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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

Chimerix initiates CMX001 Phase 2 clinical trial in stem cell transplant patients for CMV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced the initiation of a multi-center Phase 2 clinical trial designed to evaluate CMX001 in stem cell transplant recipients who are seropositive for cytomegalovirus (CMV).

9 Mar 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

Labeling update for Tibotec Therapeutics' PREZISTA tablets approved

Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for PREZISTA® (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies.

29 Jan 2010

Gilead Sciences reviewing Notice Letter regarding Teva Pharmaceuticals' generic Viread ANDA

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate).

27 Jan 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

Coformulation of rilpivirine and Truvada HIV drugs will achieve sales of more than $2 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in 2018, the fixed dose coformulation of Tibotec's rilpivirine and Gilead's Truvada will achieve blockbuster sales of more than $2 billion in the HIV drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

5 Jan 2010

Also in global health news: Kenya HIV/AIDS; Uganda bill; water project in Philippines; U.N. appeal for Yemen

U.S. Ambassador Michael Ranneberger on Wednesday announced the U.S. would provide $26.5 million (2.7 billion Kenyan shillings) between 2009 and 2013 to fight HIV/AIDS in Kenya, the Daily Nation reports (Sinundu, 12/16). In related news, the Standard reports the Kenyan government will be begin the gradual phase out of the antiretroviral drug, Stavudine, which is known to cause adverse side effects (Mwai, 12/15).

17 Dec 2009

Microbicide does not reduce women's risk of HIV infection, study shows

Pro 2000, a vaginal microbicide gel designed to reduce women's risk of HIV infection, showed "no evidence that it reduces the risk of HIV infection," according to the results of a series of clinical trials in Africa, Britain's Medical Research Council (MRC) said on Monday, Reuters reports.

15 Dec 2009

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

WHO issues new HIV/AIDS treatment guidelines

The WHO on Monday issued new recommendations that patients living with HIV/AIDS begin receiving antiretrovirals (ARVs) earlier than current HIV treatment advice suggests, the Associated Press reports

1 Dec 2009

Gilead Sciences and GSK to commercialize Viread in 5 Asian countries

Gilead Sciences, Inc. and GlaxoSmithKline today announced a licensing agreement to commercialize Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialization activities will expand access to Viread for the treatment of HBV, once approved, to patients in Asia where the prevalence in most countries is greater than 8 percent.

24 Nov 2009

R&D of HIV treatments at crossroads

IP Overview HIV Therapy 2009” ( www.frinnov.fr/en/ip-overview/sciences-de-la-vie/hiv-therapy-2.html ) establishes a panorama of the patents claiming “HIV and AIDS treatments” and analyses the key and emerging thematic and the strategic positions of the actors involved in this sector. In order to fully analyze this field, the information coming from 6800 published patents and patent applications was aggregated.

4 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

Johnson & Johnson announces financial results for the third quarter of 2009

Johnson & Johnson today announced sales of $15.1 billion for the third quarter of 2009, a decrease of 5.3% as compared to the third quarter of 2008. Operational results declined 2.8% and the negative impact of currency was 2.5%. Domestic sales declined 8.1%, while international sales declined 2.5%, reflecting operational growth of 2.4% and a negative currency impact of 4.9%.

13 Oct 2009

$7.2 million grant awarded to develop microbicide-releasing vaginal ring

The National Institutes of Health has awarded Albert Einstein College of Medicine of Yeshiva University a four-year, $7.2 million grant to develop a microbicide-releasing vaginal ring to prevent HIV transmission.

3 Oct 2009

Study: Antiretroviral drugs may prevent HIV infection in women

Hopeful that some of the same antiretroviral (ARV) drugs used to treat HIV infection can also prevent it, researchers from the Microbicide Trials Network have enrolled the first participants into a new, large-scale clinical trial testing two approaches of the strategy in women.

17 Sep 2009

VOICE clinical study for testing the efficacy of two HIV prevention strategies

A new, large-scale clinical trial is examining whether antiretroviral medications normally used to treat HIV infection can also prevent HIV infection in women when applied as a vaginal gel or taken as oral tablets once daily.

16 Sep 2009