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Genentech announces topline results from Phase III trial of Avastin

Genentech, Inc., a wholly owned member of the Roche Group, announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC).

12 Mar 2010

PolyMedix presents data from PMX-30063 defensin-mimetic antibiotic compound Phase 1B study at 8th TSIS

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has presented for the first time to the medical community data from its Phase 1B clinical study with its defensin-mimetic antibiotic compound, PMX-30063.

12 Mar 2010

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Baxter International Inc., in conjunction with DynPort Vaccine Company LLC, a CSC Company, today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data were presented at the International Congress on Infectious Disease (ICID) in Miami, Florida.

From Baxter International Inc. 12 Mar 2010

FDA provides guidance on Restanza clinical program in treatment of CABP

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

11 Mar 2010

Peregrine Pharmaceuticals' third-quarter fiscal 2010 total revenues up 45%

Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and serious viral infections, today announced financial results for the third quarter of fiscal year (FY) 2010 ended January 31, 2010. The company also provided an update on its clinical programs and corporate developments.

From Thermo Fisher Scientific Inc. 11 Mar 2010

Positive results from BioSante Pharmaceuticals' GVAX Leukemia vaccine human clinical study

BioSante Pharmaceuticals, Inc. today announced positive results of a human clinical study that show that its GVAX Leukemia vaccine may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the drug Gleevec (imatinib mesylate).

11 Mar 2010

Evotec completes first-in-human Phase I study of EVT 103 for treatment-resistant depression

Evotec AG today announced two positive aspects that strengthen its integrated product development in treatment-resistant depression in its strategic alliance with Roche.

11 Mar 2010

Clinical research trial of new treatment to restore brain cells damaged by stroke passes safety stage

A clinical research trial of a new treatment to restore brain cells damaged by stroke has passed an important safety stage, according to the UC Irvine neurologist who led the effort.

11 Mar 2010

NeuroSearch's MermaiHD study supports potential Huntington's disease modifying properties of Huntexil

NeuroSearch today announced that further analysis of the data from the MermaiHD study with Huntexil(R) (pridopidine) for the treatment of Huntington's disease supports potential disease modifying properties of the drug.

11 Mar 2010

Lithera announces positive results from Phase IIa clinical study of LIPO-102

Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction.

11 Mar 2010

Positive results from Limerick BioPharma's LIM-0705 Phase 1a trial

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump unwanted or toxic substances away from vulnerable tissues, has announced positive results of a Phase 1a trial for its lead compound, LIM-0705, which has completed its first in man study.

10 Mar 2010

NeoPharm seeks Orphan Drug Designation for IL13-PE38QQR in treatment of IPF

NeoPharm, Inc., announced today that it has filed an orphan drug application with the Office of Orphan Products Development of the United States Food and Drug Administration to have Orphan Drug Designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis.

10 Mar 2010

Affymax initiates Phase 3 clinical testing of Hematide in Japan, receives $5M milestone payment

Affymax, Inc. today announced that it has received a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies’ exclusive global agreement to develop and commercialize Hematide™, Affymax’s investigational drug for the treatment of anemia in chronic renal failure patients. The milestone was achieved with the initiation of Phase 3 clinical testing of Hematide to treat anemia in chronic renal failure patients in Japan.

10 Mar 2010

Idera Pharmaceuticals announces net income of $3.9M for fourth-quarter 2009

Idera Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2009.

10 Mar 2010

Cempra Pharmaceuticals completes Phase 1 clinical trials of CEM-101 macrolide

Cempra Pharmaceuticals today announced the successful completion of Phase 1 clinical trials of its oral formulation of CEM-101, which showed good tolerability in those studies. The company also announced plans to submit an IND to the FDA to begin a Phase 1 study with the company's intravenous formulation of CEM-101 in mid-2010.

10 Mar 2010

AMT initiates dosing in Phase I/II gene therapy clinical trial for hemophilia B

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the first patient has been dosed in the Phase I/II exploratory clinical trial with a gene therapy product for hemophilia B, a seriously debilitating and potentially lethal disease.

10 Mar 2010

Helix BioPharma reports 29.9% increase in total revenues for second-quarter fiscal 2010

Helix BioPharma Corp. today announced financial results for the second quarter ended January 31, 2010.

10 Mar 2010

Diamyd Medical enrolls over 430 children with newly diagnosed type 1 diabetes in global Phase III program

Diamyd Medical announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company’s lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.

10 Mar 2010

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.

10 Mar 2010

Cellectar completes enrollment in (131)I-CLR1404 Phase I dosimetry trial for advanced solid malignancies

Cellectar, Inc., a privately held radiopharmaceutical company that designs and develops products to detect, treat and monitor human cancers, today announced that enrollment for its Phase I dosimetry trial for its lead drug candidate, (131)I-CLR1404 has been completed. Results of this trial will be used to set the starting dose in a follow-on Phase I dose escalation study planned for later this year. Institutions that participated in the trial include City of Hope, Duke University Medical Center, Georgetown University/Lombardi Cancer Center, and Johns Hopkins Hospital.

10 Mar 2010

Drug Trial News

Genentech announces topline results from Phase III trial of Avastin

PolyMedix presents data from PMX-30063 defensin-mimetic antibiotic compound Phase 1B study at 8th TSIS

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

FDA provides guidance on Restanza clinical program in treatment of CABP

Peregrine Pharmaceuticals' third-quarter fiscal 2010 total revenues up 45%

Positive results from BioSante Pharmaceuticals' GVAX Leukemia vaccine human clinical study

Evotec completes first-in-human Phase I study of EVT 103 for treatment-resistant depression

Clinical research trial of new treatment to restore brain cells damaged by stroke passes safety stage

NeuroSearch's MermaiHD study supports potential Huntington's disease modifying properties of Huntexil

Lithera announces positive results from Phase IIa clinical study of LIPO-102

Positive results from Limerick BioPharma's LIM-0705 Phase 1a trial

NeoPharm seeks Orphan Drug Designation for IL13-PE38QQR in treatment of IPF

Affymax initiates Phase 3 clinical testing of Hematide in Japan, receives $5M milestone payment

Idera Pharmaceuticals announces net income of $3.9M for fourth-quarter 2009

Cempra Pharmaceuticals completes Phase 1 clinical trials of CEM-101 macrolide

AMT initiates dosing in Phase I/II gene therapy clinical trial for hemophilia B

Helix BioPharma reports 29.9% increase in total revenues for second-quarter fiscal 2010

Diamyd Medical enrolls over 430 children with newly diagnosed type 1 diabetes in global Phase III program

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

Cellectar completes enrollment in (131)I-CLR1404 Phase I dosimetry trial for advanced solid malignancies

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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