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MannKind receives FDA Complete Response letter for AFREZZA NDA

MannKind Corporation today announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.

15 Mar 2010

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I, its first development-stage antibiotic drug candidate. MRX-I, an orally-administered oxazolidinone, targets multi-drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

15 Mar 2010

Enzo Biochem to market MultiGEN’s multiplex DNA sequencing based diagnostic tests in state of New York

Enzo Biochem, Inc. today announced that it has entered into an agreement with MultiGEN Diagnostics Inc., of San Diego, California, for exclusive rights to market MultiGEN’s unique diagnostic tests based on multiplex DNA sequencing, in the state of New York. In addition, Enzo has been granted marketing rights for other non-exclusive territories in United States.

15 Mar 2010

St. Jude Medical announces updates to PressureWire platform at ACC and SIR annual meetings

St. Jude Medical, Inc., a global medical device company, announced several updates to its PressureWire™ platform, including a new marketing agreement with Siemens Medical Solutions USA, for the wireless PressureWire™ Aeris and the availability of the next-generation of PressureWire™ Certus technology, at the American College of Cardiology and the Society of Interventional Radiology annual meetings.

15 Mar 2010

Clinical trial results from MASCOT Trial evaluating AngioSculpt PTA Scoring Balloon Catheter announced

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today favorable clinical trial results from the MASCOT Trial, an important study evaluating the AngioSculpt® PTA Scoring Balloon Catheter for the treatment of femoro-popliteal PAD (peripheral artery disease).

15 Mar 2010

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc., a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products.

15 Mar 2010

St. Jude Medical to exhibit cardiac clinical solution products portfolio at ACC 2010

St. Jude Medical, Inc. today announced it will display products and technologies from the company’s wide array of clinical solutions in the cardiology, cardiac surgery, atrial fibrillation and cardiac rhythm management markets at ACC 2010.

12 Mar 2010

$Stryker's Orthopaedics Division releases three new plating systems for bone fracture repair$

Stryker's Orthopaedics Division releases three new plating systems for bone fracture repair

Stryker Corporation's Orthopaedics Division today announced the release of three new plating systems: the VariAx Elbow Locking Plate System, the VariAx Fibula Locking Plate System and the AxSOS Extremity Plating System, which are all designed to expand the range of treatment options for bone fracture repair.

From Stryker 12 Mar 2010

TGen, Virginia G. Piper Cancer Center and Side-Out Foundation team up for breast cancer study

Many women live with breast cancer that does not respond to standard medical treatment, a condition that researchers at the Virginia G. Piper Cancer Center at Scottsdale Healthcare want to change by aggressively targeting specific genes.

12 Mar 2010

Microchip Biotechnologies renamed as IntegenX

Microchip Biotechnologies, a maker of automated microscale biotech laboratory systems, today announced that it has changed its business name to IntegenX. The new name articulates the company's focus on integrating sample preparation and analysis technologies into complete products that address generic problems shared by life science and biotechnology research laboratories worldwide.

12 Mar 2010

Genomatix systems utilized to analyze cis and epigenetic elements that control reproductive events

The C.S. Mott Center for Human Growth and Development, Department of Obstetrics and Gynecology, at the Wayne State University School of Medicine, in collaboration with the Center for Molecular Medicine and Genetics, the Karmanos Cancer Institute and the Institute for Environmental Health Sciences, installed a Genomatix Mining Station and a Genomatix Genome Analyzer last year at their labs in Detroit, MI in order to support the analysis of Next Generation Sequencing (NGS) data.

11 Mar 2010

Cellectis’ 1485475 European patent: EPO confirms revocation of previously granted claims

Precision BioSciences, Inc., today announced that the Opposition Division of the European Patent Office has issued a written decision confirming its November 18, 2009 revocation of the previously granted claims of Cellectis’ European Patent No. 1 485 475.

11 Mar 2010

Scientists identify specific causative genetic mutation associated with CMT

Scientists using advanced genomic analysis technologies from Life Technologies Corporation have sequenced an individual’s genome and identified the specific causative mutation associated with Charcot-Marie-Tooth Disease (CMT), one of the most common inherited neurological disorders currently affecting 1 in 2,500 individuals in the United States.

11 Mar 2010

RTI Biologics launches BTB Select and BioCAP Select implants for use in sports medicine surgeries at AAOS 2010

RTI Biologics Inc., the Florida-based processor of orthopedic, dental, surgical specialties and other biologic implants, is launching two new biologic implants for use in sports medicine surgeries at the American Academy of Orthopaedic Surgeons annual meeting in New Orleans this week.

11 Mar 2010

Nabi Biopharmaceuticals closes exclusive option and license agreement for NicVAX with GSK

Nabi Biopharmaceuticals announced today that the closing requirements set forth in the exclusive option and license agreement for NicVAX® (Nicotine Conjugate Vaccine), dated November 13, 2009 with GlaxoSmithKlineBiologicals S.A. have been met and the companies have closed the agreement.

11 Mar 2010

Eureka Genomics announces closing of $3.7M private financing round

Eureka Genomics today announced the closing of a $3.7 million private financing round whose participants included private individuals and undisclosed angel investors. The proceeds will further discovery research aimed at identifying novel microorganisms associated with specific cancers and other important diseases, as well as help grow Eureka Genomics’ high-throughput sequencing and bioinformatics service business on a global basis.

11 Mar 2010

Accelr8 Technology to present results of culture-free, quantitative pathogen identification study at 110th ASM

Accelr8 Technology Corporation today announced that it has received acceptance to present results for a study on 2-hour, culture-free, quantitative pathogen identification. The study was co-authored with principal investigators at the Denver Health Medical Center and the Barnes-Jewish Hospital in St. Louis.

10 Mar 2010

ZixCorp renewes and expandes contract with Wake Forest University Baptist Medical Center

Zix Corporation, the only email encryption service designed with your most important relationships in mind, has renewed and expanded its contract with Wake Forest University Baptist Medical Center, a leading North Carolina health system.

10 Mar 2010

TGen deploys Isilon IQ to power multiple genome sequencing devices to discover new treatments for diseases

Isilon® Systems today announced that The Translational Genomics Research Institute has deployed Isilon scale-out NAS as the primary storage solution powering its next-generation biomedical research. By using Isilon IQ to power multiple genome sequencing devices, TGen has unified its mission-critical operations onto a single, high-performance, highly scalable shared pool of storage, increasing workflow productivity and reducing costs to accelerate the discovery of new treatments for life-threatening diseases.

10 Mar 2010

FDA approves Abbott's TECNIS Multifocal 1-Piece intraocular lens for cataract patients

Abbott announced today it has received U.S. Food and Drug Administration approval for the TECNIS® Multifocal 1-Piece intraocular lens (IOL) for cataract patients with and without presbyopia.

10 Mar 2010

Next Generation News and Research

MannKind receives FDA Complete Response letter for AFREZZA NDA

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

Enzo Biochem to market MultiGEN’s multiplex DNA sequencing based diagnostic tests in state of New York

St. Jude Medical announces updates to PressureWire platform at ACC and SIR annual meetings

Clinical trial results from MASCOT Trial evaluating AngioSculpt PTA Scoring Balloon Catheter announced

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

St. Jude Medical to exhibit cardiac clinical solution products portfolio at ACC 2010

Stryker's Orthopaedics Division releases three new plating systems for bone fracture repair

TGen, Virginia G. Piper Cancer Center and Side-Out Foundation team up for breast cancer study

Microchip Biotechnologies renamed as IntegenX

Genomatix systems utilized to analyze cis and epigenetic elements that control reproductive events

Cellectis’ 1485475 European patent: EPO confirms revocation of previously granted claims

Scientists identify specific causative genetic mutation associated with CMT

RTI Biologics launches BTB Select and BioCAP Select implants for use in sports medicine surgeries at AAOS 2010

Nabi Biopharmaceuticals closes exclusive option and license agreement for NicVAX with GSK

Eureka Genomics announces closing of $3.7M private financing round

Accelr8 Technology to present results of culture-free, quantitative pathogen identification study at 110th ASM

ZixCorp renewes and expandes contract with Wake Forest University Baptist Medical Center

TGen deploys Isilon IQ to power multiple genome sequencing devices to discover new treatments for diseases

FDA approves Abbott's TECNIS Multifocal 1-Piece intraocular lens for cataract patients

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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