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Idaho Technology Expands Its High Resolution Melting Patent Portfolio

Tue, 29 Sep 2009 21:32:00 0500

SALT LAKE CITY-(Business Wire)-September 29, 2009 - Idaho Technology’s patent portfolio continues to grow as the U.S. Patent and Trademark Office granted the company U.S. Patent No. 7,582,429 relating to methods of performing genetic analysis in the presence of a double-stranded nucleic acid...

AZBio Announces Recipients of 2009 Awards

Tue, 29 Sep 2009 20:57:00 0500

PHOENIX-(Business Wire)-September 29, 2009 - AZBio (Arizona BioIndustry Association) announced the winner of the association's annual awards, which were presented at the 2009 AZBio Awards Dinner, the largest annual gathering of Arizona's bioscience community, on Thursday, September...

Luminex Corporation Hosts Seventh Annual Planet xMAP Europe

Tue, 29 Sep 2009 14:00:00 0500

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it will host Planet xMAP Europe 2009, its annual European multiplexing technology symposium, October 7-8, 2009, at Beurs van Berlage in Amsterdam. The program for...

SFC Fluidics, LLC Receives Funding from US Army for Development of Traumatic Brain Injury Diagnostic Device

Tue, 29 Sep 2009 12:30:00 0500

FAYETTEVILLE, Ark.-(Business Wire)-September 29, 2009 - SFC Fluidics, LLC recently announced it has received a...

Cerus to Present Proposal for INTERCEPT Platelet US Phase III Clinical Trial at November BPAC Meeting

Tue, 29 Sep 2009 12:30:00 0500

CONCORD, Calif.-(Business Wire)-September 29, 2009 - Cerus Corporation (NASDAQ:CERS) announced today that it will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA's Blood Products Advisory...

BSD Medical Corporation Sells Hyperthermia System to University of California, San Francisco Medical Center

Tue, 29 Sep 2009 12:00:00 0500

SALT LAKE CITY-(Business Wire)-September 29, 2009 - BSD Medical Corporation (NASDAQ: BSDM) (Excelsior Medical, one of the...

Merck & Co., Inc. Obtains Exclusive U.S. Marketing Rights for AFLURIA®, Seasonal Influenza Vaccine from CSL Biotherapies

Mon, 28 Sep 2009 12:11:00 0500

WHITEHOUSE STATION, N.J.-(Business Wire)-September 28, 2009 - Merck & Co., Inc. announced today that the Company has entered into an exclusive agreement with CSL Biotherapies, a subsidiary of CSL Limited, to market and distribute AFLURIA^® (Influenza Virus Vaccine), CSL's...

Merck Receives Positive CHMP Opinion for JANUVIA® (sitagliptin) and JANUMET® (sitagliptin/metformin) as Add-On to Insulin in the European Union

Fri, 25 Sep 2009 21:36:00 0500

WHITEHOUSE STATION, N.J.-(Business Wire)-September 25, 2009 - Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for...

Merck Statement About JANUVIA™ (sitagliptin) and JANUMET™ (sitagliptin/metformin)

Fri, 25 Sep 2009 16:37:00 0500

WHITEHOUSE STATION, N.J.-(Business Wire)-September 25, 2009 - Merck & Co., Inc., issued the following statement today in response to the U.S. Food and Drug Administration's (FDA's) update on JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin).

"Merck has thoroughly...

Quintiles and Allergan Announce Co-Promotion for Sanctura XR®

Fri, 25 Sep 2009 13:00:00 0500

RESEARCH TRIANGLE PARK, N.C.-(Business Wire)-September 25, 2009 - Quintiles Transnational Corp. and Allergan, Inc. (NYSE: AGN) today announced an agreement under which Quintiles will co-promote Allergan's SANCTURA XR^® (trospium chloride extended release capsules), an...

EnzymeRx Announces Its IND for Uricase-PEG 20 Becomes Effective

Fri, 25 Sep 2009 12:10:00 0500

PARAMUS, N.J.-(Business Wire)-September 25, 2009 - EnzymeRx, LLC (www.enzymerx.com), a...

Altor BioScience Awarded $3 MM SBIR Bridge Grant by NCI to Advance Clinical Trials for its Targeted Cancer Therapeutic ALT-801

Fri, 25 Sep 2009 12:00:00 0500

MIRAMAR, Fla.-(Business Wire)-September 25, 2009 - Altor BioScience Corporation announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II Bridge Grant by the National Cancer Institute (NCI). The award of $3 MM over three years will help Altor further its...

Allos Therapeutics’ FOLOTYN™ First and Only FDA-Approved Therapy for Relapsed or Refractory Peripheral T-cell Lymphoma

Fri, 25 Sep 2009 11:00:00 0500

WESTMINSTER, Colo.-(Business Wire)-September 25, 2009 - Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN^TM (pralatrexate injection) for use as a single agent for the treatment...

Reverse Medical Corporation Receives FDA IDE Clinical Study Approval for the ReStoreTM Microcatheter

Thu, 24 Sep 2009 22:56:00 0500

IRVINE, Calif.-(Business Wire)-September 24, 2009 - Reverse Medical Corporation announced today that it has received US Food and Drug Administration (FDA) conditional approval to begin a neurothrombectomy IDE study for its ReStore™ Microcatheter at twenty US centers. The study is planned to...

NEVO™ Sirolimus-Eluting Coronary Stent Associated with Significantly Less Chest Pain at Six Months Than Taxus® Liberte® Stent

Thu, 24 Sep 2009 22:00:00 0500

SAN FRANCISCO-(Business Wire)-September 24, 2009 - At six months, patients receiving the NEVO^™ Sirolimus-eluting Coronary Stent reported significantly less chest pain (also known as angina) than those receiving the Taxus^® Liberte^® Stent. Patients also reported...

Priority Health to Cover Seasonal and H1N1 Flu Vaccines

Thu, 24 Sep 2009 15:54:00 0500

GRAND RAPIDS, Mich.-(Business Wire)-September 24, 2009 - Priority Health has announced its coverage of both the seasonal flu and H1N1 flu vaccines. “Preventing the flu through immunization is the best way to keep yourself and your family healthy,” said John Fox, M.D., associate vice president...

Dr. Danny Bluestein Joins MicroMed Science Advisory Board

Thu, 24 Sep 2009 14:05:00 0500

HOUSTON-(Business Wire)-September 24, 2009 - On Sept. 24, MicroMed Cardiovascular (www.micromedcv.com

Genzyme’s Campath Meets Primary Endpoint in Phase 3 Combination Therapy Trial for Chronic Lymphocytic Leukemia

Thu, 24 Sep 2009 12:30:00 0500

CAMBRIDGE, Mass.-(Business Wire)-September 24, 2009 - Genzyme Corporation (Nasdaq: GENZ) announced today...

17th Annual BioPartnering Europe™ and BioPartnering China™ Presents Innovative and Informative Program, Addressing Latest Trends Affecting the Biotech Industry Today

Thu, 24 Sep 2009 12:11:00 0500

LONDON-(Business Wire)-September 24, 2009 - Technology Vision Group (TVG) is pleased to announce details of the program for the 17^th Annual BioPartnering Europe (BPE) and BioPartnering China (BPC) conference in London from 11-14 October 2009, providing four days of networking in...

BSD Medical Corporation Files $50 Million Shelf Registration

Thu, 24 Sep 2009 12:00:00 0500

SALT LAKE CITY-(Business Wire)-September 24, 2009 - BSD Medical Corporation (NASDAQ:BSDM) (Fractional Flow Reserve (FFR) vs. Angiography in

Walgreens to Compound Tamiflu Oral Suspension for Children in Response to Supply Shortage

Wed, 23 Sep 2009 17:55:00 0500

DEERFIELD, Ill.-(Business Wire)-September 23, 2009 - Less than a month after launching the largest flu prevention initiative in the company’s 108-year history, Walgreens (NYSE: WAG)(NASDAQ: WAG) is taking proactive measures to ensure its nearly 7,000 pharmacies can provide the suspension - or...

Genzyme Provides Update on Cerezyme and Fabrazyme Supply

Wed, 23 Sep 2009 12:49:00 0500

CAMBRIDGE, Mass.-(Business Wire)-September 23, 2009 - Genzyme Corporation (NASDAQ: GENZ) today provided an update on its progress to restore supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) for patients worldwide and revised its 2009 revenue guidance for these...

Philips and Celsion Advance Development of ThermoDox® and MR-Guided HIFU

Wed, 23 Sep 2009 12:00:00 0500

ANDOVER, Mass. & COLUMBIA, Md.-(Business Wire)-September 23, 2009 - Royal Philips Electronics (NYSE: PHG; AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that their joint research program to evaluate ThermoDox® in combination with MR-HIFU (Magnetic Resonance guided High...

Lifeline Biotechnologies Updates Pink Sheets

Wed, 23 Sep 2009 12:00:00 0500

RENO, Nev.-(Business Wire)-September 23, 2009 - Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today announced that it is preparing to establish a demonstration site for its First Warning System™ to be located in Reno, Nevada.

Jim Holmes, Lifeline’s CEO, said, “We...

CombinatoRx Stock Trading Halted Today; FDA Advisory Committees Meet to Discuss Exalgo

Wed, 23 Sep 2009 11:05:00 0500

CAMBRIDGE, Mass. & VANCOUVER-(Business Wire)-September 23, 2009 - CombinatoRx, Incorporated (NASDAQ: CRXX) announced that NASDAQ has halted trading in the Company’s common stock today. The U.S. Food and Drug Administration’s (FDA) Anesthetics and Life Support Advisory Committee and its...

Taylor Swift Makes History at Pop Radio

Wed, 23 Sep 2009 00:23:00 0500

NEW YORK-(Business Wire)-September 23, 2009 - Big Machine recording artist Taylor Swift has once again entered the history books, this time as the first artist ever to score two #1 records at Top 40 radio with a country crossover recording. This week the unstoppable country/pop superstar locked...

The Honest Kitchen® Thinks Outside of the Coop

Tue, 22 Sep 2009 19:02:00 0500

SAN DIEGO-(Business Wire)-September 22, 2009 - The Honest Kitchen, makers of all-natural...

Bio-Path Holdings, Inc. Announces Plans to Develop Liposome Tumor Targeting Technology Licensed from The University of Texas M. D. Anderson Cancer Center

Tue, 22 Sep 2009 16:54:00 0500

HOUSTON-(Business Wire)-September 22, 2009 - Bio-Path Holdings, Inc. (OTCBB: BPTH), a publicly traded biotechnology company with drug development operations in Houston, Texas, announced today the Company has executed an exclusive license with The University of Texas M. D. Anderson Cancer Center...

Imaging Diagnostic Systems Sells CTLM System in Malaysia

Tue, 22 Sep 2009 13:40:00 0500

FORT LAUDERDALE, Fla.-(Business Wire)-September 22, 2009 - Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast imaging systems, announced today the sale of another CT Laser Mammography system in Asia. The system, which was sold to and installed at the Katherine...

Physio-Control Receives Market Approval from Health Canada for LIFEPAK® 15 Monitor/Defibrillator

Tue, 22 Sep 2009 13:00:00 0500

REDMOND, Wash.-(Business Wire)-September 22, 2009 - Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today it received approval by Health Canada to market the LIFEPAK 15 monitor/defibrillator within Canada. Official license notification was received on...

BSD Medical Reports News Briefing at Europe’s Largest Cancer Congress: Hyperthermia and Chemotherapy Treatment Prolongs Survival of Sarcoma Cancer Patients

Tue, 22 Sep 2009 12:00:00 0500

SALT LAKE CITY-(Business Wire)-September 22, 2009 - BSD Medical Corporation (NASDAQ:BSDM) reports that significant and “medical practice changing” clinical study results were the subject of a news briefing at Europe’s largest cancer congress, ECCO15 – ESMO34, which is being held September...

Health Research International Expands Services to Include Subscription Databases and Market Models

Tue, 22 Sep 2009 12:00:00 0500

CLEVELAND-(Business Wire)-September 22, 2009 - Health Research International, a leading medical products consulting firm, is pleased to announce the availability of several of its proprietary in-house data resources on a subscription basis. The HRI company database, which includes organized...

CombinatoRx and Neuromed Announce Posting of Briefing Documents for FDA Advisory Committee

Tue, 22 Sep 2009 12:00:00 0500

CAMBRIDGE, Mass. and VANCOUVER, B.C.-(Business Wire)-September 22, 2009 - CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing...

New England IRB Announces Results of FDA Audit

Mon, 21 Sep 2009 20:37:00 0500

WELLESLEY, Mass.-(Business Wire)-September 21, 2009 - New England IRB is pleased to announce that FDA has sent written notification that the results of their audit conducted in November 2008 indicate no significant findings. No further action is required.

In the current...

Mentor Capital, Inc. Completes 2nd Year Audit for OTCBB Move; Reporting $0.16 Per Share in Basic Earnings

Mon, 21 Sep 2009 19:29:00 0500

SAN DIEGO-(Business Wire)-September 21, 2009 - Mentor Capital, Inc. (Pink Sheets:MNTR) completed its FY 2008 audit in preparation for filing a self-registration statement with the SEC and applying to move from the Pink Sheets to begin being quoted on the Over-the-Counter Bulletin Board system...

2.25 MM CYPHER® Sirolimus-eluting Coronary Stent Approved by FDA

Mon, 21 Sep 2009 16:30:00 0500

BRIDGEWATER, N.J.-(Business Wire)-September 21, 2009 - Cordis Corporation, a worldwide leader in the...

Medtronic’s Resolute® Drug-Eluting Stent Maintains Strong, Sustained Efficacy and Safety in Long-Term Follow-up

Mon, 21 Sep 2009 16:00:00 0500

SAN FRANCISCO-(Business Wire)-September 21, 2009 - New clinical data released today at a major meeting of interventional cardiologists show strong and sustained efficacy and safety of the Resolute^® Zotarolimus-Eluting Coronary Stent from Medtronic, Inc. (NYSE: MDT) in long-term...

Cannabis Science Updates Progress For Its Phytocannabinoid Pharmaceutical Products To Help Reduce ARDS-Associated Deaths From Both The Avian And Swine Influenza Infections

Mon, 21 Sep 2009 14:08:00 0500

COLORADO SPRINGS, Colo.-(Business Wire)-September 21, 2009 - Cannabis Science Inc. (NASD OTCBB: CBIS) an emerging pharmaceutical cannabis company, is pleased to report progress for its phytocannabinoid pharmaceutical products to help reduce ARDS-associated deaths from both the Avian and Swine...

Nationwide System to Speed Product Recalls Unveiled by Food Marketing Institute and GS1 US™

Mon, 21 Sep 2009 13:33:00 0500

ARLINGTON, Va.-(Business Wire)-September 21, 2009 - The Food Marketing Institute (FMI) and GS1 US today announced the launch of Rapid Recall Exchange, an online service to enable prompt and accurate information exchange between retailers/wholesalers and suppliers about food and product recalls...

Conceptus Inc., Developer of the Essure Procedure, Recognizes World Contraception Day and Celebrates Continued Leadership

Mon, 21 Sep 2009 13:05:00 0500

MOUNTAIN VIEW, Calif.-(Business Wire)-September 21, 2009 - Conceptus, Inc. (NASDAQ:CPTS), a leader in the design and development of innovative women's healthcare, recognizes September 26^th as World Contraception Day, and shares its mission of raising awareness of contraception by...

Sabril® Now Available in U.S. for Patients with Two Difficult-to-Treat Epilepsies

Mon, 21 Sep 2009 13:00:00 0500

DEERFIELD, Ill.-(Business Wire)-September 21, 2009 - Lundbeck Inc. (“Lundbeck”), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that Sabril^® (vigabatrin) Tablets and Powder for Oral Solution are now available for prescribing in the...

CyDex Pharmaceuticals Extends Agreement with Hovione

Mon, 21 Sep 2009 13:00:00 0500

LENEXA, Kan.-(Business Wire)-September 21, 2009 - CyDex...

PerkinElmer Launches Columbus™ 2.0 High Content Screening Platform for High-Volume Image Data Management and Analysis

Mon, 21 Sep 2009 12:00:00 0500

BOSTON-(Business Wire)-September 21, 2009 - At the High Content Analysis East conference...

Enzo Biochem and National Institutes of Health to Cooperate in Development of Enzo’s Novel Therapeutic Candidate for Treatment of Autoimmune Uveitis

Mon, 21 Sep 2009 11:36:00 0500

NEW YORK-(Business Wire)-September 21, 2009 - Enzo Biochem, Inc. (NYSE: ENZ), announced today that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute, part of the National Institute of Health, to conduct a human clinical trial of...

Data Safety Monitoring Board Recommends Continuation of Celsion’s Phase III ThermoDox® Study for Primary Liver Cancer

Mon, 21 Sep 2009 11:30:00 0500

COLUMBIA, Md.-(Business Wire)-September 21, 2009 - Celsion Corporation (NASDAQ:CLSN) announced today the Data Safety Monitoring Board (“DSMB”) has reviewed the safety data from the first group of patients enrolled in its pivotal ThermoDox® Phase III clinical trial for primary liver cancer...

National Institute of Allergy and Infectious Diseases to Give Update On NIAID-Supported Clinical Trials of 2009 H1N1 Influenza Vaccines in Children Six Months to 17 Years of Age

Mon, 21 Sep 2009 11:00:00 0500

-(Business Wire)-September 21, 2009 - HHS Media Advisory:

Impax Laboratories Confirms Patent Challenge Relating to ORACEA® Delayed-Release Capsules, 40mg

Mon, 21 Sep 2009 11:00:00 0500

HAYWARD, Calif.-(Business Wire)-September 21, 2009 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Galderma Laboratories, L.P. in connection with its ORACEA® (doxycycline) delayed-release capsules, 40 mg.

Impax filed...

Quidel Issues Clarification Regarding Special 510(k) Clearance to Add 2009 H1N1 Influenza A Virus Reactivity Information to the QuickVue Influenza A+B Test Package Insert

Fri, 18 Sep 2009 23:30:00 0500

SAN DIEGO-(Business Wire)-September 18, 2009 - Quidel Corporation (NASDAQ: QDEL), a global leader in point-of-care (POC) rapid diagnostic tests, issues clarification regarding the Special 510(k) clearance for an update to the Company's QuickVue® Influenza A+B test package insert. A news wire...

Hyperion Therapeutics to Present at UBS 2009 Global Life Sciences Conference

Fri, 18 Sep 2009 14:40:00 0500

SOUTH SAN FRANCISCO, Calif.-(Business Wire)-September 18, 2009 - Hyperion Therapeutics, Inc. today announced that Donald Santel, Chief Executive Officer, will present at the UBS 2009 Global Life Sciences Conference on Wednesday September 23, 2009 at 4:30 pm ET. The conference will be held at...

FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE® (bortezomib) for Injection

Fri, 18 Sep 2009 14:18:00 0500

CAMBRIDGE, Mass.-(Business Wire)-September 18, 2009 - Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall...

BSD Medical Corporation Reports FDA Review of BSD-2000 Hyperthermia System Continues

Fri, 18 Sep 2009 14:15:00 0500

SALT LAKE CITY-(Business Wire)-September 18, 2009 - BSD Medical Corporation (NASDAQ: BSDM) (

NCPA: Baucus Health Reform Proposal Includes Pharmacy Provisions That Improve Patient Access

Wed, 16 Sep 2009 19:48:00 0500

ALEXANDRIA, Va.-(Business Wire)-September 16, 2009 - The National Community Pharmacists Association (NCPA) commended Senate Finance Committee Chair Max Baucus (D-MT) for including several critical provisions to help community pharmacies better serve patients in the “America’s Healthy Future...

Internationally Acclaimed Inventor, Dean Kamen, to Receive Prestigious BioMed SA Palmaz Award for Innovation in Healthcare and the Biosciences

Wed, 16 Sep 2009 15:00:00 0500

SAN ANTONIO-(Business Wire)-September 16, 2009 - Internationally renowned inventor, entrepreneur and thought leader, Dean Kamen of Manchester, NH, can add another prestigious award to his resume when he accepts BioMed SA’s NMT Medical, Inc. (NASDAQ: NMTI) announced today that, upon...

Plan B® One-Step Emergency Contraception Now Available At U.S. Pharmacies

Wed, 16 Sep 2009 12:00:00 0500

NORTH WALES, Pa.-(Business Wire)-September 16, 2009 - Teva Women’s Health, Inc. announced...

Celsion’s ThermoDox® Study for RCW Breast Cancer Aired on ABC and CBS Affiliate Stations

Wed, 16 Sep 2009 11:30:00 0500

COLUMBIA, Md.-(Business Wire)-September 16, 2009 - Celsion Corporation (NASDAQ:CLSN) announced today the Company’s DIGNITY clinical trial evaluating the use of ThermoDox® in combination with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer was aired during...

BioClinica™ Acquires Tourtellotte Solutions

Wed, 16 Sep 2009 10:00:00 0500

NEWTOWN, Pa.-(Business Wire)-September 16, 2009 - BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced that it has acquired privately-held Tourtellotte Solutions, Inc. (Tourtellotte), a leader in software and services for the bio-pharmaceutical industry...

Quintiles Debuts at # 50 in InformationWeek 500

Tue, 15 Sep 2009 16:47:00 0500

RESEARCH TRIANGLE PARK, N.C.-(Business Wire)-September 15, 2009 - Quintiles has been ranked in the 2009 InformationWeek 500, the publication’s annual ranking of the nation’s most innovative users of information technology. Quintiles was ranked 50^th in its first time on the...

Acorda Therapeutics Announces Data on Retention Rates and Safety from Two Phase 3 Fampridine-SR Extension Studies

Tue, 15 Sep 2009 11:00:00 0500

HAWTHORNE, N.Y.-(Business Wire)-September 15, 2009 - Data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment...

NCPA Urges CMS to Preserve Patient Access to Durable Medical Equipment by Suspending Looming Pharmacy Accreditation Requirement

Mon, 14 Sep 2009 20:39:00 0500

ALEXANDRIA, Va.-(Business Wire)-September 14, 2009 - The National Community Pharmacists Association (NCPA), has written a letter to Charlene Frizzera, Centers for Medicare and Medicaid Services (CMS) Acting Administrator, urging a suspension of the Medicare Part B Durable Medical Equipment...

STEMCELL Technologies Applauds Feeder-Free Derivation of Human Induced Pluripotent Stem Cells

Mon, 14 Sep 2009 17:26:00 0500

VANCOUVER-(Business Wire)-September 14, 2009 - In a landmark The Wall Street Journal has selected GTC as first runner-up in the “Medicine-Biotech” category of the Journal’s 2009 Technology Innovation Awards. The...

FDA Classifies Voluntary Notification Related to SC Catheters and IsoMed Pump Incompatibility as Class I Recall

Mon, 14 Sep 2009 14:30:00 0500

MINNEAPOLIS-(Business Wire)-September 14, 2009 - Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has classified its letters to physicians related to the incompatibility of its Sutureless Connector (SC) intrathecal catheters with the IsoMed^®

Wright Medical Group, Inc. Announces FDA Clearance for PRO-STIM™ Osteoinductive Bone Graft Substitute

Mon, 14 Sep 2009 12:30:00 0500

ARLINGTON, Tenn.-(Business Wire)-September 14, 2009 - Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, today announced the 510K clearance of PRO-STIM™ Injectable Osteoinductive Bone Graft Substitute. PRO-STIM™ graft is a composite grafting material...

Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease

Mon, 14 Sep 2009 12:00:00 0500

CARMIEL, Israel-(Business Wire)-September 14, 2009 - Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher...

St. Jude Medical Announces FDA Approval of EnSite Velocity Cardiac Mapping System

Mon, 14 Sep 2009 12:00:00 0500

ST. PAUL, Minn.-(Business Wire)-September 14, 2009 - St. Jude Medical, Inc. (NYSE: STJ) today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of its Genzyme Corporation (Nasdaq: GENZ) reported today that...

Weekly Media Briefing on 2009 H1N1 Flu Friday, September 11 at 1:00 p.m. at HHS

Fri, 11 Sep 2009 15:24:00 0500

-(Business Wire)-September 11, 2009 - The Department of Health and Human Services will host the weekly H1N1 press briefing this Friday, September 11, in Washington, D.C. Top scientists and doctors from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA...

Aeolus Pharmaceuticals Submits White Paper to BARDA for Funding of AEOL 10150 as a Countermeasure to Lung Injury Due to Radiation Exposure

Fri, 11 Sep 2009 13:00:00 0500

MISSION VIEJO, Calif.-(Business Wire)-September 11, 2009 - Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today that it has submitted a white paper to the Biomedical Advanced Research and Development Authority (BARDA) in response to Special Instructions Amendment 4 to a Broad Agency...

GenSpera Receives FDA Approval for G-202 Phase I Cancer Trial

Fri, 11 Sep 2009 12:01:00 0500

SAN ANTONIO-(Business Wire)-September 11, 2009 - GenSpera, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to begin a Phase I study with its target activated pro-drug, G-202, for the treatment of cancer.

Xerox Offers Customized Packaging with New Digital Solution; Opens Up Growth Market for Print Providers

Fri, 11 Sep 2009 12:00:00 0500

CHICAGO-(Business Wire)-September 11, 2009 - Think what’s in the package is more important than what’s on it? Not necessarily. As retailers increasingly look for new ways to catch the eyes of consumers, customized packaging is the next wave in marketing and it’s driven by a technology...

Biodel Inc. to Present at Morgan Stanley 2009 Global Healthcare Unplugged Conference on September 14th, 2009

Fri, 11 Sep 2009 11:00:00 0500

DANBURY, Conn.-(Business Wire)-September 11, 2009 - Biodel Inc. (Nasdaq: BIOD) today announced that Dr. Solomon Steiner, Chairman and CEO of Biodel, will present a corporate update at the Morgan Stanley 2009 Global Healthcare Unplugged Conference in New York on Monday, September 14, 2009 at...

QPharma, Inc. Announces Its Specialized Pharmacy, QPharmaRx

Thu, 10 Sep 2009 17:01:00 0500

MORRISTOWN, N.J.-(Business Wire)-September 10, 2009 - QPharma, Inc., the industry leader in regulatory and compliance solutions for the life science industry, announced today the opening of its Specialized Pharmacy, QPharmaRx.

QPharma currently manages fulfillment programs...

Adventist Health System Signs Agreement with Dolbey to Implement Fusion CAC Powered by EMscribe, Computer-Assisted Coding Solution

Thu, 10 Sep 2009 16:44:00 0500

CONCORD, Ohio-(Business Wire)-September 10, 2009 - Dolbey Systems, Inc. and Adventist Health System have signed an agreement to implement Fusion CAC™ Powered by EMscribe™, Dolbey’s computer-assisted coding solution. Dolbey will install Fusion CAC across the Adventist Health System’s 33...

SigmaQuest CEO, Nader Fathi, to Speak on Preparing for the FDA Sentinel Initiative at 2009 SMTA Medical Electronics Symposium

Thu, 10 Sep 2009 12:27:00 0500

SUNNYVALE, Calif.-(Business Wire)-September 10, 2009 - SigmaQuest Inc., the leader of on-demand...

Scarab Genomics and NeoClone Have Entered Into License Agreement for Antibodies Against Shiga Toxin

Thu, 10 Sep 2009 11:42:00 0500

MADISON, Wis.-(Business Wire)-September 10, 2009 - Scarab Genomics, a leader in E coli technology, has entered into a license agreement with NeoClone to market and distribute their proprietary antibodies against Shiga toxin. “We are confident the research and diagnostic markets will...

Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine

Thu, 10 Sep 2009 10:45:00 0500

BERKELEY, Calif.-(Business Wire)-September 10, 2009 - Dynavax Technologies Corporation (Nasdaq:DVAX) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAV^TM Investigational New Drug (IND) application in individuals with...

Real Health Care Reform Requires Safe Food, Says Food Safety Advocate Bill Marler

Wed, 09 Sep 2009 17:32:00 0500

SEATTLE-(Business Wire)-September 9, 2009 - Linda Rivera’s excruciating case of food poisoning ParaPRO, LLC has...

Company Profile for Microline Surgical, Inc.

Fri, 24 Apr 2009 14:40:00 0500

-(Business Wire)-September 8, 2009 - Microline Surgical, Inc.:

Mission

• Offer Minimally Invasive Solutions for the Operating Room to improve patient care

• Be a customer-centric Company which develops and markets medical devices...

A New Audio Interview with Andrew Whelan, CEO of BioElectronics, Inc., is now at SmallCapVoice.com

Tue, 08 Sep 2009 15:00:00 0500

AUSTIN, Texas-(Business Wire)-September 8, 2009 - SmallCapVoice.com, Inc. announced today that a new audio interview with BioElectronics Corp. (Pinksheets:BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices is now available. The interview can be heard at

APCER Pharma Solutions, Inc. President and CEO Suneet Walia Comments on FDA Proposed Mandatory Electronic Safety Reporting Program

Tue, 08 Sep 2009 14:42:00 0500

PRINCETON, N.J.-(Business Wire)-September 8, 2009 - APCER Pharma...

Salix Receives FDA Marketing Approval for METOZOLV™ ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

Tue, 08 Sep 2009 14:00:00 0500

RALEIGH, N.C.-(Business Wire)-September 8, 2009 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for...

Pharmatech Conference in Shanghai Lends Insight to Chinese Firms Looking to Meet New SFDA Regulatory Guidelines

Tue, 08 Sep 2009 13:00:00 0500

HAYWARD, Calif.-(Business Wire)-September 8, 2009 - Pharmatech Associates, consultants to the pharmaceutical, biotech, medical device manufacturing and other regulated life sciences industries is hosting a pair of two-day conferences next week in Shanghai for companies working in...

CytRx Receives FDA Letter Regarding Arimoclomol Phase IIb Clinical Trial for ALS

Tue, 08 Sep 2009 12:30:00 0500

LOS ANGELES-(Business Wire)-September 8, 2009 - CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol...

Thermo Fisher Scientific Wins Food Safety Innovation Award for its Melamine Detection Program in China

Tue, 08 Sep 2009 12:30:00 0500

WALTHAM, Mass.-(Business Wire)-September 8, 2009 - Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has received a Ringier Technology Innovation Award for its role in helping Chinese laboratories quickly develop melamine detection...

FDA Grants Protalix Orphan Drug Designation for prGCD

Tue, 08 Sep 2009 11:30:00 0500

CARMIEL, Israel-(Business Wire)-September 8, 2009 - Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Orphan Products Development has granted orphan drug designation to prGCD, the...

DuraSeal™ Spine Sealant Receives FDA Approval

Tue, 08 Sep 2009 11:00:00 0500

WALTHAM, Mass.-(Business Wire)-September 8, 2009 - Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal™ spine sealant for use in the United States. This is the first product that has...

FDA and BioTrove Collaborate to Evaluate BioTrove’s Novel Genetic Profiling and Pathogen Detection System for Possible Use in Detecting Threats to the Nation’s Blood Supply

Tue, 08 Sep 2009 10:30:00 0500

WOBURN, Mass.-(Business Wire)-September 8, 2009 - BioTrove announced a collaboration with the U.S. Food...

FDA Approves ZEVALIN® Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin’s Lymphoma

Fri, 04 Sep 2009 14:46:00 0500

IRVINE, Calif.-(Business Wire)-September 4, 2009 - Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN^® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S...

Novel Evidence-Based Systemic Lupus Erythematosus (SLE) Responder Index Described in Peer Reviewed Publication as Potentially Significant Advance in Lupus Drug Development

Fri, 04 Sep 2009 11:00:00 0500

ROCKVILLE, Md.-(Business Wire)-September 4, 2009 - Human Genome Sciences, Inc. (NASDAQ:HGSI) today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder...

DDN Exec Orchestrates Local Prescription Drug Collection Effort

Thu, 03 Sep 2009 22:27:00 0500

MENOMONEE FALLS, Wis.-(Business Wire)-September 3, 2009 - In an effort to keep unused prescription drugs out of the hands of pre-teens and teenagers, DDN executive Joe Otto enlisted the support of Menomonee Falls Police Chief Anna Ruzinski, Community Memorial Hospital, and his company. As a...

Luminex Receives 510(K) Clearance for New Cystic Fibrosis Test

Thu, 03 Sep 2009 21:10:00 0500

AUSTIN, Texas-(Business Wire)-September 3, 2009 - Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG^®

Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application

Thu, 03 Sep 2009 20:22:00 0500

NEW YORK-(Business Wire)-September 3, 2009 - Bristol-Myers Squibb Company (NYSE:BMY) announced today...

QPharma, Inc. Offers On-Demand Printing Services

Thu, 03 Sep 2009 15:36:00 0500

MORRISTOWN, N.J.-(Business Wire)-September 3, 2009 - QPharma, Inc., the industry leader in FDA Regulatory and Compliance Solutions, announced today the official release of their On-Demand Printing capabilities. This ordering tool offers QPharma’s pharmaceutical and biotechnology...

MEDICREA PASS® LP Iliac Fixation Receives FDA Clearance

Thu, 03 Sep 2009 13:01:00 0500

LYON, France-(Business Wire)-September 3, 2009 - MEDICREA® (Paris:ALMED) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the PASS® LP Iliac Fixation within the United States. This new Iliac Fixation supplements the PASS® LP range, a ultra...

AHF Challenges Merck’s “Criminal AIDS Drug Pricing” for Isentress

Thu, 03 Sep 2009 12:00:00 0500

WASHINGTON-(Business Wire)-September 3, 2009 - As part of its ongoing campaign to lower drug prices and increase access,

FDA Advisory Committee Recommends Gloucester Pharmaceuticals’ Romidepsin for Approval for Cutaneous T-cell Lymphoma

Wed, 02 Sep 2009 18:28:00 0500

CAMBRIDGE, Mass.-(Business Wire)-September 2, 2009 - Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients...

FDA to Review Supplement Containing Long-Term Survival Data For VELCADE® (bortezomib) For Injection

Wed, 02 Sep 2009 15:44:00 0500

CAMBRIDGE, Mass.-(Business Wire)-September 2, 2009 - Millennium: The Takeda Oncology...

Medtronic Initiates Phase II Hepatitis C Clinical Study ''COPE-HCV'' to Determine Tolerability and Safety of Continuous Interferon Infusion for Patients with HCV

Wed, 02 Sep 2009 15:30:00 0500

MINNEAPOLIS-(Business Wire)-September 2, 2009 - Medtronic, Inc. (NYSE: MDT), today reported the initiation and first enrollments of patients in COPE-HCV (COntinuous Interferon Delivery via the Medtronic

Ikonisys to Present at the Thomas Weisel Partners Healthcare Conference 2009

Wed, 02 Sep 2009 12:05:00 0500

NEW HAVEN, Conn.-(Business Wire)-September 2, 2009 - Ikonisys announced today that Dr. Petros Tsipouras, Chairman and Chief Executive Officer, will present at the Thomas Weisel Partners Healthcare Conference 2009.

Presentation details are as follows:

Genzyme Corporation (Nasdaq: GENZ) announced today that...

TCA Cellular Therapy Presents Adult Stem Cell Findings to European Society of Cardiology Congress

Tue, 01 Sep 2009 15:51:00 0500

BARCELONA, Spain-(Business Wire)-September 1, 2009 - This week TCA Cellular Therapy`s Medical Director The National Council for...

Frozen Culinary Circle™ Fettuccini Alfredo with Chicken Recalled Due to Possible Listeria Contamination

Sat, 29 Aug 2009 21:16:00 0500

MINNEAPOLIS-(Business Wire)-August 29, 2009 - SUPERVALU INC.® (NYSE:SVU) is voluntarily recalling frozen Culinary Circle™ Fettuccini Alfredo with Chicken products because they may have the potential to be contaminated with Listeria monocytogenes. The products are found in the frozen...

FDA Advisory Committee to Discuss Genzyme’s Clolar for Adult AML on September 1

Fri, 28 Aug 2009 16:22:00 0500

CAMBRIDGE, Mass.-(Business Wire)-August 28, 2009 - Genzyme Corporation (Nasdaq: GENZ) announced today that...

Geneuity Releases Biomarker Assays for Early Detection of Kidney Damage

Fri, 28 Aug 2009 15:10:00 0500

MARYVILLE, Tenn.-(Business Wire)-August 28, 2009 - Geneuity Clinical Research Services announces the recent validation and use in clinical trials of two human biomarker assays that play a key role in the early detection of kidney damage.

These quantitative, predictive...

Scientist Calls for Federal Review to Protect Workers in Pharmacies Using Air Pressure-Driven Pill Dispensing Machines

Fri, 28 Aug 2009 12:00:00 0500

OVERLAND PARK, Kan.-(Business Wire)-August 28, 2009 - A leading U.S. aerosol scientist released his analysis, adding further questions about risks posed to workers in pharmacies using air-pressure activated pill dispensing machines. Two machines of this type are presently in use...

Forest Laboratories, Inc. and Nycomed Announce a Conference Call to Review Publication of Daxas® Phase III Clinical Trial Results

Thu, 27 Aug 2009 22:45:00 0500

NEW YORK-(Business Wire)-August 27, 2009 - Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products and Nycomed, a privately owned pharmaceutical company, will host a conference call at 7:15 AM EDT on Friday, August 28, 2009. Dr. Lawrence...

Wellstone Filters Becomes Wellstone Filter Sciences, Inc.

Thu, 27 Aug 2009 14:10:00 0500

CHAPEL HILL, N.C.-(Business Wire)-August 27, 2009 - Wellstone Filters (OTCBB: InnovationRx, a wholly owned subsidiary of

Bard Receives FDA Approval for the LifeStent® Vascular Stent

Tue, 17 Feb 2009 13:30:00 0500

MURRAY HILL, N.J.-(Business Wire)-February 17, 2009 - C. R. Bard, Inc., (NYSE: BCR) today announced that it has received Pre-Market Approval (PMA) from the United States Food and Drug Administration to market the LifeStent^® FlexStar and FlexStar XL Vascular Stent Systems. The...

AVANIR Announces Fiscal 2009 First Quarter Financial Results

Tue, 17 Feb 2009 13:30:00 0500

ALISO VIEJO, Calif.-(Business Wire)-February 17, 2009 - AVANIR Pharmaceuticals (NASDAQ:AVNR) today reported unaudited financial results for the three months ended December 31, 2008.

For the first quarter of fiscal 2009, AVANIR reported a net loss from continuing operations...

Vitrolife: Swemed Sense™ approved by the American Food and Drug Administration

Mon, 16 Feb 2009 13:06:00 0500

STOCKHOLM, Sweden-(Business Wire)-February 16, 2009 - Regulatory News:

Vitrolife (STO:VITR) has received approval from the American Food and Drug Administration, so-called 510(k) clearance, for its new needle for the collection of human oocytes, Swemed Sense™ (patent pending...

Multiple Brands of Trail Mix and Fruit and Nut Trail Mix Recalled as Part of Nationwide Peanut Corporation of America Recall

Sun, 15 Feb 2009 00:24:00 0500

MINNEAPOLIS-(Business Wire)-February 15, 2009 - SUPERVALU INC.® (NYSE:SVU) is voluntarily recalling trail mix and fruit and nut trail mix products sold under the ACME, Albertsons, Jewel, and Shaw’s brands because they may contain peanut products that have the potential to be contaminated...

Teijin Pharma and Takeda Announces ULORIC® (TMX-67, febuxostat) Received FDA Approval for the Chronic Management of Hyperuricemia in Patients with Gout

Sat, 14 Feb 2009 04:19:00 0500

TOKYO & OSAKA, Japan-(Business Wire)-February 14, 2009 - Teijin Pharma Limited (Head office: Chiyoda-ku, Tokyo; President: Osamu Nishikawa, hereafter “Teijin Pharma”) and Takeda Pharmaceutical Company Limited (Head office: Chuo-ku, Osaka; President: Yasuchika Hasegawa, hereafter...

Revolution Tea Selects International Dispensing's Multiserve SafePaks for New Line of Super Premium Iced Teas

Fri, 13 Feb 2009 20:23:00 0500

NEW YORK-(Business Wire)-February 13, 2009 - Revolution Tea, one of the fastest growing premium tea companies in the country, today announced the introduction of a new line of aseptic, super premium iced teas to be introduced at restaurants and restaurant chains nationwide. The teas will be...

VGX Pharmaceuticals Announces Filing of Device Master File Amendment with the FDA for CELLECTRA Device – Intradermal Electroporation (ID-EP)

Fri, 13 Feb 2009 16:20:00 0500

BLUE BELL, Pa.-(Business Wire)-February 13, 2009 - VGX Pharmaceuticals today announced the filing of a Device Master File (MAF) amendment with the U.S. Food and Drug Administration (FDA) for its patented CELLECTRA^® adaptive constant current electroporation device for use with...

U.S. Department of Health and Human Services Offers 30-Second TV Public Service Announcement for Consumers Regarding the Peanut Products Recall

Thu, 12 Feb 2009 22:47:00 0500

U.S. Department of Health and Human Services:

Merck & Co., Inc. Acquires Biologic Manufacturing Capabilities and Developmental Follow-on Biologics Portfolio from Insmed

Thu, 12 Feb 2009 12:00:00 0500

WHITEHOUSE STATION, N.J.-(Business Wire)-February 12, 2009 - Merck & Co., Inc. today announced that it has entered into a definitive agreement with Insmed Inc. (Nasdaq CM: INSM), to purchase Insmed's portfolio of follow-on biologic therapeutic candidates and its commercial manufacturing...

Osiris Reports Positive Two-Year Data on Stem Cell Treatment for Acute Myocardial Infarction

Thu, 12 Feb 2009 11:00:00 0500

COLUMBIA, Md.-(Business Wire)-February 12, 2009 - Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced the final two-year results for the Company's trial evaluating Prochymal^® for the treatment of acute myocardial infarction. Prochymal is a proprietary formulation of adult stem...

Emergent BioSolutions Announces That BioThrax (Anthrax Vaccine Adsorbed) Receives Market Authorization in India

Thu, 12 Feb 2009 06:00:00 0500

ROCKVILLE, Md.-(Business Wire)-February 12, 2009 - Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax^® (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the...

Oscient Pharmaceuticals Restructures Commercial Organization

Wed, 11 Feb 2009 22:25:00 0500

WALTHAM, Mass.-(Business Wire)-February 11, 2009 - Oscient Pharmaceuticals Corporation (NASDAQ: OSCI) today announced a strategic realignment of its commercial organization to more aggressively preserve the Company’s financial resources, while retaining coverage of those physicians with...

NeoPharm Submits Application for a Multicenter, Open-Label, Phase II Study of LE-DT for Castrate Resistant Prostate Cancer

Wed, 11 Feb 2009 21:05:00 0500

LAKE BLUFF, Ill.-(Business Wire)-February 11, 2009 - NeoPharm, Inc. (NASDAQ: NEOL) today announced that it has submitted a Phase II protocol to the FDA for the study of liposome entrapped docetaxel (LE-DT), a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of...

Transoma Medical Receives FDA Marketing Clearance for Sleuth AT™ Implantable Cardiac Monitoring System

Wed, 11 Feb 2009 19:23:00 0500

ST. PAUL, Minn.-(Business Wire)-February 11, 2009 - Transoma Medical, manufacturer of Sleuth, the first wireless, automated implantable cardiac monitoring system has now received FDA marketing clearance on its second-generation product, Sleuth AT™ (Advanced Trending) Cardiac Monitoring...

CLSI Publishes Guideline for Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data

Wed, 11 Feb 2009 17:34:00 0500

WAYNE, Pa.-(Business Wire)-February 11, 2009 - Susceptibility statistical data, consisting of the cumulative and ongoing summary of the patterns of antimicrobial susceptibility of clinically important microorganisms, are important to the practice of medicine.

Clinical and...

ClassOne Orthodontics Announces Revolutionary New Orthodontic Product Line Proven To Dramatically Improve Oral Hygiene: SeLECT Defense™

Wed, 11 Feb 2009 17:10:00 0500

LUBBOCK, Texas-(Business Wire)-February 11, 2009 - A breakthrough new orthodontic product line - SeLECT Defense™ - with implications for improved oral hygiene, has been released by ClassOne Orthodontics to the Texas market, to be followed by a worldwide launch in April.

BioImagene Receives FDA 510(k) Clearance for iScan Digital Pathology Hardware

Wed, 11 Feb 2009 15:46:00 0500

CUPERTINO, Calif.-(Business Wire)-February 11, 2009 - BioImagene, the leading provider of innovative digital...

VasoGenix Pharmaceuticals Selects a Lead CGRP (Calcitonin Gene-Related Peptide) Agonist Analog to Develop as a Heart Failure

Wed, 11 Feb 2009 14:00:00 0500

LENEXA, Kan.-(Business Wire)-February 11, 2009 - VasoGenix Pharmaceuticals Inc. (www.vasogenix.net

Strong Fourth Quarter for Genzyme Concludes Productive Year

Wed, 11 Feb 2009 13:51:00 0500

CAMBRIDGE, Mass.-(Business Wire)-February 11, 2009 - Genzyme Corp. (NASDAQ: GENZ) today announced solid fourth-quarter revenue and earnings growth and provided guidance for 2009 that underscored its positive outlook for the year.

GAAP net income rose to $86.7 million, or $0.31...

UT Southwestern Performs First Local Implant in Deep Brain Stimulation Study for Depression

Wed, 11 Feb 2009 13:00:00 0500

DALLAS-(Business Wire)-February 11, 2009 - UT Southwestern Medical Center neurological surgeons have begun implanting patients as part of a clinical study that is investigating whether deep brain stimulation (DBS) therapy may help people who suffer from major depressive disorder, a severe form of...

Taro Receives FDA Approval for Levetiracetam Oral Solution

Wed, 11 Feb 2009 12:00:00 0500

HAWTHORNE, N.Y.-(Business Wire)-February 11, 2009 - Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for...

Stimulus Package Pushes for More Technology in Hospitals and Clinics

Tue, 10 Feb 2009 21:39:00 0500

-(Business Wire)-February 10, 2009 - The following is a statement from Medsphere Systems Corporation:

WHAT:

Absorption Systems, LP, today announced...

Progenics Selects Subcutaneous Form of PRO 140, a Novel HIV Antibody Therapy, for Further Development

Tue, 10 Feb 2009 13:00:00 0500

MONTREAL & TARRYTOWN, N.Y.-(Business Wire)-February 10, 2009 - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that it has selected for further development the subcutaneous form of PRO 140 for the treatment of HIV infection. The decision follows positive results from a recently...

K2M Receives 510(k) Clearance for Its tifix CAYMAN Plate Systems

Tue, 10 Feb 2009 13:00:00 0500

LEESBURG, Va.-(Business Wire)-February 10, 2009 - K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its...

OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva

Tue, 10 Feb 2009 12:30:00 0500

MELVILLE, N.Y.-(Business Wire)-February 10, 2009 - OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug...

VIVUS Initiates Second Pivotal Phase 3 Trial of Avanafil for Treatment of Erectile Dysfunction

Tue, 10 Feb 2009 12:00:00 0500

MOUNTAIN VIEW, Calif.-(Business Wire)-February 10, 2009 - VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its...

Renowned Bioscience Leaders to Address BIOZONA 2009 Conference

Mon, 09 Feb 2009 17:38:00 0500

PHOENIX-(Business Wire)-February 9, 2009 - Two senior industry leaders — Roger Newton and Christopher Gleeson — will keynote Arizona’s life sciences industry conference www.vai.net), a leader in...

Crospon Appoints Experienced Vice President of Sales for Americas Market

Mon, 09 Feb 2009 14:15:00 0500

GALWAY, Ireland-(Business Wire)-February 9, 2009 - Crospon, a medical device developer based in Galway, Ireland today announced the appointment of Larry Fulton as Vice President of Sales - Americas located at the company’s newly established US operation in Carlsbad, California.

GORE Flow Reversal System Cleared by FDA

Mon, 09 Feb 2009 13:03:00 0500

FLAGSTAFF, Ariz.-(Business Wire)-February 9, 2009 - W. L. Gore & Associates...

Gore Receives FDA Approval for Modification to GORE TAG® Thoracic Endoprosthesis

Mon, 09 Feb 2009 13:03:00 0500

FLAGSTAFF, Ariz.-(Business Wire)-February 9, 2009 - W. L. Gore & Associates...

NVIC Vaccine Risk Report Reveals More Serious Reaction Reports After Gardasil

Mon, 09 Feb 2009 12:30:00 0500

WASHINGTON-(Business Wire)-February 9, 2009 - Comparing serious adverse event reports to the federal Vaccine Adverse Events Reporting System (VAERS) following Gardasil (HPV) and another vaccine for meningococcal (Menactra), the National Vaccine Information Center (Biosense Webster, Inc., a Johnson &...

ATryn® (Antithrombin [Recombinant]) Approved by the FDA

Fri, 06 Feb 2009 17:34:00 0500

GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved ATryn^®(Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum...

Rite Aid Announces Voluntary Recall of Peanut Products

Fri, 06 Feb 2009 15:00:00 0500

CAMP HILL, Pa.-(Business Wire)-February 6, 2009 - Rite Aid is voluntarily recalling two of its products containing peanuts that were sold in many Rite Aid stores. The company has been notified by the manufacturer that these products contain peanuts from Peanut Corporation of America, which is the...

Luminex Corporation Reports Fourth Quarter and Year-End 2008 Results

Thu, 05 Feb 2009 21:01:00 0500

AUSTIN, Texas-(Business Wire)-February 5, 2009 - Luminex Corporation (NASDAQ:LMNX) today announced financial results for the fourth quarter and year ended December 31, 2008. Recent financial and operating highlights include the following:

Net income...

St. Jude Medical Announces U.S. Approval of Industry’s First Connector System Designed to Simplify Implant Process for Cardiac Resynchronization Therapy Devices

Thu, 05 Feb 2009 21:01:00 0500

ST. PAUL, Minn.-(Business Wire)-February 5, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) approval of the industry’s first medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy...

King Pharmaceuticals Offers New Dosage Strengths of AVINZA® to Provide More Treatment Options for People with Chronic Pain

Thu, 05 Feb 2009 13:00:00 0500

BRISTOL, Tenn.-(Business Wire)-February 5, 2009 - King Pharmaceuticals, Inc. (NYSE: KG) today announced the launch of two new FDA-approved dosage strengths for AVINZA^® (morphine sulfate extended-release capsules). The new dosing strengths, 45mg and 75mg, complement the currently...