• Home
• Partneringtools
• Reports

• In-licensing
• Out-licensing
• Companies

• Articles
• Events
• Outsourcing

• Consulting
• Jobs
• Forums

• About us
• Products
• Newsletter

Pharmalicensing Ltd
is a division of

News of the day

Industry news search

Recent news

To keep up to date with news from this category use our

TomoTherapy Receives FDA 510(k) Clearance for TomoDirect(TM) Radiotherapy Technology
MADISON, Wis. - August 26, 2008 - TomoTherapy Incorporated (NASDAQ: TOMO) today announced that it has received FDA 510(k) clearance for its TomoDirect(TM) radiation therapy technology. TomoDirect is an innovative new...

ZOSTAVAX(TM) APPROVED IN CANADA THE FIRST AND ONLY VACCINE FOR THE PREVENTION OF SHINGLES
TORONTO, Ontario - August 26, 2008 - Adult Canadians will soon have the opportunity to protect themselves against shingles - a reactivation of the virus that causes chickenpox. Merck Frosst Canada Ltd. announced today...

Two lots of DAYTRANA
25 Aug 2008 - Shire announces a voluntary recall of two (2) lots of the ADHD patch DAYTRANA (lots 2819811 and 2764211; NDC number is 54092-553-30). Shire is taking this action because DAYTRANA patches in these lots do...

Oxygen Biotherapeutics, Inc. to Meet With FDA to Discuss Proposed Phase II-b Oxycyte Clinical Trial
COSTA MESA, Calif., Aug 25, 2008-- Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that the company will meet with the U.S. Food and Drug Administration (FDA) to discuss two remaining issues that the agency...

Biovail Receives Canadian Approval for Ralivia(TM) for the Treatment of Moderately Severe Pain
TORONTO--Aug. 25, 2008--Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an expanded indication for once-daily Ralivia(TM) - to include the treatment of moderately severe pain in addition to...

FDA Approves ALOXI
August 24, 2008 -- Eisai Corporation of North America (Headquarters: New Jersey, United States, Chairman & CEO: Hajime Shimizu, "ECA"), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo...

FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP
THOUSAND OAKS, Calif., Aug 22, 2008 -- Amgen Inc. (NASDAQ: AMGN) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nplate(TM) (romiplostim), the first and only platelet...

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
August 22, 2008 -- The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder...

Cymbalta Receives European Approval for the Treatment of Generalised Anxiety Disorder
INDIANAPOLIS, August 22, 2008 -- Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta

AMAG Pharmaceuticals Receives Fast Track Designation for Ferumoxytol for Vascular-Enhanced Magnetic Resonance Imaging
CAMBRIDGE, Mass.--August 21, 2008--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ferumoxytol for its development as a...

VIDAZA(R) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
SUMMIT, N.J.--Aug. 21, 2008--Celgene Corporation (Nasdaq:CELG) today announced VIDAZA (azacitidine) received expanded U.S. Food and Drug Administration (FDA) approval to reflect new overall survival achieved in the...

FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia
Raritan, NJ (August 21, 2008 - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the U.S. Food and Drug Administration (FDA) requires additional information before it will...

VIDAZA(R) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
SUMMIT, N.J.--Aug. 21, 2008--Celgene Corporation (Nasdaq:CELG) today announced VIDAZA (azacitidine) received expanded U.S. Food and Drug Administration (FDA) approval to reflect new overall survival achieved in the...

ARPIDA'S ICLAPRIM MAA ACCEPTED FOR REVIEW BY EMEA
Reinach, Switzerland, 21 August 2008. Arpida Ltd. (SWX: ARPN) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim....

DELSITE FILES IND FOR NASAL POWDER H5N1 (BIRD FLU) INFLUENZA VACCINE
IRVING, TEXAS August 20, 2008 DelSite Inc., (OTC: DSII) today announced DelSite Biotechnologies, Inc., its wholly-owned subsidiary, filed an Investigational New Drug (IND) application with the FDA for its lead product...

St. Jude Medical Announces FDA Approval of Arecibo Manufacturing Plant
ST. PAUL, Minn.----Aug. 20, 2008--St. Jude Medical, Inc. (NYSE: STJ) today announced U.S. Food and Drug Administration (FDA) approval of the company's new facility in Arecibo, Puerto Rico, for the manufacturing of...

Barr Announces Approval of Generic Aredia(R) Injection, 30mg/mL, 60mg/mL and 90mg/mL Injectable
MONTVALE, N.J., Aug. 20 -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic...

Onmark Adds Recently Approved FUSILEV (levoleucovorin) for Injection to its Contract Portfolio
SOUTH SAN FRANCISCO, Calif. August 19, 2008. Onmark, the leading national group purchasing organization (GPO) for community-based practices and a McKesson Specialty company, has added FUSILEVTM (levoleucovorin) for...

FDA 510(k) Process Provides Framework for Effective Medical Device Regulation
WASHINGTON , D.C. -August 19, 2008 The Advanced Medical Technology Association (AdvaMed) today released a white paper explaining the history and evolution of FDA's premarket notification, or "510(k)," process for...

Xamiol
August 19, 2008 -- The UK will be the first country to market Xamiol

VICTHOM'S NEUROBIONIX BUSINESS UNIT ACHIEVES ISO 13485:2003 CERTIFICATION
Quebec (Canada), August 19, 2008 - Victhom Human Bionics Inc., "Victhom" (TSX: VHB), is pleased to announce that its Neurobionix business unit has obtained ISO 13485:2003 certification for its Quality Management System...

Sarnoff Corporation Receives ISO 9001:2000 Certification
PRINCETON, NJ -- August 19, 2008 -- Sarnoff Corporation is pleased to announce that it has received the International Organization for Standardization's (ISO) 9001:2000 certification. This certification acknowledges...

PreMD Inc. - FDA Upholds Previous NSE Decision
TORONTO, Aug. 18, 2008 - Predictive medicine company PreMD Inc. (TSX: PMD - News; Amex: PME - News) today announced that the U.S. Food and Drug Administration ("FDA") has upheld their decision regarding the company's...

St. Jude Medical Announces CE Mark Approval and FDA Clearance for New Family of HIFU Surgical Ablation Products
ST. PAUL, Minn., Aug 18, 2008-- St. Jude Medical, Inc. (NYSE:STJ) has received European CE Mark approval and U.S. Food and Drug Administration (FDA) clearance for the Epicor(TM) LP Cardiac Ablation System, a second...

Actavis receives approval of generic Wellbutrin XL
August 18, 2008--Actavis has received approval from the US Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (XL) 300mg. Distribution of the product will commence immediately.

DGAP-News: Biotest AG: Biotest: US approval increases potential of diagnostic business
Dreieich, 18 August 2008. Biotest has made significant progress in the internationalisation of its business operations driven forward as part of its strategic corporate development. Last Friday the US Food and Drug...

Introgen's ADVEXIN(R) MAA Accepted for Review by European Medicines Agency
AUSTIN, Texas-- August 18, 2008--Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted molecular therapies for cancer, and its subsidiary Gendux Molecular Limited, today announced that the European...

First FLEXUS(TM) Interspinous Spacer Surgeries for IDE Clinical Trial
Audubon, Pa. (August 15, 2008) - Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world, today announced that the first FLEXUS(TM) Interspinous Spacers have been implanted under an...

IRIDEX Announces FDA Clearance for New Product Family of IRIDEX IQ Laser Systems
MOUNTAIN VIEW, Calif., August 15, 2008 -- IRIDEX Corporation (Nasdaq: IRIX) announces receipt of FDA 510(k) clearance for its Family of IRIDEX IQ Laser Systems. This clearance covers the IRIDEX IQ 532, IQ 577, IQ...

XENAZINE
WASHINGTON, D.C., August 15, 2008 -Prestwick Pharmaceuticals, Inc., a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved XENAZINE

Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA
August 15, 2008 - Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announces today that the US Food and Drug Administration (FDA) has granted orphan drug...

FDA Approves First Drug for Treatment of Chorea in Huntington's Disease
August 15, 2008 -- The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in...

CONMED Linvatec's Bio Mini-Revo(TM) Suture Anchor Receives 510(k) FDA Clearance for Arthroscopic Hip Repair
UTICA, N.Y.--Aug. 14, 2008--CONMED Corporation's (Nasdaq: CNMD) CONMED Linvatec arthroscopy unit announced today that the U.S. Food and Drug Administration (FDA) has cleared its 510(k) application for marketing of the...

ATS Medical Announces CE Mark Regulatory Approval for ATS CryoMaze(TM)
MINNEAPOLIS, Aug. 14 -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today reported that it has received ISO certification for its Quality System...

CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
PALO ALTO, Calif., Aug. 14-- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has received approval from the European Medicines Agency (EMEA) for the brand name Ranexa(R) (ranolazine).

IMPAX Sued Based on ANDA for Generic Ultram
August 13, 2008 -- HAYWARD, Calif.-- IMPAX Laboratories, Inc. today announced Purdue Pharma Products L.P. ("Purdue"), Napp Pharmaceutical Group Ltd. ("Napp"), Biovail Laboratories International, SRL ("Biovail") and...

FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
SAN DIEGO, August 13, 2008 -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has approved its supplemental regulatory application to use the PROCLEIX(R) ULTRIO(R)...

Zemea
LOUDON, Tenn., Aug. 13, 2008 - DuPont Tate & Lyle Bio Products today announced that its breakthrough product, Zemea

Lexicon Pharmaceuticals Identifies New Drug Candidate for Glaucoma
The Woodlands, Texas, August 13, 2008 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it...

EMEA assesses incidents of progressive multifocal leukoencephalopathy (PML) in sclerosis patients receiving Tysabri
Danish Medicines Agency, 13 August 2008 --The European Medicines Agency (EMEA) has received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS)....

St. Jude Medical Receives U.S. and European Approvals of EonC, the First Extended-Life Primary Cell Neurostimulator for the Treatment of Chronic Pain
ST. PAUL, Minn. - August 13, 2008 - St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of EonC(TM), the first extended-life primary cell...

St. Jude Medical Receives U.S. and European Approvals of EonC, the First Extended-Life Primary Cell Neurostimulator for the Treatment of Chronic Pain
ST. PAUL, Minn.----Aug. 13, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of EonC(TM), the first extended-life primary cell...

European Medicines Agency update on progressive multifocal leukoencephalopathy (PML) and Tysabri
August 13, 2008 -- At the end of July 2008, the European Medicines Agency (EMEA) received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who...

FDA Accepts REMOXY New Drug Application and Grants Priority Review
SAN MATEO, Calif. and BRISTOL, Tenn., Aug. 12, 2008 -- Pain Therapeutics, Inc. (Nasdaq:PTIE) and King Pharmaceuticals, Inc. (NYSE:KG) today announced that the New Drug Application (NDA) for REMOXY(r) was accepted and...

Duska Therapeutics Receives Comments From FDA on Phase 3 ATPace(TM) Protocol Synopsis
LA JOLLA, Calif., Aug. 12 -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA - News; "Duska") announced today that it has received comments from the U.S. Food and Drug Administration's (the "FDA") Division of...

ASX - FDA Approves Enhancements to EVERLAST(TM) Trial
Sydney AUSTRALIA 12 August 2008: Ventracor Limited (ASX:VCR) today announced that the US Food and Drug Administration (FDA) has approved several enhancements to the EVERLAST(TM) Destination Therapy (DT) Trial of the...

FDA approves registration of AbSorber's transplantation test
August 12, 2008--The Swedish biotech company AbSorber has been given clearance by the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE

Cerus' INTERCEPT Blood System Receives CE Mark Label Expansion for Treatment of Previously Frozen Plasma
CONCORD, Calif.--Aug. 12, 2008--Cerus Corporation (NASDAQ:CERS) announced today that it has received an expanded label claim allowing the use of its INTERCEPT Blood System(TM) to treat previously frozen plasma. Under...

ANGIOTECH RECEIVES CE MARK APPROVAL OF HEMOSTREAM. CHRONIC DIALYSIS CATHETER
VANCOUVER, BC, August 12, 2008 . Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has received CE Mark approval to begin...

FDA Accepts Remoxy® New Drug Application and Grants Priority Review
SAN MATEO, Calif. and BRISTOL, Tenn. - August 12, 2008 - Pain Therapeutics, Inc. (NASDAQ: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that the New Drug Application (NDA) for REMOXY was accepted and...

CARDIOM AND ASTELLAS ANNOUNCE RECEIPT OF FDA APPROVABLE LETTER FOR KYNAPID
Vancouver, Canada and Deerfield, Lllinois, USA, August 11, 2008--Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astelles Pharma US, Inc ("Astells") today announced that they have received...

GE HEALTHCARE RECOGNIZES FIRST MAGNETIC RESONANCE IMAGING SYSTEM TO RECEIVE ECOMAGINATION CERTIFICATION
CHALFONT ST. GILES, UK, AUGUST 11, 2008 - GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced its Signa HDe 1.5T Magnetic Resonance Imaging (MRI) system as the first medical imaging product...

CARDIOME AND ASTELLAS ANNOUNCE RECEIPT OF FDA APPROVABLE LETTER FOR KYNAPIDTM
Vancouver, Canada and Deerfield, Illinois, USA, August 11, 2008 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have...

Applied Biosystems' Singapore Facility Achieves ISO 13485 Certification
SINGAPORE and FOSTER CITY, Calif. - August 11, 2008 - Applied Biosystems (NYSE:ABI) today announced that its Singapore facility has received an important ISO quality certification, enhancing the company's ability to...

Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID
Vancouver, Canada and Deerfield, Illinois, USA, August 11, 2008 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have...

MEDRAD Receives FDA 510(k) Clearance for Wireless MR Infusion System
WARRENDALE, Pa., August 11, 2008 - MEDRAD, INC., announced today that the wireless version of its Continuum MR Infusion System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

HemCon Bandages Receive Expanded Indications for Antibacterial Barrier, Including MRSA
PORTLAND, Ore. - August 11, 2008 - The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million hospital patients acquire infections each year, and 103,000 die as a result. HemCon Medical Technologies...

U.S. Food and Drug Administration Approves Viread(R) for Chronic Hepatitis B in Adults
FOSTER CITY, Calif -- August 11, 2008--Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Viread(R) (tenofovir disoproxil fumarate)...

VitiGam(TM) Inhibits Melanoma Growth in a Dose Dependent Manner
August 11, 2008 -- KIRYAT ONO, Israel & NEW YORK-- GammaCan International, Inc. ("GammaCan" or "the Company") (OTCBB: GCAN), a developer of proprietary immunotherapies for the treatment of melanoma and other cancers,...

Key Studies Published Supporting FDA Approval of Regeneron's ARCALYST® (rilonacept)
Tarrytown, NY (August 11, 2008) - Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced the publication of the results of three studies which supported the U.S. Food and Drug Administration (FDA) regulatory...

Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia
August 08, 2008-Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company focused on neuromuscular diseases, today gave an update on the clinical and regulatory processes surrounding the...

Watson Announces Limited Recall Of Fentanyl
CORONA, CA - August 8, 2008 - Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being...

Multaq® (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
Paris, France - August 8, 2008 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for...

FDA EXTENDS REVIEW TIMELINE FOR USTEKINUMAB BIOLOGIC LICENSE APPLICATION THREE MONTHS
HORSHAM, PA, August 8, 2008 -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous...

FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Horsham, PA (August 8, 2008) - Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) hasextended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous...

DELSITE SUBSIDIARY SÁBILA INDUSTRIAL IN COSTA RICA COMPLETES ISO 9001:2000 INSPECTION
IRVING, TEXAS August 8, 2008 DelSite, Inc. (OTC: DSII), a drug delivery technology company, today announced that its bulk pharmaceutical manufacturing subsidiary, Sábila Industrial, S.A., located in Liberia,...

Sorin Group Announces FDA Approval and First U.S. Implant of the World's Smallest Implantable Dual Chamber Pacemaker
Denver, Colorado, August 7, 2008 - The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announced today the U.S. Food and Drug...

Abbott Study Shows Investigational Heat-Stable Norvir® Tablet Provides Similar Drug Levels to Current Norvir Capsule
Mexico City, August 7, 2008 - Abbott presented pivotal data at the XVII International AIDS Conference (AIDS 2008) in Mexico City today showing that its investigational Norvir® (ritonavir) tablet and the current...

BioSante Pharmaceuticals Announces Reacquisition of Elestrin(TM), FDA Approved for Treatment of Hot Flashes
Lincolnshire, Illinois (August 7, 2008) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it has reacquired Elestrin (estradiol gel) from Nycomed US who in February 2008 acquired Bradley...

FDA Allows Phase 2 Study for Sound Pharmaceuticals' Novel Drug to Prevent Chemotherapy Induced Hearing Loss
SEATTLE, Aug 07, 2008 -- Sound Pharmaceuticals (SPI) has received FDA notification that it may proceed with its Phase II study to prevent chemotherapy induced hearing loss. The Ph-II study will enroll 80 patients with...

GTC BIOTHERAPEUTICS COMPLETES BLA SUBMISSION FOR ATryn®
FRAMINGHAM, MA - August 7, 2008 - GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn® in the United States. The...

SuperGen Granted Orphan Drug Designation for MP-470 in Glioblastoma Multiforme
DUBLIN, Calif., Aug. 7,2008-- SuperGen, Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery, rapid development and commercialization of therapies for solid tumors and hematological malignancies,...

Cleveland BioLabs Receives Notice of Allowance From FDA to Commence Clinical Testing With Protectan CBLB502
BUFFALO, NY, August 07, 2008 -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today the allowance from the U.S. Food and Drug Administration (FDA) to begin Phase I clinical trials in human volunteers with Protectan...

Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter
Warrington, PA - August 6, 2008, -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that it has made significant progress in addressing key remaining requirements identified by the U.S. Food and Drug Administration...

SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
BELLEVUE, Wash., Aug. 6 ,2008-- SCOLR Pharma, Inc. (Amex: DDD - News) announced today that it has submitted to the Food and Drug Administration an Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour...

St. Jude Medical Announces Japanese Approval of the Durata Defibrillation Lead
ST. PAUL, Minn.----Aug. 6, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare (MHLW), for the...

BOVIE MEDICAL CORPORATION ANNOUNCES FDA CLEARANCE FOR SALE AND MARKETING OF ITS MEG LAPAROSCOPIC LINE; SUBMITS 510(k) APPLICATION FOR ICON GP GENERATOR
Melville, New York, August 5, 2008 - Bovie Medical Corporation (the "Company") (Amex: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Food & Drug Administration has cleared its...

FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR "Dual Opioid" Pain Therapy
Sydney, Australia & Bedminster, NJ - QRxPharma Limited (ASX: QRX and OTCQX: QRXPY), a clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapies for pain and central...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105
PRINCETON, N.J., August 5, 2008 -- Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1105, for the...

Green light for Straumann's oral tissue regeneration products in the US
Basel, 5. August 2008: Straumann announced today that the import detention on Biora products in the US, which has been in place since the beginning of 2007, has been lifted following a re-inspection of the Group's Biora...

FDA Approves Expanded Label for CANCIDAS® (caspofungin acetate) as the First and Only Echinocandin Therapy for the Treatment of Pediatric Patients (3 months and older) with Indicated Fungal Infections
WHITEHOUSE STATION, N.J., August 5, 2008 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded label for CANCIDAS®, which makes it the first and only echinocandin...

Artes Medical Initiates Market Launch and Commercial Sale of Elevess, a New FDA-Approved Hyaluronic Acid-Based Dermal Filler
SAN DIEGO--Aug. 5, 2008--Artes Medical (NASDAQ:ARTE) today announced the immediate availability of Elevess(TM), a new, FDA-approved hyaluronic acid (HA) based dermal filler for the treatment of facial wrinkles, such as...

FDA Approves 2008-2009 Flu Vaccines
August 5, 2008 -- The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States...

Pharmion Ltd withdraws its marketing authorisation application for Orplatna (satraplatin)
August 05, 2008 -- The European Medicines Agency (EMEA) has been formally notified by Celgene Europe Ltd of Pharmion Ltd's decision to withdraw the application for a centralised marketing authorisation for the medicine...

Cognis Achieves NSF International GMP Registration for Natural Vitamin E, Phytosterols and CLA... Complies with New FDA Regulations
August 4, 2008, La Grange, Ill. - Cognis Nutrition and Health, a global leader in health-enhancing ingredients for dietary supplements and functional foods, is proud to announce that it is one of the first suppliers to...

CardiacAssist, Inc. Announces Record Breaking Case Volume for Month of July
August 4, 2008 (Pittsburgh, PA) - CardiacAssist, Inc. announced that it reached a new seasonal high of over 50 cases performed in the month of July, despite the recent FDA 510(k) approval and follow on industry...

Cook Medical Receives FDA Approval to Market Improved Zenith® AAA Iliac Flex Legs and Z-Trak(TM) Introduction System
Bloomington, Ind., August 4, 2008 - Further innovating the field of advanced aortic disease repair technologies, Cook Medical today announced approval from the U.S. Food and Drug Administration (FDA) to market its...

Orchid receives EU approvals for Piperacillin Tazobactam injection
Chennai, India - August 04, 2008 - The Chennai-based generic pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received approvals of its Marketing Authorization (MA) for...

Alkermes Announces Approval of VIVITROL(R) for the Treatment of Alcohol Dependence in Russia
CAMBRIDGE, Mass.-Aug. 4, 2008--Alkermes, Inc. (NASDAQ: ALKS) today announced that its partner, Cilag GmbH International, a subsidiary of Johnson & Johnson, received approval from the Russian Regulatory Authorities to...

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting with FDA for Amigal in Fabry Disease
Cranbury, NJ, August 4, 2008 - Amicus Therapeutics (Nasdaq: FOLD), a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of human genetic diseases,...

Registration application for azelastine Extra Strength submitted to the FDA
August 04, 2008 -- The registration application for azelastine nasal spray in the new formulation with Extra Strength has been submitted to the US Food and Drug Administration (FDA), seeking approval to treat symptoms...

FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
August 4, 2008 -- The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial...

Single-pill combinations Diovan HCT® and Exforge® approved in US as first-line treatments for high blood pressure
Basel, August 4, 2008 - The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT® (valsartan and hydrochlorothiazide) and Exforge® (amlodipine and valsartan), as...

Aurobindo Pharma receives tentative approval for Losartan Potassium tablets
August 01, 2008--Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Losartan Potassium tablets in the strengths 25mg, 50mg and 100mg from the US Food &...

EKR Therapeutics Receives Approval for Ready-to-Use Intravenous Bags of Cardene
Bedminster, N.J., August 1, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the...

Simultaneous Detection Of Multiple Mycotoxins Method Receives AOAC
Watertown, MA (August 2008) -- VICAM, a world leader in food safety diagnostics, today announced that the AOAC

U.S. FDA Issues Action Letter for Sugammadex
KENILWORTH, N.J., Aug. 1, 2008 -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the...

Industry news: Pharmalicensing provides comprehensive industry coverage.

Products:	Partnering Consulting	Partnering Search	Company Profiling	Comparision	Partneringtools	Reports
In-licensing:	Latest records	Industry Sector	Therapeutic Target	Search	Profile your company	Pharma partnering
Out-licensing:	Latest records	Industry Sector	Therapeutic Target	Search	Profile your company	Pharma partnering
Companies:	Profiled companies	Industry Sector	Therapeutic Target	Geographic Location	Search	Add your company
Reports:	Biotechnology	Business Development	Management	Market & Sales	Medical Devices	Pharmaceuticals
Jobs:	Pharmaceutical jobs	Browse jobs	Search for jobs	Create your CV	Employer profiles	Post your jobs
Forums:	Talk to an expert	Industry Gossip	Business Development	What's new	Reports	Outsourcing
News:	Deals & Alliances	Development	Financial Results	Financings	Intellectual Property	Regulatory
Events:	Pharma events	Calendar	Organizers	Featured events	Search	Add your event
Articles:	Business Development	Technologies	Events	Legal and regulatory	Therapeutic	Post your article
Deals:	Industry Sector	Therapeutic Target	Deals Date	Search	Reports	Company releases
About us:	Our Audience	Case Studies	Newsletter	Careers	FAQ	Contact us