In this article Millennium Pharmaceuticals, Inc. informs that the Company intends to file a New Drug Application NDA with the U.S. Food and Drug Administration FDA to market VELCADE as a treatment for relapsed and refractory multiple myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status by...
US launch of Dysport([R]) on track PARIS -- Regulatory News: Ipsen (Paris: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([R]) botulinum toxin of type A Biologics License Application BLA for...
NEW YORK -- 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 ([R]) vitespen to Russia. The Russian Ministry of Public Health approved the therapeutic cancer vaccine in April 2008 for...
WILMINGTON, N.C. -- PPD, Inc. (NASDAQ:PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, to the Ministry of Health, Labour and Welfare in Japan. PPD partnered with Takeda to develop the...
BOTHELL, Wash., Sept. 26 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Company's Abbreviated New Drug Application ANDA for a 120 milligram 12-hour pseudoephedrine tablet based on the Company's patented Controlled Delivery Technology (CDTR) platform....
TOKYO and INDIANAPOLIS, Sept. 26 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, and Eli Lilly and Company confirmed today that the U.S. Food and Drug Administration FDA did not complete its review for the prasugrel new drug application NDA by the Prescription Drug User Fee Act goal date...
Takeda Pharmaceutical Company Limited Takedaannounced today that its wholly owned subsidiary, Takeda Global Research &Development Center, Inc. (U.S.), submitted a New Drug Application NDA tothe U.S. Food and Drug Administration FDA for marketing approval ofalogliptin (SYR-322) and ACTOS® pioglitazone HCl ("alogliptin/ACTOS") ina single tablet for the treatment of type 2...
Dragon International Group Corp. (OTCBB: DRGG), a manufacturer and distributor of specialty paper products andpackaging materials in China, recently announced it has completed theevaluation and testing of a new and improved suppository composite filmproduct that meets all the requirements for pharmaceutical packagingapplications. Dragon International has recently requested a permit...
* Presentation included results of three Phase III studies of eslicarbazepine acetate in more than 1,000 patients with refractory partial epilepsy * Studies demonstrated marked and sustained seizure reduction and significant improvement in quality of life and depressive symptoms over a one-year treatment period * U.S....
OSAKA, Japan, Sept. 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited Takeda announced today that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), submitted a New Drug Application NDA to the U.S. Food and Drug Administration FDA for marketing approval of alogliptin (SYR-322) and ACTOSR (pioglitazone...
WILMINGTON, N.C. -- PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application to the U.S. Food and Drug Administration for marketing approval of alogliptin (SYR-322) and ACTOS([R]) pioglitazone HCl in a single tablet for the treatment of type 2 diabetes. ...
ST. LOUIS -- Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration FDA has granted approval for the Company's Abbreviated New Drug Application ANDA for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's generic...
www.nicox.com NicOx S.A. (Euronext Paris: COX) today announced it has signed an exclusiveagreement with Capsugel, the leading producer of two-piece capsules, forthe commercial manufacturing and global supply of naproxcinod capsules.Naproxcinod is NicOx' lead investigational product and the first compoundin the Cyclooxygenase-Inhibiting Nitric Oxide-Donating CINOD class ofanti-inflammatory agents. The aim...
SOPHIA ANTIPOLIS, France, September 23 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced it has signed an exclusive agreement with Capsugel, the leading producer of two-piece capsules, for the commercial manufacturing and global supply of naproxcinod capsules. Naproxcinod is NicOx' lead investigational product and the first compound in...
BROOMFIELD, Colo., Sept. 23 /PRNewswire/ -- ARCA biopharma, Inc. announced today that the U.S. Food and Drug Administration FDA has accepted a New Drug Application NDA for the company's lead product candidate, bucindolol, an investigational and pharmacologically unique beta-blocker and mild vasodilator developed for the treatment of chronic heart...
PMX-60056 Heptagonist Is The Only Reversing Agent for Heparin and Low Molecular Weight Heparins in Clinical Development PMX-60056 is the Company's Second Clinical Trial Initiation in the Past Month RADNOR, Pa. -- PolyMedix, Inc. (OTC BB: PYMX, http://polymedix.com), an emerging biotechnology company developing new therapeutic drug...
More than half of all supporting clinical trials for U.S. Food and Drug Administration-approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States, say University of California, San Francisco researchers. They combed the medical literature to determine the publication status...
Mozobil Receives Priority Review with FDA Action Expected by Year End; Synvisc-ONE FDA Action also Expected by Year End CAMBRIDGE, Mass. -- Genzyme Corporation (Nasdaq: GENZ) today provided updates on three therapies with regulatory actions anticipated by year end. The company reported that it expects FDA to act...
Common Genetic Variations Predict Patient Response to Novel Beta Blocker Therapy TORONTO, Sept. 22 /PRNewswire/ -- Bucindolol, an investigational, pharmacologically unique beta-blocker and mild vasodilator, significantly reduces hospitalization and death among heart failure patients with very favorable genotypes, according to results of a large DNA study presented...
DEERFIELD, Ill., Sept. 22 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation today announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration FDA review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous IGIV], marketed as KIOVIG in European Union, for the treatment...
Articles 2008-09-22
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