTRESS 400 mg twice-daily (88.3 percent, 235/266), each in combination therapy with TRUVADA® (emtricitabine/tenofovir disoproxil fumarate); with ......
×
×
×
×