The paper described the technology for producing highly pure populations of GMP-grade neuronal cells suitable for preclinical studies and clinical trials

and KAHR Medical Ltd. (portfolio companies of Hadasit Bio-Holdings Ltd.; Jerusalem) Israeli Ministry of Industry and Commerce, Office of the Chief Scientist NIS10.7 ($2.8) Grant To support product development and advance their clinical trials programs 1/29/13 Savant HWP Inc. (San Carlos, Calif.) National Institute on Drug Abuse $6.5 Three-year grant To support the development of 18-MC as a potential orally active treatment for drug addiction, obesity and other forms of compulsive behavior 1/4/13

India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong...policy, guidelines and standard operating procedures" for clinical trials and how they relate to approvals, as well as for banning drugs and regulating fixed-dose combinations

Pelus and his team intend to start a clinical trial "very soon" that adds an NSAID to the drug regimen that is used for bone marrow transplant

Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment into clinical trials...They're open to looking at the biomarkers that companies test in these clinical trials and having an open mind" about which might demonstrate an effect, she observed

Transdel raised $13 million in capital to fund clinical trials in order to get FDA approval for the topical formulation of ketaprofen

clinical trials conducted by its sponsor, Philadelphia-based Hemispherx Bioscience Inc

The funding allows Mesoblast to significantly broaden its clinical trial program

Cell Medica is expanding operations after raising $26.5 million in July 2012 in a mixture of public and private funding, including a grant from the Cancer Prevention and Research Institute of Texas, under which it is setting up a manufacturing facility and will run a clinical trial of Cytorex EBV, a cancer immunotherapy developed at Baylor College of Medicine in Houston. (See BioWorld International, July 25, 2012.) Cell Medica licensed rights to Cytorex EBV from Baylor at the beginning of 2011

Astellas exercised its right to terminate the program as part of the worldwide license agreement inked with Ambit in 2009. (See BioWorld Today, Dec. 21, 2009.) Over the next six months, the companies will work together to transfer management of ongoing clinical trials and their governing investigational new drug applications to Ambit, which will then regain all rights to the quizartinib clinical trial and development program

Proceeds will be used to fund clinical trials of IMO-8400, an agonist of Toll-like receptors 7, 8 and 9, which is in development for autoimmune and inflammatory diseases, as well as for working capital and other general corporate purposes

The funding allows Mesoblast to significantly broaden its clinical trial program

At issue is the London-based EMA's commitment to almost complete disclosure of the clinical trial data submitted to it by drug developers seeking regulatory approval of their products...Advisory groups dealing with the protection of patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice and legal aspects of the new regime are due to report by April 30, and the EMA is due to publish a draft policy for public comment by June 30

At issue is the London-based EMA's commitment to almost complete disclosure of the clinical trial data submitted to it by drug developers seeking regulatory approval of their products...Advisory groups dealing with the protection of patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice and legal aspects of the new regime are due to report by April 30, and the EMA is due to publish a draft policy for public comment by June 30

Inc., of Whitehouse Station, N.J., said researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive (extended-release niacin/laropiprant) during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco...Findings were presented during the late-breaking clinical trial session

POPE was tested in a clinical trial to assure the FDA's Study Endpoints and Label Development division that verbal responses of patients to physician questions following treatment would accurately reflect their clinical response to the drug

Company (Location) Product Description Indication Status Date CANCER Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Zaltrap Ziv-aflibercept Metastatic colorectal cancer European Commission granted marketing authorization in the European Union 2/6/13 Seattle Genetics Inc. (Bothell, Wash.) Adcetris Brentuximab vedotin Hodgkin lymphoma and systemic anaplastic large cell lymphoma Health Canada approved it for HL after failure of autologous stem cell transplant or failure of

Company (Location) Product Description Indication Status Date CANCER ArQule Inc. (Woburn, Mass.) and Daiichi Sankyo Co. Ltd. (Tokyo) ARQ197 Tivantinib Hepatocellular carcinoma Enrolled their first patient in a pivotal Phase III trial 2/1/13 AVEO Pharmaceuticals Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Showed overall survival trends favoring the comparator drug Nexavar (sorafenib) at 29.3 months, compared with 28.8