The L-PPDS was well tolerated over the testing period with adverse events similar to those reported for commercial punctal plugs and a previous PPL GLAU 11 study...Patients will be monitored for development of clinical symptoms and viral shedding

Derma Sciences Inc., of Princeton, N.J., said it plans to begin its Phase III program in December for DSC127, a clinical formulation of NorLeu3-A(1,7), in diabetic foot ulcers, to support the filing of a new drug application...Methylgene Inc., of Montreal, presented Phase I data for MGCD290, an antifungal compound, showing that all doses and schedules of the drug were tolerated with no severe or serious adverse events, and that pharmacokinetics were dose dependent

Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas...Doses of 0.5 mg and 1 mg laquinimod also were well tolerated, with adverse events similar to placebo

The clinical relevance of neratinib as a 'pan-HER' family inhibitor and it being irreversible is yet to be proven," the paper said...Funds will be used to support the clinical development of cancer drugs aldoxorubicin and tamibarotene and for general corporate purposes, which could include working capital, capital expenditures, R&D and commercial activities.

The most frequently reported adverse events were dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, back pain and asthenia...The positive clinical effects of the twice-daily dose of the drug relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses accumulating over the 24 weeks

Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients, with a primary endpoint of six-month retention rate and other assessments, including seizure frequency, adverse events and quality of life...Additional results from the PHOENIX-2 study showed that high levels of clinical responses were achieved and maintained with up to five years of ustekinumab treatment

No serious adverse events were reported in the primary analysis period, and no clinically meaningful differences in related adverse events were reported between the two treatment groups

No serious adverse events were reported, and there were no patient discontinuations...Data were published in the Journal of Allergy and Clinical Immunology

The study is the first of two identical trials, and the endpoints of both will include vitamin D status, adverse events, physical and clinical laboratory assessments and changes in serum calcium, serum phosphorous and plasma intact parathyroid hormone

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...The product had a good safety and tolerability profile, with no unexpected adverse events

Clinical response rates were high across all treatment groups and similar to daptomycin...Brilacidin was safely administered and adverse events appeared to be exposure-related, with overall adverse event rates under 10 percent in each dose group

Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported that it received verbal notice that the FDA placed a clinical hold on IDX19368, the company's next-generation nucleotide polymerase inhibitor under development as a hepatitis C virus (HCV) treatment...A few weeks ago, the FDA placed a partial clinical hold on an ongoing Phase IIb trial of IDX184, Idenix's lead nucleotide polymerase inhibitor for HCV, for the same reason...News of the most recent clinical hold sent Idenix shares (NASDAQ:IDIX

The compound was well tolerated at all doses evaluated, with no serious adverse events...Serious adverse events were lower in the enzalutamide group than in the placebo group

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...In a multicenter Phase II study, the compound demonstrated symptomatic relief and clinical and mycological benefits after a single administration delivered as a vaginal suppository formulation

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...ICT-121 is the second dendritic-cell-based vaccine to enter clinical trials...Novavax Inc., of Rockville, Md., reported positive top-line results from a Phase II trial of its seasonal influenza virus-like particle (VLP) candidate showing that the product had immunogenicity against all four viral strains, and was well tolerated with no vaccine-related serious adverse events

Results showed that the orally administered selective Cav2.2 blocker was well tolerated in all subjects, with few adverse events reported at doses expected to fall within the predicted therapeutic range...Data also showed statistically significant results across secondary endpoints of other cognitive and clinical measures, and the drug was generally safe and well tolerated over the six-month dosing period

Anthera reported top-line data from the PEARL-SC study late last month, showing that the trial missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups...The results showed there was no difference in gastrointestinal tolerance and adverse events between the test and control groups

A prior Phase I trial, enrolling 17 NYHA Class III heart failure patients, showed promising safety results and signs of clinical benefit...That Phase I trial met its primary safety endpoint, with no serious drug-related adverse events

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 fraction from baseline, with a mean change of 92 percent...Low plasma concentration also indicated that no serious systemic adverse events can be expected