Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease

Formed in 2011, Ascletis also has added late-stage candidates ASC-06 (ALN-VSP), a first-in-class, systemically delivered RNAi therapeutic for liver cancers, and ASC-08 (danoprevir), a hepatitis C protease inhibitor, to its portfolio

Enanta Pharmaceuticals Inc., of Watertown, Mass., and AbbVie Inc., of Chicago, said ABT-450, AbbVie's investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin to treat genotype 1 (GT1) hepatitis C virus (HCV) infection, was designated as a breakthrough therapy by the FDA

BioLineRx Ltd., of Jerusalem, said the first patient was enrolled in a Phase I/II trial of BL-8020, an orally available, interferon-free treatment for hepatitis C virus (HCV

Formed in 2011, Ascletis also has added late-stage candidates ASC-06 (ALN-VSP), a first-in-class, systemically delivered RNAi therapeutic for liver cancers, and ASC-08 (danoprevir), a hepatitis C protease inhibitor, to its portfolio. (See BioWorld Today, April 7, 2011

Ligand Pharmaceuticals Inc., of San Diego, reported preclinical data showing highly targeted liver delivery of a clinically active NS5B polymerase inhibitor using the firm's HepDirect technology platform and also demonstrating that HepDirect liver targeting of active nucleosides may be an effective method to improve efficacy while reducing systemic side effects in hepatitis C treatment

Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported detailed resistance data from in vitro studies and from a three-day monotherapy clinical trial of IDX719, its once-daily pangenotypic NS5A inhibitor for hepatitis C virus (HCV) infection...The regulatory submission for simeprevir is supported by data from three phase III studies in patients with genotype 1 hepatitis C: QUEST-1 and QUEST-2 in treatment-naïve patients, and PROMISE in patients who have relapsed after prior interferon-based

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

Roche AG and Ascletis Inc., of Hangzhou, China, have entered into a collaboration to develop and commercialize Roche's investigational protease inhibitor danoprevir in China for the treatment of hepatitis-C virus

Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application (NDA) to the FDA for sofosbuvir, its once-daily oral nucleotide analogue to treat chronic hepatitis C virus (HCV) infection

Vertex Pharmaceuticals Inc., of Cambridge, Mass., agreed with Bristol-Myers Squibb Co., of New York, to carry out Phase II studies of hepatitis C virus treatment regimens that contain Vertex's nucleotide analogue polymerase inhibitor VX-135

Santaris Pharma A/S, of Hoersholm, Denmark, said the New England Journal of Medicine published online the final Phase IIa hepatitis C virus (HCV) data

Janssen Research & Development LLC, of Titusville, N.J., a division of Johnson & Johnson, submitted a new drug application to the FDA seeking approval for simeprevir (TMC435), an NS3/4A protease inhibitor, administered as a 150-mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C virus in adult patients. (See BioWorld Today, Dec. 26, 2012

Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV

BioLineRx Ltd., of Jerusalem, said it received approval from French regulators to start a Phase I/II trial of BL-8020, an oral, interferon-free treatment for hepatitis C virus (HCV

Medivir AB, of Huddinge, Sweden, said that its partner Janssen Pharmaceuticals Inc., part of Johnson & Johnson, of New Brunswick, N.J., submitted a regulatory application to the Japanese Ministry of Health and Welfare for simeprevir in genotype 1 chronic hepatitis C. The drug is an NS3/4A protease inhibitor, and would be administered with pegylated interferon (Peg-IFN) and ribavirin for patients who are treatment-naïve, prior nonresponders, or relapsed after Peg-IFN with or without RBV