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Industry game changers to watch in healthcare IT

Whatever the outcome of healthcare reform, this much is clear: Information technology will play a critical role in the improvement and delivery of patient outcomes. So, will government contractors — they already are. So, who’s in the lead?

17 Mar 2010

Unigene Laboratories enters into amended and restated financing agreement

Unigene Laboratories, Inc. (http://www.unigene.com) today announced that it has entered into an amended and restated financing agreement for $33 million three-year convertible senior secured term notes.

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

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Hospitals can save more than $1M annually by implementing Masimo Patient SafetyNet with SET pulse oximetry

Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new cost-effectiveness study shows that implementation of the Masimo Patient SafetyNet remote monitoring and clinician notification system with Masimo SET pulse oximetry saved one hospital $817,000 in its first year.

17 Mar 2010

MiddleBrook Pharmaceuticals, DoctorDirectory.com enter into agreement to expand IncreaseRx promotion program

MiddleBrook Pharmaceuticals, Inc. today announced that it has entered into an agreement with DoctorDirectory.com Inc., the Company’s promotion partner for MOXATAG (amoxicillin extended-release) Tablets, 775 mg, to expand its previously announced IncreaseRx® promotion program.

17 Mar 2010

Synergetics launches fully disposable instrument line for retinal surgery

Synergetics USA, Inc., a medical device company that designs, manufactures, and markets innovative microsurgical instruments for ophthalmic and neurosurgical applications, today announced the launch of its newest fully disposable line of hand-held instruments for retinal surgery, Pinnacle 360oTM. The launch occurred at Vail Vitrectomy 2010, a surgical meeting held on March 13 - 17, 2010.

17 Mar 2010

ICID provides online planning tools to help non-profit organizations develop pandemic flu plans

On the heels of the recent H1N1 pandemic, the International Centre for Infectious Diseases is providing online planning tools to help non-profit organizations develop pandemic flu plans. It is urging vigilance against future waves of the virus, and advises organizations to take action now to plan for events that could threaten the delivery of service to their clients.

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

HST Global announces final negotiations to obtain needed capital to acquire first wellness center

HST Global, Inc., today announced that it is in final negotiations to obtain the needed capital to complete the acquisition of its first wellness center. This infusion of cash will allow HST to complete the wellness center acquisition and provide operating capital.

17 Mar 2010

HDC, SPM enter into development and licensing agreements with Quest Diagnostics

Health Discovery Corporation and Smart Personalized Medicine, LLC announced today that they have entered into development and related licensing agreements with Quest Diagnostics Incorporated, the world’s leading provider of diagnostic testing, information and services.

From Quest Diagnostics 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

Use of simulation technology in Florida's nursing education programs expanding

A recent report from the Florida Center for Nursing found that pre-licensure nursing education programs turned away more than 13,000 qualified applicants during 2008-2009, and, for the third year in a row, limited access to clinical training sites was reported as a major barrier for nursing education programs in Florida.

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

CDISC approves Nextrials as one of 15 registered solutions providers

Nextrials, Inc., a leader in clinical research software and services, has been approved by the Clinical Data Interchange Standards Consortium as one of 15 registered solutions providers, and is the only company offering an electronic data capture (EDC) product supporting the CDISC Healthcare Link Initiative.

17 Mar 2010

CNS Network purchases Logos Technologies' pro-active EDC system for streamlining clinical trials

It is announced today that CNS Network has purchased ALPHADAS®, Logos Technologies Inc’s early phase, e-source data capture system and site automation tools to accelerate and streamline its clinical trials. ALPHADAS is to be implemented in their Orange County Research Center, California, USA.

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

Somanetics first-quarter 2010 net revenues up 18%

Somanetics Corporation reported net revenues of $13.1 million for the first quarter ended February 28, 2010, an 18 percent increase from $11.2 million in the same period of 2009.

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

Medical News

Industry game changers to watch in healthcare IT

Unigene Laboratories enters into amended and restated financing agreement

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

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

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

Hospitals can save more than $1M annually by implementing Masimo Patient SafetyNet with SET pulse oximetry

MiddleBrook Pharmaceuticals, DoctorDirectory.com enter into agreement to expand IncreaseRx promotion program

Synergetics launches fully disposable instrument line for retinal surgery

ICID provides online planning tools to help non-profit organizations develop pandemic flu plans

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

HST Global announces final negotiations to obtain needed capital to acquire first wellness center

HDC, SPM enter into development and licensing agreements with Quest Diagnostics

FDA approves Medtronic's MiniMed Paradigm integrated diabetes management system

Use of simulation technology in Florida's nursing education programs expanding

ImmunoCellular Therapeutics receives Notice of Allowance covering antibodies targeting pancreatic cancer

CDISC approves Nextrials as one of 15 registered solutions providers

CNS Network purchases Logos Technologies' pro-active EDC system for streamlining clinical trials

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

Somanetics first-quarter 2010 net revenues up 18%

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

Exploring electron microscopy for plant and microbial imaging at the John Innes Centre

Extending the reach of Amperia™

Modular cleanrooms: Enhancing flexibility and compliance

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