The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland

clinical trial planning and execution of trials guided by Merck Serono's strategy The deal spans five years 5/16/13 NextBio (Santa Clara, Calif.) Sanofi SA (Paris) ND Multiyear collaboration aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi's drug R&D Terms were not disclosed 5/1/13 ScinoPharm Taiwan Ltd. (Tainan, Taiwan) Coland Holdings Ltd. (Hong Kong) ND Strategic alliance to develop a series of generic oncological drugs for mainland China ScinoPharm

Getting Fresh Eggs For non-patient specific stem cells currently in clinical trials, getting source cells is a one-time issue...Clinical trials involving personalized cellular therapies are closely supervised by the FDA, because while small-molecule drugs are static, destined to have a certain efficacy and safety profile, cellular therapies intrinsically vary between patients – and that variation is magnified by having not just a different patient each time, but a different egg donor for each

That realization – and the fact that dozens of drug hopefuls have failed in clinical trials – has prompted a search for new ways to fight sepsis. (See BioWorld Today, Jan. 3, 2012, Aug. 15, 2012, and Aug. 27, 2012.) Labeta and his team have turned their attention on the TLR system, but not in the typical way of targeting one class of TLRs

Based on early findings, Oncos was launched in 2008 to take the technology into conventional clinical trials and seek a commercial path forward

ACT is currently enrolling patients in three clinical trials in the U.S

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