Amylin Pharmaceuticals Inc., of San Diego, Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Waltham, Mass, said a thorough QT (tQT) study required by the FDA to satisfy safety issues for Bydureon (exenatide extended-release) in Type II diabetes met its primary endpoint by demonstrating that at and above therapeutic levels the drug did not prolong the corrected QTc interval in healthy individuals...Halozyme Therapeutics Inc., of San Diego, and Baxter International Inc., of Deerfield, Ill

The Russian Ministry of Health and Social Development granted clearance to Cardium Therapeutics Inc., of San Diego, for a Phase III registration study of Generx (alfergminogene tadenovec, Ad5FGF-4), a biologic product in development for ischemia

Neurelis Inc., of San Diego, said results of a randomized, crossover pilot study in healthy volunteers showed a similar bioavailability of NRL-1, its intranasal diazepam, compared to intravenous administration...Sangart Inc., of San Diego, started a Phase IIb study of MP4OX, an oxygen therapeutic agent, plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock

Ambit Biosciences Corp., of San Diego, and partner Astellas Pharma Inc., of Tokyo, reported data from an interim analysis of a Phase II study of AC220, a selective FLT3 inhibitor, as a once-daily monotherapy in acute myeloid leukemia patients with FLT3-ITD activating mutations who have relapsed or are refractory to other treatments

Adamis Pharmaceuticals Corp., of San Diego, reported that the FDA has accepted an investigational new drug application for APC-100, clearing the way for a Phase I/IIa trial in men with castrate-resistant prostate cancer...Cytori Therapeutics Inc., of San Diego, said 18-month data from its randomized, placebo-controlled, double-blind trial of the Celution System for using fat-derived stem cells after a heart attack resulted in an 11.2 percent reduction in infarct size for treated patients versus a 4

According to a study by Amylin Pharmaceuticals Inc., of San Diego, treatment with metreleptin, an analogue of leptin, improved diabetes and lipid control in patients with partial lipodystrophy

Ardea Biosciences Inc., of San Diego, presented data from an ongoing blinded extension of its Phase IIb lesinurad trial that show adding lesinurad to allopurinol produced a 91 percent response rate at 28 weeks in gout patients who failed to respond to allopurinol alone...Arena Pharmaceuticals Inc., of San Diego, presented meta-analyses of the three trials in its lorcaserin Phase III program that showed the investigational drug caused statistically significant weight loss compared with placebo at

Ambrx Inc., of San Diego, said that a Phase I/II study demonstrated safety, efficacy and dosing frequency of ARX201, a growth hormone in development for hormone deficiency, compared to native hormone therapy...Cytori Therapeutics Inc., of San Diego, said Japanese regulators approved an independent study conducted by Nagoya University to assess the efficacy of adipose-derived stem and regenerative cells (ADRCs) in the treatment of stress urinary incontinence

Santarus Inc., of San Diego, reported that an open-label study of Rhucin (recombinant human C1 inhibitor) for angioedema supported safety and efficacy conclusions from earlier studies

Cytori Therapeutics Inc., of San Diego, said independent surgeons presented data showing that 19 of 23 patients undergoing adipose-derived regenerative cell fat grafting with the company's Celution system for reconstructive breast surgery reported good to excellent results

Meritage Pharma Inc., of San Diego, said a Phase IIb trial of oral budesonide suspension for eosinophilic esophagitis met its primary endpoin...Optimer Pharmaceuticals Inc., of San Diego, said additional analyses from Phase III trials of Dificid (fidaxomicin) in Clostridium difficile infection (CDI) showed that immunosuppression is associated with higher death and lower CDI cure rates and that the rate of CDI recurrence remained substantially lower among immunosuppressed patients treated with

Santaris Pharma AS, of Hoersholm, Denmark, and San Diego, advanced SPC5001 into Phase I trials for the treatment of high cholesterol

Amira Pharmaceuticals Inc., of San Diego, reported initial positive data from a Phase I study of AM152, an oral selective antagonist of the LPA1 receptor

Otonomy Inc., of San Diego, reported positive data from a Phase Ib study of the company's lead product candidate, OTO-104, in patients with Ménière's disease

HemaQuest Pharmaceuticals Inc., of San Diego, enrolled its first patient in a Phase II study of HQK-1001 for sickle cell disease

Neurelis Inc., of San Diego, completed dosing in its study of diazepam pharmacokinetics and bioavailability after administration of certain formulations of intranasal diazepam and intravenous injection of diazepam

Halozyme Therapeutics Inc., of San Diego, said results in a Type I diabetes study of patients who receive their insulin treatment via pump demonstrated that Aspart-PH20, a formulation of the company's rHuPH20 (recombinant human hyaluronidase) with the active ingredient in NovoLog (aspart, Novo Nordisk A/S), accelerated insulin absorption and shortened its duration of action...Data were presented at the American Association of Clinical Endocrinologists meeting in San Diego

Data were presented at the American Association of Clinical Endocrinologists meeting in San Diego

Lpath Inc., of San Diego, began enrollment in a Phase Ib/IIa trial of iSONEP, an ocular drug candidate partnered with New York-based Pfizer Inc