Gilead Sciences has received notice of compliance from Health Canada for its once-daily oral nucleotide analog polymerase inhibitor Sovaldi or sofosbuvir 400mg tablets for the treatment of chronic hepatitis C or CHC infection. Sovaldi is ...
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
Janssen-Cilag (Janssen) has submitted a marketing authorization application to the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet of HIV-1 medicine darunavir with cobicistat. ...
Tags: European Marketing, HIV-1
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
The European Commission has approved Gilead Sciences' Stribild for marketing as the single tablet regimen for HIV-1 treatment in all 27 countries of the European Union. Four of the Gilead's compounds elvitegravir 150mg, cobicistat 150mg, ...
EMC has announced new solutions and enhancements across its Documentum solution portfolio for the energy, life sciences and healthcare industries. At its flagship EMC World conference in Las Vegas, the company said the solutions are ...
Tags: Computer Products, software
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine
Biopharmaceutical company Pfizer has decided to discontinue the development of filibuvir, an experimental hepatitis C drug, following a strategic review and capital allocation. The drug, which is in mid-stage clinical testing, is facing ...
Tags: Pfizer, filibuvir drug, drug
Biopharmaceutical company Gilead Sciences has issued a voluntary recall of one lot of Vistide (cidofovir injection) at user level due to incidence of particulate matter in few vials. The recalled lot of the product was distributed to ...
Biopharmaceutical company Gilead Sciences has completed the acquisition of YM BioSciences. A Gilead subsidiary acquired all YM's outstanding common shares as per the terms of a plan of arrangement. Thus, YM has become a wholly-owned ...
Tags: Gilead Sciences, YM BioSciences, acquisition
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
Aptalis Pharmaceutical Technologies announced that the European Commission has approved the marketing authorization of new oral granule formulation of Gilead Sciences' Viread, covering 27 countries of the European Union. Viread is ...
Tags: oral granule formulation, Pharmaceutical Technologies, Pharmaceutical
Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) has received approval from the US Food and Drug Administration (FDA). Truvada is the first agent to get approval for HIV prevention in uninfected adults, a strategy ...
Tags: HIV testing, Truvada, PrEP, pre-exposure prophylaxis
Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild is a complete once-daily single tablet ...