Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Completed NDA submission could lead to marketing approval in Q4-2009 SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administratio...Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive
ARDEE, Ireland, May 27 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (Nasdaq: WCRX ) announced today that the U.S. Food and Drug Administration (FDA) has filed for standard review the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The NDA for WC 3016 was submitted by...Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone
CTI to Request Priority Review SEATTLE, April 14 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it began a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or...Schering-Plough Announces European Submission of Fertility Medicine Corifollitropin Alfa
Corifollitropin alfa, a sustained follicle stimulant, extends options for patients and Schering-Plough's leadership in fertility KENILWORTH, N.J., Dec. 31 /PRNewswire-FirstCall/ -- Schering-Plough Corp., (NYSE: SGP ), a leading provider of fertility treatments, announced today that the Euro...Electronic Submission for Dental Predeterminations May Increase Efficiency, Patient Satisfaction
HARRISBURG, Pa., Dec. 3 /PRNewswire/ -- Many dentists and dental office staff have realized the benefits of electronic claim submission; however, very few dental professionals have taken advantage of electronic predeterminations. These electronic transactions may increase office efficiency, while ...Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
BRIDGEWATER, N.J., Nov. 20 /PRNewswire/ -- Ortho Biotech Products, L.P. today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treat...Labopharm files New Drug Submission with Health Canada for novel antidepressant
LAVAL, QC, Aug. 5 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS ) today announced it has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone. "We are pleased to file our New Dru...FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
CHADDS FORD, Pa., March 12 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP ) and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission to...FDA Submission of B-R-A-H-M-S MR-proANP Kryptor
HENNIGSDORF, Germany, March 6 /PRNewswire/ -- B-R-A-H-M-S Aktiengesellschaft today announced it has submitted 510(k) file to the U.S. Food and Drug Administration (FDA) to market its patented B-R-A-H-M-S MR-proANP Kryptor Test. Atrial Natriuretic Peptide (ANP) is predominantly produced ...Pharmaxis Announces New Drug Application Submission for Aridol(TM)
SYDNEY, March 1 /PRNewswire-Asia-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS, Nasdaq: PXSL ) today announced it had submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Aridol, a bronchial challenge test. Bronchial challenge tests are designed ...MannKind Updates Status of NDA Submission for AFRESA
VALENCIA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD ) today provided an update on the status of its new drug application ("NDA") for AFRESA(R), an ultra rapid-acting insulin that has completed Phase 3 clinical trials. As previously announced, our internal ...Kensey Nash Announces IDE Submission for Cartilage Repair Device
EXTON, Pa., Feb. 24 /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY ) announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company's unique biomaterials technology for tr...Alfacell Provides ONCONASE(R) NDA Submission Update
SOMERSET, N.J., Dec. 5 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL ) today reported that the U.S. Food and Drug Administration (FDA) has scheduled a pre-NDA meeting date at the end of January 2009 for discussion of the company's planned submission of the final components of the ...FDA Reviewing Biomoda Submission for Cancer Screening Study
ALBUQUERQUE, N.M., Aug. 4 /PRNewswire-FirstCall/ -- Biomoda, Inc. (OTC Bulletin Board: BMOD) ( http://www.biomoda.com ), a development stage medical diagnostics company, submitted to the FDA a pre-IDE (Investigational Device Exemption) protocol for a clinical study using Biomoda's proprietary ...AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))
AMSTERDAM, June 13 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it has concluded enrollment and treated the last patient in the pivotal trial for it's lead product AMT-011 (Glybera(R)) for Hyperlip...Raintree Billing Manager and Collections Administrator
Features:... Paper, electronic and fax billing and form submission options Electronic billing and remittance Security controls Automatic diagnosis code check and claim submission verification Rules-based alerts and Triggers NSF and ANSI-coded claim sub...Cerner PowerChart Electronic Medical Record
Features:... inpatient visits Positively impact cash flow by using an online electronic signature to reduce the number of incomplete charts Speed the bill submission process Reduce the risk and costs of waiting hours or days for paper-based results Provide access to records from any location, at any time, a...'Canadian excellence' strengthened by extensive adoption of open access
... The Canadian Institutes of Health Research (CIHR) now requires authors to publish research results into open access journals and also encourages dual submission into an institutional repository. Complying with this mandate and also heeding wider position statements from bodies such as the Canadian Library Asso...Open-access membership: Reporting tool brings convenience and control
... claiming their "Article Processing Charge" payment via a Prepay or Postpay Membership, whilst also providing an unprecedented level of reporting into submission dates, costs-per-article and forecasts into future balances once 'in progress' submissions are published. The system gives BioMed Central's members...Supply-Chain Council Announces Winners of 2009 Supply Chain Excellence Awards
...X (Retrograde) Project thought leadership and commitment to process excellence pushed the envelope in adapting SCOR throughout this organization. This submission was in recognition of the work and commitment that the US Army's CECOM Life Cycle Management Command (LCMC) has formally made to Supply Chain Excellen...2009 Signature Genomic Laboratories Travel Award winner announced
...stry. A new award in 2008, the Signature Genomics Travel Award is given to a selected student, trainee or junior faculty ACMG member whose abstract submission was chosen as a platform presentation during the ACMG Annual Clinical Genetics Meeting. The ACMG program committee selects the Travel Award recipient ...Jonathan Berg, M.D., Ph.D. awarded Richard King Trainee Award for Best in Genetics in Medicine
...l Biochemical Genetics Clinical Cytogenetics Clinical Molecular Genetics PhD Medical Genetics Eligible trainees should identify themselves upon submission of manuscripts to Genetics in Medicine. The editorial board of Genetics in Medicine will determine the winning trainee and presentation of the award w...Meet-the-expert sessions on 20 key topics to enhance scientific programme of IOFWCO-ECCEO10
... joint global congress, IOF WCO- ECCEO10, in Florence, Italy from May 5-8, 2010. Complete programme information, online registration and abstract submission will be available on www.iofwco-ecceo10.org . IOF WCO-ECCEO10 will be an excellent forum for interaction and the exchange of ideas among researc...Call for abstracts and registration for the EMBO Meeting 2009
...ences forum for scientific exchange in Europe. The deadline for abstract submission and discounted early registration for The EMBO Meeting 2009 is 25 April. Online submission and registration can be found at the conference website: http://the-embo-m...World Congress on Osteoporosis 2010 presents outstanding scientific program
...WCO- ECCEO10, a global congress to be held in Florence, Italy from May 5-8, 2010. Complete programme information, online registration and abstract submission will be available on www.iofwco-ecceo10.org . IOF WCO-ECCEO10 will offer an overview of the most recent developments and cutting-edge research i...Acorda Therapeutics submits new drug application for Fampridine-SR in multiple sclerosis
...ruary 2, 2009 Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on... the most challenging aspect of their disease 1 . The Fampridine-SR NDA submission is based on data from a comprehensive development program assessing the saf...High school students' paper published in prestigious college math journal
... been published in the January 2009 issue of The Mathematical Association of America's College Mathematics Journal . The paper, which was the winning submission in the 2008 Moody's Mega Math Challenge, is the first M3 Challenge entry to be published in a peer-reviewed journal. It was submitted to the Internet-...Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination Delivery System
IRVINE, Calif., July 30 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (Pink Sheets: CGCP), a market leader in laser transmyocardial revascularization (TMR), today announced that it has submitted a pre-IDE (Investigational Device Exemption) to the Food and Drug Administrat...Event Alert: 'SPL R4 Compliance and its Impact on Regulatory Submission Processes'
Register for an Educational Webinar "How Organizations Can Make the Transition to SPL R4 Compliance," Hosted by Pilgrim Software and featuring Virtify, Inc. CAMBRIDGE, Mass., April 30 /PRNewswire/ -- Virtify, Inc. ( www.virtify.com ), the market leader in Enterprise Content Compliance solu...Warner Chilcott Announces NDA Submission for Low Dose Oral Contraceptive
HAMILTON, Bermuda, March 27 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (Nasdaq: WCRX ) announced today that its affiliate, Warner Chilcott Company Inc. has submitted a New Drug Application for WC 3016, a low-dose oral contraceptive, to the U.S. Food and Drug Administration. About W...FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
THOUSAND OAKS, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. Th...Alfacell Provides ONCONASE(R) NDA Submission Update
SOMERSET, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Alfacell Corporation (OTC Bulletin Board: ACEL) today reported that it has conducted a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the company's planned submission of the final components of the ONCONASE rolling New ...Synvista Therapeutics Announces 510(k) Submission for Its HAPTOCHEK(TM) Test Kit
MONTVALE, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (AMEX: SYI ) today announced that it has submitted, and that the FDA has received its application for 510(k) clearance for its HAPTOCHEK(TM) diagnostic test kit. The 510(k) submission begins a 90-day review process,...SALVAT Announces Submission of Complete Response to FDA Approvable Letter for CETRAXAL(R)
BARCELONA, Spain, November 5 /PRNewswire/ -- SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL(R) (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In an Approvable Letter received on April 6, 2006, the FDA requested additional data wit...ULURU Inc. Announces the Filing of a 510k Submission With the FDA for Altrazeal(TM) Silver
ADDISON, Texas, Sept. 30 /PRNewswire-FirstCall/ -- ULURU Inc. (Amex: ULU) today announced that it has filed a 510k application with the United States Food and Drug Administration (FDA) for Altrazeal(TM) Silver. Preclinical studies conducted to support the filing have shown that superior heal...