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Micromet outlines the design of registration study for blinatumomab in ALL

At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.

11 Feb 2010

MUHC commences clinical trial of Exsulin for type 1 diabetes

A clinical trial of Exsulin, an innovative new treatment that targets the underlying cause of type 1 diabetes, has begun at the McGill University Health Centre (MUHC). Under the direction of Dr. George Tsoukas of the MUHC and the McGill University Faculty of Medicine, the study will assess the effectiveness of Exsulin.

11 Feb 2010

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

QRxPharma Limited announced today initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.

11 Feb 2010

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

Raptor Pharmaceutical Corp., today announced the presentation of cystinosis data at the Annual Lysosomal Disease Network WORLD Symposium 2010, being held February 10-12 in Miami, Florida. Biomarker data from a Phase IIb pilot study of Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") will be the subject of a poster titled, "Correlation of Plasma Cysteamine and WBC Cystine Levels at Steady State in Patients Treated with Cysteamine Bitartrate." The results will also be published in an upcoming issue of the journal Molecular Genetics and Metabolism.

10 Feb 2010

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

10 Feb 2010

Genzyme and Isis Pharmaceuticals: Phase 3 mipomersen study in heFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.

10 Feb 2010

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13.

10 Feb 2010

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

10 Feb 2010

QR Pharma commences clinical trial of Posiphen in early stage AD patients

QR Pharma, Inc. , a developer of novel drugs to treat Alzheimer’s disease, announced today that it began a clinical trial of its lead compound, Posiphen, in early stage AD patients.

10 Feb 2010

Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects. Takeda has been evaluating all published data and communications from the U.S. Food and Drug Administration (FDA) regarding the potential risks associated with concomitant use of clopidogrel and PPIs.

10 Feb 2010

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

Neogenix Oncology, Inc. (Neogenix) announced today that the Johns Hopkins Hospital has initiated a Phase I trial with the company’s first therapeutic antibody, NPC-1C, in patients with late stage pancreatic or colorectal cancer.

10 Feb 2010

TI commences Phase IIa clinical trial for its lead molecule in CDH

Trigemina, Inc. (TI), a Mountain View based startup, has begun a Phase IIa clinical trial for its lead molecule in Chronic Daily Headache (CDH) in collaboration with Dr. Egilius Spierings at MedVadis Research Corporation located outside of Boston.

10 Feb 2010

Palatin Technologies completes first cohort dosing in bremelanotide trial for sexual dysfunction

Palatin Technologies, Inc. today announced the completion of first cohort dosing in a placebo-controlled, multiple dose study of bremelanotide, its experimental treatment for sexual dysfunction. The primary endpoint in this double-blind safety study is evaluation of blood pressure effects of subcutaneous bremelanotide in men between 45 and 65 years old. The study will also evaluate consistency of plasma exposure of bremelanotide given as repeated subcutaneous injections.

10 Feb 2010

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.

10 Feb 2010

FDA expands indication for Crestor

On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

10 Feb 2010

Thrombogenics announces publication of positive microplasmin Phase II trial results

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that the positive microplasmin Phase II trial results, evaluating the product's efficacy and safety in patients who require vitrectomy, have been published in the prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the leading journal for the vitreoretinal community.

9 Feb 2010

USPTO awards NexBio patent covering sialidase pharmaceutical compositions and methods of treating influenza

NexBio, Inc. today announced the issuance by the United States Patent and Trademark Office of United States Patent No. 7,645,448 entitled "Class of Therapeutic Protein Based Molecules". This patent covers NexBio's sialidase pharmaceutical compositions, including its lead compound DAS181 (Fludase®), and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions.

9 Feb 2010

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today announced the signature of an exclusive licence agreement with Novartis for the development, manufacture and commercialisation of Debio 025 (alisporivir), a selective, first-in-class cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C virus (HCV) effect. The product is currently in phase 2b clinical development for the treatment of hepatitis C. Debiopharm granted Novartis worldwide commercialisation rights to Debio 025 except for Japan.

9 Feb 2010

Resverlogix completes Phase 2 ASSERT trial enrollment 5 months ahead of schedule

Resverlogix Corp. announced today the completion of patient enrollment in the Phase 2 clinical study of its lead drug RVX-208. "The completion of enrollment for our Phase 2 ASSERT trial, a full 5 months ahead of our original schedule, is a very exciting achievement for our staff and our collaborators at the Cleveland Clinic.

9 Feb 2010

Drug Trial News

Micromet outlines the design of registration study for blinatumomab in ALL

MUHC commences clinical trial of Exsulin for type 1 diabetes

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Genzyme and Isis Pharmaceuticals: Phase 3 mipomersen study in heFH patients meets primary endpoint

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

QR Pharma commences clinical trial of Posiphen in early stage AD patients

Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

TI commences Phase IIa clinical trial for its lead molecule in CDH

Palatin Technologies completes first cohort dosing in bremelanotide trial for sexual dysfunction

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

FDA expands indication for Crestor

Thrombogenics announces publication of positive microplasmin Phase II trial results

USPTO awards NexBio patent covering sialidase pharmaceutical compositions and methods of treating influenza

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

Resverlogix completes Phase 2 ASSERT trial enrollment 5 months ahead of schedule

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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