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.

Astex Pharmaceuticals Inc., of Dublin, Calif., said it started an open-label Phase II trial testing Hsp90 inhibitor AT13387 in anaplastic lymphoma kinase-positive non-small-cell lung cancer (NSCLC) patients or other potentially Xalkori- (crizotinib, Pfizer Inc.) sensitive NSCLC patients who have been receiving Xalkori. The study will test AT13387 as both a single agent and in combination with Xalkori. The study will consist of three parts: The primary objective of Part A is to determine safety

Agenus Inc., of Lexington, Mass., said it started a Phase II study of HerpV, a recombinant off-the-shelf therapeutic vaccine candidate, containing the company's QS-21 Stimulon adjuvant, for treating genital herpes in herpes simplex virus 2-positive subjects. The study will enroll 75 patients who have a history of frequent disease recurrences and will test the efficacy of the vaccine as measured by effect on genital viral shedding. Celgene Corp., of Summit, N.J., said its Celgene International

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

Nabi Biopharmaceuticals Inc., of Rockville, Md., reported Phase II data showing that smoking cessation candidate NicVAX (nicotine conjugate immunotherapeutic) in combination with Chantix (varenicline, Pfizer Inc.) did not meet the study's primary endpoint. A preliminary assessment of the data showed that subjects treated with the combination quit smoking at a similar rate to those treated with placebo plus Chantix. The study enrolled 558 subjects in the Netherlands. NicVAX previously failed two

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

Amgen Inc., of Thousand Oaks, Calif., presented data at the American Society for Bone and Mineral Research meeting in Minneapolis, including results from the open-label extension study of the pivotal Phase III trial of Prolia (denosumab), which showed continued increases in bone mineral density (BMD) and low fracture incidence over six years. Data demonstrated that nearly all women who received six years of treatment with the RANK ligand-targeting drug showed gains in BMD at the lumbar spine

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

Actinium Pharmaceuticals Inc., of New York, presented Phase I data showing that Actimab-A, its antibody-directed alpha-emitter drug candidate for front-line acute myeloid leukemia (AML) in older patients, demonstrated significant antileukemic activity across all dose levels. Data were presented at the Hematologic Malignancies 2012 Conference in Houston. Actimab-A is being testing in a Phase I/II trial in combination with low-dose cytarabine in older AML patients. Canyon Pharmaceuticals 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

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