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Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.

12 Mar 2010

Phase III clinical study: Vimpat demonstrates fewer partial-onset seizures versus placebo in adults with epilepsy

UCB today announced that the antiepileptic drug (AED) Vimpat® (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia.

12 Mar 2010

Pfizer discontinues ADVIGO 1018 trial of figitumumab-erlotinib combination therapy for advanced NSCLC

Pfizer Inc. announced today the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).

12 Mar 2010

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

Neoprobe Corporation, a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®.

12 Mar 2010

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

Drug Trial News

Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Phase III clinical study: Vimpat demonstrates fewer partial-onset seizures versus placebo in adults with epilepsy

Pfizer discontinues ADVIGO 1018 trial of figitumumab-erlotinib combination therapy for advanced NSCLC

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

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

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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