FDA Newswire

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1 - Idaho Technology Expands Its High Resolution Melting Patent Portfolio

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...

2 - AZBio Announces Recipients of 2009 Awards

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 24th at the...

3 - Luminex Corporation Hosts Seventh Annual Planet xMAP Europe

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 Planet xMAP Europe 2009...

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

FAYETTEVILLE, Ark.-(Business Wire)-September 29, 2009 - SFC Fluidics, LLC recently announced it has received a contract for approximately $5 million from the Congressionally Directed Medical Research Program for development of a handheld device for rapid diagnosis of traumatic brain injury (TBI...

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

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...

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

SALT LAKE CITY-(Business Wire)-September 29, 2009 - BSD Medical Corporation (NASDAQ: BSDM) (www.BSDMedical.com) announced today that the University of California, San Francisco Medical Center (UCSF) has acquired a BSD-500 Hyperthermia System (BSD-500). UCSF is a world leader in hyperthermia and...

7 - Computable Genomix Announces Contest For Genomics Researchers

MEMPHIS, Tenn.-(Business Wire)-September 29, 2009 - Memphis-based Computable Genomix today announced it will launch a contest on Oct. 1, 2009, to coincide with the release of GeneIndexer, the company’s next-generation Web-based text-mining tool. Publish or Perish will award a $10,000 grant to each...

8 - pSivida Reports Safety and Efficacy Results from 18-Month Interim Readout of Human PK Iluvien® Study

WATERTOWN, Mass.-(Business Wire)-September 29, 2009 - pSivida Corp (NASDAQ: PSDV)(ASX: PVA), a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today...

9 - Spectranetics Submits 510(k) Application to Food and Drug Administration Seeking Clearance for the Treatment of In-Stent Restenosis in the Legs

COLORADO SPRINGS, Colo.-(Business Wire)-September 29, 2009 - Spectranetics Corporation (Nasdaq: SPNC) today announced that it has filed a 510(k) application with the Food and Drug Administration seeking clearance for the treatment of in-stent restenosis (ISR) in the legs with its commercially...

10 - Repros Therapeutics Inc. Provides Update on Proellex

THE WOODLANDS, Texas-(Business Wire)-September 29, 2009 - Repros Therapeutics (NasdaqGM:RPRX) today announced that the Company has received further clarification from the Food and Drug Administration (FDA) on the Full Clinical Hold status of Proellex. As announced in early August 2009, and after...

11 - Maxygen Announces Management Changes

REDWOOD CITY, Calif.-(Business Wire)-September 28, 2009 - Maxygen, Inc. (Nasdaq:MAXY) announced today that James Sulat, who currently serves as a director of the company, has been appointed to serve as Maxygen’s Chief Executive Officer, effective October 1, 2009. Mr. Sulat will replace Russell...

12 - Biomagnetics Diagnostics Receives a Financing Commitment up to $1 Million to Speed Development of Malaria Testing Technology

GENEVA-(Business Wire)-September 28, 2009 - Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a producer of revolutionary diagnostic systems and technology for malaria, tuberculosis, HIV and hepatitis testing today announced it has received a equity-based financing commitment up to $1 million...

13 - Excelsior Medical Launches SwabCap to Disinfect Catheter Luer Access Valves

NEPTUNE, N.J.-(Business Wire)-September 28, 2009 - Excelsior Medical, one of the leading manufacturers of pre-filled catheter flush syringes and syringe pump systems, announced that it has launched a major new product: the SwabCap™ Luer Access Valve Disinfection Cap. SwabCap™ is a simple...

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

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 seasonal influenza...

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

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 JANUVIA...

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

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 reviewed the safety data...

17 - Quintiles and Allergan Announce Co-Promotion for Sanctura XR®

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 anticholinergic approved for...

18 - EnzymeRx Announces Its IND for Uricase-PEG 20 Becomes Effective

PARAMUS, N.J.-(Business Wire)-September 25, 2009 - EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, today announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become...

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

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...

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

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 FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients...

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

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...

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

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 improvements in their overall...

23 - Priority Health to Cover Seasonal and H1N1 Flu Vaccines

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 of...

24 - Dr. Danny Bluestein Joins MicroMed Science Advisory Board

HOUSTON-(Business Wire)-September 24, 2009 - On Sept. 24, MicroMed Cardiovascular (www.micromedcv.com) announced that Danny Bluestein, PhD, Professor of Bioengineering at SUNY-Stony Brook, has joined the Science Advisory Board (SAB) to provide industry expertise and guidance for the HeartAssist 5...

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

CAMBRIDGE, Mass.-(Business Wire)-September 24, 2009 - Genzyme Corporation (Nasdaq: GENZ) announced today that its randomized Phase 3 clinical trial investigating Campath® (alemtuzumab) in combination with Fludara® (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL...

26 - 17th Annual BioPartnering Europe™ and BioPartnering China™ Presents Innovative and Informative Program, Addressing Latest Trends Affecting the Biotech Industry Today

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

27 - BSD Medical Corporation Files $50 Million Shelf Registration

SALT LAKE CITY-(Business Wire)-September 24, 2009 - BSD Medical Corporation (NASDAQ:BSDM) (www.BSDMedical.com) today announced the filing of a shelf registration statement on Form S-3 with the Securities and Exchange Commission. The shelf registration statement, when declared effective by the...

28 - FDA Advisory Committee Hears Presentations and Public Comment on EXALGO Extended-Release Tablets

CAMBRIDGE, Mass. & VANCOUVER-(Business Wire)-September 23, 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) in a joint meeting of its Anesthetics and...

29 - FDA Advisory Committee Hears Presentations and Public Comment on EXALGO Extended-Release Tablets

ST. LOUIS-(Business Wire)-September 23, 2009 - Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation...

30 - FAME Trial Two-Year Follow-Up Results Demonstrate Continued Reduction in Risk of Death or Heart Attack When Physicians Use St. Jude Medical Fractional Flow Reserve Technology Prior to Implanting Coronary Stents

ST. PAUL, Minn.-(Business Wire)-September 23, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced that the two-year results from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial demonstrated the durability of the improved outcomes noted at...

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

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...

32 - Genzyme Provides Update on Cerezyme and Fabrazyme Supply

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...

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

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...

34 - Lifeline Biotechnologies Updates Pink Sheets

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 have filed the...

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

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...

36 - Taylor Swift Makes History at Pop Radio

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 down...

37 - The Honest Kitchen® Thinks Outside of the Coop

SAN DIEGO-(Business Wire)-September 22, 2009 - The Honest Kitchen, makers of all-natural, human-grade pet products, today announced that the company will transition all of its chicken-based dehydrated raw pet foods to 100 percent sustainably-farmed, free-range chicken this fall. The chicken will...

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

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 to...

39 - Imaging Diagnostic Systems Sells CTLM System in Malaysia

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 Women’s...

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

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...

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

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 20...

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

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...

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

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...

44 - New England IRB Announces Results of FDA Audit

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 climate of increased...

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

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. The...

46 - 2.25 MM CYPHER® Sirolimus-eluting Coronary Stent Approved by FDA

BRIDGEWATER, N.J.-(Business Wire)-September 21, 2009 - Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a new, smaller version of the...

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

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 patient follow-up...

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

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...

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

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...

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

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 26th as World Contraception Day, and shares its mission of raising awareness of contraception by improving education...

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

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 United States. In...

52 - CyDex Pharmaceuticals Extends Agreement with Hovione

LENEXA, Kan.-(Business Wire)-September 21, 2009 - CyDex Pharmaceuticals, Inc. today announced the extension of its relationship with Hovione SA as the company’s exclusive supplier of Captisol® for an additional five years. “The extension of our relationship with Hovione through 2019 provides...

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

BOSTON-(Business Wire)-September 21, 2009 - At the High Content Analysis East conference in Boston, PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, today announced the launch of the Columbus™ 2.0 platform, its flagship high content...

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

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 Optiquel...

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

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...

56 - 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

-(Business Wire)-September 21, 2009 - HHS Media Advisory: WHAT: Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, will give an update on NIAID-supported clinical trials of 2009 H1N1 influenza vaccines in children six months to 17 years of age.   Jesse...

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

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 its Abbreviated New Drug...

58 - 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

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 agency...

59 - Hyperion Therapeutics to Present at UBS 2009 Global Life Sciences Conference

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 the...

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

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...

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

SALT LAKE CITY-(Business Wire)-September 18, 2009 - BSD Medical Corporation (NASDAQ: BSDM) (www.bsdmedical.com) reported today that the U.S. Food and Drug Administration (FDA) continues its review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s...

62 - Pancreatic and Colorectal Cancer Novel Antibody Developed from a Vaccine to Begin Phase I Trial

GREAT NECK, N.Y.-(Business Wire)-September 17, 2009 - Neogenix Oncology, Inc. (Neogenix) announced today that NPC-1C, the company’s first IND (Investigational New Drug Application) was granted permission by the Food and Drug Administration (FDA) for the company to begin a Phase I trial. NPC-1C...

63 - New Program Offers Community Pharmacies an Expanded Role in Diabetes Self-Management Training, Increases Access and Treatment Options for Patients

ALEXANDRIA, Va.-(Business Wire)-September 17, 2009 - The National Community Pharmacists Association (NCPA) and the American Association of Diabetes Educators (AADE) today announced a partnership that will expand counseling options for patients while offering community pharmacies a path to be...

64 - Hythiam Raises Approximately $7 Million in Registered Direct Offering

LOS ANGELES-(Business Wire)-September 17, 2009 - Hythiam, Inc. (NASDAQ:HYTM) announced today that it has entered into definitive agreements to sell 9,333,334 shares of its common stock at a price per share of $.75 to institutional investors pursuant to a registered direct offering, representing...

65 - Medifocus, Inc. Files Response to its Investigational Device Exemption (IDE) With the Food and Drug Administration (FDA) in the United States for its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer

VANCOUVER-(Business Wire)-September 17, 2009 - Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has filed a comprehensive response to its IDE application with the FDA in the United States to obtain clearance to initiate a pivotal phase III clinical trial using the Company’s Microfocus APA...

66 - Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Hepatic Encephalopathy

SOUTH SAN FRANCISCO, Calif.-(Business Wire)-September 17, 2009 - Hyperion Therapeutics, Inc. today announced that its investigational product HPN-100 (glycerol phenylbutyrate) has received orphan product designation from the U.S. Food and Drug Administration for intermittent or chronic treatment...

67 - APP Pharmaceuticals Receives Approval for Deferoxamine Mesylate for Injection, USP

SCHAUMBURG, Ill.-(Business Wire)-September 17, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate...

68 - Bioheart Inc. Announces Positive Results in the MARVEL Phase II/III Clinical Trial

SUNRISE, Fla.-(Business Wire)-September 16, 2009 - Bioheart, Inc. (OTCBB:BHRT), presented positive efficacy data from part 1 of its Phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston, Massachusetts. Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine...

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

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...

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

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 Julio Palmaz Award for Innovation in Healthcare and the Biosciences. BioMed...

71 - NMT Medical to Accelerate CLOSURE I Data Analysis Timing

BOSTON-(Business Wire)-September 16, 2009 - NMT Medical, Inc. (NASDAQ: NMTI) announced today that, upon recommendation of the CLOSURE I Executive Committee, it will commence data analysis for its landmark patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial...

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

NORTH WALES, Pa.-(Business Wire)-September 16, 2009 - Teva Women’s Health, Inc. announced today that its Plan B® One-Step (levonorgestrel) tablet, 1.5 mg emergency contraceptive is now available at licensed U.S. retail pharmacies. Approved by the U.S. Food and Drug Administration (FDA) on July...

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

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 commercial...

74 - BioClinica™ Acquires Tourtellotte Solutions

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...

75 - Quintiles Debuts at # 50 in InformationWeek 500

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 50th in its first time on the list. This distinction...

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

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 time...

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

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...

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

VANCOUVER-(Business Wire)-September 14, 2009 - In a landmark paper, researchers at Stanford University have described a new way to derive human induced pluripotent stem cells (iPSCs) without the use of contaminating mouse feeder cells. Using adipose cells as the starting cell population and...

79 - GTC Biotherapeutics Named in Annual Wall Street Journal Technology Innovation Awards

FRAMINGHAM, Mass.-(Business Wire)-September 14, 2009 - GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) today announced that 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 Journal cited...

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

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® constant-flow...

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

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 that...

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

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 disease...

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

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 EnSite Velocity™ Cardiac Mapping System. This new system has been designed to help physicians more efficiently diagnose...

84 - Celsion and the American Liver Foundation Partner to Promote Awareness of Primary Liver Cancer and the ThermoDox® Phase III Global HEAT Study to Patients and Physicians

COLUMBIA, Md. & NEW YORK-(Business Wire)-September 14, 2009 - Celsion Corporation (NASDAQ:CLSN) and the American Liver Foundation (ALF) announced today that they have formed a partnership to provide education to physicians and liver patients about the treatment options for hepatocellular...

85 - FDA and EMEA Grant Orphan Drug Designation for Antisense Pharma's Investigational Drug Trabedersen in Pancreatic Carcinoma

REGENSBURG, Germany-(Business Wire)-September 14, 2009 - The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received orphan drug designation from both the European Medicines Agency EMEA and the US Food and Drug Administration FDA for its investigational drug...

86 - Genzyme’s Alemtuzumab for Multiple Sclerosis Shows Durable Treatment Benefit in Review of Four-Year Phase 2 Trial Data

CAMBRIDGE, Mass.-(Business Wire)-September 11, 2009 - Genzyme Corporation (Nasdaq: GENZ) reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years...

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

-(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) and...

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

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...

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

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. GenSpera’s...

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

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 solution...

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

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 4:30...

92 - QPharma, Inc. Announces Its Specialized Pharmacy, QPharmaRx

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 for numerous clients...

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

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...

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

SUNNYVALE, Calif.-(Business Wire)-September 10, 2009 - SigmaQuest Inc., the leader of on-demand, scalable solutions for product quality management, today announced that company CEO, Nader Fathi will be giving a presentation titled, “Preparing Today for the FDA Sentinel Initiative: Tracking the...

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

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 welcome access...

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

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 HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney...

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

SEATTLE-(Business Wire)-September 9, 2009 - Linda Rivera’s excruciating case of food poisoning (Severe Case Gives Context to Issue of Food Safety Washington Post 9/1/09) should shine some light on a crucial reality that is missing from most health care reform plans: you can’t fix America’s...

98 - Cempra Pharmaceuticals Initiates Phase 2/3 Clinical Study for an Oral Antibiotic to Treat Acute Bacterial Skin Structure Infections

CHAPEL HILL, N.C.-(Business Wire)-September 9, 2009 - Cempra Pharmaceuticals today announced that enrollment is underway in an adaptive design Phase 2/3 clinical study with CEM-102 for patients suffering from acute bacterial skin structure infections (ABSSI). CEM-102 is an oral antibiotic with an...

99 - CBR Pharma Insights: New Report – Lifecycle Management Strategies - Key Tools to Maximize Return on Investment in a Tough Healthcare Environment (CBRSV007)

MONROE TOWNSHIP, N.J.-(Business Wire)-September 9, 2009 - Pharmaceutical companies continuing to face the challenges of declining R&D productivity and rising costs, while trying to negotiate an increasingly risk averse and cost constrained healthcare marketplace, need to focus on improving their...

100 - Leading U.S. Epilepsy Organizations Unite on H1N1 Virus “Swine Flu” Public Health Recommendations for Children with Epilepsy

WEST HARTFORD, Conn. & CHICAGO & WASHINGTON & MIDDLEBURG, Va. & BOSTON & NEW YORK-(Business Wire)-September 9, 2009 - AES, CURE, Epilepsy Foundation, Epilepsy Therapy Project and FACES today announced their support for increased public awareness of H1N1 Virus (“Swine Flu...

101 - St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease

ST. PAUL, Minn.-(Business Wire)-September 9, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced CE (Conformité Européenne) Mark approval of the Brio™ neurostimulator, the world’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of...

102 - ParaPRO Launches MyHeadLiceTreatment.com – A Comprehensive Head Lice Web Portal

CARMEL, Ind.-(Business Wire)-September 9, 2009 - Just in time for peak head lice season, ParaPRO, LLC has launched MyHeadLiceTreatment.com, a free, engaging and comprehensive “one-stop shop” about head lice. Treating head lice can be an issue. The U.S. Centers for Disease Control and...

103 - Company Profile for Microline Surgical, Inc.

-(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 that uniquely provide value to the healthcare community, both...

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

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...

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

PRINCETON, N.J.-(Business Wire)-September 8, 2009 - APCER Pharma Solutions, Inc. (“APCER”) President and CEO Suneet Walia commented on the US Food and Drug Administration’s (FDA) proposed rules to amend postmarket safety reporting regulations for three of its centers, to require...

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

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...

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

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 biotech...

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

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 for its...

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

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 capabilities...

110 - FDA Grants Protalix Orphan Drug Designation for prGCD

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...

111 - DuraSeal™ Spine Sealant Receives FDA Approval

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 been...

112 - 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

WOBURN, Mass.-(Business Wire)-September 8, 2009 - BioTrove announced a collaboration with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research to investigate the utility of the company’s Standardized NanoArray PCR (SNAP) gene expression profiling system for the...

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

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. Food and Drug...

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

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 Index selected...

115 - DDN Exec Orchestrates Local Prescription Drug Collection Effort

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...

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

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® Cystic...

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

NEW YORK-(Business Wire)-September 3, 2009 - Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company’s submission of a biologic license application for belatacept, which is in ongoing phase III...

118 - QPharma, Inc. Offers On-Demand Printing Services

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 clients a...

119 - MEDICREA PASS® LP Iliac Fixation Receives FDA Clearance

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 Low...

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

WASHINGTON-(Business Wire)-September 3, 2009 - As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress...

121 - Laughlin Joins MPI Research as Sales & Marketing EVP

MATTAWAN, Mich.-(Business Wire)-September 3, 2009 - MPI Research announced today that Thomas Laughlin will join the company as Executive Vice President of Sales and Marketing and will be a member of the company’s Corporate Management Team. Laughlin’s 30+ years of executive experience span...

122 - Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN™ (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

SILVER SPRING, Md.-(Business Wire)-September 2, 2009 - Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM...

123 - AHF: Pfizer Wrongdoing Echoes Viagra Case

WASHINGTON-(Business Wire)-September 2, 2009 - As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today lauded the U.S. Justice Department’s crackdown on Pfizer, Inc. for its fraudulent drug marketing practices. It was reported today that...

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

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...

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

CAMBRIDGE, Mass.-(Business Wire)-September 2, 2009 - Millennium: The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark...

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

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 Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV), the company’s first-ever...

127 - Ikonisys to Present at the Thomas Weisel Partners Healthcare Conference 2009

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: Date:     Friday, September 11, 2009 Time...

128 - Celsion to Present at the Rodman & Renshaw 11th Annual Healthcare Conference

COLUMBIA, Md.-(Business Wire)-September 2, 2009 - Celsion Corporation (NASDAQ: CLSN) announced today that Michael H. Tardugno, Celsion’s President and CEO, will present at the Rodman & Renshaw 11th Annual Healthcare Conference on Wednesday, September 9th at 10:50 A.M. ET at the New York Palace...

129 - Meda: FDA Approval of the First Once-Daily Nasal Antihistamine

STOCKHOLM-(Business Wire)-September 2, 2009 - Regulatory News: Meda AB (STO:MEDAA) The U.S. Food and Drug Administration (FDA) has approved Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. This new Astepro nasal spray 0.15...

130 - Knopp Neurosciences Receives FDA Fast Track Designation for KNS-760704 in ALS

PITTSBURGH-(Business Wire)-September 2, 2009 - Knopp Neurosciences Inc. announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of KNS-760704 in amyotrophic lateral sclerosis (ALS). Knopp has completed the randomized...

131 - EpiCept Corporation to Present at the Rodman & Renshaw Healthcare Conference

TARRYTOWN, N.Y.-(Business Wire)-September 2, 2009 - Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Jack Talley, President and CEO, will be presenting at the Rodman & Renshaw 11th Annual Healthcare Conference. The presentation is scheduled for...

132 - STEMCELL Technologies Inc. to Host Stem Cell Training Courses

VANCOUVER-(Business Wire)-September 2, 2009 - STEMCELL Technologies has announced the schedule for their fall training program. This includes 2-day courses on mesenchymal stem cell biology (October 2nd and 3rd), mammary stem cell biology (October 17th and 18th), neural stem cell biology (October...

133 - FDA Advisory Committee Recommends Randomized Trial to Support Proposed Indication for Clolar in Adult AML

CAMBRIDGE, Mass.-(Business Wire)-September 1, 2009 - Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult...

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

BARCELONA, Spain-(Business Wire)-September 1, 2009 - This week TCA Cellular Therapy`s Medical Director Gabriel Lasala, M.D. presents advances in adult stem cell treatments for severe limb ischemia and refractory coronary ischemia at the European Society of Cardiology Congress in Barcelona, Spain...

135 - Pennsylvania Father Receives Fourth Heart in Five Years

TUCSON, Ariz.-(Business Wire)-September 1, 2009 - Over the last five years, Jim Hennigan has had four different hearts beating in his chest… the heart he was born with, two donor hearts and a Total Artificial Heart. Hennigan received his newest donor heart on May 8, 2009, after living for more...

136 - ResearchPoint Expands Services with New Resource Management Organization

AUSTIN, Texas-(Business Wire)-September 1, 2009 - ResearchPoint, a leading global CRO providing drug development services to pharmaceutical, biotechnology and device companies, is pleased to announce the formation of a new resource management organization. The affiliate organization...

137 - Biovail Announces Results from ACADIA’s Phase III Trial of Pimavanserin in Parkinson’s Disease Psychosis

TORONTO-(Business Wire)-September 1, 2009 - Biovail Corporation (NYSE/TSX:BVF) today announced top-line results from ACADIA Pharmaceutical Inc.’s first pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis, or PDP. The study did not meet its primary endpoint of...

138 - Leaders of MDA Venture Philanthropy and Biodesign Institute to Address 2009 AZBio Awards Dinner

PHOENIX-(Business Wire)-August 31, 2009 - AZBio (Arizona BioIndustry Association) announced today that Sharon Hesterlee and Alan C. Nelson will be the featured speakers at the 2009 AZBio Awards Dinner, the largest annual gathering of Arizona's bioscience community, on September 24th at the Arizona...

139 - Peplin Results for the Financial Year Ended 30 June 2009

EMERYVILLE, Calif. & BRISBANE, Australia-(Business Wire)-August 31, 2009 - Peplin, Inc. (ASX:PLI) today announced financial results for the year ended 30 June 2009, reporting a US$17.7 million cash balance. Peplin will use these funds to complete Phase 3 clinical trials for its lead product...

140 - NeuroLogica Corporation Announces FDA 510(k) Clearance for inSPira HD: portable high resolution SPECT

DANVERS, Mass.-(Business Wire)-August 31, 2009 - NeuroLogica Corporation announced today at the XIV World Congress of Neurological Surgery in Boston, MA, receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its portable high resolution SPECT system: inSPira HD...

141 - NCPDP Announces “Hot Topic” Healthcare Webinars Featuring Speakers from CMS, FDA and MN Dept of Health

SCOTTSDALE, Ariz.-(Business Wire)-August 31, 2009 - The National Council for Prescription Drug Programs (NCPDP), a not-for-profit pharmacy standards development organization, announced today registration is open for its upcoming web-based seminars, “CMS NonMatched NDC List” and “Minnesota...

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

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 foods section...

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

CAMBRIDGE, Mass.-(Business Wire)-August 28, 2009 - Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring...

144 - Geneuity Releases Biomarker Assays for Early Detection of Kidney Damage

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 measurements for the biomarkers...

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

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...

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

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...

147 - Wellstone Filters Becomes Wellstone Filter Sciences, Inc.

CHAPEL HILL, N.C.-(Business Wire)-August 27, 2009 - Wellstone Filters (OTCBB: WFLR) announced that the company has changed its name to Wellstone Filter Sciences, Inc. as part of a shift in focus to Reduced Exposure Filters. The name change will be effective on or about September 14, 2009. ABOUT...

148 - Kamada Announces US Distribution Agreement for Intravenous Alpha-1 Antitrypsin

NESS ZIONA, Israel-(Business Wire)-August 27, 2009 - Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has entered into an exclusive agreement with a large US specialty...

149 - Geron Comments on FDA Hold on Spinal Cord Injury Trial

MENLO PARK, Calif.-(Business Wire)-August 27, 2009 - Geron Corporation (Nasdaq:GERN) today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND. As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve...

150 - Nutra Pharma Announces Licensing Agreement with XenaCare Holdings to Market and Distribute Cobroxin, a Treatment for Chronic Pain

PLANTATION, Fla.-(Business Wire)-August 26, 2009 - Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has successfully completed a licensing agreement that grants...

151 - HealthYes!® Wins Austin Business Journal’s Healthcare Heroes Award

AUSTIN, Texas-(Business Wire)-August 25, 2009 - HealthYes!® co-founders, Dale Wood and Craig Lindley, won the Austin Business Journal’s Healthcare Heroes Award for Business Leaders in the small employer category. The award honors individuals, organizations and companies for their contributions to...

152 - Sweet Green Fields’ “Reb-A” Issued FDA GRAS Status

BELLINGHAM, Wash.-(Business Wire)-August 25, 2009 - Sweet Green Fields (SGF), the first U.S. company to commercialize and file a patent for the extraction of high purity Rebaudioside A (Reb-A), a sweetener derived from the Stevia plant, has received official notification from the Food and Drug...

153 - Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS

HAWTHORNE, N.Y.-(Business Wire)-August 25, 2009 - Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company’s New Drug Application (NDA) for...

154 - Profectus BioSciences Enters into Research Collaboration Agreement with the PATH Malaria Vaccine Initiative (MVI)

BALTIMORE-(Business Wire)-August 25, 2009 - Profectus BioSciences, Inc. (Profectus), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, announced today it has entered into a research collaboration agreement with the...

155 - LabConnect Appoints Chief Operating Officer

SEATTLE-(Business Wire)-August 25, 2009 - LabConnect, LLC, today announced the appointment of Frank D. Morrow, Ph.D., FACN, as its chief operating officer. Dr. Morrow is a veteran of the central lab business, having served as founding executive, president and chief scientific officer at Quintiles...

156 - ZOLL Receives FDA Approval to Market New LifeVest Model

CHELMSFORD, Mass.-(Business Wire)-August 24, 2009 - ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of resuscitation devices and related software solutions, has received approval from the U.S. Food and Drug Administration (FDA) to market and sell a new model of the LifeVest® wearable...

157 - Diagnostic HYBRIDS Releases Thyretain ™ for the Specific Detection of Thyroid Stimulating Immunoglobulin (TSI)

ATHENS, Ohio-(Business Wire)-August 24, 2009 - Diagnostic HYBRIDS announces the FDA clearance, for marketing under the 510(k) pre-notification process, of the Thyretain TSI Reporter BioAssay. Thyretain is an in vitro diagnostic use test that specifically detects auto-antibodies called thyroid...

158 - HiFi DNA President Challenges NCI Endorsement of Inaccurate HPV Tests for Referring Women to Unnecessary and Costly Cervical Biopsies

TRUMBULL, Conn.-(Business Wire)-August 24, 2009 - A National Cancer Institute (NCI) investigator’s endorsement of inaccurate high-risk HPV test to refer women to cervical cancer tests, despite the weak evidence of its value, is “unfortunate and inappropriate.” Sin Hang Lee, MD, president of...

159 - Nanotherapeutics Awarded $30.9 Million NIAID Contract to Develop Inhaled Antiviral for Prophylaxis and Treatment of Smallpox

ALACHUA, Fla.-(Business Wire)-August 24, 2009 - Nanotherapeutics, Inc., today announced that it has been awarded a $30.9 Million, 5-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version...

160 - Aperio Receives Second FDA Clearance for HER2 Image Analysis Application for Breast Cancer

VISTA, Calif.-(Business Wire)-August 24, 2009 - Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the IHC HER2 Breast Tissue Image Analysis...

161 - BrainStorm Cell Therapeutics Secures Funding to Reach Clinical Trials for ALS

NEW YORK & PETACH TIKVAH, Israel-(Business Wire)-August 24, 2009 - BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that the company has secured the funding required to complete pre-clinical trials underway for...

162 - Covidien Announces Global Launch of New Automatic Leak Adjustments Software Option for the Puritan Bennett 840™ Ventilator

BOULDER, Colo.-(Business Wire)-August 24, 2009 - Covidien (NYSE: COV), a leading global supplier of healthcare products, today announced the global launch of its Leak Compensation software option for the Puritan Bennett 840™ ventilator. This new feature will provide a ventilation solution in...

163 - NextDocs and TranSenda Partner to Offer Unified Document and Clinical Trial Management Systems

BELLEVUE, Wash.-(Business Wire)-February 17, 2009 - NextDocs Corporation and TranSenda International, LLC, have entered into a collaborative agreement to integrate and cross-sell their solutions. Combining NextDocs’ Microsoft Office SharePoint Server-based document management solutions with...

164 - CalorieKing Appoints Thomas L. McKnight as Medical Director

SAN DIEGO-(Business Wire)-February 17, 2009 - CalorieKing, the leading provider of online weight management tools, announces that Thomas L. McKnight, MD, MDIV, MPH, has been named Medical Director. Dr. McKnight is a family physician and nationally recognized expert in the field of obesity and has...

165 - InnovationRx and Advanced BioHealing Partner to Provide Patient Support Program

NEWTON, Mass.-(Business Wire)-February 17, 2009 - InnovationRx, a wholly owned subsidiary of Innovation Group (LSE: TiG), announced today that it has partnered with Advanced BioHealing, Inc. (ABH) to conduct a pilot program providing support for patients receiving Dermagraft® treatment. Dermagraft...

166 - Bard Receives FDA Approval for the LifeStent® Vascular Stent

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 devices are approved...

167 - AVANIR Announces Fiscal 2009 First Quarter Financial Results

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 of $5.2 million, or...

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

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), which reduces the...

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

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 with...

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

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...

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

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...

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

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 intradermal...

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

U.S. Department of Health and Human Services:     What: Thirty-Second PSA   Why: The number of recalls related to products containing ingredients produced by Peanut Corporation of America has been rising and is now more than 2,000. The recalls related to salmonella affect a wide variety of...

174 - American Shared Hospital Services to Develop Proton Beam Radiation Therapy Facility in San Francisco Bay Area

SAN FRANCISCO-(Business Wire)-February 12, 2009 - AMERICAN SHARED HOSPITAL SERVICES (AMEX:AMS), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, announced today that it is developing a proton beam radiation therapy (PBRT) facility in the...

175 - Oral Laquinimod for Multiple Sclerosis Granted Fast Track Status by FDA

JERUSALEM & LUND, Sweden-(Business Wire)-February 12, 2009 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast...

176 - Research and Markets: New 2009 GenericHandbook - The Industry's Most Comprehensive Guide and Source to the Generic Drug Industry in the US

DUBLIN, Ireland-(Business Wire)-February 12, 2009 - Research and Markets - Fougera - G&W Laboratories - Glades Pharmaceuticals - Glenmark Pharmaceuticals - Global Pharmaceuticals - Greenstone - Hercon Laboratories - Hi-Tech Pharmacal Co - Hospira - Interpharm - IVAX - Kremers Urban - Lannett...

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

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...

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

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 cells designed...

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

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 vaccine in India...

180 - Oscient Pharmaceuticals Restructures Commercial Organization

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...

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

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...

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

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 System. The...

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

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 Laboratory Standards...

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

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. Product Development - Texas...

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

CUPERTINO, Calif.-(Business Wire)-February 11, 2009 - BioImagene, the leading provider of innovative digital pathology solutions, today announced that the company has received FDA 510(K) clearance for their PATHIAM™ System with iScan™ for assessment of HER2/neu immunohistochemistry tests. The...

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

LENEXA, Kan.-(Business Wire)-February 11, 2009 - VasoGenix Pharmaceuticals Inc. (www.vasogenix.net) announced today that initial in vitro screening of a series of synthetic agonist analogs of calcitonin gene-related peptide (CGRP) exhibit similar receptor site binding properties as CGRP. These...

187 - Strong Fourth Quarter for Genzyme Concludes Productive Year

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 per diluted share...

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

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...

189 - Taro Receives FDA Approval for Levetiracetam Oral Solution

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...

190 - Stimulus Package Pushes for More Technology in Hospitals and Clinics

-(Business Wire)-February 10, 2009 - The following is a statement from Medsphere Systems Corporation: WHAT: Medsphere Systems Corporation, the leading provider of Open Source healthcare IT solutions, anticipates the transition to a new era this week with Congressional approval for $20 billion in...

191 - Maxygen Reports Fourth Quarter and Year End 2008 Financial Results

REDWOOD CITY, Calif.-(Business Wire)-February 10, 2009 - Maxygen, Inc. (Nasdaq:MAXY), a biotechnology company focused on the development of improved protein drugs, today announced financial and business results for the quarter and year ended December 31, 2008. Fourth Quarter 2008 Financial Results...

192 - Participant Media's and River Road Entertainment's Food, Inc. Opens 3rd Annual Culinary Cinema of the Berlin International Film Festival

LOS ANGELES-(Business Wire)-February 10, 2009 - Participant Media's and River Road Entertainment's documentary Food, Inc., directed by Robert Kenner, opened the 3rd annual Culinary Cinema of the Berlin International Film Festival on Sunday, February 8. At the sold-out event, the film was screened in...

193 - Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of CB7630 (Abiraterone Acetate) in Chemotherapy Naïve Castration Resistant Prostate Cancer Patients

LOS ANGELES-(Business Wire)-February 10, 2009 - Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company's lead drug...

194 - FDA Awards Absorption Systems Phase I SBIR Grant for CellPort Technologies™

EXTON, Pa.-(Business Wire)-February 10, 2009 - Absorption Systems, LP, today announced that the company has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the U.S. Food and Drug Administration (FDA) to develop an innovative tool to help determine the potential for...

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

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...

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

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 CAYMAN™ Buttress...

197 - OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva

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 Administration...

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

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 investigational new drug...

199 - Renowned Bioscience Leaders to Address BIOZONA 2009 Conference

PHOENIX-(Business Wire)-February 9, 2009 - Two senior industry leaders — Roger Newton and Christopher Gleeson — will keynote Arizona’s life sciences industry conference BIOZONA 2009 at the Sheraton Phoenix Downtown on April 7. The Arizona BioIndustry Association (AZBio) event will...

200 - VAI Integrates S2K Software with rfXcel’s Pedigree Tracking to Help the Pharmaceutical Supply Chain Meet FDA and State Requirements

RONKONKOMA, N.Y.-(Business Wire)-February 9, 2009 - VAI (Vormittag Associates, Inc.) (www.vai.net), a leader in enterprise solutions for the distribution, manufacturing, retail and service industries, and an IBM Premier Business Partner, today announced a partnership with San Ramon, California...

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