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Anadys begins dosing in ANA598 Phase IIb study for hepatitis C

Anadys Pharmaceuticals, announced today that dosing has begun in the Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin in hepatitis C patients.

26 Jan 2011

FDA grants BioSante Orphan Drug designation for Melanoma Cancer Vaccine

BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for its Melanoma Cancer Vaccine in the treatment of stage IIb to IV melanoma, from the FDA's Office of Orphan Products Development. Melanoma is the most deadly form of skin cancer.

25 Jan 2011

Emergent BioSolutions initiates TRU-016 Phase Ib/II study for chronic lymphocytic leukemia

Emergent BioSolutions Inc. today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

25 Jan 2011

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

Cutting edge, patient-specific vaccine treatments like DCVax® provide for a longer life expectancy along with a better quality of life for brain cancer patients, an improvement over current conventional brain tumor treatments. "The vaccine that I received has extended the median survival of Grade IV brain cancer (GBM) from 14.6 months, with conventional treatment, to over 36 months," stated Bob Gibbs, a 7 year brain cancer survivor, who has defied the odds statistically, thanks to the experimental brain cancer vaccine DCVax®.

25 Jan 2011

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

Diamyd completed screening for US Phase III study in type 1 diabetes. The screening of patients for the US Phase III study, DiaPrevent, was completed, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age had, at the completion of screening, been enrolled in the study and received their first injection of the antigen-based therapy Diamyd® or placebo.

25 Jan 2011

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

Drug Trial News

Anadys begins dosing in ANA598 Phase IIb study for hepatitis C

FDA grants BioSante Orphan Drug designation for Melanoma Cancer Vaccine

Emergent BioSolutions initiates TRU-016 Phase Ib/II study for chronic lymphocytic leukemia

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

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

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

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