Meanwhile, Gary Burgess, senior vice president of clinical research and chief medical officer, joined Conatus in 2011 from Pfizer, where he oversaw the assimilation of Idun, including data integration, clinical oversight of ongoing Phase II studies, development of clinical plans and registration strategies for emricasan...In all, emricasan has completed nine clinical studies, including some at Pfizer, enrolling more than 500 participants, according to Conatus...After four years of development, in 2011

Genmab A/S, of Copenhagen, Denmark, said teprotumumab (RG1507), an antibody developed by Genmab under a collaboration with Roche AG, of Basel, Switzerland, will restart clinical development in a Phase II study in patients with active thyroid eye disease...Clinical development will be conducted by River Vision Development Corp., which licensed teprotumumab from Roche...The company recently launched the Crohn's disease clinical trial and is actively recruiting participants with moderate to severe

At 24 months, overall safety data were similar, including incidence of adverse events (92.8 percent for abatacept plus MTX vs. 91.5 percent for adalimumab plus MTX), serious adverse events (13.8 percent vs. 16.5 percent, respectively) and malignancies (2.2 percent vs. 2.1 percent, respectively...According to cumulative safety data assessed at week 268, common adverse events in the three studies included upper respiratory tract infection, bronchitis or sinusitis and nasopharyngitis

The most common adverse events observed in the MYRROR trial that occurred with a frequency of 2 percent or more were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis...Vanda Pharmaceuticals Inc., of Washington, presented additional entrainment and patient-level clinical data at SLEEP 2013, the meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of

The following data were presented at the American Society of Clinical Oncology meeting in Chicago...To date, no treatment-related serious adverse events have been observed

The most common treatment-emergent adverse events across all grades were hand-foot skin reaction, diarrhea, alopecia, rash/desquamation, fatigue, weight loss, hypertension, metabolic/laboratory, anorexia, oral mucositis, pruritis and nausea...and the clinical benefit response rate was 82 percent

But this time, they'll be listening to a version conducted by the Duke Clinical Research Institute (DCRI), which was hired by GSK to satisfy the FDA's 2010 demand for an independent readjudication of the CV safety results from the unblinded trial as a condition for allowing the drug to remain on the market for a restricted group of patients...This readjudication addressed a major concern raised during the original RECORD review, namely an allegation that there was widespread and potentially biased

The company is exploring the best options for a new clinical study with higher doses of amitifadine in that population...La Jolla Pharmaceutical Co., of San Diego, said data from a Phase I (Part A) portion of the Phase I/II trial of GCS-100 in patients with chronic kidney disease (CKD) showed no serious adverse events, and there were no adverse changes in laboratory measures

Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...There were no cell-related or immunological adverse events reported in any of the patients treated

The majority of adverse events were similar in the placebo and treatment groups...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies

While no adverse events have been reported, Health Canada warned of possible allergic reactions...959, biologics may only be compounded from an approved biologic for a patient for whom the drug produces a clinical benefit, upon receipt of a prescription or medical order

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer...The second cohort will explore the effect of more prolonged vemurafenib treatment on adverse events and efficacy

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