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Cardinal Health resolves controlled substance license suspension
DUBLIN, Ohio, Oct. 2, 2008 -- Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, today announced agreements with the U.S. Drug Enforcement Administration...

PHARMAXIS FILES FIRST MARKETING APPLICATION FOR BRONCHITOL IN AUSTRALIA
October 01, 2008-Pharmaceutical company Pharmaxis (ASX:PXS, NASDAQ:PXSL) today announced that a marketing application for the mucus clearing agent, Bronchitol, has been submitted to the Therapeutic Goods Administration...

FDA's first-cycle review of Dysport
Paris (France), 30 September 2008 - Ipsen (Euronext; IPN) today announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport

Arana Files IND for Lead Anti-Inflammatory Product ART621
September 30, 2008 Sydney, Australia--Biotechnology company Arana Therapeutics Limited (ASX: AAH) today announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug...

Takeda Submitted a New Drug Application for Alogliptin in Japan for Treatment of Type 2 Diabetes
Osaka, Japan, September 29, 2008-Takeda Pharmaceutical Company Limited ("Takeda") announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for Alogliptin (development code:...

Takeda Submitted a New Drug Application in Japan for Actos
Osaka, Japan, September 29, 2008 ---Takeda Pharmaceutical Company Limited ("Takeda") announced today that it submitted a new drug application to the Ministry of Health, Labour and Welfare for Actos

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"
September 29, 2008 -- A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often...

ELITE ANNOUNCES DRUG APPLICATION FILING FOR SYNTHETIC NARCOTIC ANALGESIC ACCEPTED BY FDA
Northvale, New Jersey, Monday, September 29, 2008: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX: ELI) in collaboration with ThePharmaNetwork, LLC., announced today the acceptance by the U.S. Food and...

FDA Grants Permission For Export of Antigenics' Oncophage
NEW YORK -- September 29, 2008 -- Antigenics Inc. (NASDAQ: AGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted the necessary permission to allow for the export of Oncophage

U.S. Food and Drug Administration Selects Applied Biosystems to Provide Mass Spectrometry Instrument Systems for Food Contaminant Testing
FOSTER CITY, Calif. - September 29, 2008 - Applied Biosystems Inc. (NYSE: ABI) today announced that the U.S. Food and Drug Administration has purchased seven of the company's 4000 QTRAP

FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval
INDIANAPOLIS, September 29, 2008 -- Eli Lilly and Company (NYSE: LLY) announced today it received approval from the U.S. Food and Drug Administration (FDA) for the use of ALIMTA(R) (pemetrexed for injection), in...

Neuropharm Announces Submission of Rolling NDA for NPL-2008 in Autistic Disorder
September 29, 2008 -- Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on neurodevelopmental disorders, is pleased to announce it has begun submission of a New Drug Application (NDA) seeking...

Synvista Therapeutics Receives Approval to Begin Phase 2 Trial of Topical SYI-2074 in Psoriasis
MONTVALE, N.J., Sept. 29, 2008 -- Synvista Therapeutics, Inc. (Amex: SYI) announces that it has received approval from the Israeli Ministry of Health to begin a Phase 2 trial of a topical formulation of SYI-2074 in...

Alchemia Announces IND Filing for Anti-Cancer Agent
Brisbane, AUSTRALIA - 29 September, 2008 - Australian drug developer, Alchemia Limited (ASX:ACL), today announced that it has submitted its Investigational New Drug (IND) Application with the United States Food and Drug...

UCB Pharma withdraws its marketing authorisation application for Lacosamide Pain UCB Pharma
September 26, 2008 -- The European Medicines Agency (EMEA) has been formally notified by UCB Pharma S.A. of its decision to withdraw the application for a centralised marketing authorisation for the medicine Lacosamide...

Merck KGaA's Kuvan
Darmstadt, September 26, 2008 - Merck KGaA and its Merck Serono division announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA),...

Merck KGaA's Kuvan
Darmstadt, September 26, 2008 - Merck KGaA and its Merck Serono division announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA),...

Indevus and FDA Agree on Path Forward for NEBIDO(R)
LEXINGTON, Mass., September 26, 2008 -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)
IRVINE, Calif., September 26, 2008 -- IDM Pharma, Inc. (Nasdaq: IDMI) today announced that it met with representatives of the Committee for Medicinal Products for Human Use (CHMP) and Secretariat of the European...

SCOLR Pharma's ANDA for 12-Hour CDT-Based Pseudoephedrine Accepted for Review by U.S. FDA
BOTHELL, Wash., Sept. 26, 2008-- SCOLR Pharma, Inc. (Amex: DDD - News) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Company's Abbreviated New Drug Application...

FDA Classifies Medtronic's Notification Related to Improper Connection of Sutureless Intrathecal Catheters as a Class I Recall
MINNEAPOLIS - September 26, 2008 - Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has classified its safety alert about the proper connection of sutureless catheters used...

Alsius Corporation Receives 510(K) Market Clearance for Solex(TM) Catheter
IRVINE, Calif., Aug 26, 2008-- Alsius Corporation (Nasdaq: ALUS), the worldwide leader in intravascular temperature management (IVTM(TM)) therapies, today announced that the U.S. Food and Drug Administration has granted...

Upsher-Smith Laboratories New Analyses Indicate that Divigel(R) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes
MAPLE GROVE, Minn., Sept. 25, 2008 -- Upsher-Smith Laboratories, Inc. today announced that clinical abstracts featuring Divigel(R) (estradiol gel) 0.1% were presented at the North American Menopause Society's 19th...

European Medicines Agency makes first recommendation for use of a medicine in children based on PIP data
September 25, 2008 -- The European Medicines Agency (EMEA) has made its first recommendation for the use of a centrally-authorised medicine in children on the basis of clinical trial data generated in accordance with an...

European Medicines Agency recommends update of product information of Tysabri and risk of progressive multifocal leukoencephalopathy (PML)
September 25, 2008 -- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness...

Takeda withdraws its marketing authorisation application for Ramelteon
September 25, 2008 -- The European Medicines Agency (EMEA) has been formally notified by Takeda Global Research & Development Centre (Europe) Ltd of its decision to withdraw its application for a centralised marketing...

Digirad Corporation Receives FDA 510(K) Clearance for nSPEED
POWAY, Calif.-September 22, 2008...Digirad Corporation (Nasdaq: DRAD), a leading provider of diagnostic imaging systems and services to physicians' offices, hospitals and other medical services providers, today...

Stem Cell Therapeutics Corp. Receives Letter From Health Canada and Verbal Request From FDA to Place a Clinical Hold on Its REGENESIS Phase IIb Stroke Trial in Canada and the US, Respectively
CALGARY, ALBERTA--(Sept. 18, 2008) - Stem Cell Therapeutics Corp. ("SCT")(TSX VENTURE:SSS) has received a letter from Health Canada and a verbal request from the U.S. Food and Drug Association (FDA) calling for a...

The European Commission Grants Orphan Drug Designation to Alseres Pharmaceuticals' Spinal Cord Injury Treatment, Cethrin(R)
HOPKINTON, Mass., Sept 18, 2008 -- Alseres Pharmaceuticals, Inc., (Nasdaq: ALSE) announced today that Cethrin has been granted designation as an orphan medicinal product for the treatment of traumatic spinal cord injury...

Gore Announces Broadened FDA Indication for GORE VIABAHN
September 17, 2008-W. L. Gore & Associates (Gore) today announced it has received approval from the US Food and Drug Administration (FDA) to market the GORE VIABAHN

Preliminary Data from Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa
BRIDGEWATER, NJ -- (September 17, 2008) -- Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke. In...

FDA Grants Orphan Drug Designation For Use Of Proprietary Stem Cells In Bone Marrow Transplants
September 17, 2008 -- Australia's regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), announced that the United States Food and Drug Administration (FDA) has granted an orphan drug designation for...

Preliminary Data from Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa
BRIDGEWATER, NJ -- (September 17, 2008) -- Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke. In...

PreMD Provides Corporate Update
TORONTO, Sept. 16, 2008 - Predictive medicine company PreMD Inc. (TSX: PMD) today offered a corporate update on the activities of the company and indicated that an appeal to the U.S. Food and Drug Administration (the...

Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal
PITTSBURGH, September 16, 2008 -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated...

Orthovita, Inc. (VITA) Files Response to FDA's Initial Review of the CORTOSS(R) 510(k) Application
MALVERN, Pa.--September 16, 2008---Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced that it recently submitted its response to the initial set of comments received from the U.S. Food...

Barr Receives Approval for Generic Version of Razadyne(R) ER Capsules
MONTVALE, N.J., Sept 16, 2008 -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture...

GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira(TM) for Restless Legs Syndrome
RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., Sept. 16, 2008-- GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration...

GSK and Xenoport announce submission of new drug application requesting FDA approval of Solzira(TM) for Restless Legs Syndrome
September 16, 2008, London, UK -- GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA)...

Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
FOSTER CITY, Calif.-- September 16, 2008--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug...

QUEST DIAGNOSTICS AND FUJIREBIO DIAGNOSTICS ANNOUNCE AVAILABILITY OF NEW FDA-CLEARED BLOOD-BASED TEST FOR OVARIAN CANCER
MALVERN, PA and MADISON, NJ, September 16, 2008 - Fujirebio Diagnostics, Inc. and Quest Diagnostics Incorporated (NYSE: DGX) today announced the launch of the HE4 test as an aid for monitoring recurrence of epithelial...

Teva Receives EU Marketing Authorization for TevaGrastim
Jerusalem, Israel, September 16, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the European Commission's Directorate General for Enterprise and Industry granted Teva a Marketing...

SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND
CALGARY, Sept. 16, 2008 - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it is eligible to...

Pluristem Presents Final PLX-PAD Efficacy Data Supporting Upcoming IND Submission to the U.S. FDA
NEW YORK--September 16, 2008---Pluristem Therapeutics Inc. (Nasdaq:PSTI - News)(DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a...

Bayer's Xarelto
Leverkusen, Germany / Toronto, Canada, September 16, 2008 - Health Canada has granted Bayer HealthCare marketing authorization for the anticoagulant Xarelto

Stem Cell Therapeutics Corp. Receives 'No Objection Letter' From Health Canada for Its Traumatic Brain Injury Trial
CALGARY, ALBERTA--(Sept. 15, 2008) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT") is pleased to announce it has received a No Objection Letter (NOL) from Health Canada for the Company supported, investigator...

Invitrogen, Biocare to Market FDA Approved Breast Cancer Test HER2 CISH Gene Amplification Test Now Available
Carlsbad, Calif., Sept. 15, 2008 - Invitrogen Corporation, (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, has signed an exclusive U.S. distribution agreement...

DOR BioPharma Announces Second orBec
Ewing, NJ - Septmber 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 and...

FDA Grants Approval to Talecris Biotherapeutics for Gamunex
RESEARCH TRIANGLE PARK, N.C. (September 15, 2008) -- Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10%...

Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
FRAZER, Pa., Sept. 15 -- Cephalon, Inc. (Nasdaq: CEPH) announced today receipt of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R)...

Lundbeck submits New Drug Application (NDA) for Serdolect
September 15, 2008 -- H. Lundbeck A/S announced today that the U.S. Food and Drug Administration (FDA) has completed the initial check for completeness and accepted the New Drug Application on Serdolect

BIOLASE Countersues Reseller of Modified Lasers Leading Manufacturer Defends Itself Against NLT's Claims; Seeks Permanent Injunction
IRVINE, CA, Sep 15, 2008 -- BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, today filed a counterclaim lawsuit against Indianapolis, IN-based National Laser Technology (NLT), alleging...

Invitrogen, Biocare to Market FDA Approved Breast Cancer Test
CARLSBAD, Calif.-- September 15, 2008--Invitrogen Corporation, (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, has signed an exclusive U.S. distribution...

FDA APPROVES BAUSCH & LOMB AKREOS(TM) ADVANCED OPTICS ASPHERIC LENS
ALISO VIEJO, CALIF. SEPTEMBER 15, 2008--Bausch & Lomb announced today it has received U.S. Food and Drug Administration (FDA) approval to market the Akreos(TM) Advanced Optics Aspheric Lens (model AO60) in the United...

FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
Basel, Switzerland, September 15, 2008 --Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA)...

Medtronic Starts U.S. and International Trials of Endeavor
MINNEAPOLIS - September 15, 2008 - Consistent with its commitment to advancing the treatment of cardiovascular disease through innovative product design and rigorous clinical research, Medtronic, Inc. (NYSE: MDT),...

Sinovac Initiates Clinical Trials for Inactivated Hepatitis A Vaccine in Ukraine
BEIJING, Sept. 15, 2008 -- Sinovac Biotech Ltd. (Amex: SVA - News), a leading provider of vaccines in China, today announced the initiation of clinical trials in Ukraine for its inactivated hepatitis A vaccine, Healive,...

Elesclomol Two-Year Survival and Integrated Safety Data Presented at the 33rd Congress of the European Society for Medical Oncology
LEXINGTON, Mass.----Sept. 15, 2008--Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that two-year follow up survival data from its Phase 2b clinical trial in metastatic melanoma were presented at the 33rd...

ProStrakan Group plc
Galashiels, Scotland, 15 September, 2008 - ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, today announces that it has received approval from the US Food and Drug Administration...

Novartis receives FDA priority review for Coartem
Basel, September 15, 2008 - Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review for Coartem

Keppra XR(TM) approved in the U.S.
Brussels, BELGIUM - September 15, 2008 at 7:00 am CEST - press release, regulated information: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR(TM) (levetiracetam...

Teva Announces Appellate Court Reverses Generic Risperdal
erusalem, Israel, September 14, 2008 - Jerusalem, Israel, September 14, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that following a hearing on September 12, 2008, the U.S. Court of Appeals...

FDA APPROVES FOUGERA'S CLOTRIMAZOLE CREAM USP 1%
Melville, New York, September 12, 2008 - Fougera, a division of Nycomed US Inc., today announced the FDA has approved its Clotrimazole Cream USP 1%. The generic formulation compares to Taro's Referenced Listed Drug...

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
September 12, 2008 -- The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in...

FDA Approves Treatment for Rare Neurologic Disease
September 12, 2008 -- The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a...

Sun Pharma gets USFDA approval for generic Fosamax
Mumbai, September 12, 2008: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for the Company's Abbreviated New Drug...

Merck KGaA Submits New License Application for Erbitux in Firstline Non-Small Cell Lung Cancer in Europe
Darmstadt, September 11, 2008 - Merck KGaA announced today that its Merck Serono division has submitted an application to the European Medicines Agency (EMEA) to license Erbitux

Vanda Pharmaceuticals Provides Update on Iloperidone
ROCKVILLE, Md., Sept. 11, 2008 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system...

Novacea Update on Asentar(TM)
SOUTH SAN FRANCISCO, CA - September 11, 2008 -- Novacea, Inc. (NASDAQ: NOVC), today reported that it has received notice from the United States Food and Drug Administration (FDA) that the agency has released the...

Cell Genesys Reconfirms Ongoing Plans with FDA for Phase 3 Program for GVAX Immunotherapy for Prostate Cancer While on Partial Clinical Hold
SOUTH SAN FRANCISCO, Calif.--Sept. 11, 2008--Cell Genesys, Inc. (Nasdaq:CEGE) today announced that the U.S. Food and Drug Administration (FDA) has, as expected, placed a partial clinical hold on the GVAX Phase 3 program...

Merck KGaA Submits New License Application for Erbitux in Firstline Non-Small Cell Lung Cancer in Europe
Darmstadt, September 11, 2008 - Merck KGaA announced today that its Merck Serono division has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the firstline treatment...

St. Jude Medical Announces FDA Clearance of Implantable Device to Monitor Cardiac Conditions
ST. PAUL, Minn.---Sept. 11, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance of its SJM Confirm(TM) implantable cardiac monitor (ICM), a compact device designed...

Glenmark to initiate phase I studies for GBR 500 by filing its IND application with the US-FDA
Bangalore, September 11, 2008: Glenmark Pharmaceuticals has filed its molecule GBR 500 for phase I trials with the US FDA. The filing of this IND (Investigational New Drug Application) signifies the successful...

Approval for silver wound gel
September 11, 2008--Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global medical technology company, is pleased to announce that its silver anti-microbial wound gel has received 510(k) approval from...

European Commission Grants Approval for LibertyLink
Monheim, September 10, 2008 - LibertyLink

ANGIOTECH'S CORPORATE PARTNER, COOK MEDICAL, COMPLETES ENROLLMENT IN FIRST INTERNATIONAL TRIAL OF DRUG-ELUTING PERIPHERAL STENT AND FILES FOR CE MARK IN EUROPE
VANCOUVER, BC, September 10, 2008 - Angiotech Pharmaceuticals, Inc. ("Angiotech") (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that its corporate partner, Cook...

Rexahn Pharmaceuticals Receives FDA Approval to Initiate Phase II Trial for Serdaxin in Patients with Major Depressive Disorders
Rockville, Md., Sept. 10, 2008 - Rexahn Pharmaceuticals, Inc. (AMEX: RNN), a leader in innovative therapeutics for life-threatening and life-debilitating diseases, announced today that the Company has received FDA...

Pfizer withdraws its marketing authorisation application for Exulett (dalbavancin)
September 10, 2008 -- The European Medicines Agency (EMEA) has been formally notified by Pfizer of its decision to withdraw its application for a centralised marketing authorisation for the medicine Exulett...

Oxygen Biotherapeutics, Inc. Sets FDA Meeting Date for Proposed Phase IIb Oxycyte Clinical Trial
COSTA MESA, Calif.--Sept. 10, 2008--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that the company is tentatively scheduled to meet with the U.S. Food and Drug Administration (FDA) during the week of Oct....

Focus Diagnostics Receives FDA 510(k) Clearance for Two Plexus(TM) Test Kits for Detecting Epstein-Barr Virus Antibodies
Cypress, CA - September 9, 2008 -- Focus Diagnostics, Inc., a wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE: DGX), today announced that it has received 510(k) clearance from the U.S. Food and Drug...

ORTHO BIOTECH FILES sNDA FOR DOXIL
Bridgewater, N.J. (September 8, 2008) -Ortho Biotech Products, L.P. today announced that the Company has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the...

Stereotaxis Announces First Procedures Successfully Performed With Recently Re-introduced Magnetic Irrigated Catheter
ST. LOUIS, Sept. 8, 2008-- Stereotaxis, Inc. (Nasdaq: STXS) announced today that the first atrial fibrillation procedures using its re-introduced partnered magnetic irrigated catheter were successfully performed in...

EMEA releases guidelines on development of medicines for Alzheimer's disease and Parkinson's disease
September 04, 2008 -- The European Medicines Agency (EMEA) has released two guidelines for companies developing medicines for the treatment of Alzheimer's disease and other dementias, and for Parkinson's disease, in the...

Sandoz receives FDA approval for Omnitrope
September 03, 2008 -- Sandoz has received US Food and Drug Administration approval for its Omnitrope

ImClone Submits Supplemental Biologics License Application for ERBITUX(R) in First-Line Head and Neck Cancer
NEW YORK-- September 3, 2008--ImClone Systems Incorporated (NASDAQ: IMCL) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX(R) (cetuximab)...

Inhaled Treprostinil New Drug Application Filed by FDA
SILVER SPRING, Md., Sept 03, 2008 -- United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review...

Anavex completes successful preclinical studies on lead Alzheimer's drug candidate
ATHENS, GREECE, Sept. 2 - Anavex Life Sciences Corp. ("ANAVEX") (OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases...

Aurobindo Pharma receives tentative approval for its Abacavir Sulfate tablets
September 01, 2008--Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Abacavir Sulfate tablets 60mg from the US Food & Drug Administration (USFDA).

Withdrawal of the marketing authorisation in the European Union
August 29, 2008 -- On 1 August 2008, the marketing authorisation holder (MAH) responsible for Quintanrix, GlaxoSmithKline Biologicals, notified the European Commission of its decision to voluntarily withdraw the...

ACTIVAERO'S WATCHHALER(TM) RECEIVES FDA 510(K) CLEARANCE
Gem

FDA Grants Conditional Approval to Interventional Spine's PercuDyn(TM) System IDE Application
Irvine, CA - Tuesday, July 1, 2008, -- Interventional Spine, Inc. announced today that the U.S. Food and Drug Administration has approved the Company's investigational device exemption (IDE) application for its PercuDyn...

Fujirebio Diagnostics Receives FDA Clearance for the HE4 EIA Assay for the monitoring of patients with ovarian cancer.
June 19, 2008 -- Fujirebio Diagnostics received the Food and Drug Administration (FDA) clearance for the HE4 EIA assay. HE4 is a simple blood test for use as an aid in monitoring recurrence or progressive disease in...

FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
Carlsbad, Calif. -- January 16, 2008 - Ablation Frontiers, Inc. today announced the expansion of enrollment in the first ever U.S. Investigational Device Exemption (IDE) clinical trial for interventional treatment of...

Interventional Spine, Inc. Receives Expanded CE-Mark Approval of its PercuDyn(TM) Dynamic Stabilization System
Irvine, CA - April 26, 2007, -- Interventional Spine , Inc. announced today it had recently received CE Mark approval from its European Union Notified Body for expanded indications for use beyond its original focus.

ABLATION FRONTIERS ANNOUNCES CE MARK FOR NOVEL CARDIAC ABLATION CATHETERS
Carlsbad, CA, December 19, 2006--Ablation Frontiers, Inc., developer and manufacturer of three-dimensional catheters for the treatment of atrial fibrillation (AF) announced today that it has received the CE Mark for its...

Interventional Spine, Inc. Announces CE Mark Approval of its Percutaneous Dynamic Stabilization For the Treatment of Spinal Disease
Irvine, CA - Thursday, November 30, 2006, -- Interventional Spine, Inc. (formerly Triage Medical

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