Eli Lilly and Co., of Indianapolis, reported negative results from study H8Y-MC-HBBM investigating pomaglumetad methionil, also known as mGlu2/3, in patients with acute exacerbations of schizophrenia. The drug did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation at the two doses investigated.

Bayer HealthCare Pharmaceuticals Inc., a Wayne, N.J.-based subsidiary of Bayer AG, began enrolling patients in an international Phase II/III trial to evaluate BAY94-9027 as a prophylactic and on-demand treatment of hemophilia A. The PROTECT VIII trial will investigate whether the recombinant human factor VIII (rFVIII) can prolong the duration of protection from bleeds and allow for fewer infusions when used prophylactically, while also treating acute bleeding events. The partially randomized

Teva Pharmaceutical Industries Ltd., of Jerusalem, presented Phase III results showing that lipegfilgrastim and balugrastim, long-acting granulocyte colony-stimulating factors, achieved the primary endpoint in breast cancer studies, demonstrating reduction in the duration of severe neutropenia in cycle 1, comparable to Neulasta (pegfilgrastim, Amgen Inc.) in both efficacy and safety measures. Data were presented at the Multinational Association of Supportive Care in Cancer/International Society

A.P. Pharma Inc., of Redwood City, Calif., reported additional data from a Phase III trial of APF530, for chemotherapy-induced nausea and vomiting

Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported data from a two-year study showing that Trajenta (linagliptin) provided similar blood glucose improvements when compared to sulphonylurea glimepiride in adult patients with Type II diabetes who are inadequately controlled on metformin alone. Linagliptin also was associated with significantly fewer hypoglylcemic events and resulted in relative weight loss of 2.7 kg compared to glimepiride. Data were published in The Lancet. Shire plc

CSL Behring, of King of Prussia, Pa., reported data from a single-arm, open-label study showing that Privagen (immune globulin intravenous [human], 10 percent liquid), an intravenous immunoglobulin (IVIG), may lead to improvement in function in patients with chronic inflammatory demyelinating polyneuropathy. Results showed an overall response rate of 60.7 percent, and the 25-week treatment period also showed that a response to IVIG can occur late – after more than six weeks of therapy. Eisai

Baxter International Inc., of Deerfield, Ill., said the FDA approved Gammagard Liquid 10 percent (immune globulin infusion [human]) as a treatment for multifocal motor neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the U.S. It was approved for use with MMN patients in Europe in 2011 . Baxter was granted orphan drug designation for the indication; the prevalence of MMN is estimated at between one or two people for approximately 100,000 individuals. The

Novo Nordisk A/S, of Bagsvaerd, Denmark, said its ultra-long-lasting insulin degludec significantly reduced the rate of hypoglycemia at night in adults with Type II diabetes, while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period. Data from that Phase IIIa trial were presented at the American Diabetes Association meeting in Philadelphia.

Iroko Pharmaceuticals LLC, of Philadelphia, reported Phase III study results that showed patients treated with its submicron particle, lower-dose diclofenac experienced significant pain relief following surgery compared with placebo. In the 428-patient, randomized, double-blind, active- and placebo-controlled trial, both the 18-mg and 35-mg doses of the nonsteroidal anti-inflammatory drug met the primary objective of significant improvement in pain relief, measured by the combined differences

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the American Heart Journal published the design of the RE-ALIGN study, a Phase II trial aimed at evaluating the safety and pharmacokinetics of oral Pradaxa (dabigitran etexilate) in patients after heart valve replacement. The study is intended to evaluate Pradaxa as an alternative to warfarin.

The results of a 12-week, head-to-head, Phase III study, published online in Hypertension, found systolic blood pressure reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. The fixed-dose combination (azilsartan medoxomil and chlorthalidone) is currently marketed as Edarbyclor in the U.S. by Takeda Pharmaceuticals U.S.A. Inc., part of

A new retrospective subanalysis of the RE-LY trial suggested similar rates of periprocedural bleeding and thromboembolic complications in nonvalvular atrial fibrillation patients undergoing a surgical or invasive procedure treated with Pradaxa (dabigatran etexilate mesylate), from Boehringer Ingelheim GmbH, of Ingelheim, Germany, compared to warfarin. RE-LY was a global, Phase III, randomized trial of 18,113 patients enrolled in 951 centers in 44 countries, investigating whether dabigatran

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

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

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