Sinovac Biotech Ltd., of Beijing, reported that its vaccine for hand, foot and mouth disease (HFMD) showed positive top-line results in a Phase II trial
NeurogesX Inc., of San Mateo, Calif., reported top-line data from a Phase II study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia, showing that the trial met its primary endpoint of a percentage change from baseline vs
Biogen Idec, of Weston, Mass., reported positive top-line results from CONFIRM, the second of two pivotal Phase III trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis (RRMS...Dynavax reported top-line Phase III data on Heplisav in July. (See BioWorld Today, July 21, 2011
Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Top-line data are anticipated by year-end
Forest Laboratories Inc., of New York, reported top-line results from its Phase III trial of cariprazine (RGH-188) for mania of bipolar disorder, showing that treated patients had significant symptom improvement compared to placebo...Top-line data are expected by the end of 2012.The FDA has granted the compound fast-track status
Dynavax reported top-line data from the study in July, showing that it met its primary endpoints. (See BioWorld Today, July 21, 2011...Novavax Inc., of Rockville, Md., said top-line data from a Phase I trial showed that its respiratory syncytial virus (RSV) recombinant nanoparticle vaccine candidate was well tolerated and highly immunogenic, inducing levels of functional immunity that potentially could correlate with protective immunity in future trials
Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury
Santarus Inc., of San Diego, said analysis of top-line safety data from a 12-month extended-use study in patients treated daily with either budesonide MMX 6 mg or placebo showed a similar frequency of treatment-related adverse events for both groups (21 percent to 21.3 percent) and no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end of the study between the budesonide and placebo groups
Spectrum Pharmaceuticals Inc., of Henderson, Nev., reported top-line data from part one of a two-part Phase I study of SPI-1620, a selective endothelin-B agonist, in combination with docetaxel showing a total of five partial responses seen in the 30 patients treated...Tarsa reported top-line data earlier this year
Innocoll Inc., of Ashburn, Va., said top-line data from its Phase II study of XaraColl for managing postoperative pain demonstrated a statistically significant reduction in the total use of opioid medication through 24 hours and 48 hours postsurgery, as well as a statistically significant increase in the time before patients took any opioid medication
Top-line results indicated that lixisenatide reduced HbA1c from baseline to week 24 in both treatment regimens, compared with placebo (one-step: -0.92%; two-step: -0.83% vs. placebo: -0.42
Alcobra Ltd., of Jerusalem, and partner Teva Pharmaceutical Industries Ltd., also of Jerusalem, said top-line Phase II data showed that MG01CI met its primary efficacy endpoint by significantly improving attention deficit hyperactivity disorder symptom scores compared to placebo...Auxilium Pharmaceuticals Inc., of Malvern, Pa., reported positive top-line results from a pilot study of Xiaflex (collegenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple palpable
Sinovac Biotech Ltd., of Beijing, reported that its vaccine for hand, foot and mouth disease (HFMD) showed positive top-line results in a Phase II trial