Antisoma to amend ACCEDE phase III study of AS1413
Plexxikon Treats Initial Patient With First-in-Class Drug in Phase 1 Trial
Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex
Hanmi's LAPS-GCSF got the US FDA's approval for clinical trials
Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX(R) 0.4mg Capsules
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FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
04 Nov 2009 - Cambridge, MA - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review...
Cardiocore's Thorough QT Performance Factors in FDA's Approval of Livalo
Washington, DC--November 04, 2009-- Cardiocore, a premier centralized cardiac testing lab, announced today that a Thorough QT study it performed for Kowa Pharmaceuticals contributed to the Japan-based drug developer's...
Retigabine Regulatory Update
Monday 02 November 2009, London UK and California US -- GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX) announced today that, on 30 October, they filed a New Drug Application with the US Food and...
CardiacAssist expands market penetration of TandemHeart
PITTSBURGH, Nov. 2, 2009--Privately held CardiacAssist Inc. announced today that the Cardiovascular Institute of Stanford (University) Hospital & Clinics (Palo Alto, Calif.) is one of the newest cardiac centers to begin...
IRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM TWO PIVOTAL PHASE 3 TRIALS IN PATIENTS WITH CHRONIC CONSTIPATION
CAMBRIDGE, Mass. and New York, November 2, 2009 -- Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top line results from two Phase 3 clinical trials assessing the safety...
Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product
ST. LOUIS, Oct 30, 2009 -- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of...
Devgen nv and Dogal A.S. receive regulatory approval in Turkey for the use of Devgen's nematicide product Devguard
Zwijnaarde, Belgium and Instanbul, Turkey, October 30, 2008--Devgen nv (Euronext Brussels: DEVG) and Dogal A.S. today announced the approval by the Turkish Ministry of Agriculture for the use of Devgen's nematicide...
ELEKTA'S RADIOSURGERY SOLUTIONS ON CENTER STAGE AT 2009 CONGRESS OF NEUROLOGICAL SURGEONS ANNUAL MEETING EXTEND RECEIVES FDA 510(K) CLEARANCE
Stockholm, Sweden, October 23, 2009 -- At the 2009 Congress of Neurological Surgeons (CNS) Annual Meeting, October 24-28 in New Orleans, Louisiana, Elekta will demonstrate how its line of stereotactic solutions expand...
SENOMYX RECEIVES GENERALLY RECOGNIZED AS SAFE (GRAS) DETERMINATION FOR S6973 SUCROSE ENHANCER
SAN DIEGO, CA - October 23, 2009 - Senomyx, Inc. (NASDAQ: SNMX), a leading company focused on using proprietary technologies to discover and develop novel flavor ingredients for the food, beverage and ingredient supply...
European Medicines Agency maintains dosage recommendations for pandemic H1N1 vaccines
October 23, 2009 -- The European Medicines Agency (EMEA) has concluded that its recommendations adopted in September, that the three licensed H1N1 vaccines be preferably used as two doses, at least three weeks apart, be...
BD Announces Agreement to Acquire HandyLab, Inc.
Franklin Lakes, NJ (October 23, 2009) -- BD (Becton, Dickinson and Company) (NYSE: BDX) announced today that it signed a definitive agreement to acquire HandyLab, Inc., an Ann Arbor, Michigan-based company that develops...
Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
HAWTHORNE, N.Y.--Oct. 22, 2009-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application...
BioServe Selected by Government of A.P. India to Test H1N1 (Swine Flu) Patients
Beltsville, MD; and Hyderbad, AP, India, October 21, 2009 - BioServe(TM), a leading provider of clinical bio-samples and research services, today announced that it has been selected by the Government of the State of...
Cephalon Notified of Generic Filing for Armodafinil Tablets
FRAZER, Pa., Oct. 21 -- Cephalon, Inc. (Nasdaq: CEPH) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S....
Endocyte presents data on EC145 in treatment of ovarian cancer at the 16th annual meeting of the European Society of Gynaecologic Oncology
WEST LAFAYETTE, Ind. -October 21, 2009 - Endocyte, Inc., a cancer drug discovery and development company, presented data from a Phase 2a clinical trial for EC145, currently in development as a potential treatment for...
Antigenics Announces a Negative Vote From the CHMP on Oncophage
London, UK -- October 21, 2009 -- Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the Company...
Shire Targets Fourth Quarter Filing of BLA for REPLAGAL
Massachusetts - 21 Oct 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration...
Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
RESEARCH TRIANGLE PARK, N.C., Oct. 19, 2009 -- Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration for PROLASTIN
AXIS-SHIELD RECEIVES FDA CLEARANCE FOR THE ANTI-CCP RHEUMATOID ARTHRITIS TEST ON ABBOTT'S ARCHITECT ANALYSER
Dundee, Scotland, 16 October, 2009: Axis-Shield plc (LSE:ASD, OSE:ASD), the international in vitro diagnostics (IVD) company, today announces that it has received marketing clearance from the US Food and Drug...
AspenBio Pharma Announces Closing of Public Offering of 5,155,000 Common Shares
CASTLE ROCK, CO -- 10/14/2009 -- AspenBio Pharma, Inc. (NASDAQ: APPY) today announced the closing of its previously announced public offering of 5,155,000 shares of its common stock at $1.70 per share. The aggregate...
European Medicines Evaluation Agency Grants Orphan Drug Designation to ARQ 197 for Treatment of Soft Tissue Sarcoma
WOBURN, Mass.--Oct. 14, 2009-- ArQule, Inc. (NASDAQ: ARQL) today announced that the European Medicines Evaluation Agency (EMEA) has designated ARQ 197 as an orphan medical product for the treatment of soft tissue...
Hanmi's LAPS-GCSF got the US FDA's approval for clinical trials
October 14, 2009 - Hanmi Pharmaceutical Co., Ltd. announced on October 14 that the U.S. Food and Drug Administration(FDA) had approved the first phase of clinical trials of 'LAPS-GCSF (HM10460A)' which Hanmi...
ONCOLYS BIOPHARMA SIGN STRATEGIC ALLIANCE AND LICENSE AGREEMENT WITH ASTELLAS PHARMA TO DEVELOP AND COMMERCIALIZE YM753 HDAC INHIBITOR DRUG
Tokyo, Japan -- October 13, 2009 -- Oncolys BioPharma Inc. (headquarters: Tokyo; President and CEO: Yasuo Urata) announced today that it has entered into a strategic alliance and license agreement with Astellas Pharma...
HyperBranch Receives CE Mark for NuSeal 30 Hernia Mesh Fixation Sealant
Durham, NC (October 13, 2009) - HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to...
Shire and Sandoz Settle All Pending Litigation Concerning ADDERALL XR
13 Oct 2009 - Philadelphia, PA - October 13, 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz")...
Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve
MINNEAPOLIS, Minnesota and GALWAY, Ireland -October 12, 2009- Vascular Solutions, Inc. (Nasdaq:VASC) and Zerusa Limited today announced that they have received 510(k) clearance with the FDA for the sale of the Guardian
AspenBio Pharma Announces Public Offering of 4,482,609 Common Shares
CASTLE ROCK, CO -- 10/07/2009 -- AspenBio Pharma, Inc. (NASDAQ: APPY) today announced that it has priced a public offering of 4,482,609 shares of its common stock at $1.70 per share. The approximately $7.2 million of...
MedaSorb Technologies Corporation Raises $1.3M in Series B Warrant Exercise
MONMOUTH JUNCTION, NJ-- 10/09/09 - MedaSorb Technologies Corporation (OTC.BB:MSBT - News) and its wholly-owned subsidiary CytoSorbents, Inc., announced that it has raised $1.3 million in the exercise of the warrant...
BIOMET ANNOUNCES FINANCIAL RESULTS FOR FIRST QUARTER OF FISCAL YEAR 2010
WARSAW, Ind., October 9, 2009 - Biomet, Inc. announced today financial results for its first fiscal quarter ended August 31, 2009.
ADVENTRX Pharmaceuticals Announces Closing of Financing
SAN DIEGO, Oct. 9 -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has completed the previously announced sale of shares of its Series D convertible preferred stock pursuant to a registered...
Acorda Therapeutics Announces Posting of Briefing Documents for October 14 FDA Advisory Committee Meeting on Fampridine-SR
HAWTHORNE, N.Y.--Oct. 9, 2009-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Peripheral and Central...
Distinguished Reproductive Endocrinologist to Host Live Chat Event Discussing Transvaginal Ultrasound Transfers for Embryo Implantation
Bloomington, Ind., October 9, 2009 -- Fertility and reproductive specialists are invited to join a live, online chat event entitled, "Transvaginal Ultrasound Transfers" at www.CookARTLab.com. The event will be held on...
FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema
October 9, 2009 -- The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic...
FDA Awards $17.5 Million in Grants to Further Food and Feed Safety
October 9, 2009 -- The U.S. Food and Drug Administration today announced that it has awarded 83 grants in FY2009 totaling $17.5 million to state and local regulatory agencies to boost food and feed safety initiatives...
Hospira, Celltrion, Enter Business Cooperation Agreement to Develop and Market Biogeneric Drugs
LAKE FOREST, Ill., October 8, 2009 -- Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today signed a Business Cooperation Agreement with South Korea-based Celltrion, Inc. and Celltrion...
Cook Sues Endologix For Patent Infringement Over Aortic Aneurysm Endograft Technology
Bloomington, Ind., October 8, 2009 - In a move aimed at protecting its worldwide market-leading technology for endovascular repair of aortic aneurysms (EVAR), Cook Incorporated has filed a complaint with the U.S....
Antisoma to amend ACCEDE phase III study of AS1413
London, UK, and Cambridge, MA: 08 October 2009 Antisoma announces that, following discussions with FDA and trial investigators, it plans to amend the primary endpoint in the ACCEDE study of AS1413. The ACCEDE study is...
Plexxikon Treats Initial Patient With First-in-Class Drug in Phase 1 Trial
BERKELEY, Calif. - October 8, 2009 -- Plexxikon Inc. today announced that dosing of cancer patients with PLX3397 has started in a Phase 1 clinical trial. PLX3397 is a novel, oral investigational drug for treating...
New Endovascular Graft for Thoracic Aortic Aneurysm Used in Australia for the First Time
Bloomington, Ind., October 8, 2009 -- For the first time in Australia, surgeons at the Royal Brisbane and Womens' Hospital have successfully treated a patient with an innovative new endovascular graft to repair a...
American Shared Hospital Services Updates Progress in the Development of a Proton Therapy Center at Long Beach Memorial Hospital
San Francisco, CA, October 8, 2009 -- AMERICAN SHARED HOSPITAL SERVICES (AMEX:AMS), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, today shared a recent...
Leading Proxy Advisory Firms Recommend that MDS Shareholders Vote in Favour of the Divestiture of MDS Analytical Technologies
TORONTO, October 8, 2009 - MDS Inc. (TSX: MDS; NYSE: MDZ), a leading provider of products and services to the global life-sciences markets, today announced that three renowned proxy advisory firms - RiskMetrics Group,...
The Medicines Company Announces Second New Patent Issuance for Angiomax(R)
PARSIPPANY, NJ, Oct 08, 2009 -- The Medicines Company (NASDAQ: MDCO) today announced that the United States Patent and Trademark Office (PTO) issued a new U.S. patent No. 7,598,343 ('343 patent). The '343 patent relates...
The Medicines Company Files Patent Infringement Lawsuits
PARSIPPANY, NJ, Oct 08, 2009 -- The Medicines Company (NASDAQ: MDCO) today announced that it has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and APP Pharmaceuticals, LLC, and related...
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer Company allegedly failed to correct violations
October 8, 2009 -- The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop...
AdvaMed Applauds House Vote to Provide Sizeable Funding Increase to FDA Medical Device Program
WASHINGTON, D.C. -October 07, 2009 Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today after the U.S. House of Representatives voted to...
Labopharm announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA
LAVAL, QC, October 7, 2009 - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company's novel...
FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
October 6, 2009 -- The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief...
CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves
ATLANTA, Oct. 6 -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received a Humanitarian Use Device (HUD) designation from...
Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex
NATICK, Mass., Oct. 6 -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex(
Novartis completes shipment of US supply of Fluvirin
Basel, October 6, 2009 - Novartis announced today that the company has completed its entire shipment of seasonal influenza vaccine to the United States for the 2009/2010 season. As previously anticipated, the company...
Ad Hoc Announcement pursuant of
October 06, 2009 -- Epigenomics AG (ISIN: DE000A0BVT96), a cancer molecular diagnostics company, today announced, that it launched in Europe a CE-marked, in vitro diagnostic blood test for early detection of colorectal...
Depomed, Inc. Announces Positive Top-Line Results from Phase 3 Clinical Trial of DM-1796 in Postherpetic Neuralgia
MENLO PARK, Calif.--Oct. 5, 2009-- Depomed, Inc. (NASDAQ:DEPO) today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically...
FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
October 5, 2009 -- The U.S. Food and Drug Administration today ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect...
USDA Joins FDA Efforts on New Food Safety Regulations
October 5, 2009 -- USDA's fresh produce chief will join FDA to help develop new food safety rules, as part of a cooperative initiative between FDA and the U.S. Department of Agriculture (USDA). Today's announcement...
FDA Consumer Health Information Updates: FDA's Cooperative Programs Improve Food Safety
October 5, 2009 -- The U.S. Food and Drug Administration today released a listing of consumer health information updates about cooperative programs and food safety. All updates can be accessed from the agency's Web page...
Cook Medical Drives Innovation and Education in the Field of Endourology at World Congress of Endourology
Bloomington, Ind., October 5, 2009 -- Continuing to drive innovation in endourology, Cook Medical will feature a series of product demonstrations and interactive presentations with a special emphasis on kidney stone...
BioDelivery Sciences to Ring The NASDAQ Stock Market Opening Bell
October 05, 2009--BioDelivery Sciences International, Inc. (Nasdaq: BDSI) will visit the NASDAQ MarketSite in New York City to celebrate the recent FDA approval and upcoming launch of ONSOLIS (fentanyl buccal soluble...
Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX(R) 0.4mg Capsules
HAYWARD, Calif., October 05, 2009 -- Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug...
Theratechnologies Announces Financial Results for the Third Quarter 2009
Montr
GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)
PHILADELPHIA, PA, October 5, 2009 - GlaxoSmithKline [NYSE: GSK] today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the...
Cerner Receives FDA Clearance for Fetal Monitoring Solution
KANSAS CITY, Mo. -- Oct. 5, 2009 -- Despite advances in technology and medical record keeping, most patient records are missing an important piece of data. Currently, fetal monitoring waveform data gathered throughout a...
YM BIOSCIENCES ANNOUNCES OFFER FOR CYTOPIA LTD., AN AUSTRALIAN CANCER-FOCUSED DEVELOPMENT COMPANY
MISSISSAUGA, ON, Oct. 5, 2009 - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at...
Data on VIVUS' Qnexa To Be Featured at The Obesity Society Annual Meeting
MOUNTAIN VIEW, Calif., Oct 05, 2009 -- VIVUS,Inc. (Nasdaq: VVUS) today announced that data on Qnexa(TM), an investigational new drug, will be presented at the 27th annual scientific meeting of The Obesity Society (TOS)...
Allos Therapeutics Announces U.S. Availability of FOLOTYN(TM) (pralatrexate injection) for Relapsed or Refractory Peripheral T-Cell Lymphoma
WESTMINSTER, Colo.--Oct. 5, 2009-- Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that FOLOTYN(TM) (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug...
Bayer's novel oral contraceptive Qlaira
Berlin, October 5, 2009 - Qlaira
FDA Advisory Committee Recommends Approval of PEGINTRON(R) for the Adjuvant Treatment of Stage III Malignant Melanoma
GAITHERSBURG, Md., Oct. 5, 2009-- Schering-Plough Corp. (NYSE: SGP) announced today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to...
FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible
October 2, 2009 - The U.S. Food and Drug Administration will seek comments on how to ensure that information on FDA activities and decision-making is useful, understandable, and accessible to the public, during a...
Baxter Receives EMEA Positive Opinion for CELVAPAN H1N1 Pandemic Influenza Vaccine
DEERFIELD, Ill., October 2, 2009 -- Baxter International Inc. (NYSE: BAX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its "positive...
FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users
October 1, 2009 -- The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of...
New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients New Heparin to Ship Starting October 8
October 1, 2009 -- The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
Aurobindo Pharma receives three ANDA approvals from USFDA for Atomoxetine Hydrochloride Capsules, Ribavirin Tablets and Ribavirin Capsules
October 01, 2009--Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval for Atomoxetine Hydrochloride Capsules 10mg, 18mg , 25mg , 40mg, 60mg, 80mg and 100mg and final approvals for...
MAQUET CARDIOVASCULAR RECEIVES FDA CLEARANCE FOR MEGA(TM), THE WORLD'S FIRST 8Fr. 50cc INTRA-AORTIC BALLOON CATHETER
Fairfield, NJ -October 01, 2009-- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced today at the Transcatheter Cardiovascular Therapeutics (TCT) convention in San Francisco, CA,...
FDA ACCEPTS PHARMAMAR AS MANUFACTURER OF THE ACTIVE PHARMACEUTICAL INGREDIENT OF YONDELIS
Madrid, 30 September 2009: The FDA (Food and Drug Administration) has informed PharmaMar that since the inspection made between 27 and 30 July at PharmaMar premises in Colmenar Viejo has already been completed, it...
Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Sinemet
PITTSBURGH, September 30, 2009 -- Mylan Inc. (NASDAQ: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New...
Hologic Receives CE Marking for the ThinPrep
BEDFORD, Mass., September 29, 2009 - Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated...
Seroquel XR and Seroquel Approved in Europe for Prevention of Recurrence of Bipolar Disorder
September 29, 2009 AstraZeneca announced today that once-daily SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition...
BIOLASE Announces Distribution Agreements in China
IRVINE, CA, Sep 28, 2009 -- BIOLASE Technology, Inc. (NASDAQ: BLTI) today announced that it finalized three regional distribution agreements in the People's Republic of China. This announcement follows the Company's...
Cepheid Receives FDA Clearance for Xpert
Sunnyvale, CA and Bedford, MA -- September 24, 2009 -- Cepheid (NASDAQ: CPHD) and Instrumentation Laboratory (IL) today announced that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to...
Sangamo BioSciences Announces Plans to Initiate a Second Clinical Trial of CCR5-ZFP Therapeutic to Treat HIV/AIDS
RICHMOND, Calif., Sept 23, 2009 -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that the US Food and Drug Administration (FDA) has reviewed and accepted an Investigational New Drug (IND) application to...
FDA Advisory Committee Hears Presentations and Public Comment on EXALGO Extended-Release Tablets
CAMBRIDGE, Mass. & VANCOUVER, Sep 23, 2009 -- CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug...
CombinatoRx Stock Trading Halted Today; FDA Advisory Committees Meet to Discuss Exalgo
CAMBRIDGE, Mass. & VANCOUVER--Sep. 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)...
CombinatoRx and Neuromed Announce Posting of Briefing Documents for FDA Advisory Committee
CAMBRIDGE, Mass. and VANCOUVER, B.C.--Sep. 22, 2009-- CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug...
BSD Medical Corporation Reports FDA Review of BSD-2000 Hyperthermia System Continues
SALT LAKE CITY, 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...
Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results for Weight Management; NDA Submission on Track for December
SAN DIEGO, Sept 18, 2009 -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity...
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
PITTSBURGH, September 16, 2009 -- Mylan Inc. (NASDAQ: MYL) today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug...
ST-246 Used to Treat Complications From Exposure to Recombinant Vaccinia Virus
NEW YORK, Sep 15, 2009 -- SIGA Technologies Inc. (Nasdaq:SIGA) announced that its smallpox antiviral drug, ST-246, has been used to treat a Pennsylvania patient suffering from complications due to exposure to a live...
Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Evaluating Picoplatin in Small Cell Lung Cancer Reaches 320th Event Target
SOUTH SAN FRANCISCO, Calif., Sept 15, 2009 -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced that 320 evaluable events (patient deaths) have occurred in its pivotal Phase 3 SPEAR (Study of Picoplatin...
Hansen Medical Unveils Next Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart
MOUNTAIN VIEW, CA, September 15, 2009 -- Furthering the medical robotic frontier in electrophysiology (EP), Hansen Medical, Inc. (NASDAQ: HNSN) today announced it has received U.S. Food & Drug Administration (FDA)...
FDA Accepts for Filing Mylan's ANDA for Generic Copaxone
PITTSBURGH, September 14, 2009 -- Mylan Inc. (NASDAQ: MYL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for...
Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease
Sep. 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...
FDA Clears a Test for Ovarian Cancer
September 11, 2009--The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and...
Almirall aims to file once daily aclidinium bromide for COPD in Europe in early 2010
Barcelona, 9th September 2009.- Almirall, S.A. (ALM.MC) today announced its intention to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for its once-daily long acting...
FDA Grants Protalix Orphan Drug Designation for prGCD
Sep. 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...
Zimmer Holdings to Present at Upcoming Investor Conferences
WARSAW, Ind., Sept 01, 2009 -- Zimmer Holdings, Inc. (NYSE: ZMH; SWX: ZMH) announced today it will be participating in the following investor conferences during the month of September:
Integra NeuroSciences Features New MAYFIELD(R) Infinity XR2 Radiolucent Cranial Stabilization System At World Congress of Neurological Surgery
PLAINSBORO, N.J., August 31, 2009 -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) is featuring the MAYFIELD(R) Infinity XR2 Radiolucent Cranial Stabilization System at the XIV World Congress of Neurological...
Tarix Pharmaceuticals receives FDA approval for Phase 2 study to mitigate chemotherapy-induced thrombocytopenia
Brookline,MA , June 25, 2008 -- Tarix Phamaceuticals announced that it has received FDA approval to begin a Phase II clinical trial of TXA127 for the prevention of chemotherapy induced thrombocytopenia. The trial will...
Tarix Pharmaceuticals receives IND to treat HIV patients with persistently low CD4 counts
Brookline, MA, March 21, 2008 -- Tarix Phamaceuticals announced that it has received an approval of an IND to begin a Phase Ia dose escalation study to evaluate the safety of TXA127 in HIV patients maintained on HAART...
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