That "appalling tragedy" was only the worst in a large series of outbreaks associated with compounded drugs over the past decade, Janet Woodcock, director of the FDA's drug center, told the committee. (See BioWorld Today, Nov. 15, 2012.) When pressed for numbers of previous incidents, Woodcock said, "We don't know," because compounders aren't required to register with the agency or submit adverse event reports...There may be value in discussing the benefit-risk framework at end-of-Phase II

Data demonstrated that EBI-005 was safe and well tolerated in both preclinical testing and in a clinical Phase Ia study in healthy volunteers...These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013...There were no serious adverse events

The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of sialorrhea...No drug-related serious adverse events or dose-limiting toxicities were observed in either of the first two cohorts

The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment...The primary endpoint is clinical benefit, which will be assessed at six months...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a

The primary objectives include the evaluation of adverse events and a six-month clinical response...One patient suffered serious adverse events that led to discontinuation, but all other side effects were mild and transient

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...The drug was well tolerated, with similar rates of adverse events between the groups

No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature

Treatment-related adverse events with CCH were mostly localized bruising, injection site pain and swelling, hematoma and musculoskeletal pain...Tedizolid was generally well tolerated, with gastrointestinal adverse events the most commonly reported emergent adverse events (16 percent in tedizolid vs. 20.5 percent in linezolid

Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV...The primary safety endpoints are dose-limiting adverse events, and primary efficacy endpoints are serum viral load reduction and degree of hepatocyte transduction, measured by liver biopsies

The company also is preparing a clinical program for marketing in Europe and the U.S...Pluristem Therapeutics Inc., of Haifa, Israel, said the first group of six patients has been dosed in its ongoing Phase I/II trial testing PLacental Expanded (PLX) cells in the treatment of muscle injury, without a significant adverse event related to either placebo or the PLX cell product candidate

No serious adverse events were reported...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumors

Data also showed that no new safety signals were observed with repeat dosing and the types of adverse events were consistent with those reported in earlier studies...The company also said it is initiating a new financing round – about $6 million in new convertible debt – to fund further clinical development

Adverse events were consistent with those already known for eplerenone, primarily hyperkalemia...Findings were presented during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco

Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group...VX-787 was generally well tolerated, with no adverse events leading to discontinuation

Polyphor Ltd., of Allschwil, Switzerland, completed a Phase I trial demonstrating the clinical safety and tolerability of its Pseudomonas-specific antibiotic POL7080...Adverse event (AE) profiles were similar between the two treatment groups and consistent with known AEs associated with progesterone

In conjunction with the changes in its clinical program, the company said it reduced its work force by 50 percent and outsourced noncritical research and development functions...The trial reported no imbalance in serious adverse events, and there were a low number of major adverse cardiovascular events

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response

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...The most commonly reported adverse events were anorexia and fatigue

Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application...No serious adverse events or safety concerns were identified