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Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Shionogi-ViiV Healthcare to advance '572 inhibitor into Phase III clinical trials

Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.

21 Jul 2010

Antiviral therapy prevents recurrence of HCC, extends patients' lives, researchers report

Previous studies have shown that antiviral treatment reduces the incidence of hepatocellular carcinoma in patients with chronic hepatitis B. But now, researchers from the Division of Gastroenterology and Hepatology at Thomas Jefferson University are reporting that the antiviral therapy also prevents recurrence of HCC and extends patients' lives.

25 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Kun Run Biotechnology, Inc., a leading bio-pharmaceutical company in China focusing on manufacturing and sales of peptide-based and small molecule drugs, today announced that they have obtained the manufacturing approval for Entecavir from the China State Food and Drug Administration (SFDA).

17 Jun 2010

Infant nevirapine more effective in preventing HIV transmission than maternal antiretroviral therapy

The largest study to date to examine methods to prevent HIV infection among breastfeeding infants concludes that giving antiretroviral drugs to HIV-infected breastfeeding mothers in sub-Saharan Africa or giving an HIV-fighting syrup to their babies are both effective.

17 Jun 2010

Gilead Sciences doses first patient in Quad Phase III clinical program

Gilead Sciences, Inc. today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.

13 Apr 2010

ViiV Healthcare highlights S/GSK1349572, SELZENTRY and EPZICOM for HIV/AIDS at 17th CROI

At the 17th Conference on Retroviruses and Opportunistic Infections (CROI), ViiV Healthcare presented new data across its broad range of investigational and current medicines for the treatment of HIV/AIDS. Highlighted data at the conference included an oral presentation on the investigational integrase inhibitor, S/GSK1349572, as well as data presentations on SELZENTRY® (maraviroc) and EPZICOM® (abacavir/lamivudine).

24 Feb 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Enrollment of patients for Phase I/IIa clinical study of Interleukin-7 commenced

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in its Phase I/IIa clinical program evaluating the company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in combination with standard antiviral treatment and vaccination in HBeAg-negative chronic hepatitis B-infected (HBV) patients.

8 Dec 2009

Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

Bristol-Myers Squibb today announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir. The new BARACLUDE data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.

2 Nov 2009

Gilead Sciences to present Viread Phase III clinical trial data

Gilead Sciences, Inc. today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

2 Nov 2009

Merck Frosst Canada announces the use of ISENTRESS for treating HIV-1 infected adults

Merck Frosst Canada Ltd. is pleased to announce that (Pr)ISENTRESS(R) (raltegravir) is now indicated for use in treatment-naïve HIV-1 infected adults in combination with other antiretroviral agents.

20 Oct 2009

GlaxoSmithKline to allow Apotex continue manufacturing their drug in Rwanda

GlaxoSmithKline Inc. (GSK) As part of its broad commitment to improving access to medicines and its ongoing support for Canada's Access to Medicines Regime (CAMR), GlaxoSmithKline confirms it will not object - through CAMR - to allow Canadian company (Apotex) to continue manufacturing their drug for the treatment of HIV/AIDS in Rwanda.

20 Oct 2009

FDA Advisory Committee approves use of Selzentry tablets in combination with HIV therapy

Pfizer Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

9 Oct 2009

Matrix Laboratories receives tentative FDA approval for its NDA

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

16 Sep 2009

MSD's ISENTRESS approved by the EU Commission for treating HIV-1 infection in adult patients

Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients.

15 Sep 2009