FDA Confirms Paragraph IV Patent Litigation for Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide Tablets
PHILADELPHIA--(BUSINESS WIRE)--Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, announced the presentation of new data demonstrating that FORE8394, a next-generation BRAF inhibitor, provides evidence of durable anti-tumor activity and patient benefit in BRAF-mutated (V600+) cancers. Data from the ongoing Phase 1/2a study evaluating FORE8394 for the treatment of advanced solid and central nervous system (CNS) tumors with activating BRAF alterations were presented in a poster session at the European Society of Medical Oncology Congress (ESMO) taking place in Paris, France.
FDA Confirms Paragraph IV Patent Challenge of Symtuza 210455 (Darunavir, Cobicistat, Emtricitabine, Tenofovir Alefenamide) 80mg/ 150mg/ 200mg/ 10mg tablets
Johnson & Johnson’s sponsored AIDS film didn’t win at the Brand Film Festival in New York last week, but it had already won a different prize just a few days earlier.
Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks
Mylan Pharms Generic Atazanavir; Cobicistat Receives Tentative Approval in US
Stribild (elvitegravir) Japan Tobacco v. Mylan Pharma
FDA Confirms Paragraph IV Patent Challenge of Stribild 203100 (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets
NHS England (NHSE) has agreed to provide funding for Janssen’s Symtuza, a once-daily darunavir-based single tablet regimen (STR) for the treatment of HIV in adults and adolescents.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 6, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Drug Administration (CNDA) has approved Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based single tablet regimen for the treatment of HIV to be approved in China.