The agency also finalized its draft guidance on financial disclosures by clinical investigators...and explains the FDA's review of clinical investigator financial disclosure information.

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration

UCB also picked up clinical development and commercialization costs. (See BioWorld Today, May 11, 2006.) In 2009, the companies reported results from a Phase IIb dosing study of the drug showing a 24.9 percent treatment advantage over placebo in systemic lupus erythematosus (SLE) patients...The funding will support the advancement of Blaze's Tumor Paint product candidate, BLZ-100, into clinical development for use in surgery in multiple solid tumor types. (See BioWorld Today, June 11, 2012...Oxygen

The clinical trial is a randomized, double-blind, placebo-controlled parallel group study to evaluate the safety, clinical efficacy and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis...Repros Therapeutics Inc., of The Woodlands, Texas, provided a clinical update of its Androxal Phase III program following receipt of written guidance from the FDA

NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, is conducting four studies in various tumor types, which will "go a long way to helping us figure out" where to put the most resources, Look said...The multitude of clinical trials adds up to a program that "sounds like a heck of a burn requirement...The initial fundings position Cytomedix to execute on its 2013 operational business plan, the company said.

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase II study, titled "Double-Blind, Placebo-Controlled Clinical Trial of EPI-743 in Patients with Cobalamin C Defect

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...Based on those results, the company plans to initiate a repeat-dose clinical study in the third quarter of 2013 to evaluate an intravenous formulation of AT2220 co-administered with Myozyme/Lumizyme...The company is currently enrolling patients

and reduced preclinical and clinical head-to-head comparability studies...Sponsors may change the host cell type for a biosimilar only if they provide data proving that the structure of the biologic is not affected and that the clinical profile will not change...Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.

Jonathan Aschoff, of Brean Capital LLC, noted that his company had previously downgraded Regeneron shares to Hold due to a concern that the mid-2013 clinical data would be a "significant potential negative catalyst...The company reported a net loss of $0.5 million, or $0.03 per share, for 2012, compared to net income of $9.7 million, or $0.49, for 2011.

PROSTVAC and MVA-BN PRO, will be the subject of clinical presentations at the 2013 Genitourinary Cancers Symposium on Feb. 14-16, in Orlando, Fla...Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...The preliminary results from the studies supported the further clinical investigation in patients suffering from advanced prostate cancer, the company said

The data, from the latest pre-specified interim analysis of the study, were presented at the annual American Society of Clinical Oncology Genitourinary Cancers Symposium in Orlando, Fla

actions the FDA can take to mitigate the negative impact a shortage may have on research and clinical trials...Comments are due by March 14.

Among Jounce's scientific co-founders is James Allison, chairman of the department of immunology at the University of Texas MD Anderson Cancer Center, whose research led to the clinical development of Yervoy, which was approved by the FDA in 2011 to treat metastatic melanoma. (See BioWorld Today, March 28, 2011.) Others include Padmanee Sharma, associate professor in the department of genitourinary medical oncology at MD Anderson...The transaction is expected to close on Feb. 19. #kicker123

Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults

As this money is dispensed through its clinical development programs, the company expects to receive £12 million in government R&D tax credits, bringing the total pot to £60 million...The total amount raised in the private placement is $7.9 million.

Intended as a conversation starter, the other draft guidance addresses the clinical development of drugs to treat early stages of Alzheimer's disease before the onset of overt dementia...The comment deadline for the guidance is April 9.

reached the higher end of its ambitions in an issue of stocks and warrants, raising $30 million to provide funding for further clinical development of its Biopump protein drug implant technology...Funds will be used to support clinical trials and for working capital and general corporate purposes. (See BioWorld Today, Feb. 7, 2013...Shares (NASDAQ:IMMY) closed Friday at $4.95, down $3.05, or 38 percent.

The net proceeds will be used for working capital and general corporate purposes, including the continuation of the Abili-T clinical study, Opexa's ongoing Phase IIb trial of Tcelna in secondary progressive multiple sclerosis patients

The company plans to use the funds to advance the clinical development programs for rindopepimut, an immunotherapy targeting epidermal growth factor variant III (EGFRvIII) that is in a registration trial in front-line glioblastoma multiforme (GBM), and CDX-011 (glembatamumab vedotin), a fully human monoclonal antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) that completed a Phase IIb study in breast cancer...The company will receive proceeds of $8 million, which it expects to use to