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FDA Accepts for Review NDA Filing and Grants Priority Review for Velcade (Bortezomib) for Injection
In this article Millennium Pharmaceuticals, Inc. reveals that the U.S. Food and Drug Administration FDA accepted for review and granted Priority Review designation of the Company's New Drug Application NDA for VELCADE for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an...
Tags: Federal Government, Government, Priority Review, Millennium Pharmaceuticals Inc., VELCADE, FDA
White papers 2003-03-10

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CEO exits Lonmin as deadline looms
Business News In Brief MINING The chief executive of Lonmin, the world's third-biggest platinum producer, has stepped down just days ahead of a decision by suitor Xstrata about whether it will launch a formal takeover bid for Lonmin. Ian Farmer, Lonmin's chief strategic officer, is to...
Articles 2008-09-30
Serengeti and Fjordland Identify Six Priority IP Targets for Follow-Up on Their QUEST Project
Serengeti Resources Inc. (TSX VENTURE: SIR) and its 50%-50% joint venture partner, Fjordland Exploration Inc. (TSX VENTURE: FEX) are pleased to report that they have selected six priority target properties (Q, ST, MP, Copper, Ping and Mil) from their recently completed 110-line kilometer reconnaissance induced polarization IP surveys under their...
Articles 2008-09-24
Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
CAMBRIDGE, Mass. -- Dyax Corp. (NASDAQ:DYAX) announced today the completion of its Biologics License Application BLA with the U.S. Food and Drug Administration FDA for approval of Dyax's lead product candidate DX-88 ecallantide for the treatment of hereditary angioedema HAE. Dyax has requested Priority Review, which, if granted, would set...
Articles 2008-09-24
The San Diego Foundation Releases Update on 2007 Wildfire Disaster
Community Assessment Report Update Provides Accomplishments and Challenges of Recovery Efforts SAN DIEGO -- Nine months after its initial assessment, The San Diego Regional Disaster Fund has released an update to the 2007 Community Needs Assessment Report, which reviews and assesses the current situation that fire survivors face....
Articles 2008-09-24
Genzyme Provides Details of October Myozyme Advisory Panel Meeting and Additional Regulatory Updates
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...
Articles 2008-09-23
FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin® Label Expansion
Supplemental Biologics License Application sBLA on track for Q4 Submission SEATTLE, Sept. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. CTI announced today that following a meeting with the U.S. Food and Drug Administration FDA data from the First-line Indolent Trial FIT would be sufficient to support a...
Articles 2008-09-22
Nato membership for Georgia and Ukraine 'a strategic error'
Nato should stop expanding, according to a leading British think- tank. The International Institute for Strategic Studies IISS challenged the Nato secretary general yesterday by warning against embracing Georgia and Ukraine in the light of last month's Caucasus war. "The policy of Nato enlargement now, we believe,...
Articles 2008-09-19
Pain Therapeutics and King Pharmaceuticals Announce Final Data of REMOXY Phase III Study at World Pain Congress in Scotland
GLASGOW, Scotland -- Pain Therapeutics, Inc. (NASDAQ: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today presented the final data set of a previously announced pivotal Phase III study of REMOXY([R]), an investigational drug to treat chronic pain. The final data confirm REMOXY provides effective around-the-clock analgesia within a patented formulation...
Articles 2008-08-19
Introgen asks FDA to O.K. Advexin
AUSTIN, Texas -- Introgen Therapeutics Inc. became the first company to apply for Food and Drug Administration approval of a gene therapy drug, Advexin, which is used to treat recurring heed and neck cancers. The company, based here, is also seeking approval to market the medication in Europe. ...
Articles 2008-08-18
HARD to consider projects for regional bond funding
If voters in November approve a regional parks bond, projects in the greater Hayward area will get a chunk of the $500 million in land purchase and preservation funds authorized by the measure. But, which projects? The East Bay Regional Park District, the bond's...
Articles 2008-08-12
Plant Services' CMMS Review Rates Smartware's Bigfoot Software Number One
Maintenance software developer SmartwareGroup's Bigfoot maintenance software recently received the top user ratingin Plant Services magazine's 2008 review of computerized maintenancemanagement software CMMS packages. Plant Services ranked software in two categories: "essentialfunctionality" and "full functionality." Bigfoot was the top-rankedsoftware in the "essential" category. The category covered sixteenvendors,...
Articles 2008-08-07
Columbia River Crossing in Oregon made national priority
Replacement of the Interstate 5 Bridge was designated as a national priority by the White House on Tuesday. Though the decision doesn't ensure more funding for the $3.5 billion Columbia River Crossing project, the White House's acknowledgment could elevate the project's standing. U.S. Transportation Secretary Mary Peters...
Articles 2008-08-07
Manchester Financial Bank planning to open doors in October
Doug Manchester's bank, aptly named after the local hotel developer, is now targeting an October opening date, three months later than originally envisioned. "The FDIC (Federal Deposit Insurance Corp.) has some issues these days and reviewing bank applications is not a priority for them," said Rick Mandelbaum, chief...
Articles 2008-08-04
Going to N.Y.? Take in a musical
NEW YORK -- Taking in a Broadway show is a top priority for many tourists who are lucky enough to go to New York City. Of course, for true theater nuts, going to see several Broadway shows is the goal. Here's a look at the crop of...
Articles 2008-08-03
VioQuest Pharmaceuticals, Inc Valuation Upgrade Review Issued By Scimitar Equity, LLC
BOSTON, July 29 /PRNewswire/ -- Scimitar Equity, LLC issues a review of VioQuest Pharmaceuticals, Inc (BULLETIN BOARD: VOQP) , entitled, "510k Application Submitted for XyfidTM and Priority Review Voucher for LenoctaTM Focuses Milestones and Share Price Appreciation." This review is available at website: http://www.scimitarequity.com/. ...
Articles 2008-07-29
Mine safety top priority, Stickler says
Richard Stickler, the acting assistant secretary of the U.S. Mine Safety and Health Administration, on Friday responded to criticism regarding his handling of the Crandall Canyon disaster and his agency's failure to ensure safe mining practices at the Emery County mine. During a meeting with the Deseret...
Articles 2008-07-26
Tackling bug is top priority
CHIEF executive of Gateshead Health NHS Foundation Trust, Ian Renwick, said top priority was given to combating MRSA and everything was being done to tackle the issue. He said: "The trust understands absolutely the importance of achieving national performance standards and targets, gives top priority to this responsibility...
Articles 2008-07-16
U3O8 Corp. Reports Significant Uranium Mineralization in Accori South
U3O8 Corp. (TSX VENTURE: UWE), a Canadian uranium exploration company, reports significant intercepts of uranium mineralization from the Accori South area in the Kurupung Batholith, near the Roraima Basin in Guyana. The Accori South results confirm uranium mineralization in a second structure located approximately four kilometres southeast of...
Articles 2008-07-10
Amarc Work Programs Are Indentifying Significant Drill Targets
Amarc Resources Ltd. (TSX VENTURE: AHR)(OTCBB: AXREF) is pleased to report that Aeroquest Limited has recently completed 1,128 line kilometres of helicopter-borne AeroTem II magnetic geophysical surveys over the Company's 100% owned Aspira and Rapid properties located in central British Columbia. These properties are proximal to the Yellowhead...
Articles 2008-07-09
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