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

Aeterna Zentaris Inc., of Quebec City, said its ghrelin agonist, AEZS-130, showed potential as an oral diagnostic test for adult growth hormone deficiency, and that its accuracy is comparable to currently available tests. The study and its results were presented at the International Congress of the Growth Hormone Research and Insulin-like Growth Factor Society in Munich, Germany. Curis Inc., of Lexington, Mass., achieved the first two development milestones related to its agreement with the

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

ArQule Inc., of Woburn, Mass., said it reached a special protocol assessment agreement with the FDA for a pivotal Phase III trial of tivantinib in patients with hepatocellular carcinoma (HCC). The study will test the drug, a selective MET inhibitor, as a single agent in previously treated patients with MET diagnostic-high inoperable HCC, with a primary endpoint of overall survival in the intent-to-treat population. The secondary endpoint is progression-free survival. About 300 patients will be

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

Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a Phase I trial of APD811, an oral drug candidate designed to target the prostacyclin receptor for the treatment of pulmonary arterial hypertension. The dose-titration study is planned to enroll up to 30 healthy adult volunteers and will evaluate safety, tolerability and pharmacokinetics of multiple ascending doses. Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the

Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells. Euthymics Bioscience Inc

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

Argos Therapeutics Inc., of Durham, N.C., said its ongoing Phase III ADAPT study testing personalized immunotherapy candidate AGS-003 in Stage IV kidney cancer was reviewed during the International Kidney Cancer Symposium in Chicago. The ADAPT study, which is being conducted under a special protocol assessment, is testing AGS-003 in combination with well-established targeted drug therapies and is expected to enroll about 450 newly diagnosed patients with metastatic disease. Enrollment is

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.

MannKind Corp., of Valencia, Calif., said it finished recruiting patients for two Phase III studies of Afrezza (insulin human [rDNA origin]), an investigational ultra-rapid-acting mealtime insulin therapy, administered using the firm's to-be-marketed next-generation inhaler. Both studies are on track to be completed in the second quarter of 2013, with top-line results next summer and a planned new drug application resubmission in the third quarter of 2013. The Medicines Co., of Parsippany, N

Eisai Co. Ltd., of Tokyo, and Bial SA, of S. Mamede do Coronado, Portugal, reported at the European Congress on Epileptology in London that it expects data from recently launched studies designed to increase the understanding of Zebinix (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures with or without secondary generalization. Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients

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

Aduro BioTech Inc., of Berkeley, Calif., said it enrolled the first patient in a Phase Ib study of CRS-207, a therapeutic cancer vaccine, combined with chemotherapy in patients newly diagnosed with malignant pleural mesothelioma. Patients will receive two prime vaccinations with CRS-207, followed by standard-of-care chemotherapy. Astex Pharmaceuticals Inc., of Dublin, Calif., said it started a Phase II study evaluating SGI-110, a small-molecule DNA-hypomethylating agent, in combination with

Acacia Pharma Ltd., of Cambridge, UK, reported results from its Phase IIa study of APD403 for the prevention of acute nausea and vomiting in cancer patients receiving cisplatin, with initial exploratory cohorts showing that single-agent APD403 had encouraging benefit, especially in controlling nausea. When the drug was combined with a standard dose of 5-HT3 antagonist ondansetron, a complete response in 19 of 23 patients (83 percent) was achieved, higher than the 50 percent response rate that

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported new patient-reported health-related outcomes for its investigational oncology compound afatinib, including lung cancer-related symptoms and quality of life. The data are secondary endpoints of LUX-Lung 3, a Phase III trial of afatinib (n = 230) compared to chemotherapy (pemetrexed/cisplatin) (n = 115) in patients with epidermal growth factor receptor mutation-positive advanced non-small