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Chimerix announces completion of $45 million Series F financing

Chimerix, Inc., a pharmaceutical company developing orally-available broad spectrum antiviral therapeutics, today announced the completion of a $45 million Series F financing. New Leaf Venture Partners led the round, with participation by new investors Pappas Ventures and Morningside Group, as well as existing investors Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.

14 Feb 2011

Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.

10 Feb 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Idenix announces updates on HCV and HIV clinical development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

10 Feb 2011

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.

3 Feb 2011

Johnson & Johnson deal may bring HIV/AIDS drugs to developing countries faster

Johnson & Johnson's Tibotec Pharmaceuticals unit on Thursday announced it had granted multiple licenses to generic drug manufacturers "to provide copies of [the experimental HIV/AIDS drug rilpivirine hydrochloride] TMC278 in sub-Saharan Africa, India and parts of Asia if it's approved by regulators," Bloomberg Businessweek reports.

1 Feb 2011

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.

28 Jan 2011

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

28 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. today announced that its 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 Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

Pharmasset, Bristol-Myers Squibb collaborate for proof of concept study on chronic HCV

Bristol-Myers Squibb Company and Pharmasset announced today that the companies have entered into a clinical collaboration agreement to evaluate the utility of BMS-790052, Bristol-Myers Squibb's NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset's nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus.

11 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Bristol-Myers Squibb, Oncolys complete license agreement for festinavir

Bristol-Myers Squibb Company and Oncolys BioPharma Inc., a privately held biotechnology company based in Japan, announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire exclusive worldwide rights to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV.

20 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

7 Dec 2010

BioCryst reports Phase 2 trial data of forodesine in patients with CLL

BioCryst Pharmaceuticals, Inc. announced the presentation of new data that confirms forodesine's clinical activity in the treatment of chronic lymphocytic leukemia at the 52nd Annual American Society of Hematology Meeting & Exposition being held in Orlando, Florida.

6 Dec 2010

Phase 2 survival data of sapacitabine in patients with MDS presented at ASH Annual Meeting

Cyclacel Pharmaceuticals, Inc. announced today 1-year survival data from a Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes refractory to hypomethylating agents, such as azacitidine and decitabine. The data were reported at a poster presentation at the 52nd Annual Meeting of the American Society of Hematology in Orlando, Florida.

6 Dec 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761.

23 Nov 2010

Chimerix’s lipid-conjugated drugs reduces nephrotoxicity: Study

Scientists from Chimerix, Inc. today presented in vitro data demonstrating that the company's lipid-conjugated drugs, CMX001 and CMX157, are not substrates for the human Organic Anion Transporters (hOATs) and thus have significantly reduced potential to cause nephrotoxicity via this mechanism.

17 Nov 2010

Cyclacel announces publication of sapacitabine in British Journal of Cancer

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, announced today publication of data demonstrating that its sapacitabine oral nucleoside analog works synergistically with histone deacetylase (HDAC) inhibitors to induce significant reductions in tumor cell growth in both in vitro and in vivo preclinical models.

11 Nov 2010

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of new data related to the efficacy and safety of BCX4208 for the treatment of gout at the 74th ACR Scientific Meeting being held in Atlanta, Georgia.

9 Nov 2010