Top-line data are expected in the first half of 2014...Stratatech Corp., of Madison, Wis., reported top-line data from a proof-of-concept trial testing StrataGraft, a universal human skin substitute in development for treating severe burns
Top-line data revealed that at the early clinical evaluation point, between 48 hours and 72 hours of treatment initiation, 90.9 percent of subjects were considered to be stable or improving in investigator assessments, meeting the primary endpoint of the study
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said top-line results showed that all four Phase III studies of empagliflozin, a sodium glucose co-transporter-2 inhibitor, in Type II diabetes met their primary endpoints, defined as significant changes in HbA1c from baseline compared to placebo, with the 10-mg and 25-mg doses
As initially reported in December, preliminary top-line data showed that dalbavancin achieved its primary endpoint of noninferiority at 48 to 72 hours following initiation of therapy, as determined by the cessation of spread of the lesion and resolution of fever...Durata expects to report preliminary top-line results from DISCOVER 2, its second Phase III study, this quarter and to reactivate its new drug application for dalbavancin in the U.S
Alkermes plc, of Dublin, Ireland, reported positive top-line results from a Phase I study of antipsychotic candidate ALKS 3831, which combines a drug molecule ALKS 33 with Zyprexa (olanzapine, Eli Lilly and Co...Patient enrollment is slated to start later this quarter, and Relypsa anticipates top-line results in the fourth quarter
AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data from a Phase III trial demonstrating that the Sufentanil NanoTab PCA System was noninferior (p < 0.001) to intravenous patient-controlled analgesia with morphine for the primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent" (78.5 percent vs. 66.1 percent, respectively
Auxilium Pharmaceuticals Inc., of Malvern, Pa., disclosed top-line 30-day data for collagenase clostridium histolyticum for the potential treatment of adult patients with edematous fibrosclerotic panniculopathy, commonly known as cellulite
Biotie Therapies Corp., of Turku, Finland, reported top-line data from a Phase IIb study showing that tozadenant (SYN115), its adenosine A2a antagonist, met the primary endpoint of decreasing the "off" time in Parkinson's patients experiencing levodopa-related end-of-dose wearing off vs...Durata Therapeutics Inc., of Chicago, disclosed preliminary, top-line results for its DISCOVER 1 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response) Phase III study of dalbavancin
Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs...The company recently concluded enrollment in its pivotal program, with top-line data expected in the middle of 2013
Gilead Sciences Inc., of Foster City, Calif., reported top-line results from its Phase III POSITRON study examining a 12-week course of once-daily sofosbuvir, also known as GS-7977, plus ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who are not candidates for interferon (IFN
Atox Bio Ltd., of Ness Ziona, Israel, reported top-line results from a Phase IIa trial showing that AB103, a short peptide immune regulatory therapy, produced meaningful improvement across multiple endpoints vs
Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response
Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated
Top-line data are expected in the first half of 2014...Stratatech Corp., of Madison, Wis., reported top-line data from a proof-of-concept trial testing StrataGraft, a universal human skin substitute in development for treating severe burns