FDA Video: Review of Invirase and Cardiac Arrhythmias
FDA is reviewing clinical trial data suggesting that using Invirase (saquinavir) in combination with Norvir (ritonavir) may increase the risk of cardiac arrhythmias.
Diagnosis & Disease Information
Phase 2b study of Arcelis for the treatment of immunotherapeutic treatment of HIV infection
Argos announced the initiation of a Phase 2b study of Arcelis (AGS-004), its personalized immunotherapy for the treatment of HIV patients.
Phase 3 study of once-daily Isentress for the treatment of HIV-1
Merck announced results from its Phase 3 study of once-daily Isentress (raltegravir tablets) for the treatment of HIV-1.
NDA submitted for telaprevir for treatment of hepatitis C (HCV)
Vertex announced they have submitted a New Drug Application (NDA) and request for Priority Review to the FDA for telaprevir for the treatment of hepatitis C virus (HCV).
Egrifta approved for HIV-associated abdominal lipodystrophy
Merck and EMD Serono announced that the FDA has approved Egrifta (tesamorelin for injection), a growth hormone releasing factor (GRF) analog, for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Phase 2b study of TMC435 for the treatment of chronic hepatitis C virus (HCV)
Tibotec presented results from its Phase 2b study of TMC435 for the treatment of chronic hepatitis C virus (HCV).
Phase 2b trial of ANA598 for the treatment of chronic hepatitis C virus (HCV)
Anadys announced the presentation of results from its Phase 2b trial of ANA598 for the treatment of chronic hepatitis C virus (HCV) patients.
Invirase labeling updated to include cardiac risk with Norvir
The FDA announced that new safety information has been added to the label for Invirase (saquinavir, from Genentech), describing potentially life-threatening cardiac effects when used with Norvir (ritonavir, from Abbott).
Baraclude approved for chronic hepatitis B with decompensated liver disease
Bristol-Myers Squibb announced the approval of Baraclude (entecavir tablets) for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.
Tamiflu available for 2010-2011 influenza season
Genentech announced that Tamiflu (oseltamivir phosphate) is available for the 2010-2011 influenza season.
