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

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.

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