John Dingell (D-Mich.) directed a series of direct questions to Hamburg about the FDA's purview over compounding pharmacies, asking whether the agency has legislative authority to inspect such centers and investigate their records, require them to register and report adverse events to the FDA and require them to use good compounding practices...Hamburg's statement called for congressional action to include new labeling requirements, adverse events reporting and the FDA's "clear, full authority to

Within the same period, four placebo patients (22 percent) experienced four adverse events: sinus congestion, vasomotor rhinitis, diarrhea and dyspepsia...There was one patient in the Ruconest group who experienced a serious adverse event (abdominal hernia at day 79) that was assessed by the investigator as not related to the study drug

While the incidence of autoimmune events was low, reviewers, however, did note that all autoimmune adverse events occurred in Heplisav patients, but they said data from the second pivotal study did not reveal clinically significant safety concerns

In the ELECTRON trial, only one patient discontinued due to an adverse event, but it was unrelated to the study drug, and that patient still achieved SVR4 with only eight weeks of therapy...The most common adverse events observed in the trial so far have been fatigue, upper respiratory tract infection, headache and nausea

No deaths or serious adverse events were reported, and the most common adverse events were neutropenia and anemia

The most common adverse events included fatigue, rash, diarrhea, nausea, cough, joint pain, fever and itching, with seven MK-3475-related Grade 3/4 adverse events potentially immune related

The analyses showed no clinically relevant imbalances in serious adverse events (SAE), including externally adjudicated major cardiovascular events, across the three treatment arms in KODIAC-04, -05 and -07 – the safety extension of -04

The overall incidence of adverse events (AEs) was generally similar across all treatment arms

In the clinical trial (n = 39 patients), OMP-59R5 was generally well tolerated, with diarrhea as the main treatment-related and dose-related adverse event

The NS5B nucleoside inhibitor became the latest HCV drug caught amid the FDA's safety concerns regarding "nucs," following adverse events reported in trials of New York-based Bristol-Myers Squibb Co.'s nucleotide prodrug BMS-086094. (See BioWorld Today, Aug. 27, 2012.) That news was compounded by the fact that, only a week earlier, BioCryst had put down stakes in the red-hot HCV space by acquiring Presidio Pharmaceuticals Inc

Enrollees in the study each received the first of a four-dose vaccine regimen and were followed for three hours, with no adverse events observed

The most common reported adverse events were nasopharyngitis, cough and nausea

Within the same period, four placebo patients (22 percent) experienced four adverse events: sinus congestion, vasomotor rhinitis, diarrhea and dyspepsia...There was one patient in the Ruconest group who experienced a serious adverse event (abdominal hernia at day 79) that was assessed by the investigator as not related to the study drug

The trial began in summer 2010. (See BioWorld Today, July 12, 2010.) The primary efficacy and safety measures were the annualized bleeding rate (ABR) and adverse events, including inhibitor development in patients studied for up to about a year

GALNS' adverse event profile was consistent with other ERTs, with common adverse events such as vomiting, pyrexia, headache and nausea occurring in more than 25 percent of patients, but serious adverse events limited to 3.4 percent of the once-weekly treatment group

BioCryst said safety concerns at the FDA are heightened due to the recent occurrence of serious adverse events in HCV patients in trials of New York-based Bristol-Myers Squibb Co.'s nucleotide prodrug, BMS-086094

primary safety measures include serious adverse events, adverse events and major bleeding events

The trial began in summer 2010. (See BioWorld Today, July 12, 2010.) The primary efficacy and safety measures were the annualized bleeding rate (ABR) and adverse events, including inhibitor development in patients studied for up to about a year

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