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

Funds will be used to advance clinical activity according to its recently disclosed 2013 plan

The company reports having about $19 million in cash after the financing, enough for the first clinical trials for its broad-spectrum anti-influenza drug candidate, FluCide

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

DelMar is working on a cancer drug pipeline, including lead asset VAL-083, which is in clinical trials in refractory glioblastoma multiforme

30, will support clinical trials of KaloBios' Humaneered antibody pipeline, as well as general corporate purposes...Should Sanofi opt in for the CF program, the small biotech would retain co-promotion rights in the U.S. (See BioWorld Today, Jan. 12, 2010.) On its own, KaloBios has two other clinical-stage programs: KB003, a Humaneered recombinant anti-granulocyte macrophage colony-stimulating factor monoclonal antibody in Phase II testing is severe asthma patients inadequately controlled by

The company has an extensive pipeline of products in clinical development, including HyperAcute Pancreas (algenpantucel-L), HyperAcute Lung (tergenpumatucel-L), HyperAcute Melanoma, HyperAcute Renal and others...Total gross proceeds from the offering will be $38.2 million. (See BioWorld Today, Jan. 30, 2013.)

Medivir AB, of Stockholm, Sweden, said it entered a nonexclusive collaboration between Janssen Pharmaceuticals Inc., part of Johnson & Johnson, of New Brunswick, N.J., and Idenix Pharmaceuticals Inc., of Cambridge, Mass., for the clinical development of an all-oral (interferon-free) direct-acting antiviral (DAA) hepatitis C (HCV) combination therapy...Repros Therapeutics Inc., of The Woodlands, Texas, provided a revised date for expected clinical results from the first pivotal trial, ZA-301, of

Bone Therapeutics will also move an allogeneic version of the product into a clinical trial in patients with delayed union fractures later this year...If the clinical data are good, it will be able to marshal strong pharmacoeconomic arguments...KAHR will receive NIS4.95 million to assist in developing its SCP (signal converter proteins) platform technology that enables the creation of protein-based drugs with two active sites.

Data were presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in San Francisco

Anthera's Phase IIb study, PEARL-SC, missed its primary efficacy endpoint of clinical improvement at 24 weeks in the Systemic Lupus Erythematosus Responder Index...The primary efficacy endpoint will be clinical improvement in the Systemic Lupus Erythematosus Responder Index (SRI-8...Net proceeds are expected to support general corporate purposes, including working capital, R&D, clinical trials and capital expenditures

Thus, "Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling" is specifically for use in exploratory and observational studies that are intended to generate genomic hypotheses that will be tested in later confirmatory trials...identifying the basis for pharmacokinetic outliers and intersubject variability in clinical response

Sirtex Medical Ltd., of New South Wales, Australia, reported results from an analysis of 548 patients in a clinical study testing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres microspheres in patients with metastatic colorectal cancer...Those data were presented at the American Society of Clinical Oncology's 2013 Gastrointestinal Cancers Symposium in San Francisco

Tasimelteon-treated patients maintained their clinical benefits while placebo-treated patients showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep

NIH Clinical Trial News...The trial will test multiple doses of cyclodextrin in nine patients to identify a safe dose for a Phase II multicenter trial.

Gross proceeds totaled about $34.1 million and will be used for general corporate purposes, including clinical trial, preclinical and other R&D expenses, capital expenditures, working capital and general and administrative costs...Citigroup and Leerink Swann acted as joint book-running managers, while Baird acted as co-lead manager. (See BioWorld Today, Jan. 22, 2013.)

Ampio plans to start enrolling in a 450-patient clinical trial this quarter...Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013...Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said it received approval for clinical studies from Chinese regulators to test Benapenem, a carbapenem drug in the class of broad-spectrum beta-lactam antibiotics, with a Phase I program set to start in the first

Specifically, OS showed somewhat greater in the control arm than in the tivozanib arm. (See BioWorld Today, Jan. 4, 2012, and Aug. 6, 2012.) The OS glitch is "something that we have addressed with the FDA," Johnston said, and AVEO will be presenting more OS data at the American Society of Clinical Oncology's Genitourinary Cancers Symposium in Orlando, Fla., next month, along with some data from subpopulations...Clinical Cancer Research included a paper that suggested the compound, ENMD-2076, acts