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Valeant, Kadmon enter strategic agreement for taribavirin and ribavirin

Valeant Pharmaceuticals International, Inc. and Kadmon Pharmaceuticals LLC have concluded two strategic agreements for the development and commercialization of taribavirin and the commercial marketing of ribavirin in the treatment of viral diseases, including hepatitis C virus (HCV).

1 Nov 2010

Pharmasset's PSI-938 phase I monotherapy trial shows positive result for HCV treatment

Pharmasset, Inc. reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.

28 Oct 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Johnson & Johnson third quarter sales decrease 0.7% to $15.0 billion

Johnson & Johnson today announced sales of $15.0 billion for the third quarter of 2010, a decrease of 0.7% as compared to the third quarter of 2009. Operational results increased 0.1% and the negative impact of currency was 0.8%. Domestic sales declined 2.5%, while international sales increased 1.1%, reflecting operational growth of 2.6% and a negative currency impact of 1.5%.

19 Oct 2010

Phase III study influences WHO to change guidelines for HIV-infected women receiving nevirapine

Findings from a study, which appear in the Oct. 14, 2010 New England Journal of Medicine, helped influence the World Health Organization (WHO) to change its guidelines this year for the treatment of HIV-infected women who receive a single dose of the antiretroviral drug nevirapine to prevent HIV transmission to their babies.

18 Oct 2010

MTN-007 phase trial evaluates vaginal microbicide to prevent rectal transmission of HIV

Tenofovir gel, a vaginal microbicide that has shown promise for preventing HIV through vaginal sex, is being tested in a new trial looking at its safety and acceptability when used rectally. The results of the study, being led by the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), will help determine if the gel should be evaluated further for its potential to prevent HIV among both men and women who engage in receptive anal intercourse.

13 Oct 2010

Tobira completes $31 million Series B financing

Tobira Therapeutics Inc., a biopharmaceutical company focused on developing and commercializing innovative antiviral compounds to treat HIV disease, today announced the completion of a $31 million Series B financing. New investor Novo A/S is leading the round, joined by original investors, Domain Associates, L.L.C., Frazier Healthcare Ventures, Montreux Equity Partners and Canaan Partners.

30 Sep 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

BioCryst reports results from forodesine studies for CTCL and CLL

BioCryst Pharmaceuticals, Inc. announced preliminary top-line results from its multinational, open-label, single-arm trial evaluating 200 mg once-daily oral forodesine in the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), as well as interim results from the Company's exploratory Phase 2 study to investigate the efficacy and safety of 200 mg twice-daily oral forodesine as monotherapy for chronic lymphocytic leukemia (CLL).

15 Sep 2010

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Koronis Pharmaceuticals, Inc., a biotechnology company focused on the development of antiviral therapeutics, today announced that clinical trial data demonstrating that the Company's lead HIV drug, KP-1461, resulted in increased HIV mutations consistent with the Viral Decay Acceleration mechanism will be featured in a late-breaker oral presentation by James Mullins, Ph.D., Professor of Microbiology and Medicine at the University of Washington, at the upcoming 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place in Boston, MA.

10 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

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 received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

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

Alnylam Pharmaceuticals to present results on RNAi therapeutics at ACS National Meeting

Alnylam Pharmaceuticals, Inc.,a leading RNAi therapeutics company, announced today that it will make a total of 16 oral presentations at the American Chemical Society (ACS) Fall 2010 240th National Meeting & Exposition being held in Boston, Mass. from August 22-26, 2010.

24 Aug 2010

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

Researchers from this international study found that patients with chronic hepatitis B virus (HBV) infection who received at least 3 years of cumulative entecavir (antiviral) therapy achieved substantial histologic improvement and regression of fibrosis or cirrhosis. Full details of the study appear in the September issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

18 Aug 2010

Long-term Entecavir therapy reverses fibrosis and cirrhosis in chronic hepatitis B patients

17 Aug 2010

Pharmasset receives fast track designation from FDA for PSI-7977

Pharmasset, Inc. has received fast track designation from the U.S. Food and Drug Administration for PSI-7977 for the treatment of chronic hepatitis C virus infection. PSI-7977 is an oral uridine nucleotide analog polymerase inhibitor of HCV. Pharmasset recently completed dosing in a 28 day Phase 2a trial to evaluate PSI-7977 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1.

12 Aug 2010

Pharmasset third-quarter net loss increases to $16.0 million

Pharmasset, Inc., a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the quarter ended June 30, 2010.

10 Aug 2010

Access Pharmaceuticals initiates Phase I/II dose escalating study for Thiarabine

Access Pharmaceuticals, Inc., today announced it has initiated a Phase I/II dose-escalating study of its proprietary, anti-cancer drug, Thiarabine, a nucleoside analog for patients with hematologic malignancies (cancers of the blood). The primary objective of the study is to determine the maximum tolerated dose (MTD) in two different dosing schedules with various leukemias and lymphomas and recommended Phase II dose. The program is being led by Hagop Kantarjian, M.D., Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas.

4 Aug 2010

VBDS secondary to nevirapine use in HIV-positive, pregnant female: Report

Vanishing bile duct syndrome refers to a group of disorders characterized by destruction and disappearance of intrahepatic (inside the liver) bile ducts. Multiple causes have been identified including infections, malignancies, autoimmune conditions and adverse effects of medications. The usual course of this condition is variable and many patients with VBDS respond to treatment of the underlying condition and/ or removal of the offending agent. However, others progress to cirrhosis and end stage liver disease requiring liver transplantation.

31 Jul 2010