Genfit SA, of Lille, France, said the first patients have been recruited in its pivotal Phase IIb study testing GFT505 in nonalcoholic steatohepatitis (NASH

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...The trial is the second of three Phase III studies testing the CR formulation for once-daily therapy

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

Acceleron Pharma Inc., of Cambridge, Mass., said the Gynecologic Oncology Group started a Phase II study testing dalantercept, a protein therapeutic designed to target the activin receptor-like kinase 1 pathway, in patients with recurrent or persistent endometrial cancer

Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase IIb study testing EPI-743 in children with Leigh syndrome, an inherited lethal and progressive neuromuscular disease...ViroPharma Inc., of Exton, Pa., said data from an open-label study testing escalating doses of C1 INH-nf in patients with hereditary angioedema (HAE) who are not adequately controlled with 1,000 U every three or four days provide evidence of the safety profile of Cinryze (C1 esterase inhibitor [human

Amgen Inc., of Thousand Oaks, Calif., reported results from the LAPLACE-TIMI 57 and MENDEL Phase II studies testing AMG 145 in hypercholesterolemic patients with or without statins, respectively, showing that treatment with the PCSK9-directed antibody resulted in a statistically significant reduction in low-density lipoprotein cholesterol (LDL-C

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said the first patient was enrolled in a Phase IIa study testing Somatoprim, a somatostatin analogue, in acromegaly

Aerie Pharmaceuticals Inc., of Bedminster, N.J., reported top-line results from a 93-patient Phase II study testing a fixed combination of its Rho kinase inhibitor, AR-12286, with commercially available prostaglandin travoprost, for the treatment of glaucoma

Gilead Sciences Inc., of Foster City, Calif., said a Phase II study testing tenofovir alafenamide fumarate (TAF, formerly GS-7340), a prodrug of tenofovir for treating HIV-1 infection, met its primary objective

Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it started a Phase II comparator-controlled study testing ISIS-FXIRX, a Factor XI inhibitor, in patients undergoing knee replacement surgery...XBiotech Inc., of Austin, Texas, reported interim analysis results from a Phase II study testing its True Human monoclonal antibody (MABp1) in patients with Type II diabetes, showing that data continue to reinforce the role of interleukin-1-alpha as a master regulator of chronic inflammation in multiple

Ltd., of Tokyo, said it completed patient enrollment in the Hokusai-VTE Phase III study testing once-daily oral Factor Xa inhibitor edoxaban for the treatment and prevention of recurrence of venous thromboembolism in patients who have had an acute symptomatic deep vein thrombosis, pulmonary embolism or both

Vaximm AG, of Basel, Switzerland, said it completed enrollment in a Phase I/II dose-escalation study testing oral therapeutic cancer vaccine VXM01

Millennium: The Takeda Oncology Co., of Cambridge, Mass., said it started a Phase III study testing once-weekly oral MLN9708 plus dexamethasone in patients with relapsed or refractory light chain AL amyloidosis

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Seattle Genetics Inc., of Bothell, Wash., said it started a Phase II study testing its CD30-targeted antibody-drug conjugate Adcetris (brentuximab vedotin) as a front-line therapy for patients, ages 60 and older, with newly diagnosed Hodgkin lymphoma...XBiotech Inc., of Austin, Texas, reported preliminary results from a Phase II study testing its True Human monoclonal antibody (MABp1) in patients with moderate to severe psoriasis

Those and other data, including results from an eight-week study testing lower doses of Natpara in hypoparathyroidism, were presented at the American Society of Bone and Mineral Research meeting in Minneapolis

Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the European Committee for the Treatment and Research of Multiple Sclerosis meeting in Lyon, France, supporting clinical and radiological effects of the drug in people with relapsing-remitting multiple sclerosis (MS

Oxford BioMedica plc, of Oxford, UK, said it plans to close the U.S. Phase II study testing cancer vaccine candidate TroVax (MVA-5T4) in patients with progressive hormone-refractory prostate cancer

Oculus Innovative Sciences Inc., of Petaluma, Calif., said results of its open-label pilot study testing Microcyn Technology-based Atrapro Antipruritic Hydrogel in combination with Neosalus Cream in atopic dermatitis demonstrated a statistically significant 50 percent reduction in the body surface area of the atopic dermatitis from baseline to week four