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News of the day
Spectrum Pharmaceuticals Announces Sale of Injectable Generic Drugs to Sagent Pharmaceuticals, Inc.
IRVINE, Calif., May 09, 2008-- Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI): Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) announced today that it has sold its abbreviated new drug applications (ANDAs) for its injectable generic drugs, ondansetron, carboplatin, fludarabine, and mitoxantrone, to Sagent Pharmaceuticals, Inc. moreAdolor Provides Regulatory Update on Entereg(R) (alvimopan)
EXTON, Pa.--May 9, 2008--Adolor Corporation (Nasdaq:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg(R) (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date. The FDA did not provide a specific date, but informed the company that it expects to issue the action letter shortly. moreFDA Approves New Formulation of Coagulation Therapy
May 9, 2008--The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. moreIndustry news search
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- Bayer Challenges Watson and Sandoz U.S. ANDA Filings on Yasmin®
- Shire enhances its orphan drug pipeline with the acquisition of a new clinical candidate for Metachromatic Leukodystrophy
- ChemGenex Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA
- Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch
- FDA Moves Sancuso PDUFA Date to mid-June
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FDA Approves First Generic Ropinirole
May 9, 2008-- The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
FDA ADVISORY COMMITTEE VOTES IN FAVOR OF APPROVAL OF FOSPROPOFOL DISODIUM INJECTION FOR SEDATION
May 8, 2008--Eisai Corporation of North America and its U.S. subsidiary, MGI PHARMA, INC., today announced that the U.S. Food and Drug Administration (FDA) Advisory Committee on Anesthetic and Life Support Drugs...
Artes Medical to Announce First Quarter 2008 Financial Results
SAN DIEGO, May 08, 2008 -- Artes Medical, Inc. (Nasdaq:ARTE), a medical technology company whose product ArteFill(R) is the first and only FDA-approved non-resorbable injectable dermal filler for the correction of...
Marketing Authorization granted by European Commission for Adenuric® (TMX-67, febuxostat) for the treatment of hyperuricaemia in gout
May 7, 2008 - Teijin Pharma Limited ("Teijin"; headquarters: Chiyoda-ku, Tokyo; President:Osamu Nishikawa) announced today that on April 21, 2008, its licensee for Europe, Ipsen (stock code Euronext: IPN), an innovation...
St. Jude Medical Announces FDA Clearance and CE Mark Approval of Strada Carotid Guiding Sheath
ST. PAUL, Minn.--May 7, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada(TM) Carotid Guiding Sheath, a flexible tube...
GORE Receives CE Mark for GORE PRECLUDE® Vessel Guard
May 06, 2008 (Flagstaff, Arizona) -- W. L. Gore & Associates (Gore) announced today it received approval to apply the CE Mark for the commercial sale of the GORE PRECLUDE® Vessel Guard, the first non-biological membrane...
OncoVista Innovative Therapies, Inc. Announces Submission of Request for Pre-IDE Determination Meeting with FDA for AdnaGen's AdnaTest Breast Cancer Device for Detection of Circulating Breast Tumor Cells
SAN ANTONIO, TX, May 6, 2008 - OncoVista Innovative Therapies Inc. (OTC BB: OVIT.OB), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies, announced the submission...
Masimo Showcases Best-in-Class Patient Safety Solutions at the AACN Conference
Irvine, California--May 6, 2008 -- Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion Pulse Oximetry, will showcase the latest technology for patient safety solutions at the American...
Lev Pharmaceuticals Announces Cinryze(TM) Complete Response Submission Accepted for Review by FDA
NEW YORK-- May 6, 2008--Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze(TM) (C1...
Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events
WASHINGTON, MAY 6 -- Data presented today on Vanda Pharmaceuticals Inc.'s (Nasdaq: VNDA) investigational drug candidate, iloperidone, included its 4-week, short-term Phase III trial, as well as a pooled analysis of...
Sernova Concludes Successful Pre-IND Meeting with FDA
London, Ontario - May 6, 2008 - Sernova Corp. (TSX-V: SVA) -- Sernova Corp. today announced the successful conclusion of a meeting with the U.S. Food and Drug Administration (FDA) that established definitive...
Roxane Laboratories Announces the Launch of Ropinirole Hydrochloride Tablets
COLUMBUS, Ohio, May 5 -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by the U.S....
FOUGERA FIRST-TO-MARKET WITH CALCIPOTRIENE TOPICAL SOLUTION 0.005% (Rx) (SCALP SOLUTION)
Melville, New York, May 6, 2008 - Today, Fougera, a division of Nycomed US Inc., announced it has received FDA approval to bring to market the first generic Calcipotriene Topical Solution 0.005% (Rx) (Scalp Solution)....
GORE Receives Approval from FDA for Unique Patent Foramen Ovale Stroke Study
May 05, 2008 (Flagstaff, Arizona) -- W. L. Gore & Associates (Gore) today announced that it has received approval from the US Food & Drug Administration (FDA) to proceed with the Gore REDUCE* Clinical Study. The Gore...
Discovery Labs Provides Guidance on FDA Approvable Letter for Surfaxin® for RDS
Warrington, PA May 5, 2008 Discovery Laboratories, Inc. (Nasdaq: DSCO) on May 1, 2008 received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin® (lucinactant) for the prevention of...
VALEANT PHARMACEUTICALS ANNOUNCES TEMPORARY STAY IN EFUDEX® CASE
ALISO VIEJO, Calif., May 5, 2008 - Valeant Pharmaceuticals (NYSE:VRX) today announced that Spear Pharmaceuticals has agreed not to market, sell or ship a generic fluorouracil cream 5% pursuant to a stay in Valeant's...
SenoRx Receives Clearance for Modified Contura MLB Warning Label
ALISO VIEJO, California, May 5, 2008 - SenoRx, Inc. (NASDAQ: SENO) today announced that it has received clearance to modify a warning on its Contura(TM) Multi-Lumen Radiation Balloon (MLB) Catheter product label from...
Discovery Labs Receives an Approvable Letter from FDA for Surfaxin® for RDS
Warrington, PA -- May 2, 2008 -- Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin® (lucinactant) for the...
Stryker's Biotech Division Receives FDA Warning Letter
KALAMAZOO, Mich., May 2 -- Stryker Corporation (NYSE: SYK) announced today that its Biotech division has received a warning letter from the U. S. Food and Drug Administration (FDA) related to quality systems and...
Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze(TM) for Hereditary Angioedema
NEW YORK & WASHINGTON, May 02, 2008 -- Lev Pharmaceuticals, Inc. (OTCBB: LEVP) today announced that the Blood Products Advisory Committee to the U.S. Food and Drug Administration (FDA) today voted unanimously that there...
NEXMED FACILITY RECEIVES GMP CERTIFICATION FROM HEALTH CANADA
East Windsor, NJ, May 2, 2008 -- NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on the NexACT drug delivery technology, today announced that Health Canada has confirmed Good...
AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA(TM)) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer
May 02, 2008--AstraZeneca today announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA(TM)) as a treatment for locally...
Aurobindo Pharma receives nine product approvals from MCC - South Africa
May 01, 2008-Aurobindo Pharma Ltd is pleased to announce that it has received approvals from the Medicines Control Council (MCC) to manufacture and market 9 products in South Africa. These products are estimated to have...
AngioScore Receives FDA Clearance to Market AngioSculpt PTA Scoring Balloon Catheter for Additional Peripheral Indications
Fremont, CA-May 1, 2008-AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its AngioSculpt® Percutaneous Transluminal Angioplasty (PTA)...
BD Announces CE Marking of the BD GeneOhm(TM) VanR Molecular Test for the Rapid Detection of Vancomycin Resistance
San Diego, CA -- Thursday, May 01, 2008 -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the CE marking of the BD GeneOhm(TM) VanR assay for the rapid detection of vanA and vanB genes,...
Pyng Medical Receives US FDA and Health Canada Clearance For Expanded Use of FAST1(TM) Leading Sternal IO System Now Available For Both Adolescent and Adult Care Throughout the US, Canada and EU
Vancouver, BC - May 01st, 2008 - Pyng Medical Corp. (PYT: TSX .V) today announced it has received regulatory clearance from both the US Food and Drug Administration (FDA) and Health Canada to market its FAST1(TM)...
REGULATORY PATH FOR BRONCHITOL IN BRONCHIECTASIS
01 May 2008 - Pharmaxis (ASX: PXS, NASDAQ: PXSL) today announced that it has agreed with advice from the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 trial of the company's mucus clearing...
Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
01 May 2008 - PHILADELPHIA - May 1, 2008 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention Deficit...
LANNETT COMPANY TO REMAIN A MAJOR MARKETER OF DIGOXIN TABLETS
Philadelphia, PA - April 30, 2008 - Lannett Company, Inc. (AMEX: LCI) today said it will continue to market its Digoxin Tablets and that the company's Digoxin product is not subject to the recent FDA announced recall of...
Lundbeck expands geographical rights for Circadin®
April 30, 2008 -- H. Lundbeck A/S and Neurim Pharmaceuticals Ltd. today announced that Lundbeck has obtained expanded exclusive rights to commercialize Circadin® in Asia, Latin America and other major markets such as...
SPHERIX D-TAGATOSE TO BE SUPPLIED BY INALCO S.P.A.
April 30, 2008 -- BETHESDA, MD. Spherix Incorporated (NASDAQ/SPEX) announced today that it has signed letters of intent with Inalco S.p.A., an Italy-based manufacturer of bulk pharmaceutical ingredients, to supply a...
FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's TRELSTAR(R) DEPOT and TRELSTAR(R) LA
CORONA, Calif., April 30, 2008 -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has approved MIXJECT(TM), the new...
SCOLR Pharma, Inc. Announces Positive Progress for Lead Product
BELLEVUE, Wash.-April 30, 2008-SCOLR Pharma, Inc. (AMEX: DDD - News) today announced that it has received a special protocol assessment from the Food and Drug Administration (FDA) to guide the design of its Phase III...
Lombard Medical Tech - Pivotal Trial Commences
London, UK, 30 April 2008 - Lombard Medical Technologies PLC ('Lombard Medical' or 'the Company'), the specialist medical device company, today announces the commencement of its pivotal US clinical trial for its...
ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
IRVINE, Calif., April 30, 2008 -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive results from the preliminary analysis of its second and final Bepreve(TM) (bepotastine ophthalmic solution) Phase III...
FDA approves Advair 250/50 for reduction of exacerbations in patients with COPD
Research Triangle Park, N.C., April 30, 2008 -- The U.S. Food and Drug Administration today approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of...
Sucampo Pharmaceuticals Obtains FDA Approval for AMITIZA® for the Treatment of Irritable Bowel Syndrome with Constipation in Adult Women
Bethesda - Maryland, Deerfield - Illinois, and Osaka - Japan --- April 30, 2008 --- Sucampo Pharmaceuticals, Inc., (NASDAQ: SCMP, Sucampo Pharmaceuticals) and Takeda Pharmaceutical Company Limited (TSE: 4502, Takeda)...
FDA Approves Amitiza for IBS-C
April 29, 2008 -- The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently...
Coronary Artery Plaque Imaging Device Cleared by FDA
April 29, 2008 -- The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the...
Mylan Announces Final FDA Approval for Trandolapril Tablets
PITTSBURGH, April 29, 2008 -- Mylan Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application...
FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx
BURLINGTON, Mass., April 29, 2008 -- InfraReDx, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan(TM) Coronary Imaging...
Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
REDWOOD CITY, Calif., April 29 -- Cardica, Inc. (Nasdaq: CRDC) today announced that the PAS-Port(R) Proximal Anastomosis System achieved its primary endpoint in a large, prospective, randomized pivotal clinical trial...
CryoCath achieves key milestone of 270 consented patients for STOP AF IDE Trial for its Arctic Front Atrial Fibrillation therapy system
Montreal, Quebec, Canada - April 29, 2008 - CryoCath (TSX: CYT), the global leader in cryotherapy products to treat cardiac arrhythmias, today announced that it recently achieved the target of consenting 270 patients...
Watson Announces Removal of FDA Official Action Indicated Status at Its Davie, Florida Facility
CORONA, Calif., April 29, 2008 -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has completed the inspection of...
FDA Approves Second Improvement to Unigene's Calcitonin Manufacturing Process
FAIRFIELD, N.J., Apr 29, 2008 -- The U.S. Food and Drug Administration (FDA) has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical(R), Unigene Laboratories, Inc.'s...
Medtronic Receives Approval to Market Smaller Kit Sizes of Infuse® Bone Graft
MEMPHIS, Tenn. - April 29 , 2008 - Medtronic, Inc. (NYSE: MDT) today announced it has received approval to market two smaller kit sizes of INFUSE® Bone Graft for use in certain spinal fusion and dental regenerative...
Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers
EVANSTON, Ill., April 29, 2008 -- Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that Steven A. Gould, M.D., Chairman and Chief Executive Officer, presented a talk on the clinical development of...
Acusphere Submits New Drug Application for FDA Approval of Imagify(TM)
WATERTOWN, Mass., Apr 28, 2008-- Acusphere Inc. (NASDAQ: ACUS) announced today the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product...
Axis-Shield announces FDA Marketing Clearance and forthcoming global launch of its homocysteine assay on the Abbott Architect Analyser
Dundee, Scotland, 28 April, 2008: Axis-Shield (LSE:ASD, OSE:ASD), the international in-vitro diagnostics (IVD) company, today announces that it has completed the development and manufacturing of a new assay for...
Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
WHITEHOUSE STATION, N.J., April 28, 2008 - Merck & Co., Inc. today received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER...
Third Wave Completes FDA Submissions for Its Two HPV Products
MADISON, Wis., Apr 28, 2008 -- Third Wave Technologies Inc. (NASDAQ: TWTI) today announced that the company has submitted the pre-market approval (PMA) applications for its two human papillomavirus, or HPV, testing...
Teva Announces Approval Of Generic Flolan® For Injection
Jerusalem, Israel, April 28, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application...
Sorin Group Cardiac Rhythm Management Announces CE Mark and First Implant of a New-Generation CRT-D Device Designed to Provide Hemodynamic Management of Heart Failure
Paris - April 28, 2008 - Sorin Group Cardiac Rhythm Management announced today the first implant in a clinical trial of its new-generation PARADYM(TM) 8770 sonR(TM) cardiac resynchronization therapy defibrillator...
POZEN Announces Receipt of $20 Million in Milestone Payments from GlaxoSmithKline
CHAPEL HILL, N.C.--April 28, 2008--POZEN Inc. (NASDAQ: POZN), today announced the receipt of a total of $20 million in milestone payments from GlaxoSmithKline (GSK) for the U.S. Food and Drug Administration approval of,...
NeuroMetrix Receives FDA 510(k) Clearance for the ADVANCE(TM) System for the Performance of Nerve Conduction Studies and Needle Electromyography Procedures
WALTHAM, Mass.-- April 28, 2008--NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has received 510(k) clearance for its ADVANCE System ("ADVANCE") from the U.S. Food and Drug Administration (FDA). This...
Swissmedic grants Clinuvel Orphan Drug Status for CUV1647
April 28, 2008 - Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is very pleased to announce that its photo protective drug CUV1647 has been granted Orphan Drug Designation (ODD) by Swissmedic,...
FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen
CARLSBAD, Calif. and CAMBRIDGE, Mass., April 25, 2008 -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Genzyme Corp. (Nasdaq: GENZ) announced today that the FDA has provided guidance regarding approval requirements for...
Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab
PRINCETON, N.J., April 25, 2008 -- Medarex, Inc. (Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay...
EMEA's Committee for Human Medicinal Products reviews heparin issues
April 25, 2008 - The EMEA's Committee for Human Medicinal Products (CHMP) is reviewing issues related to the treatment with and supply of heparin products. The review was initiated following the detection of a...
European Regulatory Authority (EMEA) Recommends Granting of Marketing Authorization for MediGene's Drug Oracea®
Martinsried/Munich, 25. April 2008. MediGene AG (Frankfurt, Prime Standard: MDG) announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has concluded the approval...
GSK receives positive opinion for conditional approval of new oral breast cancer treatment, Tyverb (lapatinib)
Friday 25 April 2008, London, UK -- GlaxoSmithKline (GSK) announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a revised positive opinion...
Progenics and Wyeth Announce FDA has Approved Relistor
Tarrytown, N.Y. and Collegeville, Pa., April 25, 2008 - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug...
Progenics and Wyeth Announce FDA Has Approved RELISTOR
TARRYTOWN, N.Y. & COLLEGEVILLE, Pa., April 24, 2008 -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug...
Wyeth and Progenics Receive Positive Opinion From European Committee for RELISTOR for the Treatment of Opioid-Induced Constipation in Advanced-Illness Patients
COLLEGEVILLE, Pa. and TARRYTOWN, N.Y., April 24, 2008 -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received a...
FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis
CINCINNATI and BRIDGEWATER, N.J., April 24, 2008 -- The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel(R) (risedronate sodium) tablets for the treatment and prevention of...
Strides Arcolab receives 2 ANDA approvals for Ondansetron Injection USP, 2 mg/ml (20 ml vials) and 2 mg/ml (2 ml vials)
Bangalore, India: April 24, 2008 - Strides Arcolab today announced receipt of 2 ANDA approvals for Ondansetron Injection USP, 2 mg/ml (20 ml vials) and 2 mg/ml (2 ml vials).
Jerini Receives Positive CHMP Opinion Recommending European Approval for Icatibant in the Treatment of HAE; FDA Issues Not Approvable Letter
Berlin, April 24, 2008 - Jerini AG (FSE:JI4) announced today that the company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for...
FDA Approves Relistor for Opioid-Induced Constipation
April 24, 2008 -- The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a...
FDA Proposes Recommendations for Two Animal Drug Funding Programs
April 24, 2008 -- The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.
SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis
Heidelberg, April 24, 2008 - SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime Standard), today announced that it has received Orphan Drug designation from the European Commission for AX200 in the treatment of...
Shire enhances its orphan drug pipeline with the acquisition of a new clinical candidate for Metachromatic Leukodystrophy
24 Apr 2008 - Basingstoke, UK and Cambridge, MA, US - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces the acquisition of arylsulfatase -A (ASA) an Enzyme Replacement...
Wyeth And Progenics Receive Positive Opinion From European Committee For Relistor For The Treatment Of Opioid-Induced Constipation In Advanced-Illness Patients
Collegeville, Pa., and Tarrytown, N.Y., April 24, 2008 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received a...
Cimzia(R), Utilizing Enzon's Pegylation Technology, Approved in the U.S.
BRIDGEWATER, N.J., April 23, 2008 -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the U.S. Food and Drug Administration (FDA) has approved Cimzia(R), the first and only PEGylated anti-TNFa (Tumor...
Paion announces the acquisition of world-wide rights to flovagatran
Aachen ( Germany), 23 April 2008 - PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8) today announced that it has acquired the world-wide rights to flovagatran, a direct thrombin inhibitor, from UK-based Trigen...
PAION AG ACQUIRES WORLD-WIDE RIGHTS TO ANTICOAGULANT FLOVAGATRAN FROM UK COMPANY TRIGEN
Aachen (Germany), 23 April 2008 - PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8) today announced that it has acquired the world-wide rights to flovagatran, a direct thrombin inhibitor, from UK-based Trigen...
FDA Approves VYVANSE (TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Basingstoke, U.K. and Philadelphia, PA - April 23, 2008 - Shire plc (LSE: SHP, NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug...
FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform
SAN FRANCISCO, April 23, 2008 --The U.S. Food and Drug Administration (FDA) approved UCB's Cimzia(R) (certolizumab pegol) for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult...
Stem Cell Therapeutics Corp. Receives "May Proceed" From FDA for Its Phase IIb Clinical Stroke Trial and IND
CALGARY, ALBERTA-- April 23, 2008 - Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce that the U.S. Food and Drug Administration (FDA) has allowed its investigational new drug application...
More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
Collegeville, Pa., April 23, 2008- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL®...
Biovail Receives FDA Approval for Aplenzin (BVF-033)
TORONTO--April 23, 2008--Biovail Corporation (NYSE: BVF) (TSX: BVF) announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for...
FDA Clears Glove Made from New Type of Latex
April 23, 2008 -- The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is...
FDA Moves Sancuso PDUFA Date to mid-June
Galashiels, Scotland, 23 April, 2008 - ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, today announces that it has received notification from the US Food and Drug Administration...
Ark Therapeutics Grp - Regulatory Update
London, UK, 22 April 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') today announces that the Paediatric Committee at the European Medicines Agency (EMEA) has given a positive opinion on the Company's...
ImClone Announces Agreement with FDA on Special Protocol Assessment for Phase III Study of IMC-1121B in Breast Cancer
NEW YORK-- April 22, 2008--ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that it has reached agreement with...
SCIELE PHARMA ANNOUNCES FDA ACCEPTANCE OF NDA FOR ADDRENEX PHARMACEUTICALS' CLONIBID TO TREAT HYPERTENSION
ATLANTA (April 22, 2008) - Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Addrenex Pharmaceuticals for CloniBID...
Eurand Announces EUR-1008 (Zentase) Eligibility for European Centralized Review
Milan - April 22, 2008 - Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug...
Archemix' ARC1779 Granted Orphan Designation for the Treatment of TTP, a Life-Threatening Blood Disorder
CAMBRIDGE, Mass. - April 22, 2008 - Archemix Corp., a biotechnology company focused on discovering, developing and commercializing aptamer therapeutics for rare hematological diseases, today announced that ARC1779 has...
BIOVEX AGREES SPA WITH THE FDA FOR A PIVOTAL STUDY WITH ONCOVEXGM-CSF IN METASTATIC MELANOMA AND ANNOUNCES PRESENTATION OF PHASE II RESULTS AT ASCO
Woburn, MA, April 22nd, 2008 - BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration...
GlaxoSmithKline gains approval for co-administration of Avodart® (dutasteride) with tamsulosin for the treatment of benign prostatic hyperplasia under the European Mutual Recognition Procedure
Tuesday 22 April 2008, London, UK -- GlaxoSmithKline (GSK) announced today that regulatory approval has been granted in Sweden for its 5-reductase inhibitor (5ARI) Avodart®, the only dual acting 5ARI, in combination...
Zila Receives FDA 510(k) Clearance for ViziLite Eyewear
PHOENIX--April 22, 2008--Zila, Inc. (NASDAQ:ZILA) today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market ViziLite Eyewear. ViziLite Eyewear is reusable...
Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension
ATLANTA--April 22, 2008--Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Addrenex Pharmaceuticals for CloniBID to...
Oncoscience AG receives EU orphan drug status for the EGFR monoclonal antibody Nimotuzumab (Theraloc®) for the treatment of pancreatic cancer.
Wedel, Germany - April 22, 2008 - Oncoscience AG announced that their anti-cancer drug Nimotuzumab (Theraloc®) has been designated an orphan drug by the European Medicines Agency (EMEA) for the treatment of pancreatic...
Sigma-Tau Pharmaceuticals Receives Orphan-Drug Designation for Artesunate for the Immediate Treatment of Malaria from the European Commission
GAITHERSBURG, MD, April 22, 2008 - Sigma-Tau Pharmaceuticals, Inc., a US based, wholly owned subsidiary of the Sigma-Tau Group, announced that the European Commission has granted an Orphan Drug designation for...
Dosing for RVX-208 Phase 1a Clinical Study Completed
April 22, 2008, Calgary, AB - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has completed dosing of its Phase 1a safety, tolerability and pharmacokinetics study for its lead drug...
FDA Approves Cimzia to Treat Crohn's Disease
April 22, 2008 -- A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to...
Cimzia® Approved in the US for the Treatment of Moderate to Severe Crohn's Disease
Brussels (Belgium) - April 22, 2008 - 19.30 CET - UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol), the first and only PEGylated anti-TNFa (Tumor Necrosis...
CALANDO RECEIVES FDA APPROVAL FOR PHASE I CLINICALTRIAL USING A TARGETED siRNA NANOPARTICLE THERAPEUTIC
PASADENA, Calif.--- April 21, 2008-- Calando Pharmaceuticals, a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that the U.S. Food and Drug Administration (FDA) has approved...
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