Bayer AG, of Leverkusen, Germany, said results of two pivotal Phase III studies, published in The Lancet, demonstrated the efficacy of regorafenib in patients with metastatic colorectal cancer or gastrointestinal stromal tumor who have exhausted all other treatment options. Data from the CORRECT study showed regorafenib plus best supportive care significantly improved overall survival and progression-free survival compared to placebo plus BSC (6.4 months vs. 5 months and 1.9 months vs. 1.7

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

Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response. The trial is the second of three Phase III studies testing the CR formulation for once-daily therapy. The first study in partial onset seizures did not meet its primary endpoint

Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated. The study is one of three Phase III trials designed to test pregabalin CR for use as a once-daily therapy. The other two studies are testing the

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.

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

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.

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

Pfizer Inc., of New York, said a Phase III study of Inlyta (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS) vs. Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) in treatment-naïve patients with advanced renal cell carcinoma. A preliminary review of the data showed that the median PFS for Inlyta exceeded median PFS for sorafenib but fell short of statistical significance.

Chiesi Group, of Parma, Italy, said it completed a Phase I trial of inhaled PDE4 inhibitor CHF 6001 that showed the drug was well tolerated up to the highest doses administered, in single and multiple dose parts of the study. Based on those data, two Phase IIa studies are ongoing in patients with asthma and chronic obstructive pulmonary disease. Pfizer Inc., of New York, said it completed a study to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg twice daily compared to

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

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.

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported Phase III results and pooled Phase III analyses supporting the use of DPP-4 Trajenta (linagliptin) in Type II diabetes, including patients who are elderly and those at with diabetic nephropathy. Data were presented at the European Association for the Study of Diabetes meeting in Berlin. Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, reported that the reductions in