Pharmalicensing.com: PR Newswire: FDA Approval http://pharmalicensing.com/rss/ Latest market and business intelligence from the leading publishers worldwide. en-us Pharmalicensing.com: PR Newswire: FDA Approval http://pharmalicensing.com/rss/ http://pharmalicensing.com/images/pharmalicensing_logo.gif 144 FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets LAKE ZURICH, Illinois, November 17 /PRNewswire/ -- Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/4003 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/4003 Tue, 17 Nov 2009 15:33:00 +0000 Daval International Awarded Orphan Drug Designation for Motor Neurone Disease Treatment LONDON, November 9 /PRNewswire/ -- Following the provision of clinical and scientific data to the US Food and Drug Administration (FDA), privately owned UK company Daval International Limited... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3949 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3949 Mon, 09 Nov 2009 07:00:00 +0000 FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease CAMBRIDGE, Massachusetts, November 4 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the United States Food and Drug... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3928 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3928 Wed, 04 Nov 2009 12:00:00 +0000 Simbionix Introduces the Next Generation in Bronchoscopy Training CLEVELAND, Ohio, October 27 /PRNewswire/ -- Simbionix, the world's leading developer of medical simulation systems, introduces it's new advanced simulator, the GI-BRONCH Mentor, a comprehensive... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3878 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3878 Tue, 27 Oct 2009 13:55:00 +0000 Novel Cardio-Pulmonary Support Device LIFEBRIDGE(R) From Germany Gains FDA Clearance AMPFING, Germany, October 26 /PRNewswire/ -- German based LIFEBRIDGE AG has received clearance from the U.S. Food and Drug Administration (FDA) for a compact, lightweight, mobile heart-lung... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3867 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3867 Mon, 26 Oct 2009 11:12:00 +0000 FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity DUBLIN, October 26 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3862 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3862 Mon, 26 Oct 2009 07:00:00 +0000 EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer's Disease Patient WELLESLEY HILLS, Massachusetts, October 16 /PRNewswire/ -- The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3819 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3819 Fri, 16 Oct 2009 18:38:00 +0000 Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement With the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers CALGARY, Canada, October 2 /PRNewswire/ -- Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has reached an agreement with the U.S. Food and Drug Administration... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3749 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3749 Fri, 02 Oct 2009 13:00:00 +0000 New Multicenter Study Finds That Cardiac Function Measured During Stress Testing With Cheetah Medical's BIOREACTANCE(R) Noninvasive Technology Offers New Insights Into Heart Failure TEL-AVIV, Israel and PORTLAND, Oregon, October 2 /PRNewswire/ -- Results from a multicenter study of Cheetah Medical's Exercise Cardiac Output (ECO(R)) stress test protocol for chronic heart failure... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3748 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3748 Fri, 02 Oct 2009 12:00:00 +0000 Merck Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States GENEVA, September 30 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3739 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3739 Wed, 30 Sep 2009 18:02:00 +0000 Simbionix USA Corporation's Innovative Development Division Releases Two New Breakthrough Technologies CLEVELAND, Ohio, September 21 /PRNewswire/ -- Simbionix USA Corporation, the world's leading developer of medical simulation systems, just released two new products: a new Laparoscopic Essential... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3676 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3676 Mon, 21 Sep 2009 12:00:00 +0000 /C O R R E C T I O N -- Merck Serono S A/ GENEVA, September 16 /PRNewswire/ -- In the news release, "Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan" issued on 16 Sep 2009 07:00 GMT, by Merck Serono S A SWX:SEO... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3651 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3651 Wed, 16 Sep 2009 11:08:00 +0000 Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan GENEVA, September 16 /PRNewswire/ -- Merck Serono, a division of Merck KGaA Darmstadt, Germany, today announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3648 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3648 Wed, 16 Sep 2009 08:00:00 +0000 Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17 PHILADELPHIA, September 3 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3574 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3574 Thu, 03 Sep 2009 12:57:00 +0000 Pitavastatin is Non-Inferior to Atorvastatin and Simvastatin and Demonstrates Sustained Efficacy and Tolerability Over 52 Weeks BARCELONA, Spain, September 1 /PRNewswire/ -- New phase III data presented at the European Society of Cardiology congress (ESC) demonstrated that pitavastatin is non-inferior to atorvastatin and... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3558 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3558 Tue, 01 Sep 2009 13:00:00 +0000 Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials CAMBRIDGE, Massachusetts, September 1 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today reported that it has completed its submission of a New... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3549 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3549 Tue, 01 Sep 2009 07:00:00 +0000 Bavarian Nordic A/S - Half Year Interim Report 2009 KVISTGAARD, Denmark, August 28 /PRNewswire/ -- Today Bavarian Nordic published the company's half-year interim report 2009. The full financial statements are available on the company's... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3528 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3528 Fri, 28 Aug 2009 08:45:00 +0000 Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device SIOUX FALLS, South Dakota, August 27 /PRNewswire/ -- Sanford Health (www.sanfordhealth.org), a comprehensive health care provider in the Upper Midwest, announced today a spinal implant developed... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3524 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3524 Thu, 27 Aug 2009 16:43:00 +0000 Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R) KVISTGAARD, Denmark, August 24 /PRNewswire/ -- Bavarian Nordic A/S (OMX: BAVA) announced today that the US authorities have initiated negotiations for a new contract to develop a freeze-dried version... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3498 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3498 Mon, 24 Aug 2009 08:33:00 +0000 Smith & Nephew Takes Single Injection PMA to Next Stage RALEIGH and DURHAM, North Carolina, August 19 /PRNewswire/ -- Smith & Nephew (NYSE: SNN; LSE: SN) Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3491 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3491 Wed, 19 Aug 2009 21:54:00 +0000 The European Commission Approves Samsca(TM) (tolvaptan), Europe's First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) TOKYO, Japan and UXBRIDGE, England, August 3 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Europe Ltd. (OPEL) announced today that the European Commission has approved... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3433 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3433 Mon, 03 Aug 2009 20:00:00 +0000 Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA LEXINGTON, Massachusetts, August 3 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today reported positive results from the first of three Phase... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3430 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3430 Mon, 03 Aug 2009 07:00:00 +0000 FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents PHILADELPHIA, July 28 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3413 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3413 Tue, 28 Jul 2009 07:00:00 +0000 GONAL-f Approved in Japan for Ovulation Induction in Infertile Women GENEVA, Switzerland, July 16 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the Japanese Ministry of Health, Labor and Welfare has granted approval... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3380 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3380 Thu, 16 Jul 2009 09:00:00 +0000 Pulmonx Announces New President and CEO Michael A. Baker to Lead Interventional Pulmonology Company REDWOOD CITY, California, July 16 /PRNewswire/ -- Pulmonx, an emerging leader in interventional pulmonology and in the development of device therapies for the treatment of emphysema announced today... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3377 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3377 Thu, 16 Jul 2009 01:29:00 +0000 Unisense FertiliTech A/S Receives CE Mark of Approval for EmbryoScope(TM) Embryo Monitoring System AARHUS, Denmark, July 7 /PRNewswire/ -- Unisense FertiliTech A/S ( http://www.fertilitech.com) announces that the EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray have received CE... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3337 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3337 Tue, 07 Jul 2009 09:00:00 +0000 Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease LEXINGTON, Massachusetts, July 6 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3332 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3332 Mon, 06 Jul 2009 20:01:00 +0000 FDA Approves Multaq(R) for Patients With Atrial Fibrillation or Atrial Flutter PARIS, July 2 /PRNewswire/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets.... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3320 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3320 Thu, 02 Jul 2009 09:04:00 +0000 Living Cell Technologies' Diabetes Clinical Trial Authorized by New Zealand Government SYDNEY and AUCKLAND, New Zealand, June 24 /PRNewswire/ -- Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that the New Zealand Minister of Health, the Honourable Tony Ryall,... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3273 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3273 Wed, 24 Jun 2009 09:00:00 +0000 Neurim Pharmaceuticals Reports Long Term Efficacy and Safety for Circadin(R) for Insomnia in Elderly Patients SEATTLE, June 11 /PRNewswire/ -- Neurim Pharmaceuticals (http://www.neurim.com) presented today the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3195 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3195 Thu, 11 Jun 2009 09:00:00 +0000 Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards HUNTINGTON BEACH, California, and AMSTERDAM, May 28 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition.... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3126 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3126 Thu, 28 May 2009 13:33:00 +0000 HRA Pharma Granted European Marketing Authorization for ellaOne(R) PARIS, May 26 /PRNewswire/ -- HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3106 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3106 Tue, 26 May 2009 12:12:00 +0000 Nerviano Medical Sciences Receives Approval From the FDA to Enter Phase I Clinical Trials for Their Polo Like Kinase (PLK) Inhibitor NERVIANO, Italy, May 13 /PRNewswire/ -- The FDA has approved an Investigational New Drug (IND) application by Nerviano Medical Sciences to begin a phase I clinical study with its selective PLK-1... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3043 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3043 Wed, 13 May 2009 08:00:00 +0000 D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3010 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3010 Wed, 06 May 2009 13:00:00 +0000 Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma EVRY, France, May 6 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, announces today that the Company's Investigational New Drug Application (IND) to conduct a Phase III... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3004 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/3004 Wed, 06 May 2009 07:00:00 +0000 NanoVibronix Receives Wound Healing Indications in Europe for its PainShield(TM) Device NESHER, Israel, April 21 /PRNewswire/ -- NanoVibronix, a medical device company specializing in applications that implement surface ultrasound waves, announced that its novel device has received CE... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2921 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2921 Tue, 21 Apr 2009 13:30:00 +0000 Simbionix and Johnson & Johnson LLC Announce Distribution Agreement at Russia and the CIS Countries CLEVELAND, Ohio, April 16 /PRNewswire/ -- Simbionix, the world's leading developer of medical simulation systems, today announced an agreement with Johnson & Johnson LLC for distribution of... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2889 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2889 Thu, 16 Apr 2009 08:10:00 +0000 Novagali Pharma Completed a New Phase II With Cyclokat(R) in Dry Eye EVRY, France, April 15 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, today announces successful completion of a new Phase II clinical study with Cyclokat(R), its... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2882 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2882 Wed, 15 Apr 2009 13:00:00 +0000 Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA UPPSALA, Sweden, April 14 /PRNewswire/ -- Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2879 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2879 Tue, 14 Apr 2009 11:19:00 +0000 InSightec Ltd. Announces US$15 Million Investment Round TIRAT CARMEL, Israel, March 19 /PRNewswire/ -- InSightec Ltd. reported today that it has closed an internal round of financing totaling US$15 million from its existing investors. Elbit Imaging... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2736 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2736 Thu, 19 Mar 2009 09:09:00 +0000 U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent HOUSTON, March 18 /PRNewswire/ -- IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced today that the U.S. Food and... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2725 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2725 Wed, 18 Mar 2009 13:00:00 +0000 FDA Provides A Positive Review of InNexus Biotechnology Development Plan for Lead Product BRITISH COLUMBIA, Canada, March 3 /PRNewswire/ -- InNexus Biotechnology Inc. (Toronto Stock Exchange: IXS.V), a drug development company commercializing the next generation of monoclonal antibodies... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2661 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2661 Tue, 03 Mar 2009 21:46:00 +0000 Novagali Pharma Presents Results of its Innovative Latanoprost Formulation for Glaucoma EVRY, France, February 27 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, announced the results of its first set of data pertaining to Nova21027, its innovative BAK-free... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2631 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2631 Fri, 27 Feb 2009 07:00:00 +0000 Tramacet(R) Builds Gr LONDON, February 16 /PRNewswire/ -- From 1st January Gr http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2556 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2556 Mon, 16 Feb 2009 12:02:00 +0000 FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers NERVIANO, Italy, February 10 /PRNewswire/ -- Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2533 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2533 Tue, 10 Feb 2009 08:00:00 +0000 Algeta to Enroll US Patients Into Global Phase III ALSYMPCA Trial Following Successful End-of-Phase II Meeting With FDA OSLO, Norway, February 3 /PRNewswire/ -- Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that it is to enroll US patients into its ALSYMPCA phase III trial evaluating Alpharadin... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2513 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2513 Tue, 03 Feb 2009 09:00:00 +0000 Treatment Approval - a Step Forward in Managing Severe Psoriasis in Children TAPLOW, England, January 8 /PRNewswire/ -- Wyeth Pharmaceuticals has today announced that Enbrel(R) (etanercept) is approved for the treatment of chronic severe plaque psoriasis in children aged 8... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2373 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2373 Thu, 08 Jan 2009 13:30:00 +0000 FDA Approves Ferring Pharmaceuticals' Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer PARSIPPANY, New Jersey, December 24 /PRNewswire/ -- Ferring Pharmaceuticals, USA today received approval from the U.S. Food and Drug Administration (FDA) for degarelix, a new... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2345 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2345 Wed, 24 Dec 2008 23:30:00 +0000 Neuralstem Files FDA Application for First ALS Stem Cell Trial ROCKVILLE, Maryland, December 19 /PRNewswire/ -- Neuralstem, Inc. (NYSE Alternext US: CUR) announced this morning that it has filed an Investigational New Drug (IND) application with the U.S.... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2333 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2333 Fri, 19 Dec 2008 07:00:00 +0000 Committee for Medicinal Products for Human Use (CHMP) Recommends Granting Marketing Authorisation for FIRMAGON(R) (degarelix) for Treatment of Prostate Cancer SAINT PREX, Switzerland, December 18 /PRNewswire/ -- Ferring Pharmaceuticals received today notification that the Committee for Medicinal Products for Human Use (CHMP), part of the European... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2329 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2329 Thu, 18 Dec 2008 18:44:00 +0000 Kiadis Pharma Receives Two Orphan Drug Designations for Reviroc(TM) From the FDA AMSTERDAM, December 8 /PRNewswire/ -- Biopharmaceutical company Kiadis Pharma announces today that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc(TM) Orphan Drug... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2271 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2271 Mon, 08 Dec 2008 13:46:00 +0000 diaDexus Receives CE Mark Certification for the PLAC(R) Test SOUTH SAN FRANCISCO, California, December 1 /PRNewswire/ -- diaDexus, Inc. today announced that it received CE Mark approval for the automated format of the PLAC Test for Lp-PLA2. This automated... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2222 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2222 Mon, 01 Dec 2008 13:00:00 +0000 ThromboGenics N.V.: Business Update LEUVEN, Belgium, November 6 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on innovative treatments for eye disease, vascular disease and cancer, is today... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2064 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2064 Thu, 06 Nov 2008 16:40:00 +0000 Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform PLEASANTON, California, October 30 /PRNewswire/ -- Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R)... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2026 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/2026 Thu, 30 Oct 2008 23:58:00 +0000 NanoVibronix Receives FDA Clearance for its PainShield(TM) MD Device NESHER, Israel, October 23 /PRNewswire/ -- NanoVibronix, a medical device company, announced that the US Food and Drug Administration (FDA) has granted 510K clearance to market PainShield(TM) MD, a... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1973 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1973 Thu, 23 Oct 2008 13:00:00 +0000 Simbionix Launches Innovative Patient-Specific Simulation CLEVELAND, Ohio, October 3 /PRNewswire/ -- Simbionix, the world's leading developer of medical simulation systems, advances procedural simulation from theoretical promise to operating room reality. ... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1852 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1852 Fri, 03 Oct 2008 12:00:00 +0000 ITGI Medical Received a CE Mark for its Second Pericardium Covered Stent - AneuGraft(R) - for Tortuous Vessels OR AKIVA, Israel, September 30 /PRNewswire/ -- ITGI Medical, Ltd. (TASE: ITGI) a company engaged with research, development, manufacturing and marketing of heterologous tissue covered stents,... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1827 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1827 Tue, 30 Sep 2008 07:00:00 +0000 Sun Pharmaceutical Announces USFDA Approval to Market Generic Paraplatin(R) Injection MUMBAI, India, September 23 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for the Abbreviated New Drug Application (ANDA) to market... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1788 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1788 Tue, 23 Sep 2008 15:56:00 +0000 Sun Pharma Gets USFDA Approval for Generic Fosamax (R) Tablets MUMBAI, India, September 12 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1711 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1711 Fri, 12 Sep 2008 13:55:00 +0000 Positive SPA Reply From the FDA for TopoTarget's Pivotal Trial With Belinostat in PTCL COPENHAGEN, Denmark, September 5 /PRNewswire/ -- TopoTarget A/S (OMX: TOPO) announced that a positive reply from the FDA was received on a Special Protocol Assessment (SPA) for a phase III trial... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1642 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1642 Fri, 05 Sep 2008 15:51:00 +0000 Neurotech Granted Fast Track Designations from the FDA for NT-501 in Two Indications - Retinitis Pigmentosa and Dry Age-Related Macular Degeneration LINCOLN, Rhode Island, September 3 /PRNewswire/ -- Neurotech Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of sight-saving therapeutics for chronic... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1622 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1622 Wed, 03 Sep 2008 13:00:00 +0000 Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA SAN DIEGO and INDIANAPOLIS, August 27 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call today provided context and... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1572 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1572 Wed, 27 Aug 2008 00:35:00 +0000 Cambridge Laboratories Announces FDA Approval of XENAZINE(R) (tetrabenazine) in the US LONDON, August 18 /PRNewswire/ -- Cambridge Laboratories Group Limited ("Cambridge"), the privately owned specialty pharmaceutical company, announces today that XENAZINE(R) (tetrabenazine), the first... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1538 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1538 Mon, 18 Aug 2008 07:00:00 +0000 Sun Pharma Gets USFDA Approval for Generic Depakote (R) Delayed Release Tablets MUMBAI, July 30 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for generic Depakote (R),... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1466 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1466 Wed, 30 Jul 2008 13:09:00 +0000 Successful Inspection of Helsinn Birex Pharmaceuticals Dublin, Ireland by the US Food and Drug Administration DUBLIN, Ireland, July 22 /PRNewswire/ -- Helsinn is pleased to announce that Helsinn Birex Pharmaceuticals, its drug facility in Dublin, Ireland, has undergone a successful inspection by the US Food... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1431 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1431 Tue, 22 Jul 2008 11:56:00 +0000 Inion Receives 510(k) Marketing Clearance to Sell its Biodegradable Graft Containment Systems in the USA for Spinal Fusion Procedures TAMPERE, Finland and GUILDFORD, England, July 21 /PRNewswire/ -- Inion (LSE: IIN), the company focused on the development and commercialisation of novel biodegradable medical implants, today... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1426 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1426 Mon, 21 Jul 2008 14:50:00 +0000 Bioheart, Inc. to Introduce At-Home Heart Failure Monitor for Congestive Heart Failure Patients SUNRISE, Florida, July 11 /PRNewswire/ -- Bioheart, Inc. (Nasdaq: BHRT), a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1378 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1378 Fri, 11 Jul 2008 08:00:00 +0000 FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent ABBOTT PARK, Illinois, July 2 /PRNewswire/ -- Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1335 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1335 Wed, 02 Jul 2008 21:50:00 +0000 Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System PRINCETON, New Jersey, June 26 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1299 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1299 Thu, 26 Jun 2008 06:00:00 +0000 FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics' Unique Proprietary Chemistry LONDON, June 25 /PRNewswire/ -- Silence Therapeutics plc (London AIM: SLN) today announces that the U.S. Food and Drug Administration (FDA) has approved a Quark Pharmaceuticals Inc ("Quark")... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1295 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1295 Wed, 25 Jun 2008 15:01:00 +0000 Stallergenes : Sublingual Desensitisation Tablets Oralair Grasses Approved in Germany ANTONY, France, June 24 /PRNewswire/ -- Today, Stallergenes has been granted with the marketing authorisation for its sublingual desensitisation tablet, Oralair(R) Grasses in adults, by PEI (Paul... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1280 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1280 Tue, 24 Jun 2008 17:49:00 +0000 Merck Serono Announces Initiation of Second Phase II/III Clinical Study of Atacicept in Lupus GENEVA, Switzerland, June 5 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its development partner ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today the initiation of... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1152 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1152 Thu, 05 Jun 2008 07:00:00 +0000 Simbionix Takes Non-Invasive GYN Surgical Training to the Next Level CLEVELAND, Ohio, June 2 /PRNewswire/ -- Simbionix has announced the release of a new and exciting module for its LAP Mentor simulator that gives trainees hands-on experience with different techniques... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1129 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1129 Mon, 02 Jun 2008 14:36:00 +0000 Over and Under(R) Pericardium Covered Stent is now in use in England and Proves Great Deliverability OR AKIVA, Israel, June 2 /PRNewswire/ -- ITGI Medical, Ltd. (TASE: ITGI) announced today the first commercial use of the CE certified Over and Under(R) Pericardium Covered Stent (PCS) in the UK ... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1127 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1127 Mon, 02 Jun 2008 12:00:00 +0000 First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA EDMONTON, Canada, May 29 /PRNewswire/ -- The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced today that, based on its study BCIRG 006,... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1101 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1101 Thu, 29 May 2008 22:20:00 +0000 Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers COLLEGEVILLE, Pennsylvania, May 29 /PRNewswire/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1096 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1096 Thu, 29 May 2008 14:29:00 +0000 FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids TIRAT CARMEL, Israel, May 28 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1080 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1080 Wed, 28 May 2008 13:00:00 +0000 Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C PRINCETON, New Jersey, May 19 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) has nominated PSI-7851 as a lead development candidate for the treatment of chronic hepatitis C virus (HCV). PSI-7851 is... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1027 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/1027 Mon, 19 May 2008 12:05:00 +0000 Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension APPENZELL, Switzerland, May 15 /PRNewswire/ -- Ergonex Pharma today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/999 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/999 Thu, 15 May 2008 09:15:00 +0000 FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis ST. DAVID'S, Bermuda and COPENHAGEN, Denmark, May 12 /PRNewswire/ -- Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration (FDA) has approved the New Drug... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/972 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/972 Mon, 12 May 2008 14:54:00 +0000 Duska Therapeutics Plans 505(b) (2) NDA Filing Route for ATPace(TM) LA JOLLA, California, April 25 /PRNewswire/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska" or the "Company"), a biotechnology company developing medical products based on adenosine... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/866 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/866 Fri, 25 Apr 2008 08:00:00 +0000 FDA Clears First Medical Product Made From Yulex(R) Natural Rubber MARICOPA, Arizona, April 24 /PRNewswire/ -- Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/859 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/859 Thu, 24 Apr 2008 16:00:00 +0000 FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults BASINGSTOKE, England and PHILADELPHIA, April 23 /PRNewswire/ -- Shire plc (LSE: SHP) (NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/844 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/844 Wed, 23 Apr 2008 16:41:00 +0000 ES Vascular Receives CE Mark for its First Aortic Stapler for End-to-End Anastomosis Between Synthetic Grafts and Aorta During Open Repair of Aortic Aneurysmal and Occlusive Disease HAIFA, Israel, April 14 /PRNewswire/ -- ES Vascular Ltd. announced today that it has received a CE Mark approval for its Open Aortic Stapler (OAS) system for mechanical suturing technology of aortic... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/781 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/781 Mon, 14 Apr 2008 08:00:00 +0000 Galderma Completes Acquisition of CollaGenex LAUSANNE, Switzerland, April 11 /PRNewswire/ -- Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, today announced that its U.S. holding company,... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/774 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/774 Fri, 11 Apr 2008 22:32:00 +0000 Kingfisher Healthcare (KFH) Receives FDA Clearance to Market KFH Energy in the USA And Raises EUR1 Million to Accelerate Market Penetration LEUVEN, Belgium, March 31 /PRNewswire/ -- Kingfisher Healthcare, a young healthcare company focused on improving patient quality of life, announced today that the U.S. Food and Drug Administration... http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/636 http://pharmalicensing.com/redirs/news_rss/public/news/viewNewsML/636 Mon, 31 Mar 2008 07:00:00 +0000