AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies
Data from the Phase I study established that LPCN 1111 exhibited a strong safety profile and pharmacokinetics, which should allow for once-a-day dosing of the next-generation oral testosterone replacement product, Lipocine said
Galapagos NV, of Mechelen, Belgium, said GLPG0974, an inhibitor of FFA2 (free fatty acid receptor 2, formerly GPR43) in development for chronic neutrophil-driven inflammatory conditions such as inflammatory bowel disease, showed a clean safety profile and a strong biomarker signal in the second Phase I trial
The trial will be launched at Mexico's Hospital Angeles with the Regenerative Medicine Institute, using an initial cohort of five patients to help establish a safety profile and demonstrate preliminary efficacy
The results demonstrate that Pradaxa 150 mg twice daily is an effective option with a favorable safety profile for the extended prevention of recurrence of venous blood clots (known as venous thromboembolism) after a first event
At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...A third poster reviews the safety profile of poxviral vaccines from eight separate trials of PROSTVAC and the immunotherapy CV-301
The safety profile of the program remains consistent with what has been seen in the post-menopausal osteoporosis (PMO) program and is not a factor in the decision to not pursue acceleration of fracture healing
The primary objective is to establish the safety profile of VGX-100, while secondary objectives include determination of anti-tumor activity, biomarker levels and pharmacokinetics...The vaccine was well tolerated, and its safety profile was comparable to other pediatric vaccines
Spectrum Pharmaceuticals Inc., of Henderson, Nev., said data from the BELIEF trial showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma, including those who received a previous allogeneic or autologous stem cell transplant
The preliminary analysis showed that BI-505, a human antibody, has a good safety profile and in cohorts where extended therapy was available, 24 percent of the patients had stable disease for at least two months
Preclinical data have shown that Benepenem has potent in vitro and in vivo activities, a good safety profile and a long half-life compatible with once-daily dosing
Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said an interim analysis of a Phase Ib trial of Somatoprim, a somatostatin analogue, confirmed the drug's safety profile, with the maximum-tolerated dose not yet reached
Pharmacyclics Inc., of Sunnyvale, Calif., presented various results for ibrutinib (PCI-32765) showing prolonged progression-free survival with a favorable safety profile in a number of indications, including relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma...The drug, which is designed to target interleukin-1-alpha, also continued to demonstrate a good safety profile
BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy
UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies