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Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.

17 Mar 2010

AstraZeneca's CRESTOR: Health Canada approves new indication

AstraZeneca announced today that Health Canada has approved CRESTOR (rosuvastatin calcium) to reduce the risk of nonfatal myocardial infarction (heart attack), nonfatal stroke, and coronary artery revascularization in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD).

17 Mar 2010

FDA approves Medtronic's MiniMed Paradigm integrated diabetes management system

Medtronic, Inc. today announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time Revel™ System, the next generation of the industry’s only integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software).

17 Mar 2010

ImmunoCellular Therapeutics receives Notice of Allowance covering antibodies targeting pancreatic cancer

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today it received a Notice of Allowance from the United States Patent and Trademark Office covering technology relating to monoclonal antibodies that bind to certain epitopes present on pancreatic cancers. This patent will broaden the Company’s proprietary intellectual property for ICT-109 and ICT-37, two of the Company’s monoclonal antibody product candidates.

17 Mar 2010

ALS TDI, Aestus Therapeutics to test potential small-molecule compounds to stop progression of ALS

The ALS Therapy Development Institute and Aestus Therapeutics, Inc., announced their plans today to test several potential small-molecule compounds to slow or stop the progression of Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig's disease).

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

SBRT improves survival in patients with inoperable non-small cell lung cancer

Highly-focused stereotactic body radiation therapy (SBRT) can eliminate the targeted tumor while avoiding treatment-related illness and may ultimately improve survival for patients with inoperable non-small cell lung cancer, according to early findings of a Radiation Therapy Oncology Group study published in the March 17 cancer-themed issue of the Journal of the American Medical Association.

17 Mar 2010

SBRT may improve survival rates for lung-cancer patients: Study

A radiation therapy that uses multiple radiation beams to target tumors precisely has been shown to eliminate the primary tumor and ultimately may improve survival rates for lung-cancer patients unable to undergo surgery, according to UT Southwestern Medical Center physicians who led a national clinical trial of the treatment.

17 Mar 2010

Research confirms benefits of PET scan in early detection of Alzheimer's disease

Westside Medical Associates of Los Angeles and Westside Medical Imaging (WMI) of Beverly Hills announce the benefit of early positron emission tomography (PET) scanning to identify Alzheimer's in its early more treatable phase.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

New chemotherapy agents improve survival time for patients with metastatic colorectal cancer

New chemotherapy agents appear associated with improvements in survival time for patients with metastatic colorectal cancer but at substantial cost.

17 Mar 2010

Human Genome Sciences announces Phase 2 results of mapatumumab combination therapy for NSCLC

Human Genome Sciences, Inc. today announced the results of its randomized Phase 2 trial of mapatumumab (HGS-ETR1) in combination with the chemotherapy agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC).

17 Mar 2010

Stomach wrap operations more effective than acid suppression tablets in severe acid reflux treatment

Stomach wrap operations may be more effective than acid suppression tablets in the treatment of severe acid reflux, according to a new Cochrane Systematic Review. The study shows a more pronounced improvement in symptoms shortly after surgery than with drug treatment.

17 Mar 2010

Liver cancer: Treatment with intra-arterial yttrium-90 microspheres promising

An interventional radiology treatment-the use of intra-arterial yttrium-90 microspheres for liver cancer (also known as hepatocellular carcinoma)-shows promise in prolonging life for many patients with this devastating condition, according to researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

17 Mar 2010

Clarient's Ovotax test may help improve patients’ response to taxane therapy

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that data from a new study shows that Clarient's Ovotax™ assay may effectively predict which ovarian cancer patients will respond favorably to taxane therapy and could, therefore, be spared the potential side effects of this rigorous and sometimes toxic chemotherapy agent.

17 Mar 2010

Circulating tumor cells could help guide treatment and improve quality of life for cancer patients

One of the most dangerous characteristics of cancer is its ability to metastasize, or spread through the body. For this reason, oncologists have a major need for better tests to detect cells that break away from primary tumors to travel to other parts of the body.

17 Mar 2010

Medical Condition News

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

AstraZeneca's CRESTOR: Health Canada approves new indication

ONGLYZA-metformin combination: FDA accepts NDA for review

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

FDA approves Medtronic's MiniMed Paradigm integrated diabetes management system

ImmunoCellular Therapeutics receives Notice of Allowance covering antibodies targeting pancreatic cancer

ALS TDI, Aestus Therapeutics to test potential small-molecule compounds to stop progression of ALS

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

SBRT improves survival in patients with inoperable non-small cell lung cancer

SBRT may improve survival rates for lung-cancer patients: Study

Research confirms benefits of PET scan in early detection of Alzheimer's disease

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

New chemotherapy agents improve survival time for patients with metastatic colorectal cancer

Human Genome Sciences announces Phase 2 results of mapatumumab combination therapy for NSCLC

Stomach wrap operations more effective than acid suppression tablets in severe acid reflux treatment

Liver cancer: Treatment with intra-arterial yttrium-90 microspheres promising

Clarient's Ovotax test may help improve patients’ response to taxane therapy

Circulating tumor cells could help guide treatment and improve quality of life for cancer patients

Clue's CEO Rhiannon White on the Future of Femtech and PCOS

Freezing Point Osmometry in Life Science Applications

Precision in every drop: Inside Hamilton’s syringe technology

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