Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

Zealand Pharma A/S, of Copenhagen, Denmark, and partner Helsinn Group, of Lugano, Switzerland, reported that Helsinn concluded a Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients with positive results

clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Cerulean Pharma Inc., of Cambridge, Mass., will present Phase II data for investigational nanopharmaceutical product CRLX101 at the American

Secondary objectives of the trial include clinical activity by serum TTR levels...TheraVida Inc., of Mountain View, Calif., presented positive results from a Phase II trial of lead candidate, Tolenix (THVD-201), a combination of tolterodine to treat overactive bladder (OAB) and urge urinary incontinence (UUI) and pilocarpine to reduce dry mouth caused by muscarinic antagonist medications

Anacor recently disclosed positive results from a Phase II safety, pharmacokinetics and efficacy trial of its boron-based phosphodiesterase-4 inhibitor, AN2728, in adolescents with mild to moderate atopic dermatitis...Oculus Innovative Sciences pulled off positive results in an open-label pilot study of Atrapro Antipruritic Hydrogel in combination with Neosalus Cream, demonstrating statistically significant 50 percent reduction in body surface area of atopic dermatitis from baseline to week four

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...BioAlliance Pharma SA, of Paris, said the FDA approved a U.S

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...Edison Pharmaceuticals Inc., of Mountain View, Calif., reported positive results from a completed Phase IIa study on EPI-743 in children with Leigh syndrome, an inherited lethal, progressive, predominately pediatric neuromuscular disorder for which there are no approved treatments...Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat

BioDelivery Sciences International Inc., of Morrisville, N.C., reported positive results from its pharmacokinetic study of BEMA buprenorphine/naloxone (BNX) films...Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a Phase III trial of voclosporin

Three smashing clinical successes by Gilead Sciences Inc.'s nuc drug GS-7977 for hepatitis C virus (HCV) have lit up the 2012 International Liver Congress of the European Association for the Study of the Liver, sending the company's stock up 12 percent Thursday...The Interferon-Free Regimen Leader The cascade of positive results for GS-7977 drives home the point that the drug is a strong contender in a very crowded field...Novartis AG put its antiviral DEB025 on clinical hold following reports of

It will enroll up to 160 patients at clinical centers in the U.S...Piramal Imaging SA, of Mumbai, India, reported positive results from a Phase III trial of florbetaben, an imaging agent used with PET scanning for beta amyloid in the brain

Radius Health Inc., of Cambridge, Mass., reported that its transdermal BA058 microneedle patch, for osteoporosis, showed positive results in a Phase Ib clinical study...UCB Pharma SA, of Brussels, Belgium, began a trial (EXXELERATE) of Cimzia (certolizumab pegol) plus methotrexate compared with Humira (adalimumab) plus methotrexate for rheumatoid arthritis

gained 15.8 percent Tuesday on positive results of a Phase I/II trial of its JAK1/JAK2 inhibitor in myelofibrosis...Astellas Pharma Inc., of Tokyo, and Ambit Biosciences Corp., of San Diego, shared updated results from an interim analysis of a Phase II trial of quizartinib (previously AC220) in acute myeloid leukemia, showing that quizartinib monotherapy had activity in refractory and relapsed FLT3-ITD-positive acute myeloid leukemia (AML

Shire plc, of Dublin, Ireland, reported positive results from its Phase II trial of Vivanse (lisdexamfetamine dimeslate) as an adjunctive therapy in major depressive disorder...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, completed patient enrollment in ULISES 007, the first of two pivotal Phase III studies of ulimorelin, an intravenous ghrelin agonist, for the acceleration of gastrointestinal recovery in patients undergoing partial bowel

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported positive results from the Ampion-In-Knee (AIK) clinical trial, showing the drug was well tolerated and reduced pain over and above steroids...Solasia Pharma K.K., of Tokyo, reported that enrollment of a Phase I trial evaluating the safety and tolerability of darinaparsin injection (SP-02L) for the treatment of peripheral T-cell lymphoma (PTCL) has commenced in Japan

BioAlliance Pharma SA, of Paris, reported that its liver cancer product, Livatag, showed increased survival in a Phase II trial...DelMar Pharma Ltd., of Vancouver, British Columbia, said the FDA cleared its investigational new drug application to start clinical testing of VAL-083, a bifunctional alkylating agent, in refractory glioblastoma multiforme (GBM...Noxxon Pharma AG, of Berlin, said it started a Phase I trial of NOX-H94, a Spiegelmer designed to treat anemia of chronic disease by targeting the

Clinical response data was reported for 53 patients and showed a composite complete remission rate (CRc) of 45 percent, with the majority of CRc cases represented by complete remission with incomplete hematologic recovery and no CRs observed in the first 84 days...Ltd., of Seoul, South Korea, and Dr. Falk Pharma GmbH, of Freiburg, Germany, reported positive results from a one-week, open-label Phase II portal hypertension study using udenafil, a long-acting phosphodiesterase inhibitor

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported positive results from a Phase I trial of ALN-VSP in solid tumors with liver involvement...Astellas Pharma Global Development Inc., of Deerfield, Ill., said AGS-1C4D4 reduced tumor formation and metastasis in a Phase II trial of the drug in metastatic pancreatic cancer