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Maimonides, Navidea to evaluate Lymphoseek use in lymphatic mapping for colorectal cancer

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced it has entered into an agreement to collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek (technetium Tc 99m tilmanocept) Injection in lymphatic mapping procedures for colorectal cancer.

5 Feb 2013

Synageva announces 12-week data from sebelipase alfa Phase I/II study on LAL Deficiency

Synageva BioPharma Corp. (Synageva), a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, today announced publication of the 12-week Phase I/II extension study data of sebelipase alfa in adults with lysosomal acid lipase deficiency (LAL Deficiency) in the online version and an upcoming print edition of Hepatology

5 Feb 2013

BrainStorm initiates NurOwn Phase IIa dose-escalating trial in ALS

BrainStorm Cell Therapeutics, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the first patient began treatment in the Company's Phase IIa dose-escalating clinical trial for ALS.

5 Feb 2013

Topline results from Gilead’s FISSION and NEUTRINO Phase 3 studies on HCV infection

Gilead Sciences today announced topline results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic hepatitis C virus (HCV) infection.

5 Feb 2013

Two new studies examine causes, treatment of severe malnutrition

"Two studies of malnourished children offer the first major new scientific findings in a decade about the causes and treatment of severe malnutrition, which affects more than 20 million children around the world and contributes to the deaths of more than a million a year," the New York Times reports.

2 Feb 2013

Researchers await clinical trial results of potential TB vaccine, expected early next week

"After nearly 100 years, researchers could be on the verge of finding a vaccine that would eradicate tuberculosis [TB] infections," Reuters reports, noting, "Global health experts are eagerly awaiting clinical trial results, expected early next week, of the first new vaccine in 90 years designed to prevent tuberculosis infections."

2 Feb 2013

Two-step personalized immunotherapy safe for patients with ovarian cancer

Most ovarian cancer patients are diagnosed with late stage disease that is unresponsive to existing therapies. In a new study, researchers from the Perelman School of Medicine at the University of Pennsylvania School of Medicine show that a two-step personalized immunotherapy treatment - a dendritic cell vaccine using patients' own tumor followed by adoptive T cell therapy - triggers anti-tumor immune responses in these type of patients.

1 Feb 2013

Study examines effects of partial dose of polio vaccine on immune response

"A partial dose of polio vaccine was as good as a full one in providing a basic level of immunity against the crippling disease, according to a study that may offer poor countries a cheap, effective way of ensuring the disease doesn't return after it's eradicated in an area," Bloomberg reports.

1 Feb 2013

Galectin submits GR-MD-02 IND application with FDA for treatment of liver fibrosis

Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013.

1 Feb 2013

ArQule, Daiichi Sankyo initiate enrollment in tivantinib Phase 3 trial for hepatocellular carcinoma

Daiichi Sankyo Company, Limited and ArQule, Inc. today announced that the first patient has been enrolled in the pivotal Phase 3 METIV-HCC (MET-high patients with tivantinib in HCC) trial of tivantinib (ARQ 197).

31 Jan 2013

Celsion's ThermoDox does not meet primary endpoint in Phase III HCC study

Celsion Corporation, a leading oncology drug development company, today announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

31 Jan 2013

Top-line results from Vanda's tasimelteon Phase IIb/III study on major depressive disorder

Vanda Pharmaceuticals Inc. today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD.

31 Jan 2013

Cerulean initiates CRLX101 Phase 2 study in extensive-stage small cell lung cancer

Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a randomized Phase 2 study of its lead candidate, CRLX101, in patients with extensive-stage small cell lung cancer (SCLC) sensitive to first-line platinum-based chemotherapy.

31 Jan 2013

Positive results from PaxVax's Ad4-H5-Vtn vector vaccine Phase 1 trial on avian flu

PaxVax, Inc., which develops and commercializes innovative vaccines against infectious diseases in a socially responsible manner, today announced positive results in a Phase 1 clinical trial for its oral, replicating adenovirus serotype 4 (Ad4) vector vaccine for H5N1 (avian flu).

31 Jan 2013

Cerebrolysin: a promising new treatment for dementia

Dementia patients may benefit from a promising new treatment called Cerebrolysin, according to the results of a systematic review published in The Cochrane Library. The authors brought together the most up-to-date evidence on Cerebrolysin as a treatment for vascular dementia.

31 Jan 2013

Teva terminates collaboration with CureTech

Teva Pharmaceutical Industries Ltd. announced today the termination of its collaboration with CureTech Ltd.

31 Jan 2013

OncoEthix initiates OTX015 Phase I study in hematologic malignancies

OncoEthix, the Swiss-based specialist in oncology drug development, announces progress in its Phase I study of OTX015, a novel BET bromodomain inhibitor, with the first dosing of a patient.

31 Jan 2013

No added benefit from linagliptin in patients with type 2 diabetes

Linagliptin has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies.

31 Jan 2013

DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Cell Therapeutics, Inc. (CTI) today announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis.

31 Jan 2013

Genentech announces positive results from GA101 plus chlorambucil Phase III study on CLL

Genentech, a member of the Roche Group, today announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL).

31 Jan 2013

Drug Trial News

Maimonides, Navidea to evaluate Lymphoseek use in lymphatic mapping for colorectal cancer

Synageva announces 12-week data from sebelipase alfa Phase I/II study on LAL Deficiency

BrainStorm initiates NurOwn Phase IIa dose-escalating trial in ALS

Topline results from Gilead’s FISSION and NEUTRINO Phase 3 studies on HCV infection

Two new studies examine causes, treatment of severe malnutrition

Researchers await clinical trial results of potential TB vaccine, expected early next week

Two-step personalized immunotherapy safe for patients with ovarian cancer

Study examines effects of partial dose of polio vaccine on immune response

Galectin submits GR-MD-02 IND application with FDA for treatment of liver fibrosis

ArQule, Daiichi Sankyo initiate enrollment in tivantinib Phase 3 trial for hepatocellular carcinoma

Celsion's ThermoDox does not meet primary endpoint in Phase III HCC study

Top-line results from Vanda's tasimelteon Phase IIb/III study on major depressive disorder

Cerulean initiates CRLX101 Phase 2 study in extensive-stage small cell lung cancer

Positive results from PaxVax's Ad4-H5-Vtn vector vaccine Phase 1 trial on avian flu

Cerebrolysin: a promising new treatment for dementia

Teva terminates collaboration with CureTech

OncoEthix initiates OTX015 Phase I study in hematologic malignancies

No added benefit from linagliptin in patients with type 2 diabetes

DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Genentech announces positive results from GA101 plus chlorambucil Phase III study on CLL

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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