to produce and supply 123I-labeled NAV5001 for Navidea's late-phase clinical trials...The agreement focuses on Nordion's cGMP manufacturing and supply of NAV5001 clinical trial material to be produced at Nordion's Vancouver, British Columbia, facility

TAIPEI, Taiwan – In what is likely one of the first attempts by a foreign biopharma to complete the full range of clinical trials in China for a new biologic, leading to regulatory and market approval by Chinese drug approval authorities, therapeutic antibodies specialist RuiYi Inc., of La Jolla, Calif., and Shanghai, entered a collaboration agreement with Genor BioPharma Co...RuiYi is leading the joint venture to take advantage of favorable conditions in China for clinical trials, for RA

Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories

Approval was supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments

Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy

HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN-modified CD4 central memory T-cells

Nivolumab Wows as Companion to Yervoy Jedd Wolchok, medical oncologist at the Memorial Sloan-Kettering Cancer Center and the study lead on clinical trials that led to the approval of Yervoy (ipilimumab, Bristol-Myers Squibb Co.), provided the overview of a second ASCO abstract focusing on cancer immunotherapy, sponsored by BMS...Wolchok and colleagues studied the clinical activity and safety of nivolumab, an anti-PD-1 currently in clinical trials, in combination with the anti-CTLA-4 ipilimumab, in

Proceeds will be used to fund ongoing and new clinical trials and development and commercialization efforts for pimavanserin, as well as activities for other product candidates and for general corporate purposes...Gross proceeds totaled about $35 million, with net proceeds of $32.8 million to fund SFP clinical trials and for other general corporate purposes

There may be value in discussing the benefit-risk framework at end-of-Phase II meetings, in order to ensure alignment on identified and potential risks and benefits, critical efficacy and safety assessments, and risk mitigation strategies in Phase III clinical trials," PhRMA noted

With an eye on streamlining the review of clinical trials with low biosafety risks, the National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules

Funds will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as funding planned clinical trials for its OMS103HP, PDE10, MASP-2 and PDE7 programs

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement

Moving Quickly While most drugs languish in clinical trials for upwards of a decade, Zelboraf and Xalkori were able to move quickly, largely due to the fact that both were paired with companion diagnostics very early in their clinical development, allowing them to find the right patient population, establish efficacy and present a convincing case to regulators. (See BioWorld Insight, Sept. 6, 2011.) "Early development of these tests also potentially enables clinical trials to be smaller and more

Company (Location) Product Description Indication Status Date AUTOIMMUNE Acorda Therapeutics Inc. (Ardsley, N.Y.) rHIgM22 A remyelinating antibody Multiple sclerosis Enrollment began in the first trial 4/24/13 Arena Pharmaceuticals Inc. (San Diego) APD334 An oral drug targeting the sphingosine 1-phosphate subtype 1 receptor Autoimmune diseases Initiated dosing in a Phase I trial 4/8/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-8400 An agonist of Toll-like receptors 7, 8 and 9 Psoriasis

The first such cells are now in clinical trials, and corresponding author Aboody and her colleagues published preclinical studies that formed a key part of the investigational new drug (IND) application for them in the May 9, 2013, issue of Science Translational Medicine...In a clinical trial approved partly on the basis of the data now published in Science Translational Medicine, 15 patients with recurrent gliomas have now been treated with single injections of low doses of neural stem cells

Company (Location) Product Description Indication Status Date AUTOIMMUNE Rigel Pharmaceuticals Inc. (South San Francisco) and AstraZeneca plc (London) Fostamatinib Oral spleen tyrosine kinase inhibitor Rheumatoid arthritis Missed the X-ray endpoint of modified Total Sharp score, but hit statistical significance in ACR20 scoring, although the Phase III still fell short of those achieved by Pfizer Inc.'s approved Xeljanz 4/8/13 CANCER Array BioPharma Inc. (Boulder, Colo.) ARRY-520 A selective KSP

The agreement is that Array will be entitled to run a clinical trial with 162...Running the MILO trial could benefit Array financially because some overhead will be included in the clinical trial costs, but that isn't the main impetus for facilitating the trial

Company (Location) Product Description Indication Status Date AUTOIMMUNE Genzyme Corp. (Cambridge, Mass.) Aubagio Teriflunomide; once-daily Multiple sclerosis Was approved in Argentina in a 14 mg formulation for patients with relapsing forms 4/9/13 CANCER Celgene Corp. (Summit, N.J.) Revlimid Lenalidomide Transfusion-dependent anemia CHMP adopted a positive opinion for Revlimid 4/29/13 Curis Inc. (Lexington, Mass.) Erivedge Vismodegib Symptomatic metastatic basal cell carcinoma CHMP recommended