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PharmaEngine presents PEP02 phase II studies in gastric and pancreatic cancers at ASCO 2011

PharmaEngine, Inc. announced today that two phase II studies of PEP02 (liposome irinotecan) in gastric and pancreatic cancer studies were presented at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) in San Francisco, CA, USA.

25 Jan 2011

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy.

25 Jan 2011

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Based on the preliminary findings from the ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial, Eisai Inc. announced today that the company will not submit marketing authorization applications to regulatory authorities in the United States, the European Union and Japan by the end of the fiscal year (March 31, 2011), as previously planned.

25 Jan 2011

Diamyd Medical to report European Phase III trial results for type 1 diabetes

Diamyd Medical's President and CEO Elisabeth Lindner states in the CEO comments in today's quarterly report that the Company expects to begin reporting the results from the European Phase III trial in type 1 diabetes as planned in late spring 2011.

25 Jan 2011

Promising results from TheraTears Nutrition pilot trial in dry eye patients

Advanced Vision Research, Inc. today announced the publication in the journal Cornea of promising results from a pilot trial of dry eye patients taking TheraTears® Nutrition. The study demonstrated a reduction in dry eye symptoms and an increase in tear volume and tear flow for those patients taking TheraTears® Nutrition, an optimized blend of medical grade essential omega-3 oils, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and flaxseed oil.

25 Jan 2011

Unrealistic optimism appears common in early cancer trials

Can optimism be ethically problematic? Yes, according to a new study, which found unrealistic optimism prevalent among participants in early-phase cancer trials and suggested that it may compromise informed consent.

24 Jan 2011

Furiex's MuDelta for diarrhea-predominant irritable bowel syndrome receives FDA Fast Track designation

Furiex Pharmaceuticals, Inc. today announced that its novel diarrhea-predominant irritable bowel syndrome treatment called MuDelta, now in Phase II clinical trials, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

24 Jan 2011

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

ArQule, Inc. today announced the presentation of Phase 1 results of a clinical trial among patients with metastatic colorectal cancer (CRC) treated with ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, in combination with irinotecan and cetuximab. ARQ 197 is under development by Daiichi Sankyo Co., Ltd. and ArQule.

24 Jan 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced updated Phase 1/2 clinical trial results related to the Company's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San Francisco from January 20-22, 2011.

24 Jan 2011

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Alexza Pharmaceuticals, Inc. announced today that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, has published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato® loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).

24 Jan 2011

Senesco files SNS01-T IND for treatment of multiple myeloma

Senesco Technologies, Inc. today announced that the Company has filed an Investigational New Drug application with the U.S. Food and Drug Administration for Senesco's lead drug candidate SNS01-T for treatment of multiple myeloma.

24 Jan 2011

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

Northwest Biotherapeutics announced today that the Company is resuming enrollment of additional new patients into its ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical trial of DCVax for Glioblastoma multiforme brain cancer.

24 Jan 2011

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Raptor Pharmaceutical Corp., today announced it has completed enrollment in its Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Jan 2011

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

FibroGen, today announced interim results of a phase 1/2 trial of FG-3019, a therapeutic antibody against connective tissue growth factor, in combination with gemcitabine and erlotinib in individuals with unresectable pancreatic cancer.

23 Jan 2011

Immunomedics reports encouraging results from Y-90-labeled clivatuzumab tetraxetan study in pancreatic cancer

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that repeated therapy cycles of its proprietary antibody, clivatuzumab tetraxetan, labeled with yttrium-90 plus low-dose gemcitabine, extended median overall survival.

21 Jan 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California.

21 Jan 2011

Sunshine and Binghamton University enter research agreement for cancer compound

Sunshine Biopharma, Inc. a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has executed an agreement with The Research Foundation of the State University of New York (SUNY), acting for and on behalf of Binghamton University (Binghamton, NY).

21 Jan 2011

Drug Trial News

PharmaEngine presents PEP02 phase II studies in gastric and pancreatic cancers at ASCO 2011

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Diamyd Medical to report European Phase III trial results for type 1 diabetes

Promising results from TheraTears Nutrition pilot trial in dry eye patients

Unrealistic optimism appears common in early cancer trials

Furiex's MuDelta for diarrhea-predominant irritable bowel syndrome receives FDA Fast Track designation

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Senesco files SNS01-T IND for treatment of multiple myeloma

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

SuppreMol completes successful pre-IND meeting with U.S. FDA

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

Immunomedics reports encouraging results from Y-90-labeled clivatuzumab tetraxetan study in pancreatic cancer

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

Sunshine and Binghamton University enter research agreement for cancer compound

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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