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

Nine patients discontinued STEPS 2 due to adverse events, and while gastrointestinal side effects were the most common culprit, three patients developed cancer – two cases of which proved to be fatal. (See BioWorld Today, Nov. 1, 2011.) The event shook NPS's stock price, but not its faith in the product

No serious adverse events were reported

BromSite was well tolerated, with no safety concerns or drug-related serious adverse events

The rate of serious adverse events among infants receiving the vaccine was 2.2 percent, compared to 2.6 percent for those receiving a control vaccine, a difference that was not statistically significant

Through such disclosures and court-related filings, India's media – much more actively reporting on the problem than those in the U.S. – learned that between January 2005 and June 2012, the ministry approved 475 clinical trials for new chemical entities, and recorded 11,972 adverse events, excluding deaths, 506 of which were known to be caused by the trials

The documents highlight that adverse events related to implantation of Norplant and other birth control devices include pain, infection, numbness and scarring

The most common treatment-emergent adverse events were headache, indigestion and back pain

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

Through such disclosures and court-related filings, India's media – much more actively reporting on the problem than those in the U.S. – learned that between January 2005 and June 2012, the ministry approved 475 clinical trials for new chemical entities, and recorded 11,972 adverse events, excluding deaths, 506 of which were known to be caused by the trials

The rate of serious adverse events among infants receiving the vaccine was 2.2 percent, compared to 2.6 percent for those receiving a control vaccine, a difference that was not statistically significant

The drug was also well tolerated, with similar rates of occurrence of serious adverse events among drug and placebo groups...There were no product-related serious adverse events in either arm

In addition, statistically significant increases in non-fatal serious adverse events (SAE) were observed in patients on Tredaptive plus statin therapy compared to placebo plus statin therapy...Adverse events were consistent with those already known for eplerenone, primarily hyperkalemia

The rate of serious adverse events and the rate of discontinuations due to adverse events were similar between the two groups

adverse events 2/6/13 MISCELLANEOUS Hyperion Therapeutics Inc. (South San Francisco) Ravicti Glycerol phenylbutyrate Urea cycle disorders FDA issued an approval 2/4/13 Hemispherx Biopharma Inc. (Philadelphia) Ampligen Rintatolimod Chronic fatigue syndrome Received a complete response letter from the FDA 2/6/13 Notes: BLA = Biologics license application

adverse events occurring more frequently in the naloxegol arm included abdominal pain, diarrhea, nausea and headache 2/27/13 INFECTION Gilead Sciences Inc. (Foster City, Calif.) Sofosbuvir Once-daily nucleotide Chronic hepatitis C virus Phase III data showed it met the primary endpoints when used in combination with ribavirin and in combination with ribavirin and pegylated interferon

the drug was well tolerated with no significant adverse events 2/19/13 Progenics Pharmaceuticals Inc. (Tarrytown, N.Y.) PSMA ADC An antibody-drug conjugate Hormone-refractory prostate cancer Phase I data showed significant antitumor activity

The JRC-LAMP-vax vaccine already appears to have met safety goals, with no severe adverse events observed to date

This involves such factors as the adequacy of the safety database, severity and reversibility of adverse events, and the potential for suboptimal management in the postmarket setting...Moving forward this year with the framework, the FDA plans to address uncertainties in how well a benefit-risk assessment based on clinical trial data translates to the postmarket setting and how to assess postmarket findings that may come from sources of varying levels of rigor, such as adverse event reports and