The FDA requested studies to explore the safety profile of Oxycyte because perfluorocarbon emulsions as a class have been shown to cause transient thrombocytopenia in animals and humans, and have raised questions regarding potential impact of perfluorcarbon emulsions on normal immune system functions

Teva Pharmaceutical Industries Ltd., of Jerusalem, said its women's health subsidiary reported Phase III findings showing that Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an extended-regimen oral contraceptive, showed the product is efficacious for the prevention of pregnancy and has a safety profile similar to those of other oral contraceptives

An oral oxazolidinone antibiotic targeting infections due to multidrug-resistant Gram-positive bacteria, MRX-I is designed to have enhanced potency against methicillin-resistant Staphylococcus aureus and an improved safety profile compared to marketed antibiotics

Riociguat was well tolerated with a good safety profile

Riociguat was well tolerated with a good safety profile

The company announced that it would advance the compound after it showed a favorable pharmacokinetic and safety profile in animal studies

Tarsa's product was superior to placebo in increasing BMD at the lumbar spine in women with low bone mass at increased risk of fracture, and its safety profile did not differ substantially from placebo

According to Robyn Karnauskas, analyst at Deutsche Bank, the briefing documents released ahead of the meeting suggested that approval be granted with no major "red flags" on the drug's safety profile

The primary objective is to determine the maximum-tolerated dose and dose-limiting toxicity, and secondary objectives include describing the safety profile, pharmacokinetics and tumor response to CBL0137

The agreement follows promising results from early stage trials showing the vaccine candidate had an acceptable safety profile and demonstrated an immune response

Heidelberg, Germany-based Affimed said AFM13's benign safety profile gives it the potential to be used as a third-line treatment, but also in first- and second-line therapy in combination with chemotherapy

Acorda Therapeutics Inc., of Ardsley, N.Y., reported safety data from more than 62,400 people with multiple sclerosis (MS) taking Ampyra (dalfampridine) extended-release tablets during the first two years of availability in the U.S., with results showing a similar safety profile as observed in clinical trials

Heidelberg, Germany-based Affimed said AFM13's benign safety profile gives it the potential to be used as a third-line treatment, but also in first- and second-line therapy in combination with chemotherapy

TS01 selectively targets occlusive clots that cause strokes and spares hemostatic clots, resulting in a superior safety profile and reduced risk of intracranial hemorrhage

The safety profile in the CA033 trial worked out similarly to those in other pivotal trials with Abraxane, Celgene reported, but more details will not be disclosed until the Society for Melanoma Research Congress 2012 in Los Angeles, which takes place the second week of November

Analysts were exuberant after Synta Pharmaceuticals Corp. disclosed results Saturday from an interim analysis of the Phase IIb portion of its GALAXY (Ganetespib Assessment in Lung cAncer with docetaXel) trial of ganetespib, the company's lead heat-shock protein 90 (Hsp90) inhibitor, as second-line treatment in advanced non-small-cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna, Austria. Raising his price target on Synta from $10 to $16, Roth

Buono said Lutathera showed a good safety profile in the Phase I/II trial with side effects limited to Grade I or II neutropenia

The company has long touted its benign safety profile in comparison with currently marketed HDAC inhibitors, such as Zolinza (vorinostat) and Istodax (romidepsin), marketed, respectively, by Whitehouse Station, N.J.-based Merck & Co

No new safety signals emerged in the study, and the overall safety profile of tofacitinib remained consistent with that seen previously in the RA clinical development program...Pfizer also will report data from a pooled analysis of two long-term, open-label extension studies (NCT00413699, NCT00661661) demonstrating patients with moderate-to-severe RA who had participated in randomized Phase II or III studies of tofacitinib showed a consistent safety profile and sustained efficacy over 48 months