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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

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

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

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

Researchers make scientific breakthrough in fight against HIV, genital herpes with a vaginal gel

Researchers have achieved an important scientific breakthrough in the fight against HIV and genital herpes with a vaginal gel that significantly reduces a woman's risk of being infected with these viruses. The results of the ground-breaking safety and effectiveness study of an antiretroviral microbicide gel study were reported today by the Centre for the AIDS Programme of Research in South Africa at the XVIII International AIDS Conference in Vienna, Austria.

20 Jul 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

AHF applauds Gilead for offering pricing, access concessions to AIDS Drug Assistance Programs

AIDS Healthcare Foundation (AHF) lauded Gilead Sciences, maker of several key AIDS drugs, for its announcement earlier today that it will offer significant pricing and access concessions for the nation's beleaguered AIDS Drug Assistance Programs (ADAPs), the federally funded, state run programs that supply lifesaving AIDS drugs to low-income Americans in need.

5 Jun 2010

Research on new types of anti-HIV drugs presented at International Microbicides Conference

Researchers testing a vaginal microbicide based on a new type of anti-HIV drug found it provided monkeys significant protection against infection with a virus similar to HIV, according to a study reported at the International Microbicides Conference in Pittsburgh today.

24 May 2010

Avexa halts HIV drug trials

Melbourne-based biotech Avexa has announced the closure of its lead HIV program for apricitabine after failing to attract a licensing partner for the Phase III drug.

12 May 2010

Gilead Sciences board authorizes $5 billion common stock repurchase program

Gilead Sciences, Inc. today announced that the company's Board of Directors has authorized the repurchase of up to $5 billion of the company's common stock through May 2013.

12 May 2010

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Updates on development of Truvada and TMC278

Gilead Sciences, Inc. provided an update today on the development of the fixed-dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride, 25 mg).

21 Apr 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

Emory Institute of Drug Discovery and Zirus collaborate to develop new anti-viral drugs

The Emory Institute of Drug Discovery and Zirus, Inc., a biotechnology company based in Buford, Georgia, have entered into a collaboration and research agreement to develop novel compounds to treat infectious disease. Zirus uses a proprietary method for identifying genes and gene products in host cells that, when blocked, can prevent viruses from multiplying. Over the past several years, either alone or in collaboration with partners, including the Centers for Disease Control and Prevention (CDC), Zirus has identified, licensed and filed patents on more than 1000 targets.

30 Mar 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

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

Truvada 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

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

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

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

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

Researchers make scientific breakthrough in fight against HIV, genital herpes with a vaginal gel

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

AHF applauds Gilead for offering pricing, access concessions to AIDS Drug Assistance Programs

Research on new types of anti-HIV drugs presented at International Microbicides Conference

Avexa halts HIV drug trials

Gilead Sciences board authorizes $5 billion common stock repurchase program

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Updates on development of Truvada and TMC278

Gilead Sciences doses first patient in Quad Phase III clinical program

Emory Institute of Drug Discovery and Zirus collaborate to develop new anti-viral drugs

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

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

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

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The role of UV-Vis in biopharma QC

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