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Intended as a conversation starter, the other draft guidance addresses the clinical development of drugs to treat early stages of Alzheimer's disease before the onset of overt dementia...The comment deadline for the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

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.)

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

The infusion of an additional $300 million, however, will "go a long way for us to support the global launch of Iclusig," as well as advancing additional clinical programs, said Maria Cantor, Ariad's senior vice president of corporate affairs...A full readout from the pivotal PACE study was presented at the American Society of Clinical Oncology meeting in June, with data showing that 54 percent of chronic-phase CML patients showed a response, besting what had been reported previously in top-line