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ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

14 Jul 2010

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

Fredericksburg Oncology is now accepting patients for a new clinical trial supported by the National Cancer Institute (NCI) to evaluate treatment for metastatic (advanced stage) melanoma. The current trial, designed at the Mayo Clinic, combines chemotherapy with targeted molecular agents in an effort to improve control of this difficult disease, reports Dr. Frederick C. Tucker, Jr., who heads this practice.

13 Jul 2010

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

A new Australian drug has been shown to assist in protecting patients with a rare genetic disorder that makes their skin toxic to light and UV, and previously forced them to live in the shadows.

13 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™: Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

13 Jul 2010

EntreMed announces publication of preclinical data for ENMD-2076

EntreMed, Inc., today announced the publication of preclinical data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor, which demonstrated significant activity against multiple myeloma cell lines and in MM models in vivo. Results of the study, conducted by EntreMed's collaborator, Sherif Farag, M.D., Ph.D., and colleagues at the Indiana University School of Medicine, were published in the on-line version of the British Journal of Haematology on June 15, 2010 and are scheduled to be published in print in the August 1, 2010 issue.

13 Jul 2010

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

BioSante Pharmaceuticals, Inc. today announced the initiation of a LibiGel (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.

13 Jul 2010

AlphaRx reports positive preclinical results of GAI-122 injectable nanoemulsion for Acute Ischemic Stroke

AlphaRx, Inc. announced positive preclinical results of GAI-122 injectable nanoemulsion, a Mitochondria-targeted neuroprotective drug candidate being developed for the treatment of Acute Ischemic Stroke. The results will be delivered as a podium presentation during the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon July 10 - 14, 2010.

13 Jul 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).

13 Jul 2010

BioSpecifics' partner Auxilium provides update on XIAFLEX

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its strategic partner Auxilium Pharmaceuticals, Inc. has provided an update on XIAFLEX, its injectable collagenase product currently marketed in the U.S. for the treatment of Dupuytren's contracture.

13 Jul 2010

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Hemispherx Biopharma, Inc., announced that it has received a report, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease, that summarizes the results of a three year Japanese government funded program to develop and test a nasally delivered H5N1 (Avian Flu) vaccine which, when coupled with Ampligen®, an experimental therapeutic, provided a robust and long lasting immune response to the vaccine.

12 Jul 2010

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

12 Jul 2010

Reata funds second pivotal trial of bardoxolone with $78 million equity financing

Reata Pharmaceuticals, Inc. has completed a $78 million equity financing led by existing investors CPMG, Inc. and Novo A/S. This financing brings the total raised by the Company to $180 million since inception.

12 Jul 2010

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

12 Jul 2010

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Drug Trial News

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

EntreMed announces publication of preclinical data for ENMD-2076

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

AlphaRx reports positive preclinical results of GAI-122 injectable nanoemulsion for Acute Ischemic Stroke

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

BioSpecifics' partner Auxilium provides update on XIAFLEX

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Reata funds second pivotal trial of bardoxolone with $78 million equity financing

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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