The agency also finalized its draft guidance on financial disclosures by clinical investigators...and explains the FDA's review of clinical investigator financial disclosure information.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

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.

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

Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application...The ALS Therapy Development Institute, of Cambridge, Mass., received FDA approval to conduct a clinical trial of TDI-132, or fingolimod (Gilenya, Novartis AG) in amyotrophic lateral sclerosis (ALS...TG Therapeutics Inc., of New York, amended its Phase I/II study of single agent ublituximab to

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.

In a newly released list of what guidances are in the works for this calendar year, the FDA's drug center indicated one guidance will deal with submitting clinical pharmacology data as evidence of biosimilarity...Others deal with subjects such as developing drugs under the Animal Rule, working with multiple endpoints in a clinical trial and developing antimicrobials...And a year ago, the FDA warned that fake Avastin (Genentech Inc.), which contained no bevacizumab, had been shipped to providers. (See

Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Bayer AG, of Leverkusen, Germany, to evaluate the safety of PRT4445, an antidote for Factor Xa inhibitors, in healthy volunteers to have been administered oral anticoagulant Xarelto (rivaroxaban

The trial will assess safety and clinical benefit of various dose levels of cells

Tekmira is due a $5 million payment related to initiation of clinical trials for ALN-VSP in China