While no adverse events have been reported, Health Canada warned of possible allergic reactions

The majority of adverse events were similar in the placebo and treatment groups

The drug was well tolerated, with somnolence as the most commonly reported adverse event...Seven subjects experienced serious adverse events, but none was deemed related to treatment

The drug was well tolerated, with adverse events including asymptomatic elevated liver function tests as well as diarrhea and rash

Full safety data are to be revealed later, but Sanofi said the JAKARTA study mirrored earlier trials, with the most common adverse events including anemia, diarrhea, nausea and vomiting

In terms of safety, no maximum tolerated dose was seen, and there were no dose-limiting toxicities or treatment-related deaths, with the majority of adverse events (AE) considered transient

Adverse events included anemia (31 percent vs. 31 percent), neutropenia (5 percent vs. 1 percent) and thrombocytopenia (12 percent vs. 6 percent) for Xofigo compared to placebo...Non-hematologic adverse events included bone pain, nausea, diarrhea and vomiting

Therapy was very well tolerated, with no adverse events reported

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

Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety

The second cohort will explore the effect of more prolonged vemurafenib treatment on adverse events and efficacy

Xenetic Biosciences plc, of London, said it completed the Phase I safety study of multiple sclerosis vaccine candidate MyeloXen on six healthy volunteers with no adverse events

an enzyme replacement therapy Mucopoly-saccharidosis Type IVA Submitted an MAA to the EMA 4/26/13 Ipsen SA (Paris) Dysport Botulinum toxin Type A for injection Moderate to severe frown lines Health Canada granted marketing authorization 4/10/13 Medgenics Inc. (San Francisco) Epodrue Biopumps Anemia in those on dialysis with end-stage renal disease There have been no procedure- or drug-related serious adverse events in the first four patients in the Phase IIa trial in Israel 4/26/13 Nuvo Research

Overall, the relative adverse event profiles were as anticipated for each therapy, including known events such as rash, diarrhea and hypomagnesemia

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 were no serious adverse events

Thirty-two subjects completed the study, with no serious adverse events, dose-limiting safety findings or tolerability issues leading to withdrawal

No drug-related serious adverse events or dose-limiting toxicities were observed in either of the first two cohorts

Although several other VEGF tyrosine kinase inhibitors have been approved for renal cell cancer (RCC), they may not work for everyone and they each have specific adverse events that may make them intolerable for some patients