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FDA Reaches Settlement with California Hearing Device Maker
July 17, 2008 -- The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. The alleged violations involved the failure to notify the FDA of a change of outside supplier or vendor, which may have exposed patients to unnecessary health risks, such as device failure and surgery. moreBioNumerik Pharmaceuticals Observes Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept(TM) Clinical Trial
San Antonio, TX, July 17, 2008 -- BioNumerik Pharmaceuticals, Inc. ("BioNumerik") today announced that patients with adenocarcinoma (the most frequently occurring form of lung cancer) participating in a Phase II clinical trial of Tavocept(TM) showed a survival increase of approximately 198 days (6.5 months). The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept. The percentage of adenocarcinoma patients in the Tavocept group who... moreSelexis now offering rapid-development of human cell line with FDA approval pedigree
GENEVA, SWITZERLAND, July 16, 2008 - Selexis SA, a Swiss-based biotechnology company offering DNA based technologies and supportive services to enable significantly improved drug discovery, development, and cGMP production of biologics, announced today it has partnered with the National Research Counsel of Canada's Biological Research Institute (NRC-BRI) to offer the NRC-BRI HEK293 cell technologies for the contract development of high-performance stable human cell lines enabled by the Selexis... moreIndustry news search
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- Alkermes Initiates Phase 3 Clinical Study of VIVITROL(R) for the Treatment of Opioid Dependence
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FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the Treatment of Hospital-Acquired Pneumonia
Raritan, NJ (July 16, 2008) - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in favor of...
Merck: Erbitux Approved for Use in Metastatic Colorectal Cancer in Japan
Darmstadt, July 16, 2008 - Merck KGaA announced today that marketing authorization has been granted in Japan for the use of Erbitux® (cetuximab) in treating patients with epidermal growth factor receptor...
Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment
ATLANTA -- July 16, 2008 -- Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has issued an approvable letter for the head lice treatment. Sciele Pharma is working closely...
Antiosteoporotic drugs Actonel. 17.5 mg tablets and Benet. 17.5 mg tablets received approval for additional indication in patients with Paget disease of bone.
July 16, 2008 -- Ajinomoto Co., Inc. (Ajinomoto, President and CEO: Norio Yamaguchi, Headquarters: Tokyo) and Takeda Pharmaceutical Company Limited (Takeda, President: Yasuchika Hasegawa, Headquarters: Osaka) are...
EMEA PUBLIC STATEMENT ON THE SUSPENSION OF THE MARKETING AUTHORISATION FOR OPTISON (perflutren) IN THE EUROPEAN UNION
July 16, 2008 -- On 18 May 1998, the European Commission granted a marketing authorisation valid throughout the European Union for the medicinal product Optison (perflutren). Optison is a diagnostic agent for the...
Marketing and Manufacturing Approval for Differin® Gel 0.1% A topical treatment for acne vulgaris
July 16, 2008 -- Galderma KK (Head Office: Tokyo; President: Humberto C. Antunes) today announced that it received marketing and manufacturing approval for Differin® Gel 0.1% containing active ingredient, Adapalen; a...
BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for Expanded Indication of LibiGel® in FSD
Lincolnshire, Illinois (July 16, 2008) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached an additional agreement with the U.S. Food and Drug Administration...
Merck Serono: Erbitux Approved for Use in Metastatic Colorectal Cancer in Japan
Geneva, Switzerland, July 16, 2008 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that marketing authorization has been granted in Japan for the use of Erbitux® (cetuximab) in treating...
Antiosteoporotic drugs "Actonel® 17.5 mg tablets" and "Benet® 17.5 mg tablets" received approval for additional indication in patients with Paget's disease of bone: Both come in new packages.
July 16, 2008 -- Ajinomoto Co., Inc. ("Ajinomoto", President and CEO: Norio Yamaguchi, Headquarters: Tokyo) and Takeda Pharmaceutical Company Limited ("Takeda", President: Yasuchika Hasegawa, Headquarters: Osaka) are...
New England Peptide Implements Quality Management System, Prepares for ISO 9001: 2008 Registration
GARDNER, Mass., July 15, 2008 - New England Peptide, LLC (NEP), is developing a formal quality management system at its Gardner, Mass., facility, focusing on continuous process improvement and customer satisfaction.
Jerini Receives European Commission Approval for Firazyr® (Icatibant) in the Treatment of HAE
Berlin, July 15, 2008 - Jerini AG (FSE:JI4) announced today that the European Commission has granted the company marketing authorization for Firazyr® (Icatibant) in the treatment of acute attacks of hereditary...
PRO-PHARMACEUTICALS HAS REQUESTED A PRE-IND MEETING WITH THE U.S. FOOD AND DRUG ADMINISTRATION
Newton, MA - July 15, 2008 - Pro-Pharmaceuticals, Inc. (AMEX: PRW), a biopharmaceutical company developing proprietary polysaccharide-based therapeutic compounds in the treatment of cancer and fibrosis, has requested a...
Novo Nordisk files for regulatory approval of liraglutide in Japan
July 15, 2008 -- Novo Nordisk today announced the submission of a new drug application to the Ministry of Health, Labour and Welfare in Japan for the approval of liraglutide, a once-daily human GLP-1 analogue, for the...
DOR BioPharma Enters into Collaborative Agreement with IDIS for Named Patient Access of orBec® in Europe
Ewing, NJ - July 15, 2008 - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments, serious...
Inion receives 510(k) marketing clearance to sell its biodegradable graft containment systems in the USA for spinal fusion procedures
Tampere, Finland and Guildford, UK. 15 July 2008, Inion (LSE: IIN.L), the company focused on the development and commercialisation of novel biodegradable medical implants, today announces it has received 510(k)...
SYNTHEMED RECEIVES CANADIAN APPROVAL FOR REPEL-CV®
ISELIN, NJ July 15, 2008 - SyntheMed, Inc. (OTCBB: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products and other surgical implants, announced today...
St. Jude Medical Announces FDA Approval of Wireless Transmitter to Monitor Patients' Implanted Cardiac Devices
ST. PAUL, Minn. -- July 15, 2008 -- St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) approval of the Merlin(TM)@home transmitter, an RF wireless technology that remotely monitors...
Medtronic Launches First Insertable Cardiac Monitor in Japan
MINNEAPOLIS AND TOKYO - July 15, 2008 - Medtronic, Inc. (NYSE: MDT) today announced it has received Japanese regulatory approval for the Reveal DX(TM) Insertable Cardiac Monitor (ICM). The device has been designated by...
Jerini Receives European Commission Approval for FIRAZYR® (Icatibant) in the Treatment of HAE
15 July 2008 - Basingstoke, UK and Cambridge, MA, US - July 15, 2008 - Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, notes that Jerini AG (FSE:JI4) has announced today that the...
Kamada Gains Approval of KamRAB in Israel
Weizmann Science Park, Ness Ziona, Israel, July 15th 2008 Kamada, a bio-pharmaceutical company (www.kamada.com) engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced...
Micrus Endovascular Receives FDA Approval for Intracranial Stent Clinical Trial
SAN JOSE, Calif., July 14, 2008 -- Micrus Endovascular Corporation (Nasdaq:MEND) today announced that the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally...
ONCOGENEX RECEIVES COMPLETED SPECIAL PROTOCOL ASSESSMENT FOR PRIMARY REGISTRATION STUDY OF LEAD DRUG CANDIDATE OGX-011
VANCOUVER, British Columbia, Canada - July 14, 2008 - OncoGenex Technologies Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3...
Roxane Laboratories, Inc. Announces the Approval of Morphine Sulfate Tablets and Oral Solution
COLUMBUS, Ohio, July 14-- Roxane Laboratories, Inc. announced today the approval of its New Drug Application (NDA) for Morphine Sulfate Tablets and Oral Solution CII by the U.S. Food and Drug Administration. Roxane...
Cardium Announces InnerCool's New RapidBlue(TM) System Obtains CE Mark for Commercial Sale in Europe and UL certification
SAN DIEGO, July 14 -- Cardium Therapeutics (Amex: CXM) and its operating unit InnerCool Therapies, Inc., announced today that InnerCool's RapidBlue(TM) endovascular temperature modulation system conforms to the European...
Abraxis BioScience, Inc. Announces Approval to Market ABRAXANE for Metastatic Breast Cancer in China
LOS ANGELES--July 14, 2008--Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced it has received approval from the China State Food and Drug Administration to market...
Hana Biosciences' Marqibo Receives Orphan Designation From European Commission for the Treatment of Adult Acute Lymphoblastic Leukemia
SOUTH SAN FRANCISCO, Calif., July 14, 2008 -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the European Commission has granted...
FDA Accepts Genta's NDA Amendment as Complete Response for Genasense® Treatment of Chronic Lymphocytic Leukemia
BERKELEY HEIGHTS, NJ - July 14, 2008 - Genta Incorporated (OTCBB: GNTA) announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense®...
TREDAPTIVE(TM) (nicotinic acid /laropiprant) Approved in the European Union: New Lipid-Modifying Therapy to Treat LDL-C, HDL-C and Triglycerides
WHITEHOUSE STATION, N.J., July 11, 2008 - Merck Sharp & Dohme (MSD) announced today that TREDAPTIVE(TM) (nicotinic acid/laropiprant, MSD) 1 g/20 mg modified-release tablets, a new lipid-modifying therapy for patients...
Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application With a Paragraph IV Certification for Generic Version of Copaxone
CAMBRIDGE, Mass., July 11, 2008 -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug...
New PDUFA Action Date for Sancuso®
Galashiels, Scotland, 11 July, 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 (FDA)...
Micrus Endovascular Receives Approval to Market Cerecyte Microcoils in Japan
SAN JOSE, Calif., July 10, 2008 -- Micrus Endovascular Corporation (Nasdaq: MEND) today announced receipt of Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) to market in Japan its Cerecyte(R)...
Mithridion Announces Commencement of Phase I Clinical Trial of Investigational Drug for Alzheimer's Disease
Madison, Wis., Thursday July 10, 2008 - - Mithridion, Inc., a private drug discovery and development company focusing on drugs for Alzheimer's disease and other serious Central Nervous System (CNS) disorders, announces...
PURE Bioscience Announces Brazilian Regulatory Approval for SDC-Based Disinfectant
SAN DIEGO, Calif., July 10, 2008 - PURE Bioscience (NASDAQ: PURE) announced today that its distributor in Brazil has obtained national regulatory approval, recently published in the Brazilian Official Gazette No. 113,...
Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
RICHMOND, Va., July 10, 2008 -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, today announced that it has demonstrated the bioequivalence of INS-19, the...
CardioTech Receives FDA Approval for Export of Second Graft Size for CardioPass Clinical Trial
WILMINGTON, Mass.--July 10, 2008--CardioTech International, Inc. (AMEX: CTE), a leading developer and manufacturer of advanced biomaterials for a broad range of medical devices, today announced that it has received the...
St. Jude Medical Announces CE Mark Approval and European Launch of HydroSteer Guidewire Line with Hydrophilic Coating
ST. PAUL, Minn.--July 10, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval and European launch of its line of HydroSteer(TM) Hydrophilic-Coated Nitinol Guidewires.
NeuroSearch receives an IND approval from the FDA for ACR16 as part of an ongoing pivotal clinical programme in Huntington's disease
July 10, 2008 -- NeuroSearch announces that the United States' Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for ACR16, a dopaminergic stabiliser and a novel...
CV Therapeutics Receives European Marketing Authorization for Ranolazine for the Treatment of Patients With Chronic Angina
PALO ALTO, Calif., July 10-- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has received marketing authorization from the European Medicines Agency (EMEA) for ranolazine for the treatment of patients with...
EPIX Pharmaceuticals Announces South Korean Approval of Vasovist(R); Novel Contrast Agent Now Approved for Marketing in 34 Countries
LEXINGTON, Mass., July 10, 2008 -- EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient...
FDA GRANTS EPEIUS BIOTECHNOLOGIES' REXIN-G A THIRD ORPHAN DRUG DESIGNATION, THIS TIME FOR THE TREATMENT OF SOFT TISSUE SARCOMAS
San Marino, Calif. -July 9, 2008 - Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of all soft...
Oxygen Biotherapeutics Provides Update on Recent Events and Phase IIb Oxycyte Clinical Trial
COSTA MESA, Calif.--July 9, 2008--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) is providing an update on the status of the Oxycyte(R) Phase IIb protocol that has been submitted to the FDA. Oxycyte is the Company's...
Investigational New Drug Application Submitted On Behalf of Generex Biotechnology for Combination Immunotherapy Vaccine Trials
WORCESTER, Mass., July 9, 2008 -- An Investigational New Drug application (IND) has been submitted to the United States Food and Drug Administration (FDA) on behalf of Generex Biotechnology Corporation (Nasdaq:GNBT)...
Abbott Begins Post-Approval Study of XIENCE V(TM) Drug Eluting Stent
Abbott Park, Illinois (NYSE: ABT) --July 9, 2008--Abbott today announced the start of the XIENCE V(TM) USA post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the...
FDA Revises Process for Responding to Drug Applications
July 9, 2008 -- The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Investigational New Drug Application Submitted On Behalf of Generex Biotechnology for Combination Immunotherapy Vaccine Trials
July 09, 2008--An Investigational New Drug application (IND) has been submitted to the United States Food and Drug Administration (FDA) on behalf of Generex Biotechnology Corporation (NasdaqCM:GNBT)...
Sigma-Tau Pharmaceuticals Seeking FDA Approval of Medicine for Rare Genetic Disease Affecting Less than 100 Americans
July 9, 2008, Gaithersburg, MD - Sigma-Tau Pharmaceuticals, Inc. is pleased to announce the acquisition of Chenofalk® (chenodeoxycholic acid) from the Germany-based, Dr. Falk Pharma GmbH. Chenofalk® is approved in...
BIONOMICS COMPLETES GMP SYNTHESIS OF ANTI-ANXIETY DRUG BNC210
July 09, 2008--Australian biotechnology company, Bionomics Limited (ASX: BNO), announced today that it has completed the GMP (Good Manufacturing Practice) synthesis of its anti-anxiety drug candidate, BNC210. Having now...
Health Canada Approves Mammography Feature Offered With Carestream Health's Classic, Elite CR Platforms
ROCHESTER, N.Y., July 9 -- Carestream Health, Inc., announced it has received regulatory approval from Health Canada for the mammography feature offered with its new KODAK DIRECTVIEW Classic and Elite CR systems. This...
EPEIUS BIOTECHNOLOGIES' TUMOR-TARGETED REXIN-G RECEIVES FDA ORPHAN DRUG DESIGNATION FOR THE TREATMENT OF OSTEOSARCOMA
San Marino, Calif. -July 8, 2008 - Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of all soft...
Tembotrione from Bayer CropScience approved in Brazil
Monheim, July 8, 2008 - Bayer CropScience's active ingredient tembotrione has been approved for use in Brazil. This means that the new corn herbicide Soberan® (tembotrione + isoxadifen) can be launched in time for this...
Primovist® approved in the U.S. for the Detection and Characterization of Liver Lesions
Berlin, July 8, 2008 - The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma's magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and...
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
July 8, 2008 -- The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and...
FDA Approves New Genetic Test for Patients with Breast Cancer
July 8, 2008 -- The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).
Tembotrione from Bayer CropScience approved in Brazil
Monheim, July 8, 2008 - Bayer CropScience's active ingredient tembotrione has been approved for use in Brazil. This means that the new corn herbicide Soberan® (tembotrione + isoxadifen) can be launched in time for this...
Primovist® approved in the U.S. for the Detection and Characterization of Liver Lesions
Berlin, July 8, 2008 -The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma's magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and...
Bayer HealthCare Pharmaceuticals (BAY) (JOBS) Approves FDA's (JOBS) EOVIST(R) to Detect and Characterize Focal Liver Lesions First Organ-specific MRI Contrast Agent Approved in the United States in More Than a Decade
WAYNE, N.J., July 8 -- Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved EOVIST(R) (Gadoxetate Disodium) Injection, a...
Opexa's Phase IIb Study of Tovaxin® Receives Positive Review from Data Safety Monitoring Board
THE WOODLANDS, Texas - July 8, 2008 - Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of cell therapies for multiple sclerosis announced today that the Data Safety Monitoring Board (DSMB)...
ATLANTIC HEALTHCARE receives orphan drug designation for alicaforsen for the treatment of pouchitis
Cambridge UK, 8th July 2008: Atlantic Healthcare Limited ("Atlantic" or the "Company") today announced that its lead clinical candidate alicaforsen (AP 1007) has been granted orphan drug status by the US Food and Drug...
Repligen First in North America to Receive Certification for Business Continuity
WALTHAM, MA - July 8, 2008 - Repligen Corporation (NASDAQ: RGEN) announced today that it is the first company in North America to receive certification to BS25999, the new standard for business continuity management....
Hemispherx Biopharma's Ampligen® NDA for Chronic Fatigue Syndrome Accepted for Review by the FDA
Philadelphia, PA, Tuesday, July 08, 2008: Hemispherx Biopharma, Inc. (AMEX:HEB) today reported that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for...
ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
EXTON, Pa., July 8, 2008 -- ViroPharma Incorporated (Nasdaq: VPHM) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and...
FDA approves azelastine eye drops unit dose
July 08, 2008 -- The U.S. Food and Drug Administration (FDA) has approved Meda's registration application for azelastine eye drops in unit dose (Optivar Unit Dose). The substance azelastine is an antihistamine and the...
FDA Grants Invitrogen Premarket Approval of Breast Cancer Test
CARLSBAD, Calif., Jul 08, 2008 -- Invitrogen Corporation, (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, today announced it has received U.S. Food and Drug...
BD Announces CE Marking of a New Molecular Test to Diagnose Patients with Clostridium difficile Infections
San Diego, CA -- Monday, July 07, 2008 -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today the CE marking of the BD GeneOhm(TM) Cdiff molecular assay for the rapid diagnosis...
Hansen Medical Announces FDA Clearance for CoHesion(TM) Module
MOUNTAIN VIEW, CA, July 02, 2008 -- Hansen Medical, Inc. (NASDAQ: HNSN), a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received U.S. Food and Drug...
EPA approved antimicrobial could control listeria in food plants
July 01, 2008 -- Intralytix, a biotechnology firm, said that its novel food safety product, LMP-102 has already received approval from the Food and Drug Administration (FDA) as a food additive effective against Listeria...
VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid(TM), a Novel Topical Agent for the Treatment of Various Skin Disorders
BASKING RIDGE, N.J., July 1, 2008 - VioQuest Pharmaceuticals (OTCBB: VOQP) today announced the submission of a 510(k) application to the United States Food and Drug Administration (FDA). The application seeks marketing...
TissuePatch Dural receives CE mark
July 1, 2008 -- Tissuemed has been granted the CE mark for its proprietary dural sealant film. Like other members of the TissuePatch family TissuePatch Dural takes the form of a thin, synthetic , self-adhesive film...
ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
MELBOURNE, Australia, and MENLO PARK, California U.S.A--July 01, 2008 ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today that it has submitted the non-clinical section of the rolling submission of a New...
Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease
WATERTOWN, Mass., Jun 30, 2008-- Acusphere, Inc. (NASDAQ: ACUS) announced today that the New Drug Application (NDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for...
New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
SILVER SPRING, Md., June 30, 2008 -- United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application (NDA) to the U.S. Food and...
Ipsogen accelerates its develpment in Europe with the CE marking of its JAK2 diagnostic kits
Marseille, France, June 30,2008- IPSOGEN SA(Alternext- FR0010626028 -ALIPS), a molecular diagnostic company specialized in the development, the manufacturing and the commercialization of diagnostic assays for breast...
New Aivlosin® approval for poultry in Europe
June 30, 2008 -- ECO Animal Health Group plc is pleased to announce that its subsidiary Eco Animal Health Limited (ECO) has been granted a marketing authorisation from the European Commission for Aivlosin® granules for...
UCB's Vimpat(TM) recommended for approval in Europe for epilepsy
Brussels, BELGIUM, June 26, 2008 - Press release: regulated information UCB announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive...
SPECTRAL ANNOUNCES CONTINUING SUPPORT FOR THE COMBINATION OF EAA(TM) AND ANTI-ENDOTOXIN THERAPEUTICS
TORONTO, Canada - June 26, 2008 - Spectral Diagnostics Inc. (TSX: SDI) today announced the presentation of data that demonstrates the combined clinical effectiveness of its Endotoxin Activity Assay (EAA(TM)), the only...
Orexo report Abstral (Rapinyl) approval in Europe
Uppsala, Sweden, 26 June, 2008 - Orexo AB (OMX: ORX), the Swedish pharmaceutical company, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a...
AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM) Appendicitis Blood Test
CASTLE ROCK, CO--June 26, 2008--AspenBio Pharma, Inc. (Nasdaq CM: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially...
Application filed for a transdermal absorption-type continuous-action drug to treat cancer pain
June 26, 2008 -- Hisamitsu Pharmaceutical Co., Inc. (Hisamitsu; TSE:4530) announced that as of today Hisamitsu has filed an application for new drug approval with Ministry of Health, Labour and Welfare for use of a...
Alkermes Initiates Phase 3 Clinical Study of VIVITROL(R) for the Treatment of Opioid Dependence
CAMBRIDGE, Mass.--June 26, 2008--Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a phase 3 clinical trial of VIVITROL(R) (naltrexone for extended-release injectable suspension) for the treatment of...
EMEA recommends strengthening warnings and contraindications for etoricoxib-containing medicines used in the treatment of rheumatoid arthritis and ankylosing spondylitis
June 26, 2008 -- Finalising a review of the benefits and risks of etoricoxib-containing medicines, the European Medicines Agency (EMEA) has concluded that these medicines can be used to treat rheumatoid arthritis and...
EMEA recommends a new warning for epoetins for their use in cancer patients
June 26, 2008 -- The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines with a new warning for their use in cancer patients stating that blood transfusion...
European approval for Roche's Pegasys personalises treatment for a subgroup of hepatitis C patients: chance for cure with only four months of treatment
Basel, 26 June 2008 -- Roche announced today that the European Commission has approved a shortened, 16-week course of treatment with Pegasys (peginterferon alfa-2a (40 KD)) plus Copegus (ribavirin) for certain hepatitis...
RANBAXY GAINS TENTATIVE APPROVAL TO MANUFACTURE AND MARKET VALGANCICLOVIR HYDROCHLORIDE TABLETS
Princeton, New Jersey - June 25, 2008 -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market...
RANBAXY GAINS TENTATIVE APPROVAL TO MANUFACTURE AND MARKET VALGANCICLOVIR HYDROCHLORIDE TABLETS
Gurgaon , India , June 25, 2008 -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir...
Clavis Pharma receives US Orphan Drug Designation for ELACYT(TM)
Oslo, Norway, June 25, 2008 --Clavis Pharma today announced that the US Food & Drug Administration (FDA) has granted orphan drug designation to ELACYT(TM) for the treatment of Acute Myeloid Leukaemia (AML). Within...
TARGANTA'S ORITAVANCIN MAA ACCEPTED FOR REVIEW BY EMEA
CAMBRIDGE, MA - June 25, 2008 - Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorization Application (MAA) for...
Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in Women Ages 27 through 45
WHITEHOUSE STATION, N.J., June 25, 2008 - Merck & Co., Inc. announced today that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental biologics license application...
ICCVAM Approval of Eye Irritation Methods Accepted By Agencies
June 24th, 2008 -- The National Institute of Environmental Health Sciences (NIEHS) has announced that Federal regulatory agencies have accepted recommendations of the Interagency Coordinating Committee on the Validation...
Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain
TAMPA, Fla., June 24, 2008 - Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug...
Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE
Berlin, June 23, 2008 - Jerini AG (FSE:JI4) announced today that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not...
Intralytix Wins EPA Approval of Phage-Based Product
Baltimore, Maryland U.S.A., June 23, 2008 - A spokesman for Intralytix, Inc., announced today that the company has received a registration from the Environmental Protection Agency ("EPA") for LMP-102(TM) as an...
Taro Receives Final FDA Approval for RX Cetirizine Hydrochloride Syrup ANDA
HAWTHORNE, N.Y., June 23, 2008 -- Taro Pharmaceutical Industries Ltd. (Pink Sheets:TAROF) ("Taro", the "Company") reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for...
Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for PROMACTA(R) NDA
SAN DIEGO, June 20, 2008 -- Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced today that the U.S. Food and Drug Administration has extended the priority review period for GlaxoSmithKline's (GSK) New Drug...
Discovery Labs and FDA Meet to Clarify Limited Items in SURFAXIN Approvable Letter
Warrington, PA - June 19, 2008, -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on June 18, 2008 with the U.S. Food and Drug Administration (FDA) to discuss Discovery Labs' approach to addressing key...
Roxane Laboratories, Inc. Announces the Launch of Ramipril Capsules
COLUMBUS, Ohio, June 18, 2008 -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ramipril Capsules, 1.25mg, 2.5mg, 5mg and 10mg by the U.S. Food and Drug...
NanoGuardian Client Receives FDA Approval for Adding Nanoencryption Technology as Part of Supplemental New Drug Application
SKOKIE, Ill. - June 17, 2008 - NanoGuardianTM, a division of NanoInk® that focuses exclusively on delivering brand protection solutions to fight illegal diversion and counterfeiting, announced today that the Food and...
Medtronic Receives FDA Approval of Industry's First Active Fixation Left-Heart Cardiac Resynchronization Lead
MINNEAPOLIS - June 17, 2008 - Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Attain StarFix® OTW (over-the-wire) lead (Model 4195). As the first-ever active...
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