Acura Pharmaceuticals Inc., of Palatine, Ill., said it filed an investigational new drug application with the FDA for clinical testing of its hydrocodone bitartrate with acetaminophen formulated using its Aversion Technology. Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014. BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management. The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses. The second Phase II open-label study should be completed by the end of the first quarter of 2013. It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4

ARCA biopharma Inc., of Broomfield, Colo., said a paper published in the European Journal of Heart Failure discusses the post-hoc analyses of data from the Phase III study, designated BEST (Beta-Blocker Evaluation of Survival Trial), testing Gencaro (bucindolo hydrochloride) in heart failure. Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely

Eli Lilly and Co., of Indianapolis, provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with the condition, but other details of the study, which will begin no later than the third quarter of next year, are yet to come.

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, disclosed data from a Phase III study testing Eliquis (apixaban) for the prevention of recurrent venous thromboembolism (VTE). Data from the year-long trial, published in the New England Journal of Medicine, showed that treatment with Eliquis significantly reduced the recurrence of VTE and death from any cause compared to those treated with placebo.

Pfizer Inc., of New York, said randomized Phase II data showed that PD-0332991 in combination with letrozole significantly extended progression-free survival (PFS) compared to letrozole alone in postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor-1-negative locally advanced or metastatic breast cancer. Patients in the combination arm showed a median PFS of 26.1 months vs. 7.5 months in the letrozole-only arm, a statistically significant improvement (p < 0

UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis. Lacosamide exposure also was associated with a reduction in seizure frequency during the study period. A post-hoc analysis of pooled data from three Phase II/III studies suggested a greater

Jazz Pharmaceuticals plc, of Dublin, Ireland, said the first patient was enrolled and dosed in a 25-patient study testing Erwinaze (asparaginase Erwinia chrysanthemi) administered intravenously as an alternative method of administration to treat patients with acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase therapy. Preliminary pharmacokinetic data are expected in the second half of 2013. NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data

H. Lundbeck A/S, of Copenhagen, Demark, presented three-year vision data at the American Epilepsy Society meeting in San Diego. The FDA requires a risk evaluation and mitigation strategy for Sabril due to the risk of treatment-induced permanent vision loss, and the company offers an ongoing patient registry. Of the total patients enrolled in the registry, 2,676 had infantile spasms and 1,354 had refractory complex partial seizures. Because of the nature of the registry and vision testing

Theravectys SAS, of Paris, was granted authorization by the National Security Agency for Medicines and Health Products in France and the Federal Agency for Medicines and Health Products in Belgium to launch a Phase I/II trial with its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.

Bayer AG, of Leverkusen, Germany, said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete. TRUST is designed to test the recombinant Factor VIIa protein in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies. The study is composed of two parts: The first will involve sequential dose escalation for assessing dose response and

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

AesRx LLC, of Newton, Mass., said it plans to present data from its Phase I study of antisickling agent Aes-103 at the American Society of Hematology meeting in Atlanta. The data showed the drug is safe and well tolerated and suggested Aes-103 is biologically active in humans in a manner consistent with its proposed mechanism of action in sickle cell disease. The first-in-human, double-blind, placebo-controlled trial examined the effects of single doses of Aes-103 at 300 mg, 1,000 mg, 2,000 mg

MediciNova Inc., of San Diego, started enrolling a Phase IIa trial testing MN-166 (ibudilast) in prescription opioid or heroin abusers. The trial will be conducted at Columbia University and the New York State Psychiatric Institute and is funded by the National Institutes for Drug Abuse. MN-166 is a first-in-class, orally bioavailable small-molecule glial attenuator designed to suppress pro-inflammatory cytokines IL-1 beta, TNF alpha and IL-6, and may up-regulate the anti-inflammatory cytokine

Adaptimmune Ltd., of Oxford, UK, said abstracts published in Blood reported encouraging preliminary results from an early phase study using patients' own T cells that have been genetically altered to attack multiple myeloma cells. The single-arm, open-label extension study is designed to test the safety, bioactivity and antitumor effects of the infusion of those T cells, which were genetically altered to express cancer testis antigens NY-ESO-1 and LAGE-1. The initial six patients have completed

CytRx Corp., of Los Angeles, presented results from a Phase Ib/II study of tumor-targeting doxorubicin conjugate aldoxorubicin (formerly INNO-206) in advanced soft-tissue sarcoma at the Connective Tissue Oncology Society meeting in Prague, Czech Republic. Patients treated with aldoxorubicin were delivered doxorubicin in a cumulative dose of more than 3.5 times the peak cumulative dose of standard doxorubicin with no observed cardiac toxicities. Trial data showed clinical benefit, defined as

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.

Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Of 27 patients previously treated with ipilimumab (Yervoy, Bristol