Baliopharm GmbH, a subsidiary of Baliopharm AG, of Basel, Switzerland, joined the NEU2 Consortium with a project addressing the recombinant manufacturing of an Fc-free bispecific CD20-CD95 antibody construct (Novotarg) with selectivity for activated B cells and efficacy studies in disease models relevant to multiple sclerosis therapy. The two-year project was funded by the German Federal Ministry of Education and Research. Bayer AG, of Leverkusen, Germany, signed an agreement to acquire the

In the open-label trial, 44 kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of hand tremor were switched to once-daily LCP-Tacro

That event triggered a fourth $50 million milestone payment from collaborator Janssen Biotech Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. The randomized, multicenter, open-label study is testing the targeted therapy ibrutinib (PCI-32765) – designated by the FDA as a breakthrough drug – in patients 65 years or older with treatment-naïve CLL/SLL. (See BioWorld Today, Feb. 14, 2013.) Janssen and Pharmacyclics also are collaborating with Abbott, of Abbott Park, Ill., to explore the

The trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following subretinal transplantation in patients with dry AMD or SMD at 12 months, the study's primary endpoint

The open-label study is designed to confirm PM01183's activity in that indication

In one trial, open-label tiotropium will serve as active control

The Phase IV study is currently open at 12 sites and will be conducted in approximately 25 sites in the U.S. The open-label, two-arm study is enrolling mM patients with BRAF V600 oncogene mutations

the first patient was enrolled in its open-label study of the safety and efficacy

The study is an open-label, multiple-dose, dose-escalation pilot study, which will include eight infants

Dendreon also is continuing to evaluate partnering strategies for European expansion and to enroll patients in an open-label sipuleucel-T

The 24-month, open-label study is being carried out in Russia with the objective of evaluating safety, tolerance and correction of anemia with maintenance of hemoglobin levels in chronic kidney disease patients who are naïve to erythropoietin

The open-label study is designed to confirm PM01183's activity in that indication

Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S

The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients...Trevi Therapeutics Inc., of New Haven, Conn., started a Phase I, open-label study to characterize and compare the pharmacokinetics, safety and tolerability of escalating oral doses of nalbuphine hydrochloride

The new designation for SD-101 in EB patents was based on clinical data from a previously conducted open-label Phase II study with topical administration of SD-101 in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB

The urine samples supported results from patient self-reports of opioid use. (See BioWorld Today, June 11, 2011.) Data from an open-label, six-month safety re-treatment study of patients with opioid dependence who previously completed six months of treatment in the trial showed the re-treatment was well tolerated

The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment

In a conference call late Monday afternoon, Patrice Rioux, Raptor's chief medical officer, said 40 patients who participated in Procysbi's Phase III trial have remained on the open-label extension – some for up to two years – with no unexpected severe adverse events

In an open-label Phase II study conducted in children with simplex, recessive dystrophic EB or junctional EB, SD-101 application resulted in complete closure of 88 percent of target chronic lesions within one month.