No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature

It showed that the drug was well tolerated with its most common adverse events being genital mycotic infections, urinary tract infections and increased urination

The primary safety endpoints are dose-limiting adverse events, and primary efficacy endpoints are serum viral load reduction and degree of hepatocyte transduction, measured by liver biopsies...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

There were no adverse events

However, preliminary safety data analyses suggested the benefit/risk ratio might not favor the trabedersen treatment arm due to serious adverse events associated with the local mode of administration, so the company will focus on systemic I.V...The trial reported no imbalance in serious adverse events, and there were a low number of major adverse cardiovascular events

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

Safety analysis showed Elelyso was well tolerated, with no serious adverse events

In August 2012, the FDA placed IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in the Phase II trial of New York-based Bristol-Myers Squibb Co.'s BMS-986094

BioCryst withdrew an investigational new drug application last fall on FDA concerns about the toxicity profile of the drug, based in part on the occurrence of serious adverse events in HCV clinical trials of a nucleotide prodrug from New York-based Bristol-Myers Squibb Co

to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor...In other news, Novartis said the FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia

Inc., of Whitehouse Station, N.J., said it is taking steps to suspend Tredaptive (extended-release niacin/laropiprant) tablets worldwide, after preliminary data from the HPS2-THRIVE study showed the trial missed its primary endpoint of reducing major vascular events and also indicated a statistically significant increase in the incidence of some types of nonfatal serious adverse events

No serious adverse events were reported, and the drug demonstrated a dose-dependent lowering effect on growth hormone (hGH), as shown by an analysis of the pharmacodynamics effect on hGH, when stimulated by growth hormone-releasing hormone

Distribution of Prothena ordinary shares in the demerger is conditioned upon, among other conditions to the demerger, a registration statement filed with the SEC, having been declared effective by the SEC and the affirmative vote of the Elan shareholders...Galderma will continue to supply Restylane and Perlane to Valeant under the same terms and conditions that the products are supplied to Medicis, while Valeant will make undisclosed up-front and royalty payments to Galderma on sales of Sculptra...To

Oxford BioMedica plc, of Oxford, UK, and partner Sanofi SA, of Paris, disclosed a positive interim review of the ongoing UshStat Phase I/IIa study by the data safety monitoring board (DSMB), with no serious adverse events in the three patients treated at dose level one related to the product

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

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

Doses of 0.5 mg and 1 mg laquinimod also were well tolerated, with adverse events similar to placebo

The study will investigate two doses of Alpha-1 HC aerosol, an inhaled formulation of Grifols' alpha-1-proteinase inhibitor, and investigators will measure adverse events and other endpoints during the three-week study period

In other news, 3SBio said its special committee of independent directors has retained Cleary Gottlieb Steen & Hamilton LLP, of New York, as the committee's legal counsel...In other news, Boehringer said it started an open-label U.S...The objectives are to decrease or stabilize the number of blood-circulating CLL cells and to delay the onset of other signs of progression, such as swelling of lymph nodes, which then requires immunochemotherapy treatment