FDA GRANTS ORPHAN DRUG DESIGNATION FOR TNFERADE(TM)
Shire Targets Fourth Quarter Filing of BLA for REPLAGAL
Cephalon Notified of Generic Filing for Armodafinil Tablets
Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
To keep up to date with news from this category use our
Kensey Nash Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product
EXTON, Pa., November 11, 2009 -- Kensey Nash Corporation (Nasdaq: KNSY), a leading medical technology company that provides innovative resorbable biomaterial technology for a wide range of medical procedures, today...
Pandemic 2009 Influenza Update: US FDA approves GSK's pandemic H1N1 vaccine
10 November 2009, London UK & Philadelphia US -- GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted...
IRONWOOD AND ASTELLAS ANNOUNCE JAPAN LICENSING AGREEMENT FOR LINACLOTIDE
CAMBRIDGE, Mass. and TOKYO, Japan, November 10, 2009-- Ironwood Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that they have entered into an agreement providing Astellas exclusive rights to develop and...
Merit Medical Announces 510(K) Clearance for the Merit Laureate(TM) Hydrophilic Guide Wire
SOUTH JORDAN, Utah, November 10, 2009 -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures,...
Lonza successfully develops a manufacturing process for ArzerraTM (ofatumumab), a new biopharmaceutical from GSK and Genmab
Basel, Switzerland, 10 November 2009 - Lonza announces that GlaxoSmithKline (GSK) and Genmab's antibody ArzerraTM, which has just been approved for use in patients with chronic lymphocytic leukemia (CLL) by the US Food...
Teva Receives Favorable Court Decision Regarding Generic Prevacid
Jerusalem, Israel, November 10, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the...
Teva Receives Final Approval For Generic Prevacid
Jerusalem, Israel, November 10, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug...
Gore Receives European CE Mark Approval for Next Generation Conformable GORE TAG
7 November 2009 (Flagstaff, Arizona) - W.L. Gore & Associates (Gore) today announced that it has received European CE Mark approval for the next generation GORE TAG
FDA Approves Gloucester Pharmaceuticals' ISTODAX
Cambridge, MA - November 5, 2009 - Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX
Aurobindo Pharma receives final approval for Lamotrigine Tablets from USFDA
November 05, 2009--Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Lamotrigine Tablets (Chewable, Dispersible) 5mg and 25mg from the US Food & Drug Administration (USFDA).
FDA GRANTS ORPHAN DRUG DESIGNATION FOR TNFERADE(TM)
GAITHERSBURG, MD - November 4, 2009 - GenVec, Inc. (NASDAQ: GNVC) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TNFerade(TM) for the treatment of pancreatic...
AGA Medical Receives Product Approvals in China
MINNEAPOLIS, Nov. 4, 2009 -- AGA Medical Holdings, Inc. (AGA Medical) (NASDAQ: AGAM) has received regulatory approvals and licenses in China for its AMPLATZER
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...
InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
BRISBANE, Calif., November 4, 2009 -- InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to...
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...
XOFT SHOWCASES MULTI-DISCIPLINARY ELECTRONIC BRACHYTHERAPY CANCER TREATMENT PLATFORM AT ASTRO
CHICAGO, Nov. 2, 2009 - Xoft, Inc., developer of the Axxent
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...
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...
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...
Apotex to Distribute Important Transdermal System for Management of Chronic Pain in the U.S. Market
Weston, FL -October 20, 2009 Apotex Corp announced today that it has signed an exclusive distribution agreement with Hisamitsu Pharmaceutical Company of Japan. Apotex will sell to the U.S. healthcare market, Hisamitsu's...
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...
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...
ELECTRONIC BRACHYTHERAPY A VIABLE OPTION FOR INTRAOPERATIVE RADIATION THERAPY (IORT)
CHICAGO, Oct. 12, 2009 - Clinical experience with the FDA cleared Axxent
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...
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...
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 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...
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...
I-Flow Corporation Receives 510(k) Clearance From FDA for Oxygenated Topical Dressing Company to Now Start Clinical Studies on First of Its Kind Oxygen
LAKE FOREST, Calif.--Sept. 24, 2008--I-Flow Corporation (NASDAQ: IFLO), through its wholly-owned subsidiary AcryMed Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA)...
Results for the First Six Months of 2009
Jerusalem/Needham - August 24, 2009 - Oridion Systems Ltd. (SIX: ORIDN) - reports revenues of USD 19.1 million for the six-month period ended June 30, 2009. The decline compared to the revenues for the first six months...
I-Flow Corporation Receives FDA Clearance for Stabilized Antimicrobial Wound Gel
LAKE FOREST, Calif.--Mar. 12, 2009-- I-Flow Corporation (NASDAQ:IFLO), through its wholly-owned subsidiary AcryMed Inc., announced today that it received 510(k) clearance on February 26, 2009 from the Food and Drug...
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...
© Copyright 1995-2009 Pharmalicensing, a division of UTEK Europe Ltd 
All rights reserved. Terms and Conditions | Contact us
