and reduced preclinical and clinical head-to-head comparability studies...No changes in host cell type will be permitted for glycoproteins – such as darbepoetin alpha (Aranesp, Amgen Inc.), etanercept (Enbrel, Amgen/Pfizer Inc.), epoetin alfa (Epogen/Procrit/Eprex, Amgen/Janssen Pharmaceutica NV) and some interferon products – because glycosylation patterns vary significantly between different host cell types, according to the guidelines

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...Celldex largely eschewed early stage partnerships after it was spurned by

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing dalantercept (ACE-041), an angiogenesis inhibitor designed to target the activin receptor-like kinase pathway, in combination with Inlyta (axitinib, Pfizer Inc.), a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with metastatic renal cell carcinoma...Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of

The trial will assess safety and clinical benefit of various dose levels of cells...Cytos Biotechnology Ltd., of Zurich, Switzerland, said Pfizer Inc., of New York, dosed the first patient in a Phase I trial of Pfizer's anti-IgE vaccine, which is being developed using Cytos' virus-like-particle (VLP) vaccine platform

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.

Iclusig is hitting the market shortly after two other CML drugs – Pfizer Inc.'s Bosulif (bosutinib) and Synribo (omacetaxine mepesuccinate) from Teva Pharmaceuticals Industries Ltd...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 results

The proposed trail is intended to cut through the undergrowth of current clinical trial requirements by allowing for smaller, more targeted studies that wouldn't take as long to complete...Clinical trials represent an aggregate expense of about $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...It's hoped that the results will help guide decisions in the future on whether a drug warrants further clinical

that included a $30 million equity investment and a $50 million synthetic royalty agreement linked to future sales of Meningitec, a vaccine Nuron acquired earlier this month from Pfizer Inc., and its HibTiter vaccine (Haemophilus b conjugate vaccine [diphtheria CRM197 protein conjugate]), in-licensed from Wyeth LLC and subsequently out-licensed in January to Mitsubishi Tanabe Pharma Corp., of Osaka, Japan. (See BioWorld Today, Jan. 13, 2012.) In a second biotech deal on the same day, HC Royalty

delafloxacin showed an 88 percent clinical response rate dosed at 300 mg twice daily, compared to 82 percent for Tygacil (tigecyline, Pfizer Inc

AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...A Phase Ib study of ProHema achieved its primary objective of demonstrating safety and tolerability and established early clinical proof of concept, including trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-vs.-host

The trial is designed to show an overall survival benefit with IMA901 in combination with sunitinib (Sutent, Pfizer Inc.), standard first-line therapy in comparison to sunitinib alone in patients with metastatic and/or locally advanced RCC...Novartis also plans to pursue clinical development in combination with a Raf inhibitor in BRAF mutant melanoma, with regulatory submissions projected on or after 2016

The trial will compare AZD4547 in combination with AstraZeneca's anastrozole (Arimidex) or letrozole (Femara, Novartis AG) to exemestane (Aromasin, Pfizer Inc.) alone...Data showed that those who received the PCSK9-targeting antibody in a 1 ml injection every two weeks in combination with Lipitor (atorvastatin, Pfizer Inc.) achieved a mean reduction of 73 percent in LDL-cholesterol, compared to a mean reduction of 17 percent for patients who switched to atorvastatin alone (p < 0.001) after eight