The Journal of the American Academy of Dermatology published results from two pivotal trials by Valeant Pharmaceuticals International Inc., of Montreal, of efinaconazole 10 percent topical solution for onychomycosis, a nail infection caused by fungi. The primary endpoint of the randomized, double-blind, vehicle-controlled study enrolling 1,655 subjects was complete cure rate at week 52. In Study 1, 17.8 percent of subjects given efinaconazole achieved complete cure, compared to 3.3 percent of

Merck & Co. Inc., of Whitehouse Station, N.J., presented data from a post-hoc subgroup analysis of three studies, which found that integrase inhibitor Isentress (raltegravir) demonstrated consistent long-term viral suppression and a well-established safety profile in adults co-infected with HIV-1 and hepatitis C virus and/or hepatitis B virus, compared to adults with HIV-1, at 240 weeks. Data were presented at the International Congress on HIV and Drug Therapy in HIV Infection meeting in

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban. The Phase III study will investigate the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. About 20,000 patients will be enrolled.

Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Of 27 patients previously treated with ipilimumab (Yervoy, Bristol

Agenus Inc., of Lexington, Mass., reported that the second complete set of results from the Phase III trial of London-based GlaxoSmithKline plc's RTS,S malaria vaccine candidate (also known as Mosquirix), which contains Agenus' QS-21 Stimulon adjuvant, were published online in The New England Journal of Medicine and announced at the International Vaccines for Africa Conference in Cape Town, South Africa. The Phase III study met its primary endpoint and demonstrated statistically significant

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, disclosed interim results from the RELY-ABLE trial, a long-term extension of the RE-LY study. During more than two years of randomized follow-up, key safety outcomes such as major bleeding, total bleeding and life-threatening bleeding were similar to the results of the dabigatran 110-mg and 150-mg arms of the pivotal RE-LY trial that evaluated Pradaxa (dabigatran etexilate mesylate) capsules in

Taiho Pharmaceutical Co. Ltd., of Tokyo, presented early stage data for multiple oncology compounds at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Irealnd, including Phase II results showing that TAS-102 produced an improvement in overall survival in patients with metastatic colorectal cancer. Additional presentations focused on TAS-114, a dUTPase dual and DPD dual inhibitor, and TAS-115, a dual inhibitor of hepatocyte and vascular endothelial growth

Asahi Kasei Pharma America Corp., of Waltham, Mass., said it started an 800-patient Phase III trial of ART-123 (recombinant human thrombomodulin, sold as Recomodulin in Japan) in severe sepsis patients with coagulopathy

AstraZeneca plc, of London, said it started a Phase III study, dubbed FALCON, to compare fulvestrant to Arimidex (anastrozole) in hormone therapy-naïve postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer. The study is expected to involve 450 women and will evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg.

Daiichi Sankyo Co. Ltd., of Tokyo, said it completed patient enrollment in the Hokusai-VTE Phase III study testing once-daily oral Factor Xa inhibitor edoxaban for the treatment and prevention of recurrence of venous thromboembolism in patients who have had an acute symptomatic deep vein thrombosis, pulmonary embolism or both.

Teva Pharmaceutical Industries Ltd., of Jerusalem, said its women's health subsidiary reported Phase III findings showing that Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an extended-regimen oral contraceptive, showed the product is efficacious for the prevention of pregnancy and has a safety profile similar to those of other oral contraceptives. Data were presented at the American Society of Reproductive Medicine meeting in San Diego.

Abbott, of Abbott Park, Ill., said results from a post-hoc subanalysis of the 52-week Humira (adalimumab) ULTRA 2 study showed clinically meaningful rates of mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis who failed, were intolerant or had contraindications to certain other medications and achieved a response to Humira induction therapy at eight weeks. Of the 494 patients included in the analysis and who responded at eight weeks, significantly more

Abbott, of Abbott Park, Ill., said results from three-year long-term data from an ongoing extension study of the Humira (adalimumab) ULTRA 1 and ULTRA 2 studies in ulcerative colitis showed a reduction in observed mean Partial Mayo score from 5.9 at the time of first Humira dose to 1.4 at week 172. A 55.3 percent remission rate, per Partial May score, at week 60 of the extension study also was seen. Data were presented at the American College of Gastroenterology meeting in Las Vegas. Eli

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Abbott, of Abbott Park, Ill., said initial results from its Phase IIb study of its interferon-free regimen for hepatitis C virus (HCV) showed sustained virological response at 12 weeks post-treatment in 99 percent of treatment-naïve and 93 percent of null responder patients with genotype I HCV. Patients received a combination of ABT-450/r, ABT-267, ABT-333 and ribavirin for 12 weeks. Almirall SA, of Barcelona, Spain, reported data from the MOVE 2 study supporting the use of Sativex, an

Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). The anti-diuretic effect of desmopressin melt correlated strongly with reduced PLMS, with 90 percent of children in the study experiencing reduced PLMS. Data were presented at the Joint Congress of the International Children's

Pierre Fabre Dermatolgie Laboratories, of Castres, France, a subsidiary of Pierre Fabre Laboratories, reported Phase III data showing that propranolol oral solution in infantile hemangioma resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants who were treated, compared to an almost complete lack of effect from placebo. The company said it expects to submit for the drug's use in children in both the U.S. and Europe. Teva Pharmaceutical

Eli Lilly and Co., of Indianapolis, reported detailed data from two Phase III trials of solanezumab in Alzheimer's disease, showing that a prespecified analysis of pooled data in patients with mild disease, a statistically significant slowing of cognitive decline was shown, representing a 34 percent reduction in decline. The company previously reported that the drug missed its endpoints in two Phase III trials in Alzheimer's. The company said next steps for the drug, a monoclonal antibody that

Grupo Ferrer Internacional SA, of Barcelona, Spain, said it successfully completed an absorption, tolerability and safety trial in adult and juvenile patients from 2 months of age with impetigo involving Ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The study will form the basis for the first regulatory filing for nonfluorinated quinolone antibacterial agent in 2013.