Bristol-Myers Squibb Co., of New York, reported six-year follow-up results from a Phase III trial of Sprycel (dasatinib) in Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia adult patients resistant or intolerant to Glivec (imatinib, Novartis AG), demonstrating a progression-free survival rate of 49.3 percent and an overall survival rate of 71 percent for patients receiving dasatinib, with 6 percent of patients progressing to accelerated or blast phase of the study at six

Sanofi SA, of Paris, presented results from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial at the American Diabetes Association 72nd Scientific sessions, reporting that Lantus (insulin glargine [rDNA] injection) showed no statistically significant positive or negative impact on cardiovascular (CV) outcomes compared to standard of care during the six-year study period and no association with increased risk of any cancer. The findings, also published online in The New

Merck & Co. Inc., of Whitehouse Station, N.J., reported data from two pivotal Phase III trials of suvorexant in insomnia at SLEEP 2012, the annual Meeting of the Associated Professional Sleep Societies. The orexin receptor antagonist reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at three months, compared to placebo. Endpoints from the trials included mean change from baseline for suvorexant compared to placebo

Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented results from two Phase II studies of their investigational basal insulin analogue LY2605541 at the American Diabetes Association meeting in Philadelphia. In a Type I diabetes trial, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received insulin glargine. The LY2605541 patients also had a 17 percent reduction in their mealtime insulin dose while

Grifols SA, of Barcelona, Spain, said Phase I data published in the Journal of Thrombosis and Haemostasis demonstrated good safety and tolerability for investigational therapy plasmin in treating patients with acute peripheral atrial occlusion. While the 83-patient study was not powered for efficacy, the data demonstrated that thrombolysis (greater than or equal to 50 percent) occurred in 79 percent of subjects receiving 125 mg to 175 mg of plasmin, compared to 50 percent who received 25 mg to

UCB SA, of Brussels, Belgium, reported data from a post-hoc analysis of the Phase IIIb REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) study, showing that, overall, 81.1 percent of rheumatoid arthritis patients treated with Cimzia (certolizumab pegol) during both the 12-week and open-label extension had a change in DAS28 equal to or greater than 1.2 and 89.3 percent had at least a 29 percent change in swollen joint count from baseline by week 12. Data were

Otsuka Pharmaceutical Co. Ltd., of Tokyo, said Phase IIb safety and efficacy data for delamanid, its investigational compound in multidrug-resistant tuberculosis (MDR-TB) were published in the New England Journal of Medicine. Results from the trial showed a 53 percent increase in sputum culture conversion (SCC) after two months for subjects who received delamanid 100 mg twice daily plus a background regimen (BR) consistent with World Health Organization treatment guidelines, compared with

Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, reported data from the Phase III PHOENIX study showing that maintenance treatment with Stelara (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Among responders receiving Stelara 45 mg or 90 mg and randomized to continue maintenance therapy through five years, 79 percent and 81 percent, respectively, experienced at

Bristol-Myers Squibb Co., of New York, reported four-year results from the long-term extensions of the BENEFIT and BENEFIT-EXT trials evaluating Nulojix (belatacept), its selective T-cell co-stimulation blocker indicated for the prophylaxis of organ rejection in adult Epstein-Barr virus-seropositive patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids. Results showed that the safety profile of the drug through year four was

Eli Lilly and Co., of Indianapolis, and Kowa Pharmaceuticals America Inc., of Montgomery, Ala., reported results from the PREVAIL (Pitavastatin compaREd with praVAstatin in Lowering LDL-C in the U.S.) study, which showed that Livalo (pitavastatin) 4 mg had superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy. Data for secondary endpoints showed that Livalo reduced apoliprotein B, non-HDL-C and total cholesterol compared with pravastatin and improved high-density

Boehringer Ingelheim Pharmaceuticals Inc., of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported Phase III results for Tradjenta (linagliptin) 5 mg once-daily, which showed significant hemoglobin A1c reduction of 0.88 percent compared with 0.24 percent in the placebo group at 24 weeks. The trial was the first published study of a DPP-4 inhibitor specifically conducted in African American adults with Type 2 diabetes. The data were presented at the American Association of

Shire plc, of Dublin, Ireland, reported Phase III results demonstrating the long-term maintenance efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents, ages 6 to 17, with attention deficit hyperactivity disorder (ADHD). A significantly lower proportion of ADHD treatment failures (13.5 percent) were seen in the LDX group, compared to placebo (65.8 percent), and the majority of placebo-treated subjects who met protocol-defined ADHD symptom relapse criteria did so within two

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said Phase II data showed tiotropium delivered once daily via the Respimat inhaler in adolescents with symptomatic, moderate persistent asthma produced greater lung function at all doses tested, compared to placebo. Data were presented at the American Thoracic Society meeting in San Francisco. A Phase III program is ongoing to evaluate the long-acting bronchodilator in pediatric, adolescent and adult asthma patients. Eli Lilly and Co., of

Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported data showing that once-daily olodaterol, a long-acting beta2-agonist, as a maintenance treatment in chronic obstructive pulmonary disease provided a significant and identical increase in the lung function parameter FEV1 over a 24-hour period compared to twice-daily treatment, when delivered via the Respimat inhaler. Data were presented at the American Thoracic Society meeting in San Francisco. Janssen Research & Development, of

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal Phase III trial. The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNFα antagonists. Many of the patients included in the study had failed two or more TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to Latuda (lurasidone HCl). The six-week open-label study included 244 patients who were clinically stable for at least eight weeks prior to the start of the study and had been on stable doses of other antipsychotic agents for at least four weeks. The study's primary endpoint was time

H. Lundbeck A/S, of Copenhagen, Denmark, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported data showing significant improvements in overall symptoms of depression in elderly patients taking Lu AA21004, with patients taking 5 mg of the multimodal depression drug showing a significantly greater (p = 0.0011) improvement on the primary efficacy endpoint of HAM-D24 total score vs. placebo at week eight. Rates of HAM-D24 response were 53.2 percent vs. 35.2 percent, and rates of HAM-D17

Sanofi SA, of Paris, said vaccine division Sanofi Pasteur reported Phase III data from a pediatric study of quadrivalent influenza vaccine (QIV) in children 6 months through 8 years of age, with results supporting results in prior studies in adults. The noninferiority comparisons also demonstrated that the addition of a fourth influenza strain to the investigational vaccine does not adversely affect the safety and immunogenicity profiles of QIV compared to those of Sanofi's licensed vaccine

Shire plc, of Dublin, Ireland, said its Phase II trial of Vyvanse (lisdexamfetamine dimesylate) for adults with binge-eating disorder met its primary endpoint of significantly reducing the number of binge days per week at the two highest of three doses tested. Vyvanse is currently approved for attention-deficit hyperactivity disorder. Shire said it will work with regulatory agencies to determine a path forward for larger trials in binge-eating disorder and it will explore opportunities to