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Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Merck and Bill & Melinda Gates Foundation commit additional $60M to support Botswana's ACHAP

Merck today announced the Merck Company Foundation and the Bill & Melinda Gates Foundation are committing an additional $60 million to support Botswana's African Comprehensive HIV/AIDS Partnerships (ACHAP). Merck is known as MSD outside the US and Canada. A unique program developed with and led by the Government of Botswana, ACHAP is one of sub-Saharan Africa's oldest, most successful public-private partnerships.

24 Aug 2010

Bristol-Myers Squibb, ACTF announce enhanced agreement to support ADAPs

Bristol-Myers Squibb Company and the ADAP Crisis Task Force today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs to provide antiretroviral medicines to people living with HIV and AIDS. Building on an agreement signed in March of 2010, today's announcement marks a multi-year enhancement to assist ADAPs in meeting the challenges of increasing patient case loads and strained government funding.

12 Aug 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

New York Times examines questions left unanswered by microbicide trial

The New York Times examines a set of questions raised by news out of the International AIDS Conference-AIDS 2010 last week that a microbicide gel containing the antiretroviral tenofovir used by women before and after sex helped reduce their risk of HIV infection by 39 percent.

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

AIDS 2010: Obama, Clinton vow U.S. support to global fight against HIV/AIDS

During the closing ceremonies of the International AIDS Conference-AIDS 2010, President Barack Obama "on Friday pledged to redouble efforts to fight HIV and AIDS through his Global Health Initiative, despite dealing with economic hard times in the wake of a global recession," Reuters reports. According to the news service, "Obama and his Secretary of State Hillary Clinton said their focus was on a broad, sustainable and effective approach to the global epidemic" (Kelland, 7/23).

26 Jul 2010

AVAC releases GPP Guidelines at International AIDS Conference

The draft second edition of The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials were released yesterday at the International AIDS Conference in Vienna by AVAC. The GPP Guidelines aim to provide trial funders, sponsors, and implementers with systematic guidance on how to effectively work with a range of stakeholders as they design and conduct biomedical HIV prevention trials.

23 Jul 2010

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

New HIV drug on the block

Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.

22 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

Study marks significant milestone for microbicide research field, HIV prevention

Today we congratulate the Centre for the AIDS Programme of Research in South Africa and the people of South Africa on the positive findings from the CAPRISA 004 microbicide study, which marks a significant milestone both for the microbicide research field and HIV prevention as a whole.

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

HIV and Human Rights March to prevent new infections, provide treatment for people with HIV

The call for human rights as a fundamental component of efforts to prevent new infections and provide treatment for people living with HIV pervaded the XVIII International AIDS Conference today as delegates and local residents prepared for the HIV and Human Rights March through the streets of Vienna this evening. Conference participants are giving voice to the conference theme of Rights Here, Right Now through a number of plenary presentations, sessions, and Global Village and Youth Programme activities.

21 Jul 2010

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

A microbicide gel containing Gilead's HIV drug tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by nearly 40%, according to a study unveiled at the International AIDS Conference-AIDS 2010, Reuters reports

21 Jul 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Researchers who conducted a study testing a vaginal microbicide with an antiretroviral (ARV) drug called tenofovir found its use before and after sex was significantly more protective against HIV infection than a placebo gel among women at high risk of HIV. Results of the study, known as CAPRISA 004, are to be reported at the International AIDS Conference (AIDS 2010) in Vienna and published online by the journal Science.

20 Jul 2010

Global Campaign for Microbicides praises CAPRISA 004 gel trial for women's HIV prevention

Results of an advanced clinical trial of an antiretroviral-based microbicide candidate are being announced at the International AIDS Conference in Vienna, Austria. The CAPRISA 004 trial, which tested the safety and effectiveness of 1% tenofovir gel among nearly 900 women at two sites in South Africa, found that using the gel before and after sex provided moderate protection against sexually transmitted HIV.

20 Jul 2010

AVAC applauds CAPRISA 004 microbicide gel trial for preventing sexual transmission of HIV infection

"This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection," said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.

20 Jul 2010

Tenofovir News and Research

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Merck and Bill & Melinda Gates Foundation commit additional $60M to support Botswana's ACHAP

Bristol-Myers Squibb, ACTF announce enhanced agreement to support ADAPs

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

New York Times examines questions left unanswered by microbicide trial

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

AIDS 2010: Obama, Clinton vow U.S. support to global fight against HIV/AIDS

AVAC releases GPP Guidelines at International AIDS Conference

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New HIV drug on the block

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

Study marks significant milestone for microbicide research field, HIV prevention

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

HIV and Human Rights March to prevent new infections, provide treatment for people with HIV

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Global Campaign for Microbicides praises CAPRISA 004 gel trial for women's HIV prevention

AVAC applauds CAPRISA 004 microbicide gel trial for preventing sexual transmission of HIV infection

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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