Manhattan Pharmaceuticals Inc., of New York, agreed with the FDA on a special protocol assessment for a Phase III trial of its intranasal hydroxocobalamin, AST-726, for vitamin B12 deficiency
and Pfizer Inc., both of New York, announced topline results of the Phase III ARISTOTLE trial of Eliquis (apixaban) for treatment of patients with atrial fibrillation and at least one additional risk factor for stroke, that showed Eliquis met the primary efficacy objective of noninferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism
Alder Biopharmaceuticals Inc., of Bothell, Wash., will receive a $15 million milestone payment from Bristol-Myers Squibb Co. (BMS), of New York, for the initiation of a Phase IIb trial in rheumatoid arthritis for ALD518/BMS-945429, an investigational antibody therapeutic that blocks interleukin-6
Tonix Pharmaceuticals Inc., of New York, presented data showing that a very low dosage (VLD) of cyclobenzaprine given at bedtime decreased pain, fatigue, tenderness and depressive symptoms in patients with fibromyalgia syndrome
BrainStorm Cell Therapeutics Inc., of New York, and CNS Therapeutics Inc., of St. Paul, Minn., began a Phase I/II trial at the Hadassah Medical Center in Jerusalem to evaluate BrainStorm's NurOwn treatment for patients with amyotrophic lateral sclerosis
Ziopharm Oncology Inc., of New York, said the FDA accepted its investigational new drug application for a clinical study of ZIN ATI-001, a DNA-based therapeutic candidate (also known as Ad-RTS-IL-12 + AL
NovaDel Pharma Inc., of Bridgewater, N.J., opened an investigational new drug application with the FDA for Duromist, an oral spray formulation of New York-based Pfizer Inc.'s Viagra (sildenafil) for erectile dysfunction
BioSpecifics Technologies Corp., of Lynbrook, N.Y., said Pfizer Inc., of New York, reported data showing no statistically meaningful differences between hands that had undergone previous surgery for Dupuytren's contracture vs
Amgen Inc., of Thousand Oaks, Calif., and Pfizer Inc., of New York, reported results from several studies of Enbrel (etanercept) at the European League Against Rheumatism meeting in London and at the World Congress of Dermatology meeting in Seoul, South Korea...Pfizer Inc., of New York, presented full data from its ORAL Sync trial of tofacitinb, an oral JAK inhibitor, which met its endpoint earlier this year, at the European League Against Rheumatism meeting in London
Juventas Therapeutics Inc., of Cleveland, reported Phase I data showing that lead product JVS-100, which is designed to encode stromal cell-derived factor-1, met its safety endpoints and was tolerated at all doses tested by all 17 patients with targeted New York Heart Association (NYHA) Class III heart failure
The largest study of its kind, MARINE showed that pure EPA (icosapent ethyl) therapy reduces triglyceride levels and improves a broad array of lipid and nonlipid parameters, without a significant increase in LDL-C. The results were presented at the National Lipid Association 2011 Annual Scientific Sessions in New York
BrainStorm Inc., of New York, and Hadasit, the technology transfer company of the Hadassah Medical Organization in Petach Tikvah, Israel, said Israeli regulators approved a Phase I/II study of NurOwn, BrainStorm's autologous stem cell therapy in amyotrophic lateral sclerosis
Keryx Biopharmaceuticals Inc., of New York, disclosed the final dataset from its Phase III short-term trial of Zerenex (ferric citrate) in hyperphosphatemia in end-stage renal disease patients on dialysis, with data showing changes in mean serum phosphorus of -2.0 mg/dL for the 6-g dose group and -2.2 mg/dL for the 8-g group, both with a "p" value of less than 0.0001
Pfizer Inc., of New York, reported top-line data from its ORAL Scan Phase III study of JAK inhibitor tofacitinib (formerly tasocitinib), showing that the drug met all primary endpoints and showed statistically significant changes vs
Manhattan Pharmaceuticals Inc., of New York, agreed with the FDA on a special protocol assessment for a Phase III trial of its intranasal hydroxocobalamin, AST-726, for vitamin B12 deficiency